PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2000 493.801 ENROLLMENT AND TESTING OF SAMPLES PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2000 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the Form CMS-209, the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, and interviews with the Point-of-Care Supervisor (PS), Technical Supervisor (TS) #8, Testing Personnel (TP) #5 and #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), and four confidential interviews, the laboratory failed to test proficiency testing samples in the same manner as patients' specimens. Findings Include: 1. The laboratory failed to test the K-B 2014 chemistry proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. (Refer to D2006, Item 1) 2. The laboratory failed to test the CM-B 2014 LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE (X6) DATE TITLE Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that other safeguards provide sufficient protection to the patients . (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14 days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to continued program participation. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 1 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2000 Continued From page 1 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2000 clinical microscopy proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. (Refer to D2006, Item 2) 3. The laboratory failed to test the XL-F 2014 microbiology proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. (Refer to D2006, Item 3) 4. The laboratory failed to test the CM-A 2014 clinical microscopy proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. (Refer to D2006, Item 4) 5. The laboratory failed to test the CM-A 2013 clinical microscopy proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. (Refer to D2006, Item 5) 6. The laboratory failed to test the FH9-B 2013 hematology proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. (Refer to D2006, Item 6) 7. The laboratory failed to test the HFC-B 2014 hematology proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. (Refer to D2006, Item 7) 8. The laboratory failed to test activated clotting time (ACT) proficiency testing samples it receives FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 2 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2000 Continued From page 2 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2000 from the proficiency testing program in the same manner as it tests patient specimens. (Refer to D2006, Item 8) 9. The laboratory failed to test the FH9-A 2013 and FH9-B 2013 complete blood count (CBC) and blood cell identification proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. (Refer to D2006, Item 9) 10. The laboratory failed to ensure that Gram stain, wet preparation, and activated clotting time (ACT) proficiency testing (PT) samples were tested or examined with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. (Refer to D2007, Item 1) 11. The laboratory failed to ensure that complete blood count (CBC), manual differential, urinalysis (UA), urine sediment (umic), osmolality (OSMO), manual body fluid counts, C-Reactive protein (CRP), prothrombin time (PT), activated partial thromboplastin time (PTT), fibrinogen, and D-Dimer proficiency testing (PT) samples were tested or examined with the laboratory's regular patient workload by the personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. (Refer to D2007, Item 2) 12. The laboratory failed to test body fluid manual differential, urine microscopic, and urine osmolality proficiency testing (PT) samples the same number of times that it routinely tests patient samples. (Refer to D2010) FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 3 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2000 Continued From page 3 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2000 13. The laboratory failed to maintain a copy of all proficiency testing (PT) documentation for a minimum of two years from the date of the PT event. (Refer to D2015) D2006 493.801(b) TESTING OF PROFICIENCY TESTING SAMPLES D2006 The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Item 1: Based on review of the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, interview with Testing Personnel (TP) #7 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), and four confidential interviews, the laboratory failed to test the K-B 2014 chemistry proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. Findings Include: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 4 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 4 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 1. Review the laboratory's policies and procedures found a policy titled "Proficiency Testing Protocol" which stated: "III. CAP Accepted Proficiency Programs C. Analysis 4. Duplicate analyses are not permitted unless patient samples are tested in the same manner. Quality Control should be run per routine procedures for patient testing. Group review and consensus identifications are permitted only if actual patient specimens would ordinarily be reviewed by more than one person. 5. Proficiency survey samples will be analyzed in the same manner as patient specimens as much as possible with some exceptions: a. Due to differences between survey and patient samples, survey samples will be tested in the same manner as patient samples except where survey materials/reporting require modifications in processing i.e. hydration of lyophilized survey materials." "III. CAP Accepted Proficiency Programs C. Analysis 7. There will be no communications with other laboratories about proficiency testing at any time until final results are returned. Under CLIA regulations, there is a strict prohibition against intralaboratory communications about proficiency testing samples until after the deadline for submission of data to the proficiency testing provider. This includes between Family Health Center laboratories because they have different CLIA numbers. For alternate FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 5 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 5 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 assessment/proficiency there can be no communication with an outside performing Reference Laboratory until that laboratory's final test results are received at the Cleveland Clinic. 8. Proficiency survey testing will be completed and results submitted by the survey's due date. Results will be recorded on the laboratory worksheet, on a copy the CAP results form and/or entered into LIS. All instrument or assay printouts will be returned to the supervisory personnel or quality control (QC) laboratory. 9. Worksheets and printouts will be reviewed for questionable results, transcription errors or other problems prior to final submission of results." "III. CAP Accepted Proficiency Programs D. Reporting of Results 7. CAP proficiency survey test results will be submitted online to CAP by the testing personnel within the technical areas before midnight of the due date. This function can be centralized within one CLIA number for point of care sites. Testing sites with different CLIA numbers will not centralize result submission and results will be submitted independently within that CLIA address/CLIA number." "III. CAP Accepted Proficiency Programs D. Reporting of Results 9. When entering online results, double check the entry for clerical errors either online or via a printout per laboratory area guidelines. This clerical check must be performed by testing personnel who would normally be responsible for this type of function for the patient testing procedure. There must be clear documentation who entered the online results and who FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 6 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 6 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 conducted the clerical check i.e. name and date. This check must include a check that all analytes have been tested and reported for that survey utilizing the mandatory site specific survey list." "III. CAP Accepted Proficiency Programs J. Record Retention 1. Per CLIA regulations, all records of proficiency testing will be kept on file for a minimum of two (2) years. Records must include worksheets, instrument tapes, computer printouts, reporting forms, evaluation reports, evidence of review, participant summaries and documentation of any follow-up or corrective action. This documentation should be electronic as much as possible. There is no need to retain copies of quality control data unless specifically requested as part of the survey. Quality control data is available in the LIS." 2. Review of the PT documentation for the chemistry PT event titled "K-B 2014 Ligand Assay - General" found the laboratory initially analyzed PT samples K-06 and K-07 on 07/23/2014. Instrument printouts and handwritten notes on the printouts then demonstrate the laboratory reanalyzed PT samples K-06 and K-07 on 07/27/2014 multiple times on both Cobas 6000 analyzers as follows: Cobas 6000 Instrument Printouts: K-B 2014: Sample K-06: a) Date: 07/23/14 13:27:52 Handwritten notes stated: "K-06" "K-06 'TP #7' first name" Folate, Seru 1.72 ng/mL FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 7 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 7 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 b) Date: 07/23/14 13:27:52 Handwritten note stated: "K-06" Quant Beta H 10.18 H mIU/mL c) Date: 07/23/14 13:27:52 Handwritten note stated: "K-06" Ferritin 12.70 L ng/mL Free T4 0.580 L ng/dL TSH 0.074 L uIU/mL d) Date: 07/23/14 13:27:52 Handwritten note stated: "K-06" Vitamin B12 56.50 L pg/mL T4 3.22 L ug/dL FT3 III 3.63 L pg/mL e) Date: 07/27/14 12:54:53 Handwritten notes stated: "COBAS 1" "RERUN" The ID number 6 and date and time were circled. The word rerun was underlined twice. Each numeric result listed below had a checkmark to left. Folate, Seru 1.50 ng/mL Ferritin 12.67 L ng/mL Free T4 0.591 L ng/dL Quant Beta H 10.40 H mIU/mL TSH 0.077 L uIU/mL Vitamin B12 66.07 L pg/mL T4 3.32 L ug/dL FT3 III 3.82 L pg/mL f) Date: 07/27/14 11:00:41 Handwritten notes stated: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 8 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 8 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 "Cobas 2" "RERUN" The ID number 6 and date and time were circled. The word rerun was underlined twice. Each numeric result listed below had a checkmark to left. Ferritin 13.25 L ng/mL Folate, Seru 1.98 ng/mL Free T4 0.618 L ng/dL Quant Beta H 10.41 H mIU/mL TSH 0.073 L uIU/mL Vitamin B12 56.65 L pg/mL T4 3.27 L ug/dL FT3 III 3.77 L pg/mL Folate, Seru - Serum Folate Quant Beta - Quanitative Beta hCG TSH - Thyroid Stimulating Hormone Free T4 - Free Thyroxine T4 - Thyroxine FT3 III - Free Triiodothyronine L - Low H - High --------------------------------------------------------CAP Result Submission Form (Handwritten): K-B 2014: Sample K-06: Ferritin K-06 13 Folate, Serum K-06 1.7 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 9 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 9 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 hCG - Serum, Quant. K-06 10.2 Free T-3 K-06 3.6 Thyroxine (T4) K-06 3.2 Free Thyroxine (Free T4) K-06 0.6 Thyroid Stimulating Hormone (TSH) K-06 0.07 Vitamin B12 K-06 57 -----------------------------------------------------CAP Result Submission Form (Typed): K-B 2014: Sample K-06 Ferritin K-06 13 Folate, Serum K-06 1.7 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 10 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 10 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 Free T-3 K-06 3.6 Thyroxine (T4) K-06 3.2 -----------------------------------------------------Cobas 6000 Instrument Printouts: K-B 2014: Sample K-07: a) Date: 07/23/14 13:20:10 The date and time were circled. Ferritin 14.02 L ng/mL Free T4 1.17 L ng/dL TSH 0.934 L uIU/mL b) Date: 07/23/14 13:20:10 Quant Beta H 8.44 H mIU/mL c) Date: 07/23/14 13:27:52 Handwritten note stated: "K-07" Folate, Seru 2.48 ng/mL d) Date: 07/23/14 14:38:58 Handwritten note stated: "K.07" "DUPL" "W7133790" was circled. Free T4 0.586 ng/dL Vitamin B12 62.41 pg/mL T4 3.15 ug/dL FT3 III 3.56 pg/mL FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 11 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 11 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 e) Date: 07/23/14 14:38:58 Handwritten note stated: "K-07" The Free T4 result was circled with an arrow pointing to a handwritten statement "not whats resulted in LIS" An arrow was drawn from FT3 III pointing to a handwritten statement "paper" Free T4 0.586 L ng/dL Vitamin B12 62.41 L pg/mL T4 3.15 L ug/dL FT3 III 3.56 pg/mL f) Date: 07/27/14 12:54:5. Handwritten notes stated: "COBAS 1" "RERUN" The ID number was 7. The word rerun was underlined twice. Each numeric result listed below had a checkmark to left with the exception of the Vitamin B12 result which was circled. Folate, Seru 2.03 ng/mL Ferritin 14.00 L ng/mL Free T4 1.15 ng/dL Quant Beta H 8.70 H mIU/mL TSH 0.955 uIU/mL Vitamin B12 261.7 pg/mL T4 4.95 L ug/dL FT3 III 4.77 pg/mL g) Date: 07/27/14 11:00:41 Handwritten notes stated: "Cobas 2" "RERUN" The ID number was 7. The word rerun was underlined twice. Each numeric result listed below had a checkmark to left with the exception of the Free T4 and Vitamin B12 results which FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 12 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 12 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 were circled. Ferritin 14.46 L ng/mL Folate, Seru 2.75 ng/mL Free T4 1.16 ng/dL Quant Beta H 8.59 H mIU/mL TSH 0.933 uIU/mL Vitamin B12 172.9 L pg/mL T4 4.96 L ug/dL FT3 III 4.60 pg/mL h) Date: 07/27/14 18:23 "7 REDO 7 REDO" 07/27/14 17:42:24 B12 (E2-1) 172.3L Folate, Seru - Serum Folate Quant Beta - Quanitative Beta hCG TSH - Thyroid Stimulating Hormone Free T4 - Free Thyroxine T4 - Thyroxine FT3 III - Free Triiodothyronine B12 - Vitamin B12 L- Low H - High ------------------------------------------------------Marymount Pending Test Log Received/Unreceived Specimens 07/23/2014: 07/24/2014 11:09 ACC#/REQ# W7133790 B12 was circled with a handwritten note that FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 13 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 13 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 stated "change". A handwritten note stating "ok" was written next to FERR. FREET3 was circled with a handwritten note that stated "change". A handwritten note stating "ok" was written next to HCGQT and SERFOL. "07" was written to the right under the heading TEST,PATIENT. T4 was circled with a handwritten note that stated "change". "Change" was written to the left of TSH, scribbled out, and "OK" was written to the right. ACC# - Accession Number REQ# - Requisition Number B12 - Vitamin B12 FREET3 - Free Triiodothyronine FERR - Ferritin SERFOL - Serum Folate HCGQT - hCG Quantitative T4 - Thyroxine TSH - Thyroid Stimulating Hormone ----------------------------------------------------CAP Result Submission Form (Handwritten): K-B 2014: Sample K-07: Ferritin K-07 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 14 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED D2006 Continued From page 14 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 14 Folate, Serum K-07 2.5 hCG - Serum, Quant. K-07 8.4 Free T-3 K-07 4.8 White out was present in the result box with 4.8 written over the white out. Thyroxine (T4) K-07 5.0 White out was present in the result box with 4.8 written over the white out. Free Thyroxine (Free T4) K-07 0.6 was written with 1.2 boldly written over the 0.6. Thyroid Stimulating Hormone (TSH) K-07 0.93 Vitamin B12 K-07 173 White out was present in the result box with the 73 written over the white out. -----------------------------------------------------FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 15 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED D2006 Continued From page 15 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 CAP Result Submission Form (Typed): K-B 2014: Sample K-07: Ferritin K-07 14 Folate, Serum K-07 2.5 Free T-3 K-07 4.8 Thyroxine (T4) K-07 5.0 ---------------------------------------------------------------CAP Evaluation Report Test: Your Result: Ferritin: K-06 K-07 13 14 Folate, serum K-06 K-07 1.7 2.5 hCG, serum, quant K-06 10.2 K-07 8.4 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 16 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 16 Free T-3 K-07 K-07 3.6 4.8 Thyroxine K-06 K-07 3.2 5.0 Thyroxine, free K-06 K-07 0.6 0.93 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 Thyroid Stim Hormone K-06 0.07 K-07 0.93 Vitamin B12 K-06 K-07 57 173 3. TP #7 stated, between February 2014 and November 2014, the TP would print the interim PT results from the Cobas 6000 analyzers and provide the printouts to the previous supervisor. They stated they would not enter the results in the CAP website or complete the result submission forms. TP #7 further stated TP would not repeat testing on a PT sample unless the analyzer gave an error or the result was outside of the linear range. In those situations, the maximum number of times a sample would be run would be two times. TP #7 stated if the TP had a hard time getting an unflagged or acceptable result they would consult with another TP or the previous supervisor. The interview occurred 03/11/2015 at 11:50 AM. 4. During confidential interviews, which occurred 03/12/2015 from 3:25 PM through 6:36 PM, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 17 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 17 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 individuals stated the following: For liquid PT samples they have never run samples twice for chemistry or hematology. The TP would only repeat PT sample testing in situations where they would repeat patient testing. TP do not fill out the CAP result submission forms, they print out the instrument printouts, LIS report, and provided to the previous supervisor. TP only rerun a sample if they get a sample error during analysis. In cases where they receive an error on a PT sample they would reanalyze the sample on the same machine. TP print results from the LIS or analyzer and give the hard copies to the previous supervisor. The previous supervisor never had them reanalyze a PT sample or change a PT result. TP gave the instrument and LIS printouts to the previous supervisor to enter into the CAP website and the previous supervisor has never returned PT to the analyzing TP to be rerun. TP would only run sample more than once if they received a strange results or had a bad sample. They would never run a vitamin B12 sample multiple times on two analyzers because there would be no reason to. The previous supervisor never returned samples or results to the TP for reanalysis prior to the due date. Item 2: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 18 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 18 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 Based on review of the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, and interviews with Technical Supervisor (TS) #8, the Laboratory Director (LD) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015), and four confidential interviews, the laboratory failed to test the CM-B 2014 clinical microscopy proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. Findings Include: 1. Review the laboratory's policies and procedures found a policy titled "Proficiency Testing Protocol" which stated: "III. CAP Accepted Proficiency Programs C. Analysis 4. Duplicate analyses are not permitted unless patient samples are tested in the same manner. Quality Control should be run per routine procedures for patient testing. Group review and consensus identifications are permitted only if actual patient specimens would ordinarily be reviewed by more than one person. 5. Proficiency survey samples will be analyzed in the same manner as patient specimens as much as possible with some exceptions: a. Due to differences between survey and patient samples, survey samples will be tested in the same manner as patient samples except where survey materials/reporting require modifications in FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 19 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 19 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 processing i.e. hydration of lyophilized survey materials." "III. CAP Accepted Proficiency Programs C. Analysis 7. There will be no communications with other laboratories about proficiency testing at any time until final results are returned. Under CLIA regulations, there is a strict prohibition against intralaboratory communications about proficiency testing samples until after the deadline for submission of data to the proficiency testing provider. This includes between Family Health Center laboratories because they have different CLIA numbers. For alternate assess/proficiency there can be no communication with an outside performing Reference Laboratory until that laboratory's final test results are received at the Cleveland Clinic. 8. Proficiency survey testing will be completed and results submitted by the survey's due date. Results will be recorded on the laboratory worksheet, on a copy the CAP results form and/or entered into LIS. All instrument or assay printouts will be returned to the supervisory personnel or quality control (QC) laboratory. 9. Worksheets and printouts will be reviewed for questionable results, transcription errors or other problems prior to final submission of results." "III. CAP Accepted Proficiency Programs D. Reporting of Results 7. CAP proficiency survey test results will be submitted online to CAP by the testing personnel within the technical areas before midnight of the due date. This function can be centralized within one CLIA number for point of care sites. Testing FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 20 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 20 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 sites with different CLIA numbers will not centralize result submission and results will be submitted independently within that CLIA address/CLIA number." "III. CAP Accepted Proficiency Programs D. Reporting of Results 9. When entering online results, double check the entry for clerical errors either online or via a printout per laboratory area guidelines. This clerical check must be performed by testing personnel who would normally be responsible for this type of function for the patient testing procedure. There must be clear documentation who entered the online results and who conducted the clerical check i.e. name and date. This check must include a check that all analytes have been tested and reported for that survey utilizing the mandatory site specific survey list." "III. CAP Accepted Proficiency Programs J. Record Retention 1. Per CLIA regulations, all records of proficiency testing will be kept on file for a minimum of two (2) years. Records must include worksheets, instrument tapes, computer printouts, reporting forms, evaluation reports, evidence of review, participant summaries and documentation of any follow-up or corrective action. This documentation should be electronic as much as possible. There is no need to retain copies of quality control data unless specifically requested as part of the survey. Quality control data is available in the LIS." 2. Review of the PT documentation for the clinical microscopy testing event titled CM-B 2014 found the following: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 21 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 21 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 Result submission form: Page 10 A handwritten result for sample CMP-17 (Urine Sediment Color Photographs and CD-ROM) was documented as result code 141. This result code was crossed out and to the left the result code of 133 was written. A handwritten result for sample CMP-25 (Body Fluid Photographs and CD-ROM) was documented as result code 221. The 1 was then overwritten with a 5. A hand written result for sample CMP-26 (Body Fluid Photographs and CD-ROM) was documented as result code 215. Body Fluid Photographs: Beneath the picture labeled "CMP-25" was a handwritten result code of 225. Beneath the picture labeled "CMP-26" was a handwritten result code of 221. PT Attestation Form: LD signed as "Director (or Designee)" Testing Personnel (TP) #5, #7, #10, and an individual not listed on the Form CMS-209 signed as "Testing Personnel". No individuals identified as pathologists on the Form CMS-209 signed the attestation form as a "Testing Personnel". Result Evaluation: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 22 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 22 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 For samples CMP-25 and CMP-26 the laboratory received an exemption code [26] (Educational Challenge). The laboratory documented a self-assessment that stated "Educational Challenge. These items are non-graded survey items. The participant summary was reviewed, and CMP-25 is acceptable. CMP-26 was non-graded, and our response matched only 2.6% of the peer group. The image was circulated to the staff to increase awareness of this cell type." 3. TS #8 and the LD stated pathologists review patients' samples if the TP are unsure or unable to identify a finding microscopically. Surveyor #1 asked how the pathologist's reviews of patients' slides are documented. TS #8 and the LD explained there is a pathologist review form that is completed for patient samples. Surveyor #1 asked TS #8 and the LD to provide the pathologist review documentation for the PT samples in question. TS #8 and the LD stated that documentation did not exist for this survey. The interview occurred 03/10/2015 at 11:30 AM. 4. During confidential interviews, which occurred 03/12/2015 from 3:25 PM through 6:36 PM, individuals stated the following: TP has always examined and interpreted manual PT pictures by themselves with no additional input. TP had never consulted a pathologist for a patient's urine microscopic examination. TP get a consensus from additional TP on some PT samples but have never consulted a FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 23 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 23 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 pathologist for urine microscopic or manual differential PT samples. Item 3: Based on review of the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, and interviews with Testing Personnel (TP) #5, Technical Supervisor (TS) #8, the Laboratory Director (LD) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015), and four confidential interviews, the laboratory failed to test the XL-F 2014 microbiology proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. Findings Include: 1. Review the laboratory's policies and procedures found a policy titled "Proficiency Testing Protocol" which stated: "III. CAP Accepted Proficiency Programs C. Analysis 4. Duplicate analyses are not permitted unless patient samples are tested in the same manner. Quality Control should be run per routine procedures for patient testing. Group review and consensus identifications are permitted only if actual patient specimens would ordinarily be reviewed by more than one person. 5. Proficiency survey samples will be analyzed in the same manner as patient specimens as much as possible with some exceptions: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 24 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 24 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 a. Due to differences between survey and patient samples, survey samples will be tested in the same manner as patient samples except where survey materials/reporting require modifications in processing i.e. hydration of lyophilized survey materials." "III. CAP Accepted Proficiency Programs C. Analysis 7. There will be no communications with other laboratories about proficiency testing at any time until final results are returned. Under CLIA regulations, there is a strict prohibition against intralaboratory communications about proficiency testing samples until after the deadline for submission of data to the proficiency testing provider. This includes between Family Health Center laboratories because they have different CLIA numbers. For alternate assess/proficiency there can be no communication with an outside performing Reference Laboratory until that laboratory's final test results are received at the Cleveland Clinic. 8. Proficiency survey testing will be completed and results submitted by the survey's due date. Results will be recorded on the laboratory worksheet, on a copy the CAP results form and/or entered into LIS. All instrument or assay printouts will be returned to the supervisory personnel or quality control (QC) laboratory. 9. Worksheets and printouts will be reviewed for questionable results, transcription errors or other problems prior to final submission of results." "III. CAP Accepted Proficiency Programs D. Reporting of Results FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 25 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 25 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 7. CAP proficiency survey test results will be submitted online to CAP by the testing personnel within the technical areas before midnight of the due date. This function can be centralized within one CLIA number for point of care sites. Testing sites with different CLIA numbers will not centralize result submission and results will be submitted independently within that CLIA address/CLIA number." "III. CAP Accepted Proficiency Programs D. Reporting of Results 9. When entering online results, double check the entry for clerical errors either online or via a printout per laboratory area guidelines. This clerical check must be performed by testing personnel who would normally be responsible for this type of function for the patient testing procedure. There must be clear documentation who entered the online results and who conducted the clerical check i.e. name and date. This check must include a check that all analytes have been tested and reported for that survey utilizing the mandatory site specific survey list." "III. CAP Accepted Proficiency Programs J. Record Retention 1. Per CLIA regulations, all records of proficiency testing will be kept on file for a minimum of two (2) years. Records must include worksheets, instrument tapes, computer printouts, reporting forms, evaluation reports, evidence of review, participant summaries and documentation of any follow-up or corrective action. This documentation should be electronic as much as possible. There is no need to retain copies of quality control data unless specifically requested as part of the survey. Quality control data is available in the LIS." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 26 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 26 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 2. Review of the PT documentation for the microbiology testing event titled XL-F 2014 found the following: Result Submission Form: 5 rows of samples labeled D5-06, D5-07, D5-08, D5-09, and D5-10. 3 columns titled "Stain Reaction - Graded", "Morphology - Graded", and "Polymorphonuclear Leukocytes (PMN) - Ungraded". Sample D5-06 Source: Blood The result bubbles next to "Gram-positive", "Cocci in pairs and chains", and "Absent" were filled in with black ink. The "Gram-positive" and "Absent" results were circled with black ink. The result bubble next to "Cocci" was filled in with blue ink and circled twice with black ink. The result "Cocci in pairs and chains" had an X marked over it in black ink. The results "Gram-positive", "Cocci", and "Absent" were highlighted in pink. Sample D5-07 Source: Peritoneal Fluid The result bubbles next to "Gram-positive", "Rods/bacilli", and "Present" were filled in with black ink. The word "underdecolorized" was handwritten above the morphology result options. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 27 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 27 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 A "?" and an indecipherable word were written next to the result "Present". The results "Rods/bacilli" and "Present" were circled in black ink. An X was written over the result "Gram-positive" in black ink. The result bubble next to "Gram-negative" was filled in with blue ink and circled in black and blue ink. A question mark was written next to the result. The results "Gram-negative" and "Present" were highlighted in pink. Sample D5-08 Source: Blood Culture The result bubbles next to "Gram-positive", "Rods/bacilli", and "Absent" were filled in with black ink. All three results were circled in black ink. All three results were highlighted in pink. Sample D5-09 Source: Sputum The result bubbles next to "Gram-negative", "Cocci", and "Present" were filled in with black ink. The result "Cocci" was marked out with an X and the result bubble next to "Diplococci" was filled in with black ink and circled twice. The results "Gram-negative", "Diplococci", and "Present" were all highlighted in pink. The word "Dip" was hand written above the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 28 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 28 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 morphology and then scratched out. The word "underdecolorized" was then hand written next to it. Sample D5-10 Source: Bronchoalveolar Lavage The result bubbles next to "Gram-negative", "Rods/bacilli", and "Absent" were filled with black ink. All three results were circled in black ink and highlighted in pink. PT Attestation Form: LD signed as "Director (or Designee)" TP #5 and #9 signed as "Testing Personnel". No individuals identified as pathologists on the Form CMS-209 signed the attestation form as a "Testing Personnel". 3. When Surveyor #1 showed TS #8 the documentation described above they stated they knew it wasn't good and this testing event occurred before they started at this laboratory. TS #8 further stated they know it's bad. The interview occurred 03/10/2015 at 8:50 AM. 4. TP #5 stated when they submitted the result submission form to the previous supervisor only 1 bubble per sample and per column was marked. TP #5 stated they wrote the two "underdecolorized" notes but did not circle, write, or highlight any of the additional results. Lastly, TP #5 stated they did not know who made the additional markings and results or why that was done. The interview occurred 03/10/2015 at 10:50 AM. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 29 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 29 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 5. TS #8 and the LD stated pathologists review patients' samples if the TP are unsure or unable to identify a finding microscopically. Surveyor #1 asked how the pathologist's reviews of patients' slides are documented. TS #8 and the LD explained there is a pathologist review form that is completed for patient samples. Surveyor #1 asked TS #8 and the LD to provide the pathologist review documentation for the PT samples in question. TS #8 and the LD stated that documentation did not exist for this survey. The interview occurred 03/10/2015 at 11:30 AM. 6. During confidential interviews, which occurred 03/12/2015 from 3:25 PM through 6:36 PM, individuals stated the following: TP stated that the supervisors and pathologists have never read patient Gram stains slides with them. TP stated that a supervisor has never returned the result submission form to them to reassess the sample or their answers. Item 4: Based on review of the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, and interviews with Technical Supervisor (TS) #8, the Laboratory Director (LD) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015), and four confidential interviews, the laboratory failed to test the CM-A 2014 clinical microscopy proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 30 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 30 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 Findings Include: 1. Review the laboratory's policies and procedures found a policy titled "Proficiency Testing Protocol" which stated: "III. CAP Accepted Proficiency Programs C. Analysis 4. Duplicate analyses are not permitted unless patient samples are tested in the same manner. Quality Control should be run per routine procedures for patient testing. Group review and consensus identifications are permitted only if actual patient specimens would ordinarily be reviewed by more than one person. 5. Proficiency survey samples will be analyzed in the same manner as patient specimens as much as possible with some exceptions: a. Due to differences between survey and patient samples, survey samples will be tested in the same manner as patient samples except where survey materials/reporting require modifications in processing i.e. hydration of lyophilized survey materials." "III. CAP Accepted Proficiency Programs C. Analysis 7. There will be no communications with other laboratories about proficiency testing at any time until final results are returned. Under CLIA regulations, there is a strict prohibition against intralaboratory communications about proficiency testing samples until after the deadline for submission of data to the proficiency testing provider. This includes between Family Health FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 31 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 31 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 Center laboratories because they have different CLIA numbers. For alternate assess/proficiency there can be no communication with an outside performing Reference Laboratory until that laboratory's final test results are received at the Cleveland Clinic. 8. Proficiency survey testing will be completed and results submitted by the survey's due date. Results will be recorded on the laboratory worksheet, on a copy the CAP results form and/or entered into LIS. All instrument or assay printouts will be returned to the supervisory personnel or quality control (QC) laboratory. 9. Worksheets and printouts will be reviewed for questionable results, transcription errors or other problems prior to final submission of results." "III. CAP Accepted Proficiency Programs D. Reporting of Results 7. CAP proficiency survey test results will be submitted online to CAP by the testing personnel within the technical areas before midnight of the due date. This function can be centralized within one CLIA number for point of care sites. Testing sites with different CLIA numbers will not centralize result submission and results will be submitted independently within that CLIA address/CLIA number." "III. CAP Accepted Proficiency Programs D. Reporting of Results 9. When entering online results, double check the entry for clerical errors either online or via a printout per laboratory area guidelines. This clerical check must be performed by testing personnel who would normally be responsible for this type of function for the patient testing FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 32 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 32 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 procedure. There must be clear documentation who entered the online results and who conducted the clerical check i.e. name and date. This check must include a check that all analytes have been tested and reported for that survey utilizing the mandatory site specific survey list." "III. CAP Accepted Proficiency Programs J. Record Retention 1. Per CLIA regulations, all records of proficiency testing will be kept on file for a minimum of two (2) years. Records must include worksheets, instrument tapes, computer printouts, reporting forms, evaluation reports, evidence of review, participant summaries and documentation of any follow-up or corrective action. This documentation should be electronic as much as possible. There is no need to retain copies of quality control data unless specifically requested as part of the survey. Quality control data is available in the LIS." 2. Review of the PT documentation for the clinical microscopy testing event titled CM-B 2014 found the following: Result submission form: Page 10 For sample CMP-08 (Body Fluid Photographs and CD-ROM) a result code of 221 was written in blue ink. The 1 was overwritten with a 7 in black ink. To the right of the result box a result code of 213 was written in black in and crossed out with a single line. A black checkmark was written in black ink on the top right outside corner of the result box. For sample CMP-09 (Body Fluid Photographs FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 33 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 33 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 and CD-ROM) a result code of 219 was written in blue ink. A black checkmark was written in black ink on the top right outside corner of the result box. For sample CMP-10 (Body Fluid Photographs and CD-ROM) a result code of 160 was written in blue ink. For sample CMP-11 (Body Fluid Photographs and CD-ROM) a result code of 109 was written in blue ink. For sample CMP-12 (Body Fluid Photographs and CD-ROM) a result code of 135 was written in black ink. For sample CMP-13 (Body Fluid Photographs and CD-ROM) a result code of 207 was written in blue ink. Page 12 For sample CMMP-35 (Vaginal Wet Preparation) four columns with the headings spermatozoa, trichomonas, clue cells, and epithelial cells were present. The result bubbles next to the results "Spermatozoa are absent", "Trichomonas are absent", "Clue cells are present", and "Epithelial cells are present" were filled with blue ink. The result bubble next to "Clue cells are present" and crossed out with one line in black in ink and the result bubble next to "Clue cells are absent" was filled with black ink. PT Attestation Form: LD signed as "Director (or Designee)" Testing Personnel (TP) #5, #9, #10, #43, and an FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 34 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 34 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 individual not listed on the Form CMS-209 signed as "Testing Personnel". No individuals identified as pathologists on the Form CMS-209 signed the attestation form as a "Testing Personnel". 3. TS #8 and the LD stated pathologists review patients' samples if the TP are unsure or unable to identify a finding microscopically. Surveyor #1 asked how the pathologist's reviews of patients' slides are documented. TS #8 and the LD explained there is a pathologist review form that is completed for patient samples. Surveyor #1 asked TS #8 and the LD to provide the pathologist review documentation for the PT samples in question. TS #8 and the LD stated that documentation did not exist for this survey. The interview occurred 03/10/2015 at 11:30 AM. 4. During confidential interviews, which occurred 03/12/2015 from 3:25 PM through 6:36 PM, individuals stated the following: TP has always examined and interpreted manual PT pictures by themselves with no additional input. TP get a consensus from additional TP on some PT samples but have never consulted a pathologist for urine microscopic or manual differential PT samples. Item 5: Based on review of the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, and interviews with Technical Supervisor (TS) #8, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 35 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 35 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 the Laboratory Director (LD) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015), and four confidential interviews, the laboratory failed to test the CM-A 2013 clinical microscopy proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. Findings Include: 1. Review the laboratory's policies and procedures found a policy titled "Proficiency Testing Protocol" which stated: "III. CAP Accepted Proficiency Programs C. Analysis 4. Duplicate analyses are not permitted unless patient samples are tested in the same manner. Quality Control should be run per routine procedures for patient testing. Group review and consensus identifications are permitted only if actual patient specimens would ordinarily be reviewed by more than one person. 5. Proficiency survey samples will be analyzed in the same manner as patient specimens as much as possible with some exceptions: a. Due to differences between survey and patient samples, survey samples will be tested in the same manner as patient samples except where survey materials/reporting require modifications in processing i.e. hydration of lyophilized survey materials." "III. CAP Accepted Proficiency Programs C. Analysis FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 36 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 36 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 7. There will be no communications with other laboratories about proficiency testing at any time until final results are returned. Under CLIA regulations, there is a strict prohibition against intralaboratory communications about proficiency testing samples until after the deadline for submission of data to the proficiency testing provider. This includes between Family Health Center laboratories because they have different CLIA numbers. For alternate assess/proficiency there can be no communication with an outside performing Reference Laboratory until that laboratory's final test results are received at the Cleveland Clinic. 8. Proficiency survey testing will be completed and results submitted by the survey's due date. Results will be recorded on the laboratory worksheet, on a copy the CAP results form and/or entered into LIS. All instrument or assay printouts will be returned to the supervisory personnel or quality control (QC) laboratory. 9. Worksheets and printouts will be reviewed for questionable results, transcription errors or other problems prior to final submission of results." "III. CAP Accepted Proficiency Programs D. Reporting of Results 7. CAP proficiency survey test results will be submitted online to CAP by the testing personnel within the technical areas before midnight of the due date. This function can be centralized within one CLIA number for point of care sites. Testing sites with different CLIA numbers will not centralize result submission and results will be submitted independently within that CLIA address/CLIA number." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 37 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 37 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 "III. CAP Accepted Proficiency Programs D. Reporting of Results 9. When entering online results, double check the entry for clerical errors either online or via a printout per laboratory area guidelines. This clerical check must be performed by testing personnel who would normally be responsible for this type of function for the patient testing procedure. There must be clear documentation who entered the online results and who conducted the clerical check i.e. name and date. This check must include a check that all analytes have been tested and reported for that survey utilizing the mandatory site specific survey list." "III. CAP Accepted Proficiency Programs J. Record Retention 1. Per CLIA regulations, all records of proficiency testing will be kept on file for a minimum of two (2) years. Records must include worksheets, instrument tapes, computer printouts, reporting forms, evaluation reports, evidence of review, participant summaries and documentation of any follow-up or corrective action. This documentation should be electronic as much as possible. There is no need to retain copies of quality control data unless specifically requested as part of the survey. Quality control data is available in the LIS." 2. Review of the PT documentation for the clinical microscopy testing event titled CM-A 2013 found the following: Result submission form: Page 10 For sample CMP-04 (Urine Sediment Color Photographs and DC-ROM) a result code of 141 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 38 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 38 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 was written in the result boxes in blue ink. The word hyaline and an indecipherable word were written in black ink and then scribbled out in blue ink. The word fiber was written below in blue ink. For sample CMP-05 (Urine Sediment Color Photographs and DC-ROM) a result code of 139 was written in the result boxes in blue ink. The words uric acid were written in black ink to the left. For sample CMP-06 (Urine Sediment Color Photographs and DC-ROM) a result code of 114 was written in the result boxes in blue ink. The words uric acid were written above in and scratched out in black ink. The result code 112 was written in black ink with an X drawn over it in blue ink. The word epi was written in black ink to the far left. For sample CMP-07 (Urine Sediment Color Photographs and DC-ROM) the result code of 183 was written in the result boxes and the word "NRBC" (Nucleated Red Blood Cell) was written to the left in black ink. For sample CMP-08 (Body Fluid Photographs and CD-ROM) the result code of 222 was written in the result boxes and the word blast written to the right both in black ink. The result code was lined through twice and the word blast was marked out with an X both in blue ink. The result code 180 and word meta were written to the left in blue ink. The result code 180 had a square drawn around it in blue ink. For sample CMP-13 (Body Fluid Photographs and CD-ROM) a result code of 222 was written in the result boxes and the word blast was written to FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 39 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 39 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 the right in black ink. Two question marks were written below the word blast in blue ink. Page 12 For sample CMMP-35 (Vaginal Wet Preparations) four columns with the headings spermatozoa, trichomonas, clue cells, and epithelial cells were present. The result bubbles next to the results "Spermatozoa are present", "Trichomonas are absent", "Clue cells are present", and "Epithelial cells are present" were filled. The result bubble next to "Clue cells are present" was crossed out with an X and the result bubble next to "Clue cells are absent" was filled in. A question mark was written above the result "Clue cells are present". PT Attestation Form: LD signed as "Director (or Designee)" Testing Personnel (TP) #3, #5, #7, and two individuals not listed on the Form CMS-209 signed as "Testing Personnel". No individuals identified as pathologists on the Form CMS-209 signed the attestation form as a "Testing Personnel". Result Evaluation: For sample CMP-05 the laboratory received a result of "Unacceptable". The laboratory documented the following statement: "Images were reviewed by Pathologist (as they would be for patient samples), and the crystal in question was identified as Uric Acid. The image as well as feedback and the participant summary was provided to the section and everyone was FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 40 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 40 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 instructed to read and sign off the review." 3. TS #8 and the LD stated pathologists review patients' samples if the TP are unsure or unable to identify a finding microscopically. Surveyor #1 asked how the pathologist's reviews of patients' slides are documented. TS #8 and the LD explained there is a pathologist review form that is completed for patient samples. Surveyor #1 asked TS #8 and the LD to provide the pathologist review documentation for the PT samples in question. TS #8 and the LD stated that documentation did not exist for this survey. The interview occurred 03/10/2015 at 11:30 AM. 4. During confidential interviews, which occurred 03/12/2015 from 3:25 PM through 6:36 PM, individuals stated the following: TP has always examined and interpreted manual PT pictures by themselves with no additional input. TP had never consulted a pathologist for a patient's urine microscopic examination. TP get a consensus from additional TP on some PT samples but have never consulted a pathologist for urine microscopic or manual differential PT samples. Item 6: Based on review of the laboratory's policies and procedures and College of American Pathologists (CAP) proficiency testing (PT) documentation, the laboratory failed to test the FH9-B 2013 hematology proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 41 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 41 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 tests patient specimens. Findings Include: 1. Review of the laboratory's policy and procedure titled "Manual of Operations PROFICIENCY TESTING PROTOCOL" found the following statements: "III. CAP Accepted Proficiency Programs C. Analysis 5b. Proficiency samples will never be referred to an outside reference lab for further or confirmatory testing. This includes testing at a satellite (FHC or ASC) that would ordinarily send its confirmatory testing to a larger Cleveland Clinic laboratory." "III. CAP Accepted Proficiency Programs C. Analysis 7. There will be no communication with other laboratories about proficiency testing at any time until final results are returned. Under CLIA regulations, there is a strict prohibition against intralaboratory communications about proficiency testing samples until after the deadline for submission of data to the proficiency testing provider." 2. Review of the laboratory's FH9-B 2013 CAP PT documentation revealed the following: BCP-14 (blood cell identification) i. post-it note indicates Seg/PMN ii. page 9 of the CAP result form indicates a hand written neut toxic neut result in different hand writing iii. also on page 9 of the CAP result form indicates a hand written result code of 284 with a FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 42 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 42 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 circle drawn around it in different hand writing As listed on the CAP Hematology Blood Cell Identification Master List 284; Neutrophil, segmented or band The laboratory reported "Neutrophil, Seg/Band" to the PT provider. Seg; segmented neutrophil PMN; polymorphonuclear neutrophil neut; neutrophil BCP-19 (blood cell identification) i. post-it note indicates ortho/plasmo ii. page 9 of the CAP result form indicates hand written polychrome result in different hand writing iii. a duplicate page 9 indicates a hand written result code of 134 in different hand writing As listed on the CAP Hematology Blood Cell Identification Master List 134; Polychromatophilic (non-nucleated) red cell The laboratory reported "Polychromatophilic RBC" to the PT provider. RBC; red blood cell BCP-20 (blood cell identification) i. page 9 of the CAP result form indicates a hand written plt vs plasma result ii. a duplicate page 9 indicates a hand written result code of 171 in different hand writing with a circle drawn around it As listed on the CAP Hematology Blood Cell Identification Master List 171; Platelet, normal FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 43 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 43 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 The laboratory reported "Platelet, Normal" to the PT provider. plt; platelet plasma; plasma cell Item 7: Based on review of the laboratory's policies and procedures and College of American Pathologists (CAP) proficiency testing (PT) documentation, the laboratory failed to test the HFC-B 2014 hematology proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. Findings Include: 1. Review of the laboratory's policy and procedure titled "Manual of Operations PROFICIENCY TESTING PROTOCOL" found the following statements: "III. CAP Accepted Proficiency Programs C. Analysis 7. There will be no communication with other laboratories about proficiency testing at any time until final results are returned. Under CLIA regulations, there is a strict prohibition against intralaboratory communications about proficiency testing samples until after the deadline for submission of data to the proficiency testing provider." 2. Review of the laboratory's HFC-B 2014 CAP PT documentation revealed the following: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 44 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 44 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 HFC-04 (body fluid differential) i. a single post-it note which indicated two sets of hand written body fluid differential results, side by side, in different hand writing 84 segs 16 lymphs S 70 L 25 E4 M1 Segs, S; segmented neutrophils lymphs, L; lymphocytes E; eosinophil M; monocyte ii. page 2 of the CAP result form indicated the following numerical results in different hand writing Neut/Gran% Lymph% Mono% Eosin% Baso% 84 16 0 0 0 Neut/Gran%; segmented neutrophil percent Lymph%; lymphocyte percent Mono%; monocyte percent Eosin%; eosinophil percent Baso%; basophil percent HFC-06 (body fluid differential) i. a single post-it note which indicated two sets of hand written body fluid differential results, side by side, in different hand writing 73 segs 24 lymphs 3 Eos 70 25 4 M1 ii. page 2 of the CAP result form indicated the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 45 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 45 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 following numerical results in different hand writing Neut/Gran% Lymph% Mono% Eosin% Baso% 73 24 0 3 0 Item 8: Based on review of the Form CMS-209, the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, and interview with the Point-of-Care Supervisor (PS) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to test activated clotting time (ACT) proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. Findings Include: 1. Review of the Form CMS-209 found 17 individuals, Testing Personnel (TP) #17 through #33, certified by the LD to perform moderate complexity testing. The PS stated TP #17 through #33 performed ACT testing under this CLIA number. The PS further explained the ACT testing was performed in two locations of the hospital, interventional radiology (rad) and general surgery (surg). The interview occurred 03/09/2015 at 8:46 AM. 2. On 03/09/2015, Surveyor #2 requested the laboratory's PT policy and procedure from Technical Supervisor (TS) #9. TS #9 provided a policy and procedure titled "Cleveland Clinic Robert J. Tomsich Pathology & Laboratory FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 46 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 46 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 Medicine Institute Manual of Operations Proficiency Testing Protocol". 3. Review of the above mentioned policy found the following directives: "C. Analysis 1. Proficiency samples will be processed in a routine patient run by the routine testing personnel who routinely test patient/client samples. All testing personnel on all shifts who routinely perform these tests will participate in proficiency testing. Every effort will be made to rotate the survey samples amongst all the testing personnel who routinely perform testing. Each laboratory area must have a plan or process to distribute the surveys amongst all testing personnel on all shifts." "C. Analysis 5. Proficiency survey samples will be analyzed in the same manner as patient specimens as much as possible with some exceptions: a. Due to differences between survey and patient samples, survey samples will be tested in the same manner as patient samples except where survey materials/reporting require modifications in processing i.e. hydration of lyophilized survey materials." 4. Review of the laboratory's 2013 and 2014 CAP ACT PT documentation found TP #8 signed 2 out of 5 PT events' attestation forms as the testing analyst. Additionally, on the 1st testing event of 2014 "Survey Result Form" two sets of test results, titled "SURG" and "RAD", were documented for 3 out of 3 samples. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 47 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 47 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 5. Surveyor #1 asked the PS to describe the method in which ACT PT samples were analyzed. The PS stated, prior to the dates of survey, the core laboratory received the PT survey, interventional radiology and surgery would bring the ACT instruments to the laboratory, the samples would be analyzed by either the core laboratory TP or Point-of-Care (POC) TP, the samples would be run on both instruments, and the laboratory personnel would submit the PT results to the PT provider. The PS confirmed that patients were not tested in the manner described for PT. The interview occurred 03/09/2015 at 12:13 PM. Item 9: Based on review of the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, and an interview with Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to test the FH9-A 2013 and FH9-B 2013 complete blood count (CBC) and blood cell identification proficiency testing samples it received from the College of American Pathologists (CAP) in the same manner as it tests patient specimens. Findings Include: 1. Review of the laboratory's policy and procedure titled "Manual of Operations PROFICIENCY TESTING PROTOCOL" found the following statements: "I. Principle FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 48 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 48 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 The purpose of proficiency testing is to evaluate a laboratory's analytical performance by comparing results with other laboratories' results or by comparing results with a known sample. It is imperative that the proficiency survey testing process mirror the actual patient testing process as much as possible in order to detect any possible errors in the patient testing process." "C. Analysis 4. Duplicate analyses are not permitted unless patient samples are tested in the same manner." "C. Analysis 5. Proficiency survey samples will be analyzed in the same manner as patient specimens as much as possible with some exceptions: a. Due to differences between survey and patient samples, survey samples will be tested in the same manner as patient samples except where survey materials/reporting require modifications in processing i.e. hydration of lyophilized survey materials." 2. Review of the laboratory's policy and procedure titled "Department of Laboratories Policy Manual Quality Management (Q.M.) and Performance Improvement (P.I.) Plan" revealed the following statements: "Proficiency Testing While the Team Leader or Section Head is responsible to ensure the proper handling, analysis, review and reporting of the test results on proficiency testing (surveys), all personnel working in that section will be involved on a rotational basis in the performance of testing on survey material. For testing purposes, survey FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 49 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 49 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 samples are to be treated no different than patient samples; they are to be incorporated within the routine workload. If multiple methods are used for an analyte, proficiency samples will be analyzed by the primary method. A written procedure will be in place in each section addressing the aforementioned items. Replicate analysis of any proficiency sample is acceptable only if patient/client specimens are routinely analyzed in the same manner. With respect to morphologic examinations (identification of cell types and microorganisms, etc.), group review and consensus identifications are permitted only for unknown samples that would ordinarily be reviewed by more than one person in an actual patient sample." 3. Review of the laboratory's 2013 hematology auto differentials CAP PT documentation revealed the PT specimens were tested on the XE-5000 and XS-1000i analyzers as follows: For the survey titled FH9-A: Sample Date/Time tested *XE-5000 Date/Time tested XS-1000i FH9-01 02/04/2013 07:34:24 02/04/2013 07:46:54 FH9-02 02/04/2013 7:34:56 02/04/2013 07:48:04 FH9-03 02/04/2013 07:35:26 02/04/2013 07:49:12 FH9-04 02/04/2013 07:35:59 02/04/2013 07:50:25 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 50 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 50 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 For the survey titled FH9-B: Sample Date/Time tested *XE-5000 Date/Time tested XS-1000i FH9-06 05/14/2013 15:51:51 05/14/2013 15:13:11 FH9-07 05/14/2013 15:52:25 05/14/2013 15:12::05 FH9-08 05/14/2013 15:52:57 05/14/2013 15:10:54 FH9-10 05/14/2013 15:53:59 05/14/2013 15:08:38 4. Further review of the laboratory's 2013 Hematology Auto Differentials CAP PT documentation found more than one test result for each of the PT samples as described below. For the survey titled FH9-A, Blood Cell Identification, two post-it notes in different handwriting with the following results documented were attached to the result submission form (or on pictures): post-it note initialed by TP#1 BCP-01 reactive lymph *post-it note initialed by LD 266 reactive lymph BCP-02 platelet 171 platelet BCP-03 mono" written 236 mono FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 51 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 51 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 above a crossed out "reactive lymph BCP-04 lymph 265 lymph BCP-05 Rbc-NL 135 RBC BCP-06 target 150 target BCP-07 granular lymph 307 granular lymph BCP-08 H-J body 155 HJ Body BCP-09 nucleated RBC 253 nRBC BCP-10 Schniffner's 225 pappenheimer Additionally, for the survey titled FH9-A, two CAP result forms were found with the following hand written results documented by unknown testing personnel (TP): CAP result *CAP result form with form with cell description CAP code BCP-01 No result 266 BCP-02 platelet 171 BCP-03 mono 236 BCP-04 lymph 265 BCP-05 RBC 135 BCP-06 target cell 150 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 52 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 52 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 BCP-07 No result 307 BCP-08 Howell Jolly Body 155 BCP-09 NRBC 253 BCP-10 Pappenheimer 225 For the survey titled FH9-B, Blood Cell Identification, one post-it note with cell description results, one CAP result form with cell description, and CAP code numbers in different hand writing were found as listed below: post-it note CAP *CAP result form result form with cell with CAP description code BCP-11 elliptocyte eliptocyte 146 BCP-12 lymph lymph 265 BCP-13 B. Stippling Basophilic Stippling 152 BCP-14 Seg/PMN neut toxic neut BCP-15 platelet platelet BCP-16 Plasmodium Plasmodium 156 sp FORM CMS-2567(02-99) Previous Versions Obsolete 284 with a circle around it 171 Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 53 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 53 BCP-17 PMN seg neut BCP-18 Mono monocyte PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 284 236 BCP-19 ortho/plasmo polychrome 134 BCP-20 Unreadable result plt vs plasma 171 with a circle around it No TP identifiers were present. 5. TS#9 explained the Sysmex XE-5000 is the primary hematology analyzer on which routine patient testing is performed and the Sysmex XS-1000i is the back-up hematology analyzer that is utilized when the XE-5000 is down. TS#9 confirmed the laboratory tested PT samples for FH9-A 2013 and FH9-B 2013 on both hematology analyzers. TS#9 further confirmed the blood cell identification pictures for FH9-A 2013 and FH9-B 2013 were examined and interpreted by multiple TP prior to the due date and patient specimens were not examined in this manner. The interview occurred on 03/09/2015 at 10:34 AM. lymph; lymphocyte mono; monocyte Rbc, RBC; red blood cell NL; normal H-J, HJ; Howell Jolly NRBC, NRBC; nucleated red blood cell B Stippling; Basophilic Stippling Seg; segmented neutrophil neut; neutrophil PMN; polymorphonuclear neutrophil sp; species plasmo; plasmodium FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 54 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2006 Continued From page 54 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2006 plasma; plasma cell plt; platelet *; PT results reported to CAP D2007 493.801(b)(1) TESTING OF PROFICIENCY TESTING SAMPLES D2007 The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Item 1: Based on review of the Form CMS-209, the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, and interview with the Point-of-Care Supervisor (PS) and Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to ensure that Gram stain, wet preparation, and activated clotting time (ACT) proficiency testing (PT) samples were tested or examined with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. Findings Include: 1. Review of the Form CMS-209 found 17 individuals, Testing Personnel (TP) #17 through #33, certified by the LD to perform moderate complexity testing. The PS stated TP #17 through #33 performed ACT testing under this CLIA number. The interview occurred 03/09/2015 at 8:46 AM. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 55 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2007 Continued From page 55 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2007 Further review of the Form CMS-209 found an additional 18 individuals, TP #1 through #16; #43; #44, certified by the LD to perform moderate and high complexity testing. 2. On 03/09/2015 at 8:38 AM, TS #8 verbally provided the following list of testing performed by each TP: TP #1: TP #2: TP #3: TP #4: Hematology; Blood Bank All departments Microbiology; Chemistry All departments (exception: no body fluids) TP #5: Hematology; Microbiology TP #6: Chemistry; Coagulation TP #7: Coagulation; Chemistry TP #8: Hematology; Chemistry; Urinalysis; Coagulation TP #9: Hematology; Coagulation; Chemistry; Blood Bank; Microbiology TP #10: Chemistry; Hematology; Microbiology TP #11: All departments TP #12: All departments (exception: no Blood Bank) TP #13: All departments TP #14: Hematology; Urinalysis; Chemistry TP #15: All departments TP #16: All departments TP #43: Chemistry; Microbiology TP #44: Not originally listed on Form CMS-209 3. On 03/09/2015, Surveyor #2 requested the laboratory's PT policy and procedure from TS #9. TS #9 provided a policy and procedure titled "Cleveland Clinic Robert J. Tomsich Pathology & Laboratory Medicine Institute Manual of Operations Proficiency Testing Protocol". FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 56 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED D2007 Continued From page 56 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2007 4. Review of the above mentioned policy found the following directives: "C. Analysis 1. Proficiency samples will be processed in a routine patient run by the routine testing personnel who routinely test patient/client samples. All testing personnel on all shifts who routinely perform these tests will participate in proficiency testing. Every effort will be made to rotate the survey samples amongst all the testing personnel who routinely perform testing. Each laboratory area must have a plan or process to distribute the surveys amongst all testing personnel on all shifts." 5. Review of the laboratory's 2013 and 2014 CAP ACT, Gram stain, and wet preparation PT attestation forms found the following: ACT: 2015 1st Testing Event Analyst: TP #8 2014 2nd Testing Event Analyst: TP #17 1st Testing Event Analyst: TP #26 & #27 2013 2nd Testing Event Analyst: TP #8 1st Testing Event FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 57 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2007 Continued From page 57 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2007 Analyst: TP #20 Gram Stain: 2014 3rd Testing Event Analyst: TP #5 & #9 2nd Testing Event Analyst: TP #5 1st Testing Event Analyst: TP #5 2013 3rd Testing Event Analyst: TP #5 2nd Testing Event Analyst: TP #5 1st Testing Event Analyst: TP #5 Wet Preparation: 2014 2nd Testing Event Analysts: TP #5, #7, #10, 1 individual not listed on the Form CMS-209 1st Test Event Analysts: TP #5, #9, #10, #43, and 1 individual not listed on the Form CMS-209 2013 2nd Testing Event FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 58 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2007 Continued From page 58 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2007 Analyst: TP #5, #6, and 2 individuals not listed on the Form CMS-209 1st Testing Event Analyst: TP #3, #5, #7, and 2 individuals not listed on the Form CMS-209 5. The PS stated, prior to the dates of survey, the laboratory received the PT survey, interventional radiology and surgery would bring the ACT instruments to the laboratory, the samples would be analyzed by either the core laboratory TP or Point-Of-Care TP, the samples would be run on both instruments, and the core laboratory personnel would submit the PT results to the PT provider. The interview occurred 03/09/2015 at 12:13 PM. TS #8 confirmed the PT methods did not rotate PT amongst all TP. The interviews occurred 03/09/2015 at 12:13 PM and 03/10/2015 at 8:40 AM. Item 2: Based on review of the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, and interviews with Technical Supervisor (TS) #8, TS#9, and Quality Coordinator (QC) #2 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to ensure that complete blood count (CBC), manual differential, urinalysis (UA), urine sediment (umic), osmolality (OSMO), manual body fluid counts, C-Reactive protein (CRP), prothrombin time (PT), activated partial thromboplastin time (PTT), fibrinogen, and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 59 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2007 Continued From page 59 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2007 D-Dimer proficiency testing (PT) samples were tested or examined with the laboratory's regular patient workload by the personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. Findings Include: 1. Review of the laboratory's policy and procedure titled "Manual of Operations PROFICIENCY TESTING PROTOCOL" found the following statements: "I. Principle The purpose of proficiency testing is to evaluate a laboratory's analytical performance by comparing results with other laboratories' results or by comparing results with a known sample. It is imperative that the proficiency survey testing process mirror the actual patient testing process as much as possible in order to detect any possible errors in the patient testing process." "III. CAP Accepted Proficiency Programs C. Analysis 1. Proficiency samples will be processed in a routine patient run by the routine testing personnel who routinely test patient/client samples. All testing personnel on all shifts who routinely perform these tests will participate in the proficiency testing." 2. Review of the laboratory's policy and procedure titled "Department of Laboratories Policy Manual Quality Management (Q.M.) and Performance Improvement (P.I.) Plan" revealed the following statement: "6. Process and Performance Control: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 60 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2007 Continued From page 60 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2007 Proficiency Testing While the Team Leader or Section Head is responsible to ensure the proper handling, analysis, review and reporting of the test results on proficiency testing (surveys), all personnel working in that section will be involved on a rotational basis in the performance of testing on survey material." 3. Review of the Form CMS-209 found 18 individuals certified by the LD to perform moderate and high complexity testing. On 03/09/2015 at 8:38 AM, TS #8 verbally provided the following list of testing performed by each TP: TP #1: TP #2: TP #3: TP #4: Hematology; Blood Bank All departments Microbiology; Chemistry All departments (exception: no body fluids) TP #5: Hematology; Microbiology TP #6: Chemistry; Coagulation TP #7: Coagulation; Chemistry TP #8: Hematology; Chemistry; Urinalysis; Coagulation TP #9: Hematology; Coagulation; Chemistry; Blood Bank; Microbiology TP #10: Chemistry; Hematology; Microbiology TP #11: All departments TP #12: All departments (exception: no Blood Bank) TP #13: All departments TP #14: Hematology; Urinalysis; Chemistry TP #15: All departments TP #16: All departments TP #43: Chemistry; Microbiology TP #44: Not originally listed on Form CMS-209 4. Review of the laboratory's CAP attestation FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 61 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2007 Continued From page 61 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2007 forms for 2013 and 2014 found no documentation indicating the following TP, who perform patient testing, participated in PT: Survey: FH9 (CBC and manual differential) TP: #1, #5, #8, #9, #14, #44 Survey: CM (UA and umic) TP: #1, #2, #4, #8, #11, #12, #13, #14, #16, #44 Survey: CM (OSMO) TP: #2, #4, #8, #11, #12, #13, #14, #16, #44 Survey: HFC/CM (manual body fluid count and differential) TP: #13 Survey: S (CRP) TP: #2, #6, #8, #11, #12, #14, #16, #43, #44 Survey: CGL (PT, PTT, Fibrinogen, and D-Dimer) TP: #1, #2, #4, #7, #11, #12, #13, #14, #16, #44 5. Documentation demonstrating PT participation for the individuals listed in finding #4 was requested from TS#9 and QC#2. TS#9 stated no documentation was available and confirmed all TP who routinely perform patient testing did not participate in PT. The interview occurred on 03/09/2015 at 12:07 PM. D2010 493.801(b)(2) TESTING OF PROFICIENCY TESTING SAMPLES D2010 The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 62 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2010 Continued From page 62 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2010 Based on review of the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, testing worksheets, and an interview with Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to test body fluid manual differential, urine microscopic, and urine osmolality proficiency testing (PT) samples the same number of times that it routinely tests patient samples. Findings Include: 1. Review of the laboratory's policy and procedure titled "Manual of Operations PROFICIENCY TESTING PROTOCOL" found the following statements: "I. Principle The purpose of proficiency testing is to evaluate a laboratory's analytical performance by comparing results with other laboratories' results or by comparing results with a known sample. It is imperative that the proficiency survey testing process mirror the actual patient testing process as much as possible in order to detect any possible errors in the patient testing process." "III. CAP Accepted Proficiency Programs C. Analysis 4. Duplicate analyses are not permitted unless patient samples are tested in the same manner." 2. Review of the laboratory's policy and procedure titled "Department of Laboratories Policy Manual Quality Management (Q.M.) and Performance Improvement (P.I.) Plan" revealed FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 63 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2010 Continued From page 63 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2010 the following statements: "Proficiency Testing While the Team Leader or Section Head is responsible to ensure the proper handling, analysis, review and reporting of the test results on proficiency testing (surveys), all personnel working in that section will be involved on a rotational basis in the performance of testing on survey material. For testing purposes, survey samples are to be treated no different than patient samples; they are to be incorporated within the routine workload. If multiple methods are used for an analyte, proficiency samples will be analyzed by the primary method. A written procedure will be in place in each section addressing the aforementioned items. Replicate analysis of any proficiency sample is acceptable only if patient/client specimens are routinely analyzed in the same manner. With respect to morphologic examinations (identification of cell types and microorganisms, etc.), group review and consensus identifications are permitted only for unknown samples that would ordinarily be reviewed by more than one person in an actual patient sample." 3. Review of the laboratory's 2013 and 2014 CAP survey documentation revealed the following: For the survey titled FH9-B 2014 (submission due 05/20/2014) Sample: BCP-19 (blood cell identification) Three individual "CAP BLOOD CELL ID BCP-B" worksheets indicated the following: 111 neutrophil myelocyte; initialed by TP#13, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 64 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2010 Continued From page 64 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2010 dated 05/14/14 Neutrophil, metamyelocyte 112; initialed by TP#16, undated 259 neutrophil, toxic; initialed by TP#11, undated page 6 of the CAP result form indicates a hand written 112 As listed on the CAP Hematology Blood Cell Identification Master List: 111; Neutrophil, myelocyte 112; Neutrophil, metamyelocyte 259; Neutrophil, toxic (to include toxic granulation and/or Dohle bodies, and/or toxic vacuolization) For the survey titled HFC-B 2013: (submission due 12/3/2013) Sample: HFC-04 (body fluid cell count) Date tested: 11/27/2013 TP not listed on Form CMS-209 Documented on Fluid Worksheet as follows: Side 1 Side 2* Avg. Cells Reported 13 RBC= 13 25 13 33 WBC= 18 19 17 18 45 * Side 2 had 2 counts documented Sample: HFC-05 (body fluid cell count) Date tested: 11/27/2013 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 65 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2010 Continued From page 65 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2010 TP not listed on Form CMS-209 Documented on Fluid Worksheet as follows: Side 1* Side 2* Avg. Cells Reported RBC= 140 146 137 143 139 218 348 363 WBC= 33 23 22 30 28 blank 70 68 *each side was counted in duplicate For the survey titled HFC-B 2014: Sample: HFC-04 (body fluid differential) Date tested: 11/27/2013 TP unknown; two sets of results in different hand writing documented on a single post-it note as follows: 84 segs 16 lymphs S 70 L 25 E4 M1 Sample: HFC-06 (body fluid differential) Date tested: 11/27/2013 TP unknown; two sets of results in different hand writing documented on a single post-it note as follows: 73 segs 24 lymphs 3 Eos 70 25 4 M1 For the survey titled CM-B 2014: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 66 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2010 Continued From page 66 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2010 Documented on the CAP result submission worksheet as follows: Sample: CM-14 (OSMO) 3 sets of OSMO results 270, 267, 270 Sample: CM-15 (OSMO) 3 sets of OSMO results 845, 841, 845 Sample: CM-16 (OSMO) 3 sets of OSMO results 757, 758, 757 4. TS#9 confirmed the PT samples were tested, examined and/or interpreted multiple times by multiple testing personnel. TS#9 further confirmed patients were not tested in this manner. The interviews occurred on 03/09/2015 at 10:34 AM, 10:55 AM, and on 03/11/2015 at 8:40 AM. Side 1/Side 2; A hemocytometer, utilized for manual cell counts, consists of two counting chambers identified as such. RBC; red blood cell WBC; white blood cell avg; average segs, S; segmented neutrophil lymphs, L; lymphocyte eos, E; eosinophil mono, M; monocyte D2015 493.801(b)(5)(6) TESTING OF PROFICIENCY TESTING SAMPLES D2015 (5) The laboratory must document the handling, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 67 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2015 Continued From page 67 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2015 preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, College of American Pathologists (CAP) proficiency testing (PT) documentation, and an interview with Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to maintain a copy of all proficiency testing (PT) documentation for a minimum of two years from the date of the PT event. Findings Include: 1. Review of the laboratory's policy and procedure titled "Manual of Operations PROFICIENCY TESTING PROTOCOL" found the following statements: "III. CAP Accepted Proficiency Programs C. Analysis 8. Proficiency survey testing will be completed and results submitted by the survey's due date. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 68 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2015 Continued From page 68 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2015 Results will be recorded on the laboratory worksheet, on a copy the CAP results form and/or entered into LIS. All instrument or assay printouts will be returned to the supervisory personnel or quality control (QC) laboratory." "III. CAP Accepted Proficiency Programs D. Reporting of Results 6. A copy of the signed attestation form, worksheets, if any, and any instrument printouts, if any, will be retained in the laboratory areas." "III. CAP Accepted Proficiency Programs E. Electronic Review of CAP Proficiency Testing Results 17. Each testing area ensures retention of its paper worksheets, instrument tapes, and signed attestation sheets." "III. CAP Accepted Proficiency Programs J. Record Retention 1. Per CLIA regulations, all records of proficiency testing will be kept on file for a minimum of two (2) years. Records must include worksheets, instrument tapes, computer printouts, reporting forms, evaluation reports, evidence of review, participant summaries and documentation of any follow-up or corrective action." 2. Review of the laboratory's 2013 and 2014 CAP PT documentation revealed the following PT documentation was not retained as required: HFC-B 2014 No PT body fluid testing worksheets and instrument printouts were available for review. S-B 2014 PT result worksheets (pages 1 and 2) and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 69 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D2015 Continued From page 69 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D2015 attestation form were unavailable for review. CGL-A 2013 No PT result worksheets, instrument printouts, reporting forms, evaluation reports, and evidence of review for Coagulation testing (Protime, Activate Partial Thromboplastin Time, Fibrinogen, and D-Dimer) were available for review. CGL-B 2013 No PT result worksheets, instrument printouts, reporting forms, evaluation reports, and evidence of review for Coagulation testing (Protime, Activate Partial Thromboplastin Time, Fibrinogen, and D-Dimer) were available for review. CGL-C 2013 No PT result worksheets, instrument printouts, reporting forms, evaluation reports, and evidence of review for Coagulation testing (Protime, Activate Partial Thromboplastin Time, Fibrinogen, and D-Dimer) were available for review. 3. TS#9 confirmed the above mentioned PT documentation could not be located and was unavailable for review on the dates of survey. The interview occurred on 03/09/2015 at 2:34 PM. D5024 493.1215 HEMATOLOGY D5024 400H If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in §§493.1230 through 493.1256, §493.1269, and §§493.1281 through 493.1299. This CONDITION is not met as evidenced by: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 70 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5024 Continued From page 70 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5024 Based on direct observation, review of the laboratory's policies and procedures, patient test records, quality control (QC) records, performance specification documentation, calibration and calibration verification documentation, activated clotting time (ACT) test records and final test reports, and interviews with the Laboratory Director (LD), Technical Supervisor (TS) #9, Technical Consultant (TC) #2, and the Point-of-Care Supervisor (PS) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015), the laboratory failed to meet the requirements in the specialty of Hematology specified in §§493.1230 through 493.1256, §493.1269, and §§493.1281 through 493.1299. Findings Include: 1. The laboratory failed to follow the written procedures manual for the test activated clotting time (ACT). (Refer to D5401, Item 1) 2. The laboratory failed to ensure written procedures for all tests, assays, and examinations performed by the laboratory were available to laboratory personnel. (Refer to D5401, Item 2) 3. The laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for 1)(i)(A) Accuracy, (1)(i)(B) Precision, (1)(i)(C) Reportable range of test results for the test system, and (1) (ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population for automated body fluid cell count testing procedures performed on the Sysmex XE-5000 Hematology FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 71 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5024 Continued From page 71 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5024 analyzer. (Refer to D5421, Item 2) 4. The laboratory failed to perform and document hematology centrifuge maintenance procedures. (Refer to D5429) 5. The laboratory failed to perform and document hematology microscope maintenance procedures. (Refer to D5433, Item 3) 6. The laboratory failed to perform and document calibration procedures for the analytes D-Dimer and fibrinogen. (Refer to D5437) 7. The laboratory failed to perform and document D-Dimer and fibrinogen calibration verification procedures (b)(3) At least once every 6 months and whenever any of the following occurred: (b) (3)(i) A complete change of reagents, (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance, and (b)(3)(iii) Control materials reflect an unusual shift, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (Refer to D5439) 8. The laboratory failed to, over time, rotate activated clotting time (ACT) control material testing among all operators who perform the testing on the Hemachron Junior (Jr.) Signature +. (Refer to D5463) 9. The laboratory failed to perform and document manual hemocytometer cell count quality control (QC) each 8 hours of testing. (Refer to D5543) 10. The laboratory failed to perform and document two levels of control materials each 8 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 72 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5024 Continued From page 72 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5024 hours of operation for the activated clotting time (ACT) nonmanual coagulation test system Hemachron Junior (Jr.) Signature +. (Refer to D5545) 11. The laboratory failed to retain automated body fluid count instrument printouts and manual body fluid differential worksheets. (Refer to D5789) 12. The laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in §§493.1251 through 493.1283. (Refer to D5791, Item 1) 13. The laboratory failed to correct problems identified in the analytic systems for the subspecialty of coagulation. (Refer to D5791, Item 2) 14. The laboratory failed to have an adequate manual or electronic system(s) in place to ensure activated clotting time (ACT) test results and other patient-specific data are accurately and reliably sent from the point of data entry to final report destination. (Refer to D5801, Item 2) 15. The laboratory failed to indicate the test performed, the test result, and the units of measurement on the activated clotting time (ACT) final test reports. (Refer to D5805) 16. The laboratory failed to provide access to completed activated clotting time (ACT) test reports. (Refer to D5823, Item 2) D5026 493.1217 IMMUNOHEMATOLOGY FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 D5026 Facility ID: OHC05083 If continuation sheet Page 73 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5026 Continued From page 73 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5026 520H 530H If the laboratory provides services in the specialty 540H of Immunohematology, the laboratory must meet 550H the requirements specified in §§493.1230 through 493.1256, §493.1271, and §§493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, review of the laboratory's policies and procedures, manufacturers' operating instructions, product delivery documentation, transfusion reaction workup documentation, manufacturer's package insert instructions, patient test records, emergency release documentation, laboratory information system (LIS), hospital information system (HIS), returned unit reports, and interviews with Technical Supervisors (TS) #8 and #9, the Compliance Specialist (CS), Testing Personnel (TP) #1 and #9, the Laboratory Director (LD) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015), the Head of Transfusion Medicine (HTM), and a "Short Stay" unit nurse, the laboratory failed to meet the requirements specified in §§493.1230 through 493.1256, §493.1271, and §§493.1281 through 493.1299. Findings Include: 1. The laboratory failed to ensure written procedures for all tests, assays, and examinations performed by the laboratory were available to laboratory personnel. (Refer to D5401, Item 2) 2. The laboratory failed to monitor and document FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 74 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5026 Continued From page 74 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5026 the incubator temperature conditions of the ORTHO Workstations for ID-MTS Gel Cards. (Refer to D5413) 3. The laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer when it introduced the unmodified, FDA-cleared ORTHO Workstations for ID-MTS Gel Cards. (Refer to D5421, Item 1) 4. The laboratory failed to perform and document immunohematology pippette function checks as defined by the manufacturer prior to patient testing. (Refer to D5431) 5. The laboratory failed to establish, perform, and document a maintenance and function check protocol that ensures microscope performance which is necessary for accurate and reliable immunohematology test results and test result reporting. (Refer to D5433, Item 2) 6. The laboratory failed to check each lot number and shipment of commercially prepared Ortho Reagent Red Blood Cells 0.8% Resolve panel reagents when opened for positive and negative reactivity, as well as graded reactivity. (Refer to D5471) 7. The laboratory failed to perform unexpected antibody identification testing according to the manufacturer's package insert instructions and ensure out-dated reagents were not routinely used for antibody identification testing. (Refer to D5551, Item 1) 8. The laboratory failed to perform and document emergency release patient testing and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 75 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5026 Continued From page 75 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5026 procedures as specified in 21 CFR 606.151(e). (Refer to D5551, Item 2) 9. The laboratory failed to ensure and document that blood products were within acceptable temperature ranges when returned to the laboratory after issue. (Refer to D5555) 10. The laboratory failed to promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility. (Refer to D5559) 11. The laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in §§493.1251 through 493.1283. (Refer to D5791, Item 1) 12. The laboratory failed to have an adequate manual or electronic system(s) in place to ensure immunohematology test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. (Refer to D5801, Item 1) 13. The laboratory failed to maintain immunohematology test reports in a manner that permitted ready identification and timely accessibility. (Refer to D5819) 14. The laboratory failed to provide access to completed immunohematology test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. (Refer to D5823, Item 1) FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 76 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5221 493.1236(d) EVALUATION OF PROFICIENCY TESTING PERFORMANCE PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5221 610H All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, American Society for Clinical Pathology (ASCP) CheckPath proficiency testing (PT) Participant Score Reports, and an interview with the Laboratory Director (LD) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015), the laboratory failed to document all Histology proficiency testing (PT) evaluation and verification activities. Findings Include: 1. Review of the laboratory's policy and procedure titled "Manual of Operations PROFICIENCY TESTING PROTOCOL" found the following statements: "IV. Alternate Proficiency Testing/Assessment (analytes with no available proficiency) F. Review of Results 3. The appropriate supervisory personnel in the operational laboratory area will actively review the survey results. 'Active review' includes: - investigation of unacceptable results - examination for trends or bias of acceptable results - etc." "IV. Alternate Proficiency Testing/Assessment (analytes with no available proficiency) F. Review of Results FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 77 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5221 Continued From page 77 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5221 4. The prompt corrective action investigation must be a thorough investigation and root cause analysis. The corrective action must include a plan to prevent re-occurrence when applicable." 2. Review of the laboratory's 2013 CheckPath Anatomic Pathology Participant Score Report revealed an unacceptable response for case number C1832.11. The target response was "D" and the laboratory's reported response was "C". The documentation did not include any indication of PT result review, evaluation, and corrective action measures taken for the unacceptable result. 3. Review of the laboratory's 2014 CheckPath Anatomic Pathology Participant Score Report revealed an unacceptable response for case number C1595.11. The target response was "C" and the laboratory's reported response was "B". The documentation did not include any indication of PT result review, evaluation, and corrective action measures taken for the unacceptable result. 4. The LD stated no evaluation of the conflicting CheckPath results was documented in 2013 or 2014. The interview occurred 03/10/2015 at 8:28 AM. D5311 493.1242(a) SPECIMEN SUBMISSION, HANDLING, AND REFERRAL D5311 320M The laboratory must establish and follow written policies and procedures for each of the following, if applicable: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 78 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5311 Continued From page 78 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5311 (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, Safety Event Reporting System (SERS) report, and an interview with Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to follow written policies and procedures for (7) Specimen acceptability and rejection. Findings Include: 1. Review of the laboratory's policy and procedure titled "Specimen Rejection Guidelines" found the following statements: "Policy: The laboratory follows this policy so as to ensure patient safety and provide accurate test results. Criteria: Specimens are rejected utilizing the following criteria. - Unlabeled or incorrectly labeled specimens (Specimen labeling requirements must be met See Section 3, III of the Lab Manual for Physicians and Nurses.) FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 79 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5311 Continued From page 79 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5311 - Specimen label/requisition information mismatch - Unsuitable specimen: incorrect specimen, insufficient volume (QNS), improper specimen transport temperature, age of specimen, improper patient preparation, etc. - Broken, leaking or damaged specimen container." 2. Review of the laboratory's SERS report from 02/10/2014 through 08/07/2014 revealed the following 17 issues: 16 out of 17 issues were documented as "Urine sample leaked in transport bag." 8 out of 16 of the documented leaking urine samples had the outcome reported as "New sample was collected." The other 8 out of 16 of the documented leaking urine samples had the outcome reported as "Specimen container disinfected & specimen was processed." 1 out of 17 issues was documented as "Wet Prep leaked in transport bag." The documented outcome of the wet prep (preparation) sample had the outcome reported as "Specimen container disinfected & specimen was processed." 3. Surveyor #2 asked TS#9 how the laboratory determined which leaking samples to process versus which leaking sample to reject. TS#9 stated they were not employed at this facility during the time of the occurrences and was unable to identify how the laboratory made a FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 80 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5311 Continued From page 80 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5311 determination on which leaking samples to process and which to reject. In addition, no identification of the potential contaminated containers was documented. TP#9 stated the laboratory's current process was if there was more than one specimen container in the same transport bag as a leaking specimen, the laboratory would reject the leaking specimen, disinfect the remaining containers, and process them as usual. The interview occurred on 03/12/2015 at 1:10 PM. D5401 493.1251(a) PROCEDURE MANUAL 110H 120M 130M 220M 310M 320M 330M 400M 610H 620H D5401 A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Item 1: Based on review of the laboratory's policy and procedure manual, activated clotting time (ACT) test records and final test reports, and interview with Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to follow the written procedures manual for the test activated clotting time (ACT). Findings Include: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 81 of 333 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 09/10/2015 FORM APPROVED OMB No 09300391 lined "Amwaled Tnne - Low Range 1ouno me Inllowing direclIons ~Reading/Repomng Results A ReporIIng Results/Result Format 1 Upon les1oomplelion, ImmedIalely lepnfl all les1 resulls, in seoonos, lo lne thsicIan who aide/ed me ACT les1 The resulls are also leoomeo In me 'Inlra-Fmoeduval Nuvsing Notes' Lug Procedures 1o1AbnomleI Results 1 Results lnel exoeeo '400' slum/Io he reponeo as 'gree1er than 400' Jr - Junior 2 Review 01 the Ieboremry's 2015 ACT 1esl leooms tilled JR SIGNATURE DAILV PATIENT 100/10 [he result documenlal/on Da1e 'nme- ResuIls 1/0/15 1235 - omnhange-HI 1/9/15 1252 Unkn HIm/Iclrange 1/10/15 0930 - H/gnouloIrenge 2/0/15 1030 HI 2/10/15 1320 -- Hlm/lnlrange 2/12/15 1432 HI-HI>>HIomnIrange 1/9/15 0945 oulo/rangemlgn~ 1/9/15 1515 -- blank 1/20/15 0925 -- oulo/nangemlgn~ 1/29/15 1404 - ~01/1ohange" 2/10/15 0920 1 Review o11ne laboratory's and plooeolne arm on me Hemoonron Signe1lne daily snug/em or DEFICIENCIES (x1) mnoeo/suppLIeo/em (x2) momma oonsmuonon 1st one suRva mo pun or eon/semen Inn/ago man eomgeo :laDosnnsu a we "mm" 5 NAME or pom/logo some>>: om em: up 12m ROAD unnvuloum noselm neon/1mm seamen: HEIGHTS, on 15 1on ID sum/m sum/em or oenoleneles .o PROVIDERS PLAN or common as (awn oenolenov MUST BE 9v Fuu poem 12m sumo 9E com/nine" TAG REGULATORY OR LSD IDENTIFYING INFORMATIONI TAG CROSSREFERENCED To THE APPROPRIATE oenolenoo 05401 Continued From page 91 05401 oul o/ range man ensign/mo Pmmuxvaman: ammo EvlnI ID own/1 anIlly ID monsoon neonllnoanon sneel Fly: 92 D1 PRINTED 09/10/2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE as MEDICAID SERVICES 0MB NO 093311301 omens/n or name/ores 1x1) pmroemupprremm 1x1) norm: EONSWUETIDN 1st one mo HAN or minimum NUMBER man oer/pram JEMIIDSU WING-- we or pom/rose on superior: cm em: 21>> 12:00 ROAD umvuoum HOSPIYAL uaommnv GARFIELD HEIGHTSIOH uus 1x010 sum/rm swam/r or more/ores .o pnovrozR-s PLAN or ammo/1 as poem INN omormov vusr oz av n/u new 12m coaaecnvuonon 9101/10 as WW YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED YHE APPROPRIAYE omorenon 05401 Continued From page 32 05401 Unkn - Unknown HI - Hign MR3 Medical Rewm Number 3. On 03/25/2015 a1 7 52 AM, Surveyor :11 [equesled' vio mail final Ies1 repons 1or1ne ACT lest lesul's listed above 1rorn TS 110 and 15 1112 TS 119 repIied, via email, on 03/25/2015 at 5-01 PM and slated "In response 1o 0011's request reoeived 3/25/2015 5117-52 on me lab worked 1o identify and oo1oin me requested Iewms In EPIC 01 me 15 records requested, 9 were identified and are ausched to emaII Iransmilisl For me remaIning 7 vewms, 1ne lab oanno1 pmduoe lewms 1rorn EPIC Prior Io Moron 13, 2015,1ne resuns Ieinng pedonned during prooedures in 1ne OperaIIng Room (OR) (i inIraoperoIive 1esIs) were verboIIy reported Io the nperaling physia'an and 1m vest/"s o1 me ACT Ies1 were recorded in 1ne 0R log book ThIs allowed 1ne physia'an sppropnalely order during Ine prooedure and respond Io Ine results prompuy However, 1ne HospiIsI Iewgnized eonier mIs rnon1n 1naI mis pramme wL/Id oreoie simonon in Much a po1ien1'sACT Ies1 resuII was no1 renamed in 1ne palienl's EPIC Iewr EPIC - HospiIaI's lnlc/malmn 5ys1enr 4. Review o11ne 0 nnoIIes1repons by TS 110 found 1ne fclIoerIg. Dale. 'nme- Resuns 1/5/15 1235 - omotrange@1235 :om 057.5671me Pram: Ila/Sm: omre Ev-m ID 01115011 non, ID humans: 11 sneel Pogo 03 av :33 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 09/10/2015 FORM APPROVED 0MB NO Ttre 1ollowrng regueated final tes1 reports were not provided Da1e. 'nme- ResuIts 1/9/15 1252 Unkn H1outo1range 2/5/15 1050 -- HI 2/10/15 1320 -- H1omo1range 2/12/15 1452 - HI-H1>>Hio01o1range 2/10/15 00211 outo/range 5. Included In the ACT 1est reoords was a document ma1 stale/1 anatysia waa perimde on all Teviewahle 1onris willrin1tre Iaoora1ory. Mul1rple cocurrenoes were observed wnere review was no1docurnen1ed. During velmacllve o11ornia no trends were noted Correcllve aotion includes revew o11ornrs by Me desingnee '15 110' or 110' at sta1ed intervals and mommy revew by teonnieal supervisors TS 113' or :19- aoproved by the medical director eIreo1we irrirnedia1ety.~ The document was slgned by the LD and dated 02/25/2015 Item 2- Based on review o1 tne laboratory's policies and procedures, Imerviews wi1n Supervisor (TS) as and Testing Personnel (TP) :9 (as llsled on the Laboratory Personnel Report (CLIA) anls slgned by the Laboratory amenem or oenerevciss 1x1) psovroes/euperes/em 1x1) numpLe coNsTRucTIoN our one sumv awn soul or coRREcnoN NUMBER man mvpLereo asmaansu a Wine 03mm" 5 was or pom/rose 01: some: cm em: 21>> 12:00 uccnacnew ROAD MARVMOUNT HOSPITAL LABORATORY GARFIELD OH 44125 1x41 ID sum/rm smeveur or oenoreveres .o psovroert-s mm or coscecnov oer were (BEN oenorsuov MUST as pcecsoeo av n/u poem 12m snouio as Wired TAG REGULATORY OR LSD IDENTIFYING INFORMATIONI TAG CROSSREFERENCED THE APPROPRIATE oenorsnon 05401 Continued From page 33 05401 1/15/15 00513 - High out o1 range 1/9/15 0045 out o1 range ~rrign~ 1/20/1 5 0025 - out o1 range ~rrign~ 1/29/1 5 1404 . out o1 range FORM culszsanmrwI Pram: Wm: omia Ev-m ID 01115011 quIIly ID oncosnaa sneel page 04 or 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5401 Continued From page 84 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5401 Director (LD) on 03/09/2015), and four confidential interviews, the laboratory failed to ensure written procedures for all tests, assays, and examinations performed by the laboratory were available to laboratory personnel. Findings Include: 1. Review of the laboratory's policy and procedure titled "Department of Laboratories Policy Manual Quality Management (Q.M.) and Performance Improvement (P.I.) Plan" found the following statements: "7. Documents and Records: The laboratory shall ensure that documents are identified, reviewed, approved, and retained and that records are created, stored, and archived in accordance with established policies. The laboratory maintains a complete set of current Policies and Procedures that apply to the Lab. They are readily available to personnel at the workbench in each section as hard copies or online. Institutional policies are available online. When an electronic manual is used, a backup hard copy or storage device will be available that can be accessed within a reasonable time to satisfy relevant needs and requirements." 2. Review of the laboratory's policy and procedure titled "Marymount Hospital Department of Laboratories - Transfusion Service Quality Program" found the following statements: "Section 1: Organization 1.3 Policies, Processes and Procedures: Quality and operational policies, processes and procedures are written in substantial compliance with the National Committee for Clinical FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 85 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5401 Continued From page 85 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5401 Laboratory Standards (NCCLS) in order to ensure satisfaction of blood bank standards. Policies, processes and procedures are available online in the LabQMS document control system. Paper copies are available in the Transfusion Service Departmental Policy Manual and the Department Technical Procedure Manuals." 3. A request was made of TS#8 on 03/10/2015 at 5:50 PM for the laboratory's policies and procedures for Prothrombin Time (PT), Activated Partial Thromboplastin Time (PTT), Fibrinogen, and D-Dimer. TS#8 attempted to access and print the above mentioned policies and procedures at the time of the request via the "LabQMS" document control system and was unable to login to the network. TS#8's attempt to access and print the requested policies and procedures from 3 other computer terminals was found to be unsuccessful. TS#8 stated the electronic information network was down at the time of the request. A second request was made of TS#8 on 03/10/2015 at 5:58 PM to access the laboratory's policies and procedures utilizing the back-up or alternative methods. TS#8 stated back-up method #1 is to contact a manager with managerial access to the "LabQMS" document control system. TS#8 attempted their managerial access and was not able to access the network. TS#8 further stated back-up method #2 is to contact Information System (IT) and have them print or fax the policies and procedures to the laboratory. TS#8 attempted to contact the IT department at 6:03 PM but there was no answer. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 86 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5401 Continued From page 86 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5401 TS#8 left a voice mail but never received a response. The requested policies and procedures for PT, PTT, Fibrinogen, and D-Dimer were provided to Surveyor #2 on 03/10/2015 at 6:16 PM (26 minutes from the requested time) after multiple attempts via back-up method #1. 4. During confidential interviews, which occurred 03/12/2015 from 3:25 PM through 6:36 PM, individuals stated the following: TP does not know how or where to retrieve policies and procedures when the network is down. TP stated if the network is down then they believe TP can access a "dummy" computer for policies and procedures. 5. TP #9 stated they were unsure how to get access to blood bank policies and procedures when the network is down. The interview occurred 03/12/2015 at 10:51 AM. D5413 493.1252(b) TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 510H 520H 530H 540H 550H D5413 The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 87 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5413 Continued From page 87 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5413 (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's policies and procedures, manufacturer's operating instructions, and interview with Testing Personnel (TP) #1 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to monitor and document the incubator temperature conditions of the ORTHO Workstations for ID-MTS Gel Cards. Findings Include: 1. Direct observation of the blood bank department on 03/10/2015 at 1:17 PM found two Ortho Clinical Diagnostics ORTHO Workstations, each unit consisting of an incubator and centrifuge, named, by the laboratory, "1" and "2". ORTHO Workstation "1" Serial Number: 51000866 ORTHO Workstation "2" Serial Number: 51000831 2. Review of the ORTHO Workstation manufacturer's operating instructions titled "ORTHO Workstation for ID-MTS Gel Cards Reference Guide" found the following directives: "Operational Guidelines The ORTHO Workstation incubator has one FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 88 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5413 Continued From page 88 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5413 heated block with two sections able to hold up to 10 cards each. NOTE: The incubator must not be used if the timer or temperature is out of specification." "Operational Guidelines NOTE: If the temperature indicator flashes red during incubation, discard all cards in incubation process. Avoid incubation until the temperature indicator returns to green." "Procedure- Incubate ID-MTS Gel Cards 2. Wait until the temperature of the ORTHO Workstation is stabilized (10 to 15 minutes) and the incubator temperature status display is green. If the temperature is not within the required limits the indicator will flash red and the incubator should not be used." 3. Review of the laboratory's policy and procedure titled "Antibody Identification by Gel Card Test Method Anti-IgG" found the following statements: "Antibody Identification Test Procedure: 5. Incubate at 37 degrees Celsius +/- 2 degrees Celsius for 15 minutes in the MTS gel card incubator." "Procedure Limitations: 5. Adherence to the test procedure is critical to test performance and outcome." Review of the laboratory's policy and procedure titled "Department of Laboratories - Transfusion Service Quality Program" found the following statement: "Section 3: Equipment 3.0 Equipment: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 89 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5413 Continued From page 89 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5413 3.5 Equipment Monitoring and Maintenance: The blood transfusion service has a process for scheduled monitoring and maintenance of equipment that at a minimum is in accordance with manufacturer's instructions. The process shall include: frequency of checks, check methods, acceptance criteria, and actions to be taken for unsatisfactory results." 4. Surveyor #1 requested the laboratory's temperature monitoring documentation for the ORTHO Workstations from TP #1. TP #1 stated the laboratory ensures the temperature indicator light is green before use but the laboratory does not currently document checking or monitoring the temperature indicator. TP #1 further stated "we were just working on re-doing the worksheet." The interview occurred 03/11/2015 at 10:19 AM. D5415 493.1252(c) TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT D5415 610H Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's policies and procedures, and an interview with the Laboratory Director (LD), Quality Coordinator #1 (as listed on the Laboratory Personnel Report (CLIA) Forms FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 90 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5415 Continued From page 90 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5415 CMS-209 signed by the LD on 03/09/2015) and the histopathology processor, the laboratory failed to label histopathology reagents and solutions to indicate expiration dates and lot numbers. Findings Include: 1. Review of the laboratory's policy and procedure titled "Quality Control in Histology" found the following statements: "Reagents, Solutions and Stains: All reagents, solutions and stains are properly labeled, as applicable and appropriate, with the following elements: Content, quantity, concentration or titer; stock or working solution reusable or to be discarded after use; storage requirements; date prepared or reconstituted by the section (including initials of the individual preparing the product) and the expiration date. These elements can be recorded in {sic} a paper or electronic log or on the container." 2. Review of the laboratory's policy and procedure titled "Frozen Section (FS) H&E Staining Using Leica ST4020 Linear Stainer & Manual Method" found the following: "Materials: All reagents/solutions have appropriate required dating on the original or subsequent containers." "Alternative Manual Staining Method: Solution Labels and Materials are identical. The slides are stained in the following order: 1. Frozen section fixative FORM CMS-2567(02-99) Previous Versions Obsolete 6-8 Dips Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 91 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5415 Continued From page 91 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5415 2. Distilled water Wash till slide clears 3. Gill's III Hematoxylin 45-60 seconds 4. Distilled water 8-10 dips 5. Acid rinse 2 dips 6. Distilled water Wash 7. Ammonia water 4-6 dips 8. Distilled water Wash till slide clears 9. Eosin 1 dip 10. 95% Reagent Alcohol 6-8 dips 11. 95% Reagent Alcohol 6-8 dips 12. 100% Alcohol 10 dips 13. Xylene 6-8 dips 14. Coverslip using synthetic mounting media" H&E; hematoxylin and eosin %; percent till; until 3. Direct observation of the Histology department's manual "staining line-up" under the ventilation hood on 03/11/2015 at 11:21 AM found a manual Histopathology slide staining station with 13 reagent, solution, and stain containers. Each container label was found lacking the lot number and expiration date of its' contents, as required. 4. The LD, Quality Coordinator #1, and Histopathology processor confirmed the laboratory did not label the containers of reagents, solutions, and stains to indicate expiration dates and lot numbers. The interview occurred on 03/11/2015 at 11:21 AM. D5417 493.1252(d) TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 510H 520H 530H 540H D5417 Reagents, solutions, culture media, control materials, calibration materials, and other FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 92 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5417 Continued From page 92 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5417 550H supplies must not be used when they have 610H exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's policies and procedures, and interviews with the Laboratory Director (LD) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015) and the Histopathology processor, the laboratory failed to ensure the histopathology reagent Xylene was not used when it had exceeded its expiration date. Findings Include: 1. Review of the laboratory's policy and procedure titled "Quality Control in Histology" found the following statements: "Reagents, Solutions and Stains: All reagents must be used within their indicated expiration date. Reagents lacking expiration date (or traceability to the expiration date) are not used. Once expired, the reagent or stain is discarded." 2. Review of the laboratory's policy and procedure titled "Frozen Section and Operating Room Consultation Procedure" found the following statement: "Quality Control: 3. Change stain solutions and Xylene once a month." 3. Direct observation of the Histopathology department's "staining line-up" under the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 93 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5417 Continued From page 93 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5417 ventilation hood on 03/11/2015 at 11:21 AM revealed a glass Coplin jar labeled "Xylene 10/10/13". When asked what the handwritten date referred to, the Histopathology processor stated the date on the container was the expiration date of the Xylene. 4. The LD and the Histopathology processor confirmed the glass Coplin jar found under the ventilation hood in the Histopathology "staining line-up" that was labeled "Xylene 10/10/13" was used beyond its expiration date. The interview occurred on 03/11/2015 at 11:21 AM. D5421 493.1253(b)(1) ESTABLISHMENT AND VERIFICATION OF PERFORMANCE 400M 510H 520H 530H 540H 550H D5421 Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i)(B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Item 1: Based on direct observation, review of the laboratory's policies and procedures, and interviews with Technical Supervisor (TS) #8, the Compliance Specialist (CS), and Testing Personnel (TP) #1 (as listed on the Laboratory FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 94 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5421 Continued From page 94 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5421 Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer when it introduced the unmodified, FDA-cleared ORTHO Workstations for ID-MTS Gel Cards. Findings Include: 1. Direct observation of the blood bank department on 03/10/2015 at 1:17 PM found two Ortho Clinical Diagnostics ORTHO Workstations, each unit consisting of an incubator and centrifuge, named, by the laboratory, "1" and "2". ORTHO Workstation "1" Serial Number: 51000866 ORTHO Workstation "2" Serial Number: 51000831 2. TP #1 stated the ORTHO Workstations were new to the laboratory as of January 2015. Surveyor #1 requested the laboratory's validation documentation, demonstrating the laboratory could obtain the same performance specifications as stated by the manufacturer, for both ORTHO Workstations. TP #1 stated the manufacturer calibrated and validated the units prior to shipping and the laboratory had not performed or documented any additional validations or verifications when they received the units. The interview occurred 03/11/2015 at 10:13 AM. The CS provided the manufacturer's performance FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 95 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5421 Continued From page 95 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5421 specification and validation documentation titled "PLEXUS STORM S/N Measurement Reporting" which contained the following information: STORM - Board History (Measurements) Assembly: J56346 Serial: 51000831 Date: 05-Jan-15 10:13 AM STORM - Board History (Measurements) Assembly: J56346 Serial: 51000866 Date: 19-Jan-15 12:05 PM The documents were signed by TP #1 and dated 03/04/15. Additionally, the CS provided documentation from the hospital's clinical engineering department, titled "Asset Detail", which contained the following information: Asset Number: 182699 - Ortho Workstation Category: Centrifuge, Blood Bank Status: Active - PM Scheduled Location: Marymount - Marymount Hospital (Main) - Blood Bank Blood Bank Model Number: 6904630 Serial Number: 51000866 Notes: #182698 and #182699 are replacements sent by OEM for #182551 (which was also a replacement) Two-part device is a centrifuge and an incubator. Work Order 2195644 Category Incoming Inspection Status Complete Scheduled 02/20/2015 Completed 02/17/2015 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 96 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5421 Continued From page 96 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5421 Asset Number: 182698 - Ortho Workstation Category: Centrifuge, Blood Bank Status: Active - PM Scheduled Location: Marymount - Marymount Hospital (Main) - Blood Bank Blood Bank Model Number: 6904630 Serial Number: 51000831 Notes: #182698 and #182699 are replacements sent by OEM for #182551 (which was also a replacement) Two-part device is a centrifuge and an incubator. Work Order 2195642 Category Incoming Inspection Status Complete Scheduled 02/20/2015 Completed 02/17/2015 PM - Preventative Maintenance 3. Surveyor #1 requested the laboratory's instrument validation policies and procedures from TS #8, the CS, and TP #1. The laboratory provided the following policies and procedures: - "Department of Laboratories - Transfusion Service Quality Program" which stated: "Section 3: Equipment 3.0 Equipment: Marymount Hospital Transfusion Service has identified the equipment that is critical to the provision of blood, blood components and services. Marymount Hospital Transfusion Service has policies, processes and procedures that ensure that calibration, maintenance and monitoring of equipment conform to these standards and other specified requirements. (See BB Policy Manual - Qualification of Suppliers/Supplies/Equipment Policy)" FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 97 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5421 Continued From page 97 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5421 "Section 3: Equipment 3.0 Equipment: 3.5.1 Calibration of Equipment Calibrations and/or adjustments shall be performed using equipment and materials that have adequate accuracy and precision. At a minimum, calibrations shall be performed 1) before use 2) After activities that may affect the calibration, and 3) at prescribed intervals (See BB QC and Instrument Maintenance Manual)" - "Qualification of Suppliers/Supplies/Equipment Policy" which stated: "Critical Equipment: Critical equipment is defined as equipment that is critical to the provision of blood or blood components. 1. Qualifications: Manufacturers must meet FDA and AABB guidelines/standards. The Transfusion Service has policies, processes, and procedures in place to ensure that calibration, maintenance, and monitoring of equipment conforms to AABB standards and requirements. 2. Equipment List" The following were listed on the "Equipment List": Equipment: MTS Incubator A MTS Incubator B MTS Centrifuge A MTS Centrifuge B Manufacturer: Ortho Ortho Ortho Ortho Serial Number: 2250773571 2251777350 01113009 08097801 The laboratory's current ORTHO Workstations FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 98 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5421 Continued From page 98 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5421 were not included on the equipment list. "Critical Equipment: 3. Calibration and Maintenance - See the QC and Instrument Maintenance Manual for details." - No additional blood bank policies and procedures were provided. Item 2: Based on review of the laboratory's policies and procedures, body fluid test records, and interviews with Technical Supervisor (TS)#9 and Testing Personnel (TP) #10 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for (1)(i)(A) Accuracy, (1)(i)(B) Precision, (1)(i)(C) Reportable range of test results for the test system, and (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population for automated body fluid cell count testing procedures performed on the Sysmex XE-5000 Hematology analyzer. Findings Include: 1. Review of the laboratory's policy and procedure titled "Body Fluid Analysis Procedure Manual Serous Fluids (Pleural, Pericardial, Peritoneal)" found the following statement: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 99 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5421 Continued From page 99 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5421 "Notes: 4. If the fluid is grossly bloody and not clotted or too viscous, it can be run through the XE5000 analyzer to get the RBC count. The WBC count should be verified by dilution." 2. Review of 2 patients' pleural fluid records from 01/14/2015 and 01/25/2015 found a Sysmex XE-5000 body fluid instrument printout, a manual cell count "Fluid Worksheet", and a laboratory information system (LIS) result printout for each patient. 3. TP#10 stated they only run pleural fluids through the XE-5000 to gauge if manual dilution is needed. TP#10 further stated they do not report the automated results. The interview occurred 03/12/2015 at 8:21 AM. 4. Surveyor #2 requested the laboratory's performance specification documentation for automated body fluid cell count testing performed on the Sysmex XE-5000 Hematology analyzer. TS#9 explained the laboratory had performed a small study in 2014, utilizing patient body fluid samples (when available), to assess performance specifications. The laboratory sent all of their performance specification documentation to another facility for evaluation. TS#9 further stated they received verbal communication from the facility evaluating the performance specification documentation indicating body fluid cell counts on the Sysmex XE-5000 Hematology analyzer could not be validated. Lastly, TS#9 stated the laboratory had not FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 100 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5421 Continued From page 100 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5421 maintained documentation of the activities described above. The interview occurred on 03/12/2015 at 8:25 AM. D5429 493.1254(a)(1) MAINTENANCE AND FUNCTION CHECKS D5429 310M 320H For unmodified manufacturer's equipment, 400H instruments, or test systems, the laboratory must 610H perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's policies and procedures, and an interview with Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to perform and document hematology and urinalysis centrifuge maintenance procedures. Findings Include: 1. Review of the laboratory's policy and procedure titled "Department of Laboratories Policy Manual Quality Management (Q.M.) and Performance Improvement (P.I.) Plan" found the following statements: "3. Equipment: All instruments must have a routine preventative maintenance schedule. There will be a written policy and procedure for preventative maintenance including periodic inspection and appropriate performance testing. The manufacturer's guidelines may be used in writing such a policy. The document details the maintenance, service and repair aspects of the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 101 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5429 Continued From page 101 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5429 program. Appropriate steps will be undertaken to prevent or reduce ultraviolet light exposure from any instrument so equipped. This will be done in conjunction with Biomedical Engineering and will be so documented: Manufacturer, supplier or representatives address and phone numbers; date purchased; date placed in use, etc. Service manuals on all equipment/instruments are to be saved and readily available. It is the responsibility of the Team Leader of Section Head to ensure that all aspects of preventative maintenance are being complied with. The acceptability and/or performance limits for the instruments, service records (contract if utilized) and other necessary documentation are to be reviewed, updated and saved." 2. Review of the laboratory's policy and procedure titled "Urinalysis Quality Control Program" found the following statement: "B. Instrument Function and Maintenance: 2. The EBA-20 centrifuge is cleaned and checked daily." 3. Direct observation of the Hematology centrifuges and an interview with TS#9 on 03/10/2015 at 11:42 AM revealed the following: Centrifuges Hettich Zentrifugen EBA 20S (143287) a. TS#9 explained this centrifuge is used for processing coagulation samples. b. A service sticker on the coagulation centrifuge indicated "SERVICE DUE 5/15". Hettich Zentrifugen Rotofix 32 (336489) a. TS#9 explained this is the cytospin FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 102 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5429 Continued From page 102 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5429 centrifuge used for preparing patient body fluid differential slides. b. A service sticker on the cytospin centrifuge indicated "SERVICE DUE 5/15". Hettrich Zentrifugen EBA 20 (143288) a. TS#9 explained this centrifuge is used for processing urine samples for microscopic examination. b. A service sticker on the urine centrifuge indicated "SERVICE DUE 5/15". 4. Surveyor #2 requested policies, procedures, and maintenance documentation for the 3 centrifuges from TS#9. TS#9 stated another hospital department was responsible for vendor services and records and the laboratory did not maintain any centrifuge service and maintenance records. No documentation was provided for review by the survey exit date. The interviews occurred 03/10/2015 at 11:42 AM and 03/12/2015 at 4:30 PM. D5431 493.1254(a)(2) MAINTENANCE AND FUNCTION CHECKS 510H 520H 530H 540H 550H D5431 For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, manufacturer's operating instructions, product delivery documentation, and interview with Testing Personnel (TP) #1 and the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 103 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5431 Continued From page 103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5431 Compliance Specialist (CS) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to perform and document immunohematology pippette function checks as defined by the manufacturer prior to patient testing. Findings Include: 1. Review of the laboratory's policy and procedure titled "Department of Laboratories - Transfusion Service Quality Program" found the following statements: "Section 3: Equipment 3.0 Equipment: Marymount Hospital Transfusion Service has identified the equipment that is critical to the provision of blood, blood components and services. Marymount Hospital Transfusion Service has policies, processes and procedures that ensure that calibration, maintenance and monitoring of equipment conform to these standards and other specified requirements. (See BB Policy Manual - Qualification of Suppliers/Supplies/Equipment Policy)" "Section 3: Equipment 3.0 Equipment: 3.5 Equipment Monitoring and Maintenance: The blood transfusion service has a process for scheduled monitoring and maintenance of equipment that at a minimum is in accordance with manufacturer's instructions. The process shall include: frequency of checks, check methods, acceptance criteria, and actions to be taken for unsatisfactory results." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 104 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5431 Continued From page 104 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5431 "Section 3: Equipment 3.0 Equipment: 3.5 Equipment Monitoring and Maintenance: 3.5.1 Calibration of Equipment Calibrations and/or adjustments shall be performed using equipment and materials that have adequate accuracy and precision. At a minimum, calibrations shall be performed 1) before use 2) After activities that may affect the calibration, and 3) at prescribed intervals 3.5.1.1 There are safeguards in place to prevent equipment from adjustments that would invalidate the calibrated setting." - Review of the laboratory's procedure titled "Qualification of Suppliers/Supplies/Equipment Policy" found the following statements: "Critical Equipment: Critical equipment is defined as equipment that is critical to the provision of blood or blood components. 1. Qualifications: Manufacturers must meet FDA and AABB guidelines/standards. The Transfusion Service has policies, processes, and procedures in place to ensure that calibration, maintenance, and monitoring of equipment conforms to AABB standards and requirements. 2. Equipment List" The following were listed on the "Equipment List": Equipment: MTS Pipettor A MTS Pipettor B Manufacturer: Ortho Ortho Serial Number: A11710111 A10105651 2. Surveyor #1 requested the laboratory's FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 105 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5431 Continued From page 105 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5431 calibration documentation for the pipettes utilized in the immunohematology department from TP #1. TP #1 stated the laboratory received new pipettes in June 2014 and August 2014 and so calibrations were not due yet. Surveyor #1 asked TP #1 if the laboratory had calibrated the pipettes upon receipt and TP #1 stated no because the manufacturer had performed calibrations on the pipettes prior to shipping. The interview occurred 03/11/2015 at 9:50 AM. Surveyor #1 then requested documentation of the manufacturer's calibration and documentation demonstrating when the laboratory received the new pipettes from TP #1 and the CS. 3. Review of the requested documentation provided by TP #1 and the CS found the following: Cleveland Clinic Health System Delivery Ticket Vend PurchFrLoc: Pl J & J Healthcare Receipt Date: 08/21/14 Requesting Location: MALBB Blood Lab Del to Lab 12300 MCCRACKEN RD SH-SH-NONE GARFIELD HEIGHTS OH 44125 Deliver To: Blood Bank - Lab Item: 216939 PIPETR ANLZR ID TIPMASTER REPL ------------------------------------------------------------FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 106 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5431 Continued From page 106 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5431 Cleveland Clinic Health System Delivery Ticket Vend PurchFrLoc: Pl J & J Healthcare Receipt Date: 06/26/14 Requesting Location: MALBB Blood Lab Del to Lab 12300 MCCRACKEN RD SH-SH-NONE GARFIELD HEIGHTS OH 44125 Deliver To: Blood Bank - Lab Item: 216939 PIPETR ANLZR ID TIPMASTER REPL ----------------------------------------------------------Micro Typing Systems, Inc Test Report Pippette type: ID-Tipmaster TM-A Serial No.: A14302481 Test Date: 2014/03/20 Date Printed: 2014/03/20 The documentation demonstrated calibration utilizing 3 test volumes. Micro Typing Systems, Inc Test Report Pippette type: ID-Tipmaster TM-A Serial No.: A14406251 Test Date: 2014/04/18 Date Printed: 2014/04/18 The documentation demonstrated calibration utilizing 3 test volumes and included a handwritten note that stated "in use 8-21-14". Included with both test reports was a 1/3 sheet of paper with the following statement: "Inspection and Calibration Statement The enclosed pipettor was tested and calibrated under closely controlled environmental conditions FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 107 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 12300 MCCRACKEN ROAD GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5431 Continued From page 107 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5431 to ensure that it meets published calibration specifications. The precision and accuracy results obtained for this pipettor are provided on the enclosed calibration certificate. Because temperature and humidity conditions affect the calibration results of liquid measurement devices, your pipettor should be calibrated under conditions of use. The calibration results obtained in your laboratory may vary from our results due to differences in environmental testing conditions." D5433 493.1254(b)(1) MAINTENANCE AND FUNCTION CHECKS 320M 400H 510H 520H 530H 540H 550H 610H 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ D5433 For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Item 1: Based on direct observation, review of the laboratory's policies and procedures, and interview with Testing Personnel (TP) #5 and Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to establish, perform, and document a maintenance and function check protocol that ensures microscope performance which is necessary for accurate and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 108 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5433 Continued From page 108 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5433 reliable Gram stain and wet preparation test results and test result reporting. Findings Include: 1. Review of the laboratory's policies and procedures found: A procedure titled "Gram Stains" which stated: "Interpretation of Direct Gram Stains: Gram stains are examined microscopically under oil immersion with a 100X objective." A procedure titled "Wet Preparation Trichomonas, Yeast, Clue Cells" which stated: "Instrumentation: Microscope" 2. Direct observation of the microbiology laboratory on 03/10/2015 at 11:15 AM found a Zeiss Axioskop microscope with the serial number of 113417. TP #5 stated testing personnel also examine Gram stains on the hematology microscope. Direct observation of the hematology department on 03/10/2015 at 11:15 AM found an Olympus BX43 microscope with the serial number of 0G89174. 3. TP #5 stated testing personnel clean the microbiology microscope, on average, two times per week. Surveyor #1 requested documentation of the microscope maintenance described by TP #5. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 109 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5433 Continued From page 109 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5433 TP #5 stated the testing personnel did not document any of the weekly microscope maintenance. The interview occurred 03/10/2015 at 11:23 AM. 4. The surveyor requested the laboratory's microscope maintenance policies and procedures from TS #8 and #9, the Point-of-Care Supervisor, and the Compliance Specialist on 03/10/2015, 03/11/2015, 03/12/2015, and 03/13/2015. The laboratory provided a procedure titled "Histology and Cytology - Equipment". No additional microscope maintenance policies and procedures were provided. Item 2: Based on direct observation, review of the laboratory's policies and procedures, and interview with Technical Supervisor (TS) #8, the Compliance Specialist (CS), Testing Personnel (TP) #9, and the Laboratory Director (LD) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015), the laboratory failed to establish, perform, and document a maintenance and function check protocol that ensures microscope performance which is necessary for accurate and reliable immunohematology test results and test result reporting. Findings Include: 1. Upon request for the laboratory's microscope maintenance policies and procedures from TS #8, the CS, and TP #9 the laboratory provided the following policies and procedures: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 110 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5433 Continued From page 110 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5433 - "Department of Laboratories - Transfusion Service Quality Program" which stated: "Section 3: Equipment 3.0 Equipment: Marymount Hospital Transfusion Service has identified the equipment that is critical to the provision of blood, blood components and services. Marymount Hospital Transfusion Service has policies, processes and procedures that ensure that calibration, maintenance and monitoring of equipment conform to these standards and other specified requirements. (See BB Policy Manual - Qualification of Suppliers/Supplies/Equipment Policy)" - "Qualification of Suppliers/Supplies/Equipment Policy" which stated: "Critical Equipment: Critical equipment is defined as equipment that is critical to the provision of blood or blood components. 1. Qualifications: Manufacturers must meet FDA and AABB guidelines/standards. The Transfusion Service has policies, processes, and procedures in place to ensure that calibration, maintenance, and monitoring of equipment conforms to AABB standards and requirements. 2. Equipment List" The following were listed on the "Equipment List": EBA20-S Centrifuge DH4 Plasma Thawer IB245 2 Door Refrigerator A IB245 2 Door Refrigerator B IPF 125-8 Freezer FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 111 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5433 Continued From page 111 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5433 PC100i Platelet Incubator PF15i Platelet Agitator EBA21 Serofuge A EBA 21 Serofuge B UltraCW Cellwasher MTS Incubator A MTS Incubator B MTS Centrifuge A MTS Centrifuge B MTS Pipettor A MTS Pipettor B "Critical Equipment: 3. Calibration and Maintenance - See the QC and Instrument Maintenance Manual for details." - No additional blood bank policies and procedures were provided. 2. Direct observation of the blood bank department on 03/10/2015 at 1:17 PM found a Zeiss Standard25 double-headed microscope with the serial number of 009812. 3. On 03/12/2015, Surveyor #1 requested the blood bank microscope maintenance documentation from the CS and TP #9. The CS provided an Ohio Optics Microscope Service Record which was dated 4/14. TP #9 stated testing personnel did clean the microscope occasionally but was unable to locate the documentation. The interview occurred 03/12/2015 at 10:54 AM. 4. The surveyor requested the laboratory's microscope maintenance policies and procedures from TS #8 and #9, the Point-of-Care Supervisor, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 112 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5433 Continued From page 112 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5433 and the CS on 03/10/2015, 03/11/2015, 03/12/2015, and 03/13/2015. The laboratory provided multiple policies and procedures (as mentioned above) and a procedure titled "Histology and Cytology Equipment". No additional microscope maintenance policies and procedures were provided. The LD stated there was no specific microscope maintenance policy and procedure for the blood bank microscope. The interview occurred 03/13/2015 at 11:15 AM. Item 3: Based on direct observation, review of the laboratory's policies and procedures, and interviews with the Laboratory Director (LD), Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015), and the Histopathology processor, the laboratory failed to perform and document hematology, urinalysis, and histopathology microscope maintenance procedures. Findings Include: 1. Review of the laboratory's policy and procedure titled "Department of Laboratories Policy Manual Quality Management (Q.M.) and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 113 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5433 Continued From page 113 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5433 Performance Improvement (P.I.) Plan" found the following statements: "3. Equipment: All instruments must have a routine preventative maintenance schedule. There will be a written policy and procedure for preventative maintenance including periodic inspection and appropriate performance testing. The manufacturer's guidelines may be used in writing such a policy. The document details the maintenance, service and repair aspects of the program. Appropriate steps will be undertaken to prevent or reduce ultraviolet light exposure from any instrument so equipped. This will be done in conjunction with Biomedical Engineering and will be so documented: Manufacturer, supplier or representatives address and phone numbers; date purchased; date placed in use, etc. Service manuals on all equipment/instruments are to be saved and readily available. It is the responsibility of the Team Leader of Section Head to ensure that all aspects of preventative maintenance are being complied with. The acceptability and/or performance limits for the instruments, service records (contract if utilized) and other necessary documentation are to be reviewed, updated and saved." 2. Review of the laboratory's policy and procedure titled "Quality Control in Histology" found the following statements: "Equipment and Instruments: Appropriate monitoring including function verification and preventative maintenance is undertaken on all equipment used. This is documented in logs. Compliance with instrument maintenance and following of regular procedure FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 114 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5433 Continued From page 114 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5433 pertaining to cases, solutions, etc are strictly enforced. Procedures for such are available in the section and compliance is recorded. Log sheets are maintained and documented for temperatures (refrigerator - 2° to 8° and freezer: -15° to -25° C), daily care of instruments and any service performed on instruments in the maintenance service records. Recordkeeping: All required record keeping is undertaken. Elements can be recorded in a paper or electronic log. Included in the recordkeeping are the following: Daily Accession Log with Histology Summary Daily CoPath Embedding Log Special Stains and Recut Log Instrument Maintenance/Service Logs" C; Celsius 3. Review of the laboratory's policy and procedure titled "Histology and Cytology Equipment" found the following statements: "Microscopes: Annual servicing is performed by a vendor." 4. Direct observation of the Hematology department on 03/10/2015 at 11:42 AM revealed the following: Microscopes Olympus BX43 (401579) a. TS#9 explained this microscope is used for manual blood and body fluid cell counts and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 115 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5433 Continued From page 115 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5433 differential examinations. b. A service sticker on the microscope indicated "Done 4/14 Due 4/15". Zeiss Axoskop40 (115122) a. TS#9 explained this digital microscope is a back-up microscope used for manual blood and body fluid cell counts and differential examinations. b. No service sticker was on the microscope. Olympus BX43 (151834) a. TS#9 explained this microscope is used for urine sediment examinations. b. A service sticker on the microscope indicated "Done 4/14 Due 4/15". 5. Direct observation of the Histopathology department on 03/12/2015 at 4:30 PM revealed the following: Olympus BX43 (1G31493) a. The Histopathology processor explained this microscope is used for frozen section slide interpretations. b. No service sticker was on the microscope. Olympus BX43 (0L57685) a. The LD explained this microscope is used for Histopathology biopsy slide interpretations. b. A service sticker on the microscope indicated "Due 4/15". 6. Surveyor #2 requested policies, procedures, and maintenance documentation for the 5 microscopes from the LD, TS#9, and the histopathology processor. The LD, TS#9, and the histopathology processor stated another hospital department was responsible for vendor services FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 116 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5433 Continued From page 116 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5433 and records and the laboratory did not maintain any microscope service and maintenance records. No documentation was provided for review by the survey exit date. The interviews occurred 03/10/2015 at 11:42 AM and 03/12/2015 at 4:30 PM. D5437 493.1255(a) CALIBRATION AND CALIBRATION VERIFICATION D5437 400M Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in §493.1253(b)(3)-(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, quality control (QC) Levey Jennings graph documentation, calibration documentation, and an interview with Technical Supervisor (TS)#9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 117 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5437 Continued From page 117 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5437 Laboratory Director (LD) on 03/09/2015), the laboratory failed to perform and document calibration procedures for the analytes D-Dimer and fibrinogen. Findings Include: 1. Review of the laboratory's policy and procedure titled "Manual of Operations Quality Control Policy and Procedure" found the following statements: "G. Records The laboratory must document and maintain records of all quality control activities including QC records, corrective action, calibration, and calibration verification and retain records for at least two years." "II. Quality Control (QC) H. Review 2. Monthly Review For quantitative assays, quality control statistics are performed at least monthly to define analytic imprecision and to monitor trends over time." "H. Review 2. Monthly Review a. Medical Director or designee must review and sign the QC report. Review the monthly QC report for the following: 1) Trends, shifts and corrective action" "IV. QC Action Guidelines for Quantitative and Semi-Quantitative/Qualitative Testing A. Daily Quality Control Action Procedure for Quantitative Tests 8. Shifts and Trends a. The detection of shifts and trends will be FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 118 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5437 Continued From page 118 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5437 monitored in the Sunquest laboratory computer system with the appropriate Westgard Rules, including, but not limited to: R2S3: Two out of three consecutive QC results are greater than two SD on the same side of the mean. R41S: Four consecutive QC results are more than one SD away from the mean in the same direction." "IV. QC Action Guidelines for Quantitative and Semi-Quantitative/Qualitative Testing A. Daily Quality Control Action Procedure for Quantitative Tests 8. Shifts and Trends c. The testing personnel are responsible for investigating and determining if a corrective action is required. If investigation indicated potential incorrect patient results, do not release patient results until the problem has been corrected or an alternative procedure employed. If the testing personnel feel that corrective action, such as a calibration, is indicated, that action should be taken and documented. The run should be checked or repeated as appropriate." 2. Review of the laboratory's policy and procedure titled "Innovance D-Dimer - CA1500" found the following statements: "Calibration: The reference curve is valid for the respective lot of the reagent employed. A new curve should be prepared with a new lot of Innovance D-Dimer using Innovance D-Dimer Calibrator provided in the same kit and if indicated by any change in analytical conditions. The calibration curve can be used as long as the assay-dependent FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 119 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5437 Continued From page 119 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5437 assigned values are within the corresponding acceptance ranges. A new curve should be run every 6 months if the lot of reagent does not change." 3. Review of the laboratory's policy and procedure titled "Fibrinogen - Calibration and QC" found the following statements: "Principle: Calibration - The reference curve is valid for the respective lot of the reagent employed. A new curve should be prepared with a new lot of Thrombin, if indicated by any change in analytical conditions, or every six months, using Standard Human Plasma Calibrator." 4. Review of the manufacturer's package inserts found the following statements: "Siemens Innovance D-Dimer Calibration A new calibration is required: For each new lot of Innovance D-Dimer Kit. After major maintenance or service, if indicated by quality control results As indicated in laboratory quality control procedures When required by government regulations" "Siemens Dade Thrombin Reagent Calculating the Reference Curve A new reference curve must be established each time there is a change in equipment or a new lot of Dade Thrombin Reagent is used." 5. Review of the laboratory's 2014 and 2015 CA-1500 (A7391) and CA1500 (A8134) fibrinogen and D-Dimer QC Levey Jennings FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 120 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5437 Continued From page 120 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5437 graphs and instrument calibration printouts revealed the following on-going shifts of consecutive QC data points and calibration procedures performed: CA-1500 (A7391) D-Dimer Citrol 1, lot #560762 February 2014 - 33 below the mean March 2014 - 18 below the mean and a second shift of 23 below the mean April 2014 - 50 below the mean May 2014 - 37 below the mean and a second shift of 15 below the mean June 2014 - 44 below the mean Calibration performed 6/25/2014 July 2014 - 17 below the mean and a second shift of 32 below the mean Calibration performed 7/4/2014 August 2014 - 28 below the mean September 2014 - 39 below the mean Calibration performed 9/22/2014 October 2014 - 25 above the mean Calibration performed 11/10/2014 Citrol 1, lot #560777 November 2014 - 20 above the mean Calibration performed 11/21/2014 January 2015 - 12 and 13 above the mean D-Dimer Control 2, lot #560663 February 2014 - 19 below the mean and a second shift of 28 below the mean March 2014 - 44 below the mean April 2014 - 50 below the mean May 2014 - 42 below the mean and a second shift of 12 below the mean June 2014 - 39 below the mean Calibration performed 6/25/2014 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 121 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5437 Continued From page 121 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5437 July 2014 - 50 below the mean Calibration performed 7/4/2014 August 2014 - 24 below the mean September 2014 - 21 below the mean and a second shift of 19 below the mean Calibration performed 9/22/2014 Fibrinogen Citrol 1, lot #528149B May 2014 - 24 below the mean July 2014 - 12 below the mean August 2014 - 18 below the mean September 2014 - 19 below the mean Citrol 1, lot #548001 February 2015 - 11 above the mean Fibrinogen Abnormal Control, lot #528672 September 2014 - 17 below the mean October 2014 - 13 below the mean CA1500 (A8134) D-Dimer Citrol 1, lot #560663 February 2014 - 20 below the mean and a second shift of 13 below the mean Citrol 1, lot #560777 November 2014 - 11 above the mean January 2015 - 28 above the mean D-Dimer Control 2, lot #560678 January 2015 - 21 above the mean Fibrinogen Citrol 1, lot #528149B November 2014 - 10 below the mean Citrol 1, lot #548001 February 2015 - 10 above the mean FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 122 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5437 Continued From page 122 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5437 6. Surveyor #2 requested the laboratory's 2014 and 2015 D-Dimer and fibrinogen calibration documentation from TS#9. TS#9 was unable to locate any additional D-Dimer calibration documentation and no fibrinogen calibration documentation. The interview occurred on 03/10/2015 at 10:55 AM. D5439 493.1255(b) CALIBRATION AND CALIBRATION VERIFICATION D5439 400M Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under §493.1253(b)(3)-(b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 123 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5439 Continued From page 123 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5439 or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and an interview with Technical Supervisor (TS)#9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to perform and document D-Dimer and fibrinogen calibration verification procedures (b)(3) At least once every 6 months and whenever any of the following occurred: (b) (3)(i) A complete change of reagents, (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance, and (b)(3)(iii) Control materials reflect an unusual shift, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. Findings Include: 1. Review of the laboratory's policy and procedure titled "Manual of Operations Quality Control Policy and Procedure" found the following statement: "II. Quality Control (QC) G. Records FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 124 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5439 Continued From page 124 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5439 The laboratory must document and maintain records of all quality control activities including QC records, corrective action, calibration, and calibration verification and retain records for at least two years." 2. Review of the laboratory's policies and procedures titled "Innovance D-Dimer - CA1500" and "Fibrinogen - Calibration and QC" found no mention of calibration verification procedures. 3. Surveyor #2 requested the laboratory's D-Dimer and fibrinogen calibration verification policies and procedures. TS#9 stated that the laboratory performed the same 2 levels of quality control (QC) materials each time D-Dimer and fibrinogen reagents are put on the analyzer and after calibration procedures. The interview occurred 03/10/2015 at 10:40 AM. D5447 493.1256(d)(3)(i)(g) CONTROL PROCEDURES D5447 320M Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-At least once a day patient specimens are assayed or examined perform the following for-Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, urine quality control (QC) documentation, and an interview with Technical FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 125 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5447 Continued From page 125 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5447 Supervisor (TS)#9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to perform and document two control materials of different concentrations each day quantitative urine microscopic examinations were performed. Findings Include: 1. Review of the laboratory's policy and procedure titled "Manual of Operations Quality Control Policy and Procedure" found the following statements: "II. Quality Control (QC) A. General Criteria Controls are used to ensure that a test system is performing correctly. For each test procedure, the identity, concentration, number, and frequency of testing controls should be defined. The quality control samples should be included during routine testing and are subjected to as much of the total testing process as possible. QC samples must be tested in the same manner and by the same testing personnel as patient specimens. The principle is that the quality control samples detect system failures or errors in patient testing." "II. Quality Control (QC) C. Quality Control Frequency 2. Non-Waived Tests 1) Quantitative For quantitative tests, a minimum of two controls at two different concentrations must be run daily or with each batch of samples/reagents FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 126 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5447 Continued From page 126 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5447 unless a different frequency is specifically required." 2. Review of the laboratory's policy and procedure titled "Urinalysis (Microscopic Examination)" found the following statements: "Quality Control: Pour off Quantify Plus liquid control Level I and II into urisystem tube. Swirl contents gently to mix contents. Allow to stand for a minimum of 20 minutes before analysis. Store at 2-8°C. Analyze control materials in the same manner as patient samples." "Procedure: 9. Enumerate the number of RBCs and WBCs per high power field. Count 10 fields and take the average." 3. Review of 10 patient urine microscopic test reports revealed the following quantitative test results: 09/24/2013 WBC, Urine 0-5 RBC, Urine 0-3 09/25/2013 WBC, Urine 0-5 RBC, Urine 0-3 09/25/2013 WBC, Urine 0-5 RBC, Urine 6-10 05/05/2014 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 127 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5447 Continued From page 127 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5447 WBC, Urine 11-25 RBC, Urine >25 05/05/2014 WBC, Urine >25 RBC, Urine 3-5 05/05/2014 WBC, Urine 0-5 RBC, Urine 0-3 05/05/2014 WBC, Urine 0-5 RBC, Urine 0-3 05/05/2014 WBC, Urine 0-5 RBC, Urine 0-3 03/03/2015 WBC, Urine 0-5 RBC, Urine 0-3 03/05/2015 WBC, Urine 0-5 RBC, Urine 0-3 4. Review of the laboratory's 2014 and 2015 "Routine Urine Quality Control" log sheets found no quantitative urine microscopic QC documentation from November 2014 through March, 10, 2015. 5. Surveyor #2 requested the laboratory's quantitative urine microscopic QC documentation for November 2014 through March, 10 2015 from TS#9. TS#9 stated the laboratory had revised the "Routine Urine Quality Control" log sheet and accidentally removed the "Micro WBC/RBC" FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 128 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5447 Continued From page 128 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5447 column. TS#9 further stated the laboratory has photographs for urine microscopic QC and the laboratory did not document any urine microscopic QC testing from November 2014 through March 10, 2015. The interview occurred on 3/10/2015 at 9:17 AM. WBC; white blood cell RBC; red blood cell micro; microscopic D5463 493.1256(d)(7)(g) CONTROL PROCEDURES D5463 400M Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-Over time, rotate control material testing among all operators who perform the test. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's policies and procedures, quality control (QC) records, Form CMS-209, and interview with Technical Consultant (TC) #2 and the Point-of-Care Supervisor (PS) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to, over time, rotate activated clotting time (ACT) control material testing among all operators who perform the test on the Hemachron Junior (Jr.) Signature +. Findings Include: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 129 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5463 Continued From page 129 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5463 1. Review of the Form CMS-209 found 17 individuals, Testing Personnel (TP) #17 through #33, certified by the LD to perform moderate complexity testing. The PS stated TP #17 through #33 performed ACT testing under this CLIA number. The PS further explained the ACT testing was performed in two locations of the hospital, interventional radiology and general surgery. The interview occurred 03/09/2015 at 8:46 AM. 2. Direct observation of the interventional radiology department on 03/10/2015 at 9:39 AM found a Hemachron Jr. Signature + instrument with the serial number of SP2990. Direct observation in a general surgery office on 03/10/2015 at 9:54 AM found a Hemachron Jr. Signature + instrument with the serial number of SP5639. 3. Review of the laboratory's policy and procedure titled "Quality Control Policy and Procedure" found the following directions: "II. Quality Control (QC) A. General Criteria Controls are used to ensure that a test system is performing correctly. For each test procedure, the identity, concentration, number, and frequency of testing controls should be defined. The control samples should be included during routine testing and are subjected to as much of the total testing process as possible. QC samples must be tested in the same manner and by the same testing personnel as patient specimens. The principle is that the quality control samples detect system failures or errors in patient testing." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 130 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5463 Continued From page 130 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5463 4. Review of the ACT QC logs titled "HEMACHRON JR. SIGNATURE QUALITY CONTROL LOG" found: TC #2 exclusively performed the external QC activities on the following dates: 12/10/2014 01/06/2015 02/06/2015 TP #30 exclusively performed the external QC activities on the following dates: 01/06/2015 02/03/2015 5. TC #2 stated electronic QC is done by whomever is on shift, however, only "expert users" perform the external QC. The interview occurred 03/10/2015 at 10:03 AM. 6. The PS stated they had recently taken over administrative oversight of the ACT testing at this facility and stated that during an initial review of the ACT documentation they noted several issues in the proficiency testing, QC, temperature monitoring, and documentation activities. The interview occurred 03/10/2015 at 10:30 AM. D5471 493.1256(e)(1)(g) CONTROL PROCEDURES 510H 520H 530H 540H 550H D5471 (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in §493.1261 (a)(3)) and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 131 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5471 Continued From page 131 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5471 identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, manufacturers' package insert instructions, and interview with Testing Personnel (TP) #1 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to check each lot number and shipment of commercially prepared Ortho Reagent Red Blood Cells 0.8% Resolve panel reagents when opened for positive and negative reactivity, as well as graded reactivity. Findings Include: 1. Review of the following policies and procedures found: - A policy titled "Department of Laboratories Transfusion Service Quality Program" which stated: "5.1 General Elements: 5.1.3 Quality Control: MMH Transfusion Service has established a program of quality control that is sufficiently comprehensive to ensure that reagents, equipment and methods function as expected. Results are reviewed and corrective action taken, where appropriate. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 132 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5471 Continued From page 132 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5471 5.1.4 Use of Material: All materials and solutions used for collection, preservation and storage of blood and components and all reagents used for required testing on blood samples at MMH Transfusion Service are used in accordance with the manufacturer's written instructions and meet specified requirements." "5.13 Pretransfusion Testing of Patient Blood: 5.13.3 Unexpected Antibodies to Red Cell Antigens: 5.13.3.4 A control system appropriate to the method of testing is used" "9.2 Preventative Action: MMH Transfusion Service has a process for preventative action that includes the following elements: 9.2.1 The review of appropriate sources of information including assessment results, proficiency testing results, quality control records and complaints to detect and analyze potential cases of nonconformance." - A policy titled "Quality Control Policy and Procedure" which stated: "II. Quality Control (QC) D. Quality Control of Reagents by Shipment/Lot External quality control must be performed with each complete change of reagents, with each new lot number or shipment of reagents, following preventative maintenance, after system maintenance; after software upgrades or following replacement of critical parts that may influence the test system's performance." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 133 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5471 Continued From page 133 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5471 "II. Quality Control (QC) H. Review Quality control data are organized and presented so they can be evaluated daily by the technical staff to detect problems, trends, ect. Results of controls must be recorded or plotted to readily detect a malfunction in the instrument or in the analytic system. These control records must be readily available to the person performing the test." - A policy titled "Antibody Identification by Gel Card Test Method Anti-IgG" which stated: "Supplies and Equipment: 0.8% Antibody identification panel cells" "Quality Control: To recognize reagent deterioration, the reagents must be tested daily with the appropriate controls." "Additional Considerations for Selected Cell Panel: 1. One positive cell may be selected as a 'control'." "Procedure Limitations: 5. Adherence to the test procedure is critical to test performance and outcome." 2. Review of the "ORTHO Reagent Red Blood Cells 0.8% Resolve Panel A" manufacturer's package insert instructions found the following statement: "Control of Error 2. For quality assurance, 0.8% RESOLVE Panel A should be tested periodically with weak FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 134 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5471 Continued From page 134 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5471 antibodies." 3. Surveyor #1 asked TP #1 if the laboratory performed QC on each new lot or shipment of antibody identification reagent red cells panels. TP #1 stated the laboratory had not performed quality control on antibody identification panels in 2013, 2014, or 2015. The interview occurred 03/11/2015 at 8:41 AM. D5485 493.1256(h) CONTROL PROCEDURES D5485 110M If control materials are not available, the 120M laboratory must have an alternative mechanism to 130M detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, patient test logs, and interviews with Technical Supervisors (TS) #2 and #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to perform and document an alternative mechanism to detect immediate errors and monitor wet preparation test performance over time. Findings Include: 1. Review of the laboratory's policy and procedure titled "Wet Preparation - Trichomonas, Yeast, Clue Cells" found the following directions: "Reporting Results The slide is to be reviewed by two technologists. Documentation of dual review for alternative FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 135 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5485 Continued From page 135 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5485 proficiency purposes will be recorded on the daily Quality Control sheet for Trichomonas." 2. Review of the wet preparation test logs titled "Daily Quality Control Log Sheet Wet Prep" found a spreadsheet with 8 columns titled as follows: Date Tech Tech Patient Trich Clue Yeast Comment Further review of the test logs from June 2014 through December 2014 found: 32 out of 507 patients' test documented failed to include the initials of a second quality control (QC) technician. 1 out of 507 patients' test documented contained an "X" in the second "Tech" column with a handwritten note in the "Comment" column that stated "tech at dinner". 1 out of 507 patients' test documented lacked testing personnel initials in the second "Tech" column with a handwritten note in the "Comment" column that stated "other tech at dinner". 1 out of 507 patients' test documented contained a handwritten note in the "Comment" column that stated "no other tech available", however, the initials of TS #2 were present in the second "Tech" column. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 136 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5485 Continued From page 136 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5485 1 out of 507 patients' test documented contained a handwritten note in the second "Tech" column that stated "one tech in lab". 17 out of 21 test logs contained TS #2's initials in the "Reviewed by:" space. 15 out of 21 test logs contained the LD's signature or initials at the bottom of the page. 3. Included with the wet preparation test logs titled "Daily Quality Control Log Sheet Wet Prep" was documentation that stated "GAP analysis was performed on all reviewable forms within the laboratory. Multiple occurrences were observed where review was not documented. During retroactive analysis of forms no trends were noted. Corrective action includes review of forms by the designee 'TS #8' or 'TS#9' at stated intervals and monthly review by technical supervisors 'TS #8' or 'TS #9', approved by the medical director 'LD' effective immediately." The statement was signed and dated by the LD on 02/25/2015. 4. TS #2 stated the laboratory used to read slides with 2 technicians but would only document one set of results. TS #2 further stated the laboratory discontinued the practice of two technicians reading each slide in December 2014 and are not currently performing or documenting any alternative QC for the test wet preparation. TS #8 confirmed TS #2's statements as being accurate. The interviews occurred 03/10/2015 at 11:32 AM. D5543 493.1269(a)(d) HEMATOLOGY D5543 400H (a) For manual cell counts performed using a hemocytometer-FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 137 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5543 Continued From page 137 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5543 (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, data summary report, and interviews with the Laboratory Director (LD) and Technical Supervisor (TS)#9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015), the laboratory failed to perform and document manual hemocytometer cell count quality control (QC) each 8 hours of testing. Findings Include: 1. Review of the laboratory's policies and procedures titled "Body Fluid Analysis Procedure Manual Cerebrospinal Fluid Examination", "Body Fluid Analysis Procedure Manual Serous Fluids (Pleural, Pericardia, Peritoneal)", and "Synovial Fluid Examination" found no mention of manual hemocytometer cell count QC procedures. 2. Review of the laboratory's "Data Summary" report for February (Feb) 2015 revealed 35 patients had manual body fluid cell count testing performed on the following dates: Feb 2, two patients Feb 3, two patients Feb 4, one patient Feb 5, one patient Feb 6, three patients Feb 13, two patients Feb 16, one patient Feb 17, two patients Feb 18, two patients Feb 20, two patients FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 138 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 12300 MCCRACKEN ROAD GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5543 Continued From page 138 Feb 7, two patients Feb 9, three patients Feb 10, two patients Feb 11, two patients Feb 12, one patient 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5543 Feb 22, one patient Feb 24, one patient Feb 25, one patient Feb 26, three patients Feb 28, one patient 3. Surveyor #2 requested the laboratory's policy and procedure and QC documentation for manual hemocytometer cell count QC from TS#9. TS#9 stated manual cell count QC material is not available and so the laboratory does not perform any manual hemocytometer QC. The interview occurred on 03/10/2015 at 1:05 PM. The LD stated there is a result review of every manual hemocytometer body fluid cell count performed by the LD and thought that would suffice for QC. The interview occurred on 03/10/2015 at 1:17 PM. D5545 493.1269(b)(d) HEMATOLOGY D5545 400M (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's policies and procedures, patient test records, quality control (QC) records, and interview with the Point-of-Care Supervisor (PS) (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to perform and document two levels of control materials each 8 hours of operation for the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 139 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5545 Continued From page 139 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5545 activated clotting time (ACT) nonmanual coagulation test system Hemachron Junior (Jr.) Signature +. Findings Include: 1. The PS stated ACT testing was performed in two locations of the hospital, interventional radiology and general surgery. The interview occurred 03/09/2015 at 8:46 AM. 2. Direct observation of the interventional radiology department on 03/10/2015 at 9:39 AM found a Hemachron Jr. Signature + instrument with the serial number of SP2990. Direct observation in a general surgery office on 03/10/2015 at 9:54 AM found a Hemachron Jr. Signature + instrument with the serial number of SP5639. 3. Review of the laboratory's policy and procedure titled "Activated Clotting Time - Low Range (ACT-LR)" found the following directions: "Quality Control (QC) Routine quality control testing and tracking should be a part of a comprehensive quality assurance program. HEMOCHRON Microcoagulation System Quality Control products are available to make routine QC convenient and affordable. All HEMOCHRON Microcoagulation instruments should be quality controlled at two levels of performance, including both the normal and abnormal ranges. Quality control should be performed once every 8 hours on any shift during which the instrument is to be used." "Internal Controls FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 140 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5545 Continued From page 140 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5545 Electronic Quality Control (EQC) for Signature + Microcoagulation System: To assist in accomplishing daily QC, both normal and abnormal Electronic Verification Cartridges (EVC) are used to provide a two level check of the instrument. The EVC Cartridges (two levels) will be performed once every 8 hours on any shift during which the instrument is utilized. This ensures proper instrument operation." "Use of Electronic Verification Cartridges (EVC): 3. The instrument should detect the simulated endpoint within the acceptable range shown on the system verification cartridge. Compare the result displayed to the label on the cartridge. 4. Record results on the 'Quality Daily Log' sheet." 4. Review of the patient test logs titled "HEMACHRON JR. DAILY PATIENT LOG" found patients' samples were analyzed on the following dates: 01/08/2015 - 2 samples analyzed 01/09/2015 - 4 samples analyzed 02/06/2015 - 3 samples analyzed 03/04/2015 - 3 samples analyzed 5. Review of the ACT QC logs titled "HEMACHRON JR. SIGNATURE QUALITY CONTROL LOG" found no documentation demonstrating that EVC QC was performed and documented on the following dates: 01/08/2015 01/09/2015 02/06/2015 03/04/2015 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 141 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5545 Continued From page 141 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5545 6. The PS provided documentation, initialed by an individual not listed on the Form CMS-209 and dated 03/04/2015, which stated: "GAP analysis was performed on all records within point of care. Multiple occurrences were observed where liquid and electronic QC was late. During retroactive analysis of records, point of care personnel were educated and corrective actions put into place. Please refer to GAP analysis." 7. The PS stated they had recently taken over administrative oversight of the ACT testing at this facility and stated that during an initial review of the ACT documentation they noted several issues in the proficiency testing, QC, temperature monitoring, and documentation activities. The interview occurred 03/10/2015 at 10:30 AM. D5551 493.1271(a)(f) IMMUNOHEMATOLOGY 510H 520H 530H 540H 550H D5551 (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 142 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 142 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Item 1: Based on direct observation, review of the laboratory's policies and procedures, manufacturers' package insert instructions, patient test records, and interview with Testing Personnel (TP) #1 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to perform unexpected antibody identification testing according to the manufacturer's package insert instructions and ensure out-dated reagents were not routinely used for antibody identification testing. Findings Include: 1. Direct observation of the blood bank department refrigerator "B" on 03/10/2015 at 1:54 PM found the following expired reagents: ORTHO Reagent Red Blood Cell 0.8% Resolve Panels: Lot Number: Expiration Date: VRA 215 VRA 213 VRA 211 VRA 209 VRA 207 VRA 205 2-17-15 1-20-15 12-23-14 11-25-14 10-28-14 9-30-14 BIO-RAD Biotestcell FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 143 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 12300 MCCRACKEN ROAD GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 143 Lot Number: 8503011-00 8450011-00 8446011-00 8442011-00 8438011-00 8434011-00 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 Expiration Date: 3-9-15 2-2-15 1-5-15 12-8-14 11-10-14 10-13-14 2. Review of the laboratory's policies and procedures found: - A policy titled "Department of Laboratories Transfusion Service Quality Program" which stated: "5.1 General Elements: 5.1.3 Quality Control: MMH Transfusion Service has established a program of quality control that is sufficiently comprehensive to ensure that reagents, equipment and methods function as expected. Results are reviewed and corrective action taken, where appropriate. 5.1.4 Use of Material: All materials and solutions used for collection, preservation and storage of blood and components and all reagents used for required testing on blood samples at MMH Transfusion Service are used in accordance with the manufacturer's written instructions and meet specified requirements." "5.13 Pretransfusion Testing of Patient Blood: 5.13.3 Unexpected Antibodies to Red Cell Antigens: 5.13.3.4 A control system appropriate to the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 144 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 144 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 method of testing is used" "9.2 Preventative Action: MMH Transfusion Service has a process for preventative action that includes the following elements: 9.2.1 The review of appropriate sources of information including assessment results, proficiency testing results, quality control records and complaints to detect and analyze potential cases of nonconformance." - A policy titled "Inventory Control of Blood Bank Supplies" which stated: "Procedure: Appropriate Handling of Reagents and Supplies 3. Product Expiration: to ensure the quality of results reported, the expiration date of supplies must be adhered to when in use: a) Reagents - all reagents must be used within the expiration date defined by the manufacturer on the container or in the package insert (exceptions: rare antisera, reagent red cell panels for extended antibody identification studies)." - A policy titled "Antibody Identification by Gel Card Test Method Anti-IgG" which stated: "Supplies and Equipment: 0.8% Antibody identification panel cells" "Quality Control: To recognize reagent deterioration, the reagents must be tested daily with the appropriate controls." "Additional Considerations for Selected Cell Panel: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 145 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 145 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 1. One positive cell may be selected as a 'control'." "Procedure Limitations: 5. Adherence to the test procedure is critical to test performance and outcome." - A policy titled "Ordering and Processing Blood Bank Reagents and Supplies" which stated: "Policy: It is the responsibility of the Blood Bank Team leader, or designee to keep the department stocked with the appropriate level of reagents and supplies. A standing order will be placed at the beginning of the year for red cell reagents. Other reagents and supplies will be ordered on an as needed basis." "Ortho Standing Order Resolve Panel A 1. Remove the panel from the box, writing the lot number and expiration date on the panel. (see current panel for example) 2. Remove one panel sheet. On the "in use" date, place the panel sheet in the current section of the Master List Binder, using a protective plastic cover. Move the panel that is being replaced to the expired panel section. 3. Discard the oldest Resolve Panel A in Refrigerator B, along with the corresponding panel sheet, saving the plastic protective sheet." - A policy titled "Red Blood Cell Antigen Typing" which stated: "Procedure Notes: 7. When the Blood Bank runs out of specific antisera needed immediately for testing, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 146 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 146 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 additional antisera may be requested from the Cleveland Clinic Blood Bank if available. 8. Rare antisera may be used beyond its expiration date if proper quality control procedures are performed and quality results achieved. Antisera is considered rare if it cannot be procured from manufacturer's due to manufacturing or donor problems." 3. Review of the manufacturers' package insert instructions found the following statements: "ORTHO Reagent Red Blood Cells 0.8% Resolve Panel A Reagent Use 0.8% RESOLVE Panel A directly from the vials. As with all reagent red blood cells, the reactivity of the cells may decrease during the dating period." "ORTHO Reagent Red Blood Cells 0.8% Resolve Panel A Reagent FOR IN VITRO DIAGNOSTIC USE. No U.S. Standard of Potency. Do not freeze. Do not use beyond expiration date. The expiration date of each lot is no longer than 63 days, excluding the days in frozen storage, from the date of collection of red blood cells from any donor in the lot. Studies demonstrate consistent performance of this product from the time the vial is opened until the specified expiration date." "ORTHO Reagent Red Blood Cells 0.8% Resolve Panel A Control of Error 2. For quality assurance, 0.8% RESOLVE Panel A should be tested periodically with weak antibodies." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 147 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 147 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 "BIO-RAD Reagent Red Blood Cells Biotestcell-I Precautions - Do not use beyond the expiration date." "BIO-RAD Reagent Red Blood Cells Biotestcell-I Quality Control For quality assurance the Biotestcell Reagent Red Blood Cells intended for antibody identification should be tested according to any site specific procedures." "BIO-RAD Reagent Red Blood Cells Biotestcell-I Limitations - The reactivity of the product may decrease during the dating period and therefore should not be used after the expiration date. The rate of decrease in reactivity is partially dependant on individual donor characteristics that are neither controlled nor predicted by the manufacturer." 4. The laboratory filed antibody identification test records in 3-ring binders divided by year and then by last name. Review of the laboratory's 2015 antibody identification test records and 2014 "F H" and "R - Z" antibody identification test records found the following: - The laboratory performed antibody identification testing utilizing expired reagents as follows: Date Tested: Panel Lot: Expiration Date: 01/06/2015 VRA211 2014-12-23 Reviewed by Technical Supervisor (TS) #9 on 01/13/2015. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 148 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 148 Date Tested: Panel Lot: Expiration Date: 01/11/2015 VRA211 2014-12-23 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 Reviewed by General Supervisor (GS) #1 on 01/13/2015 Date Tested: Panel Lot: Expiration Date: 01/13/2015 VRA211 2014-12-23 Reviewed by TS #9 on 01/23/2015 Date Tested: Panel Lot: Expiration Date: 01/25/2015 VRA213 2015-01-20 Reviewed by GS #1 on 01/31/2015 Date Tested: Panel Lot: Expiration Date: 01/31/2015 VRA213 2015-01-20 Date Tested: Panel Lot: Expiration Date: 02/05/2015 VRA213 2015-01-20 Reviewed by GS #1 on 02/14/2015 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 149 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 149 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 Date Tested: Panel Lot: Expiration Date: 02/10/2015 02/10/2015 VRA211 VRA209 2014-12-23 2014-11-25 Reviewed by TS #8 on 03/08/2015 Date Tested: Panel Lot: Expiration Date: 02/19/2015 VRA215 2015-02-17 Reviewed by TS #8 on 03/08/2015 Date Tested: Panel Lot: Expiration Date: 01/16/2014 VRA189 2014-01-07 Reviewed by GS #1 on 01/18/2014 Date Tested: Panel Lot: Expiration Date: 02/13/2014 VRA187 2013-11-12 02/13/2014 VS668 2013-10-15 02/13/2014 VS695 2014-02-04 02/13/2014 8349011-00 2014-01-28 Reviewed by GS #1 on 02/16/2014 Date Tested: Panel Lot: Expiration Date: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 150 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 12300 MCCRACKEN ROAD GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 150 04/20/2014 04/20/2014 VRA191 VRA193 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 2014-03-04 2014-04-15 Reviewed by GS #1 on 04/23/2014 Date Tested: Panel Lot: Expiration Date: 06/21/2014 VRA197 2014-06-10 Reviewed by personnel not listed on Form CMS-209 on 07/23/2014 Date Tested: Panel Lot: Expiration Date: 07/03/2014 07/03/2014 07/03/2014 VRA197 VRA195 VRA193 2014-06-10 2014-05-13 2014-04-15 Reviewed by GS #1 on 07/03/2014 Date Tested: Panel Lot: Expiration Date: 07/08/2014 VRA197 2014-06-10 Reviewed by personnel not listed on Form CMS-209 on 07/23/2014 Date Tested: Panel Lot: Expiration Date: 07/10/2014 VRA197 2014-06-10 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 151 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 12300 MCCRACKEN ROAD GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 151 07/10/2014 VRA199 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 2014-07-08 Reviewed by GS #1 on 07/12/2014 Date Tested: Panel Lot: Expiration Date: 07/12/2014 VRA195 2014-05-13 Reviewed by GS #1 on 07/13/2014 Date Tested: Panel Lot: Expiration Date: 07/17/2014 VRA199 2014-07-08 Reviewed by personnel not listed on Form CMS-209 on 07/23/2014 Date Tested: Panel Lot: Expiration Date: 07/17/2014 VRA199 2014-07-08 Reviewed by personnel not listed on Form CMS-209 on 07/23/2014 Date Tested: Panel Lot: Expiration Date: 07/19/2014 VRA199 2014-07-08 Reviewed by GS #1 on 07/25/2014 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 152 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 152 Date Tested: Panel Lot: Expiration Date: 08/26/2014 VRA201 2014-08-05 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 Reviewed by personnel not listed on Form CMS-209 on 08/26/2014 Date Tested: Panel Lot: Expiration Date: 10/07/2014 10/07/2014 10/07/2014 VRA203 VRA197 VRA201 2014-09-02 2014-06-10 2014-08-05 Reviewed by GS #1 on 10/17/2014 Date Tested: Panel Lot: Expiration Date: 10/09/2014 VRA205 2014-09-30 Reviewed by GS #1 on 10/17/2014 Date Tested: Panel Lot: Expiration Date: 10/17/2014 10/17/2014 VRA205 VRA201 2014-09-30 2014-08-05 Date Tested: Panel Lot: Expiration Date: 11/10/2014 VRA207 2014-10-28 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 153 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 153 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 Reviewed by personnel not listed on Form CMS-209 on 11/12/2014 Date Tested: Panel Lot: Expiration Date: 11/28/2014 VRA209 2014-11-25 Reviewed by GS #1 on 12/09/2014 Date Tested: Panel Lot: Expiration Date: 12/06/2014 VRA209 2014-11-25 Reviewed by TS #9 on 01/13/2015 Date Tested: Panel Lot: Expiration Date: 12/31/2013 12/31/2013 VS687 VRA187 2013-12-10 2013-11-12 Reviewed by TS #9 on 02/28/2015 5. TP #1 stated the laboratory used expired antibody identification panels, however, the initial panel run for each patient was always an in-dated panel. If additional rule out cells were needed then the TP used expired panels. TP #1 further stated the laboratory did not routinely run quality controls on the expired antibody panels used for patient testing. If a control was run then the laboratory would use either a known patient or anti-sera for control material. TP #1 stated if a control was performed on a panel it would be FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 154 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 154 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 documented on the panel worksheet in the "Special Antigen Typing" column. TP #1 reviewed the 2014 antibody identification workups and was able to locate one instance where a control was analyzed. The interview occurred 03/11/2015 at 8:41 AM. Item 2: Based on direct observation, review of the laboratory's policies and procedures, emergency release documentation, laboratory information system (LIS), hospital information system (HIS), and interviews with Testing Personnel (TP) #1 and #9, the Compliance Specialist (CS), Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the Head of Transfusion Medicine (HTM), and a "Short Stay" unit nurse, the laboratory failed to perform and document emergency release patient testing and incidents as specified in 21 CFR 606.151(e). Findings Include: 1. Review of the laboratory's policies and procedures found the following: - A policy titled "Department of Laboratories Transfusion Service Quality Program" which stated: "5.25 Urgent Requirement for Blood and Blood Components: 5.25.4 Compatibility testing shall be completed expeditiously using a patient sample collected as early as possible in the transfusion sequence." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 155 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 155 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 "5.27 Medical Record Documentation: 5.27.1 The patient's medical record shall include: Transfusion order, documentation of patient consent, the name of the component, the donation identification number, the date and time of transfusion, pre- and post-transfusion vital signs, the amount transfused, the identification of the transfusionist, and, if applicable, transfusion-related adverse events" "6.2 Records: MMH Transfusion Service ensures identification, collection, indexing, access, filing, storage and disposition of records as required by AABB Reference Standards. 6.2.1 Records shall be complete, retrievable in a period of time appropriate to the circumstances and protected from accidental or unauthorized destruction or modification." - A policy titled "Emergency Release of Blood Uncrossmatched" which stated: "Procedure: In extreme situations, a patient sample may not be available or the transfusion request is so urgent that the physician cannot wait for the group and type to be determined. In these situations, the following steps should be followed: 5. Remove the yellow copy of the Compatibility Record (Unit Tag) and issue the blood according to SOP (Person picking up blood must have Patient Name, MR#, or other 2nd Identifier). The Blood Bank will retain a copy of the Emergency Release Waiver (filled out ahead of time and placed in the 'Emergency Release' folder located on the side of the Blood Bank Refrigerator) until FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 156 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 156 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 the Signed Waiver is returned to the Blood Bank. 6. If Blood Bank testing has already been ordered, issue the unit(s) in the LIS as 'Uncrossmatched'. 7. If Blood Bank testing has not been ordered, document all unit(s), issuing information, as well as testing results (once patient sample is obtained) on downtime sheets until an order is placed." "Procedure Notes: 1. In an emergency situation where a name and medical record number is unavailable, Fill out the Emergency Release Waiver with as much information as possible. (i.e. John Doe, Jane Doe) Add name and medical record number to the Emergency Release Waiver as information becomes available." "Procedure Notes: 4. All testing must be completed as soon as a patient sample is available. All results are entered into the LIS." 2. On 03/12/2015 at 11:30 AM Surveyor #1 requested the laboratory's emergency release documentation from 2014 and 2015 from TP #9. TP #9 provided a manila folder that contained emergency release documentation from 09/27/2014 through the dates of survey. Surveyor #1 randomly selected 2 patients' emergency release records from the manila folder and requested that TP #9 locate the type, screen, and compatibility test records in the LIS that corresponded to the emergency release units. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 157 of 333 PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE a; MEDICAID SERVICES 0MB NO 0933mm amateur er DEFICIENCIES txit 1x1) naming ixai we squv AND HAN or CORRECVION tpennricmaw NUMBER man comm: JEMIIDSU WING-- we or PROVIDER on SUPPLIER am em: 21>> none tmu ICCRACKEN ROAD nosvth uaommnv GARFIELD uus 1on ID SUMMARY mime/r or DEFICIENCIES in PROVIDERS PLAN er magnum as were tum DEFICIENCY MUSY as engaging: av Fuu new (EALH mm as Win" YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED THE APPROPRIATE aerteienen D5551 Continued Frorn page 157 D555t a. Review at the form titied "Emergency Release Waiver", which was dated 02/t2/2m5, round the following. at the lop right hand section a/ the term was two patient identification slinkers. The first wntained the patients name, date at hinh medical record number (MR3) oi - and patient nurnper (I:th oi -- The second comairted the name date at bIflh n1 -- MR3 oi and barmde at vzaeotamn 2 units at teroup O--Negative Paeked were requested. >012 box nexl lo the statement of donor mood with patients bIond tar eompatipitity was NOT eurnpteted was marked 4 unit lag stickers were present, sit at which were type 0 Negative, and had expiration dates Dina/0512015, 03/09/2015, 03/17/2015 and 03/18/2015 next to the um] tag stipker W204215165761 0 Negative with an expiration date at 03/05/2015 was a handwritten note which stated mans/used" the date and time and 13 55 was indicated at the bollom oi the page with the physinian's signature and printed name. a handwritten note at the pattern at the page stated ONE UNIT FORM culszsanmrwi Warmtini Dmla Ettlm ID omit quIIly ID minim/:1 sheet Page 153 av :33 PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES 0MB NO 09330301 ems/rem or ozrrerzuorss 1x1) pmrosweuppuswem no MULTIPLE our one sum/Ev mo mu or coRREcmm NUMBER man mwlmo JEMIIDSU WING-- we or pom/logs 0R SUPPLIER swarm/sees cm ewe 20> 12:00 ROAD MARVMOLINY HOSPIYAL uaorumnv GARFIELD HEIGHTSIOH 44125 1on lo sum/rm swans/Ir or osrrorsueres .p poor/rows mm or as were osrrorsuov Muer e: pasosozo av n/u emu PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE 0 MEDICAID SERVICES 0MB NO 00300301 ems/am or name/mes 1x1) 011) 110mm: EONSWUETIDN 1st we sum/Ev AND HAN or Immune/mm NUMBER man cor/merge JEMIIDSU WING-- was or pram/men on sums>>: smeermmee cm em: 21>> ease moo ROAD vauoum HOSPIYAL uaommnv GARFIELD HEIGHTSIOH 44125 1x010 ear/my sum/em or veneer/mes wow/news PLAN or magnum as new Imn veneer/av a: pages/5:0 av new 12m comm/same" mm as YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED YHE APPROPRIAYE Danes/1m D5551 Continued From page 159 05551 Ine s1aIernenI transfusmn 0aIa lound""' on me sureen IIlled FaIIem history TransfusIon Data. on 0001 aforemenlmned screens, 1ne neadIngs Iiued UniIs Tlansl' and "Last Transr' were blank. RC - Red Transf - Transmsed/Transfusmn 7. Review 01 the LIS blood bank unII history documenIaI/on fanne packed red blood cell uniI (PRBC) w204215105761 found The unit was assIgned Ine sums of on 02/05/2015 a1 7.54 AM The unit was assIgned Ine sums of on 02/00/2015 51 11.02 PM In a paliem win 3 01-- The unit was assIgned Ine sums of on 02/06/2015 a1 11 -03 PM to a paIIenI win. a MR1: 0f-- The unit was assIgned Ine sums of on 02/00/2015 a1 11-37 PM WIlh me wmmem Ior pmnessing" 'Flease Mme Ine unit was reIurrIed 10 me blood bank depanmenl greaIer 1113711)) :10 mInmes aner issue No documenlalmn 01 Ire unirs Iemperamre when velumed was presenI (Refer In D5555) The unit was assIgned Ine sums of on 02/07/2015 51 I 45 PM In Me palienl with me MR1: mu. 13/525671me Prawn/ivemmi 5mm Ev-m ID 02mm new, .5 meme: 1/ mm Page 10051333 PRINTED 02/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES OMB No 00300391 sum/em or DEFICIENCIES (x1) (x2) MULTIPLE cowsrsucnoh 1st one suRva mo my or cossecneh NUMBER man comers/o JEDOSIIDSU WING-- NAME or 0R summers srseersoosess c/Tv sure as cooe moo emu GARFIELD 44125 vauoum HOSPITAL 1on I0 sum/m swam/r or oencrewcres .o PROVIDER-s pow or museum as psenx (we oencrewcy MUST BE pseceoeo 0v Fuu rem SHOULD BE munch TAG REGULATORY OR LSD IDENTIFYING INFORMATIONI TAG CROSSREFERENCED To THE APPROPRIATE canon/Icy) 05551 Continued Frorn page 160 05551 The unit was assIgned Ihe sIah/s DI on 02/12/2015 a1 1 00 PM Io Ihe paI/errI Ihe MRI: The unit was asSIgned Ihe sIaIus oI on 02/14/2015 aI 7-49 AM In due patient me a Review oI Ihe document Pick up provided hy T5 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 09/10/2015 FORM APPROVED 0MB NO 09380301 ems/rem or 1x1) pooping/summon 1x1) naming coNsTRucTIoN 1x31 one sum/Ev nun min or coRREcnoN NUMBER man oer/warm aaoomnsu a we 03mm" 5 mu: or pom/men 0R some: swarm/tees cm em: 21>> 12300 ROAD MARVMOUNT HOSPITAL LABORATORY GARFIELD OH 44125 1x010 aunt/rm swam/r or oerroreneree .p poor/rows pm or do were (BEN oerrorenov a: poeceoeo av n/u poem PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5551 Continued From page 162 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5551 "Description of Operation:" which stated "Given evidence of active bleeding, blood was appropriately ordered by anesthesia." Additionally, documents titled "Anesthesia Record", dated 02/12/2015, was included which stated "300 cc" under the headings "RBC:" and "Tot Blood Prds:". Lastly, on the documents titled "Anesthesia Record" in the column titled "Comments And Notes" a note which stated "RBC@13:09" was under the heading "Blood Product/Fluid Info". Tot - Total Prds - Products The RN stated they were unable to locate a transfusion record for an emergency O negative unit of PRBCs. The interview occurred 03/12/2015 at 12:12 PM. D5555 493.1271(c)(f) IMMUNOHEMATOLOGY 510H 520H 530H 540H 550H D5555 (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, returned unit reports, and interviews with Technical Supervisor (TS) #8, the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 163 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5555 Continued From page 163 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5555 Compliance Specialist (CS), and Testing Personnel (TP) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to ensure and document that blood products were within acceptable temperature ranges when returned to the laboratory after issue. Findings Include: 1. Review of the laboratory's procedure titled "Department of Laboratories - Transfusion Service Quality Program" found the following statements: "Section 5: Process Control 5.24 Reissue of Blood, Blood Components MMH Blood Transfusion Service only reissues blood or blood components if the following conditions have been observed: - The container closure has not been disturbed - The appropriate temperature has been maintained - For Red Cell components, at least one sealed segment of integral donor tubing has remained attached to the container. Removed segments shall be reattached only after confirming that the tubing identification numbers on both the removed segment(s) and the container are identical - The records indicate that the blood or blood components has been inspected and that it is acceptable for reissue" "Section 7: Deviations, Nonconformances, and Adverse Events: 7.1 Nonconformances: 7.1.2 Blood, components, critical materials or FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 164 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5555 Continued From page 164 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5555 services that do not conform to specified requirements are prevented from unintended distribution or use." "Section 7: Deviations, Nonconformances, and Adverse Events: 7.1 Nonconformances: 7.1.4 Released Nonconforming Blood, Blood Components, Tissues or Derivatives: Blood and Blood Components that are determined after release not to conform to specified requirements shall be evaluated to determine the effect of the nonconformance of the quality of the product. In cases where quality may have been affected, the nonconformance shall be reported to the customer. Records of the nature of the nonconformance and subsequent actions taken, including acceptance for use, shall be maintained." 2. In verbally describing the laboratory's blood product issuing processes to Surveyor #1, TP #9 stated if a unit is issued and returned within 30 minutes of issue then it is reallocated in the Laboratory Information System (LIS). TP #9 further stated the laboratory performs a visual inspection of the unit prior to reallocation but does not verify or document the temperature of the returned unit. Lastly, TP #9 stated testing personnel do not check the temperatures of unit(s) returned from the floors because temperature indicator stickers are not affixed to the unit(s) prior to issue. The interview occurred 03/10/2015 at 1:42 PM. Surveyor #1 also asked TP #9 to describe the laboratory's emergency O Negative release FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 165 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5555 Continued From page 165 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5555 procedures. TP #9 stated the units are issued to the emergency department in coolers and the unit(s) contain temperature indicator stickers. If the unit(s) are returned unused, the TP check the temperature stickers to ensure the temperature is below 6 degrees Celsius. The surveyor asked TP #9 if the temperature of the returned unit(s) are documented. TP #9 stated the laboratory does not document the temperature of the returned unit(s). The interview occurred 03/10/2015 at 1:46 PM. TS #8, who was present during the interview of TP #9, informed TP #9 that TP should be verifying and documenting the temperature of red cell unit(s) returned to the blood bank. The statement occurred 03/10/2015 at 1:49 PM. 3. Surveyor #1 requested the laboratory's returned blood product(s) policy and procedure from TS #8 and the CS. Review of the provided policy and procedure titled "Cooler Transport and Storage of Blood and Thawed Frozen Plasma" and blank form titled "Return of Blood Product Worksheet" found the following: "Cooler Transport and Storage of Blood and Thawed Frozen Plasma Procedure: Release of units from the Blood Bank to Surgery: 4. Attach an activated Hemotemp(c) indicator on the back of each unit." "Cooler Transport and Storage of Blood and Thawed Frozen Plasma Procedure: Return of Cooler From Surgery: 3. Perform a visual inspection of the unit(s). 4. Check the temperature of the unit(s) to see FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 166 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5555 Continued From page 166 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5555 whether it is between 1-6 degrees Celsius. (Check the Hemotemp indicator on the back of the unit(s)). 5. If the unit(s) is acceptable, return the unit(s) to the blood storage refrigerator crossmatch shelf (B2) and update the unit status in the Sunquest computer system. From the Blood Bank tab in Sunquest, double click on the 'Blood Status Update' icon to change the status of the unit. Enter or scan the unit number and component type. Enter the date and time the unit was returned, select INV to return the unit back the inventory, and press the tab button. After the visual inspection has been completed, check the box marked 'Yes' next the 'Pass Visual Inspection'. Select a reason code from the '...' search list, or enter a free text comment and click 'Add'. When the code or free text comment is displayed in the window, click on 'Save'. Select the new status of the unit from the drop down box as either 'Allocated' if you wish to keep the unit allocated to the current patient, or 'Released' if you want to release the unit back to the inventory. Click on 'Save' to finish." "Cooler Transport and Storage of Blood and Thawed Frozen Plasma Procedure Notes: 7. If the unit(s) is returned without the Hemotemp indicator (Blood Bank personnel did not attach one), place another activated indicator on the back of the unit(s) to check the temperature and verify acceptance or rejection. A missing indicator alone is not valid criteria to discard the unit. If the unit(s) was returned in the cooler, and a valid temperature can be established, the unit can be placed back into the general inventory or allocated to the patient. If Hemotemp indicator FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 167 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5555 Continued From page 167 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5555 was removed by transfusing personnel, contact BB Team Leader or senior Blood Bank Technologist for further instructions." Review of the "Return of Blood Product Worksheet" did not find any instruction or heading for verifying or documenting the temperature of the issued unit(s). 4. Surveyor #1 requested records of all blood compnent unit(s) that were issued and then returned to the blood bank in 2013, 2014, and 2015 from the CS and TS #9. Review of the provided documentation found: 90 blood product units were issued and returned in 2013, 2014, and 2014. 68 out of 90 blood product units were issued for one patient, returned, and reissued to a different patient. 2 out of 90 blood product units were issued for one patient, returned, issued to a second patient, returned, and then issued to a third patient. D5559 493.1271(e)(f) IMMUNOHEMATOLOGY 510H 520H 530H 540H 550H D5559 (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 168 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5559 Continued From page 168 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5559 taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and transfusion reaction workup documentation, the laboratory failed to promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility. Findings Include: 1. Review of the laboratory's policy and procedure titled "Department of Laboratories - Transfusion Service Quality Program" found the following statements: "Section 7.4 Adverse Events of Transfusion: All suspected transfusion complications are evaluated promptly and reviewed by the Transfusion Service Medical Director." "Section 7.4 Adverse Events of Transfusion: 7.4.2 Laboratory Evaluation and Reporting of Immediate Transfusion Reactions: 7.4.2.3 Interpretation of the evaluation by the Medical Director shall be recorded in the patient's medical record and, if suggestive of hemolysis, bacterial contamination, TRALI, or other serious adverse event related to transfusion, the interpretation shall be reported the patient's physician immediately." - Review of the laboratory's procedure titled FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 169 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5559 Continued From page 169 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5559 "Investigation of Transfusion Reactions" found the following statements: "NOTE: If no atypical results or discrepancies are found, additional testing is not required. Tier 1 Transfusion Reaction Investigation is complete pending a Pathologist's final interpretation and signature. Document tech signature and date and post at the technical manager's desk for review. Place the blood bag and administration set in quarantine in the storage refrigerator, right-hand side, bottom shelf. Blood bag must be kept for 7 days post transfusion." "Procedure Notes: NOTE: additional units of blood CAN NOT be released from the Blood Bank for transfusion until transfusion reaction investigation testing has taken place and a hemolytic transfusion reaction has been ruled out. Tier 1 testing must be complete and no discrepancies noted. In the event that blood or blood components are needed before an investigation is completed, a blood bank waiver must be signed by a physician indicating that all testing has not been completed." - Review of the policy and procedure numbered "LTR 54836" found the following statements: "Transfusion Reaction Investigation: Turnaround Time: Preliminary investigation (checks for clerical errors, hemolysis, and DAT): approximately 15 minutes. Other Studies: 24 hours or more." 2. Review of the laboratory's 22 transfusion reaction records from 2013, 2014, and 2015 found the following turnaround times (TAT) for FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 170 of 333 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 00/10/2015 FORM APPROVED OMB No 00300301 STATEMENT or DEFICIENCIES (x1) AND PLAN or 00002010314 IDENTIFICATION wuss: 3500000000 1sz MULTIPLE CONSYRUCTION A BUILDING 0 WING 1st 047; 50/?va COMPLETED 03/13/2015 NAME or PROVIDER 00 SUPPLIER MARVMOUNY HOSPIYAL LABORATORY cm 5747: 2100002 12:00 0040 GARFIELD HEIGHTSIDH 44125 1on ID sum/4m STAYEMENY or Damn/mas mm (mm 0mm;ch Musr 0: 00502050 0v FULL YAG 0500017on on IDENTIFYING INFORMAYIONI ID 005m 740 PROVIDERS PLAN or 00005071150 as>> 12400 CORRECYIVEACTION SHOULD 05 we 400001>>:ng WE D5559 continued From page 170 pamcIugis1 (Pam I Inletpre'almn (inIerp I 01 IIans/L/sicn reaction (TRX) markups Dale TRX IniIIal Dale 01 Pam TAT RN Workup InIe/p - (days) 05/20/2014 00/03/2014 14 '00/27/2013 00/00/2013 13 03/06/2014 03/10/2014 13 04/05/2013 04/10/2013 11 00/00/2013 00/10/2013 11 07/02/2013 07/10/2013 05/26/2014 00/03/2014 11/17/2013 11/25/2013 03/16/2014 03/24/2014 05/26/2014 00/03/2014 05/06/2013 05/13/2013 01/20/2013 02/04/2013 07/00/2014 07/15/2014 12/26/2014 12/20/2014 _06/30/2014 Unknown' 12/16/2013 12/13/2013 01/10/2014 01/20/2014 03/16/2014 03/10/2014 11/25/2013 11/20/2013 01/24/2014 01/24/2014 10/20/2013 10/20/2013 03/17/2014 03/17/2014 'The pamangIs1 Inletpre'almn was not dated 05000 40312731eI11) HISTOFATHOLOGV 01m The labovalnry must use acneplahle IemI/nqugy o1a sys1em 01 disease nomenclature In Iepan/ng lesulls 11) The laboratory mus! document alI pinnedmes perm/mm as speu'ned in PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5609 Continued From page 171 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5609 section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, Histopathology slide stain reactivity quality control (QC) documentation, and an interview with the Laboratory Director (LD) and Quality Coordinator #1 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the LD on 03/09/2015), the laboratory failed to document all histopathology control procedures performed. Findings Include: 1. Review of the laboratory's policy and procedure titled "Quality Control in Histology" found the following statements: "Staining: The stains are checked for their intended reactivity. The quality of the cytoplasmic and nuclear staining is assessed. Poor quality may be due to over or under staining of cells." "Special Stains: Controls are to be documented for their intended reactivity (i.e., controls are acceptable) in the log or the pathology report before reporting patient results." "Immunohistochemistry Controls: Controls are to be documented for their intended reactivity (i.e., controls are acceptable) in the log or the pathology report before reporting patient results." "All Stains are checked for their intended reactivity and results documented each day of use in the 'H&E, SPECIAL STAINS & IHC SLIDE QUALITY CONTROL LOG'." 2. Review of the laboratory's 2013, 2014, and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 172 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5609 Continued From page 172 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5609 2015 "H&E, Special Stains & IHC Slide Quality Control Log" found a monthly chart format with the following column headings: "Date", "PTH", "Sectioning", "Staining" ("Nuc" "Cyto"), "Labeling", "Mounting", "Cover-Slipping", "Special Stains" ("+" "-"), "IHC Controls" ("+" "-"), and "Comments and/or Corrective Action". Further review of the "H&E, Special Stains & IHC Slide Quality Control Log" found the following information below the chart: "Pathologist (PTH) will initial this sheet on days slides are reviewed. Entries are placed in the appropriate column. For special stains and IHC (Immunohistochemistry) indicate whether the positive (+) and negative (-) controls stained appropriately. If the technical quality is less than satisfactory, an entry will be placed in the comment column. P=Poor; F=Fair; G=Good. Nuclear; Muddy, Crisp; v=OK; ? None Received" No documentation of the actual stain reactivity and/or observation were present. 3. The LD and Quality Coordinator #1 confirmed that no documentation of the actual stain reactivity and/or observations were recorded. The LD and Quality Coordinator #1 explained letters or symbols are documented if the quality of the stain reactivity is acceptable. The LD and Quality Coordinator #1 confirmed no definition of acceptable or intended stain reactivity was provided. The interview occurred on 03/12/2015 at 9:21 AM. D5789 493.1283(b) TEST RECORDS FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 D5789 Facility ID: OHC05083 If continuation sheet Page 173 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5789 Continued From page 173 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5789 320M 400H Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, quality control (QC), patient test worksheets, instrument printouts, and interviews with Technical Supervisor (TS) #9 and Testing Personnel (TP) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to retain urinalysis and automated body fluid count instrument printouts and manual body fluid differential worksheets. Findings Include: 1. Review of the laboratory's policy and procedure titled "Department of Laboratories Policy Manual Quality Management (Q.M.) and Performance Improvement (P.I.) Plan" found the following statements: "7. Documents and Records: All records and materials are retained for an appropriate length of time as required by regulatory agencies (See Record and Material Retention Policy in the General Laboratory Manual)." 2. Surveyor #2 requested the laboratory's 2013, 2014, and 2015 Clinitek Advantus urinalysis analyzer instrument printouts for QC and patient testing from TS#9 and TP#9. TS#9 and TP#9 stated the laboratory shreds the urine analyzer printouts periodically. The interview occurred on 03/10/2015 at 11:50 AM. 3. Surveyor #2 requested the laboratory's 2013 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 174 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5789 Continued From page 174 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5789 manual body fluid differential worksheets and automated body fluid cell count instrument printouts from TS#9. TS#9 stated they were unable to locate January through March and July through December 2013 test records. The interview occurred on 03/10/2015 at 1:25 PM. D5791 493.1289(a)(c) ANALYTIC SYSTEMS QUALITY ASSESSMENT D5791 320M 400H (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in §§493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Item 1: Based on review of the laboratory's policies and procedures, 2014 Quality Summary, and quality assessment (QA) documentation, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in §§493.1251 through 493.1283. Findings Include: 1. Review of the laboratory's policy and procedure titled "Department of Laboratories Policy Manual Quality Management (Q.M.) and Performance Improvement (P.I.) Plan" found the following statements: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 175 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 175 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 "Procedure Some crucial elements of the Laboratory QM and PI Plan include use of established concepts of quality control (QC) supplemented with additional processes of Quality Improvement/Assurance (QI/QA) and involve analysis of high risk, high volume and problem prone activities." "Procedure QI/QA is process oriented and concerns itself with outcomes, results, ends and information content (problem finding and problem solving activities). Continuous monitoring, analysis and improvement represent the core of this function and are supplemented by on-going comparison with other establishments enrolled in similar pursuits." "1. Organization: The laboratory Medical Director has ultimate responsibility for all quality management activities in the laboratory and the Laboratory Manager is responsible to ensure that the plan is being carried out as written. He/she will review QC from all areas on at least a monthly basis or more frequently, if necessary. Any variances in the program are to be discussed by the Laboratory Manager with the Director so that any problems identified can be rectified and the plan can operate in an optimal manner." "1. Organization: Each Team Leader or Section Head is responsible for implementation and oversight of this plan in their section. The Team Leader, Section Head or alternate are to ensure active FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 176 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 176 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 review of the QC program in their section on all shifts on a regular basis and as specified in each section manual." "3. Equipment: The acceptability and/or performance limits for the instruments, service records (contract if utilized) and other necessary documentation are to be reviewed, updated and saved." "4. Supplies and Suppliers: Reagents, Chemicals, Media, Standards, Controls and Water: Items used must meet or exceed requirements set forth by appropriate accreditation agencies and/or organizations. All such items (except water when produced in the laboratory) are to be properly labeled, as applicable and appropriate, as to their content, quality, concentration or titer, storage requirements, and dated upon receipt or preparation and when placed in use. All such items upon receipt (or prior to being placed in use) are to be checked to see if they are satisfactory (including not past expiration date) and received without damage. All containers are to be stored in accordance with labeling requirements. They will be marked (when required) as to: date received, date opened, expiration date. They are to be removed from the usual storage place after the expiration date and discarded in a safe and acceptable manner. Any of these items are not used past the expiration date." "6. Process and Performance Control: Quality control data is generated and used daily. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 177 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 177 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 Control results are established by calculating the mean and standard deviations for appropriate tests on a regular basis. Tolerance limits are defined for control procedures and details pertaining to appropriate corrective action to be undertaken when controls exceed defined tolerance limits are to be indicated in each section. An active and on-going review of all these parameters including reagents, equipment and instrument maintenance (from all three shifts) is to be undertaken by the Team Leader/Section Head or designated alternate. Review is to be performed concurrently and on a daily basis. Corrective action when quality control results indicate lack of process control will be taken before patient testing is permitted. This QC program applies to all sections and shifts; sections may have additional section specific QC related items." "6. Process and Performance Control: Each section has a detailed Quality control (QC) program. Appropriate statistical (QC) data is maintained. Frequency of review of such data and appropriate corrective action to be undertaken are indicated in the QC program of each section. All QC, from the three shifts, is reviewed on a regular basis (daily, weekly and monthly depending on the nature of the data) by the Team Leader or alternate. All test results and reports from various shifts are also reviewed by the next regular workday. Review is to be indicated by initialing and dating the appropriate document." "7. Documents and Records: The laboratory shall ensure that documents are FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 178 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 178 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 identified, reviewed, approved, and retained and that records are created, stored, and archived in accordance with established policies. The laboratory maintains a complete set of current Policies and Procedures that apply to the Lab. They are readily available to personnel at the workbench in each section as hard copies or online. Institutional policies are available online. When an electronic manual is used, a backup hard copy or storage device will be available that can be accessed within a reasonable time to satisfy relevant needs and requirements." "7. Documents and Records: All records and materials are retained for an appropriate length of time as required by regulatory agencies (See Record and Material Retention Policy in the General Laboratory Manual)." "7. Documents and Records: When a new procedure is initiated, all details pertaining to the evaluation process are to be appended to the written procedure. This will include what testing was undertaken prior to implementation and the supporting data. Also, include documented review of the results by the Team Leader and Pathologist." "8. Occurrence Management: There is ON-GOING MONITORING in all areas and on all shifts with special emphasis on reference laboratory, information system (IS) functions, irregular occurrences, incident reports, laboratory accidents and evaluation of problems which are detected by personnel or reported at FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 179 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 179 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 meetings or brought to the attention of laboratory staff either internally or externally by sources such as *patients, nurses, physicians, volunteers, visitors, etc. Every occurrence, be it internal or external, is documented in SERS (Safety Event Reporting System)." "8. Occurrence Management: After investigation, appropriate corrective steps with resolution and preventative actions are undertaken by the laboratory management team." "8. Occurrence Management: While every effort is undertaken to prevent errors , when an error is detected (or brought to our attention), it is to be investigated immediately and appropriate corrective action undertaken. When a significant error is detected (or brought to out attention), which may have an immediate and harmful impact on the well being of a patient, this is to be brought to the immediate attention of the attending physician and/or unit nurse. While this is usually done after consulting with the Pathologist, in instances where time is a critical factor it may be necessary for the laboratory personnel to inform the attending physician or unit nurse first and the Pathologist subsequently. Instances of such a nature would include mismatched blood or components released for transfusion, significantly elevated chemical values; erroneous test data released which may lead to invasive intervention by the physician, etc." "10. Process and Performance Improvement: An annual evaluation/review is undertaken by the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 180 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 180 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 Director and Laboratory Manager for assessing the objectives, scope, organization and effectiveness of the Plan so as to make appropriate changes (when necessary) to the performance improvement activities; address issues and concerns identified through various reporting mechanisms and look at the strategic direction outlined in yearly Department reports." 2. Review of the laboratory's "Performance Improvement Report" from January 2013 through December 2014 revealed the following statements: "Problem: To identify any potential laboratory errors that may have occurred during this time period due to detected laboratory gaps." "Sample Size: A random sample of 120 patient charts was reviewed during the following time frames: February 2013 September 2013 February 2014 September 2014 Approximately 30 patients for each of the months were reviewed. Acceptance Criteria: All results should be concordant, without deviations that impact clinical decision making. Evaluation/Action: The charts were reviewed by a clinical nurse who found no inconsistencies. There were six patient charts that require additional examination by 'previous LD'. 'Previous LD's' review of the data and additional examination of six patient charts also concurred that there were no inconsistencies FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 181 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 181 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 between the laboratory's test results and the patient's clinical course. Conclusion The audit was accepted as showing no detectable or significant discrepancies were found. No laboratory errors or deviations were detected that attributed to any patient safety concerns." 3. Review of the laboratory's "2014 Quality Summary" revealed the laboratory's "2014 Patient Safety Monitors" for the analytic system as listed below: "3. Analytic: Error corrections 4. Analytic: Amended reports 5. Analytic: ED turn around times" 4. Surveyor #2 requested the laboratory's 2014 analytic system QA documentation from TS#9. TS#9 provided electronic graphs regarding blood culture contamination rates, emergency department turn around times, stroke protocol turn around times, and specimen integrity logs. On the dates of survey, the following failures in quality were identified: D5401 D5431 D5471 D5559 D5413 D5433 D5485 D5609 D5415 D5417 D5421 D5429 D5437 D5439 D5447 D5463 D5543 D5545 D5551 D5555 D5789 The laboratory failed to provide documentation demonstrating the monitoring, identifying, and correcting of failures in quality that addressed all facets of the analytic system. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 182 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 182 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 Item 2: Based on review of the laboratory's policies and procedures, quality control (QC) Levey Jennings graphs, calibration documentation, and an interview with Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to correct problems identified in the analytic systems for the subspecialty of coagulation. Findings Include: 1. Review of the laboratory's policy and procedure titled "Manual of Operations Quality Control Policy and Procedure" found the following statements: "II. Quality Control (QC) H. Review 1. Daily and/or Weekly Quality Control Review 1) Check for appropriate QC failure corrective action (QC modifiers) documentation. 2) Check for any possible trends, shifts or chronic failures as applicable. 3) Take appropriate actions to correct where necessary. Document any actions on outlier report. 4) Initial report indicating review. 5) Bring chronic problems to the attention of the supervisory personnel and/or staff." "II. Quality Control (QC) H. Review 2. Monthly Review FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 183 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 183 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 For quantitative assays, quality control statistics are performed at least monthly to define analytic imprecision and to monitor trends over time. The laboratory must use statistical methods such as calculation SD and CV at specified intervals to evaluate variance in numeric QC data. a. Medical Director or designee must review and sign the QC report. Review the monthly QC report for the following: 1) Trends, shifts and corrective action 2) Means, standard deviation and coefficient of variation for the current month are compared with the previous months and the expected values if applicable. 3) Determine if the QC ranges need to be updated 4) Assess need for further or additional corrective action or procedural changes" "IV. QC Action Guidelines for Quantitative and Semi-Quantitative/Qualitative Testing A. Daily Quality Control Action Procedure for Quantitative Tests 8. Shifts and Trends a. The detection of shifts and trends will be monitored in the Sunquest laboratory computer system with the appropriate Westgard Rules, including, but not limited to: R2S3: Two out of three consecutive QC results are greater than two SD on the same side of the mean. R41S: Four consecutive QC results are more than one SD away from the mean in the same direction." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 184 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 184 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 "IV. QC Action Guidelines for Quantitative and Semi-Quantitative/Qualitative Testing A. Daily Quality Control Action Procedure for Quantitative Tests 8. Shifts and Trends c. The testing personnel are responsible for investigating and determining if a corrective action is required. If investigation indicated potential incorrect patient results, do not release patient results until the problem has been corrected or an alternative procedure employed. If the testing personnel feel that corrective action, such as a calibration, is indicated, that action should be taken and documented. The run should be checked or repeated as appropriate." 2. Review of the laboratory's "Performance Improvement Report" from January 2013 through December 2014 revealed the following statements: "Problem: To identify any potential laboratory errors that may have occurred during this time period due to detected laboratory gaps." "Sample Size: A random sample of 120 patient charts was reviewed during the following time frames: February 2013 September 2013 February 2014 September 2014 Approximately 30 patients for each of the months were reviewed. Acceptance Criteria: All results should be concordant, without deviations that impact clinical decision making. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 185 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 185 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 Evaluation/Action: The charts were reviewed by a clinical nurse who found no inconsistencies. There were six patient charts that require additional examination by 'name previous LD'. 'Name of previous LD's' review of the data and additional examination of six patient charts also concurred that there were no inconsistencies between the laboratory's test results and the patient's clinical course. Conclusion The audit was accepted as showing no detectable or significant discrepancies were found. No laboratory errors or deviations were detected that attributed to any patient safety concerns." 3. Review of the laboratory's 2014 and 2015 QC "Levey Jennings Charts" for D-Dimer and Fibrinogen testing revealed cover pages for each of the 2014 Levey Jennings graphs that stated: "GAP analysis was performed on all reviewable forms within the laboratory. Multiple occurrences were observed where review was not documented. During retroactive analysis of forms no trends were noted. Corrective action includes review of forms by the designee 'TS#8' or 'TS#9' at stated intervals and monthly review by technical supervisors 'TS#8' or 'TS#9' approved by the medical director 'LD' effective immediately." Signed by LD and dated 2/25/15 Review of the 2014 and 2015 monthly D-Dimer and fibrinogen QC Levey Jennings graphs and instrument calibration printouts for both of the laboratory's coagulation analyzers (SN: A7391 and A8134) found the following: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 186 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 186 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 CA-1500 (A7391) D-Dimer Control 1 February 2014 - 33 points below the mean reviewed by an individual not listed on CMS-209 3/3/14 March 2014 - 18 points below the mean and a second shift of 23 points below the mean reviewed by TS#8 3/3/15 April 2014 - 50 points below the mean reviewed by TS#8 3/3/15 May 2014 - 37 points below the mean and a second shift of 15 points below the mean reviewed by TS#8 3/3/15 June 2014 - 44 points below the mean reviewed by TS#8 3/3/15 Calibration performed 6/25/2014 reviewed by TS#8 3/3/15 July 2014 - 17 points below the mean and a second shift of 32 points below the mean reviewed by TS#8 3/3/15 Calibration performed 7/4/2014 reviewed by TS#8 3/3/15 August 2014 - 28 points below the mean reviewed by TS#8 3/3/15 September 2014 - 39 points below the mean reviewed by TS#8 3/3/15 Calibration performed 9/22/2014 reviewed by TS#8 3/3/15 October 2014 - 25 points above the mean reviewed by TS#8 3/3/15 Calibration performed 11/10/2014 reviewed by TP#9 11/10/14 November 2014 - 20 points above the mean reviewed by TS#8 3/3/15 Calibration performed 11/21/2014 reviewed by TS#8 3/3/15 January 2015 - 12 points above the mean and a second shift of 13 points above the mean NO REVIEW DATE/INITIALS FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 187 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 187 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 D-Dimer Control 2 February 2014 - 19 points below the mean and a second shift of 28 points below the mean reviewed by an individual not listed on CMS-209 3/3/14 March 2014 - 44 points below the mean reviewed by TS#8 3/3/15 April 2014 - 50 points below the mean reviewed by TS#8 3/3/15 May 2014 - 42 points below the mean and a second shift of 12 points below the mean reviewed by TS#8 3/3/15 June 2014 - 39 points below the mean reviewed by TS#8 3/3/15 Calibration performed 6/25/2014 reviewed by TS#8 3/3/15 July 2014 - 50 points below the mean reviewed by TS#8 3/3/15 Calibration performed 7/4/2014 reviewed by TS#8 3/3/15 August 2014 - 24 points below the mean reviewed by TS#8 3/3/15 September 2014 - 21 points below the mean and a second shift of 19 points below the mean reviewed by TS#8 3/3/15 Calibration performed 9/22/2014 reviewed by TS#8 3/3/15 Fibrinogen Citrol 1 May 2014 - 24 points below the mean reviewed by TS#8 3/3/15 July 2014 - 12 points below the mean reviewed by TS#8 3/3/15 August 2014 - 18 points below the mean reviewed by TS#8 3/3/15 September 2014 - 19 points below the mean reviewed by TS#8 3/3/15 February 2015 - 11 points above the mean FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 188 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5791 Continued From page 188 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5791 reviewed by TS#8 3/3/15 Fibrinogen Abnormal Control September 2014 - 17 points below the mean reviewed by TS#8 3/3/15 October 2014 - 13 points below the mean reviewed by TS#8 3/3/15 CA1500 (A8134) D-Dimer Citrol 1 February 2014 - 20 points below the mean and a second shift of 13 points below the mean reviewed by an individual not listed on CMS-209 3/3/14 November 2014 - 11 points above the mean reviewed by TS#8 3/3/15 January 2015 - 28 points above the mean reviewed by TS#8 2/28/15 D-Dimer Control 2 January 2015 - 21 points above the mean reviewed by TS#8 2/28/15 Fibrinogen Citrol 1 November 2014 - 10 points below the mean reviewed by TS#8 3/3/15 February 2015 - 10 points above the mean NO REVIEW DATE/INITIALS 4. Surveyor #2 requested documentation of corrective action taken for the D-Dimer and fibrinogen QC shifts identified from TS#9. TS#9 stated no additional al documentation was available. The interview occurred on 3/10/2015 at 10:40 AM. D5801 493.1291(a) TEST REPORT 400M 510H D5801 The laboratory must have an adequate manual or FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 189 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5801 Continued From page 189 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5801 520H electronic system(s) in place to ensure test 530H results and other patient-specific data are 540H accurately and reliably sent from the point of data 550H entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Item 1: Based on direct observation, review of the laboratory's policies and procedures, emergency release documentation, laboratory information system (LIS), hospital information system (HIS), and interviews with Testing Personnel (TP) #1 and #9, the Compliance Specialist (CS), Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the Head of Transfusion Medicine (HTM), and a "Short Stay" unit nurse, the laboratory failed to have an adequate manual or electronic system(s) in place to ensure immunohematology test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. Findings Include: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 190 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5801 Continued From page 190 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5801 1. Review of the laboratory's policies and procedures found the following: - A policy titled "Department of Laboratories Transfusion Service Quality Program" which stated: "5.27 Medical Record Documentation: 5.27.1 The patient's medical record shall include: Transfusion order, documentation of patient consent, the name of the component, the donation identification number, the date and time of transfusion, pre- and post-transfusion vital signs, the amount transfused, the identification of the transfusionist, and, if applicable, transfusion-related adverse events" "6.2 Records: MMH Transfusion Service ensures identification, collection, indexing, access, filing, storage and disposition of records as required by AABB Reference Standards. 6.2.1 Records shall be complete, retrievable in a period of time appropriate to the circumstances and protected from accidental or unauthorized destruction or modification." - A policy titled "Emergency Release of Blood Uncrossmatched" which stated: "Procedure Notes: 1. In an emergency situation where a name and medical record number is unavailable, Fill out the Emergency Release Waiver with as much information as possible. (i.e. John Doe, Jane Doe) Add name and medical record number to the Emergency Release Waiver as information becomes available." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 191 of 333 PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES 0MB NO 09330301 smenem or 1x1) pmroas/euppnas/cm 1x1) naming coNsTRucTIoN 1st one sum/Ev mo sun or minimum NUMBER man cor/mares JEMIIDSU WING-- was or pram/roan as summer: cm em: 21>> coca 12:00 ROAD umvuoum HOSPIYAL GARFIELD 44125 1x010 ear/my swam/r or oancrencres .a moi/roams mm or ccssacmy as INN war a: macs/sec av n/u new 9101/10 as Wires YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED THE APPROPRIATE canes/icy) 050m oonrinr/ed From page 101 05301 "Procedure Nciea. 4. All 1einng musI be compIeIed as soon as a paIienI sampie is avsiIahle A11 resuiia are en1ered inIc1ne 2. On 03/12/2015 a1 11.30 AM Surveyor reques1ed Ine Iahmalcry's emergency 2014 and 2015 TP 1:9. TP 110 provided a maana icider InaI comained emergency reiease documen1a1ion ircrn 00/27/2014 Inrcugn Ine da1ea o1 survey Surveyor :11 random/y seIecIed 2 paliems' emergency reiease records ircrn 1ne maniIa folder and requested ma1 TP :10 IccaIe Ine iype, screen and compaiiorIiiy Ies1 records in me LIS Inai corresponded to me emergency units. a. Review c11ne fnmI Ii1Ied "Emergency Waiver", wnicn was daied 02/12/2015,round1ne following. anne1op rigm nand section c11ne ion was Mn paIienI iden1rnca1ron slmkers. Tne 1rs1 wnIaIned me palienl's name, da1e o1 hinh oi-- memcal record number (MR3) o1 - and pa1ren1 number (PM oi The second comained me name daIe c1 ornn o1_, MR1: o1 - and barcode c1 vzse0100473 2 uniIa o1 uncrossmaicned ieroup O--Negauve Panked were reques1ed. mm 01525671027001 Prawn/"lam: Dmla Ev-m ID 011mm minim/01 I1 anee1 Page 192 a1 :33 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 09/10/2015 FORM APPROVED 0MB NO 0938mm the box next to the statement of donor oiood with patients oiood tor cornpatioitity was NOT cornpteted was marked 4 unit tag stickers were present, ait o1 which were type 0 Negative, and had expiration dates o103/05/2015, 03/00/2015, 03/17/2015 and 03/18/2015 next to the um] tag sticker W204215165761 0 Negative with an expiration date 000310512015 was a handwritten note which stated "trans/used" the date and time o102/12/2015 and 13 55 was indicated at the bottom ot the page with the physinian's signature and printed name. a handwritten note at the hottom oi the page stated ONE UNIT 4. TP we attempted to retrieve the testing and trans/usion data for the patient with the MR it o1 -and ot-- inthe Us The LIS indicated that a type and screen (T3) was wrnpieted on 02/12/2015 at 5-05 PM. No indication of a trans/usion or htood product unit issued was present TP its went to wnsult with TS 110 and find out why the did not wnlain a trans/usion record. The interview occurred 03/12/20t5 at tt :8 AM 5. Surveyor at went to TS 39's office to rottow>>up with the identified discrepancy. TS its stated the unknown patient and the patient with the LIS blood bank vewms were supposed to have heen merged in the us out were not. T5 :10 funher stated the hospital's iniormation sure/rem or oericrevcies 1x1) 1x1) MULTIPLE coNsTRucTtoN ixsi one sum/Ev mo new or roeunricmov NUMBER man comma asmaansu a WING 03mm" 5 more or PROVIDER OR sroeeraoosesa cm ewe ZIP cope moo uccmxew scan MARVMOUNT HOSPITAL LABORATORY GARFIELD OH 44125 ID SUMMARY swerve/r or oerrcievcies .o pocVioeo-s new or coRREcnoN do were tum oerrcievcv a: ooeceoeo av ruu poem (EALH SHOULD BE Wino TAG REGULATORY OR LSD IDENTIFYING INFORMATION TAG CROSSREFERENCED THE APPROPRIATE oerrcieucn D5001 Continued From page 102 053m FORM Pram: Wm: omia Ev-m ID 011mm ID oncoeoat i1 cnmmunlmn sheet Page 193 or 333 PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES 0MB NO 0033mm erarenanr or 1x1) 1x1) MULTIPLE coNSmucTIoN 1st one sum/Ev mo mu or CORRECVION NUMBER man cor/stereo JEMIIDSU WING-- was or PROVIDER on SUPPLIER SWEEIADDRESS cm em: 21>> moo scan HOSPIYAL uaonnonv GARFIELD HEIGHTSIOH 44125 1on ID aunt/rm smarter/r or more/eras .o murders-s PLAN or as were taco oartorsuov a: paacsoao av n/u new (EALH cosaacnvaaonon snouto as Win" YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED to ME APPROPRIAYE oartorsnon 05001 Continued Frorn page 103 053m technotogy depanrnertt (CPI) were the only indIviduaIs who can merge the two aowunts and the request tar merging the patient was sent right after the post transfusion was cornpteted Last/y, '13 stated the Ianoratory did not have any documentation demunslrallng when they submmed the merge request tor this patient to CPI The Inlervtew occurred 03/12/2015 at tt 40 AM. 5. Review at the LIS htood bank patient record for the patient with the MR: of - and -- Iound. no record of a transiusiort or wmpalihillty intorrnation on the screen titled "Blood Bank Mmlnislrallve Data~ the statement transfusion data Ioundm" on the screen titled Patiem history Transfusion Data. on both aforementioned screens, the headings titled Units Transr and "Last Transr' were blank. RC - Red Transf - Transmsed/Trartsfusion 7. Review at the LIS blood bank unit history documentation forthe packed red blood cell unit found The unit was assigned the status of on 02/05/2015 at 7.54 AM The unit was assigned the status of on 02/05/2015 at 11.02 PM to a FORM 13/525671me PtarmaVa/Sma Dmla Ev-m ID 011mm nan, ID domination sheet Page mot 333 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 09/10/2015 FORM APPROVED 0MB NO 00380301 amensur or DEFICIENCIES 1x1) 1x1) MULTIPLE our one sum/Ev awn min or CORRECTION wuuass man aamuunsu a Wine 03mm" 5 was or pom/rose OR suppuss cm ems 20> cooe 12:00 scan MARVMOUNT HOSPITAL LABORATORY GARFIELD OH 44125 ixai ID swam/r or DEFICIENCIES .p sun or connection as mm inch DEFICIENCY 0E poscsoso av n/u new (EALH SHOULD BE WW TAG REGULATORY OR LSD IDENTIFYING INFORMATION TAG CROSSREFERENCED THE APPROPRIATE DEFICIENCY) D5001 Continued Frorn page 19-1 051401 patient a 01 -- The unii was assigned ihe status of on 02/06/2015 01 11 -03 PM to a paiient with a The unii was assigned ihe status of on 02/05/2015 at 11-37 PM with the wmmem 1or processing" 'Flease Note the unit was reiurried to the blood bank depanrnerii greater than :10 minutes ariar issue No c1 ihe unit's ternperaiure when returned was present (Refer to D5555) The unii was assigned ihe status of on 02/07/2015 at i 45 PM In the patient with the MR1: The unii was assigned ihe status of on 02/12/2015 an 1.00 PM to ihe patient with the MR3 - The unii was assigned ihe status of on 02/14/2015 at 7-40 AM to the atiem with the MR3 a. Review at he document Pick up sup", provided hy T3 39, 1ound a patient ideniincaiion slinker which wnlained ihe palienl's name, date at oinh of o1 -- and ci-- The word "No' was circled next to "Ceciem ~RIac's" was Gilded next In "Componenffi the number 2 was wrillen head In 'Quamity"" and ihe number 6 was wrillen head In rpm/i 052567012va Pram: Verna": Dmla Eva In minim ID pwcuenaa i1 emu/"mum .neei Page 1951:1333 PRINTED 00/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES 0MB NO 0030mm err/renew or oerrcreucres 1x1) pmroeweuppuemcm no humor: ocusmuonou 1st one sum/Ev mo mu or connecncn NUMBER man cor/pram JEMIIDSU WING-- NAME or pom/rose on suppueo cm em: 21>> Imu ROAD nosme uaommnv GARFIELD HEIGHTSIOH uus 1on I0 cur/my crusher/r or oerroreucree .o poor/rows men or ccooecnou do were INN oerroreuov Muer e: poeceoeo 0v new (EALH coRRecnr/eecnou SHOULD as Who" YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED THE APPROPRIATE oerroreuon D5001 oohnnoed Frorn page 105 050m R00 Red BIond Cells 0R apereIrng Room 0. Men eeked by Surveyor 3L Ine CS Ihe emergency reIeese wen/er and Issue slip were Ihe ohry Ieoorerory records IneI rndicered Ihe MRI: oI_ end PT: 0f -- recerved Ihe w2042151e57s1 0an oI The inIen/iew occurred 03/12/2015 at II 44 AM I0 Survean esked TF 11 any oIner vewm of me emergency IransIueicn Ior Ine pabem wIlh Ihe oI-- end PT: of" exiered The CS end TF record oI Ihe IransIueicn may be rnIne HIS (EPIC) The CS aIIeraned Io IccaIe record oI Ihe in Ihe HIS (EPIC) but sIeIed Iney were hoI very famiIiar mn Ihe HIS (EPIC). The then/iew occurred at 11 45 AM TP 31 reIneved nurse (RN) Irorn Ihe nospners Shon Slay uan. The RN eIIenrpIed Io IoceIe a IransIueicn record from 02/12/2015 In Ine palienl's HIS (EPIC) rnediceI vewm Tne RN were able Io IoceIe a noIe 1n Ihe palient's HIS (EPIC) vewm Irorn 02/12/2015 under Ihe needing "Pmnedure' TRANSFUSION IneI ~nurse forgot Io edd procedure (horiced in GehereI InIo cornrnehIe Idood wee 247)" The RN sIeIed Iney were having dimcun Iirne IoceIrng eny record oI IrensIusron and occurred on 02/12/2015 The inIervrew occurred 011201 PM. The RN was we Io IoceIe record oI Iype end screen was perIorrned on er 5.00 PM Fer Ihe Ihe Iype end screen, wiIh mu. 057.5671me Ptarmivammi emu ID 00mm .neeI Page 19001333 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 00/10/2015 FORM APPROVED 0MB NO 093M301 an expiralicn dale 0102/15/2015, had unlls avsllable 101 issue under 1he heading ~Compenem Type" but 11 did no1 Indicate 11711! was llanslused The Tmemew downed 03/12/2015 e112-07 PM. The HTM s1a1ed1he record should be located 1n the nurses or donor's hole The inlemew occurred 03/12/2015 011209 PM. T5 :10 pmvded Surveyor :11 a packet 01 vewms, p11n1ed1mm1he HIS (EPIC), for the palienl win the MR1: al-- and PT: of -- Review of me pankel of lemma round an nperelive repan de1ed 02/12/20151er1he palienl a end ol- contained a "me under the heedlng "Description 01 Operelion.~ whieh slated "Given evidenne o1ae11ve hleeding, blood was appropriately ordered hy anesmesia Addilionally, dummems 1nIed "Aneslhesla Record", de1ed 02/12/2015, was Included s1a1ed ~3m) on" under the and Blond . Las1/y,cn1he doeumenls ~Anesmesia Record" in the wlumn lined ~Commenue And Notes" a note which s1e1ed ma" was under Ihe heading "Blond ProdueI/Fluld Inlc" T01 - Tulal Pmduels The RN s1a1ed may were unable In locate a llanslusicn record for an emergency 0 negative un11 011212003. The 1n1en/iew occurred 03/12/2015 e112-12 PM. envenem or DEEICIENCIES 1x1) pmmes/eumewem 1x1) humus CONSTRUCTION 1x31 we sum/Ev AND HAN o; Immune/new NUMBER man comma aamuunsu 0 we 03mm" 5 we or mam/men 0R sup/mes sweets/passes cm ewe 21/: none 12:00 ucemxen seen MARVMOUNT HOSPITAL LABORATORY GARFIELD OH 44125 lon sum/m ewe/em or lemme/mes women-s mm or museum/1 as were lam nenelewev MUST 0E paecenen 0v r011 peer/x 12m mum 0E TAG REGULATORY OR LSD IDENTIFYING INFORMATION TAG CROSSREFERENCED THE APPROPRIATE DEFICIENCY) D5001 Continued From page 196 05001 mu. Pram: Wm: 00mm: Ev-m ID 00mm .0 meme: 1/ emnmm we Page 10701333 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 09/10/2015 FORM APPROVED 0MB NO Item 2- Based on review oi tne laboratory's policies and procedures, activated clotting time (ACT) test vewms and final test reports, and interview witn Technical Supervisor (as listed on ttie Laboratory Personnel Repon (CLIA) Forrns OMS-209 signed by tne Laporatory Director (LD) on 03/09/2015), tne laboratory failed to have an adequate manual or electronic system(s) in place to ensure activated cloning time test results and otner palienl>>speClfiC data are accurately and reliaon sent irorn tne point oi data entry to final report destination Findings IncIude titled ~Activated Clotting Time - Low Range tound tne following directions ~Reading/Reporting Results A Reponing Results/Result Format t. Upon test wmpletion, immediately report all test results, in seconds, to ttie Physician wno ordered tne ACT test. The results are also rewrded in ttie 'Inlra-Frcoeduval Nursing Notes' Log 2. Review ol the laboratory's 2015 ACT test vewms tilled JR SIGNATURE DAILY PATIENT Iound ttie resuIt documentation. Date. 'nme- Results- 115115 1235 outclrange>>Hl t. Review at tne laboratory's policy and procedure and on ttie Hernocnron .tr. Signature daily 'Fallent amenzur or DEFICIENCIES ixit no MULTIPLE CONSTRUCTION out one sumv mo HAN 0F coaascneti IDENTIFICATION NUMBER man consterzo aaoomnsu a WING 03mm" 5 NAME or PROVIDER OR SUPPLIER srasmooszaa cm sure ZIP coog imp emu MARVMOUNT HOSPITAL LABORATORY GARFIELD OH uus Ixot ID auvvm STATEMENT OF DEFICIENCIES .o PROVIDERS PLAN or coaaecnoti no PREFIX tacit DEFICIENCY vuar a: paecsozo av rutt poem (EACH cosnecrivescrtou SHOULD as Mites TAG REGULATORY OR LSC IDENTIFYING INFORMATION TAG CROSSREFERENCED to THE APPROPRIATE DEFICIENCY) Dsam Continued From page 197 D5801 FORM Pram: Wm: emu Eli-m ID omit encuth it continuation sheet Page I93 at 333 PRINTED 09/10/2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES OMB No 09300391 ems/rem or camera/ares (x1) moromoppnemm (x2) momma CONSTRUCTION IX1I one suRva mo mo or ecoaeenen NUMBER man comers/o JEDOSIIDSU WING-- NAME or pom/roe>> 0R some: cm em: up 12:00 emu GARFIELD 44125 MARVMOLINY HOSPITAL 1x4) rc sow/m sum/em or canoe/ens .o or connecnor/ as new (we oerroIer/ov MUST BE 0v Fuu 12m mom ae mmETIar/ TAG OR LSD IDENTIFYING INFORMATIONI TAG CROSSREFERENCED To THE APPROPRIATE canon/row 05901 page 100 05901 1/9/15 - Unkn HI cm c/ range 1/14/15 139710 302 - 390222 HIgh coI c1 range 305967 HI - 305967 249 2/10/15 199970 HI c1 range 2/12/15 - 292176 2/17/15 043862 265 2/23/15 - 217919 159 1/7/15 - 144920 154 1/9/15 127913 orrIc/rarIge~Ir/grr~ 1/9/15 - 199177 bIank 1/20/15 - 479254 orrIc/rarIge~Ir/grr~ 1/29/15 I 463964 "cmo/range" 2/10/15 199970 cm o/ range MR1: Med/oaI Reocrd Nurncer HI - High 3 On 03/25/2015 an 52 AM, Son/eych requested' via eIeo1rcnio rnaiI final Ies1 vepnns 1cr1r1e ACT my rescue I/sIed above 1rcrn T5 :19 and Ts 119 TS 119 repIied, vie ernaiI on 03/25/2015 e1 5-01 PM and s1aIed "In response 1c 00H: request received 3/25/2015 a1 7-52 a nr Ine lab worked 1c idenIIiy and cc1ain me requesIed reocrds In EPIC 0/ Me 15 records requested 9 were identified and are aluched to emaII vans/"ital For Me remaIning 7 reocros,1r1eIec oannc1 pmduoe records /rcrn EPIC PricrIc March 13 2015, Me resI/Ils IesI/ng pencnned during pvnnedI/ves in Me apera1Ing Roorn (OR) (i inIrecperaIive IesIs) were verbaIly reported Ic IrIe opereI/ng physia'an and Me IesL/lls o1 me ACT Ies1 were recorded in Me 0R Icg book ThIs allowed 1ne physia'an Io order FORM meager/moor PT-mauiVa/Smni Dumb-Ia Evlm ID 011M611 nonyro menace: I1 sleet Page 1996153: DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 09/19/2015 FORM APPROVED OMB No 09390391 during Ine prooem/re and respond Io Ine results prompuy However 1ne HospIIaI reoognIzeu earIIer InIs mon1n1naIInIs praclme ooqu Neale a In Mum a palient'sACT Ies1 resuII was no1re/Ieo1eoin1ne palienl's Tenor ODH - onio Depanrnen1 o1 Healm - HospI1aI's In/orrna1Ion 5ys1enr 4 Review mm 9 finaI Ies1repons by TS :19/ound1ne/oIIoWIng Dale nrne- ResulIs' 1/5/15 1235 outo/range@1235 1/15/15 99313 HIgIIoI/Io/range 2/5/15 1213 249 1/7/15 1525 -- 154 1/9/15 9945 - 1/9/15 1515 -- ACT-279 1/20/15 0925 oqu/rangemIgn~ 1/29/15 1404 oqu/range Tne requested final Ies1 vepnns were noI provided Da1e 'nme- Resulls' 1/9/15 1252 Unkn HIomo/range 2/5/15 1030 - HI 2/10/15 1320 I HI out a! range 2/12/15 1432 om oI range 2/17/15 1319 255 2/23/15 1135 I 159 2/10/15 0020 om oI range 5 Included In the ACT 1esI records was a 1/14/15 1010 _nnreSI/Ildch/menled STATEMENT or DEFICIENCIES (x1) (x2) MULTIPLE EONSYRUETION on; SURVEY AND PLAN 0; coma;an wuss: man COMPLETED :IaDosnnsu a WING "mam" 5 NAME or PROVIDER 0R SUPPLIER smegAun/zzss am sure ZIP nous 12m ROAD HOSPIYAL GARFIELD HEIGHTS, OH 44115 1x4) ID SUMMARY sum/w or DEFICIENCIES ID PPoI/Iozn-s PLAN or us>> PREFIX (awn DEFICIENCY Musr a: PRECEDED 9v mu PREFIX (EACH CORRECYIVEACTION SHOULD 92 common YAG 0R Iso IDENTIFYING InromAnoI/I TAG In APPROPRIAYE WE DEFICIENCY) D5801 Continued From page 199 05901 roan 0.157256711127va vaIaI/iVa/imni omen EvlnI ID WMEII anIIlyID uchfina: I/oonIInInIIon sreeI Page 21/001333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 12300 MCCRACKEN ROAD GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG D5801 Continued From page 200 D5801 document that stated "GAP analysis was performed on all reviewable forms within the laboratory. Multiple occurrences were observed where review was not documented. During retroactive analysis of forms no trends were noted. Corrective action includes review of forms by the desingnee 'TS #8' or 'TS #9' at stated intervals and monthly review by technical supervisors 'TS #8' or 'TS #9', approved by the medical director 'LD' effective immediately." The document was signed by the LD and dated 02/25/2015. D5805 493.1291(c) TEST REPORT D5805 400M 510H 520H 530H 540H 550H 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ (X5) COMPLETION DATE The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, activated clotting time (ACT) test records and final test reports, and interview with Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to indicate the test performed, the test result, and the units of measurement on the activated clotting time FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 201 of 333 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 02/10/2015 FORM APPROVED OMB No 09300391 1ACT) finaI lest reporls Findings Include nueo "Ann/sled TI/ne - Low Range 1ouno me (allowing direclIons ~Reading/Repomng Results A Repomng Results/Result Format 1 Upon 1es1oomp1enon, ImmedIalely lepnfl an Ies1 resulIs, in seoonos, to me thsiCIan who aide/ed me ACT Ies1 Tne resuIIs are also venomed 1n me 'Inlra-Fmoeduval Nuvsing Notes' Log 2 Review o11nelebore1ory's 2015 ACT 1esI veooms tilled JR SIGNATURE DAILV PATIENT found the 1oIIowing result documenIaI/on Da1e 'nme- ResuIIs- 1/5/15 1235 nulclrange>>Hl 1/9/15 1252 Unkn HI cm o/ vange 1/14/15 1010 - 302 1/15/15 09313 -- HIgth/Iohange 2/5/15 1030 HI 2/5/15 1213 24a 2/10/151320 HIoqu/range 2/12/15 1432 -HI-HI>>HIomnhange 2/17/15 1319 265 2/23/15 1135 I 159 1/7/15 1525 154 1/9/15 0345 nulclrange'hIgh" 1/9/15 1515 - bIank 1/20/15 0925 nulclrange'hIgh" 1/29/15 1404 - "cmnhange" 1 Review o11ne laboratory's and pvnnedme arm on me Hemoonron Jr Signature daily STATEMENT or panama/gs (x1) pmwowsuppugmm (x2) MULTIPLE ooNsmuonoN 1st we 50/?va AND pun or eowngenm NUMBER man comma) JEDOSIIHSU 5 Wm; "mam" 5 NAME or PROVIDER 0R sup/mg: swan/amass cm 5141: 21/: none 121m ROAD MARVMOUNY HOSPIYAL GARFIELD HEIGHTS, on 44125 1x4) ID sow/4m sum/w or Denna/mes ID PROVIDERS PLAN or con/1mm us>> mm (mm DEFICIENCY Musr as women av r011 PREFIX PRINTED 09/10/2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE as MEDICAID SERVICES 0MB NO 09330301 smenenr or 1x0 pmroemuppnemm Ixz) EONSWUETIDN our one smev mo HAN or coRREcnoN Inn/oer: man oer/pram JEMIIDSU WING-- we or women 0R suppose smemomzess c/W em: up moo ROAD HOSPIYAL uaonnonv GARFIELD HEIGHTSIOH uus Ion In sum/rm swerve/r or oenormres .o poor/mews PLAN or coRREcnoN as new Imn oenormv vusr e: paeceoeo av mm rem coaaecnvuonon oz WW YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED YHE APPROPRIAYE oenorenon D5805 Continued From page 202 05305 2/10/15 0820 - cmofvange MR3 Medical Rewm Nurnoer HI - Hign Unkn - Unknown 3. On 03/25/2015 aI 7 52 AM, Surveyor :91 [equesled' vio eIemronio mail final IesI repons PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES 0MB NO 0933mm ems/rem or no pmmeweumemd 1x1) naming oer/smuorror/ our one sum/Ev mo HAN or eonneenen NUMBER man dormers/e JEMIIDSU WING-- NAME or pom/men on suppose memory/sees cm ewe 2w Imp ROAD HOSPIYAL GARFIELD HEIGHTSIOH uus ID ear/my swam/r or omens/mes .p wonders-s mm or common as new Imn sender/or war a: oneceoeo av Fuu peer/x DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 09/10/2015 FORM APPROVED 0MB NO 0938mm d. a screen shot ot a "Doc Flowstieets" for patiem MRN 306957 tound an ACT result documented as Range ACT 248 data pertonned 2/6/2015 time performed ma No documentation indicating tne test pertonned (definition ottne abbreviation and the units of measurement was present e. a document titled "Vascular Interventional Sedation Record~ tor the patient with the - found ACT results documented as. Trrne. Intra Procedure Nurse's Notes ACT 154 1640 ACT 21 5 No documentation indicating tne test pertonned (definition ottne aooreuiation and the units of measurement was present f. a document titled "Vascular Intervemional Sedation Record~ tor the patient with the --fcund ACT results documented as. Trrne. Intra Procedure Nurse's Notes tztu ACT 146 tzas ACT 271 t245 ACT 292 No documentation indicating tne test pertonned (definition ottne aooreuiation and the units of measurement was present g. a document titled "Vascular Interventional emenzm or DEFICIENCIES ixi) amtomuppuemu 1x1) numptz our one sum/Ev mo mu or NUMBER man counterzo asoomnsu a write 03mm" 5 we or pool/rose OR SUPPLIER smsmooizzee am sure 2n: coos moo ucenacxsn scan MARVMOUNT HOSPITAL LABORATORY GARFIELD OH uus our ID euwrim sruzueur or oencieucies .o moi/om mm or coRREcnoN as max (BEN oericisucv MUST as poecsozo av Fuu poem (EACH snouto as Wino TAG REGULATORY OR LSC IDENTIFYING INFORMATION TAG CROSSREFERENCED THE APPROPRIATE oencisncn D5805 Continued Frorn page 204 05305 :om Puma Wm: omie Eli-m ID Oith ID oncosnaa .neet Page ms or 333 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 00/10/2015 FORM APPROVED 0MB NO 0930mm Sedation Recovd" tor the patient with the _f0und ACT resulta documented aa. Trrne. Intra Procedure Nurse's Notes 0045 ACT - out of range "high" 0005 ACT - 272 0045 ACT - 393 1010 ACT - 304 t025 ACT - 182 No documentation indicating the test pertorrned (definition ot the abbreviation and the unita of measurement was present It. a document titled "Vascular InterventionaI Sedation Record~ tor the patient with the _iound ACT resutta documented aa. Trrne. Intra Procedure Nurse's Notes t515 ACT - 279 No documentation indicating the test pertorrned (definition ot the abbreviation and the unita of meaaurement was present i a document titted "Vascular tnteruentionat Sedation Record~ tor the patient with the - iound ACT resutta documented aa. Time. Intra Procedure Nurse's Notes 0025 ACT out of range ~nigh~ 1030 ACT 272 No documentation indicating the test pertorrned (definition ot the abbreviation and the unita of meaaurement was present a document titled "Vascular InterventionaI Sedation Recovd" tor the patient with the eurenzur or DEEICIENCIES (xi) (x1) numptz ixsi one sum/Ev mo mu or CORRECTION iogunricmou wuss: man counterzo aaoomnsu a Wine 03mm" 5 nuts or pact/rose OR SUPPLIER smgmooszse am am: ZIP coog moo uccmxeu scan MARVMOUNT HOSPITAL LABORATORY GARFIELD OH uus ID SUMMARY sruzueur or oencieucies .o moi/om mm or common as mm (ma oencigucv MUST a: pcecgozo 0v Fuu new (EACH coscecrivucriou snouto 0E Winn TAG REGULATORY OR LSC IDENTIFYING INFORMATION TAG CROSSREFERENCED to THE APPROPRIATE oencigucn 05005 Continued Front page 205 05005 :0an culszsa'unzrwi Pram: WW5 omia Eva ID 00th ID oncoenat itcmtinuanon sheet Page 205 at 333 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 99/10/2015 FORM APPROVED 0MB NO 093043391 ararEuE/tr 0F DEFICIENCIES 1x1) awn mu oE CORREGHON IDENTIFICATION NUMBER 1x1; MULTIPLE A BUILDING a 1x31 DAVE sumEv 03/13/2111 5 NAME or PROVIDER 0R SUPPLIER nosme uaommnv SYREEYADDRESS cm swE 21/: com um ROAD GARFIELD 11:1ch5011 uus 1on ID 51/va or DEFICIENCIES PREFK Ima DEFICIENCY war aE PRECEDED av roe REGULATORY 0R LSD IDENTIFYING ID PREFIX ms psovibER-s mm or CORRECTION as>> 1mm CORRECTIVEACTIDN SHOULD aE WHOM CROSSREFERENEED rd YHE APPROPRIATE WE oEEiciE/tm D5905 Continued Frorn page 206 iound ACT results documented as. Tirne. In1ra Procedure Nurse's Notes 1400 ACT out oi range 1515 ACT Dune 326 1530 ACT 230 No documentation indicating 1ne tesi per/onned (definition o1 1ne abbreviation and the units of measuremem was present The requested final tesi reports were not avaiiabie ior revrew- Da1e. 'nme- ResulIs' 1/9/15 1252 Unkn HI 0111 oi range 2/5/15 1030 - HI 2/10/15 1320 I Hiouto/range 2/12/15 1432 I-Hl>>HIomnfrange 2/17/15 1319 265 2/23/15 1135 -- 159 2/10/15 9020 ou1o/range 5. Included In the ACT 1est records was a document mai stated anatysis was perionned on an reviewabie 1onns within me Iaboraiory. Muiirpie occurrences were observed wnere review was no1documen1ed. During velmaclive oi 1orms no trends were noted Correclive action includes review o1 1orms by PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 12300 MCCRACKEN ROAD GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5819 Continued From page 207 510H 520H 530H 540H 550H 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5819 All test reports or records of the information on the test reports must be maintained by the laboratory in a manner that permits ready identification and timely accessibility. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's policies and procedures, emergency release documentation, laboratory information system (LIS), hospital information system (HIS), and interviews with Testing Personnel (TP) #1 and #9, the Compliance Specialist (CS), Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the Head of Transfusion Medicine (HTM), and a "Short Stay" unit nurse, the laboratory failed to maintain immunohematology test reports in a manner that permitted ready identification and timely accessibility. Findings Include: 1. Review of the laboratory's policies and procedures found the following: - A policy titled "Department of Laboratories Transfusion Service Quality Program" which stated: "5.27 Medical Record Documentation: 5.27.1 The patient's medical record shall include: Transfusion order, documentation of patient consent, the name of the component, the donation identification number, the date and time of transfusion, pre- and post-transfusion vital signs, the amount transfused, the identification of the transfusionist, and, if applicable, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 208 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5819 Continued From page 208 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5819 transfusion-related adverse events" "6.2 Records: MMH Transfusion Service ensures identification, collection, indexing, access, filing, storage and disposition of records as required by AABB Reference Standards. 6.2.1 Records shall be complete, retrievable in a period of time appropriate to the circumstances and protected from accidental or unauthorized destruction or modification." - A policy titled "Emergency Release of Blood Uncrossmatched" which stated: "Procedure Notes: 1. In an emergency situation where a name and medical record number is unavailable, Fill out the Emergency Release Waiver with as much information as possible. (i.e. John Doe, Jane Doe) Add name and medical record number to the Emergency Release Waiver as information becomes available." "Procedure Notes: 4. All testing must be completed as soon as a patient sample is available. All results are entered into the LIS." 2. On 03/12/2015 at 11:30 AM Surveyor #1 requested the laboratory's emergency release documentation from 2014 and 2015 from TP #9. TP #9 provided a manila folder that contained emergency release documentation from 09/27/2014 through the dates of survey. Surveyor #1 randomly selected 2 patients' emergency release records from the manila FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 209 of 333 PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE a MEDICAID SERVICES 0MB NO 0933mm ararenznr or DEFICIENCIES (Xi) no MULTIPLE ist one mo than or connacneii Ioannriomon NUMBER man JEMIIDSU WING-- we or PROVIDER OR some: SWEEYADDRESS am am: ZIP cope moo ROAD GARFIELD uus HOSPIYAL uaommnv out In SUMMARY STAYEMENY or DEFICIENCIES Io pnovioER-s mm or common as>> PREFIX imn DEFICIENCY vuar aE PRECEDED av FULL PREFIX PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE as MEDICAID SERVICES 0MB NO 09330301 ems/rm or 1x1) osmosis/summeer 1x1) MULTIPLE (XII one sumv mo mu or coRREcmm NUMBER man JEMIIDSU WING-- was or pom/logs 0R SUPPLIER cm ewe 20> 12:00 ROAD GARFIELD 44125 MARVMOLINY nosme uaorumnv 1on lo emu/rm swam/r or osrrorsweres .p poor/rows mm or as were lam osrrorewov oz oosoeozo av n/u poem PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE 0 MEDICAID SERVICES 0MB NO 00300301 ems/12m or narrow/es 1x1) pmromupprremm 1x1) humor: ooNsmuonoN 1st one sum/Ev mo HAN or common may: man comma JEMIIDSU WING-- was or pram/rose 0R suppuen swarm/sees cm em: 21>> song 12:00 ROAD vauoum HOSPIYAL uaommnv GARFIELD HEIGHTSIOH 44125 1x010 ear/my swam/r or more/ores .o women-s PLAN or museum/1 as were Imn oenormov war a: paeceoeo av new 12m coaaecnvuonoh mm as YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED THE APPROPRIATE DEFICIENCY) D5819 Continued From page 211 05010 no record of a Irsnsiusion or wmpalihility Iesirng iniormahon on Ihe soreen "Blood Bank Administrative DaIa~ Ihe sisterneni transfusion data lound""' on me sureen IIlled Psiiem history Transfusion Dais. on bcih afmemenlmned soreens,1he headIngs Iiued UniIs Transi' and "Lasi Transr' were blank. RC - Red - Transfuseleranst/smn 7. Review 01 Me LIS blood bank unIl history documenIinon fothe packed red blood cell uniI (PRBC) w204215105761 found The unit was assigned Ihe sums of on 02/05/2015 017.54 AM The unit was assigned Ihe sums of on 02/00/2015 a1 11.02 PM Io a paIienI win a o1 The unit was assigned 1he sIsIus 0f on 02/06/2015 01 11 -03 PM In a patient wiIh ww-- The unit was assigned Ihe sums of on 02/00/2015 01 11-37 PM erh me wmmem 1or prooessing" 'Flease NoIe Ihe unit was returned Io me blood bank oepsnmem greaIer 1113711)) :10 minutes afier issue No nooumemairon oi Ihe unirs Iemperaiure when relumed was presenI (Refer Io D5555) mum/15255711127251 Prawn/"lam: mantle Ev-m ID 011mm nan, ID enema: 11 common area Page 212 01333 PRINTED 02/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES OMB No 0033mm snug/em or panama/es (x1) mnemumemna (x2) MULTIPLE CONSTRUCTION 1st we suRva AND PLAN er eosseeneh NUMBER man comers>> JEDOSIIDSU WING-- NAME or pram/mes 0R summers srsemnnsess am am: at>> ease moo ROAD GARFIELD HEIGHTSIDH utzs HOSPITAL 1on sum/m swam/r or Denny/mes memes-s PLAN or museum as psenx (we Denny/av MUST a: assumes 0v Fuu PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES 0MB NO 00330301 ems/12m or 1x1) pmroeo/euppuemcm 1x1) humor: 1st one sum/Ev mo mu or coman NUMBER man cor/pram JEMIIDSU WING-- we or pom/rose on suppueo cm em: 21>> cooe 12:00 ROAD nosme uaommnv GARFIELD 44125 1x010 cur/hm crusher/r or oerrcreucree .o mm or ccorzecnou as were INN oerrcreucv Muer es poeceoeo av run peer/x 121cm comcnvucnou SHOULD es mono YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED THE APPROPRIATE oerrcreuch D5019 Continued Frorn page 213 05310 existed The CS and TF 1:1 record o1 Ihe llanslusicn may be rnIhe HIS (EPIC) The CS auernp1ed1o IocaIe record o1 me Ivansmsinn in Ihe HIS (EPIC) but s1e1ed1hey were no1 very famiIiar wIlh me HIS (EPIC). The 1n1en/iew occurred 03/12/2015 e1 11 45 AM TP 111 re1neved nuree 1:011 1rorn Ihe hospicers Shon Slay uan. The RN ehenrpIed 1o Ioce1e a llanslusicn record from 02/12/2015 In Ihe palienl's HIS (EPIC) rnediceI vewm The RN was able 1o Ioce1e a no1e In me palient's HIS (EPIC) vewm 1rorn 02/12/2015 under 1he heading "Prunedure' TRANSFUSION IheI ~nurse forgot Io edd procedure in GehereI 1n1o cornrnenre hIood wee givenIIniIials' 2.17)~ The RN sIe1ed Ihey were having dimcun Iirne Ioce1rng any record o1 1rens10sron and occurred on 02/12/2015 The inIervrew occurred 03/12/2015 e112-IoceIe record o1 we and screen was per/orrned on 02/12/2015 or 5.00 PM Fer me Ihe Iype and screen, wiIh an expiralicn dale o102/15/2015, had uans 1or issue under 1he heading Type" hur 11 did no1rnd1ce1e 0an was llanslused The ImervIew occuned 03/12/2015 e112-07 PM. The HTM sIa1ed the record shouId be located In the nurse's or donor's noIe The inIerVIew occurred 03/12/2015 3112-00 PM. TS 110 provded Surveyor :11 erh pecker o1 Iewms, prinIed 1rorn Ihe HIS (EPIC), for Ihe palienl Ihe MR1: o1_ehd PT: o1 -- Pant/10152567102001 Fromm/"lam: emu Ev-m ID coma/r Hamil/"mum .nee1 Page 21on 333 PRINTED 09/10/2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES 0MB NO 0933mm erarenem or ixi) 1x1) numpts our one sum/Ev awn sun or eoasseneti NUMBER man countess JEMIIDSU WING-- was or simmers 0R SUPPLIER cm ewe 20> Imp ROAD unnvuoum HOSPIYAL LABORATORY GARFIELD nzictthiott uus 1on ID sum/m sum/em or oenoieweies is PROVIDERS mm or connection as were tum oenoiswov war as assesses av putt PREFIX (EALH SHOULD as Whoa YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED THE APPROPRIATE DEFICIENCY) D5019 Continued Frorn page 214 D5819 Review oi the paoket oi rewrds round an operative report dated 02/12/20t5 tor the atient a at-and oi whioh contained a note under the heading ~Description atoperation.~ whioh stated "Given evidenee oi aetii/e bleeding, bInnd was appropriater ordered by anesthesia Additionally, dommems tnIed "Anesthesia Record", dated 02/12/20t5, was included whinh stated "300 on" under the headings and "Tot Lastty, cnthe documents titled ~Anesthesia Record" in the wlumn titted ~Comments And Notes" a note which stated ma" was under the heading "BIood Product/Fluid Into" Tat - Total ondunts The RN stated they were unable to Iooate a trans/usian reoord tar an emergency 0 negative unit oi PRECs. The interview ooeurred 03/12/2003 at 12-t2 PM. D5023 403 129t(I) TEST REPORTS D5823 519R Upon request by a patient tor the patients SZDH personaI representative), the laboratory may SBDH provide patients, their personaI representatives 540" and those persons spanified under 45 CPR 55?" ISA 524(c)(3wi)' as appIioahIe, with amass to wmpIeted test repcns than using the Iahcratcry's authentication prooess, can he idemified as belonging to that patiem. This STANDARD is not met as ewdenoed by. Item 1- mm pram/mam Dmla Evlm ID Oith quIIly ID unenth sheet Page 215.51 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5823 Continued From page 215 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5823 Based on direct observation, review of the laboratory's policies and procedures, emergency release documentation, laboratory information system (LIS), hospital information system (HIS), and interviews with Testing Personnel (TP) #1 and #9, the Compliance Specialist (CS), Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the Head of Transfusion Medicine (HTM), and a "Short Stay" unit nurse, the laboratory failed to provide access to completed immunohematology test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. Findings Include: 1. Review of the laboratory's policies and procedures found the following: - A policy titled "Department of Laboratories Transfusion Service Quality Program" which stated: "5.27 Medical Record Documentation: 5.27.1 The patient's medical record shall include: Transfusion order, documentation of patient consent, the name of the component, the donation identification number, the date and time of transfusion, pre- and post-transfusion vital signs, the amount transfused, the identification of the transfusionist, and, if applicable, transfusion-related adverse events" "6.2 Records: MMH Transfusion Service ensures identification, collection, indexing, access, filing, storage and disposition of records as required by AABB FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 216 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5823 Continued From page 216 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5823 Reference Standards. 6.2.1 Records shall be complete, retrievable in a period of time appropriate to the circumstances and protected from accidental or unauthorized destruction or modification." - A policy titled "Emergency Release of Blood Uncrossmatched" which stated: "Procedure Notes: 1. In an emergency situation where a name and medical record number is unavailable, Fill out the Emergency Release Waiver with as much information as possible. (i.e. John Doe, Jane Doe) Add name and medical record number to the Emergency Release Waiver as information becomes available." "Procedure Notes: 4. All testing must be completed as soon as a patient sample is available. All results are entered into the LIS." 2. On 03/12/2015 at 11:30 AM Surveyor #1 requested the laboratory's emergency release documentation from 2014 and 2015 from TP #9. TP #9 provided a manila folder that contained emergency release documentation from 09/27/2014 through the dates of survey. Surveyor #1 randomly selected 2 patients' emergency release records from the manila folder and requested that TP #9 locate the type, screen, and compatibility test records in the LIS that corresponded to the emergency release units. 3. Review of the form titled "Emergency Release FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 217 of 333 PRINTED 00/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES 0MB NO 0030mm ems/tear cr DEFICIENCIES 1x1) 1x1) naming coNsTRucTIoN out we squV awn HAN or CORRECTION NUMBER man concierge JEMIIDSU WING-- was or PROVIDER on SUPPLIER am am: ZIP cone tmu ROAD GARFIELD HEIGHTSIOH 44125 nosme uaommnv 1on ID aunt/m STAYEMENY or DEFICIENCIES snowmen-s mm or as were tum MUSY as sausage 0V new (EALH ccsnecnveacncn SHOULD as When YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED THE APPROPRIATE DEFICIENCY) D5023 Continued page 217 05023 Waiver, which was dated 02/t2/2015, round the following. at the lop right hand section at the term was two patient identification slinkers. The first wntatned the patients name, date at hinh ci- medical record number (MR3) and patent number (PM at The second contained the name date at birth ci_ MR1: oi - and parccde at v2560100473 2 unita ct tercup O--Negative Panked wete teduested. the box nexl lo the statement of donor mood with patients bIond tar compalibilily waa NOT mmpIeled was marked 4 unit lag stickers were present, an at which were type 0 Negative, and had expiration dates of 03/05/2015, 03/00/2015, 03/17/2015, and 03/10/20t5 next to the um] tag sticker W204215165761 0 Negative with an expilalicn date 000310512015 was a handwritten note which stated "llanslused" the date and time of 02/12/2015 and t3 55 was indicaled at the bollom oi the page with the physinian's signature and pnnted name. a handwritten note at the oi the page stated ONE UNIT 4. TP :10 attempted to retrieve the testing and mu. 0525671027001 Pumavemm: amia EVlm ID 00mm nan, ID anemia: sheet Page 21301333 PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES 0MB NO 09330301 ems/rem or ozrrerzuorss 1x1) pmrosn/euppuswem no promote (XII pus sum/Ev mo mu or coRREcnoM rosunrromon NUMBER man JEMIIDSU WING-- we or pom/logs 0R SUPPLIER swarm/sees cm ewe 20> 12:00 ROAD GARFIELD HEIGHTSIOH 44125 MARVMOLINY HOSPIYAL uaorumnv 1on lo SUMMARY swam/r or osnorsueres .p pnovrozR-s mm or common as were two osnorsnov Musr e: pasosozo av n/u emu >up wrih the identified TS we sleled the unknown petient end the pelrent with the MR :1 of and 0-- LIS oIood bank vewms were supposed to have heen merged in the LIS bu] were not. T5 :10 funher sleted the hospileI's information technology (CPI) were lhe only indlviduaIs who can merge the two acwums end the request for mergIng the patient was sent righl afler the post transfusion was completed Laslty, T3 :19 sleted the Iahorstory did nol have any dowmenlation dernonslrelrng when they submmed the merge request for this pstem to CPI The intervew occurred 03/12/2015 et 11 40 AM. 5. Review of lhe LIS hIood bank elient reoord for the pelrent with the MR: oi and -- found. no record of a Iranslusion or wmpalihillty inlormalicn on the soreen tilled "Blood Bank Mmlnislrallve Dans" the sleternent lrensfuslon date foundm" on the soreen lltIed Pellem history Transfuslon Fulani/525671027001 Prawn/Swing": emu Ell-m ID 011mm oncospoa 11 .neel Page 21901333 PRINTED 09/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE 0 MEDICAID SERVICES 0MB NO 00300301 aura/12m or napalm/es 1x1) 1x1) MULTIPLE aoNsmuaneN 1st we sum/Ev AND HAN or common IDENTIFICATION may: man cor/mm JEMIIDSU WING-- was or pram/raga on suppuea smeermmaa am sure 21>> 0002 mm ROAD vauoum HOSPIYAL uaommnv GARFIELD HEIGHTSIOH 44125 1x010 mum swam/r or DEFICIENCIES women-s PLAN or coaaecrm as mm Imn DEFICIENCY war a: pages/:20 av pram 12m cemenvmneh mm as YAG REGULATORY OR LSD IDENTIFYING INFORMAVIONI TAG CROSSREFERENCED THE APPROPRIATE DEFICIENCY) D5823 Continued From page 219 05023 Data. on 0001 aforemenlmned screens,1he headIngs Iiued UniIs Transr and "Las1 Transr' were blank. RC - Red Transf - Transmsed/Transfusmn 7. Review 01 Me LIS blood bank unII history documenIaI/on fanhe packed red blood cell uniI (PRBC) w204215155761 found The unit was assIgned Ihe sIah/s 0f on 02/05/2015 a1 7.54 AM The unit was assIgned Ihe sIah/s 0f on 02/00/2015 51 11.02 PM In a paIIerII a 01-- The uni1 was assIgned 1he sIaIus 0f on 02/06/2015 01 11 -03 PM In a pa11enI wiIh a mm: at-- The unit was assIgned Ihe sIah/s 0f on 02/05/2015 a1 11-37 PM wIlh Ihe wmmem Ior pmnessing" 'Flease NnIa Ihe uniI was rammed 10 me blood bank depanmenl greaIer 1113711)) 30 mInmes anar issue No documenlalmn 01 Ihe unirs Iemperamre when relumed was presenI (Refer to D5555) The unit was assIgned Ihe sIah/s 0f on 02/07/2015 51 1 45 PM In Ihe paIienI with me MR1: mu. 057.5671me Prawn/"lam: Dmla Ev-m ID 02mm mm, 15 mama: 11 00111110110000 area Page 22051333 PRINTED 02/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES OMB No 00300391 snug/em or DEFICIENCIES (x1) (x2) MULTIPLE cowsrsucnoh 1st one SuRva mo my or cossecneh rug/DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES PRINTED 09/10/2015 FORM APPROVED 0MB NO 093M301 ems/rem or 1x1) psovroes/euseres/em 1x1) MULTIPLE 1x31 one sumv nun sun or coRREcnoN NUMBER man cor/warm a we 03mm" 5 was or pom/rose 01: some: cm ewe 20> 12:00 ICCRACKEN scan MARVMOUNT HOSPITAL LABORATORY GARFIELD OH 44125 1x010 ear/vim sum/em or oerrorer/eree .p mm or ccssecnor/ no sserrx taco oerrorer/ov MUST as pseceoeo ev n/u peer/x (EALH snouto 0E mono TAG REGULATORY OR LSD IDENTIFYING INFORMATION TAG CROSSREFERENCED THE APPROPRIATE oerroreuov) D5023 Continued Frorn page 221 05323 TP 111 re1neved nurse (RN) 1rorn the hospiIsl's Short s1ay unIl. The RN 1o Ioce1e a llanslusicn record 02/12/2015 In the paliem's HIS (EPIC) rnedicei vewm The RN wee ah1e1o Ioce1e a no1e In the palient's HIS (EPIC) vewm 1rorn 02/12/2015 under 1he heedirrg "Prunedure' TRANSFUSION thet slated ~nurse forgot to add procedure (noticed in Gerrerei inio hiood wee givenlinilials' 2.17)~ The RN ste1ed they were having dimcuit tirne Ioceung eny record o1 e1rens1usron the1 occurred on 02/12/2015 The intervrew occurred 03/12/2015 et 12-01 PM. The RN was aide to Iocete record pi type erid screen which was per/orrned on 02/12/2015 at 5.00 PM Per the RM the type end screen, with an expiralicn date o102/15/2015, had units 1or issue under 1he heedirrg Type" hut i1 did no1rndioete unit were llanslused The rmewew occurred 03/12/2015 et 12-07 PM. The HTM sie1ed the record shouId be located In the nurse's or donor's note The iniemew occurred 03/12/2015 et12-00 PM. TS 110 provded Surveyor :11 with pocket o1 vewms, printed 1rorn the HIS EPIC), for the is wrih the M1230 erid PT: oi Review oi the pankel oi vewms round on operetive report de1ed 02/12/20151or1he atierd wrih a c1_ and mi which contained a note under the heeding ~Descrip1ion 01 Opereiiori.~ which stated "Given evidence o1 active bleeding, bIood was mm 01525671me Pram: Wm: 01:01.15 Ev-m ID mine/r quIIly ID madam 1/ sneei Page 222 or 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5823 Continued From page 222 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5823 appropriately ordered by anesthesia." Additionally, documents titled "Anesthesia Record", dated 02/12/2015, was included which stated "300 cc" under the headings "RBC:" and "Tot Blood Prds:". Lastly, on the documents titled "Anesthesia Record" in the column titled "Comments And Notes" a note which stated "RBC@13:09" was under the heading "Blood Product/Fluid Info". Tot - Total Prds - Products The RN stated they were unable to locate a transfusion record for an emergency O negative unit of PRBCs. The interview occurred 03/12/2015 at 12:12 PM. Item 2: Based on review of the laboratory's policies and procedures, activated clotting time (ACT) test records and final test reports, and interview with Technical Supervisor (TS) #9 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to provide access to completed activated clotting time (ACT) test reports. Findings Include: 1. Review of the laboratory's policy and procedure titled "Activated Clotting Time - Low Range (ACT-LR)" found the following directions: "Reading/Reporting Results FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 223 of 333 PRINTED 02/10/2015 DEPARTMENT or HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE 5 MEDICAID SERVICES OMB No 09350391 snug/em or DEFICIENCIES (x1) wonoen/soppnemen/x 012) rooms CONSTRUCTION 1X1I one suRva AND PLAN or eon/amen NUMBER man comers/o JEDOSIIDSU WING-- NAME or pom/lose 0R some>>: STREETADDRESS am am: up moo ROAD GARFIELD 44125 MARVMOLINT HOSPITAL 1x410) eonnm sum/em or DEFICIENCIES .o PROVIDERS 50w or connecnoN no new (awn DEFICIENCY MUST BE oneceoeo av poem >H|om0Irange 2/17/15 1310 265 2/23/15 1135 159 1/7/15 1525 154 1/0/15 0045 nutclrange'hIgh" 1/0/15 1515 bIank 1/20/15 0925 nutclrange'hIgh" 1/20/15 1404 "cm oIIange" 2/10/15 0020 cm oIIange MR1: Medical Reoom Number Unkn - Unknown HI - won 3 On 03/25/2015 an 52 AM, Sun/Cyan" quuesled' via rnaiI final Ies1 vepnns /or1ne ACT my resume listed above PRINTED 09/10/2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES 0MB NO 003341391 smenznr or nereIszes 1in wavInen/supnnemena 1x1) 1st we sum/Ev mn HAN or NUMBER man eomerzn JEMIIDSU WING-- we or PROVIDER on summer: cm em: 21>> eons 12:00 ROAD HOSPIYAL uaonnonv GARFIELD 44125 1on In SUMMARY sum/Em or vermin/mes In nnoI/InER-s nun or connecmw as>> PREFIX Imn vermin/av Musr a: PRECEDED av FULL PREFIX PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D5823 Continued From page 225 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D5823 5. Included in the ACT test records was a document that stated "GAP analysis was performed on all reviewable forms within the laboratory. Multiple occurrences were observed where review was not documented. During retroactive analysis of forms no trends were noted. Corrective action includes review of forms by the designee 'TS #8' or 'TS #9' at stated intervals and monthly review by technical supervisors 'TS #8' or 'TS #9', approved by the medical director 'LD' effective immediately." The document was signed by the LD and dated 02/25/2015. D6007 493.1407(e)(1) LABORATORY DIRECTOR RESPONSIBILITIES D6007 The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (E) The laboratory director must-(E)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's policies and procedures, instrument correlation documentation, and interview with the Point-of-Care Supervisor (PS) (as listed on the Laboratory Personnel Report (CLIA) Forms FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 226 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6007 Continued From page 226 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6007 CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the Laboratory Director failed to ensure that the Hemachron Junior (Jr.) Signature +, used for activated clotting time (ACT) analysis, provided quality laboratory services during the analytic phase of testing. Findings Include: 1. The PS stated that the ACT testing was performed in two locations of the hospital, interventional radiology and general surgery. The interview occurred 03/09/2015 at 8:46 AM. 2. Direct observation of the interventional radiology department on 03/10/2015 at 9:39 AM found a Hemachron Jr. Signature + instrument with the serial number of SP2990. Direct observation in a general surgery office on 03/10/2015 at 9:54 AM found a Hemachron Jr. Signature + instrument with the serial number of SP5639. 3. Review of the laboratory's policy and procedure titled "Quality Control Policy and Procedure" found the following directions: "III. Intermethod Comparison Protocol Intermethod comparison is required when more than one test system is used to generate a test result for a given analyte and applies only to instruments/methods accredited under a single CAP/CLIA number. If a second methodology is used as a backup to the primary method in the event the primary method is down, an intermethod comparison is required." "III. Intermethod Comparison Protocol FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 227 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6007 Continued From page 227 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6007 A. Methods of Comparison 2. Mean/match of all methods The comparative process is conducted as a mean of results for quantitative methods and an exact match of results for qualitative methods." "III. Intermethod Comparison Protocol B. Procedure 1. A minimum of five samples of the appropriate matrix are analyzed. In general, human specimens are preferred rather than commercial controls to avoid matrix effects. Pooled patient samples may be used. Sample test results should be distributed over the analytical measurement range to the extent possible." "III. Intermethod Comparison Protocol C. Data Analysis 1. Criteria for Acceptability of Data Analysis All data will be analyzed utilizing a statistical analysis calculation or application, if applicable. The criteria for acceptability will be established by the Medical Director in each operational area. Successful performance will constitute 80% or greater of the individual comparisons being within the acceptable limits." "III. Intermethod Comparison Protocol C. Data Analysis 2. Approval and Review The data report produced from the statistical analysis program must be reviewed and approved by the Medical Director or designee." 4. Review of the correlation documentation titled "Hemachron ACT Correlation POCT Non-Waived" found the following: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 228 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ D6007 Continued From page 228 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6007 02/15/2013 (Specimen) Spec. # Location #1 #2 #3 Surgery Radiology Surgery Radiology Surgery Radiology Result Corrective Action 210 228 91 102 95 103 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' No documentation of 2 additional sample analysis' was present. No documentation of the indicated corrective actions, data analysis, and/or review/approval by the Medical Director or designee was present. 08/20/2013 (Specimen) Spec. # Location #1 #2 #3 Surgery Radiology Surgery Radiology Surgery Radiology Result 70 64 130 119 93 80 Corrective Action 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' No documentation of 2 additional sample analysis' was present. No documentation of the indicated corrective action, data analysis, and/or review/approval by the Medical Director or designee was present. 02/05/2014 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 229 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 12300 MCCRACKEN ROAD GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6007 Continued From page 229 (Specimen) Spec. # Location #1 #2 #3 #1 #1 #2 #2 #3 #3 Surgery Radiology Surgery Radiology Surgery Radiology Surgery Radiology Surgery Radiology Surgery Radiology 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ Result 144 137 198 211 220 209 141 147 151 162 155 166 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6007 Corrective Action 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' 'Checkmark' No documentation of the indicated corrective action, data analysis, and/or review/approval by the Medical Director or designee was present. 11/23/2014 (Specimen) Spec. # Location Result Corrective Action Sample #1 Sample #2 Sample #3 Sample #1 Sample #2 Sample #3 Temp. Surgery Surgery Surgery Radiology Radiology Radiology Surgery Radiology QC Norm Surgery Radiology Abnormal Surgery FORM CMS-2567(02-99) Previous Versions Obsolete 141 151 155 147 162 166 37 37 30 31 299 ----------------------Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 230 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 12300 MCCRACKEN ROAD GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6007 Continued From page 230 Abnormal Radiology 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ 299 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6007 --- No documentation of data analysis and/or review/approval by the Medical Director or designee was present. 02/04/2015 (Specimen) Spec. # Location Sample #1 Sample #1 Sample #2 Sample #2 Sample #3 Sample #3 Result Corrective Action Surgery 202 Radiology 191 Surgery 141 Radiology 113 Surgery 124 Radiology 136 No documentation of 2 additional sample analysis' was present. No documentation of data analysis and/or review/approval by the Medical Director or designee was present. 5. The PS confirmed no documentation of review or evaluation of the ACT correlations was present. Additionally, the PS stated they had recently taken over administrative oversight of the ACT testing at this facility and stated that during an initial review of the ACT documentation they noted several issues in the proficiency testing, QC, temperature monitoring, and documentation activities. The interviews occurred 03/10/2015 at 10:25 AM and 10:30 AM. D6054 493.1413(b)(9) TECHNICAL CONSULTANT RESPONSIBILITIES D6054 The technical consultant is responsible for FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 231 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6054 Continued From page 231 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6054 evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Item 1: Based on review of the laboratory's policies and procedures, competency assessment documentation, Form CMS-209, Ohio Department of Health (ODH) CLIA Annual Test Volume Log, and interview with Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the Technical Supervisors failed to evaluate and document the performance of individuals responsible for performing urine microscopic examination and fibrinogen moderate complexity testing at least annually after the first year. Findings Include: 1. The ODH CLIA Annual Test Volume Log, completed by TS #8, found the following moderate complexity test procedures listed: Analyte/Test Name: Test Volume: Urinalysis w/scope Fibrinogen 6774 305 2. Review of the laboratory's policy and procedure titled "Competency Assessment" found the following statements: "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 232 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6054 Continued From page 232 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6054 responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." "V. Test Complexity C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory tests require competency assessment. The competency assessment must include all six elements." "VIII. Annual Competency Assessment of Testing Personnel A. Supervisory Responsibilities Note: While others may assist with the he competency assessment process, the ultimate responsibility for this activity falls upon supervisory personnel. - Identify Assessors who meet the qualifications to perform competency assessment for the complexity level of the test system(s) - Select assessment method(s) that fulfill all 6 CLIA competency assessment elements (refer to Section XII, 'Procedure for Competency Assessment' for specifics)." "IX. Scope of Competency Assessment The laboratory must identify the test systems that an employee uses to generate patient test results. Competency assessment can be done throughout the entire year by coordinating it with routine practices and procedures to minimize impact on workload. Documentation of these FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 233 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6054 Continued From page 233 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6054 elements, including observation of test performance, results reporting, instrument maintenance, review of worksheets, recording QC, performance of proficiency testing and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system)." 3. TS #8 stated TP perform laboratory testing as follows: TP #1: TP #2: TP #3: TP #4: TP #5: TP #6: TP #7: TP #8: Hematology, Blood Bank All Departments Microbiology, Chemistry All Departments (except Body Fluids) Hematology, Microbiology Chemistry, Coagulation Coagulation, Chemistry Hematology, Chemistry, Urinalysis, Coagulation TP #9: Hematology, Coagulation, Chemistry, Blood Bank, Microbiology TP #10: Chemistry, Hematology, Microbiology TP #11: All Departments TP #12: All Departments (except Blood Bank) TP #13: All Departments TP #14: Hematology, Urinalysis, Chemistry TP #15: All Departments TP #16: All Departments TP #43: Chemistry, Microbiology The interview occurred 03/09/2015 at 8:38 AM. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 234 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6054 Continued From page 234 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6054 4. Review of the laboratory's 2015 competency assessment documentation titled "Marymount Hospital Competency Assessment" for 16 testing personnel (TP) (TP #1, #2, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, and #44) found no documentation of competency assessment for the test procedures urine microscopic examination and fibrinogen. Item 2: Based on review of the laboratory's policies and procedures, competency assessment documentation, Form CMS-209, Ohio Department of Health (ODH) CLIA Annual Test Volume Log, wet preparation test records, and interview with Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the Technical Supervisors failed to evaluate and document the performance of individuals responsible for performing wet preparation moderate complexity testing at least annually after the first year. Findings Include: 1. The ODH CLIA Annual Test Volume Log, completed by TS #8, found the following moderate complexity test procedures listed: Analyte/Test Name: Test Volume: Trichomonas KOH/Wet Prep 644 blank 2. Review of the laboratory's policy and procedure titled "Competency Assessment" found the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 235 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6054 Continued From page 235 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6054 following statements: "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." "V. Test Complexity C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory tests require competency assessment. The competency assessment must include all six elements." "VIII. Annual Competency Assessment of Testing Personnel A. Supervisory Responsibilities Note: While others may assist with the he competency assessment process, the ultimate responsibility for this activity falls upon supervisory personnel. - Identify Assessors who meet the qualifications to perform competency assessment for the complexity level of the test system(s) - Select assessment method(s) that fulfill all 6 CLIA competency assessment elements (refer to Section XII, 'Procedure for Competency Assessment' for specifics)." "VIII. Annual Competency Assessment of Testing FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 236 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6054 Continued From page 236 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6054 Personnel B. Assessor Responsibilities - Ensure assessor is qualified to perform competency assessment for the complexity level of testing. - Prepare and distribute selected competency testing samples. - Observe testing personnel and review documentation in a professional impartial manner." "IX. Scope of Competency Assessment The laboratory must identify the test systems that an employee uses to generate patient test results. Competency assessment can be done throughout the entire year by coordinating it with routine practices and procedures to minimize impact on workload. Documentation of these elements, including observation of test performance, results reporting, instrument maintenance, review of worksheets, recording QC, performance of proficiency testing and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system)." 3. TS #8 stated TP perform laboratory testing as follows: TP #1: Hematology, Blood Bank TP #2: All Departments TP #3: Microbiology, Chemistry FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 237 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6054 Continued From page 237 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6054 TP #4: TP #5: TP #6: TP #7: TP #8: All Departments (except Body Fluids) Hematology, Microbiology Chemistry, Coagulation Coagulation, Chemistry Hematology, Chemistry, Urinalysis, Coagulation TP #9: Hematology, Coagulation, Chemistry, Blood Bank, Microbiology TP #10: Chemistry, Hematology, Microbiology TP #11: All Departments TP #12: All Departments (except Blood Bank) TP #13: All Departments TP #14: Hematology, Urinalysis, Chemistry TP #15: All Departments TP #16: All Departments TP #43: Chemistry, Microbiology The interview occurred 03/09/2015 at 8:38 AM. 4. Review of the wet preparation test logs from September 2014 through December 2014 titled "Daily Quality Control Log Sheet Wet Prep" found a spreadsheet with 8 columns titled as follows: Date Tech Tech Patient Trich Clue Yeast Comment In the columns with the headings "Tech" the initials of TP #1, #6, #7, #11, #12, #16, and #43 were identified. 5. Review of the laboratory's 2015 competency assessment documentation titled "Marymount FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 238 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6054 Continued From page 238 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6054 Hospital Competency Assessment" for TP #1, #6, #7, #11, #12, #16, and #43 found no documentation of competency assessment for the test procedure wet preparations. D6063 493.1421 LABORATORY TESTING PERSONNEL D6063 The laboratory must have a sufficient number of individuals who meet the qualification requirements of §493.1423, to perform the functions specified in §493.1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's Form CMS-209, policies and procedures, education documentation, and an interview with Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to ensure testing personnel met the qualification requirements of §493.1423 to perform functions specified in §493.1425 for the moderate complexity tests performed. Findings Include: 1. The laboratory failed to ensure Testing Personnel (TP) #2, #4, #8, #11, #20, and #26 met the qualification requirements for the moderate complexity testing performed. (Refer to D6065) D6065 493.1423(b)(1)(2)(3)(4)(i) TESTING PERSONNEL QUALIFICATIONS D6065 (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 239 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6065 Continued From page 239 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6065 osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the laboratory's Form CMS-209, policies and procedures, education documentation, and an interview with Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to ensure Testing Personnel (TP) #2, #4, #8, #11, #20, and #26 met the qualification requirements for the moderate complexity testing performed. Findings Include: 1. Review of the laboratory's Form CMS-209, approved and signed by the LD on 03/9/2015 found 35 individuals certified by the LD to perform moderate complexity testing. 2. Review of the laboratory's policy and procedure titled "Job Descriptions" found the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 240 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6065 Continued From page 240 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6065 following statements: "Testing Personnel Testing personnel at the Cleveland Clinic (CC) include medical technologists and medical laboratory technicians qualified to perform moderate and high complexity tests. The laboratory director, technical and general supervisors are also qualified testing personnel as defined in Federal Register 1992 (Feb 28): 7183 42 CFR 493.1489. The qualifications and responsibilities are also defined in the medical technologist, medical laboratory technician, medical technician and pathologists' assistant job descriptions. The responsibilities encompass all CLIA '88 testing personnel responsibilities as outlined in Federal Register 1992(Feb 28): 7182 42 CFR 493.1495 including but not limited to the following: Responsibility for following laboratory procedures for specimen processing, test performance and reporting of test results Adhering to the laboratory's quality control policies Following the laboratory's established policies and procedures whenever test systems are not within established acceptable levels of performance Identifying problems that may adversely affect test performance and immediately notify the general supervisor, technical supervisor, or laboratory director Documenting all corrective actions" FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 241 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6065 Continued From page 241 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6065 3. Review of education documentation revealed the following: TP#2 possessed a foreign Bachelor of Science in Medical Technology TP#4 possessed a foreign Bachelor of Science in Medical Technology TP#8 only had a college transcript; no degree awarded TP#11 possessed a foreign Bachelor of Science in Industrial Microbiology TP#20 possessed a master's degree in education. TP#26 possessed a foreign high school certificate 4. Surveyor #2 requested documentation demonstrating an evaluation of the foreign documentation of education performed by a nationally recognized organization for TP#2, #4, #11, and #26 from TS#8 and TS#9. Additionally, a high school diploma or degree in a science was requested for TP#8 and TP#20. TS#8 stated the lab had submitted evaluation request forms for the foreign documentation of education, however, had not yet received documentation of the evaluations. The lab failed to submit the requested documentation within 7 calendar days from the date of request. The interview occurred on 03/9/2015 at 9:08 AM. D6108 493.1447 LABORATORY TECHNICAL FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 D6108 Facility ID: OHC05083 If continuation sheet Page 242 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6108 Continued From page 242 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6108 SUPERVISOR The laboratory must have a technical supervisor who meets the qualification requirements of §493.1449 of this subpart and provides technical supervision in accordance with §493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on review of the laboratory's Form CMS-209, education documentation, policies and procedures, competency assessment documentation, four confidential interviews, Form CMS-209, Ohio Department of Health (ODH) CLIA Annual Test Volume Log, antibody identification test records, transfusion reaction test records, emergency blood product release test records, body fluid manual count and differential test records, and an interview with Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to ensure the Technical Supervisors met the qualification requirements of §493.1449 and provided technical supervision in accordance with §493.1451 of this subpart. Findings Include: 1. The laboratory failed ensure Technical Supervisors (TS) #1, #4, and #11 met the qualification requirements specified at 493.1449. (Refer to D6111, Item 1) 2. The laboratory failed to ensure Technical Supervisors (TS) #1, #6, #7, #8, #9, and #11 met the qualification requirements specified at 493.1449q for the specialty of FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 243 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6108 Continued From page 243 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6108 Immunohematology. (Refer to D6111, Item 2) 3. The Technical Supervisors failed to include direct observations of routine patient test performance, including specimen handling, processing and testing, in the evaluation of the competency of the staff. (Refer to D6121, Item 1) 4. The Technical Supervisors failed to ensure direct observations of routine patient test performance, including specimen handling, processing and testing, were evaluated and documented by qualified Technical Supervisors for the evaluation of the competency of the staff. (Refer to D6121, Item 2) 5. The Technical Supervisors failed to include monitoring the recording and reporting of test results in the evaluation of the competency of the staff. (Refer to D6122) 6. The Technical Supervisors failed to include review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records in the evaluation of the competency of the staff. (Refer to D6123) 7. The Technical Supervisors failed to include direct observation of performance of instrument maintenance and function checks in the evaluation of the competency of the staff. (Refer to D6124) 8. The Technical Supervisors failed to include assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples in the evaluation of the competency of FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 244 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6108 Continued From page 244 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6108 the staff. (Refer to D6125) 9. The Technical Supervisors failed to include assessment of problem solving skills in the evaluation of the competency of the staff. (Refer to D6126) 10. The Technical Supervisors failed to evaluate and document the performance of individuals responsible for performing investigations of transfusion reaction, emergency blood product release procedures, compatibility antiglobulin crossmatch, electronic compatibility crossmatch, prewarm antibody procedures, eluate procedures, indirect coombs antibody identification procedures, saline replacement procedures, and manual body fluid count and differential high complexity testing at least annually after the first year. (Refer to D6128, Item 1) 11. The Technical Supervisors failed to evaluate and document the performance of individuals responsible for performing high complexity blood bank testing at least annually after the first year. (Refer to D6128, Item 2) 12. The laboratory failed to complete evaluations and document a determination of competency of testing personnel at least annually after the first year. (Refer to D6128, Item 3) D6111 493.1449 TECHNICAL SUPERVISOR QUALIFICATIONS D6111 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 245 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 245 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-(b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-(c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 246 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 246 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-(d)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 247 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 247 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 248 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 248 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-(e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 249 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 249 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-(f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 250 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 250 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 (f)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 251 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 251 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-(g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 252 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 252 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must(h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 253 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 253 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-(i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 254 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 254 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 podiatry in the State in which the laboratory is located; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-(j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 255 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 255 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 (j)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-(k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 256 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 256 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 located; and (k)(1)(ii) Meet one of the following requirements-(k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii)(B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-(l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under §493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 257 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 257 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 osteopathy in the State in which the laboratory is located and-(l)(2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under §493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l)(3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-(l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 258 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 258 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under §493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-(m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under §493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 259 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 259 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-(n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 260 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 260 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-(o)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o)(2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 261 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 261 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 as the technical supervisor must-(p)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-(q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 262 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 262 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: Item 1: Based on review of the laboratory's Form CMS-209, education documentation, and an interview with Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed ensure Technical Supervisors (TS) #1, #4, and #11 met the qualification requirements specified at 493.1449. Findings Include: 1. Review of the laboratory's Form CMS-209, approved and signed by the LD on 03/9/2015 found 11 individuals certified by the LD to fulfill the role of TS. 2. Review of the laboratory's policy and procedure titled "Job Descriptions" found the following statements: "Technical Supervisors at the Cleveland Clinic (CC) include section heads within a department, members of the CC professional staff and technical personnel who meet the educational, training and experience qualifications. These FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 263 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 263 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 individual may be responsible for the technical and scientific oversight of the laboratory. Qualifications for the technical supervisor (including training, expertise and experience) and responsibilities are included in the Curriculum Vitae and appropriate diploma/transcripts on file in the respective Department Office as well as the CC Professional Staff Performance Standards included in the Institute's Job Description Manual. The Laboratory Director is also qualified to serve in the role of Technical Supervisor. Each technical supervisor is a licensed MD or DO or meets the alternate qualifications (e.g. PhD, technical personnel) for the subspecialty areas defined in Federal Register 42 CFR 493.1449. This encompasses all CLIA '88 Technical Supervisor responsibilities as outlined in Federal Register 1992(Feb 28): 7180-7181 42 CFR 493.1451 including but not limited to the following: Accessibility to provide onsite, telephone or electronic consultation as necessary Selection of test methodology Verification of test procedures performed and establishment of test procedures Enrollment and participation in HHS/CAP approved proficiency testing program commensurate with services offered Establishment of a complete quality control program Resolving technical problems and ensuring remedial actions Ensuring patient test results are not released FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 264 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 264 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 until all corrective actions have been taken and the test system is functioning properly Identification of training needs Evaluation of competency of all testing personnel Evaluation and documentation of individual performance In addition to the technical supervisor's responsibilities, he or she is qualified to perform the duties of a general supervisor and testing personnel. He or she may also delegate these responsibilities to personnel meeting the qualifications." 3. Review of education documentation provided revealed the following: TS#1 possessed a foreign Bachelor of Science in Medical Technology TS#4 possessed a high school diploma TS#11 possessed a foreign Bachelor of Science in Medical Technology 4. Surveyor #2 requested documentation demonstrating an evaluation of the foreign documentation of education performed by a nationally recognized organization for TS#1 and #11 from TS#8 and TS#9. Additionally, Surveyor #2 requested documentation of education for TS#4 that demonstrates they met the TS qualification requirements. TS#8 stated the lab had submitted evaluation request forms for the foreign documentation of FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 265 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 265 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 education, however, had not yet received documentation of the evaluations. The lab failed to submit the requested documentation within 7 calendar days from the date of request. The interview occurred on 03/9/2015 at 9:08 AM. Item 2: Based on review of the laboratory's Form CMS-209, policies and procedures, and education documentation, the laboratory failed to ensure Technical Supervisors (TS) #1, #6, #7, #8, #9, and #11 met the qualification requirements specified at 493.1449q for the specialty of Immunohematology. Findings Include: 1. Review of the laboratory's Form CMS-209, approved and signed by the Laboratory Director (LD) on 03/9/2015, found 6 individuals certified by the LD to fulfill the role of immunohematology TS. 2. Review of the laboratory's policy and procedure titled "Job Descriptions" found the following statements: "Technical Supervisors at the Cleveland Clinic (CC) include section heads within a department, members of the CC professional staff and technical personnel who meet the educational, training and experience qualifications. These individual may be responsible for the technical and scientific oversight of the laboratory. Qualifications for the technical supervisor (including training, expertise and experience) and responsibilities are included in the Curriculum FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 266 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 266 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 Vitae and appropriate diploma/transcripts on file in the respective Department Office as well as the CC Professional Staff Performance Standards included in the Institute's Job Description Manual. The Laboratory Director is also qualified to serve in the role of Technical Supervisor. Each technical supervisor is a licensed MD or DO or meets the alternate qualifications (e.g. PhD, technical personnel) for the subspecialty areas defined in Federal Register 42 CFR 493.1449. This encompasses all CLIA '88 Technical Supervisor responsibilities as outlined in Federal Register 1992(Feb 28): 7180-7181 42 CFR 493.1451 including but not limited to the following: Accessibility to provide onsite, telephone or electronic consultation as necessary Selection of test methodology Verification of test procedures performed and establishment of test procedures Enrollment and participation in HHS/CAP approved proficiency testing program commensurate with services offered Establishment of a complete quality control program Resolving technical problems and ensuring remedial actions Ensuring patient test results are not released until all corrective actions have been taken and the test system is functioning properly Identification of training needs FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 267 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 267 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 Evaluation of competency of all testing personnel Evaluation and documentation of individual performance In addition to the technical supervisor's responsibilities, he or she is qualified to perform the duties of a general supervisor and testing personnel. He or she may also delegate these responsibilities to personnel meeting the qualifications." 3. Review of the laboratory's policy and procedure titled "Manual of Operations Competency Assessment" found the following statements: "Appendix D: Technical Supervisor CLIA requires at minimum a bachelor degreed individual for technical supervisor of most laboratory sections. CLIA requires special qualifications for technical supervisor in certain specialties (Transfusion Medicine, Cytopathology, Cytogenetics, Histopathology, Oral pathology, Histocompatibility) (493.1449). For these specialties, required qualifications include being a physician and/or doctoral scientist, and having specified training/experience. Refer to CLIA for further details. For these specialties, the technical supervisor may be referred to as the section director." 4. Review of education documentation provided revealed the following: TS#1 possessed a foreign Bachelor of Science in Medical Technology FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 268 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6111 Continued From page 268 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6111 TS#6 possessed a Bachelor of Science in Medical Technology TS#7 possessed a Bachelor of Science in Medical Technology TS#8 possessed a Bachelor of Science in Biology TS#9 possessed a Bachelor of Science in Clinical Laboratory TS#11 possessed a foreign Bachelor of Science in Medical Technology D6121 493.1451(b)(8)(i) TECHNICAL SUPERVISOR RESPONSIBILITIES D6121 The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Item 1: Based on review of the laboratory's policies and procedures, competency assessment documentation, and four confidential interviews, the Technical Supervisors failed to include direct observations of routine patient test performance, including specimen handling, processing and testing, in the evaluation of the competency of the staff. Findings Include: 1. Review of the laboratory's policy and procedure FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 269 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6121 Continued From page 269 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6121 titled "Competency Assessment" found the following statements: "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities. Each laboratory area must define and document their area specific test systems." "V. Test Complexity C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory tests require competency assessment. The competency assessment must include all six elements." "VIII. Annual Competency Assessment of Testing Personnel A. Supervisory Responsibilities Note: While others may assist with the competency assessment process, the ultimate responsibility for this activity falls upon supervisory personnel. - Identify Assessors who meet the qualifications to perform competency assessment for the complexity level of the test system(s) - Select assessment method(s) that fulfill all 6 CLIA competency assessment elements (refer to FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 270 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6121 Continued From page 270 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6121 Section XII, 'Procedure for Competency Assessment' for specifics)." "VIII. Annual Competency Assessment of Testing Personnel B. Assessor Responsibilities - Ensure assessor is qualified to perform competency assessment for the complexity level of testing. - Prepare and distribute selected competency testing samples. - Observe testing personnel and review documentation in a professional impartial manner." "IX. Scope of Competency Assessment The laboratory must identify the test systems that an employee uses to generate patient test results. Competency assessment can be done throughout the entire year by coordinating it with routine practices and procedures to minimize impact on workload. Documentation of these elements, including observation of test performance, results reporting, instrument maintenance, review of worksheets, recording QC, performance of proficiency testing and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system). A. Direct observations of routine patient test performance, including, as applicable, patient FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 271 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6121 Continued From page 271 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6121 identification and preparation; and specimen collection, handling, processing and testing. Direct observation may include: - Patient identification - Maintaining specimen identity - Specimen handling - Compliance with established operation procedures - Safety compliance - Proper technique - Proper performance of quality control" 2. Review of the laboratory's 2015 competency assessment documentation titled "Marymount Hospital Competency Assessment" for 18 testing personnel (TP) (TP #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #43, and #44) found the following statement under the heading "Competency Assessment Methods (MUST complete all 6 methods)": "1. Successful performance of routine patient testing verified by direct observation. *Proper sample analysis, proper sampling technique" The laboratory documented completion of direct observation of routine patient testing on 217 out of 217 competency assessments. 3. During confidential interviews, which occurred 03/12/2015 from 3:25 PM through 6:36 PM, individuals stated the following: During competency assessment evaluations, the observer did not directly observe the complete testing process, observations were done in a spot checking manner. Direct observations performed in a periodic FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 272 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6121 Continued From page 272 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6121 manner during the testing process, the observer does not stay and observe the testing process in it's entirety. TPs and TSs work together on the bench and as a result TS's feel comfortable signing off direct observations because they know the TP can perform the test just from working on the bench with them. The TS didn't stand over the TP while they performed the test, the TS would just come and check on the TP periodically. Item 2: Based on review of the laboratory's policies and procedures, competency assessment documentation, Form CMS-209, and documentation of education, the Technical Supervisors failed to ensure direct observations of routine patient test performance, including specimen handling, processing and testing, were evaluated and documented by qualified Technical Supervisors for the evaluation of the competency of the staff. Findings Include: 1. Review of the laboratory's policy and procedure titled "Competency Assessment" found the following statements: "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 273 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6121 Continued From page 273 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6121 consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." "V. Test Complexity C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory tests require competency assessment. The competency assessment must include all six elements." "VIII. Annual Competency Assessment of Testing Personnel A. Supervisory Responsibilities Note: While others may assist with the he competency assessment process, the ultimate responsibility for this activity falls upon supervisory personnel. - Identify Assessors who meet the qualifications to perform competency assessment for the complexity level of the test system(s) - Select assessment method(s) that fulfill all 6 CLIA competency assessment elements (refer to Section XII, 'Procedure for Competency Assessment' for specifics)." "VIII. Annual Competency Assessment of Testing Personnel B. Assessor Responsibilities - Ensure assessor is qualified to perform competency assessment for the complexity level of testing. - Prepare and distribute selected competency testing samples. - Observe testing personnel and review FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 274 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6121 Continued From page 274 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6121 documentation in a professional impartial manner." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system). A. Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing. Direct observation may include: - Patient identification - Maintaining specimen identity - Specimen handling - Compliance with established operation procedures - Safety compliance - Proper technique - Proper performance of quality control" 2. Review of the Form CMS-209 found 11 individuals certified by the LD to fulfil the role of Technical Supervisor (TS). Upon review of the TS's documentation of education, it was identified that TS #1, #4, and #11 were not qualified to fulfil the role of TS. (Refer to D6111, Item 1) Further review of the Form CMS-209 Found TP #43 was not certified by the LD to fulfill the role of TS or General Supervisor (GS). 3. Review of the laboratory's 2015 competency assessment documentation titled "Marymount Hospital Competency Assessment" for 18 testing personnel (TP) (TP #1, #2, #3, #4, #5, #6, #7, #8, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 275 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6121 Continued From page 275 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6121 #9, #10, #11, #12, #13, #14, #15, #16, #43, and #44) found the following statement under the heading "Competency Assessment Methods (MUST complete all 6 methods)": "1. Successful performance of routine patient testing verified by direct observation. *Proper sample analysis, proper sampling technique" Direct observation of routine patient test performance was performed and documented by a non-qualified TS or TP not certified by the LD to fulfil the roles of TS or GS on 29 out of 217 competency assessments as follows: TP #2: Competency: Rapid HIV Date: 03/06/2015 Initials: TS #1 Competency: Gram Stain Date: 03/06/2015 Initials: TS #1 Competency: Chemistry Date: 03/06/2015 Initials: TS #1 Competency: Urine Tox Screen Date: 03/04/2015 Initials: TS #1 Competency: Urinalysis Date: 03/06/2015 Initials: TS #1 Competency: Wet Preparation/Trichomonas FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 276 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6121 Continued From page 276 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6121 Date: 03/06/2015 Initials: TS #1 TP #4: Competency: Urine Tox Screen Date: 03/05/2015 Initials: TS #11 Competency: Osmometer Date: 03/05/2015 Initials: TS #11 Competency: Rapid HIV Date: 03/06/2015 Initials: TS #11 Competency: hCG Date: 03/06/2015 Initials: TS #11 Competency: Wet Preparation/Trichomonas Date: 03/06/2015 Initials: TS #11 Competency: Gram Stain Date: 03/05/2015 Initials: TS #11 Competency: Mono Date: 03/05/2015 Initials: TS #11 TP #5: Competency: Gram Stain Date: 02/26/2015 Initials: TP #43 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 277 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6121 Continued From page 277 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6121 Competency: Gram Stain Date: 03/05/2015 Initials: TP #43 Competency: Legionella Date: 03/03/2015 Initials: TP #43 Competency: Wet Preparation/Trichomonas Date: 03/03/2015 Initials: TP #43 TP #9: Competency: Wet Preparations/Trichomonas Date: 03/03/2015 Initials: TP #43 TP #12: Competency: CBC/CBCDIF Date: 03/07/2015 Initials: TS #11 Competency: Manual Differential Date: 03/07/2015 Initials: TS #11 Competency: Rapid HIV Date: 03/07/2015 Initials: TS #11 Competency: PT/PTT/DDIMER Date: 03/07/2015 Initials: TS #11 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 278 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6121 Continued From page 278 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6121 Competency: hCG Date: 03/07/2015 Initials: TS #11 Competency: Chemistry Date: 03/07/2015 Initials: TS #11 Competency: Urinalysis Date: 03/09/2015 Initials: TS #11 TP #13: Competency: Mono Date: 03/06/2015 Initials: TP #43 TP #14: Competency: Mono Date: 03/06/2015 Initials: TP #11 Competency: Urinalysis Date: 03/01/2015 Initials: TP #11 Competency: CBC/CBCDIF Date: 03/01/2015 Initials: TP #11 Tox - Toxicology CBC - Complete Blood Count CBCDIF - Complete Blood Count Differential Mono - Mononucleosis PT - Protime PTT - Partial Thromboplastin Time DDMR - D-Dimer FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 279 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6122 493.1451(b)(8)(ii) TECHNICAL SUPERVISOR RESPONSIBILITIES PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6122 The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, competency assessment documentation, Form CMS-209, and documentation of education, the Technical Supervisors failed to include monitoring the recording and reporting of test results in the evaluation of the competency of the staff. Findings Include: 1. Review of the laboratory's policy and procedure titled "Competency Assessment" found the following statements: "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." "V. Test Complexity C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory tests require competency assessment. The FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 280 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6122 Continued From page 280 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6122 competency assessment must include all six elements." "VIII. Annual Competency Assessment of Testing Personnel A. Supervisory Responsibilities Note: While others may assist with the he competency assessment process, the ultimate responsibility for this activity falls upon supervisory personnel. - Identify Assessors who meet the qualifications to perform competency assessment for the complexity level of the test system(s) - Select assessment method(s) that fulfill all 6 CLIA competency assessment elements (refer to Section XII, 'Procedure for Competency Assessment' for specifics)." "VIII. Annual Competency Assessment of Testing Personnel B. Assessor Responsibilities - Ensure assessor is qualified to perform competency assessment for the complexity level of testing. - Prepare and distribute selected competency testing samples. - Observe testing personnel and review documentation in a professional impartial manner." "IX. Scope of Competency Assessment The laboratory must identify the test systems that an employee uses to generate patient test results. Competency assessment can be done throughout the entire year by coordinating it with routine practices and procedures to minimize impact on workload. Documentation of these elements, including observation of test performance, results reporting, instrument FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 281 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6122 Continued From page 281 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6122 maintenance, review of worksheets, recording QC, performance of proficiency testing and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system). B. Monitoring the recording and reporting of test results, including, as applicable, reporting critical results The designated assessor monitors the recording and reporting of results through the comparison of computer entries against instrument printouts or worksheets. The assessor ensures compliance with critical value resulting and reporting policies where applicable." 2. Review of the Form CMS-209 found 11 individuals certified by the LD to fulfil the role of Technical Supervisor (TS). Upon review of the TS's documentation of education, it was identified that TS #1, #4, and #11 were not qualified to fulfil the role of TS. (Refer to D6111, Item 1) Further review of the Form CMS-209 Found TP #43 was not certified by the LD to fulfill the role of TS or General Supervisor (GS). 3. Review of the laboratory's 2015 competency assessment documentation titled "Marymount Hospital Competency Assessment" for 18 testing personnel (TP) (TP #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #43, and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 282 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6122 Continued From page 282 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6122 #44) found the following statement under the heading "Competency Assessment Methods (MUST complete all 6 methods)": "2. Supervisor review of test result recording and reporting. *Manual result entry into the medical record" Monitoring the recording and reporting of test results was performed and documented by a non-qualified TS or TP not certified by the LD to fulfil the roles of TS or GS on 29 out of 217 competency assessments as follows: TP #2: Competency: Rapid HIV Date: 03/06/2015 Initials: TS #1 Competency: Gram Stain Date: 03/06/2015 Initials: TS #1 Competency: Chemistry Date: 03/06/2015 Initials: TS #1 Competency: Urine Tox Screen Date: 03/04/2015 Initials: TS #1 Competency: Urinalysis Date: 03/06/2015 Initials: TS #1 Competency: Wet Preparation/Trichomonas Date: 03/06/2015 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 283 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6122 Continued From page 283 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6122 Initials: TS #1 TP #4: Competency: Urine Tox Screen Date: 03/05/2015 Initials: TS #11 Competency: Osmometer Date: 03/05/2015 Initials: TS #11 Competency: Rapid HIV Date: 03/06/2015 Initials: TS #11 Competency: hCG Date: 03/06/2015 Initials: TS #11 Competency: Wet Preparation/Trichomonas Date: 03/06/2015 Initials: TS #11 Competency: Gram Stain Date: 03/05/2015 Initials: TS #11 Competency: Mono Date: 03/05/2015 Initials: TS #11 TP #5: Competency: Gram Stain Date: 02/26/2015 Initials: TP #43 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 284 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6122 Continued From page 284 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6122 Competency: Gram Stain Date: 03/05/2015 Initials: TP #43 Competency: Legionella Date: 03/03/2015 Initials: TP #43 Competency: Wet Preparation/Trichomonas Date: 03/03/2015 Initials: TP #43 TP #9: Competency: Wet Preparations/Trichomonas Date: 03/03/2015 Initials: TP #43 TP #12: Competency: CBC/CBCDIF Date: 03/07/2015 Initials: TS #11 Competency: Manual Differential Date: 03/07/2015 Initials: TS #11 Competency: Rapid HIV Date: 03/07/2015 Initials: TS #11 Competency: PT/PTT/DDIMER Date: 03/07/2015 Initials: TS #11 Competency: hCG FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 285 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6122 Continued From page 285 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6122 Date: 03/07/2015 Initials: TS #11 Competency: Chemistry Date: 03/07/2015 Initials: TS #11 Competency: Urinalysis Date: 03/09/2015 Initials: TS #11 TP #13: Competency: Mono Date: 03/06/2015 Initials: TP #43 TP #14: Competency: Mono Date: 03/06/2015 Initials: TP #11 Competency: Urinalysis Date: 03/01/2015 Initials: TP #11 Competency: CBC/CBCDIF Date: 03/01/2015 Initials: TP #11 Monitoring the recording and reporting of test results was not performed and documented on 3 out of 217 competency assessments as follows: TP #16: Competency: CBC/CBCDIF Date: blank FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 286 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6122 Continued From page 286 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6122 Initials: blank Competency: PT/PTT/DDIMER Date: blank Initials: blank Competency: Manual Differential Date: blank Initials: blank Tox - Toxicology CBC - Complete Blood Count CBCDIF - Complete Blood Count Differential Mono - Mononucleosis PT - Protime PTT - Partial Thromboplastin Time DDMR - D-Dimer D6123 493.1451(b)(8)(iii) TECHNICAL SUPERVISOR RESPONSIBILITIES D6123 The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, competency assessment documentation, Form CMS-209, and documentation of education, the Technical Supervisors failed to include review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records in the evaluation of the competency of the staff. Findings Include: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 287 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6123 Continued From page 287 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6123 1. Review of the laboratory's policy and procedure titled "Competency Assessment" found the following statements: "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." "V. Test Complexity C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory tests require competency assessment. The competency assessment must include all six elements." "VIII. Annual Competency Assessment of Testing Personnel A. Supervisory Responsibilities Note: While others may assist with the competency assessment process, the ultimate responsibility for this activity falls upon supervisory personnel. - Identify Assessors who meet the qualifications to perform competency assessment for the complexity level of the test system(s) - Select assessment method(s) that fulfill all 6 CLIA competency assessment elements (refer to Section XII, 'Procedure for Competency Assessment' for specifics)." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 288 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6123 Continued From page 288 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6123 "VIII. Annual Competency Assessment of Testing Personnel B. Assessor Responsibilities - Ensure assessor is qualified to perform competency assessment for the complexity level of testing. - Prepare and distribute selected competency testing samples. - Observe testing personnel and review documentation in a professional impartial manner." "IX. Scope of Competency Assessment The laboratory must identify the test systems that an employee uses to generate patient test results. Competency assessment can be done throughout the entire year by coordinating it with routine practices and procedures to minimize impact on workload. Documentation of these elements, including observation of test performance, results reporting, instrument maintenance, review of worksheets, recording QC, performance of proficiency testing and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system). C. Review of intermediate test result or worksheets, quality control records, proficiency testing results, and preventative maintenance records (as applicable for the selected assay/test FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 289 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6123 Continued From page 289 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6123 in Part A above). - Worksheets - Quality control records - Proficiency testing - Function verification and performance maintenance records - Corrective actions" 2. Review of the Form CMS-209 found 11 individuals certified by the LD to fulfil the role of Technical Supervisor (TS). Upon review of the TS's documentation of education, it was identified that TS #1, #4, and #11 were not qualified to fulfil the role of TS. (Refer to D6111, Item 1) Further review of the Form CMS-209 Found TP #43 was not certified by the LD to fulfill the role of TS or General Supervisor (GS). 3. Review of the laboratory's 2015 competency assessment documentation titled "Marymount Hospital Competency Assessment" for 18 testing personnel (TP) (TP #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #43, and #44) found the following statement under the heading "Competency Assessment Methods (MUST complete all 6 methods)": "3. Supervisor review of intermediate test results, QC records, AND proficiency Testing. *QC records, patient logs, proficiency testing" Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records was performed and documented by a non-qualified TS or TP not certified by the LD to fulfil the roles of TS or GS on 27 out of 217 competency assessments as follows: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 290 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6123 Continued From page 290 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6123 TP #2: Competency: Rapid HIV Date: 03/06/2015 Initials: TS #1 Competency: Gram Stain Date: 03/06/2015 Initials: TS #1 Competency: Chemistry Date: 03/06/2015 Initials: TS #1 Competency: Urine Tox Screen Date: 03/04/2015 Initials: TS #1 Competency: Urinalysis Date: 03/06/2015 Initials: TS #1 Competency: Wet Preparation/Trichomonas Date: 03/06/2015 Initials: TS #1 TP #4: Competency: Urine Tox Screen Date: 03/05/2015 Initials: TS #11 Competency: Osmometer Date: 03/05/2015 Initials: TS #11 Competency: Rapid HIV Date: 03/06/2015 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 291 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6123 Continued From page 291 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6123 Initials: TS #11 Competency: hCG Date: 03/06/2015 Initials: TS #11 Competency: Wet Preparation/Trichomonas Date: 03/06/2015 Initials: TS #11 Competency: Gram Stain Date: 03/05/2015 Initials: TS #11 Competency: Mono Date: 03/05/2015 Initials: TS #11 TP #5: Competency: Gram Stain Date: 02/26/2015 Initials: TP #43 Competency: Gram Stain Date: 03/05/2015 Initials: TP #43 Competency: Legionella Date: 03/03/2015 Initials: TP #43 Competency: Wet Preparation/Trichomonas Date: 03/03/2015 Initials: TP #43 TP #9: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 292 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6123 Continued From page 292 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6123 Competency: Wet Preparations/Trichomonas Date: 03/03/2015 Initials: TP #43 TP #12: Competency: CBC/CBCDIF Date: 03/07/2015 Initials: TS #11 Competency: Manual Differential Date: 03/07/2015 Initials: TS #11 Competency: Rapid HIV Date: 03/07/2015 Initials: TS #11 Competency: PT/PTT/DDIMER Date: 03/07/2015 Initials: TS #11 Competency: hCG Date: 03/07/2015 Initials: TS #11 Competency: Chemistry Date: 03/07/2015 Initials: TS #11 Competency: Urinalysis Date: 03/09/2015 Initials: TS #11 TP #13: Competency: Mono FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 293 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6123 Continued From page 293 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6123 Date: 03/06/2015 Initials: TP #43 TP #14: Competency: Mono Date: 03/06/2015 Initials: TP #11 Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records was not performed and documented on 6 out of 217 competency assessments as follows: TP #11: Competency: Manual Differential Date: blank Initials: blank TP #14: Competency: Urinalysis Date: N/A Initials: blank TP #16: Competency: PT/PTT/DDIMER Date: blank Initials: blank Competency: Manual Differential Date: blank Initials: blank TP #44: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 294 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6123 Continued From page 294 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6123 Competency: CBC/CBCDIF Date: blank Initials: blank Competency: PT/PTT/DDIMER Date: blank Initials: blank Tox - Toxicology CBC - Complete Blood Count CBCDIF - Complete Blood Count Differential Mono - Mononucleosis PT - Protime PTT - Partial Thromboplastin Time DDMR - D-Dimer D6124 493.1451(b)(8)(iv) TECHNICAL SUPERVISOR RESPONSIBILITIES D6124 The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, competency assessment documentation, Form CMS-209, documentation of education, and four confidential interviews, the Technical Supervisors failed to include direct observation of performance of instrument maintenance and function checks in the evaluation of the competency of the staff. Findings Include: 1. Review of the laboratory's policy and procedure titled "Competency Assessment" found the following statements: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 295 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6124 Continued From page 295 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6124 "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." "V. Test Complexity C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory tests require competency assessment. The competency assessment must include all six elements." "VIII. Annual Competency Assessment of Testing Personnel A. Supervisory Responsibilities Note: While others may assist with the he competency assessment process, the ultimate responsibility for this activity falls upon supervisory personnel. - Identify Assessors who meet the qualifications to perform competency assessment for the complexity level of the test system(s) - Select assessment method(s) that fulfill all 6 CLIA competency assessment elements (refer to Section XII, 'Procedure for Competency Assessment' for specifics)." "VIII. Annual Competency Assessment of Testing Personnel B. Assessor Responsibilities FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 296 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6124 Continued From page 296 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6124 - Ensure assessor is qualified to perform competency assessment for the complexity level of testing. - Prepare and distribute selected competency testing samples. - Observe testing personnel and review documentation in a professional impartial manner." "IX. Scope of Competency Assessment The laboratory must identify the test systems that an employee uses to generate patient test results. Competency assessment can be done throughout the entire year by coordinating it with routine practices and procedures to minimize impact on workload. Documentation of these elements, including observation of test performance, results reporting, instrument maintenance, review of worksheets, recording QC, performance of proficiency testing and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system). D. Direct observation of performance of instrument maintenance and function checks All testing personnel are responsible for requesting a designated assessor to directly observe performance of instrument maintenance and function checks on the selected instrument. A review of service maintenance records meets this requirement. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 297 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6124 Continued From page 297 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6124 For manual tests that do not have an instrument involved, this element can be 'Not applicable'. If an employees role does not include instrument maintenance, this element can be 'Not applicable'." 2. Review of the Form CMS-209 found 11 individuals certified by the LD to fulfil the role of Technical Supervisor (TS). Upon review of the TS's documentation of education, it was identified that TS #1, #4, and #11 were not qualified to fulfil the role of TS. (Refer to D6111, Item 1) Further review of the Form CMS-209 Found TP #43 was not certified by the LD to fulfill the role of TS or General Supervisor (GS). 3. Review of the laboratory's 2015 competency assessment documentation titled "Marymount Hospital Competency Assessment" for 18 testing personnel (TP) (TP #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #43, and #44) found the following statement under the heading "Competency Assessment Methods (MUST complete all 6 methods)": "4. Direct observation of performance of instrument maintenance and function checks. *Direct observation of instrument maintenance" Direct observation of performance of instrument maintenance and function checks was performed and documented by a non-qualified TS or TP not certified by the LD to fulfil the roles of TS or GS on 13 out of 217 competency assessments as follows: TP #2: Competency: Urinalysis FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 298 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6124 Continued From page 298 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6124 Date: 03/06/2015 Initials: TS #1 TP #4: Competency: Osmometer Date: 03/05/2015 Initials: TS #11 TP #5: Competency: Gram Stain Date: 02/26/2015 Initials: TP #43 Competency: Gram Stain Date: 03/05/2015 Initials: TP #43 Competency: Legionella Date: 03/03/2015 Initials: TP #43 Competency: Wet Preparation/Trichomonas Date: 03/03/2015 Initials: TP #43 TP #9: Competency: Wet Preparations/Trichomonas Date: 03/03/2015 Initials: TP #43 TP #12: Competency: CBC/CBCDIF Date: 03/07/2015 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 299 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6124 Continued From page 299 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6124 Initials: TS #11 Competency: PT/PTT/DDIMER Date: 03/07/2015 Initials: TS #11 Competency: Chemistry Date: 03/07/2015 Initials: TS #11 Competency: Urinalysis Date: 03/09/2015 Initials: TS #11 TP #13: Competency: Mono Date: 03/06/2015 Initials: TP #43 TP #14: Competency: CBC/CBCDIF Date: 03/01/2015 Initials: TP #11 3. During confidential interviews, which occurred 03/12/2015 from 3:25 PM through 6:36 PM, individuals stated the following: TS and GS did not directly observe TP performing instrument maintenance. There was no direct observation of instrument maintenance when the laboratory performed the competency assessment evaluations the prior week. Tox - Toxicology FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 300 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6124 Continued From page 300 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6124 CBC - Complete Blood Count CBCDIF - Complete Blood Count Differential Mono - Mononucleosis PT - Protime PTT - Partial Thromboplastin Time DDMR - D-Dimer D6125 493.1451(b)(8)(v) TECHNICAL SUPERVISOR RESPONSIBILITIES D6125 The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, competency assessment documentation, Form CMS-209, and documentation of education, the Technical Supervisors failed to include assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples in the evaluation of the competency of the staff. Findings Include: 1. Review of the laboratory's policy and procedure titled "Competency Assessment" found the following statements: "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 301 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6125 Continued From page 301 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6125 consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." "V. Test Complexity C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory tests require competency assessment. The competency assessment must include all six elements." "VIII. Annual Competency Assessment of Testing Personnel A. Supervisory Responsibilities Note: While others may assist with the competency assessment process, the ultimate responsibility for this activity falls upon supervisory personnel. - Identify Assessors who meet the qualifications to perform competency assessment for the complexity level of the test system(s) - Select assessment method(s) that fulfill all 6 CLIA competency assessment elements (refer to Section XII, 'Procedure for Competency Assessment' for specifics)." "VIII. Annual Competency Assessment of Testing Personnel B. Assessor Responsibilities - Ensure assessor is qualified to perform competency assessment for the complexity level of testing. - Prepare and distribute selected competency testing samples. - Observe testing personnel and review FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 302 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6125 Continued From page 302 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6125 documentation in a professional impartial manner." "IX. Scope of Competency Assessment The laboratory must identify the test systems that an employee uses to generate patient test results. Competency assessment can be done throughout the entire year by coordinating it with routine practices and procedures to minimize impact on workload. Documentation of these elements, including observation of test performance, results reporting, instrument maintenance, review of worksheets, recording QC, performance of proficiency testing and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system). E. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples The testing performance of all testing personnel is evaluated by supervisory personnel or a designated assessor using comparison of results of previously resulted specimens, blind specimens, previously analyzed external proficiency testing survey samples, or other quality control samples." 2. Review of the Form CMS-209 found 11 individuals certified by the LD to fulfil the role of FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 303 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6125 Continued From page 303 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6125 Technical Supervisor (TS). Upon review of the TS's documentation of education, it was identified that TS #1, #4, and #11 were not qualified to fulfil the role of TS. (Refer to D6111, Item 1) Further review of the Form CMS-209 Found Testing Personnel (TP) #43 was not certified by the LD to fulfill the role of TS or General Supervisor (GS). 3. Review of the laboratory's 2015 competency assessment documentation titled "Marymount Hospital Competency Assessment" for 18 testing personnel (TP) (TP #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #43, and #44) found the following statement under the heading "Competency Assessment Methods (MUST complete all 6 methods)": "5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples. *Proficiency Test results, QC sheets, previously analyzed samples, ect." 4. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples was performed and documented by a non-qualified TS or TP not certified by the LD to fulfil the roles of TS or GS on 12 out of 217 competency assessments as follows: TP #5: Competency: Gram Stain Date: 02/26/2015 Initials: TP #43 Competency: Gram Stain FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 304 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6125 Continued From page 304 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6125 Date: 03/05/2015 Initials: TP #43 Competency: Legionella Date: 03/03/2015 Initials: TP #43 Competency: Wet Preparation/Trichomonas Date: 03/03/2015 Initials: TP #43 TP #9: Competency: Wet Preparation/Trichomonas Date: 03/03/2015 Initials: TP #43 TP #12: Competency: CBC/CBCDIF Date: 03/07/2015 Initials: TS #11 Competency: Manual Differential Date: 03/07/2015 Initials: TS #11 Competency: Rapid HIV Date: 03/07/2015 Initials: TS #11 Competency: PT/PTT/DDIMER Date: 03/07/2015 Initials: TS #11 Competency: hCG Date: 03/07/2015 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 305 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6125 Continued From page 305 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6125 Initials: TS #11 Competency: Chemistry Date: 03/07/2015 Initials: TS #11 TP #13: Competency: Mono Date: 03/06/2015 Initials: TP #43 Tox - Toxicology CBC - Complete Blood Count CBCDIF - Complete Blood Count Differential Mono - Mononucleosis PT - Protime PTT - Partial Thromboplastin Time DDMR - D-Dimer D6126 493.1451(b)(8)(vi) TECHNICAL SUPERVISOR RESPONSIBILITIES D6126 The procedures for evaluation of the competency of the staff must include, but are not limted to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and competency assessment documentation, the Technical Supervisors failed to include assessment of problem solving skills in the evaluation of the competency of the staff. Findings Include: 1. Review of the laboratory's policy and procedure titled "Competency Assessment" found the following statements: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 306 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6126 Continued From page 306 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6126 "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." "V. Test Complexity C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory tests require competency assessment. The competency assessment must include all six elements." "VIII. Annual Competency Assessment of Testing Personnel A. Supervisory Responsibilities Note: While others may assist with the competency assessment process, the ultimate responsibility for this activity falls upon supervisory personnel. - Identify Assessors who meet the qualifications to perform competency assessment for the complexity level of the test system(s) - Select assessment method(s) that fulfill all 6 CLIA competency assessment elements (refer to Section XII, 'Procedure for Competency Assessment' for specifics)." "VIII. Annual Competency Assessment of Testing Personnel B. Assessor Responsibilities FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 307 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6126 Continued From page 307 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6126 - Ensure assessor is qualified to perform competency assessment for the complexity level of testing. - Prepare and distribute selected competency testing samples. - Observe testing personnel and review documentation in a professional impartial manner." "IX. Scope of Competency Assessment The laboratory must identify the test systems that an employee uses to generate patient test results. Competency assessment can be done throughout the entire year by coordinating it with routine practices and procedures to minimize impact on workload. Documentation of these elements, including observation of test performance, results reporting, instrument maintenance, review of worksheets, recording QC, performance of proficiency testing and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system). F. Assessment of problem-solving skills All testing personnel are responsible for submitting documentation that demonstrates problem-solving skills to the assessor. Problem solving skills can be assessed through quizzes or documented examples of the employee's skill in resolving actual laboratory issues. Documentation may include but is not limited to: laboratory FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 308 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6126 Continued From page 308 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6126 information system or manual quality control corrective action, corrective action follow, root cause analysis, quality assurance forms, instrument corrective action, or case study review." 2. Review of the laboratory's 2015 competency assessment documentation titled "Marymount Hospital Competency Assessment" for 18 testing personnel (TP) (TP #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #43, and #44) found the following statement under the heading "Competency Assessment Methods (MUST complete all 6 methods)": "6. Assessment of problem solving skills. *Successful completion of quiz" Assessment of problem solving skills was not performed and documented on 14 out of 217 competency assessments as follows: TP #2: Competency: Osmometer Score: blank Date: blank Initials: blank Competency: Urine Tox Screen Score: blank Date: blank Initials: blank Competency: Urinalysis Score: blank Date: blank Initials: blank FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 309 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6126 Continued From page 309 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6126 Competency: Mono Score: blank Date: blank Initials: blank TP #4: Competency: Osmometer Score: blank Date: blank Initials: blank TP #12: Competency: CBC/CBCDIF Score: blank Date: blank Initials: blank Competency: Manual Differential Score: blank Date: blank Initials: blank Competency: Rapid HIV Score: blank Date: blank Initials: blank Competency: PT/PTT/DDIMER Score: blank Date: blank Initials: blank Competency: Mono Score: blank Date: blank Initials: blank FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 310 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6126 Continued From page 310 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6126 Competency: hCG Score: blank Date: blank Initials: blank Competency: Chemistry Score: blank Date: blank Initials: blank Competency: Urine Tox Screen Score: blank Date: blank Initials: blank Competency: Urinalysis Score: blank Date: blank Initials: blank Tox - Toxicology CBC - Complete Blood Count CBCDIF - Complete Blood Count Differential Mono - Mononucleosis PT - Protime PTT - Partial Thromboplastin Time DDMR - D-Dimer D6128 493.1451(b)(9) TECHNICAL SUPERVISOR RESPONSIBILITIES D6128 The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 311 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 311 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 instrumentation. This STANDARD is not met as evidenced by: Item 1: Based on review of the laboratory's policies and procedures, competency assessment documentation, Form CMS-209, Ohio Department of Health (ODH) CLIA Annual Test Volume Log, antibody identification test records, transfusion reaction test records, emergency blood product release test records, body fluid manual count and differential test records, and interview with Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the Technical Supervisors failed to evaluate and document the performance of individuals responsible for performing investigations of transfusion reactions, emergency blood product release procedures, compatibility antiglobulin crossmatch, electronic compatibility crossmatch, prewarm antibody procedures, eluate procedures, indirect coombs antibody identification procedures, saline replacement procedures, and manual body fluid count and differential high complexity testing at least annually after the first year. Findings Include: 1. The ODH CLIA Annual Test Volume Log, completed by TS #8, found the following high complexity test procedures listed: Analyte/Test Name: Coombs, Indirect Compatibility, Antiglobulin FORM CMS-2567(02-99) Previous Versions Obsolete Instrument/ Kit Name: tube tube Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 312 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 12300 MCCRACKEN ROAD GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 312 Body Fluid Count 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 N/A 2. Review of the laboratory's policies and procedures found the following: - a policy titled "Emergency Release of Blood Uncrossmatched" - a policy titled "Investigation of Transfusion Reactions" 3. Review of the laboratory's blood bank test records found: - records of 22 transfusion reaction investigations performed by testing personnel (TP) at this laboratory - records of 10 emergency blood product release procedures performed by TP at this laboratory - a Reagent Red Blood Cells 0.8% Resolve Panel A Antigram Antigen Profile, dated 01/07/2014, with a hand written note stating "Post Transfusion Elution" - a "DAT Worksheet" (Direct Antiglobulin Test Worksheet), dated 01/07/2014 and initialed by TP #1 next to "Tech:", which stated "elution" under the heading "Action Taken:" - a Bio-Rad Biotestcell 3 Antibody Screen Table with a handwritten note stating "in use 1-9-15" at the top of the page and the abbreviation "PW" under the heading "Test Results" - a "Blood Bank Downtime Worksheet" dated 01/25/2015. Under the heading "Antibody Screen" the column headers "Cell #1", "Cell #2", and "Cell #3" were circled. Two rows of test results were FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 313 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 313 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 documented below. To the right of the first row of results was a handwritten "1" which was circled. At the top of the page was a handwritten "1" which was also circled and had the statement "IS-not prewarmed" written next to it. To the right of the second row of results was a handwritten "2" which was circled and had GS #2's first name written below. At the top of the page was a handwritten "2" which was also circled and had the statement "(37 degrees - all reagents - prewarmed. Coombs " ")". A third row of results were present under the heading "Crossmatch". Below those results was a final row of test results with "Prewarm x-match" written next to them. - a "Blood Bank Downtime Worksheet" with three rows of test results under the heading "Crossmatch" and column headers "IS", "37", "AHG", "CCC", and "Cross Match Interp". - a Bio-Rad Biotestcell - I 11 Antibody Identification Table with 11 rows of test results below the heading "Test Results" and column headers "IS", "37", "IgG", and "CC". Handwritten next to the heading "Test Results" was "LISS tube". - a "Blood Bank Downtime Worksheet" with two rows of test results under the heading "Crossmatch" and column headers "IS", "37", "AHG", "CCC", and "Cross Match Interp". Next to the first row of results was written "PW". - a Bio-Rad Biotestcell 3 Antibody Screen Table with a handwritten note stating "in use 06/27/14" at the top of the page and the abbreviation "PW" under the heading "Test Results". FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 314 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 314 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 - a Bio-Rad Biotestcell - I 11 Antibody Identification Table with 11 rows of test results below the heading "Test Results" and column header "PW". - a Bio-Rad Biotestcell 3 Antibody Screen Table with a handwritten note stating "in use 8-22-14" at the top of the page and a handwritten note stating "sal replacement" next to the heading "Test Results". Below were three rows of test results under the column headers "IS", "37", "IgG", and "CC". - a laboratory information system (LIS) report identifying 35 manual body fluid analyses performed at this laboratory in February 2015 3. Review of the laboratory's policy and procedure titled "Competency Assessment" found the following statements: "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." "V. Test Complexity C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 315 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 315 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 tests require competency assessment. The competency assessment must include all six elements." "IX. Scope of Competency Assessment The laboratory must identify the test systems that an employee uses to generate patient test results. Competency assessment can be done throughout the entire year by coordinating it with routine practices and procedures to minimize impact on workload. Documentation of these elements, including observation of test performance, results reporting, instrument maintenance, review of worksheets, recording QC, performance of proficiency testing and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system)." 4. TS #8 stated TP perform laboratory testing as follows: TP #1: TP #2: TP #3: TP #4: TP #5: TP #6: TP #7: TP #8: Hematology, Blood Bank All Departments Microbiology, Chemistry All Departments (except Body Fluids) Hematology, Microbiology Chemistry, Coagulation Coagulation, Chemistry Hematology, Chemistry, Urinalysis, Coagulation TP #9: Hematology, Coagulation, Chemistry, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 316 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 316 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 Blood Bank, Microbiology TP #10: Chemistry, Hematology, Microbiology TP #11: All Departments TP #12: All Departments (except Blood Bank) TP #13: All Departments TP #14: Hematology, Urinalysis, Chemistry TP #15: All Departments TP #16: All Departments TP #43: Chemistry, Microbiology The interview occurred 03/09/2015 at 8:38 AM. 5. Review of the laboratory's 2015 competency assessment documentation titled "Marymount Hospital Competency Assessment" for 8 testing personnel (TP) (TP #1, #2, #4, #9, #11, #13, #15, and #16) found no documentation of competency assessment the following procedures: - investigations of transfusion reaction - emergency blood product release procedures - compatibility antiglobulin crossmatch - prewarm antibody procedures - eluate procedures - indirect coombs antibody identification procedures - saline replacement procedures - manual body fluid count and differential 6. TS #8 confirmed the laboratory did not have competency assessment documentation for emergency blood product release procedures. The interview occurred 03/09/2015 at 10:43 AM. Item 2: Based on review of the laboratory's policies and procedures, competency assessment documentation, Form CMS-209, proficiency FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 317 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 317 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 testing records, laboratory information system (LIS) data summary report, and interview with Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the Technical Supervisors failed to evaluate and document the performance of Testing Personnel (TP) #12, who performed high complexity blood bank testing, at least annually after the first year. Findings Include: 1. TS #8 stated TP #12 performed the following laboratory testing: TP #12: All Departments except Blood Bank The interview occurred 03/09/2015 at 8:38 AM. 2. Review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) attestation forms found TP #12 signed the first and second testing events of 2014 type and screen attestation forms as an analyst. Surveyor #1 asked TS #8 why TP #12 was performing PT for blood bank when they did not perform patient testing in blood bank. TS #8 stated TP #12 had performed blood bank patient testing in 2013, 2014, and the beginning of 2015. TS #8 further stated that when they discovered TP #12 had not had their competency assessed or documented for any blood bank procedures they required TP #12 to cease patient testing in blood bank. Surveyor #1 requested documentation from TS FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 318 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 318 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 #8 demonstrating when the discovery was made, when TP #12 ceased patient testing, and indicating corrective actions taken. TS #8 stated no such documentation was available. The interview occurred 03/09/2015 at 1:55 PM. 4. Surveyor #1 requested documentation identifying patient testing TP #12 had performed in blood bank in 2013, 2014, and 2015 from Quality Coordinator (QC) #2. Review of the documentation provided by QC #2 titled "Data Summary for specific order codes (MMH and tech code 42233 only)" found TP #12 resulted 1,088 blood bank tests in 2013, 2014, and 2015. Additionally, the report demonstrated the last blood bank test result entered by TP #12 was on 03/08/2015 at 11:17 PM, the evening prior to the dates of survey. 5. Review of the laboratory's policy and procedure titled "Competency Assessment" found the following statements: "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." "V. Test Complexity FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 319 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 319 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory tests require competency assessment. The competency assessment must include all six elements." "IX. Scope of Competency Assessment The laboratory must identify the test systems that an employee uses to generate patient test results. Competency assessment can be done throughout the entire year by coordinating it with routine practices and procedures to minimize impact on workload. Documentation of these elements, including observation of test performance, results reporting, instrument maintenance, review of worksheets, recording QC, performance of proficiency testing and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system)." Item 3: Based on review of the laboratory's policies and procedure, competency assessment documentation, and interview with Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to complete evaluations and document a determination of competency of FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 320 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 320 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 testing personnel at least annually after the first year. Findings Include: 1. Review of the laboratory's policy and procedure titled "Competency Assessment" found the following statements: "III. Required Competency Assessment Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultants, technical consultants, technical supervisors, and general supervisors who perform testing on patient specimens are required to have the six required elements in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." "V. Test Complexity C. Moderate and High Complexity Tests Testing personnel who perform non-waived (moderate and/or high complexity) laboratory tests require competency assessment. The competency assessment must include all six elements." "VIII. Annual Competency Assessment of Testing Personnel B. Assessor Responsibilities - Ensure assessor is qualified to perform competency assessment for the complexity level of testing. - Prepare and distribute selected competency testing samples. - Observe testing personnel and review FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 321 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 321 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 documentation in a professional impartial manner." "IX. Scope of Competency Assessment The laboratory must identify the test systems that an employee uses to generate patient test results. Competency assessment can be done throughout the entire year by coordinating it with routine practices and procedures to minimize impact on workload. Documentation of these elements, including observation of test performance, results reporting, instrument maintenance, review of worksheets, recording QC, performance of proficiency testing and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency." "X. Competency Assessment Elements for Testing Personnel For non-waived test systems, all the six elements below must be assessed annually for each test system (unless any are not applicable to the test system)." 2. TS #8 stated TP perform laboratory testing as follows: TP #1: TP #2: TP #3: TP #4: TP #5: TP #6: TP #7: TP #8: Hematology, Blood Bank All Departments Microbiology, Chemistry All Departments (except Body Fluids) Hematology, Microbiology Chemistry, Coagulation Coagulation, Chemistry Hematology, Chemistry, Urinalysis, Coagulation TP #9: Hematology, Coagulation, Chemistry, Blood Bank, Microbiology FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 322 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 12300 MCCRACKEN ROAD GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 322 TP #10: TP #11: TP #12: TP #13: TP #14: TP #15: TP #16: TP #43: 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 Chemistry, Hematology, Microbiology All Departments All Departments (except Blood Bank) All Departments Hematology, Urinalysis, Chemistry All Departments All Departments Chemistry, Microbiology The interview occurred 03/09/2015 at 8:38 AM. 3. Review of the laboratory's 2015 competency assessment documentation titled "Marymount Hospital Competency Assessment" for 18 testing personnel (TP) (TP #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #43, and #44) found the statement: "This employee is competent to perform this test." Followed by a: "Yes ______ No_______". Review of 217 competency assessment records found the laboratory failed to indicate a competency determination on 21 out of 217 competency assessment records as follows: TP #2: Competency: Osmometer No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: Urine Tox Screen No checkmark indicating a competency determination was present. Reviewed By: blank FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 323 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 323 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 Date: blank Competency: Urinalysis No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: Mono No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank TP #4: Competency: Osmometer No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: Blood Bank - Immediate Spin Crossmatch No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: Blood Bank - Antibody Identification No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: Blood Bank - ABORH, ABSC - Gel Method No checkmark indicating a competency FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 324 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 324 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 determination was present. Reviewed By: blank Date: blank TP #12: Competency: CBC/CBCDIF No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: Manual Differential No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: Rapid HIV No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: PT/PTT/DDIMER No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: Mono No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: hCG No checkmark indicating a competency determination was present. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 325 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 325 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 Reviewed By: blank Date: blank Competency: Chemistry No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: Urine Tox Screen No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: Urinalysis No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank TP #16: Competency: CBC/CBCDIF No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: PT/PTT/DDIMER No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank Competency: Manual Differential No checkmark indicating a competency determination was present. Reviewed By: blank FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 326 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6128 Continued From page 326 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6128 Date: blank Competency: Urinalysis No checkmark indicating a competency determination was present. Reviewed By: blank Date: blank 4. TS #8 confirmed some of the competency assessments were not completed. TS #8 further stated they did what they could with the time provided. The interview occurred 03/09/2015 at 9:02 AM. D6168 493.1487 TESTING PERSONNEL D6168 The laboratory has a sufficient number of individuals who meet the qualification requirements of §493.1489 of this subpart to perform the functions specified in §493.1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's Form CMS-209, education documentation, and an interview with Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to ensure high complexity testing personnel met the qualification requirements specified at §493.1489. Findings Include: 1. The laboratory failed to ensure Testing Personnel (TP) #2, #4, #7, #8, and #11 met the high complexity TP qualification requirements. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 327 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG D6168 Continued From page 327 D6168 (Refer to D6171) D6171 493.1489(b) TESTING PERSONNEL QUALIFICATIONS D6171 (X5) COMPLETION DATE (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-(b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-(b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-(b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-(b)(2)(ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 328 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6171 Continued From page 328 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6171 approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b) (2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under §493.1491 on or before February 28, 1992; (b)(4) On or before April 24, 1995 be a high school graduate or equivalent and have either-(b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-(b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-(b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 329 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6171 Continued From page 329 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6171 preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under §493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-(b)(6)(i) Be qualified under §493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of §493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of the laboratory's Form CMS-209, policies and procedures, education documentation, and an interview with Technical Supervisor (TS) #8 (as listed on the Laboratory Personnel Report (CLIA) Forms CMS-209 signed FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 330 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6171 Continued From page 330 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6171 by the Laboratory Director (LD) on 03/09/2015), the laboratory failed to ensure Testing Personnel (TP) #2, #4, #7, #8, and #11 met the high complexity TP qualification requirements. Findings Include: 1. Review of the laboratory's Form CMS-209, approved and signed by the LD on 03/09/2015, found 22 individuals certified by the LD to perform high complexity testing. 2. Review of the laboratory's policy and procedure titled "Job Descriptions" found the following statements: "Testing Personnel Testing personnel at the Cleveland Clinic (CC) include medical technologists and medical laboratory technicians qualified to perform moderate and high complexity tests. The laboratory director, technical and general supervisors are also qualified testing personnel as defined in Federal Register 1992 (Feb 28): 7183 42 CFR 493.1489. The qualifications and responsibilities are also defined in the medical technologist, medical laboratory technician, medical technician and pathologists' assistant job descriptions. The responsibilities encompass all CLIA '88 testing personnel responsibilities as outlined in Federal Register 1992(Feb 28): 7182 42 CFR 493.1495 including but not limited to the following: Responsibility for following laboratory procedures for specimen processing, test performance and reporting of test results FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 331 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6171 Continued From page 331 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6171 Adhering to the laboratory's quality control policies Following the laboratory's established policies and procedures whenever test systems are not within established acceptable levels of performance Identifying problems that may adversely affect test performance and immediately notify the general supervisor, technical supervisor, or laboratory director Documenting all corrective actions" 3. Review of education documentation provided revealed the following: TP#2 possessed a foreign Bachelor of Science in Medical Technology TP#4 possessed a foreign Bachelor of Science in Medical Technology TP#7 possessed a high school diploma TP#8 possessed a college transcript that failed to meet the semester hour requirements listed under 493.1489(b)(2)(ii) TP#11 possessed a foreign Bachelor of Science in Industrial Microbiology 4. Surveyor #2 requested documentation demonstrating an evaluation of the foreign documentation of education performed by a nationally recognized organization for TP#2, #4, and #11 from TS#8. Additionally, a high school diploma or science degree was requested for FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 332 of 333 PRINTED: 09/10/2015 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 36D0688090 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER 03/13/2015 STREET ADDRESS, CITY, STATE, ZIP CODE 12300 MCCRACKEN ROAD MARYMOUNT HOSPITAL LABORATORY (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ GARFIELD HEIGHTS, OH 44125 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) D6171 Continued From page 332 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE D6171 TP#7 and #8 from TS#8. TS#8 stated the lab had submitted evaluation requests forms for the foreign documentation of education, however, had not yet received documentation of the evaluations. The lab failed to submit the requested documentation within 7 calendar days from the date of request. The interview occurred on 03/9/2015 at 9:08 AM. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O9M611 Facility ID: OHC05083 If continuation sheet Page 333 of 333