PRINTED: 12/15/2016 DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS FOR MEDICARE MEDICAID SERVICES OMB NO. 0938-0391 STATEMENT OF DEFICIENCIES (X1) (x2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A COMPLETED 430081 B. WING 12/01/2016 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY. STATE, ZIP CODE HIGHWAY1B, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE PINE RIDGE, SD 57770 (x4) iD SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION (x5) annx (EACH DEFICIENCY MUST BE PRECEDED BY FULL (EACH CORRECTIVE ACTION SHOULD BE COMPLETIO TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG TO THE APPROPRIATE DATE DEFICIENCY) A 000 INITIAL COMMENTS A 000 Statement: An EMTALA investigation was done by two Regional Office surveyors from 11/28/16 to The Governing Body and leadership of the 12/1/16. Four complaints (SD00001248, PHS Indian Hospital at Pine Ridge (PRH) is SD00001249, SD00001274, and committed to safe and quality care, and take were investigated. Based on record review, seriously the findings identified during the policy review, and staff interviews, current EMTALA investigation from 11/28/2016 to deficient practice was identified. Three of the four 12/1/2016. Significant work and progress complaints were substantiated. has already been made to correct the deficiencies cited by the surveyors, and immediate jeopardy (IJ) was identified related to work will continue to make permanent the the failure to provide appropriate and adequate improvements and to build a culture Of Medical Screening Examinations (MSE), safety and quality. stabilization of patients for transfer, and appropriate transfers for patients seen in the The Chief Executive Officer (CEO) Emergency Department (EDI- The hospital was activated the PRH Hospital Incident notified Of thIS IJ at 6:00 PM on 12/1/16. Command System (HICS) to coordinate changes, ensure continuity of care, and Specifically, the is related i03 to facilitate and coordinate with external Indian Health Service support being I. Failures in the care and monitoring of patients provided to PRH A Situation Report is needing intubation and ventilation, completed daily (seven days per week) I and provided to the PRH Governing 3. ED providers not capable of intubating Body by the CEO. This will continue resulting in delays until flight team arrives at the until the EMTALA findings are resolved hospital, and changes are sustainable. b. Intubation occurring with patients not properly sedated, 0. Failure to monitor patients who are intubated and/or ventilated, d. Failure to train staff on the use of the ventilator. II. Lack of appropriate assessment (ESI) to determine the severity of the presenting LABORATORY OR REPRESENTATIVES SIGNATURE TITLE (X6) DATE WeiuomA-N?epwv CIA Err: 6c. who a 9 991143 Dan" Wain? 31. 3m to Any deficiency statement ending with an asterisk denotes a de?ciency which the institution may be excused from correcting providing it is determined that other safeguards provide suf?cient protection to the patients. (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days following the date ofsurvey 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 de?ciencies are cited. an approved plan of correction is requisite to continued program participation. FORM Previous Versions Obsolete Evenl Facility ID: 430081 If continuation sheet Page 1 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 000 Continued From page 1 conditions with appropriate, timely treatment, stabilization and transfer, PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 000 a. Lack of monitoring vital signs/neurological signs, b. Lack of cardiac monitoring. III. Inappropriate transfers of patients in labor. A2400 489.20(l) COMPLIANCE WITH 489.24 [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This STANDARD is not met as evidenced by: Based on review of the Hospital's Emergency Department (ED) logs, review of medical records, policy review, and staff interviews, it was determined the Hospital failed to comply with the provider agreement as defined in 42 C.F.R. §489.20 and 42 C.F.R. §489.24. The Hospital failed to provide a medical screening examination (MSE) that was, within reasonable clinical confidence, sufficient to determine whether or not an Emergency Medical Condition (EMC) existed, failed to stabilize unstable patients for transfer, and failed to provide appropriate transfer to patients in labor. Refer to A 2406, A 2407, and A 2409 for specifics. Immediate jeopardy (IJ) was identified related to the failure to provide appropriate and adequate Medical Screening Examinations (MSE), stabilization of patients for transfer, and appropriate transfers for patients seen in the Emergency Department (ED). The hospital was FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 A2400 A2400-Summary Statement: Governance and Leadership of PRH safeguards compliance with EMTALA by ensuring ED staff have adequate skills and competence to assess, treat, stabilize and provide transfer when appropriate. The hospital ensures quality providers are available for airway management with proper ventilation, sedation, monitoring, and equipment. The hospital ensures ED nursing staff are trained and competent in assessment/reassessment of Emergency Severity Index (ESI) for triage, vital signs, neurological, and cardiac monitoring. The hospital ensures these elements will be monitored for accuracy through the Quality Assessment Performance Improvement (QAPI) process. The hospital ensures appropriate transfer of patients in labor. I. A Certified Registered Nurse Anesthetist (CRNA) is on call 24 hours, 7 days per week for emergencies in the PRH Operating Room. These CRNAs have been credentialed, are assesses as competent, and are privileged to provide emergent airway management. They are currently providing emergent management of Facility ID: 430081 If continuation sheet Page 2 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE A2400 Continued: A2400 Continued From page 2 notified of this IJ at 6:00 PM on 12/1/16. Specifically, the IJ is related to: I. Failures in the care and monitoring of patients needing intubation and ventilation, a. ED providers not capable of intubating resulting in delays until flight team arrives at the hospital, b. Intubation occurring with patients not properly sedated, c. Failure to monitor patients who are intubated and/or ventilated, d. Failure to train staff on the use of the ventilator. II. . Lack of appropriate assessment (ESI) to determine the severity of the presenting conditions with appropriate, timely treatment, stabilization and transfer, a. Lack of monitoring vital signs/neurological signs, b. Lack of cardiac monitoring. III. Inappropriate transfers of patients in labor. A2406 489.24(a) & 489.24(c) MEDICAL SCREENING EXAM Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 A2400 airways in the Emergency Department until capabilities of physicians working in the Emergency Department are confirmed. a. Clinical Director and Chief Executive Officer (CEO) met with CRNAs on 12/08/2016 to review the interim change. b. A schedule for CRNA coverage is provided monthly, and posted in the Emergency Department which began on 12/02/2016. c. Scheduled ED providers and nurses have been instructed by the contract ED Medical Director that the CRNA on call must be called in for any patient who needs Emergent Airway Management. This instruction will be reviewed for any newly scheduled providers or nurses. d. The ED Medical Director will perform 100% chart review of patients requiring Emergent Airway Management and patients being transferred in order to assess for systems issues and failures that may lead to risk and to ensure safe airway management and ventilation. e. CRNA’s are available for all patients requiring airway management. Policies will be developed to verify appropriate proficiency for ED physicians. f. Responsible to implement this Plan of A2406 Correction: Clinical Director, Director of Nursing, and contract ED Medical Director. Facility ID: 430081 If continuation sheet Page 3 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE A2400 continued: A2406 Continued From page 3 regardless of ability to pay) "comes to the emergency department", as defined in paragraph (b) of this section, the hospital must (i) provide an appropriate medical screening examination within the capability of the hospital's emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (b) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital's obligation under this section ends, as specified in paragraph (d)(2) of this section. (2) Nonapplicability of provisions of this section. Sanctions under this section for inappropriate transfer during a national emergency or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department located in an emergency area, as specified in section 1135(g)(1) of the Act. A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 A2406 II. II. Nursing Competency III. a. Nurses performing triage are using Emergency Severity Index (ESI) for severity scoring, are competent. Performance is monitored through direct observation, chart reviews, and this is reported through QAPI. i. Contract Chief Nursing Officer (CNO) is currently onsite and is conducting daily validation of ESI competencies through chart review and real time observation. CNO is certified to perform ESI through ESITriage.com and has extensive experience with triage. ii. Nurses that have demonstrated ESI competence and have a minimum of two years of ED experience will be prioritized to staff the triage role in scheduling by 12/21/2016. iii. All current ED Nursing Staff will complete ESI online course through ESITriage.com by 12/31/2016. Any staff not scheduled through 12/31/2016 will complete before their next shift. Certifications of completion will be kept in the individual nursing files. iv. Assessment and evaluation are discussed in daily Emergency Services QAPI meeting. Corrective actions are assigned in QAPI meeting. v. Responsible party: Director of Nursing and contract ED Nursing Officer. Facility ID: 430081 If continuation sheet Page 4 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 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 (X5) COMPLETION DATE A2400 Continued: A2406 Continued From page 4 will continue in effect until the termination of the applicable declaration of a public health emergency, as provided for by section 1135(e)(1) (B) of the Act. (c) Use of Dedicated Emergency Department for Nonemergency Services If an individual comes to a hospital's dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This STANDARD is not met as evidenced by: Based on review of the Hospital's Emergency Department (ED) logs, review of medical records, policy review, and staff interviews, it was determined the Hospital failed to comply with the provider agreement as defined in 42 C.F.R. §489.20 and 42 C.F.R. §489.24. The Hospital failed to provide a medical screening examination (MSE) that was, within reasonable clinical confidence, sufficient to determine whether or not an Emergency Medical Condition (EMC) existed for 7 of 29 patients (#14, #24, #15, #16, #3, #8 and #1) reviewed. The failure to perform appropriate, adequate MSEs resulted in immediate jeopardy findings. The findings included: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 A2406 b. Training for nurses to ensure competency in neurological exams, cardiac monitoring, medication management, and vital signs will be assured. i. All ED staff nurses will complete neurological exam training through the PRH online training system by 12/30/2016 to ensure staff are trained in the requirements of a complete neurological exam, documentation, and appropriate monitoring. Certifications of completion will be kept in the individual nursing file. ii. All ED nursing staff will be retrained on the cardiac monitoring policy with an emphasis on expectations of monitoring strip frequency and conditions requiring cardiac monitoring by 12/23/2016. iii. Medication Administration Performance Evaluation to include assessment of patient response, required documentation, verification of physician order, and administration timeliness expectations. iv. Expected competency assessment for nursing staff regarding recognition of abnormal vital signs and initial/ongoing interventions will mirror the Assessment/Reassessment in ED Policy. Facility ID: 430081 If continuation sheet Page 5 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 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 (X5) COMPLETION DATE A2400 Continued: A2406 Continued From page 5 1. Review of the ED log revealed that patient #14 presented to the ED at the following times with the stated complaints, diagnoses, ESI levels, disposition: 9/17/16 at 11:51 PM, arrived via POV with a complaint of "trouble breathing"; ESI 3; diagnosis of "chronic bronchitis"; discharged to home at 2:20 AM. 9/18/16 at 3:00 AM, arrived via POV with a complaint of "can't breathe"; ESI 2; diagnosis of "respiratory failure"; discharged to Marc for transport to Rapid City hospital at 5:20 AM. 9/18/16 at 6:10 AM, arrived via ambulance with Code Blue/respiratory failure; ESI 1; Code Blue stopped at 7:05 AM; expired. Review of the patient's medical record revealed a list of chronic problems, which included cardiomegaly (added 9/28/09), history of cerebrovascular accident (CVA) without residual deficits (12/4/14), essential hypertension (12/4/14), sleep apnea (6/23/14), obesity (12/4/14), CVA (11/15/15), and episodic problems, which included expiratory wheezing (6/8/15), and dyspnea (6/8/15). Medical record review for the 57 year old patient evidenced that when he presented to the ED on 9/17/16 at 11:51 PM, the following assessments/actions occurred: 11:53 PM - Nursing triage - "trouble breathing, started this am. Took his nebulizer treatments with no releif. No distress in triage". Level 3 Urgent. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 A2406 v. Responsible party: Director of Nursing and contract ED Nursing Officer. III. Transfers of patients in labor: OB Labor and Delivery staff are responsible for providing MSE upon presenting to ED. Staff members have been educated on documentation required by EMTALA standards to include transfer packet requirements, refusal of transfer and AMA including risks & benefits by 12/30/2016. a. 100% Chart Review of all patients being transferred from the Obstetrical Labor and Delivery unit for appropriateness of transfer documentation by 12/21/2016. b. OB Labor and Delivery physicians, OB nursing staff, and Certified Nurse Midwives will be educated on documentation required by EMTALA standards to include transfer packet requirements, refusal of transfer and AMA including risks & benefits by 12/31/2016. Any staff not scheduled before 12/31/2016 will complete before c. their next shift. Training on policies related to MSE, patient stabilization, appropriate transfer with verification of staff understanding through post-test evaluations by 12/30/2016. d. Orientation for all new OB Labor and Delivery physicians, OB nursing staff, and Certified Nurse Midwives will be revised to include appropriate transfer training by 12/30/2016. Facility ID: 430081 If continuation sheet Page 6 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 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 (X5) COMPLETION DATE A2400 Continued: A2406 Continued From page 6 A2406 9/18/16 12:08 AM - ER Nursing note - nursing assessment: patient having shortness of breath; oxygen placed at 2 Liter per minute; decreased right and left breath sounds; patient in exam room 12:01 AM; provider notified 12:05 AM; patient able to speak in short answers 1-2 words only; Dr (name) in to see patient; Duo Neb given at 12:10 AM; IV started at 12:25 AM; Solumedrol IV 12:52 AM; Magnesium IV 12:52 AM; Duo Neb at 12:50 AM and 1:25 AM; vital signs at 2:15 AM; discharged home in stable condition via POV at 2:20 AM. 12:10 AM - provider arrived at patients bedside; HPI: "history of restrictive lung disease, smoker, comes with SOB, wheezy breathes since today. No fever or chills. No productive cough"; "Alert, Oriented, Pupils normal" GCS 15; bilateral wheezing; CV: regular rate and rhythm, Normal S1 and S2, No murmurs or rubs; pain 0; chronic bronchitis; Lab reports included WBC (white blood count) 19.7, Glucose 269, C-reactive protein 2.4; discharged home in good condition via POV at 1:55 AM. Clinical course...."COPD (chronic obstructive pulmonary disease) due to restrictive lung disease. comes with symptoms. Afebrile. Gave treatment, patient improved well .Lungs are clear to auscultation. Feels breathing better, O2=98%. Leukocytosis on CBC. Patient was offered the option to stay in hospital, but he refused and preferred treatment at home. Oriented to return if he does not gets any better. CXR (chest x-ray) Parenchymal changes related to his COPD/restrictive lung disease." e. Chart review findings will be discussed in daily Emergency Services QAPI meeting by 12/23/2016. Corrective actions will be assigned in QAPI meeting. f. Responsible parties include PRH Clinical Director, PRH Chief of Obstetrics, PRH OB Supervisory Clinical Nurse A2406 - The hospital is improving processes and ensures appropriate and high quality Medical Screening Exams. Collaboration between the contracted vendor and the PRH staff provides quality oversight to ensure quality care that meets EMTALA requirements is provided in the ED. I. Oversight of Medical Staff quality of care in the ED has been enhanced to provide the organized medical staff and governance information on provider performance. a. The quality and competence of the physicians caring for patients in the ED, and specifically in the conduct of Medical Screening Exams, will be monitored through direct observation, chart reviews and reported through the QAPI and reviewed with the Clinical Director. There was no evidence found to show that the patient had an EKG done or that he was placed FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 7 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 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 (X5) COMPLETION DATE A2406 Continued: A2406 Continued From page 7 on cardiac monitoring or had his cardiac status evaluated with a history of cardiac/cardiovascular diagnoses. The patient returned to the ED at 3:03 AM with increased symptoms. The hospital failed to ensure the patient's MSE was appropriate and adequate for his presenting signs and symptoms given the patient's history. The hospital did a Root Cause Analysis (RCA) on this patient's care. The only issues identified related to documentation. No Action Plan was developed. On 11/30/16 at 11:30 AM, the care and services provided to this patient were discussed with the Acting Clinical Director (ACD) and the Great Plains Area Office Medical Director. They were in agreement that the patient's care, including the MSE and stabilization, was not adequate. 2. Medical record review for 83 year old patient #24's 11/16/16 ED visit evidenced that the patient presented to the ED at 11:29 AM, was triaged at 11:38 AM as a level 3 ESI rating, and had complaints of "shakes, chills, fever". The patient's vital signs at 11:38 AM were blood pressure (BP) 83/55, pulse (P) 117, respirations (R) 24, temperature (T) 102 degrees Fahrenheit (F), pulse ox (O2) 93, pain level 10 out of 10 with the pain being in the lower back and both sides. The patient indicated that she had not eaten for four days and could not stand. The patient was placed in the waiting room. A2406 i. The credentialing and privileging process was reorganized to ensure collaboration with contract ED medical director for pre-application screening for providers to ensure providers with known quality of care issues will not proceed to full credentialing. ii. The Governing Board received training and coaching by Indian Health Service experts in credentialing and in quality management during GB meetings on 12/14/2016 and 12/21/2016. The ability for accountability and collaborative discussions between the medical executive committee and the Governing Board was modeled and mentored through live credentials reviews. iii. Area Chief Medical Officer, Clinical Director, and Area Director (GB Chair) are monitoring and supporting the revised credentialing process. b. The contract ED Director working with federal medical providers is utilizing a focused trigger tool to screen 100% of charts of patients seen in the ED. Charts that meet high risk criteria are reviewed in detail. Chart reviews began on 12/21/2016. Note: Based on the Emergency Severity Index (ESI), A Triage Tool for Emergency Department FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 8 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 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 (X5) COMPLETION DATE A2406 Continued: A2406 Continued From page 8 Care, Version 4, 2012 Edition, ESI Triage Algorithm "danger zone vitals" (pulse >100 and respiratory rate >20) and severe pain/distress (determined by clinical observation and/or patient rating of greater than or equal to 7 on 0-10 pain scale) should be considered when assigning an ESI level, resulting in a change from a level 3 to a level 2. The next documented vital signs were noted to be at 12:15 PM as BP 85/56, P 119, T 103 F, O2 93, pain 10. At 1:00 PM, the patient was given Tylenol to reduce the fever (one hour and 22 minutes after arriving at the ED and 45 minutes after the patient's temperature increased to 103 F). At 2:00 PM, the patient's vital signs included BP 70/46, P 93, R 24, T 98.3, pain 8. There was no evidence that the provider was notified of the lower BP. At 2:07 PM, only the patient's T was taken (98.9 F). The next documented vital signs were noted at 4:00 PM, BP 103/53, P 77, R 22, T 97.7, O2 94, and pain 0 (2 hours after the last full set of vital signs when the patient's BP had dropped and the patient's pain level was 8). The RN nursing assessment note was timed at 2:00 PM. The patient was assessed to be "alert, oriented", but to have labored effort breathing. The patient had the following procedures: a. Cardiac monitoring started at 2:00 PM, b. Oxygen at 6 liters/min via nasal cannula started at 2:00 PM, c. EKG done at 3:00 PM, d. Two IV accesses started (2:50 PM and 3:00 PM), e. Chest xray in bed at 3:08 PM, f. Foley catheter inserted at 3:14 PM, and g. Specimens of blood and urine sent to the lab. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 A2406 i. ii. iii. c. Initial triggers include transfers, intubations, admissions, blood transfusions, codes, labor and deliveries, and patients triaged with an ESI 1&2. Every patient visit reviewed will be assessed to ensure MSE’s are adequate, and standards of care are met. Feedback and corrections will be made through direct supervision of staff, through Medical Executive Committee, and through weekday QAPI meeting and morning reports. Corrections needed during the weekend will be addressed by contract ED directors and administrators on call. Responsible party: Contract ED Director and Clinical Director Orientation and onboarding processes have been improved for providers beginning to work in the ED. i. The contract Medical Director or designee has been onsite fulltime since 12/1/2016, and is providing direct observation and feedback to the ED providers. ii. The PRH CD added policies, procedures, and competency validation to the ED medical staff orientation process for new providers to PRH. Facility ID: 430081 If continuation sheet Page 9 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION i. ii. NAME OF PROVIDER OR SUPPLIER BUILDING WING STREET ADDRESS, CITY, STATE, ZIP CODE C 12/01/2016 HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED PINE RIDGE, SD 57770 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 (X5) COMPLETION DATE A2406 Continued: A2406 Continued From page 9 A2406 The patient's MSE was done by a provider (Physician Assistant) (PA-C) at 2:41 PM (3 hours and 12 minutes after the patient was signed into the ED). The history of the present illness was "fever, patient started to have altered mental status while waiting in the ER. She had 650 mg of Tylenol while in the waiting area, and fever came down. She has a history of urosepsis. Brought back to available bed, blood pressure low, unable to answer questions due to her mental status." The PA-C's review of systems indicated that the "patient was unable to answer questions", but the general exam noted "alert to voice, able to answer questions, and then nods off, ...in no acute distress.." Glasgow Coma Scale (GCS) score was 12. The assessment and plan was ")1 Low blood pressure, 2) Fever - 102 at presentation, 3) Septic shock." The patient was transferred to a hospital in Rapid City via a helicopter at 4:10 PM. The nurse noted at 7:46 PM that "Ceftraixone 2 GM was not administered in the hospital. Pt was administered antibiotics on the way to Rapid City by (name ) Air team." 3. Medical record review for 28 year old patient #15's 8/24/16 ED visit evidenced that the patient presented to the ED at 6:28 PM, was triaged at 6:35 PM as a level 4 ESI rating, and had complaints of "mostly likely concussion...Wake up left jaw hurting, been sleeping a lot, really not sure what happened to him". The patient's vital signs at 6:35 PM were blood pressure (BP) 155/97, pulse (P) 60, respirations (R) 18, temperature (T) 99.5 degrees Fahrenheit (F), pulse ox (O2) 99, pain level 8 out FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 iii. iv. v. A Clinical Applications Coordinator (CAC) has been made available to ED providers during their first shifts in the ED to provide orientation and oneon-one coaching on the use of the Electronic Health Records. Focused trigger tool review 100% of high risk charts will be used to document effectiveness of the providers’ use of the Electronic Health Record. The CAC is available for additional one-onone support for any issues identified. Responsible party: the PRH CD and the ED contract medical director. II. Nursing Competency a.Nurses performing triage are using Emergency Severity Index (ESI) for severity scoring, are competent. Performance is monitored through direct observation, chart reviews, and this is reported through QAPI. i. Contract Chief Nursing Officer (CNO) is currently onsite and is conducting daily validation of ESI competencies through chart review and real time observation. CNO is certified to perform ESI through ESITriage.com and has extensive experience with triage. Facility ID: 430081 If continuation sheet Page 10 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 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 (X5) COMPLETION DATE A2406 Continued: A2406 Continued From page 10 of 10. The patient was placed in the waiting room. Review of the ER Nursing note for this patient evidenced that at 8:40 PM (2 hours and 12 minutes after arriving in the ED) the patient's ESI rate was changed to a 2 and he was taken to the ER trauma room and T-sheet for Altered Mental Status Complaints was started. The patient was assessed to have bradycardia with unsteady gait. The patient had an IV started, labs drawn, CT done. The final set of vitals was done at 10:30 PM and included BP 138/86, P 66, R 20, T 99.2, O2 100, pain 0, GCS 15. Review of the patient's Physician ED note revealed an HPI of "Arrived via POV. States was intoxicated 4 days ago and was assaulted on the left side of his head. Girlfriend states that he has not been acting normally since then and has vomited several times over the past few days. Patient does complain of a headache and has been taking acteaminophen without relief. Finally came in tonight because he wasn't getting any better." The MSE done by the provider included the following: Review of system: GI: poor appetite and frequent vomiting; Neuro: headache on the left side, some staggering of his gait; Psych: girlfriend states he has been acting abnormally. Physical exam: General: alert. Palpable hematoma mostly over the left temporal region tender to touch. No overt bony deformity. Psych: mentation slow and patient has to think about his answers. when left alone, he is restless in bed rolling over frequently - cannot lie still. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 A2406 ii. Nurses that have demonstrated ESI competence and have a minimum of two years of ED experience will be prioritized to staff the triage role in scheduling by 12/21/2016. iii. All current ED Nursing Staff will complete ESI online course through ESITriage.com by 12/31/2016. Any staff not scheduled through 12/31/2016 will complete before their next shift. Certifications of completion will be kept in the individual nursing files. iv. Assessment and evaluation will be discussed in daily Emergency Services QAPI meeting. Corrective actions are being assigned in QAPI meeting. v. Responsible party: Director of Nursing and contract ED Nursing Officer. b. Training for nurses to ensure competency in neurological exams, cardiac monitoring, medication management, and vital signs will be assured. i. All ED staff nurses will complete neurological exam training through the PRH online training system by 12/30/2016 to ensure staff are trained in the requirements of a complete neurological exam, documentation, and appropriate monitoring. Certifications of completion will be kept in the individual nursing file. Facility ID: 430081 If continuation sheet Page 11 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 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 (X5) COMPLETION DATE A2406 Continued: A2406 Continued From page 11 A2406 Review of the patient's CT of head without contrast report as summarized by the physician revealed a large left frontal intraparenchymal bleed with large amount of edema; small subdural and small SAH (subarachnoid hemorrhage) also. Small right shift. The physician's assessment and plan was "intracranial hemorrhage following injury with brief loss of consciousness". The physician noted that the patient was transferred to Rapid City hospital in serious condition. The patient's medical record documentation included two sets of vital signs, one at triage and one at discharge. An EKG was done at 9:24 PM. No other evidence of cardiac monitoring was found in the record. On 11/30/16 at 11:30 AM, the care and services provided to this patient were discussed with the Acting Clinical Director (ACD) and the Great Plains Area Office Medical Director. They were in agreement that the patient's MSE was not adequate. 4. Patient #16 presented to the ED on 9/8/2016 at 16:17 (4:17 PM) by POV. The ED triage note identified the patient was screened at 16:31 (4:31 PM). "Patient is a 44 yr. old male who presents with lower back pain x 2 days, pt. c/o SOB/lightheaded". Chief complaint; CHF, side hurts." The Vital Signs included, "B/P 167/105, pulse 98, Respiration 20, Temperature FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 ii. All ED nursing staff will be retrained on the cardiac monitoring policy with an emphasis on expectations of monitoring strip frequency and conditions requiring cardiac monitoring by 12/23/2016. iii. Competency Assessment for Nursing Staff regarding recognition of abnormal vital signs and initial/ongoing interventions expected which mirrors the Assessment/Reassessment in ED Policy. iv. Responsible party: Director of Nursing and contract ED Nursing Officer. III. Clinical Documentation Improvement Training and Orientation a. Training for improvement of clinical documentation in the Electronic Health Record began 12/19/2016 for clinicians and nurses and will be completed for all nursing and provider staff. i. CD and PRH Director of Nursing are tracking attendance and post-test validation for staff in training the week of 12/19/2016 Facility ID: 430081 If continuation sheet Page 12 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2406 Continued From page 12 98.6 F and pain of 9." The patient was triaged as level 3 (urgent). The next indication of vital signs was a monitoring form at 18:43 (6:43 PM) two hours after being screened, which showed the patient's B/P was 180/122, HR 88 and O2 sat 97%. The next time on the monitoring form was at 19:42 (7:42 PM) over an hour later, B/P was 184/120, HR 90 and O2 sat 97%. [Note: This patient's blood pressure indicated a hypertensive crisis which is a severe increase in blood pressure that can lead to a stroke. Extremely high blood pressure - a top number (systolic pressure) of 180 millimeters of mercury (mm Hg) or higher or a bottom number (diastolic pressure) of 120 mm Hg or higher can cause damage blood vessels. An emergency hypertensive crisis can be associated with life-threatening complications.] The patient's record did not show a provider time or time in which the MSE was completed. The ED nursing notes at 19:00 (7:00 PM) included,"Pt. reports presents to ED w/c/o R sided flank pain that begins in front, radiates to Back. Pt. states feels like kidney pain. Pt. reports to this RN has hx of CHF. Dr.( name) called by pt. prior to arrival at ED. Dr.( name) at bedside at 1900." [Note: This was not the provider seeing patient's in the ED, however first indication the patient was seen by a provider, over three hours after presenting to ED.] The ED nursing notes also showed cardiac monitoring was not started until 19:40 (7:40 PM) FORM CMS-2567(02-99) Previous Versions Obsolete C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING Event ID: 93MX11 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE A2406 Continued: ii. PRH Director of Nursing and A2406 Contract CNO and contract will present course on the PRH online training system for all new and rotating clinical staff. Improvement in documentation iii. will be validated through chart review and OPPE. IV. Ventilation Management i. The on call CRNA is providing emergent management of airways and ventilation in the ED until capabilities of physicians and nursing competencies are validated. i. Preparations for ventilation management by nurses are underway through training on basic principles related to monitoring patients on a ventilator. This was assigned on 12/15/2016 and is in the process of being provided through a PRH online training system course. This curriculum will be completed by 12/31/2016 by medical and nursing staff and includes assessment, interventions, and documentation. Any staff not scheduled through 12/31/2016 will complete before their next shift. V. Quality Assessment/Performance Improvement a.Data is being used to identify opportunities for improvements and make improvements that are data driven. The Phoenix ED Dashboard was installed on 12/9/2016 and leadership began utilizing the data available. This dashboard provided Facility ID: 430081 If continuation sheet Page 13 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 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 (X5) COMPLETION DATE A2406 Continued: A2406 Continued From page 13 and EKG had not been done until 19:21 (7:21 PM). The note from the ED provider dated 9/10/16 (2 days later) at 13:27 (1:27 PM) stated,"Patient has emergent HTN 194/146, Dr.( name) has ordered medication for the patient, after consulting Dr.( name) advised labatalol be given to lower BP, 20:50 (8:50 PM)." The record showed labatalol (for hypertension) was given at 21:09 (9:09 PM) as well as other medication including Bumex (diuretic) and morphine for pain before being transferred out of the facility by Marc Air at 10:30 PM. 5. Patient #3 was brought in by ambulance on 8/4/2016 at 16:12 (4:12 PM). Patient is a 38 yr. old male who was assaulted last night and lost consciousness x 4 hours. Pain to left side and pelvis. ED triage note identified the patient was screened at 16:10 (?). Chief complaint; assaulted. The patient's first vital signs were at 17:13 (5:13 PM) over an hour after the patient was brought to the ED by ambulance. Vital signs included, "Temperature 99 F, pulse 92, Respiration 20, B/P 129/91, and O2 sat 97 %." The patient was triaged as level 3 (urgent). [Note: The patient's pain was noted as 5 however the date was from previous admit of July 27, 2016. The patient's current admission showed his pain not assessed by the nurse until 19:19 (7:19 PM three hours after admission) as a 7.] FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 A2406 data for leadership that allowed them to adjust ED Provider schedules to align scheduling with the highest demand times. Data from this dashboard will be used and improved to ensure safe care. QAPI Supervisor is responsible for making a printout available to leadership on a weekly basis. b. The PRH Root Cause Analysis process and follow-up activity were reviewed by IHS Quality Management Consultant on 12/19/2016 to identify outstanding and open items. The majority of the open items identified are being addressed through this Corrective Action Plan. Open items not specifically addressed will be tracked and completed by QAPI Supervisor. i. Root Cause Analysis on patient #26 with visit date 10/6/2016 was initiated and action items will be identified by 12/23/2016. Action items will be tracked through daily ED QAPI Meeting. c. 100% of charts are being screened for high acuity and high risk conditions with detailed review of nursing documentation related to ESI level, vital signs assessment/interventions, and adherence to the cardiac monitoring. Opportunities for improvement will be reported and evaluated in Emergency Services QAPI meeting. Facility ID: 430081 If continuation sheet Page 14 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2406 Continued From page 14 -ED provider's note showed the MSE was done at 16:25 (4:25 PM) which stated, "Patient states he was assaulted by gang last night. He was kicked and stomped; no other weapons used. He has pain in left posterior flank increased with respiration. Also left upper posterior pelvis. He says his urine has been bloody." The review of systems noted c/o of chest pain, hematuria and pain. Howvever, there was no evidence of a cardiac monitoring with the patient complaining of chest pain. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2406 The ED note showed the patient went to CT at 17:15 (5:15 PM) and IV of lactated ringers was started at 17:35 (5:35 PM). CT of head, thorax, abdomen and pelvis were completed. CT showed hemoperitoneum with solid organ injury suspected and left rib fractures. The patient went from 17:40 until 18:23 without vital signs documented even when morphine 2 mg IV push for pain at 17:59 (5:59 PM). At 19:28 (7:28 PM) "VS 98.6, 96, 18 , 119/84 , 96% RA, pt. reports 7/10 left lateral aspect of chest ribs, pain with deep breaths and left back/kidney pain. IV LR 200 ml/hr infusing well." At 19:45 (7:45 PM) Urine output 700 ml blood in urine. At 20:00 (8:00 PM) 131/93, 93, 18 , 97% RA pt. reports 7/10 left lateral aspect of chest ribs, pt. in bed HOB elevated no acute distress. The patient was given morphine 4 mg IV push at 21:01 (9:01 PM) for 6 of 10 pain left lateral aspect of chest/ribs. The patient was then FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 15 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2406 Continued From page 15 transferred to Rapid City Regional Hospital at 21:10 (9:10 PM) with condition at time of transfer as "Stable - High risk". PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2406 [Reference note Wikipedia: Hemoperitoneum is the presence of blood in the peritoneal cavity. The blood accumulates in the space between the inner lining of the abdominal wall and the internal abdominal organs. Hemoperitoneum is generally classified as a surgical emergency; in most cases, urgent laparotomy is needed to identify and control the source of the bleeding. In selected cases, careful observation may be permissible. The abdominal cavity is highly distensible and may easily hold greater than five liters of blood, or more than the entire circulating blood volume for an average-sized individual. Therefore, large-scale or rapid blood loss into the abdomen will reliably induce hemorrhagic shock and, if untreated, may rapidly lead to death.] 6. Patient #8 was brought in by ambulance on 9/4/2016 at 2:52 AM from a motor vehicle accident. -ED triage note identified the patient was screened at 3:37 AM, "Patient is 48 yr. old female who presents with passenger in one car roll over. Was not restrained and was thrown from vehicle. She is complaining of pain to left chest and head. Remains on back board with c spine immobilization." Vital signs-B/P 139/88, P 90, R 18, T 97.8 F, pain 10. Patient triaged at level 2 (emergent). Chief complaint as: "MVA (motor vehicle accident). The nurse identified wounds to left foot and right forehead. The wound descriptions included, "very large from mid forehead at hairline to right ear and right forehead -reported FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 16 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2406 Continued From page 16 to be avulsion." The head wound was as reported from EMS. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2406 This patient was never placed on a cardiac monitor. -ED provider's note stated provider arrived at bedside at 2:50 (arrival). "patient brought by EMS on stretcher with neck brace after patient was involved in motor vehicle accident tonight. Admitted she was not wearing seat belt when the vehicle she was a passenger in flipped in construction site and was ejected from the vehicle. patient did not remember if she has loss of consciousness. Patient complained of left chest pain at this time." The provider review of systems noted, "admitted scalp pain wrapped with gauze. Scalp laceration wide from midline to ear." There was no evidence that the provider actual examined the patient's head wounds until 5:40 AM when the patient was removed from C spine immobilization and backboard. The patient went to CT scan at 4:00 AM. A CT of head, neck, chest, abdomen and pelvis was ordered and completed which showed acute displaced fractures axillary rib 3rd to 8th. Small 10 % left pneumothorax (collapsed lung), bilateral basilar pulmonary contusions and air densities in bladder. The medical record showed that from 3:27 AM until 4:47 AM there were no vital signs documented with Morphine 4 mg given IVP at 3:45 AM for pain of 10. No vital signs at 4:00 AM before going to CT or 4:22 AM when she FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 17 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2406 Continued From page 17 returned from CT until 4:47 AM. The facility failed to provide timely monitoring for this patient. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2406 At 4:22 AM "returned from CT via stretcher. Patient continues to complain of pain 10/10. At 4:45 AM Several wounds cleansed with warm soapy water, as time permitted. Tolerates well and noted to have more bruising than abrasions to extremities. At 5:00 AM Morphine 4 mg IVP at 4:48 AM with good results. pain decreased to 8/10. At 5:14 AM Patient states her pain has returned to 10/10. At 5:40 AM "ER MD to see patient. Re-examination done. Discussed options for plan of care. Uncovered head wound after removing Cspine immobilization and backboard. Very large laceration to forehead at hairline from middle of forehead extending toward the right ear. Wound is oozing blood, no profuse bleeding noted. ER MD applied DSD and Kerlix wrap. He will call surgeon for consult." The patient was then noted to be seen by surgeon and agreed the patient needed to be transferred. The surgeon identified the patient scalp wound as "large 20 cm scalp laceration to right parietal." The patient was given Fentanyl 50 mcg IVP at 6:20 then transferred to Rapid City Regional Hospital by Marc Air at 7:13 AM with condition as guarded. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 18 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2406 Continued From page 18 7. Patient #8 presented to the ED on 9/18/2016 at 21:51 (9:51 PM) by POV. ED triage note identified the patient was screened at 22:38 (10:38 PM). Chief complaint as: Patient had a MVA on 9/5/16 where she was ejected out of the car and she has been in at RCRH (hospital). Hx of IDDM, CHF, & COPD. Has some broken ribs on the left and staples on her head and face. Main complaint is 3-4+ edema in the lower extremities and feels bloated. VS are stable. Has been out of the RCRH since the 15th released two days ago. Hard time breathing. " Vital signs-B/P 148/94, P 75, R 22, T 98.8 F, pain 7. Patient triaged at level 3 (urgent). PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2406 At 23:11 (11:11 PM) the patient was placed in bay 4 in the ED with complaints of pain at severity of 10 left side of chest and provider notified. -ED provider noted MSE at 23: 20 (11:20 PM) and noted, "48 y/o female with Hx of MVA on Sep 4, transferred to Rapid due to lt ribs fractures, D/C on sep.13 under pain medication (Percocet), pt. revisit ER to be evaluated due feel abdominal bloating, pt. is cooperative, alert, active, oriented with stable vital signs and no respiratory distress or neurological deficit, also report lt. costal pain 2/10. Auscultation is decreased at that side, symptomatic treatment will be provide to get pt. comfort and improve her respirations due are shallow related to ribs fracture, X-ray will be ordered to assess her abdominal gas pattern and lung field." No labs were ordered. The provider noted left side decreased auscultation with shallow respirations on exam. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 19 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2406 Continued From page 19 A review of the "Vital signs Summary" sheets showed the patient was not placed on the monitor until 23:30 (11:30 PM). It showed B/P 160/74, HR 74 and O2 saturation at 85%. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2406 The next entry was 1:00 AM (one and a half hours later), B/P 142/62, HR 77 and O2 saturation at 83%. ED nursing note showed this patient was not provided oxygen until 1:35 AM. "Oxygen placed at 2 liters per minute via Nasal Cannula with order to maintain O2% over 92%". The provider assessment and plan noted, " ... X-ray showed pulmonary contusion at left lung up to middle level, the progression of that can't be estimated and with clinical presentation is granted to be transported to Rapid for reevaluation." The patient was then transferred to Rapid City Regional Hospital by Marc Air at 3:12 AM. Review of the medical record from RCRH noted that in the " emergency department chest x-ray showed a large left pleural effusion with significant left sided atelectasis. Chest tube was placed with return of 1500 ml of serosanguineous fluid. ..She is extremely uncomfortable due to her chest tube but says that her breathing is significantly improved. Her hemoglobin is 6.7 and she received 2 units of PRBCs ... " 8. Patient #1 presented to the ED on 9/11/2016 at 13:45 (1:45 PM) by POV and was triaged as a level 2 (emergent). However there was no MSE provided for a patient triaged at level 2. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 20 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2406 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 A2406 The ED triage note identified the patient was screened at 14:14 (2:14 PM). Pt. is a 90 yr. old female. Chief complaint as; "Daughter states pt. has not been feeling well for 2 days. Today pt. c/o nausea, has been throwing up unable to keep anything down, c/o back and chest pain. Pt. is a 90 yr. old female. Vital signs at 14:19 (2:19 PM) included, "Temperature 101.2 F, B/P 210/82, pulse 101, Respiration 26, and pain of 10." The patient was left in the lobby and not taken back to an ED room. There was no documentation the patient was monitored or checked on again until 15:39 (3:39 PM) an hour and 20 minutes later. It was at that time the ED nurse documented, "Pt. not found in the ED lobby/hospital main lobby /OPC, called three times considered LWBS (left without being seen)." A complainant expressed concerns with lack of care by the ED staff and reported this patient was taken by family to another ED for care. Review of another area hospital record showed the pt. presented to the ED on 9/11/2016 at 15:59 (3:59 PM) where the patient was treated for dehydration, hypokalemia, pneumonia and exacerbation of COPD. The facility failed to ensure MSEs were provided which were appropriate to the individuals presenting signs and symptoms. The medical records did not reflect continued monitoring according to the individual needs prior to discharge or transfer. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 21 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 489.24(d)(1-3) STABILIZING TREATMENT (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either(i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 A2407- The hospital ensures appropriate and adequate stabilization and treatment. The hospital is working diligently to improve processes and care provided in the ED. Collaboration between the contracted vendor and the PRH staff provides quality oversight for care provided in the ED. Plan of correction, Procedure, Monitoring and Responsible Party: I. Medical Quality Oversight a.Blood is administered in a safe manner. i. ED Nursing was trained on the blood administration requirements and documentation on 11/9/2016. This training will be held again on 12/23/2016 for nurses who did not attend the first training and for newly hired nurses. ii. ED Nurse Supervisor is performing 100% chart reviews to ensure compliance with policy and documentation that is required in the administration of blood. Results of this review will be provided to the daily ED QAPI meeting and reported through the Blood Utilization Review Committee. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 22 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 22 individual (or a person acting on the individual's behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual's behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual's written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This STANDARD is not met as evidenced by: Based on medical record reviews, policy/administrative record review and staff interviews, it was determined the Hospital failed to ensure the patient's EMC was stabilized prior to discharge/transfer for 7 of 29 patients (#14, #26, #2, #11, #12, #18, and #29) reviewed who presented to the ED for care and services. The failure to perform appropriate, adequate stabilization and treatment resulted in immediate jeopardy findings. The findings included: 1. Medical record review for patient #26 evidenced two ED visits: a. On 10/6/2016 at 14:35 (2:35 PM) patient #26 was brought into the ED (emergency department) ambulance with major trauma and triaged as a level 1(requires immediate life-saving intervention). FORM CMS-2567(02-99) Previous Versions Obsolete C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING Event ID: 93MX11 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE A2407 Continued: iii. Clinical Director will develop by A2407 12/30/2016 a standardized medical staff agenda that schedules out set times for required reporting by medical staff committees and quality functions that will include reporting by the Blood Utilization Review Committee b. Physicians caring for patients in the ED and performing stabilization are qualified and performance is monitored through direct observation, chart reviews, and reported through QAPI and reviews with the Clinical Director. i. The credentialing and privileging process was reorganized to ensure collaboration with contract ED medical director for pre-application screening for providers to ensure providers with known quality of care issues will not proceed to full credentialing. ii. Review and approval of privileges is more reliable following training and coaching with the governing board by an Indian Health Service expert in credentialing and an IHS Quality Management Consultant during GB meetings on 12/14/2016 and 12/21/2016. The ability for accountability and collaborative discussions between the medical executive committee and the Governing Board was modeled and mentored through live credentials reviews. Facility ID: 430081 If continuation sheet Page 23 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION i. ii. NAME OF PROVIDER OR SUPPLIER BUILDING WING STREET ADDRESS, CITY, STATE, ZIP CODE C 12/01/2016 HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED PINE RIDGE, SD 57770 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 (X5) COMPLETION DATE A2407 Continued: A2407 Continued From page 23 A2407 The ED triage note identified the chief complaint as; "bilateral tib fib fractures, right tib fib open fracture, left tib fib closed, lung contusion, left ribs 3-5 fractured, scalp laceration." The initial vital signs at 14:35 were temperature (T) 96 degrees Fahrenheit (F), pulse (P) 152, respirations (R) 24, blood pressure (BP) 126/33, and pain level 10 out of 10. The ED provider noted the following; "Patient initially presented on backboard. No C collar, C-collar reported not to fit. Patient was breathing spontaneously fertilize (sp) complaint of back pain and shortness of breath. Patient had spontaneous speech with complaints other times was arousable. Did not respond appropriately to questions. Initial O2 sats were 100% with tachycardia. Initial exam showed blood in the hair, traces of blood in the nares lungs have distant breath sounds due to body habitus. Heart had a regular rhythm, abdomen soft. Extremities notable for pallor of the feet bilaterally. Evidence bilateral tib-fib fractures with large laceration probable compound fracture off the right. Chest X-ray showed multiple rib fractures and left lung contusion. Due to decreasing mental status and dropping O2 sats patient was intubated. A right subclavian line was placed without difficulty. Chest X-ray showed ET tube and central line to be adequate position. Patient was given crystalloid 4 tachycardia and dropping blood pressure. She was also given 4 units of packed cells. On placement of Foley blood was noted in vagina. An AP film was obtained of the pelvis which showed a bony structure to be without evidence of fracture or displacement. Urine was clear. With fluid recess sedation her heart rate FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 iii. c. Area Chief Medical Officer, Clinical Director, and Area Director (GB Chair) are monitoring and supporting the revised credentialing process. The contract ED Director working with federal medical providers is utilizing a focused trigger tool to screen 100% of charts of patients seen in the ED. Charts that meet high risk criteria are reviewed in detail. Chart reviews began on 12/21/2016. i. Initial triggers include transfers, intubations, admissions, blood transfusions, codes, labor and deliveries, and patients triaged with an ESI 1&2. ii. Every patient visit reviewed will be assessed to ensure stabilizing treatment of an emergency medical condition are adequate, and standards of care are met. Feedback and corrections will be made through direct supervision of staff, through Medical Executive Committee, and through weekday QAPI meeting and morning reports. Corrections needed during the weekend will be addressed by contract ED directors and administrators on call. iii. Responsible party: Contract ED Director and Clinical Director. Facility ID: 430081 If continuation sheet Page 24 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 24 which was 150 was brought down to 100 with blood pressure of 84/42 O2 sats 87. She was felt stable for transfer to Rapid City Regional in guarded condition." Review of the "Critical Flow Sheet" by nursing showed that five liters of Normal Saline had been started however the physician order was for LR (lactated ringers). The flow sheet did show when the second, third and fourth unit of blood was started. It did not show when the first unit of blood was started. The flow sheet did not indicate what units were actually transfused. A note documented under intake stated that four units of blood started and two units of blood finished. The review of the "Blood or blood component transfusion" sheets were review with (IHS Area Office) RN. It showed four units of blood had been checked out and one unit returned not used. It was difficult to determine what or when the blood was actually transfused. Review of the laboratory report at 15:12 (3:12 PM) identified low values which included the patient's HGB at 7.3 and HCT at 27.2. Review of the "Critical Flow Sheet" by the CRNA showed he administered medications and intubated the patient. The CRNA wrote a narrative but did not document the patient's vital signs, times of medication administration or lung assessment when the patient was turned over to transport team. Review of the X-ray reports showed that "AP portable supine chest" was completed times two and reports verified by the radiologist at 17:30 (5:30 PM) after the patients transfer out of the facility. The second chest x-ray included; FORM CMS-2567(02-99) Previous Versions Obsolete C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING Event ID: 93MX11 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE d. Orientation and onboarding processes have been improved for providers A2407 beginning to work in the ED. i. The contract Medical Director or designee has been onsite fulltime since 12/1/2016, and is providing direct observation and feedback to the ED providers. ii. The PRH CD added policies, procedures, and competency validation to the ED medical staff orientation process for new providers to PRH. iii. A Clinical Applications Coordinator (CAC) has been made available to ED providers during their first shifts in the ED to provide orientation and oneon-one coaching on the use of the Electronic Health Records. iv. Focused trigger tool review 100% of high risk charts will be used to document effectiveness of the providers’ use of the Electronic Health Record. The CAC is available for additional one-onone support for any issues identified. v. Responsible party: the PRH CD and the ED contract medical director. II. Nursing Competency a. Nurses performing triage are using Emergency Severity Index (ESI) for severity scoring, are competent. Performance is monitored through direct observation, chart reviews, and this is reported through QAPI. Facility ID: 430081 If continuation sheet Page 25 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE i. A2407 Continued From page 25 "...multiple left rib fractures are seen. These are seen involving at least the left third, fourth and sixth ribs. Left rib films are recommended. A flail chest cannot be excluded. There is artifact from the backboard present in the region of at least the left sixth rib. Increased interstitial opacity is seen in the left lung suggestive of pulmonary contusion. No definite pneumothorax is seen." Review of the Out-of-Hospital Transfer Record for the transfer to Rapid City Regional Hospital showed the patient left at 16:35 (4:35 PM) with condition at time of transfer as "Stable". SECOND ED VISIT for patient #26: b. On 10/6/2016 at 16:46 (4:46 PM) eleven minutes after leaving the ED the patient is brought back to the ED with CPR (cardio pulmonary resuscitation) in progress and a code was initiated in the ED. A review "Critical Flow Sheet" marked as Code Sheet showed treatment which included bilateral needle decompression, bilateral chest tubes and periocardiocentesis. The patient expired at 17:08 (5:08 PM). On 11/30/15 in an interview with the Director of Nursing, the patient's care in the ED was discussed and confirmed missing documentation physician orders not followed. On 12/1/16 in an interview with the Clinical ED Director, Director of Nursing, the patient's care in the ED was discussed. A Root Cause Analysis (RCA) had not been done by the Hospital to review the patient's care. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Contract Chief Nursing Officer (CNO) is currently onsite and is A2407 conducting daily validation of ESI competencies through chart review and real time observation. CNO is certified to perform ESI through ESITriage.com and has extensive experience with triage. ii. Nurses that have demonstrated ESI competence and have a minimum of two years of ED experience will be prioritized to staff the triage role in scheduling by 12/21/2016. iii. All current ED Nursing Staff will complete ESI online course through ESITriage.com by 12/31/2016. Any staff not scheduled through 12/31/2016 will complete before their next shift. Certifications of completion will be kept in the individual nursing files. iv. Assessment and evaluation will be discussed in daily Emergency Services QAPI meeting. Corrective actions are being assigned in QAPI meeting. v. Responsible party: DON contract ED Nursing Officer. b. Training for nurses to ensure competency in neurological exams, cardiac monitoring, medication management, and vital signs will be assured. i. All ED staff nurses will complete neurological exam training through the PRH online training system by 12/30/2016 to ensure staff are trained in the requirements of a complete Facility ID: 430081 If continuation sheet Page 26 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 26 2. Medical record review for patient #2 evidenced two ED visits: a. On 9/10/2016 at 4:54 AM patient #2 was brought into the ED (emergency department) by ambulance. The ambulance report identified the patient as being in respiratory failure with oxygen saturation at 41% with gasping respirations and history of stage 4 emphysema. It identified the patient being bagged until several miles out from the hospital, during which patient became responsive. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG neurological exam, documentation, and appropriate monitoring. Certifications of completion will be kept in the individual nursing file. A2407 ii. iii. -The ED nursing note identified chief complaint as unconscious and unresponsive and triaged the patient as a level 2 (emergent). [Note: Interview with the DON on 11/30/16 confirmed the patient should having been triaged at level 1(requires immediate life-saving intervention.] The ED triage note showed that the following: At 5:05 AM triaged however no vital signs documented. At 523 AM CT scan of head completed [Note: There was no documentation of the patient's care and monitoring during the CT scan completed at 5:23 AM.] (X5) COMPLETION DATE iv. All ED nursing staff will be retrained on the cardiac monitoring policy with an emphasis on expectations of monitoring strip frequency and conditions requiring cardiac monitoring by 12/23/2016. Competency Assessment for Nursing Staff regarding recognition of abnormal vital signs and initial/ongoing interventions expected which mirrors the Assessment/Reassessment in ED Policy. Responsible party: Director of Nursing and contract ED Nursing Officer. III. The PRH hospital ensures that all patients who are transported from the ED to other departments, including radiology are safe and accompanied by an appropriate staff member. At 5:26 AM NRM (non rebreather mask) placed at 50%. At 5:34 AM patient on cardiac monitoring and EKG completed noted " T-wave abnormality, consider inferior ischemia, abnormal ECG". -Review of the "Vital Signs Summary" sheets which showed the patient's first monitoring at 5:59 AM (one hour and four minutes after arriving FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 27 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 27 in the ED with B/P 98/70, HR 94, RR16 and no O2 saturation. Then 15 minute vital signs summary noted at 6:16 AM to 7:12 AM. At 7:12 AM there was noted drop in vital signs with BP 92/61, HR 85, RR 17 and O2 100%. The next vital sign on the summary sheet was at 8:04 AM (52 minutes later), BP 72/43, HR 78, RR 10 and O2 100%. -The addendums to the ED nurses notes showed the patient was given multiple medications for intubation, intubated, placed on a ventilator and given medications for low blood pressure. It also noted multiple ventilator changes before switching over to transport teams ventilator at 8:35 AM. However, there was no documentation to show who was monitoring the patient while he was on the ventilator in the ED. "At 07:54 assistance to provider intubation, pt. intubated per Dr. ( name) with 7.5 ETT at 23 cm at lip line. ETT secured with Thomas Tube Holder, confirmed with breath sounds equal and clear bilateral with bilateral chest rise. CO2 detector +color change /yellow. Pt. connected to ventilator settings TV/200, O2/100%, RR/14, PEEP/5. PCXR (portable chest X-ray) obtained. " Additional addendums showed the patient was started on a Dopamine drip at 7:36 AM, and Vecuronium 10 mg, Succinycholine 100 mg IV push at 7:46 AM and Levophed drip at 8:02 AM by the nurse. ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE a. The CEO sent a directive on 12/21/2016 to ED staff that all A2407 patients who need to be transported to another department will be accompanied by an appropriate staff member. b. The contracted charge nurse will ensure that all patients transported from the ED will be accompanied by an appropriate staff member. c. A Safe Monitoring of Interdepartmental Patient Movement Policy will be developed and submitted for approval by 12/23/2016. IV. Clinical Documentation Improvement Training and Orientation a. Training for improvement of clinical documentation in the Electronic Health Record began 12/19/2016 for clinicians and nurses and will be completed for all nursing and provider staff. i. CD and PRH Director of Nursing are tracking attendance and post-test validation for staff in training the week of 12/19/2016 ii. PRH Director of Nursing and contract CNO will require completion of online course on the PRH online training system for all new and rotating clinical staff iii. Improvement in documentation will be validated through chart review and OPPE. -Review of the provider note included; "Visit FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 28 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 28 diagnoses: respiratory failure, cardiogenic shock, non-ST elevation infarct. " "Clinical course: ... Duoneb treatment given. CXR reflects images suggestive of infiltrate, No cardiomegaly or effusions. EKG No acute ST segment elevations. Head CT Scan: No acute IC pathology. Kept with depressed mental status and O2 sat dropped to 88% at room air. Intubated. Prior to intubation, BP was 109/68 and dropped to 70/39. Started on IV Dopamine and Noreinephrine and BP rose to 96/78. Hyperkalemia treated with Dextrose 50% and Reg Insulin 10 units IV. Troponins =0.083, positive for a non-ST elevation infarct. Enoxaparin given ... " The patient was transferred at 8:50 AM and condition at discharge was not completed. [Note: There was also no documentation of the patient's care and monitoring during the CT scan completed at 5:23 AM.] There was no documentation that the CRNA on call was notified to care for the patient while on the ventilator until the patient was transferred out of the ED. Interviews on 11/30/16 revealed that the facility did not have a respiratory therapist and the CRNA was supposed to be called for patient requiring to be put on a ventilator. Additionally there was no documentation that the current ED staff had been trained on the use of the current ventilator equipment. b. Second ED VISIT for patient #2: On 9/22/2016 at 18:51 (6:51 PM) patient #2 was brought into the ED by ambulance in respiratory distress. The ED nursing note identified chief complaint as emphysema and triaged the patient as a level 2 FORM CMS-2567(02-99) Previous Versions Obsolete C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING Event ID: 93MX11 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE V. A Certified Registered Nurse Anesthetist (CRNA) is on call 24 hours, A2407 7 days per week for emergencies in the PRH Operating Room. These CRNAs have been credentialed, are assessed as competent, and are privileged to provide emergent airway management, They are currently providing emergent management of airways in the Emergency Department until capabilities of physicians working in the Emergency Department are confirmed. a. Clinical Director and Chief Executive Officer (CEO) met with CRNAs on 12/08/2016 to review the interim change. b. A schedule for CRNA coverage is provided monthly, and posted in the Emergency Department which began on 12/02/2016. c. Scheduled ED providers and nurses have been instructed by the contract ED Medical Director that the CRNA on call must be called in for any patient who needs Emergent Airway Management. This instruction will be reviewed for any newly scheduled providers or nurses. d. The ED Medical Director will perform 100% chart review of patients requiring Emergent Airway Management and patients being transferred in order to assess for systems issues and failures that may lead to risk and to ensure safe airway management and ventilation. Facility ID: 430081 If continuation sheet Page 29 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 29 (emergent). Initial vital signs included: T 98.4, Pulse 106, RR 22 and Blood pressure 65/40 and oxygen 91% on five liters of O2.[Note: Interview with the DON on 11/30/16 confirmed the patient should having been triaged at level 1(requires immediate life-saving intervention.] Review of the "Vital Signs Summary" sheets which showed the patient's monitoring started at 19:08 (7:08 PM) BP 65/40, HR 104, and O2 91%. Review of the provider note included; "Visit diagnoses: respiratory failure, sepsis, pneumonia. Clinical course; In obvious respiratory failure, intubated, WBC = 24,000, points out a sepsis which is most likely pulmonary. Blood cultures taken, IV Rocephin and Azythromycin given. Head CT Scan: No acute IC pathology. CXR parenchymal infiltrates. Referred to Rapid City, accepted as ICU admission by Dr. ( name)." A review of medications listed as pending included: Flumazenil, Midazolam, Vecuronium 10 mg times two doses, Succinycholine 70 mg IV now for rapid sequence intubation. The review of a portable chest X-ray at 7:44 PM showed it was obtained to evaluate of ET tube placement. However, there was no documentation by nursing that the medications were administered or care provided this patient during or after the intubation. On 11/30/16 interview with the DON confirmed that there were no "T Sheets" or "Critical Care Flow sheets" found for this patient. There was no documentation to show when the patient was FORM CMS-2567(02-99) Previous Versions Obsolete C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING Event ID: 93MX11 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETION DATE e. CRNAs are available for all patients requiring airway management. Policies A2407 will be developed to verify appropriate proficiency for ED physicians. f. Training for ventilation management by nurses is underway through training on basic principles related to monitoring patients on a ventilator was assigned on 12/15/2016 and is in the process of being provided through a PRH online training system course. This curriculum will be completed by 12/31/2016 by medical and nursing staff and includes assessment, interventions, and documentation. Any staff not scheduled through 12/31/2016 will complete before their next shift. g. Policies will be developed to verify appropriate proficiency for ED physicians before CRNAs are no longer called for all patients who need Emergency Airway Management. h. Responsible to implement this Plan of Correction: Clinical Director, Director of Nursing, and contract ED Medical Director. VI. Quality Assessment/Performance Improvement a. Data is being used to identify opportunities for improvements and make improvements that are data driven. The Phoenix ED Dashboard was installed on 12/9/2016 and leadership began utilizing the data available. This dashboard provided data for leadership that allowed them to adjust ED Provider schedules to align scheduling with Facility ID: 430081 If continuation sheet Page 30 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 30 intubated and the care and monitoring that was provided until this patient was transferred out of the facility at 21:30 (9:30 PM). 3. On 9/8/2016 at 10:43 AM patient #11 was brought into the ED by ambulance. -The ED nursing note at 10:43 AM identified chief complaint as combative seizures/biting self and triaged the patient as a level 1 (requires immediate life-saving intervention). Vital signs were Temp 99.3, Pulse 70, RR 24, B/P 150/89 and O2 sat at 96%. O2 on at 15 L/min via BVM and airway identified as abnormal, airway obstructed-fluid /vomit. Cardiac monitoring on at 10:45 AM. However, the first cardiac monitoring strip was at 12:06 when the patient returned from the CT scan by anesthesia. There was no documentation that the patient was on the cardiac monitor when the patient was given medication for sedation or RSI (Rapid sequence intubation) intubation. The other ED nursing notes included: At 11:00 AM 9/8/2016 " Provider assistance: Intubation, intubated Dr. ( name) 7.5 ETT/24 cm at lip line/pt. connected to ventilator/settings; 500 TV/14 rate /100% O2/5 PEEP. " At 11:00 AM 9/8/2016 -16 Fr Foley catheter inserted . PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG A2407 (X5) COMPLETION DATE the highest demand times. Data from this dashboard will be used and improved to ensure safe careQAPI Supervisor is responsible for making a printout available to leadership on a weekly basis. b. The PRH Root Cause Analysis process and follow-up activity were reviewed by IHS Quality Management Consultant on 12/19/2016 to identify outstanding and open items. The majority of the open items identified are being addressed through this Corrective Action Plan. Open items not specifically addressed will be tracked and completed by QAPI Supervisor. i. Root Cause Analysis on patient #26 with visit date 10/6/2016 was initiated and action items will be identified by 12/23/2016. Action items will be tracked through daily ED QAPI Meeting. 100% of charts are being screened for high acuity and high risk conditions with detailed review of nursing documentation related to ESI level, vital signs assessment/interventions, and adherence to the cardiac monitoring. Opportunities for improvement will be reported and evaluated in Emergency c. Services QAPI meeting. At 11:20 AM 9/8/2016 -18 Fr NGT (nasal gastric tube) inserted right nare . At 12:20 PM 9/8/2016 Central line triple lumen placed per Dr. ( name) right femoral area/sterile technique /all three lines with positive blood return/flushed each with 10 ml NS . FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 31 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 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 A2407 At 13:10 (1:20 PM) 9/8/16 bedside report given to Marc transport team/ pt. required multiple doses Fentanyl and Ketamine per Marc team due to bucking the ventilator and MAE. At 13:10 (1:20 PM) 9/8/16 pt. left the ED with Marc transport team in guarded stable. Pt transported to ( name) Hospital ICU via Marc. -Review of the provider note included: Pt. brought in by EMS with AMS, agitation and seven witnessed seizures PTA. Per family and EMS was biting and scratching himself and assaulting other family members. Has Hx of seizures and ETOH abuse, no further history obtainable secondary to clinical scenario. Review of systems; "patient obtunded with intermittent seizure activity and vomiting noted." The provider noted RSI intubation with 7.5 ETT. "... On arrival, pupilary dementia medially, no gag reflex, intubated with 7.5 ETT, given IVF, Kepra, Versed, Propofol and Vecuronium, TLC placed in R groin. Dx Status epilepticus." "Visit diagnoses:Status epilepticus due to generalized idiopathic epilepsy." The provider noted a planned discharge to higher level of care. The provider ordered chest X-ray, CT scan of the head and CBC which were completed. He also ordered a urine drug screen which was not done. -Review of the "Medical Record-Anesthesia" sheet documentation included; "To ED pt. already FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 32 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 32 tubed. Vent managed by ED personnel. Asked to sedate with Propofol gtt once patient adequately sedated. Escorted to CT Scan, continued to manage sedation until returned to trauma bay at 1200." The sheet showed vital signs and vent settings while in anesthesia care from 11:00 AM to 12:00 PM (one hour). PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 Review of the documentation showed when the patient was returned to the trauma bay at 1200 a monitor sheet showed one set of vital signs at 12:04 PM B/P 131/71, HR 113 and O2 sat at 100 %. The next vital signs documented by the nurse was 13:10 PM (over an hour later) at time of discharge. B/P 144/92, HR 99, RR 15, and O2 sat 99% .There was no further documentation by the nurse of the care and monitoring of the patient while on the ventilator when returned to ED from CT scan, such as tidal volume, peak pressure and PEEP. On 11/30/16 interview with the DON confirmed that there were no "T Sheets" or "Critical Care Flow sheets" found for this patient to show care provided. The DON reported that hand written "T Sheets" or "Critical Care Flow" sheets were supposed to be used for patients triaged as level 1 and that new staff in the ED were not always using those forms for documentation. On 11/30/16 interview with the ED nurse supervisor reported that he had not understood the purpose of the use of the form was to keep the nurse at the patient's beside to ensure care while tracking important information. He reported FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 33 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 33 he had not been enforcing the use of the form which was facility procedure/protocol. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 4. Review of the ED log revealed that patient #14 presented to the ED at the following times with the stated complaints, diagnoses, ESI levels, disposition: 9/17/16 at 11:51 PM, arrived via POV with a complaint of "trouble breathing"; ESI 3; diagnosis of "chronic bronchitis"; discharged to home at 2:20 AM. 9/18/16 at 3:00 AM, arrived via POV with a complaint of "can't breathe"; ESI 3; diagnosis of "respiratory failure"; discharged to Marc for transport to Rapid City hospital at 5:20 AM. 9/18/16 at 6:10 AM, arrived via ambulance with Code Blue/respiratory failure; ESI 1; Code Blue stopped at 7:05 AM; expired. Review of the patient's medical record revealed a list of chronic problems, which included cardiomegaly (added 9/28/09), history of cerebrovascular accident (CVA) without residual deficits (12/4/14), essential hypertension (12/4/14), sleep apnea (6/23/14), obesity (12/4/14), CVA (11/15/15), and episodic problems, which included expiratory wheezing (6/8/15), and dyspnea (6/8/15). Review of the patient's provider's note from the ED visit on 9/17/16 at 11:51 PM, evidenced an addendum, timed at 3:27 AM which stated "Patient returned. Treatment re-started. Case discussed with (name) (Hospitalist). Recommended get blood cultures and he will FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 34 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 34 admit to ACN (acute care unit in this hospital)". PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 Medical record review for the 57 year old patient evidenced that when he presented to the ED on 9/18/16 at 3:00 AM, the following assessments/actions occurred: At 3:00 AM, the ER Nursing triage note showed documentation that the patient presented with shortness of breath and chief complaint of "cant breathe"; arrived by POV, Blood pressure (BP) 115/75, O2 saturation 85, pain 0, Pulse (P) 125, Respirations (R) 26, Temperature (T) 98.2. At 3:00 AM, the ER Nursing assessment revealed Shortness of breath; nasal cannula; oxygen placed at 4 liter per minute; breathing labored; diaphoretic; pain of 0; in exam room 18 at 3:00 AM; provider notified at 3:03 AM. At 3:00 AM, "...Pt is resp distress. Pt was seen in ER earlier with same complaints was treated and sent home feeling better. Pt wife states when they got home he got SOB again and did one of his nebs but did not help. Pt is alert and orientated. Lungs are diminished, resp labored and tachypnic. Pt O2 sat on RA 85%. Pt placed on 4L of O2 via NC at this time. Pt is diaphoretic. Pt states he just cant breath. 119/82, 148, 14, 96%." At 3:10 AM, Provider in to see pt. At 3:25 AM Duoneb HHN given. At 3:35 AM 18g saline lock placed to left AC (antecubital). Blood cultures drawn and sent to lab. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 35 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 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 A2407 At 3:45 AM Duoneb HHN given as per ordered. At 3:47 AM Solumedrol 125 mg IVP given as per ordered. At 3:53 AM Ativan 1 mg IVP given as per ordered. At 3:57 AM Terbutaline 0.25 mg SQ given as ordered. At 4:05 AM Albuterol HHN given Pt continues to be SOB. O2 sat 90 - 93% with nonrebreather. At 4:20 AM Pt continues to decompinsate. Decision to intubate pt made. At 4:32 AM veconium 6mg IVP given. At 4:34 SUCC 100 mg IVP given. size 8 ET tube placed, secured at 24 cm at lips. BS bilateral upon ascultation. CO2 detector with positive color change. MARC air personal present. ET connected to MARC air ventilator. Vent setting at F102 100%, TV 600, 12, presure assist. O2 sat 96%. Good tissue perfusion noted. At 4:50 AM NG placed to left nare. connected to continuous suction. At 4:54 AM Pt bucking vent. Fentanyl 100 mg IVP given by MARC air. At 4:55 AM Versed 2 mg IVP given by MARC air. NS 1000cc bolus started by MARC air. BP 81/62. At 5:12 AM Pt transferred to MARC air stretcher FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 36 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 36 for transport. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 At 5:15 AM Ketamine 100 mg IVP given by MARC air. At 5:20 AM Pt dc'd with MARC air flight team in stable condition. At 5:43 AM report called to at Rapid hospital. (name) RN in ICU At 4:00 AM, the ER Provider Note revealed: HPI "...COPD due to restrictive lung disease. Returned due to respiratory difficulty. Wheezing widely. Treatment re-started but patient did not respond, oxygen saturation dropped to 80%even with non-breather mask. Moved to trauma room, orotracheally-intubated with a 7.5 ETT under rapid sequence induction by using IV Vecuronium 6 mg and Succinylcholine 100 mg." GCS 15. General: "Bilateral wheezings, tachypneic, hyperventilating, in obvious respiratory distress; CV Regular rate and rhythm, Normal S1 and S2, no murmurs or rubs Diagnoses: Respiratory Failure. Clinical Course: "...Went into respiratory failure, met the criteria for intubation and eventually successfully intubated. Referred to Rapid City ....." Transfer via plane with advanced life support. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 37 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 37 An Addendum note written by the provider was entered at 7:38 AM stating "...At 6:10 AM MARC personnel came in with the patient under CPR status. Then 1st epinephrine 1 mg IV given. Then at 6:12 am, regained palpable pulse and BP. Then at 6:51 am, went into PEA and CPR re-started. 2nd Epinephrine given at 6:53 am. 3rd Epinephrine 1 mg given at 6:56 am. At 7:00 am, 120 J cardioversion done. At 7:02 am, 4 th Epinephrine 1 mg IV given. At 7:03 am, 2nd cardioversion 200 J given. Then CPR ended at 7:05 am and patient declared dead." PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 Review of the ER nursing notes for the third ED visit evidenced the following: At 6:10 AM MARC air returned to ER with pt. Code Blue in progress. CPR being done at this time. MARC air flight team reports that when they went to load pt in plane he went into Brady then into VTach and Vfib. Pt was given 2 amps of Epi at airport. Pt was then also shocked at that time as he was in PEA. At 6:11 AM Epic 1 amp given. At 6:12 AM Pt noted to be SVT at this time. CPR stopped due to rhythm. Pt remains intubated. At 6:20 AM Cardiac monitor shows QRS complexes getting wider and ST elevation. BP 114/52. At 6:43 AM BP 106/60. P 148. R 14. Sat 96%. Pt continues to be intubated. Good tissue perfusion noted. Levophed at 3MCG started by MARC air. At 6:51 AM Pt noted to be in PEA. Compressions FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 38 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 38 started. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 At 6:53, 6:55, and 6:57 AM Epi 1 amp IVP given. Compressions resume. At 6:57 AM Pulse check done. No pulses palpable, PEA rhythm continues on monitor. At 6:59 AM Pulse check done. No pulses palpable, PEA rhythm continues on monitor. At 7:00 AM shock at 120 joules delivered. At 7:01 AM No change in rhythm noted. CPR resumed. At 7:02 Pulse check done. No pulses palpable. PEA noted on monitor. Epi 1 am IVP given. At 7:03 AM Shock 200 joules delivered. CPR resumed. At 7:05 AM Pulse check done. No pulses palpable, PEA continues to show on monitor. Provider called for CPR efforts to stop. Time of death at 7:05 AM... Medical record review of the patient's three ED visits, which occurred on 9/17/16 and 9/18/16 revealed that no cardiac monitoring or EKG was done until 6:32 AM when attempts to resuscitate the patient were being made. The notations on the EKG record revealed that the patient had QRS tachycardia with left bundle branch block. After the patient was intubated, there was no evidence that a chest x-ray was done to verify correct placement of the ET and NG tubes. Vital signs were not routinely recorded for the first and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 39 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 39 second ED visits. There no evidence that the patient's cardiac history was considered while assessing and treating this patient. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 Review of the autopsy report for this patient revealed Final Anatomic Diagnosis of: I. Congestive heart failure A. Cardiomegaly B. Pulmonary congestion, bilateral lungs C. Congestion, liver. II. . Occlusive coronary artery artherosclerosis A. Up to 80-90% narrowing left anterior descending coronary artery, left circumflex coronary artery, atherosclerotic change. B. Up to 40% narrowing right coronary artery, calcific atherosclerosis. III. Early bronchopneumonia, bilateral lungs IV. Diabetes mellitus, clinical record. Comment: Autopsy examination "...reveals the cause of death to be related to congestive heart failure. At autopsy, the heart was markedly enlarged weighing 660 grams. ... Possibly contributing to the death was significant coronary artery atherosclerosis. A remote subendocardial myocardial infarct was identified..." The hospital did a Root Cause Analysis (RCA) on this patient's care. The only issues identified related to documentation. No Action Plan was developed. On 11/30/16 at 11:30 AM, the care and services provided to this patient were discussed with the Acting Clinical Director (ACD) and the Great Plains Area Office Medical Director. They were in FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 40 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 40 agreement that the patient's care, including the MSE and stabilization, was not adequate. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 5. Review of the ED log revealed that 35 year old patient #12 presented to the ED on 8/11/16 at 6:11 PM with nausea, vomiting, and diarrhea (n/v/d) times 6 days after being on a "bender with Jose and vodka 8 days ago. Over hangover can't get rid of sickness", ESI 3 (urgent), pain level 8 out of 10. Review of the ER nursing note evidenced that the patient was placed in room 3 at 8.29 PM and the nurse did the assessment. The EKG was completed at 8:30 PM. The patient's assessment by the nurse noted the following: Airway was patent, unobstructed airways, Breathing spontaneous, symmetrical, Neuro: alert, oriented, pupils normal Abdomen: soft, flat, nausea, vomiting x 5 days, tenderness, looses bowel movement. Pain scale 8. At 8:28 PM, the patient's vital signs (second and final set since presenting in ED at 6:11 PM) were BP 125/70, P 69, R 18. T 97.5, O2 97 RA. Review of the nurse's charting revealed the following documentation: The nurse started an IV, gave a bolus of IV fluid (solution not specified) at 9:05 PM to 9:44 PM. At 9:05 PM the patient was given Phenergan 12.5 IM with results relaxed/sleepy at 9:10 PM. At 9:15 PM the nurse charted that the "Pt laying FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 41 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 41 in bed, resting quietly, denies other needs or complaints. States he thinks the medicine is making him sleepy. Pt provided with warm blanket per request. Pt continues to intermittently dry heave." PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 At 9:18 PM, the nurse documented "RN hears strange breathing from next room. Nurse at bedside. Pt appears to be having a seizure. Pt stops breathing, Pt sternal rubbed, pt gasps and opens his eyes widely, then stops breathing again. Pulse faint, pt unresponsive without respirations. Compressions started. At 9:20 PM Pt opens eyes, attempts to sit up and remove hands from his chest." Code Blue in progress with medications and compressions and bagging. At 9:42 PM, during the resuscitation efforts, Dr (name) notifies provider of critical lab results. [Note: Critical values included Sodium 106 (normal 136 - 145); Potassium 1.2 (3.5 5.1); Total CO2 43 (21-32); Magnesium 0.6 (1.6 2.3).] At 9:42 PM, Intubation attempted by provider, unable to open mouth due to pt clamping down. No pulse palpated. No pressure. (Note: The patient had been medicated with Epinephrine 1 mg at 9:30 PM, Amiodarone 150 mg, an antiarrhythmic, at 9:37 PM, at the time of intubation - 9:42 PM - Midazolam 1 mg, an anxiolytic, and ROcuronium 50 mg at 9:44 PM). The patient was not adequately sedated for the intubation by the provider. At 9:45 PM, and FORM CMS-2567(02-99) Previous Versions Obsolete (names) arrive Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 42 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 42 from MARC Air. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 At 9:51 PM, IV sedation and paralytics successful. Pt mouth is relaxed. Intubation attempt by Marc Air. Compressions paused once vocal chords are visualized, Rhythm checked. Asystole. No pressure. 9:57 PM Intuation attempt by Marc Air. Compressions paused once vocal chords are visualized. Rhythm checked. Asystole. Intubation successful. Pt hard to bag, Frothy red, brown discharge noted in ET tube. No pressure. 10:00 PM Shock administered. Compressions continued. 10:02 PM Physician called TOD (time of death). 11:35 PM Left ER to the viewing room. Review of the provider's documentation for the patient evidenced that the MSE was done at 8:35 PM. The provider noted that the patient was "mildly acutely ill". At 12:25 AM, the provider documented the following summary: Initial concern was for DKA (diabetic ketoacidosis) or other metabolic acidosis related to the diabetic non-compliance and the recent vomiting. approximately 2108 (9:08 PM) - notified by nursing that patient was possibly having a seizure. He had developed some twitching. Room immediately entered. Patient not having a FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 43 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 43 seizure but was having ineffective breathing which then stopped. HR stopped after breathing stopped. Resuscitative efforts started. See code sheet for medications and interventions done. He initially would respond to treatment then gradually became unresponsive. Intubation attempt x2 by myself - first time could not see landmarks (large tongue and airway deep and anterior). Second attempt - tube would not pass through the cords. MARC air paramedics arrived. One unsuccessful attempt by one paramedic then patient successfully intubated by the second paramedic. IV access could not be maintained so IO access was obtained and medications given through the IO (left leg). Resuscitative efforts were unsuccessful and patient was pronounced at 2202 (10:02 PM). PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 The provider's assessment and plan included: Cardiac arrest Cardiomyopathy Critical Hypokalemia Critical Hypomagnesemia Critical Hyponatremia Vomiting. Additionally, review of the provider orders evidenced that the urine for drug screen and a fingerstick blood glucose was not obtained as ordered. The lack of evidence to show that these orders were followed was verified by the Director of Nursing (DON) and the Health Information Management (HIM) Administrator. The hospital did a Root Cause Analysis (RCA) on this patient's care. The issues identified related FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 44 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 44 to the new staff in the ED not being familiar with the Influx of Patient policy, which was determined to have not been followed. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 On 11/30/16 at 11:30 AM, the care and services provided to this patient were discussed with the Acting Clinical Director (ACD) and the Great Plains Area Office Medical Director. They were in agreement that the patient's care, including the stabilization and intubation by the provider, did not meet the standard of practice. 6. Review of the ED log revealed that 62 year old patient #18 presented to the ED via ambulance on 9/8/16 at 7:30 PM with unresponsive following a motorcycle accident. The patient was assessed to be unresponsive with "a left parietal scalp laceration with very large hematoma, fracture left tibia with hematoma, fracture of right medial malleolus with large hematoma, apparent fracture of left midshaft ulna with small but growing hematoma....Right pupil fixed/dilated.." The patient was assessed to have a GCS of 6. The documentation indicated "the physicians agreed that the pt did not require intubation despite his GCS as he was maintaining his own airway and a ventilator was not available throughout the course of his treatment. Decided that the risk of over-inflation was too high with BVM/ETT and that adequate oxygenation (his SPO2 never dropped below 93% with 10 L NC O2) was being provided. Decision to await flight crew for intubation utilizing Ketamine, since none is available at PRIHS, was determined by the supervising physicians." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 45 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 45 At 9:00 PM, MARC air took over the care of the patient. A Foley catheter was inserted at this time. At 9:25 PM, MARC air attempting to intubate the patient, a 7.5 cm ETT inserted. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 The hospital did a Root Cause Analysis (RCA) on this patient's care. The some of the issues identified related to the patient not being adequately assessed, medications given were contraindicated based on physical assessment, there was a delay in transfer to outside facility, physician did not provide standard of care, patient was not intubated immediately, EKG was not interpreted correctly. On 11/30/16 at 11:30 AM, the care and services provided to this patient were discussed with the Acting Clinical Director (ACD) and the Great Plains Area Office Medical Director. The patient had significant brain trauma with bleeding and swelling. The ACD and the Area Office Medical Director verified that the patient needed to be intubated, there was a ventilator available, Ketamine was available in the CRNA anesthesia cart in the Operating Room and in the pharmacy, and the CRNA lived very close to the hospital so the Ketamine could be made available. They confirmed that the contract staff managing and staffing the ED needed to be educated about intubation, including the use of appropriate, adequate sedation prior to intubating a patient, the use of the current ventilator which was available, and CRNA and the use and availability of Ketamine. They were in agreement that the patient's care, including the stabilization and intubation by the provider, did not meet the standard of practice. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 46 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 46 7. Review of the ED log revealed that 23 year old patient #29 presented to the ED via ambulance on 11/27/16 at 3:46 AM with "active seizure - post ictal" and an ESI level 1. The provider assessed the patient to be unresponsive with seizures, aspiration, and GCS 7. The diagnosed with status eplicitus and pre hospital aspiration. MARC air arrived at 3:58 AM, administered medications and intubated the patient after two attempts. At 4:40 AM, an nasogastric tube was inserted. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 Review of the AP chest x-ray done at 4:34 AM noted that "the ET tube is seenheading down region of the right mainstem bronchus. A second tube is seen coiled about proximally. If this is an NG tube this is not in the stomach and is located in the esophagus." No evidence was found that the ET tube or the NG tube were repositioned. No T-sheet was available for this patient who was assessed at a level 1 ESI. On 11/30/16 at 11:30 AM, the care and services provided to patients requiring intubation was discussed with the Acting Clinical Director (ACD) and the Great Plains Area Office Medical Director. They were aware that there were failures to show that ET tubes were repositioned following the post intubation x-rays of patients. 8. Due to the patient care concerns identified, staff training on the use of ventilation equipment was reviewed. On 11/30/16 interviews with the DON, after review of personnel files, confirmed that none of the contracted ED staff had training on the ventilator use or ventilator equipment being used in the ED. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 47 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2407 Continued From page 47 On 12/1/16 an interview with a nurse working in the ED confirmed she had not received training on the ventilator equipment in the ED and did not feel comfortable with using that equipment. A2409 489.24(e)(1)-(2) APPROPRIATE TRANSFER (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual's behalf) requests the transfer, after being informed of the hospital's obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2407 A2409 - OB Labor and Delivery staff are responsible for providing MSE upon presenting to ED. Staff members are A2409 being educated on documentation required by EMTALA standards to include transfer packet requirements, refusal of transfer and AMA including risks & benefits completed by 12/31/2016. Any staff not scheduled before 12/31/2016 will complete before their next shift. a. 100% Chart Review of all patients being transferred from the Obstetrical Labor and Delivery unit for appropriateness of transfer documentation started on 12/21/2016. b. OB Labor and Delivery physicians, OB nursing staff, and Certified Nurse Midwives will be educated on documentation required by EMTALA standards to include transfer packet requirements, refusal of transfer and AMA including risks & benefits by12/31/2016. Any staff not scheduled before 12/31/2016 will complete before their next shift. c. Training of policies related to MSE, patient stabilization, appropriate transfer with verification of staff understanding through post-test evaluations by 12/31/2016. Any staff not scheduled before 12/31/2016 will complete before their next shift. (C) If a physician is not physically present in the emergency department at the time an individual FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 48 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2409 Continued From page 48 is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual's health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG A2409 (X5) COMPLETION DATE d. Orientation for all new OB Labor and Delivery physicians, OB nursing staff, and Certified Nurse Midwives will be revised to include appropriate transfer training by 12/31/2016. Any staff not scheduled before 12/31/2016 will complete before their next shift. e. Chart review findings will be discussed in daily Emergency Services QAPI meeting by 12/21/2016. Corrective actions will be assigned in QAPI meeting. f. Responsible parties include PRH Clinical Director, PRH Chief of Obstetrics, PRH OB Supervisory Clinical Nurse (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual's emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1) (ii) of this section, and the name and address of any on-call physician (described in paragraph (g) FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 49 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2409 Continued From page 49 of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital's files) must be sent as soon as practicable after transfer; and PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2409 (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This STANDARD is not met as evidenced by: Based on medical record review and staff interview, it was determined the Hospital failed to provide an appropriate transfer for one of one patients in active labor from a sample of twenty-one patients (#28) who were reviewed for out of the hospital transfers. This patient presented to the Emergency Department (ED) seeking emergency treatment, but was not logged into the ED log book. She was logged on the OB log. This failure included the failure to ensure use of appropriate staff for the transfer to ensure the safety of the patients who were in active labor. The failure to ensure appropriate transfers resulted in immediate jeopardy findings. The findings included: Medical record review for patient #28, who was 37 5/7 weeks pregnant, revealed that on 10/16/16 at 5:30 AM she presented with complaints of contracting. Record review FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 50 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2409 Continued From page 50 evidenced that this was the patient's third pregnancy, with a history of two previous Cesarean section deliveries, the baby was breech, and the patient had already experienced a PROM (premature rupture of membranes). The documentation indicated that the patient's contractions were occurring every five to six minutes with a duration of 45 seconds. The patient reported receiving her prenatal care from a provider in Rapid City and planned to go there for the c-section. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2409 During the MSE of the patient, the patient told the provider that she "wants to go by POV with her parents". The provider noted that discharge instructions were given, the patient was taken per wheelchair to their car at 6:10 AM, and report was given to the nurse at the Rapid City hospital. An addendum was written by the provider on 10/17/16 at 12:39 PM stating "Transfer via Ambulance to (name of hospital) offered to patient. Pt. declined and states 'I want to be driven by my parents.' Advised pt to go directly to (name of hospital)." There was no evidence found to show that the provider discussed the risks of going by POV without qualified medical staff to be available if the patient required increased monitoring, the baby became stressed, or had a delivery before arrival at the hospital. Additionally, there was no documentation to indicate that the patient refused care or signed an AMA (against medical advise) or that a transfer (information) packet was sent with the patient. On 11/29/16 at 9:00 AM, in an interview with the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 93MX11 Facility ID: 430081 If continuation sheet Page 51 of 52 PRINTED: 12/15/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 430081 OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE HIGHWAY 18, MAIN ST., BLDG. 159 PHS INDIAN HOSPITAL AT PINE RIDGE PINE RIDGE, SD 57770 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2409 Continued From page 51 new Quality Assurance Performance Improvement (QAPI) Supervisor, she indicated that they were doing Root Cause Analyses (RCA) and Medical Staff (M&M) reviews for patients who were seen in the ED by the contracted staff. When questioned if a RCA had been conducted on patient #28's 10/16/16 visit to the hospital, she commented that no RCA was done as the concerns had been reported to CMS (Centers for Medicare & Medicaid Services). However, the QAPI Supervisor confirmed that the staff were aware of and had discussed the issues related to the patient's visit. FORM CMS-2567(02-99) Previous Versions Obsolete C 12/01/2016 B. WING NAME OF PROVIDER OR SUPPLIER (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED A. BUILDING Event ID: 93MX11 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A2409 Facility ID: 430081 If continuation sheet Page 52 of 52 for Medi er ter 1 l t t r 1 t' 4G s m 55 641t' u€ cs s e t? F'« iURV Y 31"" P+t S id S l ce sf, Rc i ity s rrts M' are Ctty R r s 6 71 Ea t' E'# hll1M ALTF& H iT C} EPAR"CC A r s c` sERT1FI A"ft Ml flay 2, 20' 14 M l Is. P frici inne E dina, iN o o aita! N+ry 77-7 b iti 71 s ebr go, S+G+ rtifi Cl lVl+ dina. 1l. ar t}'t 4 th s caffice p i , : C?n Frc m t. ts Fed tett r 13 c F ed r r sit l th€ rad'tr yc u havs c ft r t i di fi r ri r te th f l yc ts frt i ies j ver c apar t s unr y n estic rts c ur prs t an cr` s f t irr e it 1" tt immediat j cspar tMe ht sp t at' s t# tir ue r re r al m r vic4 prc> rdy gre ri rn+ r y t f cienci y a St t fy y th th r edures, w F av r, we vil fi is o+ ming t his 1+ tt imp tirey, p# forms G s c will s h visit s° r a+tiorr tF i n icana l R s t h4spita[ s# Aft+ furt n th rt fie tt taf [. I 5 7 t t:; AC} y ' 8g t. The d mr nu rill t an unar ne n d ss ryy c c act n t ct m+ t' Lt tc to yo a ir vsrrri n ic c r t I ph ar {, ni, attc r, lC1 t"+ f1C' 1 t tfi- ca!# ke. s+ CtC1i ure• t d a l` wi r c!€ ct Ctrtly me# o ai+ t! yc t r €ccr sditir t' nci c n 7 f- IIICBC' t t' lCilll", CC lS- c ur s w e10 nd t re prcrc dure t F t r r« ubmit tc l pit c diat e j m l cfe+ d c r t s. surl n ira I t s raf r min r c tfarmatic r rrr n e tt mc vv tary ti t atir ncat r r atl r t Fic sp t 1 i lir n+ ebagc ted a nd e s ar ffe fifi€ le t y q Fotlourir g t 11 f mm s c Ic rul c tt+ the de ic he rs̀th E l fures, rr ce an r tP i tt d maave c i w to exer cl pit nclud+d c, a hca e p ummary af the mm di k s jea ar{ y cie' ici: ncie yc mailed ur r aint ic na! C re wra+ lti tice that 2t}14 if t rt in lt d ity R ar sas r l r t31 F it , f4 2- t}11 atic rt# C'!' 3t' TBCrrt C c@ Br'dttc°1 1 4 i- nca fyir g ti sm j F>RINTEQ• DEPAR'TMENT 4F HEAL.' fH A( D HUMAN SERVICES O n' flF o+ sraT J2044 O att}?' ORM APPR VED E s C Errc txi) awa t wc wsupa.ic- a oorts ta. E ucno 1 traaE st v v C A. SUIi,ONdCa B+ s s+ ov a tu t) ER E NUIJ 10EHTtFIGA' A!A} FtAN ffF CORREC310N art sua o a au STR£ ET ADt3RES8. CITY STA'1'E. 21P CQDE t.i R M!W 7"f76 WiNNEBA00 IHS H09cPiTAt WINNEBAQ{ i.NE t} PR SUMMARY STATEMENT( i IX OEFIC IEACH DEF7CIENCY i RlST 8E PRECEO TAG t. REtiULATORY NTlFYlttG lNFORl AR,TiON? t? R iSC 117 ID PR01lIDER S PIAN Of CORRECTIqN PREF}X EACH CORRECTitiE RC' 1t} N& HOU t?6E IES 8Y Pt. 85091 txS! CBt PtEttOrv DarE CR08S-REFERENCEO TO THE APPROPRIAT YAG DE iCiENCY) A 365 A 385 482.23 NURSiNG SERVICES The haspitat must have an arganized nursing s svice tlt t#trovides 241 tkr nur ng services. The nursiing s must be furnished or s supetvised by a registered nt se. This Ct?NC MON is t oi mei as evid nced l,y. Bas ct on ot servation, t cord eview,stafP ir tervievas, Policy revlew, ar d r riew ot hospital ir temal the nursing se vice faited tq ch cklists and reperts, assure the nursitt f# te trair ed and posseu s nd skflls ia ensure and aff were sdequately esssary knowl dge patier+ ts were provided sa#e ppropriate care. The hospital f ited to meet the needs of a 800-paund, 35-year oid pa#ient p tient 50} wt ct vv s r'e5s ar C i wittt rt dmitted in acute r spir8tory sive periph' al ederr a. Nutsing staff faiteti io apptopriately a: 5ess artd respond ta mulNpte adverse changes in the patierrt's i'ii{ C 1@ fn dti OY$ Y' it& f p 1"$$}? which a perron nursin Sjl f1 8 I$ 1' tt S#8 1. () t 8C1'@S(# Itc totaEly stnps brea thin) 4 1/' i 1' C! @L1lt' @tt' t and the staff was unfamiliar wikh arui unabie to operate ttre crash cart( cabine#cc rttatning aipme rt thaf physfcians at uu se cardiac ar respiratory arrest occur r ed wher a equipment. VVhile aii members of the nursing nd medical staff wete trained in advanced cardiac tife support and pediatric adv8tt cetf lifs st,tP tlOt Ch UtB COGX'$ u# thei' irt tructors did S b8S8d OCt Ut@ CURf@Itt approved Ame ican Heari Associat+ an c rriculurn. Nursinp sts ff did r t know haw#o caN a C+ o ie 8lue f1 @tliBi l3tiCJt 8}9t 8tt!'t[} L tlC$t qYBf' Ifi.'" i08 11 8E ir#ercarn system to summon assist nce when a patient requires imm adiate cardiapulmonary resuscitatlon) using the bedside tetephor e in the Nursing siatf failed to assure the patient"s foom. r. rash c trt contairred ii the LA80RATORY DlREC7CiR"& t3R i'ROViDEWSUPPLiER Aay defiaerx.y stetemen! safeguards provide s at surva}+whether ot twt end3ng deni rai with an k('} 8ster tion ta the Dat,{ plen uf corrediat doCuments 8te made a'vaNebte fcr th taCNity. 3ENTAt11,tES S16FiAT1JRE dencib s a See in Ptptrlded. Gr deficiency which fruGWns.) ntnsin9 h rtt ihe instituUon may be Extaa{ for ntrrsir s, the above Event 10. J7`! Mt 1 excwsetl ftom cnnecAin9 P«+ g tnames. V e ifnd3ngs sla findings N de8c encles ate c ted, s t 8ppraved pfaa of t tS2-69} FResAaus Yers[dsrs OCsWste Ft7RNS CMS?Xe6'i{ nc9} onrH TIT1.E arnl P rts W e are ec! abah+ or ste reGfion is t^ aqulsiEe to coniinr Fas dy! D: 2 119 detecrnk ed U+at Wt er 9 disck disdoseb abie tlaya toitowirng the de ta 14 dsy8 t oMdr! he QBte thiese d propra rt p' ticipatior. if! irtfnu8Y2att sh88t t, Ige 1 Ct 11 rr a rcnna c FC>RM APPi2t)VEi] REPARTMEN'C OF HEALTN ANU Ht1N1AN SER1tICES O STATEIY Xt} NT OF OEftCIENCIEB 4! tX2) MUL7IPLE GONSTRIlCT10N PROYidERtSUPPLiERlCUA COAAPtETED iOENTIFtCAYlON PIUM AND PI.M10F COftREC7tON R. Ci 8. v 84118 2i}1+i BTItEET ADDRESS. CITY 3TATE. 2. NAME 8F PRtriItDER t t StfPPLiER CODE MNY 777b w N r u. co ir s s Ef. 7J4 A 365 ro-r c r srn, n ac s o, ao+ nar o iEACH OEI IGlEt+ Y I ItlST BE PRECEOED 6Y FtH.E REtit11. ATURY PREFqc QR lSC NlENfs' 71Nf., IN t#tblAtsON) tAG TAG a w sso7 s t Cantinued From necessary page emergency resuacitative a nvay availabie for use when cnar+ c s FiC1ENCY! A 385 1 nt and as a resu, equi cc i+ CH CCfRREC'T1VE A 7tON 9HC JCQ 8E CRQSS EfERENCED T' THE Af+ PR4PRtATE the no qutpmeni was tient resp ratory arr sted, Tvrenty minutes elapsed be1'ore#he necessery equipment was lacaked ar d the patient t8s ReSasCits tivt etEt tts were intubateci. and the patient unsuccessf hqspita! d ed. By 4125114 ti failed to detem3ine the troot cause tsf the event and to devetop or imp+a n n c: esaaary ta ensure 1 nursi t changss personnei wosre properiy tr ined and campetertt ta en ure patieryts rec:eived sa am! appta pr ate c,a re to meet thsir needs. placi ng ail patierrts in I rtmediate Jeopars r J-a t risk t f imrrn diate thre3t to pa ents fi al#h srxt The ndings were of such s sericrus safety). nat e that the haspi ai was fc nd to be aut of campl3ance with the Cnndition of Parti ipaiic# s r Nursit g aervices. Refer to deflaer cy at A 3 7 A 397 482.23(b)(5) PATIENT CARE ASStGM A 397 NTS A registered nurse mus#assign the nursing care af each pafiertt tc athe r utsir g peraont el in accnrda+ cer vuith the patient"s needs ar d the speciaiized qualifica ot s ar d ctitr etenCe of tt e nutsing staf availebie. Thls STAND tRd is nt t met as evidenced by. Basec#on abservaiian, recarsa!!review, staff inter riews, pc lir,y rev'ey+r and review c f hospita! internal chedctists and reports, the Directar{s} of Nursing and the hospita[ failed ta ensur ji@t'St ifi8 t3 1' 1@ 8 1' O fT{At@ Catri, nurs c g 1# BnC@, sp ccialized qualiflcations and exp erience to asses patlents ca a needs on sn ongoir g hasis and pravide nurs9ru carre in ar ordance with the ir dividk t! needs of each pa ent far 1 of 1 { Pa#iemt Fot cas-2s67to- se>rra venua s oc ete Ew rt ta:.rr, ry ro: xsc ys ear, If ccnt ian she+ t ua# Page a at t, 212dt4 PRtNTE€: {? DEPARTMENT QF NEALTH AND NUMAN SERVICES FdRM APPR+ C3VE0 1 STATE1 At PIAN t CCRRECTlO i G IOEMTlFlCATiON t+ itJMBER A. 0 STFtEET Al70RESS. GFTY STATE. 21P GOGE R OR SUPPLfER ROVIt r1PLETEO NG U1NMf3 28Q118 NAN t3} DATE SUFtYEY XT MULTIPIE CONS7RUC'Ft( Mt PitOViDERlSUP' t.fiERtGLtA P 1 Ni QF DEFlCiENCiE& w+ nrr naa WIM1iE8AGO 1liS FK'!:[ AL VWNNE SUMh3hRY STATEMENT OF CIE ICIENGIE5 X4) i0 PREfiX PREFIX OR LSC IDENTIF1fING INFClRMATICINI 680T1 PROVIbEtt'S PLAN OF C4RRECTldAE ID J+ CH t1EFiClENCY Mt1ST BE PREGEDEO BY FttA. L REGUI..ATORY TAG AGO, NE t TAG pt6> N CORRECTiVE AC`f10N SM4U4D CRKaSS REFE TC#TH APPROI ttA7'E OEFiCfENCYf A 397 Conbnued From 50) page medcai reacords haspi#at 2 A 39T On 4/Z2114 U' e eviewed. ien' f'i+ eti a t tsus s# 4 pe tiBMs. Findings Induded: t' t#/23J14 tevrevv af Pafierrf 5tJ`s Ciosed mediCai i showed the 35- year otd pattent preser ted t rec the err ency d+ epartment{ ED} on 4114l14 with shortness of breath at r est and with e abes'sty ar rtianF morbid massive p tripheral edema( swal ing c. used hy excess 1uid trapped n the bady's tissues1. ' 1"ha gradually v patient tald staff h a condi n hed rsened over fhes psat morrth with an increase in tFua edema and z artness of breaih and 18CCiiT1@ ItICi88St t1Q1' t i[11i11QfitfB t UB O ft18 1' SEZ@. 1A[ 8118t t18S respiratory di+ laba t' 7g 3t1C ttJtt i#' 4( Sl i18 i ss) when breathing and had r espiratiar s with arry e certion. A ct st x-ray 5how8d lif»itet! diagrtps C quaiity due tp tt patier ts large body mass artd shallow Insp ratlons. Nis respiratay ra#e was ievatec! t 40 per mir ute and his a rygen s ture on leve!( obtained by attaching a ntsn-invasiva medtcai device ta the psti t's fi er tu'#oe to mon€ tt r the tevei of oxYi9 in tlte blood} was a owr 95-100%). of 3.S liters s 78% in th e Et7{ notm! This levet rose to 9 4° is wifh the additit r af axygen vla nasai cannula. Ar#eriat btc od gases{ blc ad test frorn an artery that musa ures the acfdit5+fPH a nd the levels of oxygen nd carbon dioxide in the biaod} t ould not b abfained because th+ a haspikaal iabor tary was not equipped was to perfc recot+! rm at His weight in me E mis test. 590 pqunds. the inpatient ltoor with th s E, He was ad itted to ve di gnoses as vvell as hypoxemia( insutficient a rygenation of arterial bi+ d} ar! a history of abstru tive sieep apnea{ the aimay raollapses or becomes bl+ ed durittg sleep) 8ttd F tM CMS2567{02- 9) PrtevbrwR Versions QDsWeier EveM D JtYtJt t F Nt+ tD: 29t1119 li rAtui lua Sl t PBge 3 4f i1 1 R H DEPARTMENT STA"(EMEWT 0# DF.FtCiENG1ES 1 i%l YJ74GfG iJ X3 QA7E SUFtVEY i%7 Mt. 71PLE C+ ISTRUCtYON pROYIDERlSt1PPLiEWCLlA COM' IDEltiIFtCAT1QN titJMBER W.AdI OF CORRECTiOPi Li. C? RN APPRQVED S ALTH AND HUMAN SERViC l' EO A. BiI LDEhK3 Li B innlv Z80119 i 1/ 2 1$ STRE£'f AOt3RE$ S. GE7Y.$ TATE. Z1P COOE OF PRQ1flOER! 3R 9 HMltf T776 WiNNE6RG0 iN8 NCSPITAL WINNEBAK3d. NE SUMIAAFCY STA7£ MENT OF 0£ftC1ENGE5 f1X EACH DEFtCiENCY M113T BE PRECEOEd BY RtR.L. REGULATi RY { S?R LSC IDENTFfYlNCi INFC1FtMAFlt7N} TAG 88071 FR(TYIDER'S PlAN OF GOl IC1 EGTIQt! EAGF# C0 lRECfiYE RCTNDN SMOt. D BE PREFIX CROSS REFERENCED TLT THi: APPRU TAG xs} COMptETiON 2tAtE DEFIC{ENCY) A 397 Con nued From hypertension. page A 397 3 ysiasrn( MO Z} On 4l15113 his presaibed the diuretic medic ion Lasix, 40 miilig ms, oral r. o e daity; ta vvei h the patient dai#y;#t>me& ute his intake and au#put e tery shi#t; and ta adminiscer a cygen via nas t canr ula ta keep hi blood a cygen s turations grea#er#h n 95°!a. from 4f14/ 14M17/14, d distress did r d t ttatia n showed cum i racoFd he p+ tt's respit taty i tmprorte with supplemental a rgen via nasal cannuia and t is weight increased 26 pou cis( fta n 58{#to 616 pcunt#s) v thout a ca camitaM chaunge p tient in h s tr ea rusnt an_ The aften slept wh sit ng on the edge of the bed with his feet on the floo ar d told nursing staff fite t tildn't bre ttte unlesS he C uld i+ an ftktWdtd. Nu rsing sta do umented chservatians ot the partierrt hyperventilating at rest arrd C ccasiatally to them. Nursing staff fiailing asi ep while talki in#tequr 3y 8ssessed ttte p' tt`s ittelg sour s using a stethasccpe. ihese are saunds hea d comin iram the lungs when you breathe ir ar Bre th sounds+ an indicate problems txeathe aut. withir tF# infe tit ungs such as obstructioE s. nftammaf on, n. An abnorm t breath s indicate fiuid in tl lungs or asihrna. und cart Breath sounds are a n impa tant part of diagnosing many di#ererrt medical showed nurr r condi# ions}. st ff faN i tX r umenta# ion Now phys at orders and did not mea sure the patienYs ir ak au# put every sfiift. Nursing staff did not and rrtor iir r and assess the patlerrt`s co di on on an ongoirtg l}8St81fl CC01'd8t1C W{ 1'i ACt:6}?EC1 S t1t 8Ft S 01` nUtsir g p"8d'tCe and did nOi apPrvPriately rep4rk ihS atient`s deteriorating candition ta hi atkending i Y$ician, FOwA CM& 25s'r(o2 9s) Pravwua veaians obsa ete Eveme tO.. ltYnti s acshty I. 2so t9 if cusstirwaticn sheeE Raqe 4 0411 4 i1 HEAl.TH ANCI HUMAN SERNICES DEPARTMENT t' E STATEMENT UEFICIEt+ lE3 AND PLAN QP GQRRECTlON { l17lHI'i/ liM 1 E VI l% 3) OATE StlRVE'V X21 Mth.TIPLE GONS7RtJC7lON PROYIpER18UPFl1ER7CLiR Xt} L/. FORN! APPRC?YEi3 COMPLETED lGEN'tIFiCAT[ON NUYBER: A. BUIWING r` 1MI+ K's 2 @11$ t&UPR4 NAA E OF PRf1it10ER{, STREET AQURESS. CITY STl4TE. Z1P#CQOf R H MY 7 7S YfiINNEBAGd IH5 HQBPITAL i WMlNEBAQtI. WE SUMMARY STATE NENT OF pEFtCiENC1E$ ce} i ttEflX w awn EI CH 0£FiCiEkCY MU.Si` BE PREGEDED BY FU, 1. REGIlL/ TORY { QR lSC IQENTIFY'lt TAC i iNFQRlMNt'I V} 680T4 s a c ar aF cc ta r rxs} t J CH CQI^tREC7'!YE AGTIQM SJ#OIk.C} BE PREFIX t1' F1iE APPROPq 7#L'a LETroN CV t'E At'E OER4CIENCYj A 39T Contint Fram documentati t oor c ge 4 A 397 AM on 4/ 17l44 tru dical record At 10:( f his showed fhe patient wss faund an the room. Tett t ospitsl rsartr et, irtduding s+ ant 30 minutes g t ing the a physiaan( Ma'V1}, patierrt nif the floor and into bed. Ir vt w c n 4122f14 at 4:30 PM, RN FF( Register d Nurae}, who is I a sa tt e#rnp ttvir t t+ anizati P} Nl rt ge', st id th Performance hospitst! dc es nc t have mechanical lifting equiprnent for a BOt?pound ent. p ti+ tJncB in bed, th patieni's oxygen i satura# Eevei was exuetn t y low af 56° i. Nu sing stat€did r ot ir h rm e patieM's tiending 4 Y c;ian. The faality phystcian v rho had assisted with iiRirtg the patient t fiF the fluor directeci nursing steff ta ab# ain sn EKG{ elet r r ardiogram is a r fing of heart's etectrical ac ivity}, wtti h hoared an undetermined cardi c rfiythm due to the t's resUessnes. patie C@ The physician requested a tà: Ml' itt f iltitrS t1 f'd8f St8{ f 81 @d# b Q} tr 1t1. At 12:40 PM tm 4l17114, msdical rec dacumentation rd aaw+ d# he patier t's biood pressure dr+ opped signficarrtly#0 78J30, i e tient be+ came unrespt sive and stopped bre2tthitsg. A Coc{e Blue an etr rgattCy Stert c2tRec! over the hwpita#' s irrtercom system to surnrnan essistance when a papeM reguires immediafe cardia rest,tscitation) was annt Ac cxdit imon ry nced at 12:44 F' M. W an irtlerview witPt RM D[} c 1: 30 PM, 4124Ji4 at the Code 81ue had to be c tted from the nurses station beca the charge nurse{ RN AA) assisting her was unfamitiar vvitt accessing the hospital fs terct3rn syst€ rs from ihe te one i the patient's room. Ouring an int rvieKr on 412 114 at 3.30 PM, MD-1N s id he was#he physi ian who tesponded ta the Code Biue. Ne said when the code teacn arrived, they could nc t locste ar y F cMs- ss as- t av v« am ae o etd cw« n o:.rrv ny n: ot a t o tr an st et Page s ot t PRINTECh DEPARTMENT C3F HEAL7H AND NUMAN SERVlCES r oF or- c stat av o a cc tr s awa t si r cT a. ra au cwrn 05l02t24114 FORM APP ZUVED r na x coksTauc t+, Suaw v txay a oN coAar+c Nur s c a auiu u C nns Qf 18 NAME C1F PROVtDER 14 8TREE7 A t SUPPUER ESS, C1TY STAtE, Z CO€1E MNY T7T5 NRF Si tEBAG{31HS# Kf. TA NtIMNEBA+ CO. ME SUMMARY STATEAIEN7 OF OEFiC1ENG p PttEflX tEACH OEflClENCY t+35i? S dit tSC iDENTIFY1NCi tNFORM1Al10h} TAG DROWGER'S PLRN p i RECEDED BY fUCC REGiR.ATORY 6807i CQRRECTION t7 sl G.' EACli CGRRECTIVE ACTtqN& HOUlO BE i ftE tX TAt3 P ETtt 7 QaTE CR4S5-REF`EREtJCEO TO THE APPRdPRiATE DEFIC1ENCl7 A 397 Continued From page 5 A 397 emergoncy airw y resuscitation equipment on the crash cart{ a cabir et containing equipmeni th t Rtrysicia tespir s anc! nunses need when a tory ardiac or He s ald he df ected atre# occurs}, cade team ED nurse to$ o to the EO and g t a cotnbitube{ 8n aitvvay c BnEway signed to establish a patent pEac.et! it Ec wt er the trachea ot esOphagus} but the r w se tetu€ned vwith returr d e ortg Another nurse then w+ ent ta the ED and equipment. h wi# the arrest rec nd( a correcE t fo€m far is terventions that occur slio+ nred the mbiturie. cioeumerr ring ' ng t1te r:atdi ail a# resuscit z r} atie nt was not irrtutsated+n th the combitube in order to pravide airl ow dirediy ta the ttutgs utrtii ap oxir atefy 1:{ 35 PM. wttich was 2t3 tninutes afte' ths initiation t f t# te re, sd txt eifatts. A,ccording to MD-W, r q eifat w s rtta sle by nursing staff to lace a backboard c der the petient tc faciiitate eftedive ttear# t:artpressicm ttte pafiieM was tao b cause Resuscitatitre eff'otis rae e big. discor tiinued at 1 14 PM aru! the paEient e aired. ML- W described # he code blue effvtts as" dtaos"' He said nursing staff did not know i ow#o use#Fte a if$1't{!!". s,/...'{' 1@ t E11f{'. @{ N1 t '{, f}' t'!3$! 8t tha# combines a, defibrillaEw, EKG dispiay, advanc. d monitaring capabilities amd an extemel pacemaker witfi communicatia, teco t3ing Ca pabilities). dafa prirtting anc MD-Vlt aiso said the patienf should never haue besn admitted to tlhhein c pltal. He said he tald#hs patienYs aitertding physician eevera! days eariier during an interdi ciplinary t am i rnee# g tha# he reaammended transferred to anvttler hospft work- up by a speaalist could e paatient l wtrere be pe# armed. ai#endin9 Physiciatt did not heed MC#-W", s recommenda on. vuhile the survey of the was being conduded firor a 41221 4 FCI+ aaszse7iox-ss f awiax vo oosoi. ce be catdfac The nsy itai Evern its r, F„ r, ro. 2ea1 t8 i conpnuaticn st ee P s ot t i i E,: , FORM APPRC. VED DEPARTMEh#T OF HEALTH ANa Ht1MA N SERVlCES MB NO NCi 8TRTEMENT OF OEF A7 lX#) S fXS7 DATE SURVEY COAP9TRUGTiON X2) MW.Tqil PRt7/ 1tJERJSUPi' LIEPf Cd.iA COMALETEP 10£ NTlF4GA'itON t+JM6ER: PIAN+DE CORRECTiQN NG J# A. i e, v 28Q4t8 G tt25f3014 STf EET RbORE3S. GRY SCRT£. Z!P C£! E NAMAE OF PR0190ER OR$ UPPI. IER HIHY 77-75 wn r c s as n'. DEFiCiE IG' t ic Ewc MUST BE PRECEOED 8Y fUG.I s REt3ULATORY esac o, rr aea nw o o aaviogas+ PitEft% FJ1CM CORRECTt1t coaaECT ocs T hCTtOM$ HOt. O CROSS-REF RENCEO TO 7ME APPItOPRU1? E TAG OR lSC IDFNTIF"YINti MIFCNtMRTtQN3 7A0 A 397 oF o aRr srar su PREFX wia t GEFtCiENC`/ y A 397 Ccmdnued From page 6 t,tuougt 41 5114 the 50 YaitBbie#t r an was Ur Med ical' i ser( ttending i an fnr Pat phyrs iMervlew Ct lt}}# rom the t The Chief Gr at Pia'sns F r a Indian Health Ser ricss O ice c me to ih att 4/25i14 e u1 reviewed the p dent' hospitai rnedical record. He ccsncurred witi MD-W and scatad the padent should not have bee t at mmitted basei! on Che hospital's the ltospital's adsnission crikeri. ' admiBSiat c riteria paliCy, dated 2l2,7i12, shows the oitowirrg i sues are#sken inta cats+ c eraiion when the rr edical pravlder makes the decision ta admit e pa tient: The histary telating#a the pati n#'s me lical p. The p tier t's past medical his t's m The possibility the p t; iicai c:oncem c uid be ser aus; Othe c, use lems ti medicai t cnuid cc mpiicafe or prot l m to wnrsen; the cutrerr t Abno mai tests, EKG's, Iab work>x-rays and other est results; Al ormai physi al exsm; Unstabte vitat signs-i nperattus, ttea t ta#e, bio d pressure, respiratory rate or oxyg n concentrat on in e patient's biood: Patiet' s diagnosis, PatieM`s ptt grtasis; Whether t#e p tient r af a consu uires fhe im ediaie servtce ant; Whether ciose fiotlaw-up is requi ed. Qn 4l27J14 8t 2;25 PA the sunteypr tequested nw^ tng staff( RN AA and RN I F3j perfcrm a ch+cic of the caMents o` the inpatient floof aduit and paciiatcic crash carts. B tr rses said ihey had r aver checked the crash carts before beca se the nighf shift performed the checks. RN AA said that the policy far canductir g cr sh Fl, M CM9-2567(82-A6) t*nlviax veur[ rs QtkaWate Ev i 1D• dTYNi 1 FBcdHY: 2BOt t9 If Catltinua#ton k Page 7 of 1t p pEPARTMENT t7F HEALTH AND HUMAN SER4lICE5 lC Xt) FIT OF L1EfiCIEFNCiE$ TATEi D E ORM pRpVEC} CES 7( 2) AAlN. T1PtE CONSTRUCTICIN PROYIbER/ 5UPPL1ERl G41A JMIO PLAN OF GL)l REC't' C1N i lDENT1FtCA"fIQN iVlN 3) DA7E SUR1/ t Eft Y 1PLE'fE£1 A BIJ. CStNC Ci QF. 11y1NG MAt t AROYlDER# d iRE t SUQPUER I t f ADDRESS. CRY STATE. ZIP COf3E nr rr B IAtiNNEBAEiQ 1f S Ft4SPtTAL WINNE8ACi0, N sw uie,a t pRE iX stnr u DEfiCiENC' t k1t1,4T t r aa a c s o PRECEQED 8V fiA.t RE4UiA7f#tV OR LSC tQENTIFYlNG NVFORMA71Utd) F1N"a 68Q? 4 av++ r as r r, n cc csttu Ucs} C0' EACN CCNiRECT1VE ACTtON SF10U10 PREFIX CRQSS- REFEREhCEO TO THE APPROPRIATE TAG lEtiqN DATE C1 FtCiEhtCY) A 39l Cocrtir' ed rom page' 7 A 397 c rt checks nac just cnangeci tne previc, s day fran being car iu+ cte+ d m cu thiy ta every week, Bofh ir! nurses said ti c ot fhe crash cacts was limitecl to ver# f ting the t uts were locketi. Obseroation shrrnwed tl e nurses were uafamilia with the tx88h c8rt c1le dclist form( a tx spitat- net8ted itxrri stir slt of U' iE tt.s that slttwtd t e prese rtt fn tkte craslt cart ar d heir Iocallonj and the prc sdure fpr usin th chec klist to dei:ermine if erach kem on the iist was present and had nat pas aed v ne e unfamil3a its ex with b iilator cardisc monitalc at iration+date. ' i'i e nurses ho4v to c e the 2{)L. e Surveya comparison the a iult cxast cart chedct st with t# contents of th8 Catf& hOw d e Sferile tr8t t8a1 Cut t{c wn tray vvas d8ted 4t2B/06 found in fhe t2tt rtd no com#utube airweiy wa s The ahedclist shcrwed fha# cark. twra-250 rnill iter bags af 594, dextraser{ it travent u fluid} w+ ere tQ t s in# he cart but no were faund. Sterile glov+ as ir s ze 6 t#rough size 81i2 vvece r# fa nd with in tha cart. The two nurses were unfamiCsar the msthod far ch cking the iaryngosr e( a med aai devhce used ta visuatize a patient's airway e anci ades fo assure they duang i ttsbation} hs were in ptoper vrorking c rder Revlew a#the aclult cr sh cart checklist showed a tong listing of the i# ems that shouid be in tF a cart and theer toc tiar accord ng ta drawer r uml3er. or#he top, sic e, frant, bottom vf the Cart. tis# ed on the c The focat c of t#e items as edclist did not match their ac ual lacabcn in#he cxash cart. Review of the inpaatient pedistric+crt sh c no A opine( a st vvith tW BB showsd fhere was rst line mecCca#on recam nended by the American H art Association for the treatment c f bredycardia o slaw heart rate} m icabort in the carf as tfirected on the checktis#and the nurse did not know why it+ ras not availabte. 1"he pedia#ic crash+cart did not Fl7RM CMS- 266T{02-99} Provlaus Vetsfans Oifaolete vent i0,JTYNi 1 FecNtty ID: 1f9 IfCOtititwBtUCp Sheei F8 $ Ct 13 PRiM? ED: OEPARTMENT C) F HEAl.TH AND NUMAN SERVICES a raana 4 ORNE APPROVED 1 ThT N} MENT QF OEFICIENCIES PWi' X1) X2) MULTIPI.E CONSIRUC71pN PROVIRERtSUPPLiERNCUA CQRRECTtt3N X3j OATE SURV Y t lL3EM1FiCA7'tt t A 3kISEit. tNPLE7EEs A. Bt! lLRII@t3 G B iii+ ttdt 8Q'' t OR St1PP. EER NA#AE OF P'Ftt) V10 4 RESS. GtM, 6Tk'TE, Z1R Ct30E STR ET I HlNY TX- T6 A.. w Si,qM1AAFtY STAFE341ENT QF DE1 tC p RREFI)t tEACH OEFtCifNCY MUSF OP2 LSC IDENTIFYtNG IPVf' TACs NGtE3 1D PRECEOED 8Y Fi,. t REGtJiA7 K7RY lIIUt'lIUI+ i) r. PRL A R'S PtAbt t7F CORREG7#ON PREFiX EACN COR1iECTIVE ACTION$ HOULD 8E TACi t ROS9 REfERENCED TO TtfE AFPROPRiATE tX53 GOMPGErtUtf W E OEFIClENCY A 397 Ccntinued Fram page cor tarn a suction me 8 A 397 hine and equipmenf and RM BS seid each patient roam w s equipped with wait Howavsr, rev suction. w cf e n ur c u{ ed paatier t room designated f r pet#iair c pa, tier ts shc ouVuOri 8( t1 Q U" b@ tYt@17t n7U 1 u16 r d rio t,lC 10R, VV$ inciuding the canister, tubing and s ctior catt eeatter in#srvi n cottcem'rng s ediatri+ c cardi c R4V AA nd RN 8B war manitcrrtdefibn'1!& ttx'. unsure of what they wa uld do If a pediatric paU+ erat suffered a cardlopuimonary 8B satd itte iy inpatiet t unii ha they wauld ca rres#. monitorlc Eventuatly RN fltxiilsfaa' ths was s n tt e adult cnash cart st t ke the pediatric c cart as rveil as the aduit crasl cart to a pedlahic Code 8tue sih,fafic n. uring a revierv of the ED asfutt and pedtaEr c c ash carls on 4J23114 at 10:Qfl AM, RN CC was ur familiar with the proc+ lur e because she said enoth+ e nurse wa#ciru v th her always checke RN CG was an# miliar aritPt U a opetation of catts. the ZOi.L cardlac monitar/detib llatar, the me ad fior cF ecicing the larynga sc pelblacies. and the ptoCedu e ftu`usi g the cresh caR chet slists to detettnine if esdt ite rt on the list w s pre ent at d had ru tp sssd its expiration date. t? b eerva on of ttte ED pecFiatric+crascfi carE shcytived Attop9ne avs3lsbEe an#he cart as ct ed tist, was ot available. ere w s no dir+ ec est by## e RN CG did noE kn uv why the Atropir The citeckiist fn the pediatric crash ca ta on both the inpatient f# oor and the EO ShOWBd Y8114 OTi," bBC C t P( 8` Wt'Itt@11 R@X## C! Atr4pine, wlth no t3& te or signa#ure af the individuat making th rwtation. [? uring interviervs on 4t23144, the depat#rnent chr̀ef af inpa ent pha nacy,#he pharmacy directar, the me ica# dita tor of tt e hos} i#a! arruff MQ-W v er'e unaware af the" t adc-otdered" Attapine. Fl iM CM$- 236T(QZ-99l Prevbnls VbiSiWte Obsplel9 The p tarmacy Event 1D; J1YN11 F Giliry ID. 264119 1P CAt4ttffi38l` tGf1 ShB@t PSgB 8 Of 11 DEPARTMENT OF HEAt.TH AND HUMAN S RVtCES 4RM APPROVED I Xt) NT OP OEffC1ENCIE& BTATft X3113A7"E SURVEY X2j MULTIPl. E CONSTRIICTtpN PROVlOERlSUPlxL1EWCliA COtAPlETEO iQENTiF1CA'M F+1 Nkit+ ER. ANt? PW F Of' CORRECTtON A BUItOtt 3 B 1MNK3 Q TRE£t AQORESS, CITY ' STATE. ZiP CO l 4ME OF PROVIOER QR 8t1PPl1ER N1AI''Y 77TQ w t} w na SWAINARY STATEMENT Qf OEFlC1ENC n PREI# X rcAc. o+ a was eu { OR TAG7 S L& C IL NTiFYiNO ii w oF cv orrt Co dnued Fr+ p8ge TAG 9 nc C R£ C a CitO&5-REFERENCED TO THE APPROPRIpT£ LTEFIC A 397 aEcrrar EACH CARRECTIYE ACTtON$ HOt1it3 PREfiX ORMATION sor cavaaeas w ao T 8E S RECEDED 8Y FUtI REGI3IATORY i&' F GENCY N EACH ep co, N NCY} A 391 director ar d inpetient p harmacy departmerrt chiefi did not krww t w bng the Attapine haci been unavaitatt te unti! they The t tec mtcian. chedt+! w th s pha nacy chnician repc rtedly s id e A#rapine had been tnissing hom the ctash cart s tt:e flctobe 2013 because tfieir pharmaceutic l verndor was unak e tt rOvit3 the meclic t n. Phartnacy tn rt gemerrt st fif did not make any attempt tct acquire the A opine fram ather sou ces unti{ 4/24I14 w en ttte suraeyor requ+ ested the Atropine tais ed as s as possible. Review of the haspitals" AAedi a! Emergency Respc rtse-Code Btue' i`ea m" polic}t, rnedicai provid rs nd nursss ars required to take Basic l.ife Suppprt. Advanced Cardiac I. ife Support and Pe diat ic Advancet! Life Supp ru# e nery two years. Ba ic i.ife Svppo t, prpcedures or BLS, inctuding CPR, cons'rsts esser iai atti ic# al ventilati, and Advanc d Card'sac basic alsway managememt. Ufe Support. or ACLS, efers tn e set o#dinica# interven ans#ar tfie urgent treatmer a rest, sfroke, anci ather eme encie. c f cardiac ti e#hreatanir g medicai nett as the k as v+ d skill ed to cleptoy thase intervt r tions for the adutt patient. Pediatric Advaneed Life Support, or pALS, is the assessrrae tt and mai tenance of putmonsry and c tculatoryr after an chiid. fur c: ti lnstance in the periad beft rs, ciur r g. and of cardioputr nary arrest in a AccaMing! a i t rview with RN FF an 4f22t14 St 5:0{ PiiAA,# he# taught the BLS, ACl. spfitai's r urse edtr ator ar ci PAl.S t 8sses for ta f until 1 112 years ago when they found she was nat teaching the cflurses based cn#he current American Heatt Asso+3aEion cur€icuit tn. insfivi ual pproved Ant3f sr ras hired to teach the cla ses. Howreve, durir g an intsrview cm 4125/ 14 the CNlC said#his fORM CMS-2567(02-98) Proria,a Ve slcns Obso6efe Event ID. JTYNt t ac iry! D 28t3118 If corrtlnualion Sheet Pa¢8 14 of 71 tnrt DEP 1i2T11AENT OF HEAL.TM AND HUMAN S RV{CES o: a roa. r os4 fO1 M APPi t}VED OI t STA"fEiIAENT 4F OEFIqENC1E3 M Xt) Pii{ NtIDEWSU+ pl1ERlG.fA P#At1 OF CQi# EC1'KX+ 1 1DEN'11FtGlifCEN ist tX2) MUL7iP1.E GONSTftUC`M' IOAi 4X3} DATE SURVEY lB. R: COMALE7ED A BUILDiMG i B WfNC ZSO' I' I$ S/ 2CU QF PROVIOER OEt$ tJPPl.1ER TREET:AGDFt& Ss. CtTY STATE. Z P COCiE FiMMY TT7'd YIflNNEBAGQ 1HS N1? SPiiAt. 41tINN SUM1AARlf STATEMENT C QFt} EC f+ Pi% tEACH i DEfkCIBtJCIES TA6 lEi tl'tfYtPX31N' ORlAATtt11+ N Bf OT! iq11iC1ER'5 P£A{+ 1 L1F CORR£C'fiE'+t 10 fiCiENCv MlJST BE PRECEOED 6Y fULL RECaUi.ATQRY R lSC AGO. NE EACH C F+REFiX tREC7N CR08S REFE TAt# Co AGTIDPI SNOW.t)BE MiCEU T{?TH£ APPR n PRiAI'E OEFtG1ENCY) A 397 Continued Fram page 10 A 387 emplayee wauid imrnediately be removed a a Mainer as he was rwt falio ring the American Hea t um and ins#it ctrn guidelir es. Associatian+ u On 4125114 the h spitai pravid d a pian pf correctian to rernave the lmmediate Jeaaardy aituation. Ta verify in SutY@y0t fSqlisSt lementatiori af the pian ttua i Charge NUfS@ RPI AA demons#rate how she would re spond io a n unrespanshre. RN AA ort sefess ar petformirtg hest com breathiess patient. ttae patients putse p it'# ttsd Checkin ss ts. SE e also sa o she wouid taegin Cheet cornpressians for one or ttvo minutes and then stap tA cail a Cod Blue. RN AA couid nttt tlemartstrate tw w to diai ttte bedsitfer tel ttc hospit e tc announce a Code Blue over the ll' s interr, c system. By 4I251#*t#F htssprtal had not cornpte#ad a oot cause analysis( process ta detetmin the und dy n9 causss af an adverse event) su tounding Pai n# 50's dsath. Th@ fsC11{ty' 8 f811tue t0# t4VidB 8t1 Qnga X@d Clt1t81!'tt service for iis patients posed an lrnmediete Jeopardy to patients that Administratar was no#i i The began on 4117t14 ci t/25/14 at 12:3fl PM that the Immediate Jet>pa rdy vwss ongoing. fORM CI AS- 2567(02-99) W'eWnur Yers ts Ob Ev rt ID: diYNt Fe itY tq. 28D1 a8 f ccu inualz ShOet Page t i Oi i i PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 000 INITIAL COMMENTS PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 000 An entrance conference was conducted with the management staff of the hospital on May 12, 2015. The members of the Federal survey team were introduced including the areas of responsibility for each team members. The purpose of the visit (follow-up survey of all deficiencies cited during the November 6, 2014, survey, a complaint survey and CLIA) was explained. The hospital had the following surveys completed by Federal surveyors from CMS Region VII that cited non-compliance: 1. A recertification survey on October 14, 2011, and cited non-compliance on nine (9) Conditions of Participation: Governing Body, Patients' Right, Quality Assessment and Performance Improvement, Medical Staff, Nursing Services, Radiological Services, Infection Control, Organ/Tissue/Eye, and Emergency Services. 2. A Complaint survey was conducted on April 25, 2014, which resulted in an Immediate Jeopardy citation on the Condition of Participation for Nursing Services. 3. A follow-up survey was completed on May 15, 2014, which resulted in a continuing Immediate Jeopardy citation on the Condition of Participation for Nursing Services. 4. Another follow-up survey was conducted on July 17, 2014, which resulted in a continuing Immediate Jeopardy citation on the Condition of Participation for Nursing Services. 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: Y0Q611 Facility ID: 280119 If continuation sheet Page 1 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 000 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 A 000 5. An EMTALA complaint survey was conducted on August 27, 2014, which resulted in Immediate Jeopardy citation on Medical Screening Examination and Stabilizing Treatment requirements. Survey jurisdiction of this hospital was transferred to Region VI in September 2014. 6. Another follow-up survey was conducted on November 6, 2014, which resulted in non-compliance findings of four (4) Conditions of Participation: Governing Body, Nursing Services, Food & Dietetic Services, and Emergency Services. An exit conference was conducted on May 14, 2015. In attendance onsite were the leadership staff of the hospital including Laboratory staff and some Great Plains IHS Area staff, and via telephone conference line were staff from the Great Plains IHS Area office and IHS HQ in Rockville, MD. The general nature of the preliminary findings were presented and 2 specific examples were discussed. The attendees were informed that the finalization of the survey findings will be dependent on when an advisory opinion from the Quality Improvement Organization is recieved on numerous cases. Based on the survey findings, the following Conditions of Participation and EMTALA FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 2 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 000 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 A 000 requirements were found out of compliance: 42 CFR 482.12 Governing Body 42 CFR 482.23 Nursing Services 42 CFR 482.54 Outpatient Services 42 CFR 482.55 Emergency Services 42 CFR 489.24(a) and (c) Appropriate Medical Screening Examination 42 CFR 489.24(d) Stabilizing Treatment 42 CFR 489.24(e) Appropriate Transfer The failure of the Governing Body to effectively discharge its oversight responsibilities on the services provided to patients, and the failure of the hospital staff to provide appropriate assessment of patients' condition and/or provide appropriate stabilizing treatments was deemed an IMMEDIATE JEOPARDY situation that exposed all patients of this hospital with the likelihood of serious harm, injury, or death. A 043 482.12 GOVERNING BODY A 043 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This CONDITION is not met as evidenced by: The Governing Body failed to discharge its oversight responsibilities effectively to ensure that patients coming to this hospital were provided appropriate care in accordance with accepted standards of practice. Such failure created a situation of immediate jeopardy to the health and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 3 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 043 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 A 043 safety of all patients who come to this hospital for medical care. Review of the incident reporting system with hospital staff showed deficient practices and medical errors were reported but, because of the ineffective Governing Body oversight, such practices were allowed to continue that resulted in the likelihood of serious harm, injury and even death Findings: 1. The Director of Nurses failed to ensure nursing staff have the requisite competency in the care of obstetric patients. The nursing staff did not have the requisite competency to read and/or interpret fetal monitoring, consequently, the nursing staff failed to recognize critical findings . Cross refer to Tag A-397 for details of findings. 2. The hospital staff failed to provide appropriate examinations and treatments within the capabilities of this hospital that adequately addressed the presenting symptoms of 10 out of 30 randomly selected patients. Consequently, some patients had multiple presentations in the Emergency Department before the emergent condition was identified, treated, or patient transferred out for definitive care. Cross refer to Tag A-1100 for details of findings. 3. The hospital staff failed to provide appropriate medical care management to a critically ill patient FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 4 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 043 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 A 043 who had presented to the Emergency Department and the Outpatient Department for back pain. The patient who presented to the Outpatient Department with a complaint of severe pain (rated as 10 on a 0 - 10 pain scale, 10 being the worst pain). The midlevel practitioner who saw the patient found out after the patient had been discharged home, that the laboratory tests done showed critical lab values. However, the midlevel practitioner simply left a message for the patient to return to the hospital in 2 days. Sadly, the patient died at home. Cross refer to Tag A-1076 for details of the findings. 4. The hospital staff failed to provide services in accordance with the EMTALA requirements. Patients that presented to the Emergency Department: a. were not provided appropriate medical screening examination that adequately addressed the patients' presenting symptoms; b. were not provided stabilizing treatment within the capabilities of this hospital; and c. were not transferred to another hospital appropriately. For details of the findings, see Tags A-2406, A-2407, and A-2409. A 049 482.12(a)(5) MEDICAL STAFF ACCOUNTABILITY A 049 [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 5 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 This STANDARD is not met as evidenced by: Based on medical records review, and interview of available and willing staff, the Governing Body failed to ensure that hospital staff provided services to patients in accordance with acceptable standards of care in 10 out of 30 randomly selected patients. Citing Patient # 2, 3, 6, 7, 8, 14, 16, 18, 22 and 28. Findings: 1. Patient #2 was a 15-month old child, who was brought by the parents on January 20, 2015, at 23:00, with complaints of "breathing rapidly, uncomfortable, fever, might need breathing treatment." The RN noted that the oxygen saturation level, at 00:10, was 95% with coarse breath sounds; nebulizer treatment was given. Temperature was recorded as 101.2F, was given Ibuprofen 100mg suspension Patient #2 was seen by a physician, at 23:25, who noted that Patient #2 had "tachypnea with accessory muscles of respiration in use." No further assessments were done and/or treatment provided to ensure that the respiratory condition of Patient #2 has been stabilized. Patient #2 was discharged home at 00:45. Patient #2 was brought back to the ED by parents on January 22, 2015, at 09:37. The RN noted that Patient #2 had "grunting and difficulty breathing." The oxygen saturation level was recorded as 95% with a pulse rate of 138 per minute. Patient #2 was examined by a pediatrician who noted that the patient was in "respiratory distress." Diagnostic work-up done. Nebulizer treatments ordered and administered. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 6 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 Pediatrician decided to transfer patient to a hospital in Sioux City, IA for definitive care. The failure of the staff to provide care and services to meet the needs of Patient #2 during the first presentation placed the health and welfare of this patient in serious jeopardy. 2. Patient #3 was 60-year old patient, who had multiple presentations to the Emergency Department with the same complaint of acute chest pain but the medical management was not provided in accordance with acceptable standards to address a likely cardiac emergency. Patient #3 presented to the Emergency Department on June 14, 2014, at 02:04, complaining of chest pain on inspiration and rated it as 6 on a 0 - 10 pain scale (10 being the worst pain). Patient #3 stated that he had a cough for the past 3 days prior to presentation. Patient #3 was seen by a physician at 02:30. The physician noted that Patient #3 has a history of COPD (chronic obstructive pulmonary disease) and was "SOB (short of breath) mostly in recumbent position." The physician further noted that the lung fields of Patient #3 were "clear to auscultation bilaterally." However, Patient #3 was treated with Albuterol nebulizer at 03:08. Patient #3 was discharged home at 04:15. No further examination or diagnostic work-up was done to evaluate the acute chest pain. Acute chest pain is an emergency medical condition that may represent ischemia or infarct. Patient #3 presented to the Emergency FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 7 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 Department again on July 3, 2014, at 12:12, with similar complaints. Patient #3 was assessed by a Registered Nurse (RN) but no medical evaluation was completed by a physician. Patient #3 was discharged home. The RN was unavailable for interview. Patient #3 presented to the Emergency Department again on July 3, 2014, at 12:49, with complaints of "chest pains/breathing problems." The RN noted that "Pt (patient) c/o (complaint of) difficulty breathing when he tries to lay down, then experiences a burning pain across his upper chest ...... " A Physician Assistant (PA) examined Patient #3 and noted that Patient #3 had "sinus tach (tachycardia)," lung fields were "clear to auscultation bilaterally, normal respiratory effort" and diagnosed the patient with "COPD exacerbation." No physician examined the patient during this presentation. Patient #3 was discharged home at 02:05. The PA was unavailable for interview. No further examination or diagnostic work-up was done to evaluate the acute chest pain. Acute chest pain is an emergency medical condition that may represent ischemia or infarct. Patient #3 presented to the Emergency Department again on July 3, 2014, at 02:58, with similar complaints. The RN noted that "Pt is in car outside ambulance entrance unable to walk per family members." The RN further noted that Patient #3 was "SOB, tearful and grabbing his chest." Patient #3 was examined by a PA at 03:00. No physician examined the patient. PA unavailable for interview. Diagnostic laboratory tests for cardiac enzymes FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 8 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 showed elevated levels: CKMB - 5.6 (normal 0 3), Troponin I - 0.500 (normal <0.35), Myoglobin 151.0 (normal 30 - 90), B-Type Natriuretic Peptide - 193.0 (100 - 300 suggest heart failure is present). Patient #3 was seen by a PA and no physician examined the patient. Patient #3 was eventually transferred to a hospital in Sioux City, IA for further evaluation and stabilizing treatment of a likely cardiac emergency. Patient left the hospital at 13:00 by ambulance. The failure of the hospital staff to conduct an appropriate examination and conduct diagnostic tests to evaluate a likely cardiac emergency condition on previous multiple presentations placed the patient in an Immediate Jeopardy situation with the likelihood of serious harm, injury and death. 3. Patient #6 was a 6-month old child, who was brought to the Emergency Department on February 13, 2015, at 10:00, by the mother. The mother informed the RN that the child had "bad congestion, phlemy (sic) nose, shallow breathing." Patient #6 was seen by a PA who noted that there was "no wheezing appreciated throughout lung fields, no retractions, no additional work of breathing, no see-saw breathing." No further examination was done and/or any diagnostic work-up. PA unavailable for interview. Patient #6 and mother were escorted to the Outpatient Department of the hospital at 10:30. A pediatrician examined Patient #6 who noted that there was "wheezing HEARD WITHOUT FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 9 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 STETHOSCOPE." The pediatrician further noted that there were "wheezes all over lung fields, SUBCOSTAL retractions present." Diagnostic work-up were done at the Outpatient Department and treatment was provided to Patient #6. ED physician on record was interviewed on May 12, 2015, at approximately 13:00. The ED physician essentially told the surveyor that he did not have to do anything for the patient in the Emergency Department. The hospital staff failed to utilize all available resources in the hospital to address the medical condition of the patient that presented in the Emergency Department. The failure of the ED staff to provide appropriate medical examination including diagnostic work-up, and necessary stabilizing treatment within the capability of the hospital placed this patient with the likelihood of serious injury, harm or death. 4. Patient #7 was a 30-year old, who presented to the Emergency Department on May 4, 2015, at 12:29, after reportedly drinking for 3 weeks. Patient #7 stated that "his last drink was around 9am." Further, Patient #7 informed the RN that he was "having frequent episodes of emesis whic (sic) is clear phlegm." Blood pressure reading was recorded as 144/91 with a pulse rate of 124 beats per minute. Patient #7 was seen by the ED physician and noted the blood pressure reading as 179/100 with a pulse rate of 144 beats per minute. The blood pressure was rechecked (time not indicated) and the reading was 185/104 with a pulse rate of 131 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 10 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 beats per minute. Intravenous (IV) fluid of Sodium Chloride with 20 mEq of potassium at 250 ml/hour was started at 14:30. The IV was discontinued at 19:25 and Patient #7 was discharged home at 19:30. No further assessment was done and/or treatment provided to ensure that the patient alcohol withdrawal status was resolved prior to discharge. Patient #7 was brought back to the Emergency Room by the family on May 5, 2015, at 15:21, after at least 2 seizure activities at home. The RN noted that the family members stated that Patient #7 was "just shaky." The RN noted that Patient #7 has fever (101.2F), irregular heart rate (144 beats per minute), and high blood pressure (179/100). The ED physician examined Patient #7. Electrocardiogram was done and showed "atrial fibrillation with RVR (Rapid Ventricular Rate)." Laboratory tests were done and showed that Patient #7 was in "high anion-gap metabolic acidosis, hyponatric/hypochloremic dehydration, and alcoholic hepatitis." Based on the diagnostic work-up done during the second presentation at the Emergency Department, a day after Patient #7 initially presented with symptomatologies of alcohol withdrawal, Patient #7 was in a state of delirium tremens and autonomic instability that required critical care services. This could have been avoided if appropriate examination was done and treatment was provided within the capabilities of this hospital rather than discharging the patient home when he was in an alcohol withdrawal state. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 11 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 5. Patient #8 was a 28-year old pregnant woman, who was a Gravida 4 and para 3 (Pregnancy 4, delivered 3) with gestational age of 36 weeks. Patient #8 presented to the Emergency Department on May 5, 2015, at 03:38, complaining of contractions since 23:00. The patient indicated that the contractions are about 4 to 5 minutes apart. She described the pain as 8 on a 0 - 10 pain scale (10 being the worst pain). Also, stated the contraction lasted about 2 minutes each. Medical record indicated that at 03:45 , Patient #8 was placed on the uterine fetal monitor and according to the ED staff documentation, the fetal heart rate were at 140's to 150's with "Good variability with no decelerations noted." At 03:55, Patient #8 was assessed by the provider and determined that Patient #8 was 2 centimeter dilated with 50% effacement. Review of the patient fetal monitor strip (monitor fetal heart rate and uterine activity for contraction) revealed: 1. The date printed in the monitor strip was 05/12/44. The patient was monitored on 05/05/15. 2. The nursing staff documented the fetal heart rate had "good variability" but there was no variability present in the monitor strip. 3. The nursing staff documented, "no contractions." However, the external tocometer revealed several waves with no reassurance of the location. External uterine contraction monitor FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 12 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 can be affected by patient movements, patient size and location of the monitor. The staff monitoring the patient needs to be present during a contraction and mark the monitor strip to indicate that a contraction started and ended. The staff should always document the frequency of the contraction. 4. The external uterine contraction monitor reads on the 70's that can be interpreted as an indication of abruptio placenta. No further evaluation was done. Abruptio placenta occurs when the placenta separates from the wall of the uterus prior to birth of the baby which can result in severe, uncontrolable bleeding. These external monitor readings can often be affected by positioning of the patient, patient size, placement of the tocometer on the uterus. The staff monitoring the patient should manually palpate the abdomen to ensure uterine relaxation. The staff should document intensity of the contraction with palpation of the abdomen. Results of the review of the patient fetal monitor strip above showed that the staff were unable to adequately assess the condition of Patient #8 either due to inadequate training or no training at all. Lack of competency in the care of obstetric patient places the health and welfare of all obstetric patients that come to this hospital in immediate jeopardy. The medical record indicated that Patient #8 was a high risk obstetric patient with possible pre-term rupture of membranes and possible pre-eclampsia. Record review of the patient fetal monitor strip on May 5, 2015, at 04:45, showed that the patient FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 13 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 was removed from the external fetal monitor. The entry in the monitor strip by the provider reads "Good variability-no decelerations, no contractions." On May 13, 2015, at 14:20, the hospital DON was interviewed concerning the care for obstetric patients. During the course of the interview, the fetal monitor strip for this patient was presented. The DON stated there was no fetal heart accelerations recorded on the monitor strip. The DON also verified that the uterine tocometer needed to be repositioned or the nurse needed to palpate the uterus to verify contractions. 6. Patient #14 was 32-year old, who presented to the Emergency Department on March 16, 2015, at 13:44, with complaints of laceration of left pointer finger and hypertension. The RN noted that the blood pressure (BP) reading was 216/120. Labetalol (anti-hypertensive drug) 20 mg was given intravenously at 14:22. BP was rechecked at 14:30 and recorded as 194/118; at 15:00, BP was 210/105. Labetalol 40 mg was given intravenously at 15:11. Furosemide (diuretic) 40 mg given intravenously (IV) at 16:02, BP was rechecked at 16:15 which was recorded as 180/102. "Nitroglycerin IV 25 mg in 250 mls (milliliter) D5W solution to infuse at 6 mls/hour = 10 mcg/min" was started at 17:14. According to www.dailymed.nlm.nih.gov, , "Nitroglycerin in 5% Dextrose is indicated for treatment of peri-operative hypertension; for FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 14 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and ß-blockers; and for induction of intraoperative hypotension." Further, it stated that "severe hypotension and shock may occur with even small doses of nitroglycerin." Medical record showed that the IV was discontinued at 19:31 and patient was discharged home. There was no further observation and/or assessment done to ensure that the hypertensive emergency was resolved. Failure to observe and assess the patient for a reasonable period of time to ensure that the patient did not have severe hypotension from the drugs administered placed the health and welfare of the patient in immediate jeopardy. 7. Patient #16 was 74-year old, who presented to the Emergency Department on April 25, 2015, at 08:58, with complaints of "unable to urinate since yesterday, bleeding." The RN noted, on arrival, that Patient #16 had a blood pressure reading of 190/95. ED physician examined Patient #16 and noted "hypertensive disorder." Urine specimen was collected via catheterization which showed a "trace" blood in urine. Blood glucose showed an elevated level, 210.2 (normal range: 65 - 100). Patient #16 was discharged home at 11:27. The FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 15 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 ED physician was no longer available for interview. There was no further assessment done on the elevated high blood pressure nor was the elevated blood glucose addressed prior to discharge. No further assessment done and/or treatment given to address the urine retention. There are emergent causes of urinary retention including infections, neurological spinal cord compression, and renal failure. 8. Patient #18 was a 28-year old pregnant woman, who presented to the Emergency Department on April 12, 2015 at 00:18, complaining of "bleeding." The RN noted that Patient 18 was "14 weeks gestation" and "several attempts were made to find fetal heart tones, but were unsuccessful." There were no further attempts made to find fetal heart tones or further assessments done to determine the health status of the fetus. Blood pressure reading on presentation was 129/91. The RN further noted that patient's urine was "turbid, light blood tinged appearance." The RN noted, at 00:45, that Patient #18 went to "bathroom and voids 100ml light blood tinged." At 02:10, "Patient voids 200 ml bright red bloody urine with no clots at this time." Physician unavailable for interview. No further examination and/or diagnostic work-up done. Patient #18 was discharged in care of the mother who was instructed to drive Patient #18 to a hospital in Sioux City, IA via the mother's private vehicle. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 16 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 Continued From page 16 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE A 049 9. Patient #22 was a 30-year old pregnant woman, who was at 25 weeks gestational age. She was a G (gravida) 7, P (para) 6, A (abortions) 0, with a history of premature delivery at 25-weeks. Patient #22 presented to the hospital on May 10, 2015, at 14:20. The RN noted that Patient #22 complained of cramping and vaginal discharge. Patient due date is August 20, 2015. According to medical record, the patient had a history of premature labor with other pregnancies. This pregnancy was number 7. At 14:55, the patient was placed on external monitor (Toco) to monitor uterine contractions and fetal heart rate. Medical record indicated that the doctor conducted a vaginal examination at 15:10. The medical record failed to show fetal heart rate with variability, or the uterine contraction patterns. The patient was discharged home at 15:30. The patient fetal monitor strip done in the Emergency Department showed the fetal heart tone, not reassuring because the heart rate was recording between 60's to 120's. For over one minute, the fetal heart tones recorded on the external toco were not reassuring. A heart rate of 60 is considered alarming in most cases of obstetric emergency. No further evaluation was done to ensure that the health of the fetus was not in jeopardy. Fetal heart tone should be between 120-160's. The uterine contraction toco was not recording any contractions even when the patient said she was cramping. The Emergency Department nurse or doctor did not FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 17 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 document anything related to the fetal activity or uterine contractions. The fetal monitor strip completed in the Emergency Department was dated 04/04/44. On May 13, 2015, at 14:00, an interview was conducted with the Emergency Department nurse. During the interview, the nurse stated that he did not realize that the monitor strip dates were wrong. He also stated that it has been years since the hospital provided a fetal monitor training to staff. On May 13, 2015, at 14:00, an interview with the Outpatient Nurse manager was conducted concerning the nurses fetal monitor training. The manager stated that "nobody here knows how to read a fetal monitor strip. The Director of Nurses may know but she don't come and assess the monitor strips from here or the ED. One or two providers may know. When those providers are not here then nobody read the monitor strips, we sent the patient home without an accurate assessment ." The manager also stated that she has been requesting the DON for a fetal monitor training for her staff and the ED staff, but the DON has not provided the training. On May 13, 2015, at 14:20, an interview with the hospital DON was conducted concerning the fetal monitor training for the nurses in the ED and Outpatient Department. The DON stated that a contract family practice group comes to the clinic once a week and they see all obstetric patients including reading the monitor strips for that day. The DON stated that if a patient needs to be monitored, the nurses or doctors should know how to read a monitor strip. When asked if any staff had request training on fetal monitor strip the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 18 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 DON stated, "no." During the same interview, the monitor strip of the patient in question was presented. The DON stated that the patient should have been monitored closely to verify the fetal heart tones and ensure there were no contractions. The DON also stated that the doctor should have written the cervical examination. The DON verified that the monitor had the wrong date. She said, she didn't know how to change the monitor to the correct date but she will call biomed. Review of the Fetal Monitor Training record provided by the DON on May 14, 2015, revealed that the last training was completed on October 2011. Patient #22 was discharged home after an inadequate medical examination in that the staff were unable to recognize the alarming fetal heart rate recorded on the toco because of either inadequate or no training in that aspect of obstetric care. The monitoring machines used were likely not functioning well due to dead batteries and poor biomedical maintenance as suggested by the wrong date recorded. 10. Patient #28 was 38-year old, who presented to the Emergency Department on May 4, 2015, at 01:01, with swollen right ankle. Patient was examined by an ED physician who noted that Patient #28 had "right ankle swelling, painful weight bearing." The ED physician ordered x-ray of the right ankle which showed "a long oblique fracture of the right distal fibula. There is approximately 2 - 3 mm posterior and lateral displacement of the distal fracture fragment with little distraction. In addition, the ankle mortise seems widened especially medially, suspect FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 19 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 049 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 A 049 underlying instability." Patient was discharged home at 02:14. No further assessment was done and/or treatment provided. The diagnostic examination was not adequate because the initial x-ray findings did not include stress views. The x-ray result showed a widened mortise which represents a potentially unstable fracture that may require surgical repair. Emergency providers typically can reduce and splint such fractures but these were not attempted or done prior to discharge. A 092 482.12(f)(1) EMERGENCY SERVICES A 092 If emergency services are provided at the hospital, the hospital must comply with the requirements of §482.55. This STANDARD is not met as evidenced by: Based on medical records review, and interview of available and willing staff, the hospital staff failed to provide services to patients that came to the Emergency Department that adequately addressed the presenting symptomatologies within the capability of this hospital and in accordance with accepted standards of care in 10 0ut of 30 randomly selected patients. Citing Patient # 2, 3, 6, 7, 8, 14, 16, 18, 22 and 28. Cross refer to Tag -1100 for details of findings. A 385 482.23 NURSING SERVICES A 385 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 20 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 385 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 A 385 This CONDITION is not met as evidenced by: Based on medical records review, and interview of available and willing staff, the Director of Nurses failed to ensure that nursing staff had the requisite competency in the care of obstetric patients. Obstetric patients were assigned to nursing staff who were unable to provide care that meets the needs and condition of patients in 3 out of 30 randomly selected patients. Citing Patient # 8, 18 and 22. Cross refer to Tag A-397 for details of findings. A 397 482.23(b)(5) PATIENT CARE ASSIGNMENTS A 397 A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available. This STANDARD is not met as evidenced by: Based on medical records review, and interview of available and willing staff, the Director of Nurses failed to ensure that patients were assigned to nursing staff according to the staff qualification and competency that meets the nursing care needs and condition of patients in 3 out of 30 randomly selected patients. Citing Patient # 8, 18 and 22. Findings: 1. Patient #8 was a 28-year old pregnant woman, who was a Gravida 4 and para 3 (Pregnancy 4, delivered 3) with gestational age of 36 weeks. Patient #8 presented to the Emergency FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 21 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 397 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 A 397 Department on May 5, 2015, at 03:38, complaining of contractions since 23:00. The patient indicated that the contractions are about 4 to 5 minutes apart. She described the pain as 8 on a 0 - 10 pain scale (10 being the worst pain). Also, stated that the contraction lasted about 2 minutes each. Medical record indicated that at 03:45, Patient #8 was placed on the uterine fetal monitor and according to the ED staff documentation, the fetal heart rate were at 140's to 150's with "Good variability with no decelerations noted." At 03:55, Patient #8 was assessed by the provider and determined she was 2 centimeter dilated with 50% effacement. Review of the patient fetal monitor strip (monitor fetal heart rate and uterine activity for contraction) revealed: 1. The date printed in the monitor strip was 05/12/44. The patient was monitored on 05/05/15. 2. The nursing staff documented the fetal heart rate had "good variability" but there was no variability present in the monitor strip. 3. The nursing staff documented, "no contractions." However, the external tocometer revealed several waves with no reassurance of the location. External uterine contraction monitor can be affected by patient movements, patient size and location of the monitor. The staff monitoring the patient needs to be present during a contraction and a mark the monitor strip to indicate that a contraction started and ended. The staff should always document the frequency of the contraction. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 22 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 397 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 A 397 4. The external uterine contraction monitor read on the 70's that can be interpreted as an indication of abruptio placenta. No further evaluation was done. Abruptio placenta occurs when the placenta separates from the wall of the uterus prior to the birth of the baby which can result in severe, uncontrollable bleeding. These external monitor readings can often be affected by positioning of the patient, patient size, placement of the tocometer in the uterus. The staff monitoring the patient should manually palpate the abdomen to ensure uterine relaxation. The staff should document intensity of the contraction with palpation of the abdomen. Results of the review of the patient fetal monitor strip above showed that the staff were unable to adequately assess the condition of Patient #8 either due to inadequate training or no training at all. Lack of competency in the care of obstetric patient places the health and welfare of all obstetric patients in immeidtae jeopardy. The medical record indicated that Pt. #8 was a high risk obstetric patient with possible pre-term rupture of membranes and possible pre-eclampsia. Record review of the patient fetal monitor strip showed that on May 5, 2015, at 04:45, the patient was removed from the external fetal monitor. The entry in the monitor strip by the provider read "Good variability-no decelerations, no contractions." The monitor strip contradicts that statement. On May 13, 2015, at 14:20, the hospital DON was interviewed concerning the care for obstetric FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 23 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 397 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 A 397 patients. During the course of the interview, the fetal monitor strip for this patient was presented. The DON stated there was no fetal heart accelerations recorded on the monitor strip. The DON also verified that the uterine tocometer needed to be repositioned or the nurse needed to palpate the uterus to verify contractions. When asked, when was the last time the ED nursing staff and providers got training on fetal heart monitor reading, the DON stated, "in 2011." 2. Patient #18 was a 28-year old pregnant woman, who presented to the Emergency Department on April 12, 2015 at 00:18, complaining of "bleeding." The RN noted that Patient 18 was "14 weeks gestation" and "several attempts were made to find fetal heart tones, but were unsuccessful." No further evaluation was done to ensure the health of the fetus. Blood pressure reading on presentation was 129/91. The RN further noted that patient's urine was "turbid, light blood tinged appearance." The RN noted, at 00:45, that Patient #18 went to "bathroom and voids 100ml light blood tinged." At 02:10, "Patient voids 200 ml bright red bloody urine with no clots at this time." Physician unavailable for interview. No further examination and/or diagnostic work-up done. Patient #18 was discharged in care of the mother who was instructed to drive Patient #18 to a hospital in Sioux City, IA via the mother's private vehicle. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 24 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 397 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 A 397 3. Patient #22 was a 30-year old pregnant woman, at 25 weeks gestational age. She was a G (gravida) 7, P (para) 6, A (abortions) 0, with a history of premature delivery at 25-weeks. Patient #22 presented to the hospital on May 10, 2015 at 14:20. The RN noted that Patient #22 complained of cramping and vaginal discharge. Patient due date is 08/20/2015. According to medical record, the patient had a history of premature labor with other pregnancies. This pregnancy is number 7. At 14:55, the patient was placed on external monitor (Toco) to monitor uterine contractions and fetal heart rate. Medical record indicated that the doctor conducted a vaginal examination at 15:10. The medical record failed to show fetal heart rate with variability, or the uterine contraction patterns. The Emergency Department sent the patient home at 15:30. Review of the patient's fetal monitor strip done in the Emergency Department showed the fetal heart tone, was not reassuring because the heart rate was recording between 60's to 120's. No further evaluation was done. For over one minute, the fetal heart tones recorded on the external toco was not reassuring. A heart rate of 60 is considered alarming in most cases of an obstetric emergency. Fetal heart tone should be between 120-160's. The uterine contraction toco was not recording any contractions even when the patient said she was cramping. The Emergency Department nurse or doctor did not FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 25 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 397 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 A 397 document anything related to the fetus activity or uterine contractions. The fetal monitor strip completed on the Emergency Department was dated 04/04/44. On May 13, 2015, at 14:00, an interview was conducted with the Emergency Department nurse. During the interview, the nurse stated that he did not realize that the monitor strip dates were wrong. He also stated that it has been years since the hospital provided a fetal monitor training to staff. On May 13, 2015, at 14:00, an interview with the Outpatient Nurse manager was conducted concerning the nurses fetal monitor training. The manager stated that, "nobody here knows how to read a fetal monitor strip. The Director of Nurses may know but she don't come and assess the monitor strips from here or the ED. One or two providers may know. When those providers are not here then nobody read the monitor strips, we sent the patient home without an accurate assessment." The manager also stated that she has been requesting the DON for a fetal monitor training for her staff and the ED staff, but the DON has not provided the training. On May 13, 2015, at 14:20, an interview with the hospital DON was conducted concerning the fetal monitor training for the nurses in the ED and Outpatient Department. The DON stated that a contract family practice group comes to the clinic once a week and they see all obstetric patient including reading the monitor strips for that day. The DON stated that if a patient needs to be monitored, the nurses or doctors should know how to read a monitor strip. When asked if any staff had request training on fetal monitor strip the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 26 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 397 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 A 397 DON stated, "no." During the same interview, the monitor strip of the patient in question was presented. The DON stated that the patient should have been monitored closely to verify the fetal heart tones and ensure there were no contractions. The DON also stated that the doctor should have written the cervical examination. The DON verified that the monitor had the wrong date. She said, she didn't know how to change the monitor to the correct date but she will call biomed. On May 13, 2015, at 16:00, the DON stated that the two batteries in the fetal monitor located in the ED were dead and that biomed will change the batteries. On May 14, 2015, at 9:00, the surveyor visited the ED to ensure that the Fetal Monitor machine batteries were changed as the DON stated the day before. The visit revealed that the batteries were still not changed and the date in the monitor strip paper was still 04/04/44. On May 15, 2015, at 10:00, an interview with the DON was conducted. The DON stated the batteries will be changed today (05/14/2015). Review of the Fetal Monitor Training record provided by the DON on May 14, 2015, revealed that the last training was completed on October 2011. The nursing staff were unable to recognize the alarming fetal heart rate recorded on the toco because of either inadequate or no training in that aspect of obstetric care. The monitoring machines used were likely not functioning well due to dead batteries and poor biomedical FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 27 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 397 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 A 397 maintenance as suggested by the wrong date recorded. Lack of competency in the care of obstetric patients placed all obstetric patients that come to this hospital in immediate jeopardy with likelihood of serious harm, injury or death. A1076 482.54 OUTPATIENT SERVICES A1076 If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice. This CONDITION is not met as evidenced by: Based on medical record review, and interview of available and willing staff, the hospital failed to provide services that meet the needs of patient in accordance with accepted standards of care in 1 of 30 randomly selected patients. Citing Pt. #29. Patient #29 was 59-year old, who had numerous presentations to the Emergency Department and the Outpatient Department due to chronic back pain. Patient #29 presented to the Outpatient Department on December 17, 2014, at 13:40, with complaint of hip and back pain. Patient #29 was examined by a physician who noted that the pain was rated by the patient as an 8 on a 0 - 10 pain scale (10 being the worst pain). Patient #29 had a history of "vertebral fractures due to what appears to be marked osteoporosis." The RN noted that Patient #29 was seen at the Emergency Department on December 16, 2014, and was "given a shot of Toradol which truly helped his pain. He was also given some Toradol pills which he feels worked better than his Hydrocodone tabs given his last visit." The physician noted that Patient #29 "had been FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 28 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1076 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 A1076 referred to Ortho for consultation and possible kypoplasty/bone wedge placement; and he was also referred for DEXA-Scan; unfortunately due to lack of resources, these were never completed." Patient #29 presented again to the Outpatient Department on December 20, 2014, at 09:34, with complaints of back pain. Patient #29 rated the pain as a 10 on a 0 - 10 pain scale (10 being the worst pain). The midlevel practitioner who saw Patient #29 noted the Patient #29's "color was grey" and "patient is very guarded with any movement, and using crutches to get up and ambulate." Patient was discharged home. There was no treatment provided or assessment of the pain status which was rated by the patient as a 10 on a 0 - 10 pain scale, where 10 is the worst. The medical condition of the patient during this presentation indicated an emergent condition but the midlevel practitioner failed to consult with a physician or asked a physician to examine the patient. Absent of a medical attention and/or intervention placed the health and life of Patient #29 in immediate jeopardy with the likelihood of serious harm, injury, or death. The midlevel practitioner wrote a note on December 30, 2014, at 13:45 that reads "Left a phone message for patient to not take any NSAIDS or calcium (TUMS) products as his calcium is elevated and his kidneys are shutting down. Return to clinic in 2 days (Jan 2nd) to have blood rechecked. Take in extra PO fluids. midlevel practitioner not available for interview. Unfortunately, Patient #29 died on January 1, 2015, at his sister's house. The family of Patient #29 was interviewed on May FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 29 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1076 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 A1076 13, 2015 at 9:00. According to the family member, she felt that the patient was mistreated by the medical staff in the Emergency Room and the Out Patient Clinic. The family member interviewed said that she tried to have him seen in the Emergency Department but the ED staff sent him to the outpatient clinic. She thought that Patient #29 was too sick for the clinic. In the outpatient clinic, he was seen by a Nurse Practitioner who ordered blood work. The family said that he was in terrible pain, 10/10, and he looked real sick. Was not able to walk, swallow or hardly talk. His skin color was like ashes; his eyes had a dead look to her. She was very surprised that Patient #29 was not admitted to the hospital. Instead, he was sent home. According to the family member the decision was very poor because he was in severe pain. "My brother used a walker to ambulate but this time I was surprised to see him in a wheel chair." The family member stated that after a few hours, the Nurse Practitioner called her and told her that the results of the blood work were "panic value," and the Nurse Practitioner told her that he needed an appointment to be seen in two days. The family said if the laboratory results were "critical," why Patient #29 was not admitted to the hospital. The family member stated that Patient #29 was so sick that he took the van to his sister house, 40 minutes away, the family started crying repeatedly saying "they killed him here, he dies two days later, why he did not get the care he needed?" A1100 482.55 EMERGENCY SERVICES FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 A1100 Facility ID: 280119 If continuation sheet Page 30 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. This CONDITION is not met as evidenced by: Based on medical records review, and interview of available and willing staff, the hospital staff failed to provide appropriate examinations and treatments within the capabilities of this hospital in order to meet the emergency needs of 10 0ut of 30 randomly selected patients. Citing Patient # 2, 3, 6, 7, 8, 14, 16, 18, 22 and 28. Findings: 1. Patient #2 was a 15-month old child, who was brought by the parents on January 20, 2015, at 23:00 with complaints of "breathing rapidly, uncomfortable, fever, might need breathing treatment." The RN noted that the oxygen saturation level, at 00:10, was 95% with coarse breath sounds; nebulizer treatment was given. Temperature was recorded as 101.2F, was given Ibuprofen 100mg suspension Patient #2 was seen by a physician, at 23:25, who noted that Patient #2 had "tachypnea with accessory muscles of respiration in use." No further assessments were done and/or treatment provided to ensure that the respiratory condition of Patient #2 has been stabilized. Patient #2 was discharged home at 00:45. Patient #2 was brought back to the ED by parents on January 22, 2015, at 09:37. The RN noted that Patient #2 had "grunting and difficulty breathing. "The oxygen saturation level was recorded as 95% with a pulse rate of 138 per FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 31 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 minute. Patient #2 was examined by a pediatrician who noted that the patient was in "respiratory distress." Diagnostic work-up done. Nebulizer treatments ordered and administered. Pediatrician decided to transfer patient to a hospital in Sioux City, IA for definitive care. The failure of the staff to use all available resources in the management of the condition of Patient #2 during the first presentation placed the health and welfare of this patient in immediate jeopardy. 2. Patient #3 was 60-year old patient, who had multiple presentations to the Emergency Department with the same complaint of acute chest pain but the medical management was not provided in accordance with acceptable standards of care to address a likely cardiac emergency. Patient #3 presented to the Emergency Department on June 14, 2014, at 02:04, complaining of chest pain on inspiration and rated it as 6 on a 0 - 10 pain scale (10 being the worst pain). Patient #3 stated that he had a cough for the past 3 days prior to presentation. Patient #3 was seen by a physician at 02:30. The physician noted that Patient #3 has a history of COPD (chronic obstructive pulmonary disease) and was "SOB (short of breath) mostly in recumbent position." The physician further noted that the lung fields of Patient #3 were "clear to auscultation bilaterally." However, Patient #3 was treated with Albuterol nebulizer at 03:08. Patient #3 was discharged home at 04:15. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 32 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 No further examination or diagnostic work-up was done to evaluate the acute chest pain. Acute chest pain is an emergency medical condition that may represent ischemia or infarct. Patient #3 presented to the Emergency Department again on July 3, 2014, at 12:12, with similar complaints. Patient #3 was assessed by a Registered Nurse (RN) but no medical screening examination was completed by a Qualified Medical Practitioner. Patient #3 was discharged home. The RN was unavailable for interview. Patient #3 presented to the Emergency Department again on July 3, 2014, at 12:49, with complaints of "chest pains/breathing problems." The RN noted that "Pt (patient) c/o (complaint of) difficulty breathing when he tries to lay down, then experiences a burning pain across his upper chest ... ... " A Physician Assistant (PA) examined Patient #3 and noted that Patient #3 had "sinus tach (tachycardia)," lung fields were "clear to auscultation bilaterally, normal respiratory effort" and diagnosed the patient with "COPD exacerbation." No physician examined the patient during this presentation. Patient #3 was discharged home at 02:05. The PA was unavailable for interview. No further examination or diagnostic work-up was done to evaluate the acute chest pain. Acute chest pain is an emergency medical condition that may represent ischemia or infarct. Patient #3 presented to the Emergency Department again on July 3, 2014, at 02:58, with similar complaints. The RN noted that "Pt is in car outside ambulance entrance unable to walk per family members." The RN further noted that FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 33 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 Patient #3 was "SOB, tearful and grabbing his chest." Patient #3 was examined by a PA at 03:00. No physician examined the patient. PA unavailable for interview. Diagnostic laboratory tests for cardiac enzymes showed elevated levels: CKMB - 5.6 (normal 0 3), Troponin I - 0.500 (normal <0.35), Myoglobin 151.0 (normal 30 - 90), B-Type Natriuretic Peptide - 193.0 (100 - 300 suggest heart failure is present). Patient #3 was seen by a PA and no physician examined the patient. Patient #3 was eventually transferred to a hospital in Sioux City, IA for stabilizing treatment of the cardiac emergency. Patient left the hospital at 13:00 by ambulance. The failure of the hospital staff to conduct an appropriate examination and conduct diagnostic tests to evaluate a likely cardiac emergency condition on previous multiple presentation placed the patient in an Immediate Jeopardy situation with the likelihood of serious harm, injury and death. 3. Patient #6 was a 6-month old child, who was brought to the Emergency Department on February 13, 2015, at 10:00, by the mother. The mother informed the RN that the child had "bad congestion, phlemy (sic) nose, shallow breathing." Patient #6 was seen by a PA who noted that there was "no wheezing appreciated throughout lung fields, no retractions, no additional work of breathing, no see-saw breathing." No further examination was done and/or any diagnostic work-up. PA unavailable for interview. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 34 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 Patient #6 and mother were escorted to the Outpatient Department of the hospital at 10:30. A pediatrician examined Patient #6 who noted that there was "wheezing HEARD WITHOUT STETHOSCOPE." The pediatrician further noted that there were "wheezes all over lung fields, SUBCOSTAL retractions present." Diagnostic work-up was done and treatment was provided to Patient #6 at the Outpatient Department. ED physician on record was interviewed on May 12, 2015, at approximately 13:00. The ED physician was asked if he examined Patient #6 and/or conducted diagnostic work-up to determine whether an emergency medical condition existed. The ED physician stated that the PA examined the patient and there was no indication that he should have to see the patient himself. The ED physician was asked to explain the discrepancy between the PA's finding regarding the patient's respiratory status and the pediatrician's finding of respiratory distress upon the patient's arrival at the Outpatient Department. The ED physician stated that he "did what was required of me by law. I didn't have to do anything else. I understand EMTALA well, and let me tell you about the law ....... " The hospital staff failed to utilize all available resources in the hospital to address the medical condition of the patient that presented in the Emergency Department. The failure of the ED staff to provide appropriate medical examination including diagnostic work-up, and necessary stabilizing treatment within the capability of the hospital placed this patient with the likelihood of serious injury, harm or death. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 35 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 4. Patient #7 was 30-year old, who presented to the Emergency Department on May 4, 2015, at 12:29, after reportedly drinking for 3 weeks. Patient #7 stated that "his last drink was around 9am." Further, Patient #7 informed the RN that he was "having frequent episodes of emesis whic (sic) is clear phlegm." Blood pressure reading was recorded as 144/91 with a pulse rate of 124 beats per minute. Patient #7 was seen by the ED physician and noted the blood pressure reading as 179/100 with a pulse rate of 144 beats per minute. The blood pressure was rechecked (time not indicated) and the reading was 185/104 with a pulse rate of 131 beats per minute. Intravenous (IV) fluid of Sodium Chloride with 20 mEq of potassium at 250 ml/hour was started at 14:30. The IV was discontinued at 19:25 and Patient #7 was discharged home at 19:30. No further assessment was done and/or treatment provided to ensure that the patient's alcohol withdrawal was resolved. Patient #7 was brought back to the Emergency Room by the family on May 5, 2015, at 15:21, after at least 2 seizure activities at home. The RN noted that the family members stated that Patient #7 was "just shaky." The RN noted that Patient #7 has fever (101.2F), irregular heart rate (144 beats per minute), and high blood pressure (179/100). The ED physician examined Patient #7. Electrocardiogram was done and showed "atrial fibrillation with RVR (Rapid Ventricular Rate)." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 36 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 Laboratory tests were done and showed that Patient #7 was in "high anion-gap metabolic acidosis, hyponatric/hypochloremic dehydration, and alcoholic hepatitis." Based on the diagnostic work-up done during the second presentation at the Emergency Department, a day after Patient #7 initially presented with symptomatologies of alcohol withdrawal, Patient #7 was in a state of delirium tremens and autonomic instability that required critical care services. This could have been avoidable if appropriate examination was done and treatment was provided within the capabilities of this hospital rather than discharging the patient home when he was in an alcohol withdrawal state. Patient #7 was transferred to a hospital in Sioux City, IA via ambulance to obtain the critical care services that Patient #7 required. 5. Patient #8 was a 28-year old pregnant woman, who was a Gravida 4 and para 3 (Pregnancy 4, delivered 3) with gestational age of 36 weeks. Patient #8 presented to the Emergency Department on May 5, 2015, at 03:38, complaining of contractions since 23:00. The patient indicated that the contractions are about 4 to 5 minutes apart. She described the pain as 8 on a scale of 0 - 10 pain scale (10 being the worst pain). Also, stated the contraction lasted about 2 minutes each. Medical record indicated that at 03:45, Patient #8 was placed on the uterine fetal monitor and according to the ED staff documentation, the fetal FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 37 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 heart rate were at 140's to 150's with "Good variability with no decelerations noted." At 03:55, Patient #8 was assessed by the provider and determined that Patient #8 was 2 centimeter dilated with 50% effacement. Review of the patient fetal monitor strip (monitor fetal heart rate and uterine activity for contraction) revealed: 1. The date printed in the monitor strip was 05/12/44. The patient was monitored on 05/05/15. 2. The nursing staff documented the fetal heart rate had "good variability but there was no variability present in the monitor strip. 3. The nursing staff documented, "no contractions." However, the external tocometer revealed several waves with no reassurance of the location. External uterine contraction monitor can be affected by patient movements, patient size and location of the monitor. The staff monitoring the patient needs to be present during a contraction and a mark the monitor strip to indicate that a contraction started and ended. The staff should always document the frequency of the contraction. 4. The external uterine contraction monitor read on the 70's that can be interpreted as an indication of abruptio placenta. No further evalulation was done. Abruptio placenta occurs when the placebta separates from the wall of the uterus prior to the birth of the baby which can result in severe. uncontrollable bleeding. These external monitor readings can often be affected by positioning of the patient, patient size, placement of the tocometer in the uterus. The FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 38 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 staff monitoring the patient should manually palpate the abdomen to ensure uterine relaxation. The staff should document intensity of the contraction with palpation of the abdomen. Results of the review of the patient fetal monitor strip above showed that the staff were unable to adequately assess the condition of Patient #8 either due to inadequate training or no training at all. Lack of competency in the care of obstetric patient places the health and welfare of all obstetric patients that come to this hospital in immediate jeopardy. The medical record indicated that Patient #8 was a high risk obstetric patient with possible pre-term rupture of membranes and possible pre-eclampsia. Record review of the patient fetal monitor strip showed that on May 5, 2015, at 04:45, patient was removed from the external fetal monitor. The entry in the monitor strip by the provider reads "Good variability-no decelerations, no contractions." On May 13, 2015, at 14:20, the hospital DON was interviewed concerning the care for obstetric patients. During the course of the interview, the fetal monitor strip for this patient was presented. The DON stated there was no fetal heart accelerations recorded on the monitor strip. The DON also verified that the uterine tocometer needed to be repositioned or the nurse needed to palpate the uterus to verify contractions. When asked, when was the last time the ED nursing staff and providers got training on fetal heart monitor reading, the DON stated, "in 2011." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 39 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 6. Patient #14 was 32-year old, who presented to the Emergency Department on March 16, 2015, at 13:44, with complaints of laceration of left pointer finger and hypertension. The RN noted that the blood pressure (BP) reading was 216/120. Labetalol (anti-hypertensive drug) 20 mg was given intravenously at 14:22. BP was rechecked at 14:30 and recorded as 194/118; at 15:00, BP was 210/105. Labetalol 40 mg was given intravenously at 15:11. Furosemide (diuretic) 40 mg given intravenously (IV) at 16:02, BP was rechecked at 16:15 which was recorded as 180/102. "Nitroglycerin IV 25 mg in 250 mls (milliliter) D5W solution to infuse at 6 mls/hour = 10 mcg/min" was started at 17:14. According to www.dailymed.nlm.nih.gov, , "Nitroglycerin in 5% Dextrose is indicated for treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and ß-blockers; and for induction of intraoperative hypotension." Further, it stated that "severe hypotension and shock may occur with even small doses of nitroglycerin." Blood pressure readings after the initiation of the Nitroglycerine IV were recorded as: 17:45 - 155/99 18:00 - 152/87 18:11 - 191/108 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 40 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 19:00 - 155/90 19:10 - 167/99 Medical record showed that the IV was discontinued at 19:31 and patient was discharged home. There was no further observation and/or assessment done to ensure that the hypertensive emergency was resolved. Failure to observe and assess the patient for a reasonable period of time to ensure that the patient did not have severe hypotension from the drugs administered placed the health and welfare of the patient in immediate jeopardy. 7. Patient #16 was 74-year old, who presented to the Emergency Department on April 25, 2015, at 08:58, with complaints of "unable to urinate since yesterday, bleeding." The RN noted, on arrival, that Patient #16 had a blood pressure reading of 190/95. ED physician examined Patient #16 and noted "hypertensive disorder." Urine specimen was collected via catheterization which showed a "trace" blood in urine. Blood glucose showed an elevated level, 210.2 (normal range: 65 - 100). Patient #16 was discharged home at 11:27. The ED physician was no longer available for interview. There was no further assessment was done on the elevated high blood pressure nor was the elevated blood glucose addressed prior to discharge. No further assessment was done and/or treatment given to address the urine FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 41 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 retention. There are emergent causes of urinary retention including infections, neurological spinal cord compression, and renal failure. 8. Patient #18 was a 28-year old pregnant woman, who presented to the Emergency Department on April 12, 2015 at 00:18, complaining of "bleeding." The RN noted that Patient 18 was "14 weeks gestation" and "several attempts were made to find fetal heart tones, but were unsuccessful." No further assessments were done to determine the health status of the fetus. Blood pressure reading on presentation was 129/91. The RN further noted that patient's urine was "turbid, light blood tinged appearance. " The RN noted, at 00:45, that Patient #18 went to "bathroom and voids 100ml light blood tinged." At 02:10, "Patient voids 200 ml bright red bloody urine with no clots at this time." Physician unavailable for interview. No further examination and/or diagnostic work-up done. Patient #18 was discharged in care of the mother who was instructed to drive Patient #18 to a hospital in Sioux City, IA via the mother's private vehicle. 9. Patient #22 was a 30-year old pregnant woman, who was at 25 weeks gestational age. She was a G (gravida) 7, P (para) 6, A (abortions) 0, with a history of premature delivery at 25-weeks. Patient #22 presented to the hospital on May 10, 2015 at 14:20. The RN noted that Patient #22 complained of cramping and vaginal discharge. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 42 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 Patient due date is 08/20/2015. According to medical record, the patient had a history of premature labor with other pregnancies. This pregnancy was number 7. At 14:55, the patient was placed on external monitor (Toco) to monitor uterine contractions and fetal heart rate. Medical record indicated that the doctor conducted a vaginal examination at 15:10. The medical record failed to show fetal heart rate with variability, or the uterine contraction patterns. The patient was discharged home at 15:30. The patient fetal monitor strip done in the Emergency Department showed the fetal heart tone, was not reassuring because the heart rate was recording between 60's to 120's. No further evaluation was done. For over one minute, the fetal heart tones recorded on the external toco was not reassuring. A heart rate of 60 is considered alarming in most cases of an obstetric emergency. Fetal heart tone should be between 120-160's. The uterine contraction toco was not recording any contractions even when the patient said she was cramping. The Emergency Department nurse or doctor did not document anything related to the fetal activity or uterine contractions. The fetal monitor strip completed on the Emergency Department was dated 04/04/44. On May 13, 2015, at 14:00, an interview was conducted with the Emergency Department nurse. During the interview, the nurse stated that he did not realize that the monitor strip dates were wrong. He also stated that it has been FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 43 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 years since the hospital provided a fetal monitor training to staff. On May 13, 2015, at 14:00, an interview with the Outpatient Nurse manager was conducted concerning the nurses fetal monitor training. The manager stated that "nobody here knows how to read a fetal monitor strip. The Director of Nurses may know but she don't come and assess the monitor strips from here or the ED. One or two providers may know. When those providers are not here then nobody read the monitor strips, we sent the patient home without an accurate assessment." The manager also stated that she has been requesting the DON for a fetal monitor training for her staff and the ED staff, but the DON has not provided the training. On May 13, 2015, at 14:20, an interview with the hospital DON was conducted concerning the fetal monitor training for the nurses in the ED and Outpatient Department. The DON stated that a contract family practice group comes to the clinic once a week and they see all obstetric patient including reading the monitor strips for that day. The DON stated that if a patient needs to be monitored, the nurses or doctors should know how to read a monitor strip. When asked if any staff had request training on fetal monitor strip the DON stated, "no." During the same interview, the monitor strip of the patient in question was presented. The DON stated that the patient should have been monitored closely to verify the fetal heart tones and ensure there were no contractions. The DON also stated that the doctor should have written the cervical examination. The DON verified that the monitor had the wrong date. She said, she didn't know how to change the monitor to the correct date but FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 44 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 she will call biomed. On May 13, 2015, at 16:00, the DON stated that the two batteries in the fetal monitor located in the ED were dead and that biomed will change the batteries. On May 14, 2015, at 9:00, the surveyor visited the ED to ensure that the Fetal Monitor machine batteries were changed as the DON stated the day before. The visit revealed that the batteries were still not changed and the date in the monitor strip paper was 04/04/44. On May 15, 2015, at 10:00, an interview with the DON was conducted. The DON stated the batteries will be changed today (05/14/2015). Review of the Fetal Monitor Training record provided by the DON on May 14, 2015, revealed that the last training was completed on October 2011. Patient #22 was discharged home after an inadequate medical examination in that the staff were unable to recognize the alarming fetal heart rate recorded on the toco because of either inadequate or no training in that aspect of obstetric care. The monitoring machines used were likely not functioning well due to dead batteries and poor biomedical maintenance as suggested by the wrong date recorded. 10. Patient #28 was 38-year old, who presented to the Emergency Department on May 4, 2015, at 01:01, with swollen right ankle. Patient was examined by an ED physician who noted that FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 45 of 46 PRINTED: 02/10/2016 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 280119 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG 05/14/2015 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 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 A1100 Patient #28 had "right ankle swelling, painful weight bearing." The ED physician ordered x-ray of the right ankle which showed "a long oblique fracture of the right distal fibula. There is approximately 2 - 3 mm posterior and lateral displacement of the distal fracture fragment with little distraction. In addition, the ankle mortise seems widened especially medially, suspect underlying instability." Patient was discharged home at 02:14. No further assessment done and/or treatment provided. The diagnostic examination was not adequate because the initial x-ray findings did not include stress views. The x-ray result showed a widened mortise which represents a potentially unstable fracture that may require surgical repair. Emergency providers typically can reduce and splint such fractures but these were not attempted or done prior to discharge. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: Y0Q611 Facility ID: 280119 If continuation sheet Page 46 of 46 EXHIBIT 20 MEDICAL RECORD Progress Notes NOTE DATED: 05/04/2012 18:42 GENERAL CLINIC VISIT: 05/04/2012 18:21 ADAMS 05/04/12 18:21 WAKANDA GONSALVES is a 19 old FEMALE who presents for Chief Complaint: 19 yr old female presents amb to clinic with c/o right upper chest pain and cough with bright red blood. Subjective: cough for 1 month. some red blood noted. has vague rt. chest pain. admits to some depression. Allergies: Patient has answered NKA Objective: (36.6 C), 02:96, WT 153.00 (69.46 kg), (175.26 cm) ent? normal neck? no masses heart- lungs? clear and chest xray done Assessment and Plan: Follow Up Plans: in Imp- cough, r/o cough Rx? robitussinac, loraxepam .5 mg tid, albutero inhaler. Signed by: /eS/ PJ ADAMS MD 05/04/2012 19:12 05/04/2012 19:13 ADDENDUM STATUS: COMPLETED recheck in 5 days. Signed by: /es/ PJ ADAMS MD 05/04/2012 19:13 ONAWA w. w. KEEBLE HEALTH CARE CENTE Printed:05/15/2012 14:39 23940 DOB 04/28/1993 Pt Loc: OUTPATIENT Vice SF 509 Page'1of5 20kg EXHIBIT 2e 0 . 9 Mldwest Medlcal Examlner .5 Office 14341 Rhinestone Street NW, Ramsey, MN 55303 Phone: 763-323-6400 an: 761L323-[ir17li 16Quinn Strobl MD. Chief Medical Examiner Anne Bracey MJ). a Michael Madsen MJ). Shannon Muclwy MJ). .July16,2012 Mr. and Mrs. Gonsalves 603 Spruce Street Summit, SD 57266 Dear Mr. and Mrs. Gonsalves: On behalf of the Midwest Medical Examiner?s Office, I would like to extend my condolences on the loss of your daughter, Wakanda. At your request, we performed an autopsy to determine the cause of Wakanda?s death. The postmortem examination identified a thromboembolus. or clot1 completely blocking one of the main arteries to the lungs (left pulmonary artery) and thromboembolus within the main pulmonary artery and right pulmonary artery. Additional, smaller thromboemboli were identified in the periphery of the lungs as well. The pulmonary arteries are large blood vessels that deliver blood from the heart to the lungs. A pulmonary embolus is a blood clot which travels from the body and circulates through the heart to the pulmonary arteries ofthe lungs. As the pulmonary arteries narrow this blood clot becomes stuck which results in decreased blood flow to the lung tissue. There are rare instances of blood clots which form in the blood vessels of the lungs themselves. It is important for the family to realize that blood clots can form as a result of several bleeding or clotting disorders that can have a heredity or genetic component. Family members should inform their personal physicians and may want to be evaluated for these certain types of clotting disorders. I would like to offer you my sincerest condolences on the death of your daughter. With deepest sympathyLil/i 3-1 3 1? ?my: A. Quinn Strobl, MD. Forensic Pathologist AQS:bab Page?l of5 ?Tl Midwest Medical Examiner?s Office Mammary 14341 Rhinestone Street: NW, Ramsey, MN 55303 Phone: 763-323-6400 0 Fax: A. Quinn Strobl MJ). Chief Medical Examiner Anne Bracey MD. 0 Michael Madson MJ). 0 Shannon Mackey M.D. FINAL AUTOPSY PROTOCOL 9642?0008 NAME: Wakanda Onawa Gonsalves DOB: 04?28?1993 SEX: AGE: 19Y DATE OF DEATH: 05-07-2012 TIME: 0819 Hours DATE OF EXAM: 06-27-2012 TIME: 1115 Hours TYPE OF EXAM: Complete Examination PLACE OF DEATH: Milbank South Dakota Area Hospital, 901 East Virgil Avenue, Milbank, SD AUTOPSY PERFORMED BY: A. Quinn Strobl, MD. PLACE OF EXAM: Midwest Medical Examiner?s Office, Ramsey, Minnesota FINAL DIAGNOSES Pulmonary thromboembolism Clinical history of sudden collapse B. Recent complaints of cough and chest tightness over preceding month C. Large pulmonary thromboembolus occupying main pulmonary artery and branches With occlusion of the left main pulmonary artery Peripheral thromboemboli A. Quinn Strobl, MD. Forensic Pathologist AQS:bab 071612 Page 2 of 5 Lid-1 Wednesday, March 30, 2016 Dear Dr. Karol: i am writing this ID, DOB 1/22/1977 seen~atPHS hospital-on Monday 3/21/2016 at 0214 and then again at 1537 on the same day. I believe the care the patient received was below the standard of care. On her initial evaluation, her initial complaint was shortness of breath. At the first visit her heart rate was found to be 116 and her respiratory rate was 24. Her chronic problems noted by the physician . Included TYPE ?diabetic peripheral neuropathy,? and ?diabetic keto-acidosis,? among other diagnoses.- in the note it indicates that ?medications were reviewed and reconciled? however the only medications listed were lorazepam, and aspirin. However, this did not re?ect that she is a diabetic who is dependent upon insulin. - . The physical exam that occurred was a limited one, but did identify that the patient was anxious. Point of care assessments such as a urine dipstick, a ?ngerstick glucose check, or an EKG were not performed although the patient?s chronic conditions due put her at increased risk for cardiac events, ketoacidosis and The assessment included ?anxiety attack,? "hyperventilation,? and ?asthma." The differential diagnoses listed included only one condition, asthma. There is no objective ?nding in the documentation to Suggest that asthma was a cause of her however. The ?nal diagnosis was i?An?xiety hyperventilation" and that an ?Emergency condition [was] not present.? The plan included "cardiopulmonary monitoring,? ?Removed nasal cannula as she is fully saturated on ?Ativan for anxiety,? ?Reassurance'no need for images or labs since all Vitals are and "Advised to avoid hyperventilation as it makes her more anxious.? From that plan it could be inferred that the patient had requested further workup and was dissuaded from it. It- also is unclear Whether any responded to the Ativa?n that was administered. And '3 although it mentions that her Vitals were normal they were not. Her only recorded heart rate was a tachycardic level and her only recorded respiratory rate was Unfortunately, the was very likely a result of her diabetic ketoacidosis and so the advice to sti?e her hyperventilation would be physiologically impossible. Twelve hours later she was evaluated by another provider and was hemodynamically unstable. She was hypotensive and unresponsive. Her heart rate and respiratory rate were both elevated again, her blood sugar was above 1000, and her pH was 6.78. She was transferred by air ambulance at that time. I believe this could and should have been avoided with a few simple measures. Simple point of care tests could have revealed an abnormality to be tested. In other settings, a provider might not be aware that a patient has diabetes but in this case it was documented in the provider? 5 own note that this patient had experience diabetic ketoacidosis in the past, which should have triggered alarm bells. Medication reconciliation does not appear to have been done in anything other than a cursory manner. .l'Ve found that for the patients we serve, I've never regretted getting .a ?ngerstick glucose check and trust that beyond simply asking about the cardinal of diabetes, which are often unreliable. I am asking that measures be taken immediately to improve the emergency care delivered to the patients in the Emergency Department at the Omaha/Winnebago PHS Hospital. I believe this is an urgent matter. . . Very Respectfully, Mark Morgan MD. CDR UPSHS Clinical Director - Carl Curtis Health Education Center WINNEBAGO IHS HOSPITAL 10/14/2011 CMS-2567 AND PLAN OF CORRECTION t""r(ll\111::.LJ. .PARTMENT OF HEALTH AND HUMAN SERVICES ,ENTERS FOR MEDICARE & MEDICAID SERVICES ,TATEMENT OF DEFICIENCIES >Jlele 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE WINNEBAGO IHS HOSPITAL ()(4) ID PREFIX (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING UPDATE: 12/27 /11 IOP director will monitor grievance procedure process for compliance. will provide monthly report on compliance CEO, DON, CD and all Team leaders (supervisors). w11111 Governing Body bylaws were updated to reflect that the grievance committee can validate and resolve complaints per the grievance policy A 119 11'\ I _I Facility JD: 280119 '_p 0 •\'-J\ ~\<\,ij- ) If continuation sheet Page 15 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION . (XI) PROVlDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING 280119 NAME OF PROVlDER OR SUPPLIER 1011412011 STREET ADDRESS, CITY. STATE, ZIP CODE HWY77·75 WINNEBAGO !HS HOSPITAL (X4)1D PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST Bl': PRECEDED BY FULL REGULATORY OR LSC IDENTIFYNG INFORMATION) A 119 Continued From page 15 GRIEVANCES PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (XS) COMPLETION DATE A 119 [The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance.] The hospital's governing body must approve and be responsible for the effective operation of the grievance process, and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee. Governing body bylaws and the Grievance Policy will be revised with the statement that the grievance team wHI verify that plan of corrections have been implemented and identify a complaint resolved. SEE: ATIACHMENTS: 1 ATIACHMENTS: 7 11/8/11 This STANDARD is not met as evidenced by: Based on Governing Body Bylaws review, policy review, patient grievances review, and staff interview, the governing body failed to delegate the responsibility to resolve patient grievances to the grievance committee and ensure staff resolved grievances to patient satisfaction. The facility identified a census of 2. Findings included: Review of the Governing Body Bylaws with a revision date of 6/23/11 states in part, "3. 02 Authority D. Grievance committee: Will review all written grievance and make decision on validation of each grievance. The committee members are IOP [Improving Operation Performance] Director, Risk Manger/IOP assistant, Compliance officer, and Human Resources. This committee will report all findings to the CEO [Chief Executive Officer]." This statement does not delegate the authority for the responsibility of the effective operation of the grievance process or the responsibility to resolve grievances. Review of policy titled, "Patient Grievance FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: !8051 I Facility ID: 280119 If continuation sheet Page 16 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (Xl) PROVIDERISUPPLIERICLIA lDENTlFlCATION NUMBER: 280119 Ei WING _ _ _ _ _ _ _ _ __ 10/14/2011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77.75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG· (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYlNG INFORMATION) A 119 Continued From page 16 Policy" with a signature by the CEO as the Chairman of the Governing Body as the final approval of the policy on 6123111, states in part, "V. Responsibilities A. Grievance committee will review all grievance investigations, verbal complaints and patient issues, they will then validate the grievances and submit findings to the CEO, department head and supervisor." Interview with the IOP/Risk Manager (RM) on 10/14/11 at 11 :46 AM confirms the Grievance Committee reviews the investigation done by the department head and validates their findings as to where the complaint is valid or not. The Grievance Committee does not discuss how to prevent the issue from happening again or how to resolve the complaint for the patient. A 123 482.13(a)(2)(iii) PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) jX5) COMPLETION DATE A 119 A 123 At a minimum: In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. This STANDARD is not met as evidenced by: Based on policy review, patient grievances review, and staff interview, the facility failed to inform patients in writing of the steps taken to investigate the grievance, the results of the grievance process, and the date of completion of the investigation. The facility identified a census of 2. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: J8DS 11 Facility IQ: 280119 If continuation sheet Page 17 of 93 PRINTED: 10/19/2011 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PRO\llDER/SUPPLIER/CLIA IDENTIFICATION NUMBER. 280119 NAME OF PROVIDER OR SUPPLIER FORM APPROVED OMB NO 0938-0391 A BUILDING B WING _ _ _ _ _ _ _ _ _ __ (X4)1D HWYn.75 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 123 Continued From page 17 Findings included: PROlllOER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG {XS) COMPLETION DAlE A123 1 ,_~~~~~~~~~~~~-'l~~­ Review of policy titled, "Patient Grievance Policy" with a signature by the CEO [Chief Executive Officer] as the Chairman of the Governing Body as the final approval of the policy on 6/23/11, states in part, "Grievance Investigation: ... F. The CEO will develop the final conclusion letter to the patient" The policy failed to outline the specific information to be contained in the notice to the patient. Review of 6 of 6 (#35, #36, #37, #38, #39, and #40) Winnebago Verbal complaint Forms Jacks evidence a letter has been sent to the patient acknowledging the complaint or any attempts to resolve the complaint.. Interview on 8/30/11 at 3:00 PM with the Improving Operation Performance/Risk Manager (!OP/RM) confirmed no preliminary Jetter has been sent to any of the 6 patients with verbal complaints. Two of the 6 (#35 and #36) fell outside the 30 day completion lime frame and had no Jetter regarding the resolution. Review of 2 of 2 (#42 and #43) complaint investigations Jacks evidence the facility sent a letter to the complainant regarding the steps taken to investigate the grievance, the results of the grievance process, or the completion date of the investigation. Interview on 8/30/11 at 3:00 PM with the IOP/RM confirmed no letter had been sent to patients #42 and #43 regarding the steps taken to investigate a grievance, the results of the grievance process, or the completion date of the investigation FORM CMS-2567(02-99) Previous Versions Obsolete 10/14/2011 STREET ADDRESS. CITY, STATE. ZIP CODE WINNEBAGO IHS HOSPITAL PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION Event lD:18DS11 The Grievance policy states verbal complaints that are unable to resolve at the time of the visit will be turned into a written grievance and processed as a formal complaint. 11/8/11 The Grievance Policy will be modified to include close out of investigation, plan of correction and resolution 11/8/11 I date. I1 111s111 The Grievance policy will be revised to state that the CEO will be notified if the investigation has not been completed within 7 working days. 11/3/11 The name and phone number of the CEO to the final letter if the patient chose to appeal the findings in the final letter 11/30/11 Staff will be trained by IOP Director on the grievance policy changes and each employee will be given a copy of approved grievance policy. A summary of the steps taken to review the grievance will be added to the final letter to the patient, including: who was notified, POC provided by the supervisors, grievance team review date and date grievance investigation was completed. The complaint monitoring log will be modified to 1nc1uae aate investigation closed; POC submitted by supervisor(s) and verification from supervisor(s) that POC have been implemented and date grievance identified as "resolved". 11/30/11 11/3~ SEE: ATTACHMENTS: 7 ATTACHMENTS: 8 ATTACHMENTS: 9 ATTACHMENTS: 10 Facility ID: 280119 lf continuation sheet Page 18 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1 I PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER. 280119 NAME OF PROVIDER OR SUPPLIER COMPLETED A BUILDING B WING _ _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG (X3) DATE SURVIEY (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 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 ID PREFIX TAG (X5) COMPLEllON DATE DEFICIENCY) A 123 Continued From page 18 because the investigation had not been completed within the 30 day timeframe. Review of 4 of 4 (#6, #8, #41, and #44) letters written to patients following a grievance investigation lacks evidence of the patient being informed of the steps taken to investigate the grievance, the results of the grievance process, or the completion date of the investigation. A 144 482.13(c)(2) PATIENT RIGHTS: CARE IN SAFE SETTING A 123 A 144 Revised Patient Fall Protocol on 4-22-11 to include The patient has the right to receive care in a safe setting. Nurse Educator will conduct re-education on Fall Physical Therapy conducted training on techniques on lifting patients in August 2011. 100% of the nursing staff will be trained by November 30, 2011. 11/30/11 Inpatient Monitor developed by Nursing Supervisor to include Fall assessment. 100% inpatient chart audit will be completed monthly by the Inpatient supervisor clinical nurse. Data will be reported to nursing departmental meetings and 10P monthly. Data will be reported to the Safety Committee quarterly. Findings included: The patient has the right to be free from all forms of abuse or harassment. 11/30/11 protocols to all nursing staff by November 30, 2011. This STANDARD is not met as evidenced by: Based on medical record review, policy review, incident report review, Medical Staff Bylaws, Rules, and Regulations review, and staff interview, the facility failed to ensure nursing staff provided care in a safe setting for 6 of 32 (#1, #7, #22, #32, #33, and #45) patients reviewed due to the failure to assess and provide appropriate interventions. The facility identified a census of 2. See A-395 See A-1100 A 145 482.13(c)(3) PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT 11/8/11 post-fall follow up by Nursing Supervisor. A 145 IOP/ Risk management Director will provide training to 100% of facility staff on the Abuse and Neglect Policy by November 30, 2011. 11/30/11 Abuse and Neglect Training will be provided annually beginning January 2012 in new orientation and mandatory staff trainings. 1/2012 SEE: ATTACHMENTS: 11 AITACHMENTS: 12 ATTACHMENTS: 13 ATTACHMENTS: 14 This STANDARD is not met as evidenced by: Based on medical record review, policy review, FORM CMS-2567(02-99) Previous Versions Obsolele EventJO.IBDS11 ATTACHMENTS: 9 Facility ID. 280119 If continuation sheet Page 19 of 93 PRINTED: 10/19/2011 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (XI) PROVIDER/SUPPLIERICLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVIDER OR SUPPLIER OMB NO 0938-0391 (X2) MULTIPLE CONSTRUCTION COMPLETED A BUILDING B. WING _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A 145 A 145 Continued From page 19 and staff interview, the facility failed to ensure nursing staff evaluated 1 of 32 (#45) patient reviewed for abuse by her mother and took action to separate the patient from the potential abuser to protect her. The facility identified a census of 2. Findings included: Review of medical record for Patient #45, 15 years old, admitted to the medical surgical unit with a diagnosis of suicidal ideations and superficial skin lacerations on 9/28/11. Further review of the medical record shows Patient #45 presented lo the emergency room with police with complaints she would hurt herself if she had to go back to her mom's house tonight. ... Relates that she has been thinking about suicide lately but that today is the first time she has said anything out loud. Denies having a plan to commit suicide." The medical record indicates Patient #45 reports that her mother hit her with a toilet brush and scratched her left arm and leg. Patient #45's mother acknowledged throwing a toilet brush at Patient #45. Physical examination shows Patient #45 had 2 superficial scratches approximately 3 cm to the left upper arm and 1 superficial scratch to left lower arm approximately 3 cm. There are also 2 moon shaped superficial scratches to lateral aspect left arm below the elbow. The medical record indicates staff transferred Patient #45 to the medical surgical unit on 9/28/11 at 1O:00 PM. Review of the medical record reveals a nursing pediatric admission form completed 9/29/11 at 3: 11 AM. Patient #45 answered 'yes' to the question "Has your partner or someone important to you ever hurt you?". Patient #45 answered FORM CMS-2567(02-99) Previous Versions Obsolete Event 10: l8DS11 A 145 !OP/RM will provide training to 100% of facility staff on the Abuse and Neglect policy by November 30, 11/30/ I1 2011. Abuse and neglect training will be proved annually beginning January 2012 in new orientation and mandatory staff trainings. UPDATE: 12/27 /11 100% of staff has been trained on the 1 abuse and neglect policy. Also -1-1~13-otc-11,---received a copy. All staff will do annual mandatory reporting training provided on line by LH.S. and provide certificate to supervisor. 1/2012 List of all reporting agencies was placed in each nursing station. AJ1 staff will be required to notify supervisor immediately if they have to report any form of abuse. The supervisor will report these to the RM. The RM will provide a report to the CEO, CD DON and !OP immediately. Facility ID: 280119 lf continuation sheet Page 20 of 93 PRINTED: 10/19/2011 FORM APPROVED . OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CL/A IDENTIFICATION NUMBER: 280119 NAME OF PROVIDER OR SUPPLIER A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77·75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 145 Continued From page 20 'yes' to the question "Are you concerned about your safety or the safety of anyone in your family?". The medical record lacks any probes related to these questions to determine potential abuse especially in light of reports of being struck by her mother. The nursing pediatric admission form questions if the patient has any safety needs which is answered 'yes' with only a statement "suicide precautions". The nurse failed to assess the patienrs need for safety from her mother. The mother is present with patient in room unsupeivised throughout the night. The patient had reported earlier that her mother had struck her with a toilet brush and did not want to return home with her. This was the precipitating cause of wishing to harm self. The medical record states, "Pt is placed in room 309, which is directly across [from] the nurses' station. Mother plans to stay with pt throughout the night; hourly checks to be performed." Documentation in the medical record reveals hourly checks on 9/28/11 at 10:00 PM and 11:00 PM, on 9/29/11at12:10 AM, 2:15 AM, 3:20 AM, 4:20 AM, 5:35 AM, and 6:38 AM. There is no documentation of an hourly check at 1:OO AM; nursing staff failed to monitor Patient #45 for over 2 hours. Documentation on 9/29/11 at 7:45 AM states, "Pt mother present in the room, sleeping in the bed window. Pt has no concerns at this time other than the room being cold. Nurse leaves pt door open as it was closed when arriving to floor at 7:00 AM." Placing Patient #45 in a room across from the nurses' station is ineffective if the door is closed. The nursing staff failed to assess Patient #45 for abuse by her mother and to protect the patient by allowing the mother to remain in the room with the patient. FORM CMS·2567(02·99) Previous Versions Obsolete (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION Event ID: 180811 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A 145 Facility ID. 280119 If continuation sheet Page 21 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (XI) PROVIOERISUPPLIERICLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVIDER OR SUPPLIER B.WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO !HS HOSPITAL (X4)10 PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST l:l:E PRECEDED BY FULL REGULATORY OR LSC IDENTIFYlNG INFORMATION) A 145 Continued From page 21 Review of policy titled, "Abuse and Neglect Policy" signed as being approved 6/23/11 states in part, "IV. Procedures The following criteria may be used to assist in the identification of abuse: A. Physical Abuse - Willful infliction of injury, unreasonable confinement or cruel punishment a. Scratches, cuts, bruises, or bums ... 11 The policy further states, "IV. Procedures E. Management of Suspected Abuse/Neglect: -c. As all staff are Mandatory Reporters in the Omaha/Winnebago PHS [Public Health Service] Hospital, all cases of suspected abuse/neglect must be reported to direct supervisor, security, and local/state/federal authorities. -d. Any person {including an employee, volunteer or other person) associated with the Omaha/Winnebago PHS Hospital, who reasonably believes or who know of information that would reasonably cause a person to believe that the physical or mental health or welfare of a patient of the hospital, who is receiving medical services, has been, is or will be adversely affected by abuse or neglect by any person shall, as soon as possible, report the information supporting the belief to local/tribal/state department of Protective Services, or the Centers for Medicare and Medicaid Services (CMS) and/or Joint Commission, by telephone or in writing. e. When domestic violence has occurred, always notify law enforcement officials, even if the patient does not want to press charges. f. A healthcare provider who fails to report suspected abuse and/or neglect shall be referred to the individual's licensing board for appropriate disciplinary action." FORM CMS-2567(02·99) Previous Versions Obsolete (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING Event ID.180511 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (XS) COMPLETION DAlE A 145 Facility ID: 280119 lf continuation sheet Page 22 of 93 PRINTED: 10/19/2011 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (XI) PROVJDERISUPPLIERICLIA IDENTIFICATION NUMBER: 280119 FORM APPROVED OMB NO 0938-0391 A BUILDING B. WING _ _ _ _ _ _ _ _ _ __ NAME OF PROVIDER OR SUPPLIER SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 145 Continued From page 22 Interview with the DON on 10/14/11 at 11 :54 AM revealed when abuse is suspected nurses should report to social services and child protective services and not leave the suspected abuser in the room with the patient. A214 482.13(g) PATIENT RIGHTS: SECLUSION OR RESTRAINT 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) {XS) COMPLETION DATE A 145 A 214 Nursing revised the Winnebago Restraint Policy to include notification of CMS by telephone no later than 11/8/11 close of business the next business day following knowledge of the patient's death. This will be documented in the patient chart when CMS was notified. 11/8/11 Death Reporting Requirements: Hospitals must report deaths associated with the use of seclusion or restraint. (1) The hospital must report the following information to CMS: Patient restraint policy revised and send to Medical Staff on November 8, 2011. Restraint training held in April, June, July, August, 2011. Nurse Educator provided sign-in documentation on restraint training for nursing on November 4, 2011. 100% nursing staff will be trained 11/30/11 ---~'---"by,_N"'o"v"'e"-m"'b"'er~30, 2011. Medical Staff,,cd::.:i•o::":orv-'-"st=aff,,,'-"r'---- Each death that occurs while a patient is in restraint or seclusion. Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion. housekeeping and security can receive training also since training is recorded. 2/9/11 Nurse Educator purchased training on 2/9/2011 from AHC Media and recorded for future training. A214 UPDATE: 12/27/11 Each death known to the hospital that occurs within 1 week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient's death. "Reasonable to assume" in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation. (2) Each death referenced in this paragraph must be reported to CMS by telephone no later than the close of business the next business day following knowledge of the patient ' s death. The nurses will notify their direct supervisor, who will then notify the DON and CD. The DON will notify the CEO and RM. 100% of staff have received a copy and training on the restraints policy and procedure. The reporting process will be added to the Nursing Restraints chart review form. Will also provide CMS reporting form to all nursing staff along with training {training completed November 2011) SEE: UPDATE Attachments: ATTACHMENTS: '-----.1----------------------'-------'ATTACHMENTS: Previous Versions Obsolete Event ID:IBDS11 FORM CMS·2567(02-99) 1/6/2012 Facility ID. 280119 lf continuation sheet Page 23 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVlDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVlDER OR SUPPLIER A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77·75 WINNEBAGO IHS HOSPITAL WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED {X2) MULTIPLE CONSTRUCTION (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 214 Continued From page 23 (3) Staff must document in the patient's medical record the date and time the death was reported to CMS. ID PREFIX TAG PROVlDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) {XS) COMPLETION DATE A214 This STANDARD is not met as evidenced by: Based on policy review and staff interview, the facility failed to ensure the restraint policy included a system to notify the Centers for Medicare and Medicaid (CMS) Regional Office of any patient death that is associated with the use of restraint or seclusion. The facility census was 2. Findings included: Review of the hospital policy titled, "Restraint Policy- Nursing Procedure", revised 12110 and 4/11, failed to show the hospital had a system in place to report the following information to the CMS Regional Office: -Each patient death that occurs while the patient is in restraint or seclusion; -Each patient death that occurs within 24 hours after the patient has been removed from restraint or seclusion; -Each patient death known to the hospital that occurs within one week after restraint or seclusion where it is reasonable to assume that the use of restraint or seclusion contributed directly or indirectly to the patient's death. During an interview on 8/24/11at1:15 PM, the Improving Operations Performance/Risk Management Director said the restraint policy is all they have related to restraints. She said if there is nothing in the policy related to restraint death reporting to CMS then there is no other policy. FORM CMS-2567(02-99} Previous Versions Obsolete Event ID: IBDS 11 Facility ID: 280119 If continuation sheet Page 24 of 93 PRINTED: 10/19/2011 FORM APPROVED 0 MB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION {X1) PROVIDER/SUPPLIERJCLIA lDENTlFtCATlON NUMBER: 280119 A BUILDING B WING NAME OF PROVlDER OR SUPPLIER 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77·75 WINNEBAGO IHS HOSPITAL {X4) ID PREFIX TAG {X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES ID (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX REGULATORY OR LSC IDENTIFYING INFORMATION) TAG A263 482.21 QAPI PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) {XS) COMPLETION DATE A263 A263 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement}; and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This CONDITION is not met as evidenced by: Based on Performance Improvement/Quality Assurance Plan review, quality assurance monitors review, Improving Operations Performance (IOP} meeting minutes review, and staff interviews, the facility failed to develop and maintain a data driven quality assurance program that collected and analyzed data then implemented interventions, and monitored and maintained the success of those interventions with oversight by the Governing Body, Medical Staff, and administrative officials. The facility identified a census of 2. Findings included: -The facility failed to identify the scope of the program through measurable improvement that will improve health outcomes or prevent medical Pharmacy will analyze and trend of all medications errors. All C -1, pharmacy will perform individual evaluations monthly to IOP, Medical Staff, Nursing Supervisors beginning November 10, 2011, 11/10/11 Pl monitor Training for team leaders 9/27/11 by IOP 9/27/11 Director. Pl monitor training for General staff 9/29/11 by IOP 9/29/11 Director. RCA and PDSA training for team leaders on 10/27/11. 10/27/11 Pl Monitor, RCA and PDSA and to be completed by each department supervisor. (reformat) 11/30/11 Pl Monitor reporting will be conducted every quarter 11/30/11 with each department reporting in a designated month in that quarter. Pl committee meeting minutes will have a designated section for issues identified by department Pl monitors will have corrective action plan. 11/30/11 Pl monitor data will be tracked in a log by department and will be reported to the Pl Committee and Governing Body Quarterly. Outliers will be reported back to team leaders and executive staff for corrective actions. 11/30/11 12/1/2011 A 263 UPDATE 12/27/11 Each department has completed an RCA to identify an issue in their department that may be impeding them from meeting goals or conducting business or providing care. The IOP Director will have the list of Pl monitors approved by GB and provide an update to GB every quarter on each Pl monitor including data, evaluation and POC. The report will identify any negative outliers and discussion and POC by GB if it is needed. The IOP director will return any POC I FORM CMSw2567{02·99) Previous Versions Obsolete Event ID:l8DS11 Facility 10: 280119 If continuation sheet Page 25 of 93 PRINTED: 10/19/2011 FORM APPROVED OMS NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CUA IDENTIFICATION NUMBER: 280119 NAME OF PROVIDER OR SUPPLIER A BUILDING SWING~~~~~~~~~~ 10/14/2011 STREET ADDRESS, CITY, STATE. ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL WINNEBAGO, NE 68071 (X4)1D SUMMARY STATEMENT OF DEFICIENCIES PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A 263 Continued From page 25 errors by measuring, analyzing, and tracking quality indicators. (See A-264) ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (XS) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) COMPLETION DATE A263 developed by the GB to the department Supervisor for Review and they will submit the interventions and timeline. -The facility failed to structure data collected in a method to monitor safety and quality of services or use the data to identify opportunities for change. The Governing Body failed to identify the frequency and detail of data collection. (See A-273) SEE; UPDATE Attachment ATTACHMENTS: 1 ATIACHMENTS: ATTACHMENTS: ATTACHMENTS: -The facility failed to utilize data in the identified manner by the Plan to develop a system to analyze the data and enact preventive actions. This prevents the facility from being able to monitor any successful implementation of interventions and ensure that the success is maintained. (See A-283) -The governing body, medical staff, and administrative officials failed to ensure the facility had a system in place for an ongoing, defined, implemented, and maintained program of quality improvement. (See A-309) The cumulative effect of the facility, Governing Body, Medical Staff, and administrative officials failure to develop and maintain a data driven quality assurance program that collected and analyzed data then implemented interventions, and monitor and maintain the success of those interventions to improve patient outcomes resulted a systemic failure of the Quality Improvement program for the facility. A 264 482.21 (a) QAPI PROGRAM SCOPE A264 Standard: Program Scope FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:l8DS11 Facility ID. 280119 If continuation sheet Page 26 of 93 .--..... ~~"''"?"••>f':"'....,.. ...-'l!l"'>""'r<'"-~~-,5"·,,·.~~'1,'C',..::s·1· iu.' Scope: As part of the Performance Improvement/Quality Assurance Program, the Omaha/Winnebago P.H.S. [Public Health Service] Hospital has identified its scope of care to include all services that may have a direct or indirect impact on patient care. .. .. The dimensions of performance of patient care and and quality control activities in the following service are monitored, assessed and evaluated. All data and reports are provided by staffs that are in the departments and as needed chart or data reviews will be done by Performance Improvement/Quality Assurance Staff." The Performance Improvement/Quality Assurance Plan further states in part, "5. Performance Improvement Methodology (duties performed by IOP Team) The Omaha/Winnebago P.H.S. Hospital uses the POCA (Plan-Do-Check-Act) format to facilitate performance improvement activities provided by performance improvement/quality assurance team .... Plan: a) Identify current processes, outputs, customers, FORM CMS·2567{02-99) Previous Versions Obsolete (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING Event ID: 18DS11 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG {XS) COMPLETION DATE A264 A264 Pl Monitor form, RCA and POSA to be completed by each department supervisor. {reformat) 11/30/11 Pl monitor Training for team leaders 9/27/11 by \OP Director. Pl monitor training for General staff 9/29/11 by IOP Director. RCA and PDSA training for team leaders on 10/27/11. 9/27/11 Pl Monitor reporting will be conducted every quarter with each department reporting in a designated month in that quarter. Pl committee meeting minutes will have a designated section for issues identified by department will have corrective action plan. Pl monitor data will be tracked in a log by department and will be reported to the Pl Committee and Governing Body Quarterly. Outliers will be reported back to team leaders and executive staff for corrective actions. 9/29/11 10/27/11 11/30/11 11/30/11 11/30/11 SEE: ATIACHMENTS: 16 ATIACHMENTS: 17 AlTACHMENTS: 18 ATIACHMENTS: 19 Facility ID. 280119 If continuation sheet Page 27 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X t) PRO\llDER/SUPPLIER/CLIA IDENTJFICATlON NUMBER: 280119 NAME OF PROVIDER OR SUPPLIER A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS. CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)10 PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IOENTIFYNG INFORMATION) A 264 Continued From page 27 expectations b) Identify root causes c) Focus on improvement opportunity d) Identify what data is needed, how you will measure and analyze e) Generate improvement list and choose solutions. ID PREFIX TAG PROVlDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) {XS) COMPLETION DATE A264 Review of monitors provided by the facility including but not limited to inpatient nursing unit, outpatient nursing unit, emergency department, radiology, laboratory, and pharmacy were essentially data collection tools. The format did not identify the root cause of the identified concern nor did it identify how the concern will be measured and analyzed. The monitor did not contain solutions specific to a root cause identified for the concern. Review of the IOP meeting minutes provided by the facility from 6/30/10 through 7/28/11 lacks evidence of staff reporting quality data and analysis related to quality improvement projects to the committee. Interview with the IOP/Risk Manager (RM) on 9/28/11 at 12:25 PM shows that none of the monitors will have a root cause analysis. Staff have not delved into the root cause of the identified concerns. Staff identified concerns with the quality improvement program in January and have been working to fix il A 273 482.21(b) QAPI PROGRAM DATA A273 Standard: Program Data This STANDARD is not met as evidenced by: Based on Perfocrnance Improvement/Quality Assurance Plan review, quality assurance monitors review, Improving Operations Performance (IOP) meeting minutes review, FORM CMS~2567{02~99) Previous Versions Obsolete Event I0.18DS11 Facility ID: 280119 lf continuation sheet Page 28 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO. 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1} PROVlDERISUPPUER/CUA IDENT1FICATION NUMBER. 280119 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION TAG COMPLETED A BUILDING B WING _ _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX (X3) DATE SURVEY WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 273 Continued From page 28 Governing Body meeting minutes review, medical record review, root cause analysis review, and staff interviews, the facility failed to structure data collected in a method to monitor safety and quality of services or use the data to identify opportunities for change. The Governing Body failed to identify the frequency and detail of data collection. The facility identified a census of 2. Findings included: Review of the 2011 Performance Improvement/Quality Assurance Plan dated 5/9/11 states in part, "3. Periodic Assessment and Improvement The POCA [Plan-Do-Check-Act] process for systematic collection of data needed to design and assess new process, or redesign existing processes is outlined below in the Organization Performance Improvement/Quality Assurance Plan." ... "5. Performance Improvement Methodology (duties performed by IOP Team) The Omaha/Winnebago P.H.S. [Public Health Service] Hospital uses the POCA (Plan-Do-Check-Act) format to facilitate performance improvement activities provided by performance improvement/quality assurance team .... Plan: a) Identify current processes, outputs, customers, expectations b) Identify root causes c) Focus on improvement opportunity d) Identify what data is needed, how you will measure and analyze e) Generate improvement list and choose solutions. ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A273 Pl Monitor form, RCA and PDSA to be completed by each department supervisor. (reformat) 11/30/11 Pl monitor Training for team leaders 9/27/11 by IOP Director. Pl monitor training for General staff 9/29/11 by lOP Director. RCA and PDSA training for team leaders on 10/27/11. 9/27 /11 9/29/11 10/27/11 Pl Monitor reporting will be conducted every quarter with each department reporting in a designated month in that quarter. 11/30/11 Pl committee meeting minutes will have a designated section for issues identified by department will have corrective action plan. 11/30/11 Pl monitor data will be tracked in a log by department and will be reported to the Pl Committee and Governing Body Quarterly. (add from previous section) Root Cause Analysis protocol being revised by IOP Director to enhance QAPI process for evaluation, resolutions of RCA in a timely manner and implementation of plans of correction. 11/30/11 11/30/11 SEE' ATTACHMENTS: 16 ~TTACHMENTS: 17 Review of monitors provided by the facility including but not limited to inpatient nursing unit, outpatient nursing unit, emergency department, FORM CMS-2567(02-99) Previous Versions Obsolete Event 10:18DS11 Facility ID: 280119 lf continuation sheet Page 29 of 93 PRINTED: 10/1912011 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PRO\llDERISUPPLIERICLIA IDENTIFICATION NUMBER: 280119 NAME OF PRO\llDER OR SUPPLIER {X4)1D (X3) DATE SURVEY COMPLETED A BUILDING B.WING _ _ _ _ _ _ _ _ __ 10/1412011 STREET ADDRESS. CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL PREFIX TAG OMS NO 0938-0391 (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 273 Continued From page 29 radiology, laboratory, and pharmacy were essentially data collection tools. The format did not identify the root cause of the identified concern nor did it identify how the concern will be measured and analyzed. The monitor did not contain solutions specific to a root cause identified for the concern. Without enacting the steps set forth in the 2011 Performance Improvement/Quality Assurance Plan for developing a plan, the facility failed to provide the structure needed to monitor services and identify opportunities for improvement. PRO\llDER'S PLAN OF CORRECTION {EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLE110N DATE A273 Review of the JOP meeting minutes provided by the facility from 6/30/10 through 7/28/11 lacks evidence of staff reporting quality data and analysis related to quality improvement projects to the committee. Review of Governing Body meeting minutes provided by the facility from 6/8/1 O to 8/15/11 lacks evidence of specifying the frequency or detail of data collection for the quality program. Further review of the 2011 Performance Improvement/Quality Assurance Plan Jacks evidence of the frequency or detail of data collection for the quality program, however; the Plan states in part, "The Improving Organization Performance Director will keep a list of the current indications being measured throughout the facility." Interview with the JOP/Risk Manager (RM) on 9/28/11 at 12:25 PM shows that none of the monitors will have a root cause analysis. Staff have not delved into the root cause of the identified concerns. There is confusion as to FORM CMS-2567(Q2..g9) Previous Versions Obsolete Event 10:180511 FaCllity ID. 280119 If continuation sheet Page 30 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PRO\/IDER/SUPPLIER/CLIA IDENTIFICATION NUMBER. (X3) DATE SURVEY COMPLETED (X.2) MULTIPLE CONSTRUCTION A BUILDING 280119 NAME OF PROVIDER OR SUPPLIER 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL WINNEBAGO, NE 68071 (X4)1D SUMMARY STATEMENT OF DEFICIENCIES PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGUlATORY OR LSC IDENTIFYlNG INFORMATION) TAG A 273 Continued From page 30 who does the analysis of the monitors. The nursing staff believe they collect the data and it is the physician's responsibility to analyze it. There won't be any analysis of the data in the monitors. Area sent out the templates to structure data collection but there is no plan for reporting. Governing Body has not specified the frequency and detail of data collection. Staff identified concerns with the quality improvement program in January and have been working to fix it. ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) {XS) COMPLETION DATE A273 Review of medical record for Patient #1 identified concerns with documentation, patient assessment, and communication between nursing staff and providers regarding patient condition. See A-395. The facility requested a root cause analysis of Patient #1 's medical record by the Area Chief Medical Officer (CMO). This request was initiated on 6/2111. Patient #1 died on 4/9/11. The CMO completed the root cause analysis and returned it to the facility on 812111 with recommendations. Interview with the Director of Nursing (DON) on 8/31/11at1:30 PM reveals she was unaware that the CMO returned the root cause analysis to the facility. There is no docomentation of any of the risk reduction strategies that have been implemented. Interview with the !OP/RM on 8/31/11 at 2:1 O PM reveals the Day and Evening Nursing Supervisors for the Medical Surgical unit were working on training for the nursing staff, but have not gotten back to the !OP /RM regarding the training. A 283 482.21 (c) OAPI PROGRAM ACTIVITIES FORM CMS-2567(02-99} Previous Versions Obsolete Even11D:IBDS11 A283 Facll!ty ID: 280119 If continuation sheet Page 31 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDERISUPPLIERICLIA IDENTIFICATION NUMBER: 280119 B. WING _ _ _ _ _ _ _ _ _ __ NAME OF PROVIDER OR SUPPLIER (X4)1D TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYJNG INFORMATION) A 283 Continued From page 31 10 PREFIX TAG A283 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) Pl Monitor form, RCA and PDSA to be completed by (XS) COMPLETION DATE 11/30/11 each department supervisor. Standard: Program Activities This STANDARD is not met as evidenced by: Based on Performance Improvement/Quality Assurance Plan review, quality assurance monitors review, Improving Operations Performance (IOP) meeting minutes review, and staff interviews, the facility failed to utilize data in the identified manner by the Plan to develop a system to analyze the data and enact preventive actions. This prevents the facility from being able to monitor any successful implementation of interventions and ensure that the success is maintained. The facility identified a census of 2. Findings included: Review of the 2011 Performance Improvement/Quality Assurance Plan dated 5/9/11 states in part, "3. Periodic Assessment and Improvement The POCA [Plan-Do-Check-Act] process for systematic collection of data needed to design and assess new process, or redesign existing processes is outlined below in the Organization Performance Improvement/Quality Assurance Plan.'' .. .''5. Performance Improvement Methodology (duties performed by IOP Team) The Omaha/Winnebago P.H.S. [Public Health Service] Hospital uses the PDCA (Plan-Do-Check-Act) format to facilitate performance improvement activities provided by performance improvement/quality assurance team .... Plan: a) Identify current processes, outputs, customers, expectations b) Identify root causes c) Focus on improvement opportunity d) Identify what data is needed, how you will FORM CMS·2567(02·99) Previous Versions Obso!ele 10/14/2011 STREET ADDRESS, CITY, STATE. ZIP CODE HWY77-75 WlNNEBAGO IHS HOSPITAL PREFIX (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING Event ID: \8DS 11 Pl monitor Training forte.am leaders 9/27 /11 by lOP 9/27/11 Director. Pl monitor training for General staff 9/29/11 by IOP 9/29/11 Director. RCA and PDSA training for team leaders on 10/27/11. 10/27/11 Pl Monitor reporting will be conducted every quarter with each department reporting in a designated month in that quarter. 11/30/11 Pl committee meeting minutes will have a designated section for issues identified by department will have corrective action plan. 11/30/11 Pl committee meeting minutes will have a designated section to evaluate and analyze all reported monitors. 11/30/11 Pl monitor data will be tracked in a log by department and will be reported to the Pl Committee and Governing Body Quarterly. Outliers will be reported back to team leaders and executive staff for corrective actions. 11/30/11 Facility ID. 280119 If continuation sheet Page 32 of 93 PRINTED: 10/19/2011 FORM APPROVED OMS NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X\) PRO\/lDERISUPPLIERICLIA IDENTIFICATION NUMBER: 280119 A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY. STATE. ZIP CODE HWY77-75 WINNEBAGO !HS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 283 Continued From page 32 measure and analyze e) Generate improvement list and choose solutions. ID PREFIX TAG PRO\/lDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) IX51 COMPLETION DATE A283 Review of monitors provided by the facility including but not limited to inpatient nursing unit, outpatient nursing unit, emergency department, radiology, laboratory, and pharmacy were essentially data collection tools. The format did not identify the root cause of the identified concern nor did it identify how the concern will be measured and analyzed. The monitor did not contain solutions specific to a root cause identified for the concern. Without enacting the steps set forth in the 2011 Performance lmprovemenUQuality Assurance Plan for developing a plan, the facility failed to provide the structure needed to monitor services and identify opportunities for improvement. The failure to identify opportunities for improvement prevents the facility from implementing the next steps in the PDCA model of Do-Check-Act. Review of the !OP meeting minutes provided by the facility from 6/30/10 through 7/28/11 lacks evidence of staff reporting quality data and analysis related to quality improvement projects to the committee. Interview with the !OP/Risk Manager (RM) on 9/28/11 at 12:25 PM shows there won't be any analysis of the data in the monitors. Staff at the facility don't know how to analyze and trend data. Staff identified concerns with the quality improvement program in January and have been working to fix it A 309 482.21 (e) EXECUTIVE RESPONSIBILITIES A309 The hospital's governing body (or organized FORM CMS-2567(02·99) Previous Versions Obsole1e Event 10:180$11 Facility ID: 280119 lf continuation sheet Page 33 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (Xt) PRO\/lDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 B. WING _ _ _ _ _ _ _ _ _ __ 10/14/2011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL ()(4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A. BUILDING WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 309 Continued From page 33 group or individual who assumes full legal authority and responsibility for operations of the hospital}, medical staff, and administrative officials are responsible and accountable for ensuring the following: This STANDARD is not met as evidenced by: Based on Performance lmprovemenUQuality Assurance Plan review, quality assurance monitors review, Medical Staff meeting minutes review, Governing Body meeting minutes review, and staff interviews, the governing body, medical staff, and administrative officials failed to ensure thet facility had a system in place for an ongoing, defined, implemented, and maintained program of quality improvement The facility identified a census of 2. Findings included: Review of the 2011 Performance lmprovemenUQuality Assurance Plan dated 5/9/11 states in part, "Ill. Authority ... The organization's leaders include members of the Governing Body, Chief Executive Officer, Administrative Officer, Clinical Director, Director of Nursing, Performance Improvement Coordinator, and all Department Heads....The organization leaders are responsible for overseeing the design of the organization's approach to improving quality and ensuring thaf this approach is carried out." ID PREFIX TAG PRO\/lDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A 309 A309 IOP Director will submit Performance Improvement Monitor form to Medical Staff monthly beginning in November 2011. 11/30/11 Medical Staff will utilize a quality of care tool for peer review, credentialing, webcidents, QoC, Pl monitors 11/30/11 related to QoC in their monthly meetings to review and analyze any necessary interventions to improve care beginning November 2011. IOP Director will provide a list of facility-wide monitors will be submitted to medical staff and governing body beginning November 2011. Once approved, this will be communicated to all staff by email. 11/30/11 12/1/11 A309 UPDATE: 12/27/11 1/10/12 lOP will monitor Hospital wide QAPI program on monthly and report quarterly to Governing body and Medical staff on all Pl monitors with any outliers and plans of correction. SEE: UPDATE Attachment ATTACHMENTS: ATTACHMENTS: Review of monitors provided by the facility including but not limited to inpatient nursing unit, outpatient nursing unit, emergency department, radiology, laboratory, and phanmacy were essentially data collection tools. The format did FORM CMS-2567(02-99) Previous Versions Obsolete Event JD: 180511 Facility ID: 280119 If continuation sheet Page 34 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROV1DER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVIDER OR SUPPLIER B WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY. STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 309 Continued From page 34 not identify the root cause of the identified concern nor did it identify how the concern will be measured and analyzed. The monitor did not contain solutions specific to a root cause identified for the concern. Without enacting the steps set forth in the 2011 Performance Improvement/Quality Assurance Plan for developing a plan, the facility failed to provide the structure needed to monitor services and identify opportunities for improvement. ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) {XS) COMPLETION DATE A309 Review of Medical Staff meeting minutes, including the Medical Staff Executive Ccmmittee meeting minutes, provided by the facility from 10/13/1 O to 5/25/11 lacks evidence of involvement in the quality assurance process through out the facility other than Morbidity/Mortality, Utilization, code Blue Reviews, Pathology Reporting, and Webcident/Complaints. This does not demonstrate responsibility for the ongoing quality program of the facility. Review of Governing Body meeting minutes provided by the facility from 6/8/1 O to 8/15/11 lacks evidence of responsibility for the ongoing quality program of the facility. Further review of the 2011 Performance Improvement/Quality Assurance Plan lacks evidence of the frequency or detail of data collection for the quality program; however, the Plan states in part, "The Improving Organization Performance Director will keep a list of the current indications being measured throughout the facility." Interview with the !OP/Risk Manager (RM) on FORM CMS·2567(02·99) Previous Versions Obsolete Event ID: 180511 Facility ID: 280119 If continuation sheet Page 35 of 93 PRINTED: 1011912011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVIDER OR SUPPLIER B. WING _ _ _ _ _ _ _ _ _ __ 10/14/2011 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYNG INFORMATION) A309 Continued From page 35 9/28/11 at 12:25 PM shows no quality monitors or results have been reported to the Medical Staff or Governing Body because no monitors have been analyzed so there is nothing to offer. Staff identified concerns with the quality improvement program in January and have been working to fix it. A338 482.22 MEDICAL STAFF The hospital must have an organized medical staff that operates under bylaws approved by the governing body and is responsible for the quality of medical care provided to patients by the hospital. This CONDITION is not met as evidenced by: Based on Medical Staff Bylaws, Rules, and Regulations review, Medical Staff meeting minutes review, Governing Body meeting minutes review, credential file review, and staff interviews, the facility failed to ensure the Medical Staff operated as described by the bylaws to ensure the quality of care provided to the patients in the facility. The facility identified a census of 2. Findings included: -The facility failed to ensure the Medical Staff conducted periodic objective reviews in a systematic manner to ensure the quality of care in the facility. (See A-340) -The facility failed to ensure the Medical Staff reviewed the qualifications and competence of practitioners and made recommendations to the Governing Body for membership in the Medical Staff. (See A-341) FORM CMS-2567(02-99} Previous Versions Obsolete A BUILDING STREET ADDRESS, CITY, STATE. ZIP CODE HWY77-75 WINNEBAGO !HS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION Event ID:ISDS11 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (XS) COMPLETION DATE A309 permanent medical staff privileged to work in the I The ER will certify in the ATlS and ACLS course by 2/1/11 02/01/2012. A338 ED QA/Pl monitor wllJ include a random annual mock code to assess response time, competence, and performance in facility's ED 11/30/11 Members of the Medical Staff will perform ongoing random chart reviews on all ED providers and report quarterly to the Medical staff. Random chart review reporting to the Medical Staff wilt be ensured by the Clinical Director, and this is an agenda item for the Medical Staff. A random selection of 3 charts of a new providers will be reviewed daily over the first 5 days in the Winnebago facility 11/30/11 11/30/11 10 Random charts per provider will be peer reviewed every 6 months. 11/30/11 Random 3 chart reviews for every provider performed every Month 11/30/11 All transferred patients will have chart reviews by permanent Med staff at morning rounds. 11/30/11 Al! patients with 72 hour returns, Against medical advice and left without being seen in the ED will have a chart reviewed. Chart reviews will include an assessment of providers practicing outside the scope of granted privileges. 11/30/11 11/30/11 Ongoing random chart reviews conducted by all of the permanent providers. Data will be reported to the Medical Staff on a quarterly basis. Facilily ID: 280119 If continuation sheet Page 36 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION (X1) PROVIDERISUPPLIER/CLIA IDENTIFICATION NUMBER; A BUILDING B. WlNG _ _ _ _ _ _ _ _ _ __ 280119 10114/2011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG WINNEBAGO, NE 68071 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) 10 PREFIX TAG A 338 Continued From page 36 DATE A338 -The facility failed to ensure that practitioners exercised only those privileges they were given by the Medical Staff following a review of their qualifications and competence. (See A-363) I Data from chart and peer reviews will be trended, analysis performed, and corrective actions developed if necessary. These corrective actions will be monitored for improvement by Medical Executive Committee (Med Exec). The Med Exec Committee report will be a standing agenda item for Medical Staff Meeting and appropriate data will be reviewed. The Clinical Director will report data to Governing The cumulative effect of the facility's failure to ensure Medical Staff made recommendations to the Governing Body regarding the qualifications and competence of practitioners prior to their providing care in the facility, failure to review practitioners for ongoing quality of care, and failure to ensure practitioners did not perform procedures outside of their scope of practice within the facility resulted in a systemic failure of the Medical Staff to ensure the quality of care provided to patients in the facility. A 340 482.22(a)(1) MEDICAL STAFF PERIODIC APPRAISALS body at least quarterly. Appropriate data will be presented to the facility QAPI program. All reports will be implemented by November 17, 2011. The Medical Executive Committee members will be Copies of granted privileges for all providers will be made available throughout the patient care areas. Credentialing Coordinator will update as changes 11/30/11 occur. Implemented by November 30, 2011. Pl monitor implemented to assess the updated posted privileges list. As part of the Medical Staff's QA/Pl monitor, chart reviews will include an assessment of providers practicing outside the scope of granted privileges. Findings included: Event ID. l8DS11 11/30/11 educated on the proper evaluation of the credentialing file. This training will be performed by November 30, 2011 This STANDARD is not met as evidenced by: Based on Medical Staff Bylaws, Rules, and Regulations review, Medical Staff credential files review, document review, and staff interview, the facility failed to ensure the medical staff conducted periodic objective appraisals of its members. The facility identified a census of 2. Review of Medical Staff Bylaws, Rules, and Regulations lacks evidence of delineation of an objective process to evaluate the performance of medical staff members. 11/17/11 The completed Credentialing files of providers applying to the Medical Staff will be reviewed in the MED EXEC ( Medical Executive) committee meeting. Recommendations will be brought forth to the governing body. The medical staff must periodically conduct appraisals of its members. FORM CMS·2567(02·99) Previous Versions Obsolete (XS} COMPLETION Any identified non·compliance of practicing outside of privileges will be reviewed by the Medical Executive Committee, report provided to Medical Staff, and a report brought to the governing body with corrective actions. 1 I SEEo Facility ID: 280119 I I !f continuation sheet Page 37 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVlDER/SUPPLIERICLIA IDENTIFICATION NUMBER: 280119 A BUILDING B. WING _ _ _ _ _ _ _ _ _ __ 10/14/2011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYNG INFORMATION) A 340 Continued From page 37 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A340 A340 Interview with the Improving Operations Performance (IOP)/Risk Manager (RM) on 9/16/11 at 3: 16 PM acknowledges the Medical Staff Bylaws fail to delineate a process to objectively review the performance of Medical Staff members. She further states that the Clinical Director has begun an appraisal process but indicates this process is not defined in writing at this time. The IOP/RM indicates the Clinical Director has a number of performance appraisals completed and that part of the process entails each provider reviewing a number of records for a peer. Review of credential files for 4 (Z, W, V, and U) of 8 providers contains a document titled, "Re-Appointment Worksheet Medical Staff of Winnebago IHS (Indian Health Service) Hospital." This form documents reviews of the providers performance in several departments of the facility but lacks an objective review by a physician of the providers diagnosis and treatment of patients in the facility. Interview with Physician Won 9/19/11at12:30 PM shows in the past the physicians had not done a good job of peer review. Physician W and Physician Z knew the providers and the quality of care they provided and would discuss this. An e-mail provided by the Improving Operations Performance (IOP)/Risk Manager (RM) reveals the following information from the Clinical Director "the PEER Review process through 12110 was a bit confusing and the PEER Review forms vague, so they were revised in 06/11 and distributed for first use in June 201 L.". FORM CMS-2567(02-99) Previous Versions Obsolete (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION Event ID: 180511 ED and outpatient chart Review form reviewed and approved at next Med Staff meeting by November 8, 11/8/11 2011, Inpatient chart review form developed and approved at next med staff meeting by November 30, 2011. 11/30/11 A random selec;tion of 3 charts of a new providers will be reviewed daily over the first S days in the Winnebago facility 10 Random charts per provider will be peer reviewed every 6 months. 11/30/11 11/30/11 Random 3 chart reviewS for every provider performed every Month 11/30/11 All transferred patients will have chart reviews by permanent Med staff at morning rounds. 11/30/11 All patients with 72 hour returns, Against medical advice and left without being seen in the ED will have a chart reviewed .. 11/30/11 Chart reviews will include an assessment of providers practicing outside the scope of granted privileges. 11/30/11 Any provider quality of care issues identified will be promptly presented to CD, who will bring the issue to the Medical staff for review, discussion, and action, if necessary. 11/30/11 D:ita tram chart and peer reviews wilt be trended a.1alysis performed, and corrective actions devel~ped if necessary. These corrective actions will be monitored for improvement by Med Exec. The Med Exec. Committee report will be a standing agenda item for Medical Staff Meeting and appropriate data will be reviewed. The Clinical Director will report data to Governing body at least quarterly. Appropriate data will be presented to QAPJ. 11/30/11 These reports(FORMS AND PROCESSES) will be implemented by November 17, 2011. 11/17/11 Facility ID: 280119 If continuation sheet Page 38 of 93 PRINTED: 10/19/2011 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION FORM APPROVED OMB NO 0938-0391 (X3) DATE SURVEY COMPLETED {X2) MULTIPLE CONSTRUCTION (X1 I PRO\llDER/SUPPLIER/CLIA IDENTIFICATION NUMBERo A BUILDING B WING _ _ _ _ _ _ _ _ _ __ 280119 10/14/2011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CJTY, STATE, ZIP CODE HWY77·75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG A 340 UPDATEo 12/27/11 The Clinical Director will collect, evaluate and aggregate the chart reviews performed by the assigned members of the Medical Staff. She will generate a Summary Report to be reviewed by the Medical Staff and lOP monthly, and to Governing Body quarterly. A 340 Continued From page 38 The facility failed to provide documentation of the process now followed for a reappraisal of each providers qualifications and competency. Interview with the Clinical Director and previous Clinical Director on 9/19/11 reveals that the peer review process is to review 5 random records per provider each month but that is probably too many and will be changed to each quarter. The physician assistants (PA) from the emergency department are reviewing all 72 hour returns as a quality improvement project. The Clinical Director believed that both chart reviews could be utilized in the peer review process. The Clinical Director acknowledges that a PA does not have the expertise to evaluate the competence of a physician. And that physician cases reviewed by the PA would either have to be reviewed by a physician or thrown out for peer review. The Clinical Director further acknowledged that the review forms provided were for outpatient and emergency services. At this time there is not a form to review the quality of treatment providers provide to inpatients. Review of medical record for patient #32 shows the patient presented to the emergency department on 12130/10 at 9:15 AM complaining of hives and SOB (shortness of breath). Further review of the medical record shows Practitioner V ordered Epinephrine 1: 1000 0. 3 mg (milligrams) IV (intravenous) push once. PRO\llDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS·REFERENCED TO THE APPROPRIATE DEFICIENCY) Event ID: 180511 DATE 1/31/12 All staff are required to report any incidences or patient care issues in the WebCident, Which is monitored by i 1 The process for monitoring Provider competence in the ER is centered around the chart review process. 1. Three charts of new providers will be assessed everyday by the Medical Staff Attending on call for the first 5 days: of practice in the Winnebago ER and any deficits or concerns in the quality of care will be brought immediately to the attention of the Medical Directo~ who will convene a meeting of the Medical Executive Body immediately if she feels: the actions: of the new provider are egregious enough to warrant removal from . the facility. Otherwise-she may initiate re-mediation and instruction in correction of presumed poor practice habits and faulty documentation styles and report such intervention to the Med. Exec. 2. I ; Review of a QIO (Quality Improvement Organization) review of the medical record for patient #32 on 6/16/11 shows there were concerns regarding the quality of care provided to the individual specifically the route of FORM CMS·2567(02·99) Previous Versions Obsolete (XS) COMPLETION Facilily ID: 280119 All Transfers are evaluated in the Multidisciplinary morning rounds by the medical staff and a determination is made regarding the competence of the provider-through the appropriateness of the diagnostic work-up, the implementation of the treatment plan and the assessment in indicating a clear need for transfer. The provider is also assessed during this review for his/her ability to adequately identify an Emergency Medical Condition through the Medical Screening Exam and their ability to adequately stabilize the oatient orior to transfer. ' If continuation sheet Page 39 of 93 PRINTED: 10/19/2011 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIERJCLIA IDENTIFICATION NUMBER: 280119 FORM APPROVED OMB NO 0938-0391 A BUILDING B. WING _ _ _ _ _ _ _ _ _ __ NAME OF PROVIDER OR SUPPLIER i TAG HWY 77.75 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 340 Continued From page 39 epinephrine was inappropriate. The appropriate route for 0.3 mg of epinephrine would be IM (intramuscular). Review of the medical record for Patient #33 reveals she presented to the Outpatient Clinic for an appointment on 7/29/11 at 10:42 AM. During the course of the visit a Depression Screen was performed with Patient #33 answering yes to every question. The ambulatory care note for Patient #33 written by Physician W states in part, "Subjective: c/o [complained of] severely depressed, thoughts about hurting herself or her spouse, having crying spells, recently had interaction between cymbalta (antidepressant) and her zomig (for treatment of migraine headaches) (seretonegic syndrome and cymbalta dose was 60 mg [milligrams], we give her cymbalta 30 mg for one week, then discontinued, having some issues with her husband, told she is suicidal, can be placeed at [Hospital G] or [Hospital HJ (close to her home), she needs to be evaluated by mental health and psychiatrist too. I will follow their recommendations, her blood sugar is ok, within normal range, needs refill of her hydrocodone (pain medication) and rest of her regular meds, told she needs placement first then will refill her pills, depression screen done by nurse showing she is severely depressed." The outpatient clinic record further states in part, "Plan Contacted tribal mental health supervisor who agreed with transfer plan, they will follow up her care as outpatient, and a referral is made to mental health, spoken to ER [emergency room] provider to transfer the patient to ER for placement, patient and her spouse taken to ER in stable condition." ORM CMS-2567(02·99) Previous Versions Obsolete 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE WINNEBAGO IHS HOSPITAL (X4)1D PREFIX (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION Event ID: 18DS11 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFlCIENCY) ID PREFIX TAG (XS) COMPLETION DATE A340 3. Practitioner competence will also be evaluated by conducting 72 hour returns daily during the morning rounds with the Medical Staff present-thus allowing a timely review of a patient's presentation with implementation of additional medical intervention-if needed. Through these prompt 24-72 hour returns, the Medical Staff will be able to further compile a profile of the treating providers and will be able to identify any shortfalls or indications of problematic practice habits quickly, affording the ability of immediate intervention or removal of providers if necessary. 4. The ER, OPD and Inpatient Services are also equipped with Scope of Privileges Binders which lists all credentialed Providers Scope of Privileges granted. Nurses and the provider will be trained by the Clinical Director and DON or their Designee on the Quality of Care policy. The nurses and providers will sign an attestation indicating their understanding of the process for questioning a practitioner who is suspected of attempted to practice outside the scope of privileges granted. Random or focused 3 chart reviews will be performed on every medical provider-including practicing seasoned ER providers, every month by assignment of the Clinical Director to the permanent Medical Staff. The contract providers will also be assigned specific provider charts to review as well. The process will assign numbers to the reviewing and reviewed charts and the written reviews will evaluated and summarized for the Medical Staff, Governing Body and IOP quarterly. ·r.· ';+- Facility ID: 280119 < ~\ ~v-J 2-/ lf continuation sheet Page 40 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDERISUPPUER/CLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVIDER OR SUPPLIER A BUILDING B. WING~--------- 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 340 Continued From page 40 Review of the ER medical record for Patient #33 revealed Practitioner V documented a clinical course of contacting several police departments to obtain emergency protective custody. The medical record documents that Patient #33 is willing to be admitted for inpatient treatment. The medical record lacks documentation that Provider V contacted any hospital in an effort to place Patient #33 in a psychiatric unit for her severe depression and suicidal ideations. PRO\llDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (XS) COMPLETION DATE A340 lnteNiew on 10/3/11 at 1:07 PM with Physician W reveals he did recall reviewing the medical record for Patient #32 and was aware there was an issue with the dosage of epinephrine given the patient on 12130/10. Physician W confirms that Patient #33 was suicidal during the clinic visit with him on 7/29/11. He transferred Patient #33 to the emergency room per protocol so the patient could be transferred to the appropriate level of care. Physician W states he was unaware that Practitioner V had Patient #33 sign out Against Medical Advice (AMA) so she could go to another hospital. Physician W indicates that Practitioner V should not have done that and that he was available to help with the transfer but Practitioner V did not call. Review of a complaint filed by Patient #33 on 8/5/11 indicates she felt she was forced to sign out AMA from the emergency department on 7/29/11 Further inteNiew with Physician Won 10/3/11 at 1:07 PM reveals the concern regarding the care provided for Patient #32 and Patient #33 by Practitioner V was not reviewed and discussed in either the Medical Staff meeting or the Medical FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: IBDS11 Facility ID: 280119 If continuation sheet Page 41 of 93 PRINTED: 10/19/2011 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES ANO PLAN OF CORRECTION (X 1) PRO\llDER/SUPPLIERICLIA IDENTIFICATION NUMBER. 280119 OMB NO 0938-0391 A BUILDING B. WING _ _ _ _ _ _ _ _ _ __ 10/1412011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY. STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4)/D PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG A341 A 340 Continued From page 41 Staff Executive meeting to date. There is not a process developed yet to get medical records with concerns regarding the quality of care provided by a Provider to the medical staff for review in a timely manner. A 341 482.22(a)(2) MEDICAL STAFF CREDENTIALING The medical staff must examine credentials of candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates. This STANDARD is not met as evidenced by: Based on Medical Staff Bylaws, Rules, and Regulations review, Medical Staff credential file review, Medical Staff meeting minutes review, and staff inteiview, the facility failed to ensure medical staff examined the credentials of candidates for medical staff membership and made recommendation for appointment to the Governing Body prior to the individual providing patient care in the facility for 3 (Practitioner T, X, and the Clinical Director) of 8 practitioners reviewed. The facility identified a census of 2. Findings included: Review of the Medical Staff Bylaws states in part, "Section 5.08 Temporary appointment and Privilege 1. May not exceed 120 days 2. May be granted by (The CEO [Chief Executive Officer] or designee) in the following circumstances: - a. To fulfill an important patient care need. The following must be obtained and primary source verified: - i. Current, valid, non-limited license from any state or territory of the United States, :oRM CMS-2567(02-99) Previous Versions Obsolete (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION Event ID: 180511 PROlllOER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) [ The completed Credentialing files of providers (XS) COMPLETION DATE '111/30/11 applymg to tne Memca1 ::.rarr wm oe careruuy assessed by Med Exec Committee and recommendations brought forth to the governing body. 11/30/11 The Med Exec Committee members will be educated on the proper evaluation of the credentialing file. This training will be performed by November 30, 2011 11/30/11 Credentialing flow Chart will be modified to reflect points of Med Exec reviews, approval of the provider, and when the Governing Body reviews recommendations from the Med Exec Committee. This flow chart will be followed for ali candidate credentials approval. A 341 UPDATE: 12/27/11 At this time we have a staff member assigned to 1/31/12 complete the files temporarily until the new credentialing officer comes on duty. The lOP Director will review the monthly credentialing report and conduct a review for compliance with time frames and documentation completion. The ER, OPD and Inpatient Services are also equipped with Scope of Privileges Binders which lists all credentialed Providers Scope of Privileges granted. Nurses and the provider will be trained by the Clinical Director and DON or their Designee on the Quality of care policy. The nurses and providers will sign an attestation indicating their understanding of the process for questioning a practitioner who is suspected of attempted to practice outside the scope of privileges granted. Any reports of issues with privileges will be sent immediately to medical staff to address any issues and develop plan of correction and IOP committee for review of quality, these committees can refer any issues to the ethics committee if needed. Facility ID: 280119 If continuation sheet Page 42 of 93 I PRINTED: 10/19/2011 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PlAN OF CORRECTION (X1) PROVlDER/SUPPLIER/CLIA IDENTIFICATION NUMBER. 280119 NAME OF PROVIDER OR SUPPLIER OMB NO 0938-0391 (X2) MULTIPLE CONSTRUCTION A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77·75 WINNEBAGO IHS HOSPITAL WINNEBAGO, NE 68071 (X4) ID SUMMARY STATEMENT OF DEFICIENCIES PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) TAG (X3)DATESURVEY COMPLETED A 341 Continued From page 42 - ii. Relevant training and experience, - iii. Current competency as determined, - iv. Current NPDB/HIPDB [National Practitioner Data Base/Healthcare Integrity and Protection Data Base] obtained and evaluated, - v. Malpractice coverage for physicians who are not federal employees, - vi. AMA[ American Medical Association] Profile b. When a complete application is awaiting review and approval by the medical executive committee and/or the governing body. 3. May only be granted if the applicant: - a. has submitted a complete application, - b. has no current or previously successful challenges to licensure or registration, - c. has not been subject to involuntary termination of medical staff membership at another organization, - d. has not been subject to involuntary limitation, reduction, denial or loss of clinical privileges, - e. has no current federal sanctions. ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) {XS) COMPLETION DAlE A341 Review of a credential flowchart provided by the facility fails to indicate the point in the process where medical staff reviews and approves the practitioner or where governing body reviews recommendations from the medical staff. The process indicates the Clinical Director will review and sign the credential file, then the CEO will review and sign the credential file, then the GMO (Chief Medical Officer - housed at the area office) will review and approve, then the Area Director will review and sign, only then is the credentialing process complete and the Provider· notified. Review of the credential file for the Clinical Director reveals a form titled Temporary FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 180511 Facility ID: 280119 If continuation sheet Page 43 of 93 PRINTED: 10/19/2011 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFJCIENCIES AND PLAN OF CORRECTION (X1) PROVlDERISUPPLIERICLIA lDENTIFICAT!ON NUMBER. 280119 NAME OF PROVIDER OR SUPPLIER OMB NO 0938-0391 A BUILDING B. WING _ _ _ _ _ _ _ __ (X4)1D 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77.75 WINNEBAGO, NE 68071 WINNEBAGO IHS HOSPITAL PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 341 Continued From page 43 Privnege Request and Approval signed by the previous Clinical Director (Physician W) and the CEO on 6/10/11. The form lacks the signature of the CMO or the Area Director. Information provided by the facility indicates the Clinical Director began practicing at the facility on 5/16/11. Review of Medical Staff meeting minutes lacks evidence of review and approval of the current Clinical Director. ID PREFIX TAG PROVlDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A341 Review of the credential file for Physician X reveals a form titled Temporary Privilege Request and Approval signed by the Clinical Director (see above) and the CEO on 6/6/11. The form lacks the signature of the CMO or the Area Director. Information provided by the facility indicates Physician X began practicing at the facility on 5/29/11. Review of Medical Staff meeting minutes lacks evidence of review and approval of Physician X. Review of credential file for Physician T reveals a form titled Medical Privileges Request and Approval signed by the Acting Clinical Director (Physician Z) on 417/11 and the CEO on 4/11/11. The form lacks the signature of the CMO or the Area Director. A letter sent to Physician T on 4/12/11 indicates the Medical Staff Executive Committee granted temporary privileges for 120 days. Information provided by the facility indicates Physician T began practicing at the facility on 4/11/11. Interview on 9/19/11 at 12:30 PM with the Clinical Director and Physician W reveals both attested repeatedly that Medical Staff never reviewed and approved Physician T for full privileges at the facility. Review of Medical Staff meeting minutes dated 5/25/11 shows the Medical Staff approved full privileges FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:18DS11 Facility JO: 280119 If continuation sheet Page 44 of g: PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROV1DER/SUPPLIERICLIA IDENTIFlCATION NUMBER: 280119 8.WING _ _ _ _ _ _ _ _ __ 10/1412011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 341 Continued From page 44 for Physician T with Physician W making the motion to approve and the Clinical Director seconding. Further review of the credential file for Physician T reveals documentation of legal action in the states of Georgia and New Mexico enacting the revocation of licensure. New Mexico revoked Physician T's license on 1/10/85. Physician T voluntarily surrendered which the document further indicates has the same effect as revocation of the license on 9/11/84 in Georgia. The facility indicates the online search that obtained the legal documentation was conducted 5/31 /11 following the 5/25/11 Medical Staff meeting. Interview on 9/19/11 at 12:30 PM with the Clinical Director and Physician W indicates that they would not have recommended Physician T for privileges had they known about the revocation of licensure in New Mexico and Georgia. Interview with the Office of Medical Care Evaluation Director on 9/20/11 at 12:50 PM reveals that the expectation for hospitals within the Aberdeen Area Office is to have credential files reviewed through the Medical Staff and Governing Body prior to appointment. A 354 482.22(c)(1) APPROVAL OF MEDICAL STAFF BYLAWS ID PREFIX TAG PR0\/1DER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS} COMPLETION DATE A341 A354 Medical Staff Bylaws will be reviewed-,-edited, and 11/8/11 approved by Medical Staff by November 8, 2011. The Medical Staff Bylaws will be presented to the 11/8/11 Governing Body by November 8, 2011, A354 UPDATE: 12/27/11 [The bylaws must] (1) Be approved by the governing body. This STANDARD is not met as evidenced by: Review of Medical Staff Bylaws, Rules, and Regulations review, Governing Body meeting minutes review, and staff interviews, the facility failed to ensure the Governing Body approved FORM CMS-2567(02-99) Previous Versions Obsolete COMPLETED A BUILDING NAME OF PROVIDER OR SUPPLIER (XA)ID PREFIX TAG (X3) DATE SURVEY (X2) MULTIPLE CONSTRUCTION Event 10:180511 The CO will have her assistant update the medical staff bylaws with any changes the CD or AAO have identified. All the Medical staff and CEO will be notified of the proposed changes. Once approved by Medical staff the CD will provide them to the Governing Body for review and approval. SEE: ATTACHMENTS: Facility ID: 280119 1/31/12 If continuation sheet Page 45 of 93 PRINTED: 1011912011 FORM APPROVED OMS NO. 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SE 0 VICES STATEMENT OF DEFICIENCIES ANO PLAN OF CORRECTION (Xl) PRO\llDER/SUPPLIER/CLIA !DENTIFICATION NUMBER. 280119 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION A BUILDING B.WJNG _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWYn-75 WINNEBAGO IHS HOSPITAL WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) (X4)10 PREFIX TAG (X3) DATE SURVEY COMPLETED A 354 Continued From page 45 the Medical Staff Bylaws, Rules, and Regulations for the facility. The facility identified a census of ID PREFIX TAG PRO\llDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A354 2. Findings. included: Review of the Medical Staff Bylaws, Rules, and Regulations reveals a cover sheet indicating an effective date of FY (fiscal year) 2009 - 2011. The bottom of the page has the date 1113110 page 1 of 49. The second page of the Medical Staff Bylaws, Rules and Regulations reveals a signature page with signatures of various providers and the former CEO (chief executive officer) with dates of 11/09 and 12109. The bottom of this page is dated 11121109 with a page number of 2 of 47. The remainder of the document contains pages consecutively numbered from 3 to 49 with a date of 1113110 on each page. The signature page contained the following statement at the top, "These Bylaws and Rules and Regulations are hereby recommended by the active Medical Staff of the United States Public Health Service, Winnebago Indian Health Service Facility and shall become effective upon the approval of the Aberdeen Area Governing Body". No member of the Aberdeen Area Governing Body has signed the page. Review of Governing Body meeting minutes dated 7/8110 states in part, Agenda item #8 "Medical Staff By-laws [Staff BJ will bring back with final changes". There is no evidence the Governing Body approved the Medical Staff Bylaws, Rules, and Regulations. Interview with the Improving Operation =ORM CMS-2567(02-99} Previous Versions Obsolete Event 10.180511 Facility 10: 280119 If continuation sheet Page 46 of 93 PRINTED: 10/19/201 FORM APPROVE[ OMB NO 0938-039' DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X3) DATE SURVEY (X2) MULTIPLE CONSTRUCTION COMPLETED A BUILDING B WING _ _ _ _ _ _ _ _ __ 280119 1011412011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE. ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A354 Continued From page 46 Performance/Risk Manager (IOP/RM) on 9/16/11 at 2: 17 PM reveals there is no documentation in the Medical Staff meeting minutes or the Governing Body meeting minutes approving the Medical Staff Bylaws, Rules, and Regulation. A363 482.22(c)(6) CRITERIA FOR MEDICAL STAFF PRIVILEGING PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (XS) COMPLETION DATE A354 A363 A363 . ------''r---- Medical Staff privileges criteria will be added and 11/8/11 updated to the Medical Staff Bylaws by November 8, 2011. [The bylaws must:] Include criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges. For distant-site physi_cians and practitioners requesting privileges to furnish telemedicine services under an agreement with the hospital, the criteria for determining privileges and the procedure for applying the criteria are also subject to the requirements in §482.12(a)(8) and (a)(9), and §482.22(a)(3) and (a}(4). As part of the Medical Staff's QA/Pl monitor, chart ----+-i--~~---~~--..,-'----r----reviews will include an assessment of providers practicing outside the scope of granted privileges. Any identified non-compliance of practicing outside of privileges will be reviewed by the Medical Exec. and a report brought to the governing body with corrective actions. SEE: ATTACHMENTS: S This STANDARD is not met as evidenced by: Based on medical record review, credential file review, Medical Staff Bylaws, Rules, and Regulations review, and staff interview, the facility failed to ensure to 2 of 8 practitioners (Practitioner S and Practitioner T) exercised only the privileges granted by the Governing Body in accordance with meeting criteria established through the Medical Staff. The facility identified a census of 2. Findings included: FORM CMS-2567(02-99) Previous Versions Obsolete Event ID, 180511 Facility ID: 280119 If continuation sheet Page 47 of PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES rATEMENT OF DEFICIENCIES ~D PLAN OF CORRECTION (X1) PROVlDERISUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 IAME OF PROVlDER OR SUPPLIER A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWYn-75 WINNEBAGO, NE 68071 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 363 Continued From page 47 Review of Medical Staff Bylaws, Rules, and Regulations dated FY (fiscal year) 2009-2011, states for all categories of Medical Staff membership including Active, Courtesy, and Provisional that the practitioner will exercise approved clinical privileges. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTJVlE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG {XSJ COMPLETION DATE A363 Review of medical record for Patient #22, dated 8/18111 at 1O:30 PM, Practitioner T completed the suture process for reattaching the tip of the second finger of the right hand. Review of the medical record for Patient #22 dated 8/21/11 at 8:39 PM reveals Practitioner T states in the History of Present Illness, "70 yr [year] male here for 3rd recheck of right index finger. Patient had a traumatic amputation of half of the distal phalanx at home on the 17 th, and I reattached it here in the ED [emergency department] within an hour. (I advised him that most orthopedic physicians would not "bathe~· with a distal phalanx but I have had success with 4 out of 5 of my previous attempts in local EDs.) He has been coming by the ED nightly for unofficial rechecks .... He came back tonight for the recheck and the reattached part is black and has some odiferous debris>>> after confirming he has BC/BS [Blue Cross/Blue Shield] insurance which can be used as a primary, I advised him we would make a referral for him to be seen in the morning but that I needed to remove the distal fragment tonight." Review of the credential file for Practitioner T reveals Medical Privileges form signed by the Acting Clinical Director (Physician Z) on 4/7/11 and by the CEO (Chief Executive Officer) on 4/11/11. The Medical Privileges form had a 1RM CMS-2567(02·99) Previous Versions Obsolete Event ID:l8DS11 Facility ID: 280119 If continuation sheet Page 48 of 93 PRINTED: 10119/20 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (XI) PROV1DER/SUPPLIER/CLIA IDENTIFICATION NUMBER. 280119 NAME OF PRO\llDER OR SUPPLIER FORM APPROV£ OMB NO 0938-03' A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES {EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 363 Continued From page 48 check-mark beside full privileges 'requested and recommended' for "repair and closure of simple lacerations (not involving tendons, nerves, or major vessels)." There was a 'not requested or recommended' check-mark beside "repair and closure of complicated lacerations." The Medical Privileges form does not have reattachment or amputation listed as a privilege for Practitioner T. ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETIC DATE A 363 Review of medical record for Patient #34 dated 7/2111 at 8:44 AM reveals Patient #34 presented to the emergency room with a deep tissue wound to the right antecubital fossa (bend of the elbow) and bicep (muscle in the upper arm) area and was bleeding profusely. A note written by Practitioner R indicates Practitioner S took the case and achieved hemostasis of venous bleeds with tie offs {surgically tied the bleeding veins in the patient's arm to stop the bleeding), stabilized the patient. There is no documentation by Practitioner S as to exact procedure he performed. Review of the credential file for Practitioner S revealed a Medical Privileges form signed by the Clinical Director and CEO on 3/7/11 and by the Chief Medical Officer and Area Director on B/1 /11. The Medical Privileges form had a check-mark for full privileges 'requested and recommended' next to "repair and closure for simple lacerations (not involving tendons, nerves, or major vessels)." There was a 'not requested or recommended' check-mark beside "repair and closure of complicated lacerations." The Medical Privileges form listed "vascular' with the only privileges 'requested and recommended' being "arterial puncture, cutdown for insertion of catheters, central venous line FORM CMS-2567(02·99) Previous Versions Obsolete Event ID: IBDS 1l Facility ID. 280119 If continuation sheet Page 49 o1 PRINTED: 10/19/2011 FORM APPROVED OMB NO. 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR "EDICARE & MEDICAID SERVICES TATEMENT OF OEF!ClENCIES ~D PLAN OF CORRECTION (X\} PROVlDER/SUPPLIER/CLIA (X2} MULTIPLE CONSTRUCTION lDENTIFICAT!ON NUMBER. A BUILDING B. WING _ _ _ _ _ _ _ _ _ __ 280119 10/14/2011 >JAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY, STATE. ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED WINNEBAGO, NE 68071 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 PREF1X TAG A 363 Continued From page 49 insertion, emergency care, and referral to outside facility." Emergency care was not specific to performing vascular surgery to stop bleeding. (XS) COMPL~N DA1E A363 Interview with the Clinical Director on 8/25/11 at 1:35 PM reveals that Practitioner T deviated from the standard of practice regarding Patient #22. The Clinical Director said, "We do not sew fingers back on at IHS hospitals". The Clinical Director said that Practitioner S was not privileged to perform vascular surgery. Further interview with the Clinical Director on 9/19111 at 3:56 PM reveals it was acceptable for Practitioner S to tie off the artery in Patient #34's ann as it was life or limb saving and he had the expertise even though he was not privileged to perform the task at the hospital. A 385 482.23 NURSING SERVICES A385 11/8/11 11/30/11 11/30/11 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This CONDITION is not met as evidenced by: Based on Medical Staff Bylaws, Rules, and Regulations review, policy review, medical record review, incident report review, and staff interview, the nursing service failed to be appropriately organized to ensure nursing staff assesses patients and provides safe and appropriate care based on that assessment. The facility identified a census of 2. Nursing Supervisor ReVised Assessment Policy on November 2, 2011. Policy will be submitted for approval to Medical Staff committee on November 8, 2011 Nurse Educator will develop schedule for training on revised Assessment Policy by November 30, 2011 Peer Review tool developed by Nursing Supervisor on November 1, 2011. 100% inpatient charts will be monitored monthly for documentation of assessment and reassessment in the patient record. 11/30/11 Data analysis, trending and corrective actions, if necessary. Corrective actions will be reviewed for effectiveness and will be reported in monthly nursing departmental meetings and IOP Committee beginning Nove"'lber 2011. Quarterly report will be submitted to Guverning Body ! 11/30/11 Contractor Med Ed consultants provided Medical legal documentation training to nursing, medical staff, medical records and PHNs on June 30, 2011. 100% nursing staff will be trained by November 30, 2011. Findings included: SEE: - The nursing staff failed to appropriately assess ATTACHMENTS: 25 ATTACHMENTS: 24 '-~~~'--~--~~~-~~~~~~~~~~-.J'--~~~'--~~~-~---~~---~-..L.~---·FORM CMS-2567(02-99) Previous Versions Obsolete Event l0.IBDS11 Facility ID: 280119 lf continuation sheet Page 50 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES ANO PLAN OF CORRECTION (X1) PROVJDERISUPPLIERICLIA IDENTIFICATION NUMBER. 280119 A. BUILDING B. WING NAME OF PROVIDER OR SUPPLIER I ! ' 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WlNNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WlNNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYNG INFORMATION) A385 Continued From page 50 patients and develop and institute care interventions that promoted the health and well being of patients in their care. ID PREFIX TAG A395 PROVIDER'S PLA.N OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) Nursing Supervisor Revised Pain Assessment and Reassessment policy approved by Medical Staff on June 22, 2011. This is included in the monthly nursing (XS) COMPLETION DATE 11/30/11 peer review. Data submitted monthly to Nursing departmental meetings and IOP Committee beginning November 2011. The cumulative effect of the systemic failure of the nursing service and Director of Nursing to ensure nursing staff were organized to assess and provide care to patients appropriately led to the system failure of the nursing service to care for patients safely. A395 482.23(b)(3) RN SUPERVISION OF NURSING CARE A registered nurse must supervise and evaluate the nursing care for each patient This STANDARD is not met as evidenced by: Based on medical record review, policy review, incident report review, Medical Staff Bylaws, Rules and Regulations review, and staff interview, the facility failed to ensure nursing staff evaluated and assessed the care provided to each patient on an ongoing basis for 3 of 32 (#1, #7, and #45) medical records reviewed. The facility identified a census of 2. Findings included: Review of medical record for Patient #1 revealed she was 45 years old and admitted to the facility on 4/5/11 with diagnosis to include: post operative transmetatarsal amputation of both feet (removal of the toes from both feet), diabetes, chronic kidney disease with hemodialysis (removal of waste and water from the bloodstream by filtering blood through an artifical membrane), peripheral vascular disease, neuropathy (numbness and pain frequently in the )RM CMS-2567(02·99) Previous Versions Obsolete Event ID:l8DS11 Pharmacy provided training on Narcotic use and side effects on September 23, 2011 to nursing staff. 100% of nursing staff will receive training by November 30, 2011. ll/3D/11 11/30/11 Contractor Med Ed consultants provided Medical legal documentation training to nursing, medical staff, medical records and PHNs on June 28-30, 2011. 100% nursing staff will be trained by November 30, 11/3D/11 2011. Medication Administration Policy was updated and approved by Medical Staff Committee. Nurse Educator will provide training on Medication Administration training to all nursing staff by November 30, 2011. Revised Patient Fall Protocol to include post-fall follow up by Nursing Supervisor. Nurse Educator will conduct re-education on Fall protocols to all nursing staff by November 30, 2011. Physical Therapy con~ucted training on techniaues on lifting patients in August 2011. 100% of the nursing staff will be trained by November 30, 2011. Inpatient Monitor developed by Nursing Supervisor to include Fall assessment. 100% inpatient chart audit will be completed monthly by the Inpatient Supervisor. Data analysis, trending and corrective actions, if necessary will be reported to nursing departmental meetings and JOP monthly. Data will be reported to the Safety Committee quarterly. 11/3D/11 11/30/11 11/30/11 11/30/11 lOP Director/Risk Manager will prov'1de training to 100% of facility staff on the Abuse and Neglect Policy 1/2012 by November 30, 2011. Facility ID: 280119 If continuation sheet Page 51 of 93 PRINTED: 10/1912011 FORM APPROVED OMS NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (XI) PROVIDER/SUPPLIER/CLlA IDENTIFICATION NUMBER: 280119 B. WING _ _ _ _ _ _ _ _ _ __ 10/14/2011 NAME OF PRO\llDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PP.ECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 395 Continued From page 51 hands and feet often associated with diabetes due to damage to the nerves), hypertension (high blood pressure), and hyperlipidemia (high fat content in the blood). The medical record further indicated Patient #1 was admitted for pain management and diabetes control. Review of medical record for Patient #1 revealed documentation inconsistent with interviews obtained from staff. Interview with the Improving Operation Performance/Risk Manager (IOP/RM) on 8/31 /11 at 2: 1O PM revealed the contract podiatrist saw Patient #1 on 4/8/11 and told the nursing staff he thought Patient #1 was oversedated. The medical record lacked documentation of the contract podiatrist visit or observations. There is an order documented on 4/8/11 at 6:25 PM to discontinue Morphine (pain medication) 30 mg (milligrams) by mouth twice daily from the contract podiatrist. The medical record revealed an order to discontinue Fentanyl ( a pain medication that provides continuous, around-the-clock delivery of the drug) 25 mcg (microgram) patch 1 patch every 72 hours from Physician Won 4/8/11 at 6:43 PM. The medical record lacked evidence nursing staff assessed and reported any significant findings to Physician W regarding Patient #1 's status at the time the Fentanyl patch was discontinued. The medical record does not indicate that nursing staff monitored Patient #1 closely following the reported concerns from the podiatrist, nor is there documentation nursing staff removed the discontinued Fentanyl patch. Interview with the Day Nursing Supervisor on the Medical Surgical unit on 8/31/11 at 3:00 PM revealed during review of this medical record she spoke with Registered Nurse E, the nurse taking the order to FORM CMS-2567(02·99) Previous Versions Obsolete (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING Event ID.180$11 ID PROVIDER'S PLAN OF CORRECTION PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) TAG (XS) COMPLETION DATE A 395 IOP Director/Risk Manager will conduct Abuse and Neglect Training annually beginning January 2012 in new orientation and mandatory staff trainings. 11/30/11 Medical Staff will update the Medical Staff Bylaws to remove the previous process of admission of suicidal patients to the inpatient unit by November 30, 2011. 11/30/11 Peer Review toot developed by Nursing Supervisor on November 2011. 100% inpatient charts will be monitored monthly for documentation of assessment and reassessment in the patient record. 11/30/11 11/30/11 Data will be reported in monthly nursing department;:il meetings and IOP beginning November 2011. A395 UPDATE: 12/27/11 1/31/12 Use multidisciplinary care rounds to identify any issues or concerns and to identify any patient care issues. If there are any recommendations will use action item tracking form to report through appropriate committees to address concerns and complete actions. Attachment 24: • Inpatient supervisor will change policy to timely. • Inpatient supervisor will provide the training to staff after the policy has been approved. • Inpatient supervisor will monitor by looking at the time stamp in the E.H.R. and the signature time stamp. This will be monitored weekly and a section will be added to her monthly report to reflect the data and the POC if needed will be submitted to DON, CEO, CD, and IOP Facility ID: 280119 lf continuation sheet Page 52 of 93 PRINTED: 1011912011 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVJDER/SUPPLIERICLIA IDENTIFICATION NUMBER. 280119 NAME OF !='ROVIDER OR SUPPLIER A BUILDING B WING _ _ _ _ _ _ _ _ _ __ 10114/2011 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 395 Continued From page 52 remove the Fentanyl patch. Registered Nurse E indicated to the Day Nursing Supervisor that she did not remove the Fentanyl patch because she thought she could leave it on until it expired in 72 hours. The medical record indicates that Patient #1 called out to the nurses' station at 8:20 PM stating that she went down. The documentation indicates that Patient #1 was alert and oriented to person, place, and time. There is no documentation regarding how the fall took place to indicate if the patient had impaired safety awareness and/or judgement that could indicate further concerns regarding sedation. The medical record indicates Registered Nurse D notified Physician Z, who was on call, regarding the fall. The medical record lacks documentation Registered Nurse D informed Physician Z of the contract podiatrists concerns regarding oversedation and the discontinuation of pain medications. The medical record does document that Patient #1 had a pain level of 5 on a scale of 1 to 10 and was given a prn (as needed) pain medication. Review of the MAR (medication administration record} revealed Patient #1 received a Temazepam (sleeping pill) 30 mg at 8:05 PM and an acetaminophen/oxycodone (pain pill) pill at 8:20 PM. There is no evidence in the medical record Patient #1 requested the sleeping pill or the pain pill. The is no evidence in the medical record Registered Nurse D assessed Patient 1's level of sedation prior to administering these medications. There are vital signs documented on 4/8111 at 8: 30 PM temperature 1DO degrees Fahrenheit, pulse 91 beats per minute (bpm), respirations 20 per minute, blood pressure 98167 and oxygen saturation 92 %. The assessment documented 4/8/11 at 9: 16 PM indicates Patient FORM CMS-2567(02-99) Previous Versions Obsolele (X3) DATE SURVEY COMPLETED jX2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE. ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG FORM APPROVED OMB NO 0938-0391 Event ID:ISDS11 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG {XS) COMPLETION DATE A395 • ER nursing supervisor will provide training on the Assessment and reassessment in the ER. • • • • ER nursing supervisor will monitor by reviewing charts of patient treated in the ER. These will be evaluated weekly and reported in the ER nursing monthly report including data and POC if needed to the DON, CEO, CD, Safety and IOP. Attachment 26: ER nursing supervisor will also provide training on the Medication administration policy and assessment and reassessment when providing treatment or medication. Deb will mon·1tor by reviewing charts of patient treated in the ER. These will be. evaluated weekly and reported in the ER nursing monthly report including data and POC if needed to the DON, CEO, CD, Safety and lOP. Attachment 29: Revisit policy and remove any terminology related to having to have any order for assessment frequency. Retrain nursing staff on increasing rounds on patients, will develop a report for the NA to use and report to charge nurse, this will be evaluated for timely assessments and reassessments, notification to the RN and any notification to MD. These will be reported monthly with any POC and analysis by supervisor. Will be reported to DON, CEO, CD and !OP SEE: UPDATE Attachment ATTACHMENTS: Facl11ty JD: 280119 If continuation sheet Page 53 of 93 PRINTED: 10/19/2011 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES !\ND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CUA IDENTIFICATION NUMBER: FORM APPROVED OMB NO 0938-0391 (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING 280119 NAME OF PROVIDER OR SUPPLIER 10114/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES {EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYNG INFORMATION) A 395 Continued From page 53 #1 was alert and oriented. There is no in depth assessment of Patient #1 's response to the pain medication and sleeping pill in light of the prior concerns regarding the patient's oversedation. Documentation in the MAR indicates Patient #1 was asleep at 10:00 PM and had a pain level of O at 10:05 PM. Documentation in the medical record indicates Registered Nursed D gave Patient #1 medication on 4/8/11 at 10: 17 PM but there is no assessment of the patient's level of sedation. Documentation in the medical record on 4/9/11 at 12: 12 AM indicates Patient #1 spit on floor. Even though it is documented earlier at 8:30 PM that Patient #1 had an oxygen saturation of 92%, Registered Nurse D does not assess breath sounds, respiratory effort, or level of sedation. Registered Nurse D did note on 4/9/11 at 12: 12 AM that the head of Patient #1 's bed was elevated 35 degrees. It is not noted if this is normal for Patient #1 or if there is a reason, such as shortness of breath, for the head of the bed to be elevated. Documentation on 4/9/11 at 3:32 AM indicates Registered Nurse D found Patient #1 low in the bed and attempted to reposition Patient #1 in the bed, but Patient #1 appeared sleepy. Registered Nurse D called a second nurse to assist in repositioning Patient #1. Further documentation at the time indicates that Patient #1 looks at the nurse but returns to sleep when her name is called and is coughing up phlegm. Registered Nurse D provided oral care. The medical record lacked an in depth assessment of Patient #1 's sedation or lung or breath sounds. The assessment on 4/8/11 at 9:16 PM indicates Patient #1 provides mouth care independently and there is no documentation Patient #1 had phlegm at that time. There is no documentation in the medical ORM CMS·2567(02·99) Previous Versions Obsolete Event 10:160511 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A395 Facility ID: 280119 If continuation sheet Page 54 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER. 280119 NAME OF PROVIDER OR SUPPLIER COMPLETED B WING _ _ _ _ _ _ _ _ __ TAG 10/14/2011 STREET ADDRESS. CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX (X3) DATE SURVEY (X2) MULTIPLE CONSTRUCTION A BUILDING WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 395 Continued From page 54 record Registered Nurse D assessed Patient #1 for this change of condition or notified the physician on call of the change in condition. Documentation on 4/9/11 at 3:56 AM showed Register Nurse D found Patient #1 hard to arouse and unable to obtain a blood pressure. Documentation by the emergency room physician (Physician K) on 4/9/11 at 4:22 AM indicates nursing found Patient #1 pulseless and apneic (no respirations). Staff attempted to resuscitate Patient #1; however, efforts failed and Patient #1 died. PROVIDER'S Pl.AN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (XS) COMPLETION DATE A395 Review of product information for Fentanyl indicates that serum concentration continues to rise for the first two system applications, however, by the end of the second 72 hour application a steady state is achieved. The product information further indicates that a fever can increase the absorption of Fentanyl and patients with fever should be monitored for opoid (a prescription narcotic pain-reliever) side effects. Review of the MAR for Patient #1 indicated the first Fentanyl patch was applied 4/5/11 at 11: 00 PM and the second Fentanyl patch was applied 4/8/11 at 10:00 AM. Patient #1 's serum concentration would have been continuing to rise. Further review of the medical record revealed Patient #1 had a fever. Patient #1 's temperatures for 4/8/11 given in degrees Fahrenheitwere 6:10 AM-100.4; 10:05 AM100.8; 3:55 PM - 101; 5:00 PM -101.6; 7:17 PM - 101.4; 8:30 PM - 100; 9:10 PM - 99.8; 10:05 PM - 99.1; and for 4/9/11at3:15 AM 99.9. Interview with the DON (Director of Nursing) on 8/31 /11 at 1: 30 PM revealed she had reviewed the medical record for Patient #1 and confirmed FORM CMS-2567(02-99) Previous Versions Obsolete Event ID.160511 Fac!llty ID. 280119 If continuation sheet Page 55 of 93 PRINTED: 10/19/2011 FORM APPROVED :JEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES rATEMENT OF DEF1CIENCIES \ID PLAN OF CORRECTION (X1) PROV1DER/SUPPLIER/CLIA IDENTIFICATION NUMBER. 280119 llAME OF PROVIDER OR SUPPLIER OMB NO 0938-0391 A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 395 Continued From page 55 the lack of documentation and the failure to assess Patient #1 's respiratory status. ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECIME ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) {XS} COMPLETION DATE A395 Interview with Physician Won 10/3/11at1:07 PM revealed nursing staff notified him between 6:00 PM and 7:00 PM on 4/8/11 regarding the contracted podiatrist concerns that Patient #1 was oversedated. Physician W told nursing staff to stop the pain medication. Physician W expressed concern that Patient #1 fell and was frothing at the mouth during the night of 4/8/11 into the morning of 4/9/11 and nursing staff did not make the physician on call aware this was a change of condition for Patient #1. Physician W stated that nursing staff should pay closer attention and notify the provider of any change in condition. Review of the medical record showed hospital staff admitted Patient #7 on 8/9/11 at 2: 17 AM with diagnosis of alcohol encephalopathy (a severe syndrome characterized by ataxia (gross lack of coordination of muscle movements}, ophthalmoplegia, confusion, and short-term memory loss), diabetes, hypertension, and mass in the left kidney. Admission data indicates Patient #7 had a fall score of 70 (anything above 50 is considered high risk). Staff documented Patient #7's level of consciousness as oriented to place, oriented person, but confused. Staff identifies that Patient #7 is ambulatory but will require stand by assistance due to unsteady gait and confusion. Staff further identify that Patient #7 has no religious, traditional, ethnic, or cultural practices that should be part of hospital care. Review of incident reports for the month of August revealed Patient #7 sustained three falls. The first report on 8/9/11 at 2:10 PM revealed FORM CMS-2567(02-99) Previous Versions Obsolete Event l0:!8DS11 Facility ID: 280119 If continuation sheet Page 56 of 93 • PRINTED: 10/19/21 FORM APPROv OMB NO 0938-0: DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PRO\/lDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVJDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION A BUILDING B WING _ _ _ _ _ _ _ _ __ TAG HWYn-75 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 395 Continued From page 56 that Patient #7 heard a loud noise and found Patient #7 sitting on his buttocks approximately 3 feet from his bed. Patient #7 stated his legs just gave out. Review of the medical record for Patient #7 revealed the only nursing documentation on 8/9/11 were alcohol withdrawal assessment flow sheets. Review of the medical record revealed a History & Physical (H&P) dated 8/9/11 at 9:09 AM. Review of the H&P showed Patient #7 was alert and oriented to person, place, and time with normal memory and judgment. The H&P showed that Patient #7 complained of stumbling around. Review of the withdrawal assessment flow sheet dated 8/9/11 at 2:20 PM revealed Patient #7 was hallucinating and agitated, Valium (anti-anxiety medication) 5 mg was given intramuscularly. There is no documentation in the medical record regarding Patient #7's fall or any nursing assessment following the fall. There is no evidence in the medical record that nursing staff notified the physician of the fall. The next withdrawal assessment flow sheet dated 8/9/11 at 5:20 PM indicates Patient #7 was hallucinating, agitated, and had a change in sensorium. Review of the incident reports revealed Patient #7 had a fall on 8/9/11 at 4:40 PM. There is no documentation in the medical record regarding Patient #7's fall or any nursing assessment following. There was no change to Patient #7's care plan interventions following the first fall. There is no documentation in the medical record indicating nursing staff notified the physician of the fall. Review of the medical record showed a note by the Clinical Social Worker dated 8/10/11 at 10:24 AM stating "Patient is also requesting an evaluation for a power chair as he feels his legs are not strong enough to carry him without him falling." Review FORM CMS·2567(02-99) Previous Versions Obsolete 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE WINNEBAGO IHS HOSPITAL (X4)1D PREFIX (X3) DATE SURVEY COMPLETED Event 10: IBDS11 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETI DATE A395 Facility ID: 280119 If continuation sheet Page 57 c PRINTED: 10/19/2011 ·FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION {X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVJDER OR SUPPLIER A BUILDING 8.WING _ _ _ _ _ _ _ __ (X4)1D HWY77-75 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 395 Continued From page 57 of a hospital inpatient physician daily progress note dated 8/10/11 at 12:27 PM stated, "the patient still having withdrawal, fell down yesterday twice but he is ok today, alert, awake, answers questions appropriately, still have unsteady gaiL" Review of incident reports revealed Patient #7 fell a third time on 8/10/11 at 6:05 PM. The incident report indicates an unidentified CNA (certified nurse aide) assisted Patient #7 to the shower with a shower bench and left the patient unattended to shower. Patient #7 sustained a 1 cm (centimeter) x 1 cm abrasion to the right elbow and a large ecchymosis (bruise) to the back. Patient #7 report pain 8 of 1O (scale of .1 to 1o with 1 being mild pain and 1O the worst pain imaginable) in his back and legs following the fall. Review of the medical record revealed nursing documentation that states"At 1805 [6:05 PM] the CNA took pt [patient] to the toilet for shower, the pt fell while taking shower, pt (patient) has an abrasion to right elbow. a 50 centimeter (cm) by 18 cm ecchymosis (bruising) to right dorsa [back] area and 8/10 pain to right lower extremities, [Clinical Director] was notified at 1810 [6:10 PM], evaluated the pt Band-Aid applied to abrasion, set of vital sign taken and entered at 1825 [6:25 PM]" The medical record further showed a crisis note written by the Clinical Director that states, ".. he is also to undergo back surgery for his leg weakness. Called [Clinical Director was called] by [Registered Nurse F] at 6:20 pm this evening and was told that pt had fallen in the bathroom. Although he fell twice yesterday and is on fall precautions -- he was showering unattended and tried to stand in the shower - per pl and found the floor slippery and fell. He reports pain level 8-9/10 to his right posterior back and right lateral FORM CMS-2567(02-99) Previous Versions Obsolete 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE WINNEBAGO !HS HOSPITAL PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION Event JD:l8DS11 PROVIDER'S PLAN OF CORRECTION {EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG {XS) COMPLETION DATE A395 Facllity ID. 280119 If continuation sheet Page 58 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDERISUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVIDER OR SUPPLIER A BUILDING B. WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWYn-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3} DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION} A 395 Continued From page 58 knee - post impact with the wall and floor." The crisis note further indicates, "Admits he has been falling repeatedly lately - even before admission to hospital. Admits to having tight caplike pressure around the top of his head - at this time since his fall and pain-headache 8/1 O in intensity. He states that he hit his head very hard on wall. Denies nausea or vomiting . Denies blurred vision. Admits that he feels very dizzy -- more so than before his fall." The neurological assessment of Patient #7 is alert and oriented to person, place and time but memory poor. The crisis note concludes with a plan to "transfer patient to [Hospital M] for acute eval [evaluation] of head trauma and tight headache and as he seems to be having repeated falls - with difficulty preventing even on fall precautions here." Review of the medical record lacks evidence that nursing staff assessed the reasons for the patient falling and instituted appropriate interventions to protect the patient and ensure his safety. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (XS) COMPLETION DAlE A395 Review of documentation by the Day Inpatient Supervisor on 8/29/11 regarding the falls experienced by Patient #7 showed the documentation validated the falls and formulated a plan of action. The review failed to identify the cause of the falls or document the trend of the falls prior to formulating a plan of action. The plan of action failed to address the lack of assessment and formulation of interventions to prevent further falls. There was no written documentation that the facility enacted the plan of action. Interview with the Day Inpatient Supervisor on 8/31/11at3:00 PM confirmed there was no written documentation of any training provided to staff. FORM CMS-2567(02·99) Previous Versions Obsolete Event ID:IBDS11 Facility ID: 280119 If continuation sheet Page 59 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES TATEMENT OF DEFICIENCIES ND PLAN OF CORRECTION (X\) PROVJDERISUPPLIERICLIA IDENTIFICATION NUMBER: 280119 I.JAME OF PROVIDER OR SUPPLIER a WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS. CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (XS) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 395 Continued From page 59 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION {EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A395 Interview with the Clinical Director on 8/25/11 at 1:35 PM revealed she transferred Patient #7 from the· facility because of concern related to the number of falls the patient experienced and the failure of the nursing staff to keep him safe. Patient #7 had alcohol withdrawal, was receiving Ativan (antianxiety medication), and was a high risk for falls. Patient #7 was allowed to shower alone and staff indicated it was because native men were very private. Interview with the DON on 8/30/11 at 4:00 PM revealed that nursing staff should have assessed Patient #7 more frequently. The CNA could have rounded on Patient #7 more frequently or could have sat with the patient. The CNA is very traditional and was trying to be culturally sensitive to allow Patient #7 privacy while showering. Documentation in the medical record indicated that Patient #7 did not identify cultural issues that should be part of the hospital care during the admission process. Further interview with the DON on 10/14/11 at 11 :54 AM confirmed there was no real assessment of this patient at high risk for falls in the medical record nor was there documentation of an assessment following the falls. Review of me'i'i~'>··'"'<'""'.:<' .-' ~·..,~ , .;:., >lA DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES TATEMENT OF DEFICIENCIES ND PLAN OF CORRECTION (X1) PROVlOERJSUPPUER/CLIA IDENTIFICATION NUMBER: 280119 •AME OF PROVIDER OR SUPPLIER "'' PK.IN i t::U: I I OMS NO 0938-0391 (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING 8.WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY. STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG IU/ l~iLU FORM APPROVED WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 395 Continued From page 62 within the facility. As soon as possible the patient shall be referred to another institution where suitable facilities are available. When transfer is not possible the patient may be admitted to a general area of the Hospital as a temporary measure. The patient will be afforded psychiatric consultation, and the Mental Health Services shall be consulted when necessary for assistance. Family members/relatives shall watch the patient (one on one), if not available nursing staff will do. Weekend admissions shall have on-call staff available from the Mental Health department." Review of policy titled, "Suicide Gestures, ldeations, and Attempts" revised 6/11 defines suicidal ideations as "a common medical term for thoughts about suicide, which may be as formulated as a formal plan, without the suicidal act itself. Although most people who undergo suicidal ideations do not commit suicide, some go on to make suicide attempts." The policy does not provide guidance to the inpatient nursing staff on how to manage a suicidal p~erit. An e-mail from the IOP/RM on 10/5111 at 5: 00 PM confirmed there was no inpatient policy related to dealing with suicidal patients. There is no indication in the medical record that nursing staff took steps to secure the environment of the room in which they place Patient #45. Nursing staff failed to observe Patient #45 every hour. The medical record failed to assess Patient #45 for abuse by the patient's mother and allowed the mother to remain in the room with the patient. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS.REFERENCED TO THE APPROPRIATE DEFICIENCY} ID PREFIX TAG {X5) COMPLETION OAT1' A395 Interview with the DON on 10114111at11:54 AM revealed there is no policy for the management of suicidal patients on the inpatient unit. Any monitoring the nursing staff would do would be ='ORM CMS..2567(02·99) Previous Versions Obsolete Event ID: 18DS 11 Facility ID. 280119 If continuation sheet Page 63 of 93 PRINTED: 10/19/2011 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES TATEMENT OF DEFICIENCIES ND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 IJAME OF PROVIDER OR SUPPLIER OMB NO 0938-0391 A BUILDING B. WING _ _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS. CITY. STATE. ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 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 A395 Continued From page 63 A39 A528 based on the orders of the provider and if there were no orders for monitoring it would be her expectation that patients be monitored every 15 to 30 minutes. Suicidal patients should be close to the nurses' station with the door open. When abuse is suspected nurses should report to social services and child protective services and not leave the suspected abuser in the room with the patient. A528 482.26 RADIOLOGIC SERVICES {X5)· COMPLETION DATE Aberdeen Area medical physicist to complete physicist acceptance survey to assure the radiological performance of the X-ray unit. 11/22-23/11 Aberdeen Area medical physicist to complete physicist periodic survey to assure the radiological performance of the portable unit. 11/30/11 Winnebago Hospital Clinical Engineering staff to provide training on the existing new equipment policy and procedures to departmental staff. 11/30/11 The hospital must maintain, or have available, diagnostic radiological services. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications. -QAPI: A sign-in sheet will be used, and training repeated, until all Radiology department staff have attended training. And will be reported to the Improving Operation Performance Director when completed. 11/30/11 This CONDITION is not met as evidenced by: Based on policy review, document review, Medical Staff Bylaws.Rules, and Regulations review, and facility staff interviews, the facility failed to ensure the safety of radiological services provided at the facility by not implementing systems to ensure the radiologic equipment was safe for patient use prior to placing it into service and that the Medical Staff appointed a qualified Radiologist to supervise the department in a manner to ensure the safety of patients and staff, and/or delineate the radiologic tests that require specialized interpretation by a radiologist. The facility identified a census of 2 but all patients who received an x-ray at the facility could be affected. The Medical Staff will review, approve, and incorporate into the Bylaws as required, the statement provided by the contract Radiologist dated 12/3/2010 agreeing to "Clinical Supervision over the Radiology Department as required by 42 CRF 482.26 11/8/11 (c) ... ". AS28 UPDATE: 12/27/11 10/12/11 Radiology Supervisor will develop a survey tool for the Radiologist to use when he does an onsite review. Radiology Supervisor will update Contract to state that the Radiologist will review program 2 times a year. Radiology Supervisor will follow up with any POC from the survey. Findings included: -The failure to ensure a medical physicist FORM CMS-2567(02-99) Previous Versions Obsolete Event 10:160$11 SEE: UPDATE Attachment ATIACHMENTS: $ Facility ID: 280119 If continuation sheet Page 64 of 93 - PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES :TATEMENT OF DEFICIENCIES .ND PLAN OF CORRECTION (X1) PROVJDER/SUPPLIERICLIA IDENTIFICATION NUMBER; (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING 280119 10/14/2011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTlFYlNG INFORMATION) A 528 Continued From page 64 evaluated new equipment for safety prior to placing it in service for patient use for both the only x-ray suite and the only portable x-ray machine available at the facility. (See details at A-537) ID PREFIX TAG PROVJDER'S PLAN OF CORRECTION (EACH CORRECTNE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) {XS} COMPLETION DATE A528 -The failure to ensure that the the Medical Staff designated a qualified Designated Radiology Director to supervise the Radiology department or to designate which radiologic images should be interpreted by a radiologist. (See details at A-546) The cumulative effect of the facility's failure to ensure that a qualified medical physicist evaluated radiologic equipment prior to placing the equipment in use to assure it was functioning properly and not exposing patients and staff to unnecessary dosages of radiation and to ensure that the Medical Staff designated a qualified Radiology Director to supervise the Radiology department resulted in a systemic failure of the radiology service. A 537 482.26{b){2) PERIODIC EQUIPMENT MAINTENANCE A537 Periodic inspection of equipment must be made and hazards identified must be promptly corrected. This STANDARD is not met as evidenced by: Based on standards of practice for radiology review, document review, and facility staff interview, the facility failed to ensure a medical physicist evaluated the safety of 2 of 2 radiology units prior to the units being placed into patient use. The facility identified a census of 2. ORM CMS-2567(02-99) Previous Versions Obsolete Event !D.180511 Facility 10: 280119 If continuation sheet Page 65 of 93 PRINTED: 10/19/2011 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES >TATEMENT OF DEFICIENCIES \NO PLAN OF CORRECTION (X1) PROVlDERISUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 OMB NO 0938-0391 A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 NAME OF PROVlDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFlCIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 537 Continued From page 65 Findings included: ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A537 A537 Review of standards of practice for the American College of Radiology (ACR} reveals, " The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation oncologists, and clinical medical physicists in the United States. The College is a nonprofit professional society whose primary purposes are to advance the science of radiology, improve radiologic services to the patient, study the socioeconomic aspects of the practice of radiology, and encourage continuing education for radiologists, radiation oncologists, medical physicists, and persons practicing in allied professional fields. The American College of Radiology will periodically define new practice guidelines and technical standards for radiologic practice to help advance the science of radiology and to improve the quality of service to patients throughout the United States. Existing practice guidelines and technical standards will be reviewed for revision or renewal, as appropriate, on their fifth anniversary or sooner, if indicated. Each practice guideline and technical standard, representing a policy statement by the College, has undergone a thorough consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council. The practice guidelines and technical standards recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document A standard titled, ACR TECHNICAL JRM CMS-2567(02-99) Previous Versions Obsolete (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION Event ID: 180511 Aberdeen Area medical physicist to complete physicist acceptance survey to assure the radiological 11/22-23/ll performance of the X~ray unit. Aberdeen Area medical physicist to complete physicist periodic survey to assure the radiological performance of the portable unit. 11/30/11 Winnebago Hospital Clinical Engineering staff to provide training on the existing new equipment policy and procedures to departmental staff. 11/30/11 -QAPI: A sign-in sheet will be used, and training repeated, until all Radiology department staff have attended train_ing. And will be reported to the Improving Operation Performance Director when completed. 11/30/11 SEE: ATTACHMENTS: 31 Facility ID: 280119 If continuation sheet Page 66 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CUA IDENTIFICATION NUMBER. 280119 NAME OF PROVIDER OR SUPPLIER A. BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE. ZIP CODE HWYn-75 WINNEBAGO, NE 68071 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 537 Continued From page 66 STANDARD FOR DIAGNOSTIC MEDICAL PHYSICS PERFORMANCE MONITORING OF RADIOGRAPHIC AND FLUOROSCOPIC EQUIPMENT, states in part, This standard was revised by the American College of Radiology (ACR) with assistance from the American Association of Physicists in Medicine (AAPM). The performance of all radiographic and fluoroscopic equipment must be evaluated upon installation and monitored at least annually by a Qualified Medical Physicist to ensure that the equipment is functioning properly and that patients are not exposed to unnecessary doses of radiation. " ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS·REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A 537 Review of documentation provided by the facility regarding the assembly and installation of the Shimadzu portable x-ray unit and the GE (General Electric) stationary general radiology unit revealed the following: -A biomedical technician assembled the Shimadzu portable unit on 3/27/09. -A biomedical technician assembled the GE stationary unit on 6/15/11. Review of a fax forwarded by the facility on 9/9/11 at 3:27 PM reveals in part a statement from the Aberdeen Area Institutional Environmental Health Officer, "It should be clarified that VA (Veterans Affairs) conducts biomedical acceptance testing; not medical physics acceptance testing (the FDA [Food and Drug Administration] 2579 form documents testing and adjustments to certify compliance with federal x-ray equipment performance standards). " FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 180511 Facility ID: 280119 If continuation sheet Page 67 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (XI) PROVlDERISUPPLIER/CLIA IDENTIFICATION NUMBER. 280119 NAME OF PROVIDER OR SUPPLIER COMPLETED A BUILDING 8. WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY. STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 537 Continued From page 67 Review of documentation provided by the facility regarding periodic survey of the portable Shimadzu on 11/4/10 reveals "Available manuals neither provided manufacturer specific quality control testing procedures nor provided instruction for placing the unit in a non-imaging mode to protect the digital detector plate. Therefore, the unit could not be tested without risking damage to the detector. Upon returning to Aberdeen, the service contractor for the Shimadzu portable digital radiological unit was contacted and information was acquired for placing the unit in a manual/non-digital mode for future testing." PROVlDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (XS) COMPLETION DATE A537 Interview with the Radiology Supervisor on 8/23/11 at 2:40 PM reveals that the Aberdeen Area Institutional Environmental Health Officer did not return to evaluate the Shimadzu portable unit after 11//4/10 and has not evaluated the GE stationary unit. The Aberdeen Area Institutional Environmental Health Officer will evaluate both x-ray units when he returns in November of this year for his annual inspection. Interview with the Radiology Supervisor on 9/16/11 at 9:49 AM reveals the Shimaduz portable x-ray unit was put into service for patients on 9/10/1 D and the GE stationary x-ray unit was put into service for patients on 7/22/11. A 546 482.26(c}(1} RADIOLOGIST RESPONSIBllTIES A546 A qualified full-time, part-time, or consulting radiologist must supervise the ionizing radiology services and must interpret only those radiological tests that are determined by the medical staff to require a radiologist's specialized knowledge. For purposes of this section, a FORM CMS-2567(02-99) Previous Versions Obso\ele Eventl0:18DS11 Faci!lty ID: 280119 If continuation sheet Page 68 of 93 ---~"'"-··•-r- ... .,. . ..., ,,.~:----..-....~-...;;;-.~,.,.~· ..·· ~~'~:(' ··~·s,,7 '""'""' ,., PRINTED: 10/19/201' FORM APPROVE[ OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PlAN OF CORRECTION (X1) PROVlDER/SUPPLIER/CLIA IDENTIFICATION NUMBER. 280119 A BUILDING B WING NAfo'IE OF PROVlDER OR SUPPLIER 1011412011 STREET ADDRESS, CITY. STATE. ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTl~NG INFORMATION) A 546 Continued From page 68 radiologist is a doctor of medicine or osteopathy who is qualified by education and experience in radiology. This STANDARD is not met as evidenced by: Based on Medical Staff Bylaws, Rules, and Regulations review, Medical Staff Committee meeting minutes, Governing Body meeting minutes review, policy review, and staff interview, the facility failed to ensure the Medical Staff appointed a Designated Radiology Director to supervise the Radiology department in a manner to ensure patient safety or designated which radiologic tests require interpretation by a radiologist. The facility identified a census of 2. PROVlDER'S PLAN OF CORRECTION {EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (XS} COMPLETION DATE A546 A546 The Medical Staff will review, approve, and incorporate into the Bylaws as required, the statement provided by the contract Radiologist dated 12/3/2010 agreeing to "Clinical Supervision over the Radiology Department as required by 42 CRF 482.26 (c) .•. ". 11/8/11 SEE: ATTACHMENTS: 5 . -·- .. -- - ... Findings included: Review of Medical Staff Bylaws, Rules, and Regulations dated FY (fiscal year) 2009 - 2011 states in part, "Section 13. 07 Designated Radiology Director - The courtesy Medical Staff Director/consultant is the designated overall consultant in regards to the Radiology Services provided. The clinical Director or designee will serve as the Service Unit's Radiology Director." ' Interview with the Radiology Supervisor on 8123111 at 9:25 AM and 9/16111 at 9:49 AM reveals that Radiologist Y was the supervising Radiologist for the Radiology Department. Review of the signature sheet for the Radiology Department policies shows signatures by the Radiology Supervisor as the Chairperson for the Initiating Committee/Department and Signature by the Chairperson of Concurring Committee Medical Staff, Physician Z, the area for the FORM CMS-2567(02-99) Previous Versions Obsolele Event JD: 18DS11 Facility JD: 280119 If continuation sheet Page 69 of 93 PRINTED: 1U/l~ILU I I FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES TATEMENT OF DEFICIENCIES ND PLAN OF CORRECTION {Xl) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO 0938-0391 (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A. BUILDING 280119 ~AME OF PROVIDER OR SUPPLIER 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77·75 WlNNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG WlNNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 546 Continued From page 69 Director of Radiology to sign is again signed by the Radiology Supervisor. ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION OAlE A546 Interview with the Radiology Supervisor on · · 9/16/11 at 11 :01 AM revealed at the time staff signed the policies Radiology Supervisor on 3/18/11 and Physician Z on 3/29/11 respectively, that Physician Z was the Director of Radiology. Review of the credential file for Physician Z reveals his speciality is Internal Medic;ine not Radiology. Review of the contract with Radiology group A dated 4/13/10 lacks evidence of designating one radiologist as the Designated Radiology Director nor does it delineate the responsibilities of the Designated Radiology Director. Review of Medical Staff meeting minutes dated 4/27/11, 5/3/11, 5/25/11, and 6/22/11 lacks evidence of the appointment of Radiologist Y as the Designated Radiology Director. Review of Governing Body meeting minutes dated 6/23/11 and 8/15/11 lacks evidence of the appointment of Radiologist Y as the Designated Radiology Director. Review of policies for the Radiology department lacks evidence of a policy defining which radiological tests require the specialized knowledge of a radiologist for interpretation. The Medical Staff approved the policies of the Radiology department on 3/29/11. Interview with the Radiology Supervisor on 9/16/11 at 9:49 AM confirms the facility lacks a FORM CMS-2567(02·99) Previous versions Obsolete Event !0:18DS11 Facility ID: 280119 If continuation sheet Page 70 of 93 • 1111111 PRINTED: 10/19/2011 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES >TATEMENT OF DEFICIENCIES \ND PLAN OF CORRECTION (X1) PRO\llDERISUPPLIER/CLIA IDENTIFICATION NUMBER. 280119 NAME OF PRO\llDER OR SUPPLIER FORM APPROVED OMB NO. 0938-0391 8 WING _ _ _ _ _ _ _ __ 10/1412011 STREET ADDRESS, CITY, STATE, ZlP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 546 Continued From page 70 policy defining which radiological tests required the specialized knowledge of a radiologist for interpretation. PRO\llDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (XS) COMPLETION DATE A546 Review of the Medical Staff Bylaws, Rules, and Regulation lacks evidence of which radiologic tests require the specialized knowledge of a radiologist for interpretation. Interview of 9/16111at2:17 PM with the Improving Operations Performance Director/Risk Manager confirms that there is no evidence that Medical Staff or Governing Body has appointed a Designated Radiology Director nor is there evidence of the Medical Staff defining which radiological tests require a radiologists interpretation. Interview on 9/19111at12:30 PM with the Clinical Director and Physician W reveals the Clinical Director is the Director of Radiology. Physician W states the radiologists don't have anything to do with the internal direction of the hospital. The radiologists don't come to the hospital. The radiologists couldn't be the director of any department. A 710 482.41(b)(1)(2)(3) LIFE SAFETY FROM FIRE A 710 (1) Except as otherwise provided in this section(i) The hospital must meet the applicable provisions of the Life Safety Code of the National Fire Protection Association. The Director of the Office of the Federal Register has approved the NFPA 101 2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. A copy of the Code is available for inspection at the CMS Information ORM CMS.2567(02·99) Previous Versions Obsolete Event ID:!SOS1 I Facility ID; 280119 If continuation sheet Page 71 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1} PROVIDER/SUPPLIER/CLIA IOENTlFICATION NUMBER: 280119 A BUILDING B WING _ _ _ _ _ _ _ _ _ __ NAME OF PROVIDER OR SUPPLIER 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 710 Continued From page 71 Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of _federal_regulations/ibr_locations.html Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS will publish notice in the Federal Register to announce the changes. (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition of the LSC does not apply to hospitals. (2) After consideration of State survey agency findings, CMS may waive specific provisions of the Life Safety Code which, if rigidly applied, would result in unreasonable hardship upon the facility, but only if the waiver does not adversely affect the health and safety of the patients. (3) The provisions of the Life Safety Code do not apply in a State where CMS finds that a fire and safety code imposed by State law adequately protects patients in hospitals. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, this facility is not in compliance with the 2000 edition of the Life Safety Code. This affects all occupants in this facility with a capacity of 13 and a census of 2 at the ti me of the survey. Findings include: PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG A 71 C Kl:l: Sprinkler heads will be added to the room located on level 3 1/2 per requirements NFPA 13. A waiver will be submitted to allow for time to procure (XS) COMPLEllON DATE Waiver a contract and then install the system. In the interim, a fire extinguisher will be added to the area, storage will not be allowed in the area, and the , area will be inspected weekly. K29: A door closure was installed on 10/18/11 by 10/18/11 Facilities K37: The dead-end corridor has been alleviated by the addition of a wall closing off the corridor. the common path of travel still exceeds the allowed maximum. Additional smoke detection has been added to this area for quicker detection/notification of a fire in this area. quicker notification allows for more time for the occupants to egress from the area. An annual waiver will be completed and submitted on an annual basis regarding the common path of travel. Waiver request K48: the current fire response plan will be modified to include horizontal and vertical evacuation between smoke zones. Once the plan is complete, it will then go through the approval process. Once approved, the staff will be trained on the new plan and fire drills will ! be periormed accordingly. 11/8/11 K52: The fire alarm system in the DOU will be tied into the alarm system on the hospital. Once complete the hold-open devices installed on the fire doors between the two buildings will function upon activation of either fire alarm system. A waiver will be submitted to allow for time to procure a contract and then periorm the tie-in. In the interim, the hold-open devices will be disabled to keep the doors closed at all times. Waiver request i 1. See the results of the Life Safety Code survey FORM CMS-2567(02-99) Previous Versions Obsolete Event 10.180$11 Facility ro: 280119 If continuation sheet Page 72 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION IDENTIFICATION NUMBER. B.WING NAME OF PROVIDER OR SUPPLIER 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77·75 WINNEBAGO IHS HOSPITAL WINNEBAGO, NE 68071 (X4) ID SUMMARY STATEMENT OF DEFICIENCIES PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, this facility does not have a plan in place to promptly report fires. Lack of written policies and procedures could result in staff failing to promptly report a fire preventing an investigation into the cause. This affects all occupants in this facility with a capacity of 13 and a census of 2 at the time of the survey. Findings include: The hospital must maintain written evidence of regular inspection and approval by State or local fire control agencies. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, this facility does not maintain regular inspections by local fire control agencies. Lack of written policies and procedures to coordinate with Event 10:180811 (XS) COMPLETION DATE Waiver request an The hospital must have written fire control plans that contain provisions for prompt reporting of fires; extinguishing fires; protection of patients, personnel and guests; evacuation; and cooperation with fire fighting authorities. 1. Record review on 8/24/11, between s:ooa.m. and 6:00 p.m., of the facility's fire policy and procedure records showed that there was not a plan in place to report fires. This deficient practice was confirmed by Safety Manager A on 8/25/11. A 715 482.41(b)(B) REGULAR FIRE AND SAFETY INSPECTIONS PROVlDER'S PlAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) K 62: The existing fire suppression contract will be modified to include quarterly inspections. Annual inspection of the sprinkler heads will alsO be added to the existing contract. The sprinkler heads that were found to have paint or other foreign material will be replaced. The sprinkler heads will then be inspected annually to ensure heads remain free from paint or other foreign material. A waiver will be submitted to allow time to procure a contract and then replace the heads. A 710 Continued From page 72 • K12, K29, K37, K4B, K52, K62, K154 and K155 A 714 482.41(b)(7) FIRE CONTROL PLANS FORM CMS-2567(02-99} Previous Versions Obsolete COMPLETED A BUILDING 280119 TAG (X3) DATE SURVEY (X2) MULTIPLE CONSTRUCTION (X1) PROVlDER/SUPPLIERICLIA A 714 K 154: The current Interim Life Safety policy has been modified and is waiting for approval. Measures taken when the fire suppression system is out of services for more than 4 hours in a 24 hour period. 11/8/11 K 155: The current Interim Life Safety policy has been modified and is waiting approval. Measures taken when the fire alarm system is out of service for more than 4 hours in a 24 hour period. 11/8/11 'Uie current fire response plan will be modified to 11/8/11 include horizontal and vertical evacuation between smoke zones. Once the plan is complete, it will then go through the approval process. Once approved, the staff will be trained on the new plan and fire drills will be performed accordingly. responsible party: Johnnie Williams, Safety Officer 11/30/11 SEE: ATTACHMENTS: 34 ATTACHMENTS: 3B I A 715 ' the current fire response plan will be modified to include horizontal and vertical evacuation between smoke zones. Once the plan is complete, it will then go through the approval process. Once approved, the staff will be trained on the new plan and fire drills will be performed accordingly. responsible party: Johnnie Williams, Safety Officer Local fire department will survey hospital lay out annually and when new staff are hired. they will also be part of fire drills annual. Facility ID: 280119 11/8/11 11/30/11 11/30/11 If continuation sheet Page 73 of 93 PRINTED: 10/19/201 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES ANO PLAN OF CORRECTION (X1) PROVJDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: FORM APPROVE! OMS NO 0938-039 (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING B WING _ _ _ _ _ _ _ _ _ __ 280119 10/14/2011 NAME OF PROVJDER OR SUPPLIER STREET ADDRESS, CITY, STATE. ZJP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG A 747 A 715 Continued From page 73 the local fire department could result in a failure of thefife department to be familiar with the structure and the hazards within. This affects all occupants in this facility with a capacity of 13 and a census of 2 at the time of the sU1vey. Findings include: 1. Record review on 8/24/11, between 8:00 a.m. and 6:00 p.m., of the facility's fire policy and procedure records showed that there was not a plan in place to coordinate inspections with the local fire department. This deficient practice was confirmed by Safety Manager A on 8/25/11. A 747 482.42 INFECTION CONTROL The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on Infection Prevention Plan review, Medical Staff meeting minutes review, Governing Body meeting minutes review, and staff interview, the facility failed to promote an active program to identify, report, and investigate infections. The facility identified a census of 2, but all inpatients and outpatients at the facility could be affected. Findings included: PROVJDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) Infection Prevention plan updated to include the Medical provider designated to the Infection Prevention meeting. The existing infection prevention !og will be used in identifying, reporting, and invest'.gating infections. The CDC guidelines used by the Winnebago Hospital Infection Preventlon program for identifying and preventing healthcare associated infections (including employees) are as follows: "Guideline for Prevention of CatheterAssociated Urinary Tract Infections, 2009", "Guideline · for Prevention of Surgical Site Infection, 1999" Guideline for Preventing Health-Care-Associat~d Pneum~n~a, 2003", "Guidelines for Preventing the Transmrss1on of Mycobacterium tuberculosis in Health-Care Settings, 2005", Guidelines for the Prevention of lntravascular Catheter-Related Infections, 2011", "Guideline for Isolation Precaution· Preventing Transmission of Infectious Agents in . Healthcare Settings, 2007", "Guideline for Infection Control in Health Care Personnel, 1998", "Guideline for Disinfection and Sterilization in Healthcare Fac'.fities, 2008", "Management of Multi-drug Resistant Organisms in Healthcare Settings 2006" ~nd "Guidelines for Environmental lnfectio~ Cont:or m Health-Care Facilities", {XS) COMPLETION DATE 10/26/11 11/15/11 ~ctive. and passive surveillance is used to identify, · investigate and report infections to the medical staff nursing, and administrative staff evidenced by ' monthly reports and quarterly report added as a standing agenda item to the Governing Body. Act~v~ surveillance wi/J include Winnebago Hospital's ~nt1b1ogram (positive culture reports) and chart reviews. Passive surveillance includes Infection. Prevention consults generated by the electronic health record and a hard copy of passive surveillance forms placed at patient care areas (e.g. OPD nurses station and inpatient nurse's station). 11/30/11 11/30/11 ·The facility failed to have an effective system to identify, report, and investigate infections in the facility. (See A•747) FORM CMS-2567(02-99) Previous Versions Obsolete Even! ID:IBDS11 Facility ID: 280119 If continuation sheet Page 74 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PRO\llDER/SUPPLIER/CLIA IDENTIFICATION ':'JUMBER: 280119 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION B WING _ _ _ _ _ _ _ _ _ __ HWY77-75 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 747 Continued From page 74 -The facility failed to maintain a log of all community and healthcare acquired infections and communicable diseases for both patients and staff members. (See A-749) -The chief executive officer (CEO), medical staff, and director of nursing (DON) failed to demonstrate responsibility for quality assurance activities and training of issues identified by the Infection Prevention Nurse. (See A-756) The cumulative effect of the facility's failure to ensure an effective system to identify, report, and investigate infections within the facility, failure to maintain a complete log of infections and communicable diseases, and the failure of the CEO, Medical Staff, and DON to demonstrate responsibility for the quality assurance and training of problems identified by the infection prevention program resulted in the systemic failure of the infection control program. A 749 482.42(a)(1) INFECTION CONTROL OFFICER RESPONSIBILITIES The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. This STANDARD is not met as evidenced by: Based on Infection Prevention Plan review, document review, medical record review, and staff inteNiew, the facility failed to ensure the Infection Prevention Nurse developed a system that identified, investigated, and controlled all infections and communicable diseases within the facility for patients and staff. The facility FORM CMS-2567(02-99) Previous Versions Obsolete 10/14/2011 STREET ADDRESS, CITY, STATE. ZIP CODE WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED A BUILDING Event ID: 180511 ID PREFIX TAG PRO\llDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A 747 Attached is the existing Infection Prevention log for healthcare associated infections (HAI) and community acquired infections. Also attached is the existing investigative reports of community acquired infections. An application granting access to the Indian Health Service (IHS) WebCident online incident reporting system for reporting employee occupational illnesses was submitted for the Infection Prevention nurse to allow readily accessible report (including email notifications), investigating and reporting of all employee occupational illnesses that are submitted by employees. Currently, the Safety Officer investigates occupational injuries and illnesses and reports such injuries and illnesses on a "Summary of Work-Related Injuries and Illnesses" as required by 29 CFR 1904. The OSHA 300A reporting log for CY2010 is attached. Annual and new employee orientation training will be revised to ensure employees are aware to report all occupational illnesses and injuries in the IHS WebCident reporting system. The integrity of the WebCident incident reporting system data is assessed by the Area Institutional Environmental Health Officer during routine safety management surveys (copy of data gathering form is attached). 11/30/11 The Employee Reporting Illness policy will be revised to reference' the CDC "Guideline for Infection Control in Health Care Personnel, 1998" which provides the necessary guidance to employees that pose a risk for transmitting infectious/communicable diseases to patients, staff, and visitors at the Winnebago hospital. This reference will be sent to all Team Leaders to ensure staff are aware of which Communicable disease applies to their department, Training will be included in annual orientation scheduled for November 9, 2011. All employees will be trained on the Reporting Employee Illness policy and WebCident by 11/302011. Reporting information derived from the IHS WebCident incident reporting system will be used to Facility JD: 280119 If continuation sheet Page 75 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1} PROVIDERISUPPLIER/CUA IDENTIFICATION NUMBER: 280119 NAME OF PRO\llDER OR SUPPLIER COMPLETED B.WING _ _ _ _ _ _ _ _ _ __ 10/14/2011 WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES {EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYJNG INFORMATION) A 747 Continued From page 74 -The facility failed to maintain a log of all community and healthcare acquired infections and communicable diseases for both patients and staff members. (See A-749) -The chief executive officer (CEO), medical staff, and director of nursing (DON) failed to demonstrate responsibility for quality assurance activities and training of issues identified by the Infection Prevention Nurse. (See A-756) The cumulative effect of the facility's failure to ensure an effective system to identify, report, and investigate infections within the facility, failure to maintain a complete log of infections and communicable diseases, and the failure of the CEO, Medical Staff, and DON to demonstrate responsibility for the quality assurance and training of problems identified by the infection prevention program resulted in the systemic failure of the infection control program. A 749 482.42(a){1) INFECTION CONTROL OFFICER RESPONSIBILITIES The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. This STANDARD is not met as evidenced by: Based on Infection Prevention Plan review, document review, medical record review, and staff interview, the facility failed to ensure the Infection Prevention Nurse developed a system that identified, investigated, and controlled all infections and communicable diseases within the facility for patients and staff. The facility :oRM CMS-2567{02·99) Previous Versions Obsolete (X3) DATE SURVEY STREET ADDRESS, CITY. STATE. ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X2l MUlTlPLE CONSTRUCTION A BUILDING Event ID: 18DS11 ID PREFIX TAG PROlllDER'S PLAN OF CORRECTION {EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS\ COMPLETION DATE A 747 identify, investigate and report employee related infections to the medical staff, nursing, and administrative staff evidenced by monthly reports and quarterly reports added as a standing agenda item to the Governing Body. A 747 UPDATE: 12/27/11 The hospital IC has adopted the CDC Infection Control Guidelines. 12/30/11 All antibiotics ordered will be reviewed by the pharmacist. Jf plan of care does not meet the CDC guidelines for antibiotic use, these will be report to Antimicrobial stewardship committee. All outliers will be reported Clinical director for follow up. Antibiogram report will be sent to all physicians annually to treat empirically and they will receive one each time they order a culture. These are provided quarterly to Pharmacy and therapeutics and medical staff quarterly. Attachment 39: Verna will make changes to the IC committee profile and add DON or designee and CD or designee Attachment 40: Follow CDC guidelines for infection control in healthcare personnel. Attachment 41: The infection control nurse will monitor all reports of staff call in for sick leave. She will receive the call in slips from each supervisor. All return clearance will go though Employee Health. An occupational illnesses will be reported in the WebCident system. 12/23/11 12/23/11 12/1/11 le SEE: UPDATE Attachments ATTACHMENTS; Facility ID: 280119 If continuation sheet Page 75 of 93 PRINTED: 10/19/2011 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES 3TATEMENT OF DEFICIENCIES A.ND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIERICLIA IDENTIFICATION NUMBER: 280119 OMB NO 0938-0391 B WING _ _ _ _ _ _ _ _ _ __ 10/14/2011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY 77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYJNG INFORMATION) A 749 Continued From page 75 identified a census of 2. 10 PRE AX TAG PROVlDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS·REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A 749 A 749 Active and passive surveillance will be used to 10/26/11 identify, investigate and report infections to the Findings included: Review of medical record for Patient# 29 reveals the patient had head lice at the time of admission. Interview with the Infection Prevention Nurse on 8/30/11 at 11: 30 AM identifies that the facility did not have a policy on the management of head lice but did have a number of patients present to the facility with head lice. The Infection Prevention Nurse further identifies that patients also frequently present with scabies and indicates that she does not track or trend either scabies or lice. The Infection Prevention Nurse indicates she was not aware that there was a need to track lice or scabies as neither is a reportable infection for the State of Nebraska. Review of the Infection Prevention Plan approved 6/23/11 states in part, "Purpose: The executive committee directs that the Winnebago Comprehensive Health Care Facility has a functioning and coordinated process in place to reduce the risks of endemic, epidemic and health-care associated infections (HAi's) in patients, visitors, and healthcare workers." medical staff, nursing, and administrative staff, monthly reports and quarterly report added as a standing agenda to the Governing Body. 10/26/11 Active surveillance includes Winnebago Hospital's antibiogram (positive culture reports) and chart reviews. Passive surveillance includes Infection Prevention consults generated by the electronic health record and a hard copy passive surveillance forms placed at patient care areas {e.g. Outpatient nurse's station, inpatient nurse's station). Training for the existing Isolation Precautions policy and the isolation protocols for the nursing and medical staff wilt occur by November 14, 2011. And will include the process and indications for isolation precautions and how to send an EHR consult. hospital Isolation Precautions policy will be consistent with the CDC "Guideline for Isolation Precaution: Preventing Transmission of Infectious Agents in Healthcare Setting, 2007". 11/30/11 11/30/11 Attached is the existing Infection Prevention log for healthcare associated infections (HAI) and community acquired infections. Attached is the existing investigative reports of community acquired Further review of the Infection Prevention Plan states in part, "Surveillance Methods include: 1. Total house surveillance-historically, healthcare associated infections have been very low at this institution. A low inpatient census and low number of superficial surgical wound makes it possible to investigate all potential healthcare associated infections." ORM CMS-2567(02-99) Previous Versions Obsolele Event ID:l8DS11 Facility ID: 280119 If continuation sheet Page 76 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CL~ IDENTIFICATION NUMBER: 280119 A BUILDING B. WING _ _ _ _ _ _ _ _ _ __ 10/14/2011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS) (EACH DEFICIENCY MUST BE PRECEDED BYFULL REGULATORY OR LSC IDENTIFYING INFORMATION) PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPR~TE DEFICIENCY) COMPLETION A 749 Continued From page 76 TAG A 749 infections. An application granting access to the IHS WebCident online incident reporting system for reporting employee occupational illnesses was submitted for the Infection Prevention nurse to allow readily accessible reports (including e-mail notifications), investigating and reporting of all employee occupational illnesses that are submitted by employees. Currently, the Safety Officer investigates occupational injuries and illnesses and reports such injuries and illnesses on a "Summary of Work Related Injuries and Illnesses" as required by 29 CFR 1904. The OSHA 300A reporting log for CY2010 is attached. Annual and new employee orientation training will be revised to inform employees are aware to report all Occupational illnesses and injuries in the IHS WebCident incident reporting system. The Infection Prevention Plan fails to discuss community acquired infections, tracking and trending infections and communicable diseases, or how noted trends will be investigated to determine the causative effect Interview with the Infection Prevention Nurse on 8/31/11 at 2:00 PM acknowledges that there is no log for employee illnesses, the log for infection tracking contains only the reportable infections for the State of Nebraska, and there is no process in place for tracking and trending employee infections within the facility at this time. Further review of the Infection Prevention Plan lacks evidence of a system for reporting or investigating infections. Interview with the Infection Prevention Nurse on 9/28/11 at 1:48 PM confirms there was nothing in the Infection Prevention Plan regarding reporting or investigating infections and communicable diseases. The Infection Prevention Nurse identifies that reports on infections and communicable diseases are available but she has not been asked for them by the Improving Operations Performance/Risk Manager, Medical Staff or Governing Body. The Infection Prevention Nurse also identifies that she is not invited to the Medical Staff or Governing Body meetings to report findings for infections or communicable diseases. A 750 482.42(a)(2) INFECTION CONTROL LOG The infection control officer or officers must maintain a log of incidents related to infections FORM CMS-2567(02~99) Previous Versions Obsolete DATE Event ID:l8DS11 SEE: A 750 IP plan update~ to include all aspects of IP log that includes community acquired infections for patients and staff, and WebCident for Occupational injury or illness. A monthly report will be provided to medical staff, nursing and administrative staff and a quarterly report added as a standing agenda item to the Governing Body. 11/30/11 11/30/11 Training for the existing Isolation Precautions policy and the isolation protocols for the nursing staff will occur by 11/14/2011. And will include the process and indications for isolation precautions and how to send an EHR consult. 11/15/11 Active and passive surveillance will be used to identify, investigate and report infections to the medical staff, nursing, and administrative staff evidenced by monthly reports and quarterly report added as a standing agenda item to the Governing Body. An investigation will be completed once an outbreak has been identified in the Winnebago Hospital, communit'-{, or onset of a new unusual Facility JD: 280119 I If continuation sheet Page 77 of 93 11111 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVlDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVIDER OR SUPPLIER B.WlNG _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO !HS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED ()(2) MULTIPLE CONSTRUCTION A BUILDING WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 750 Continued From page 77 and communicable diseases. ID PREFIX TAG PRDVlDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) {XS} COMPLETION DATE A 750 This STANDARD is not met as evidenced by: Based on Infection Prevention Plan review and staff interview, the facility failed to ensure the Infection Prevention Nurse developed and maintained a log of all hospital acquired and community acquired infections and communicable diseases for patients and staff. The hospital identified a census of 2. Findings included: Review of the Infection Prevention Plan approved 6/23/11 states in part, "Purpose: The executive committee directs that the Winnebago Comprehensive Health Care Facility has a functioning and coordinated process in place to reduce the risks of endemic, epidemic and health-care associated infections (HAi's} in patients, visitors, and healthcare workers." Further review of the Infection Prevention Plan states in part "Surveillance Methods include: 1. Total house surveillance-historically, healthcare associated infections have been very low at this institution. A low inpatient census and low number of superficial surgical" wound makes it possible to investigate all potential healthcare associated infections." The Infection Prevention Plan failed to discuss community acquired infections, tracking and trending infections and communicable diseases, or how noted trends will be investigated to determine the causative effect. Interview with the Infection Prevention Nurse on JRM CMS-2567(02-99) Previous Versions Obsolete Event 10:180511 Facility ID: 280119 tf continuation sheet Page 78 of 93 PRINTED: 10119/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROlllDERISUPPLIERICL\A IDENTIFICATION NUMBER: 280119 SWING NAME OF PROVIDER OR SUPPLIER 10/14/2011 STREET ADDRESS. CITY. STATE, ZIP CODE HWY77-75 WINNEBAGO !HS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A. BUILDING WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 750 Continued From page 78 8/31 /11 at 2: 00 PM acknowledges that there is no log for employee illnesses, the log for infection tracking contains only the reportable infections for the State of Nebraska, and there is no process in place for tracking and trending infections within the facility at this time. A 756 482.42(b) LEADERSHIP RESPONSIBILITIES PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE GROSS-REFERENCED TO THE APPROPR\ATE DEFICIENCY} ID PREFIX TAG disease. 11/1/11 The use of my existing IP log will assist in identifying, reporting, and investigating infections. Active and passive surveillance will be used to identify, i investigate and report infections to the medical staff, nursing, and administrative staff on a monthly basis and quarterly reports added as a standing agenda item to the Governing Body. SEE: ATTACHMENTS: 39 ATTACHMENTS: 40 lP plan updated to include the CEO, medical staff, and Director of Nursing to insure that a hospital-wide infection control plan is in place. The IP plan will be submitted for approval through the appropriate chain of approval by November 30, 2011. Monthly reports will be submitted to medical staff, nursing and administrative staff and quarterly report added as a standing agenda item to the Governing Body. A 756 (2) Be responsible for the implementation of successful corrective action plans in affected problem areas. This STANDARD is not met as evidenced by: Based on Infection Prevention Plan review, Medical Staff meeting minutes review, Governing Body meeting minutes review, and staff interview, the facility failed to ensure that the chief executive officer (CEO), medical staff, and/or director of nursing (DON) assured staff implemented quality assurance activities, including corrective action, and training programs to address issues identified by the Infection Prevention Nurse. The hospital identified a census of 2. DATE A 750 Standard: Responsibilities of chief executive officer, medical staff and director of nursing services. The chief executive officer, the medical staff, and the director of nursing must(1) Ensure that the hospital-wide quality assurance program and training programs address problems identified by the infection control officer or officers; and (XS} COMPLETION 11/30/11 SEE: ATTACHMENTS: 39 I Findings included: FORM CMS-2567(02-99) F'revious Versions Obsolete Event ID:IBDS11 Facility ID: 280119 !f continuation sheet Page 79 of 93 Ill PRINTED: 10/19/201 FORM APPROVE! OMB NO 0938-039 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVlDERISUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVlDER OR SUPPLIER B.WING 10(14/2011 STREET ADDRESS, CITY, STATE. ZIP CODE HWY77·75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY DR LSC IDENTIFYTNG INFORMATION) A 756 Continued From page 79 Review of the Infection Prevention Plan dated 6/23/11 states in part, "When problems or opportunities for improvement are identified, action taken/recommended will be documented in the WCHCF (Winnebago Comprehensive Health Care Facility) Infection Prevention Committee minutes. Minutes are forwarded to ' the Medical Staff for review and assistance in resolution as necessary." The Infection Prevention Plan failed to address notification and involvement of the CEO and DON. ID PREFIX TAG PROVlDER'S PLAN OF CORRECTION (EACH CORRECTNE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (XS) COMPLETION DATE A 756 Review of Medical Staff meeting minutes, including the Medical Staff Executive Committee meeting minutes for 10/13/10, provided by the facility from 10/13/1 O to 5/25/11 lacks evidence of any report from the Infection Prevention Nurse or any discussion or action on Infection Prevention. Review of Governing Body meeting minutes provided by the facility from 6/8/1 O to 8/15/11 lacks evidence of any report from the Infection Prevention Nurse or any discussion or action on Infection Prevention. Interview with the Infection Prevention Nurse on 9/28/11at1:48 PM reveals she identified problems with staff identifying the correct isolation procedure to follow and the implementation of the basic criteria for contact isolation and developed a monitor. The Infection Prevention Nurse further identified that she does not send reports to the Medical Staff or Governing Body and has not attended any Medical Staff or Governing Body meetings to inform them of infection prevention concerns. The Infection Prevention Nurse states that she FORM CMS-2567(02·99) Previous Versions Obsolete Event JD.180511 I I Facility ID: 280119 If continuation sheet Page 80 of 93 PRINTED: 10/19/2011 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (XI) PROV1DER/SUPPLIERICLIA IDENTIFICATION NUMBER: 280119 OMB NO 0938-0391 A BUILDING B WING _ _ _ _ _ _ _ _ _ __ 10/1412011 NAME OF PROV1DER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 756 Continued From page 80 communicates concerns to the DON through emails. She also notifies the DON and nursing supervisors of training sessions but there is not always a good showing. Nursing administration neither encourages attendance nor do they cover the nurses where they can attend. A 884 482.45 ORGAN, TISSUE, EYE PROCUREMENT PROV1DER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG Incorporate an agreement with an OPO designated under part 486 of this chapter, under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the hospital. The OPO determines medical suitability for organ donation and, in the Event JD:IBDS11 DATE A884 This CONDITION is not met as evidenced by: Based on document review and interview the hospital: - Failed to have a signed agreement with the Nebraska Organ Recovery System (NORS is the hospitals local organ procurement organization for organ donation) (see A886); -Failed to incorporate the agreement with the Lions Eye Bank into policy to ensure the opportunity to secure eye donors; also, there is no signed agreement for tissue procurement as NORS is responsible for this. (see A887). The cumulative effect of the hospitals failure to have a signed agreement with NORS and failure to incorporate the agreement with the Lions Eye Bank into policy resulted in a failure to meet the Condition of Participation for Organ, Tissue and Eye Procurement. A 886 482.45(a)(1) OPO AGREEMENT (XS) COMPLETION A 756 A884 Organ, Tissue and Eye Procurement "ORM CMS-2567(02·99) Previous Versions Obsolete (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION Revise Organ, Tissue, Eye Procurement policy. Send revised policy forward to Medical Staff on November 8, 2011. Training or inservices will be provided to Medical and Nursing Staff before November 30, 2011. 11/8/11 Nursing Staff will review & verify they read and understand the policy with a staff signature. Attendance sheets will be collected. 11/30/11 11/30/11 A884 UPDATE: 12/27/11 DON is responsible for monitoring the Collaborative agreements annually for any changes by AAO or NORS. 1/31/12 Report to GB with any changes and reporting that agreement is signed and current. Inpatient Supervisor provided the NORS documents to all nursing staff A886 Nursing ::.uperv1sor obtained signed Collaborative Agreement for Nebraska Organ Retrieval Services an November 4,2011 11/4/11 SEE: ATTACHMENTS: 43 I Facility ID: 280119 If continuation sheet Page 81 of 93 PRINTED: 10/19/2011 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (XI) PROVlDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO 0938-0391 (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING B WING _ _ _ _ _ _ _ _ __ 280119 NAME OF PROVIDER OR SUPPLIER 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES {EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 886 Continued From page 81 absence of alternative arrangements by the hospital, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose; ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (XS) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) COMPLETION DATE A886 This STANDARD is not met as evidenced by: Based on document review and interview, the hospital failed to ensure they had a signed agreement with the Nebraska Organ Recovery System (NORS is the hospitals designated organ procurement organization [OPO] for organ and tissue donation) that included all the necessary components as identified in the regulation. The hospital census was 2. Findings included: On 8/24/11 the hospital provided two documents relating to their organ procurement responsibilities. The first document was titled, "Collaborative Agreement Between Aberdeen Area Indian Health Service, Winnebago Service Unit, and Nebraska Organ Recovery System. This two (2) page document contained date stamps on the cover letter page for 2/28/08 and 2/25/09 and was signed by a representative from NORS on 2/28/08 and the Acting Area Director of the Aberdeen Area Indian Health Service in Aberdeen, South Dakota on 2122/08. The second document was titled, "Nebraska Organ Recovery System Donor Institution Agreemenf'. The document included: - definitions of organ procurement terms, - responsibilities of NORS, - responsibilities of the hospital, FORM CMS-2567(02·99) Previous Versions Obsolele Event 10:180$11 Facility ID: 280119 Jf continuation sheet Page 82 of 93 PRINTED: 10/19/2011 FORM APPROVEC DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVJOERISUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO 0938-0391 (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A BUILDING B WING _ _ _ _ _ _ _ _ __ 280119 NAME OF PROVIDER OR SUPPLIER 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO !HS HOSPITAL (X4)1D PREFIX TAG WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 886 Continued From page 82 - reimbursement, - term and termination of the agreement, - relationship of the parties, and - miscellaneous. The signature page of the document contained the handwritten signature for a NORS representative and dated 10/15/07. The signature page was not signed by the hospital. During an interview on 8/25/11 at 8: 30 AM, the Improving Operations Performance/Risk Management Director said the firs~ signed document was a pre-collaborative agreement with NORS that the Aberdeen Area Health Service in Aberdeen, South Dakota required prior to the Winnebago Service Unit entering into a contractual agreement with NORS. The Improving Operations Performance/Risk Management Director said the second document was the contractual agreement between NORS and the Winnebago hospital and confirmed the agreement had not been signed by the hospital. A 887 482.45(a)(2) TISSUE AND EYE BANK AGREEMENTS Incorporate an agreement with at least one tissue bank and at least one eye bank tci cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement, PROVIDER'S PLAN OF CORRECTION {EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TD THE APPROPRIATE DEFICIENCY) ID PREFIX TAG {XS) COMPLETION DATE A886 A887 Nursing Supervisor obtained signed Collaborative Agreement for Lions Eye Bank dated January 31, 11/7/11 2002. SEE: ATTACHMENTS: 45 This STANDARD is not met as evidenced by: Based on policy and procedure review, contract review, and staff interview, the facility failed to ensure staff incorporated the contract for the FORM CMS-2567(02-99) Previous Versions Obsolete Event 10.180511 Facility ID: 280119 If continuation sheet Page 83 of 92 PRINTED: 10119/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PRD\.1DER/SUPPLIERICLIA IDENTIFICATION NUMBER: 280119 NAME OF PROV1DER OR SUPPLIER A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG (X3) DATE SUR\.1EY COMPLETED {X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A 887 Continued From page 83 Lions Eye Bank of Nebraska (LEBN) into the policy for organ and tissue donation for facility donations of eyes. The facility further failed to have a contract in place for tissue donation with the Nebraska Organ Recovery System (NORS). The hospital identified a census of 2. ID PREFIX TAG PR0\.1DER'S PLAN OF CORRECTION (EACH CORRECTl\.1E ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) {XS) COMPLETION DATE A887 Findings included: Review of contract with NORS lacks a signature from the Aberdeen Area Director to effectuate the terms of the contract. However the contract states in part, "Responsibility of NORS 2.1 Referral Source. NORS agrees to become the Hospital's sole referral source for all organ placement and tissue placement, excluding eye tissue, unless the Hospital has an existing agreement with Spirit of the North." Therefore, the hospital has no contract with a tissue bank. Review of the contract with LEBN states in part, "B. Responsibilities of Lions Eye Bank 1. Provide a twenty-four (24) hour answering service and available personnel qualified to evaluate patient deaths regarding medical suitability for potential eye donations. LEBN must determine the medical suitability for eye donation." Review of the policy and procedure titled, "Organ and Tissue Donation" revised/reviewed 7/06 lacks directive to contact LEBN to determine the medical suitability of eye donation. There is a form attached where either NORS or LEBN can be checked as having had a referral. It is not clear from the policy and procedure or the form that both entities must be notified. A1100 482.55 EMERGENCY SERVICES FORM CMS-2567(02-99} Previous Versions Obsolete Event ID:IBDS11 A1100 Facility ID: 280119 If continuation sheet Page 84 of 93 PRINTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (XI) PROVlDERISUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVlDER OR SUPPLIER B WING _ _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-75 WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION A. BUILDING WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1100 Continued From page 84 ID PREFIX TAG A110 The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) The Clinical Director is the current Acting ED (XS) COMPLETION DATE 12/31/11 Supervisor and will obtain ATLS training by December 31, 2011 to meet Medical Staff Bylaws criteria as the Emergency Room Director. The Interim ED Director is ALSO, BCLS, and ACLS certified. 2/1/12 A random selection of 3 charts of a new providers will be reviewed daily over the first 5 days in the Winnebago facility 11/30/11 10 Random charts per provider will be peer reviewed every 6 months. 11/30/11 Random 3 chart reviews for every provider performed every Month 11/30/11 Findings included: All transferred patients will have chart reviews by permanent Med staff at morning rounds. 11/30/11 -The facility failed to ensure there was a qualified director of the emergency department by experience or training. (See A-1102) All patients with 72 hour returns, Against medical advice and left without being seen in the ED will be chart reviewed. 11/30/11 This CONDITION is not met as evidenced by: Based on Medical Staff Bylaws, Rules, and Regulations review, QIO (Quality Improvement Organization) document review, medical record review, credential file review, and staff interview, the facility failed to meet the emergency needs of it's P>> after confirming he has BC/BS [Blue Cross/Blue Shield] FORM CMS-2567(02-99) Previous Versions Obsolete Event ID.18DS11 Facility ID: 280119 If continuation sheet Page 91 of 93 PRINTED: 10/19/2011 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (Xt) PRO\llDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: 280119 NAME OF PROVIDER OR SUPPLIER OMB NO 0938-0391 A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/14/2011 STREET ADDRESS, CITY, STATE, ZIP CODE HWY77·75 WINNEBAGO IHS HOSPITAL (X4)1D PREFIX TAG ()(3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1112 Continued From page 91 insurance which can be used as a primary, I advised him we would make a referral for him to be seen in the morning but that I needed to remove the distal fragment tonight." ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (XS) (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) COMPLETION DATE A1112 Review of the credential file for Practitioner T reveals Medical Privileges signed by the Acting Clinical Director (Physician Z) on 4/7/11 and by the CEO (Chief Executive Officer) on 4/11/11. The Medical Privileges had a check for full privileges 'requested and recommended' by repair and closure for simple lacerations (not involving tendons, nerves, or major vessels. There was a 'not requested or recommended' beside repair and closure of complicated lacerations. The Medical Privileges do not have reattachment or amputation listed as a privilege for Practitioner T. Interview with the Clinical Director on 8/25/11 at 1:35 PM reveals that Practitioner T deviated from the standard of practice regarding Patient l/!2.2. "We do not sew fingers back on at IHS hospitals". Interview with the Clinical Director on 9/19/11 at 4:40 PM reveals that Practitioner T had poor judgement The Clinical Director indicates the vessels in a finger are so small that they seal off in a couple of hours and revascularization is impossible. Given the fact that Patient #22 had poor perfusion and was on dialysis the poor outcome should have been predicted. It was a significant risk to the patient to reattach the finger due to the probability of failure and infection. Interview with the Clinical Director on 9/19/11 at FORM CMS-2567(02-99) Previous Versions Obsolete Eventt0:18DS11 Facility ID: 280119 If continuation sheet Page 92 of 93 PR! NTED: 10/19/2011 FORM APPROVED OMB NO 0938-0391 DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES ANO PLAN OF CORRECTION (X1) PRO\/IDER/SUPPUER/CLIA IDENTIFICATION NUMBER: 280119 A BUILDING B WING _ _ _ _ _ _ _ _ __ 10/1412011 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE HWY77-7S WINNEBAGO IHS HOSPITAL (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED (X2) MULTIPLE CONSTRUCTION WINNEBAGO, NE 68071 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1112 Continued From page 92 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (XS) COMPLETION DATE A1112 4:40 PM reveals that the facility had a vague process for peer review when she became Clinical Director. The Clinical Director indicates that new forms and a new process for peer review started in June. There is no written procedure for the process to perform the peer review at this time. Interview with the former Clinical Director (Physician W) on 10/3/11 at 1:07 PM reveals there is no formal process to bring medical records that have concerns related to patient care to the Medical Staff for review. Without a delineation of qualifications and an effective review system for the quality of diagnosis and treatment within the facility there is no effective manner to determine the medical staff of the emergency department is qualified to meet the needs of the patients it serves. FORM CW.S-2567(02-99) Previous Versions Obsolete Event 10.180$11 Facility ID: 280119 lf continuation sheet Page 93 of 93