Statement of Deficiencies Citation Summary Sheet PRINTED: 12/28/2018 For: HEALTHPLUS SURGERY CENTER, LLC ( 23116 / NJ23116 ) Survey Event: LGDO11, Exit Date 09/07/2018 Citations Cited This Visit Regulation Type Regulation ID Regulation Version Building Number Tag Number Tag Title State 3B6I 9.00 00 0000 INITIAL COMMENTS State 3B6I 9.00 00 1157 GEN REQUIREMENTS: PERSONNEL State 3B6I 9.00 00 2278 PHARMACEUTICAL SVCS: POLICIES & PROCEDURES State 3B6I 9.00 00 2299 PHARMACEUTICAL SVCS: POLICIES & PROCEDURES State 3B6I 9.00 00 2306 PHARMACEUTICAL SVCS: POLICIES & PROCEDURES State 3B6I 9.00 00 2320 PHARMACEUTICAL SVCS: POLICIES & PROCEDURES State 3B6I 9.00 00 2432 PHARMACEUTICAL SVCS: STORAGE OF DRUGS State 3B6I 9.00 00 3070 SURG & ANES SVCS: SURG POL & PROCEDURES State 3B6I 9.00 00 4050 INFEC PREV & CONTROL: ADMINISTRATOR'S RESP State 3B6I 9.00 00 4057 INFEC PREV & CONTROL: ADMINISTRATOR'S RESP State 3B6I 9.00 00 4071 INFEC PREV & CONTROL: POL & PROCEDURES State 3B6I 9.00 00 4098 INFEC PREV & CONTROL: POL & PROCEDURES State 3B6I 9.00 00 4183 INFEC PREV & CONTROL: INFEC PREV MEASURES State 3B6I 9.00 00 4190 INFEC PREV & CONTROL:STRILIZATN PT CARE ITEMS State 3B6I 9.00 00 4215 INFEC PREV & CONTROL:STRILIZATN PT CARE ITEMS State 3B6I 9.00 00 4216 INFEC PREV & CONTROL:STRILIZATN PT CARE ITEMS State 3B6I 9.00 00 4218 INFEC PREV & CONTROL:STRILIZATN PT CARE ITEMS State 3B6I 9.00 00 4260 INFEC PREV & CONTROL: CARE/USE OF STERILIZERS Scope/ Severity PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 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) COMPLETE DATE A 000 The facility is not in compliance with N.J.A.C. Title 8 Chapter 43A- Standards for Licensing of Ambulatory Care Facilities for this complaint investigation (C# NJ00114661). Findings during the investigation resulted in the Office of Program Compliance of the Department of Health ordering an immediate curtailment of services on September 7, 2018. A1157 8:43A-3.5(a) GEN REQUIREMENTS: A1157 PERSONNEL The facility shall develop written job descriptions and ensure that personnel are assigned duties based upon their education, training, and competencies, and in accordance with their job descriptions. This REQUIREMENT is not met as evidenced by: Based on review of employee personnel files and staff interviews, it was determined that the facility failed to ensure that job competencies are performed. Findings include: 1. Upon interview, Staff #8 stated that he/she completed the competencies for the sterile processing (SPD) technicians. Staff #8 stated that he/she also completed his/her own SPD competencies. 2. Upon review of SPD employee personnel files, LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE STATE FORM TITLE 6899 LGDO11 (X6) DATE If continuation sheet 1 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A1157 Continued From page 1 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A1157 Staff #8, Staff #9 and Staff #10 lacked evidence of competencies in sterile processing. 3. The above findings were confirmed with Staff #1 and Staff #2. A2278 8:43A-9.3(b)(4) PHARMACEUTICAL SVCS: A2278 POLICIES & PROCEDURES The facility's policies and procedures for the administration, control, and storage of medications shall include, but not be limited to, policies and procedures for the use of parenterals, if used, including the labeling of intravenous infusion solutions, such that a supplementary label is affixed to the container of any intravenous infusion solution to which drugs are added. This REQUIREMENT is not met as evidenced by: Based on observation and staff interview conducted on 9/7/18, it was determined that the facility failed to ensure the development and implementation of policies and procedures addressing the preparation and use of parenteral medications. Findings include: Reference #1: The Center for Disease Control website http://www.cdc.gov/injectionsafety/providers/provi der_faqs_med-prep.html states, "Medication Preparation Questions, 1. How should I draw up medications? Parenteral medications should be STATE FORM 6899 LGDO11 If continuation sheet 2 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2278 Continued From page 2 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A2278 accessed in an aseptic manner. ... Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it." 1. At 10:40 AM, Staff #19 was observed preparing two (2) parenteral medications in OR #3. a. Staff #19 failed to perform hand hygiene prior to handling the medication. b. Staff #19 failed to disinfect the rubber septum of the vials with alcohol prior to piercing them. 2. Policies addressing medication preparation were requested from Staff #1 and #2. The policies provided did not address the deficient findings listed above. Reference #2: Facility policy titled "Storage of Medications" states, "Purpose ... 6. ...If not administered immediately, all medications (injectable, oral, etc.) removed from the original container or packaging are labeled in a standard format in accordance with law, regulations and standards of practice. The labeling of such medication. At a minimum, the policy requires that labels include: ... Expiration date and time ..." 1. Two (2) single dose bags of 3000 ml of 0.9% Sodium Chloride for Irrigation, with an auxiliary label indicating that 3 ml of epinephrine had been added on 9/7/18 at approximately 8:45 AM, were found attached to an irrigating system in OR #1 and #2 at 10:30 AM. a. Staff #3 stated that the bags were attached to tubing on the irrigation system and used until finished, or until the end of the day, for multiple STATE FORM 6899 LGDO11 If continuation sheet 3 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2278 Continued From page 3 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A2278 patients. i. Single dose bags can only be used for one patient. b. The label affixed to the bag stated the date and time of preparation. It did not include the expiration date and time. 3. All policies related to pharmacy and medication preparation were requested from Staff #1 and #2. A policy addressing the use of a single dose bag of Sodium Chloride for Irrigation to which a drug is added, for irrigation of surgical sites, was not included in the policies provided. A2299 8:43A-9.3(b)(7) PHARMACEUTICAL SVCS: A2299 POLICIES & PROCEDURES The facility's policies and procedures for the administration, control, and storage of medications shall include, but not be limited to, policies and procedures for the control of drugs subject to the Controlled Dangerous Substances Acts and amendments thereto, in compliance with the New Jersey State Board of Pharmacy Rules, N.J.A.C. 13:39, and all other Federal and State laws and regulations concerning procurement, storage, dispensing, administration, and disposition. This REQUIREMENT is not met as evidenced by: A. Based on document review and staff interview conducted on 9/7/18, it was determined that the STATE FORM 6899 LGDO11 If continuation sheet 4 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2299 Continued From page 4 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A2299 facility failed to ensure the development and implementation of policies and procedures addressing Drug Enforcement Agency (DEA) requirements for controlled drug accountability. Findings include: Reference #1: Drug Enforcement Agency (DEA) Regulations Title 21 CFR, Part 1305, Section 1305.13(e) states, "The purchaser must record on Copy 3 of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser." 1. The number of commercial containers received by the facility and the date received was not recorded on Copy 3 of the DEA Form 222 in the following instances: a. DEA 222 form, dated 3/15/18, for the purchase of 375 vials of Fentanyl b. DEA 222 form, dated 4/4/18, for the purchase of 375 vials of Fentanyl c. DEA 222 form, dated 4/11/18, for the purchase of 375 vials of Fentanyl d. DEA 222 form, dated 5/29/18, for the purchase of 200 vials of Fentanyl e. DEA 222 form, dated 6/7/18, for the purchase of 100 vials of Fentanyl and 100 Oxycodone/APAP 10/325 tablets. f. DEA 222 form, dated 6/13/18, for the purchase of 200 vials of Fentanyl g. DEA 222 form, dated 1/18/18, for the STATE FORM 6899 LGDO11 If continuation sheet 5 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2299 Continued From page 5 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A2299 purchase of 100 vials of Fentanyl Reference #2: Drug Enforcement Agency (DEA) Regulations Title 21 CFR, Part 1304, Section 1304..04(a) states, "(1) Inventories and records of controlled substances listed in Schedules I and II shall be maintained separately from all of the records of the registrant; ..." Reference #3: Facility policy titled "Control and Accountability of Controlled Dangerous Substances (CDS)" states, "Procedure II. ...9. Keep records of Schedule II drugs separate from all other controlled substances." 1. Upon request, Staff #1 and #2 failed to provide corresponding records of purchase invoices for the purchase of Schedule II CDS recorded on DEA 222 forms dated 3/15/18, 4/4/18, 4/11/18, 5/29/18, 6/6/18, 6/7/18, and 6/13/18. B. Based on document review and staff interview conducted on 9/7/18, it was determined that the facility failed to ensure the development and implementation of policies and procedures addressing the intentional wasting of the entire contents of CDS medication vials. Findings include: 1. Upon interview, Staff #2 stated that the facility does not have a policy and procedure addressing the intentional wasting of the entire contents of a CDS medication vial by an anesthesiologist. Review of Controlled Substance Records identified instances where entire vials of a CDS were wasted, without any indication for the reason it was wasted. Examples include but are not limited to: STATE FORM 6899 LGDO11 If continuation sheet 6 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2299 Continued From page 6 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A2299 a. The wasting of 300 mcg of Fentanyl (100mcg/2ml vial), a Schedule II CDS, by Staff #18 on 6/20/18 b. The wasting of 100 mcg of Fentanyl (100mcg/2ml), a Schedule II CDS, by Staff #18 on 7/3/18 c. The wasting of 100 mcg of Fentanyl (100mcg/2ml vial), a Schedule II CDS, by Staff #18 on 8/1/18 d. The wasting of 4 mg of Versed (2mg/2ml vial), a Schedule IV CDS, by Staff #18 on 6/8/18 e. The wasting of 150 mcg of Fentanyl (100mcg/2ml vial), a Schedule II CDS, by Staff #18 on 5/28/18 (two vials were taken for one patient and 50 mcg were given) 2. These findings were confirmed by Staff #2. A2306 8:43A-9.3(b)(7)(i) PHARMACEUTICAL SVCS: A2306 POLICIES & PROCEDURES The facility's policies and procedures for the control of drugs subject to the Controlled Dangerous Substances Acts and amendments thereto shall include, but not be limited to, a provision for a verifiable record system for controlled drugs. This REQUIREMENT is not met as evidenced by: Based on document review and staff interview STATE FORM 6899 LGDO11 If continuation sheet 7 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2306 Continued From page 7 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A2306 conducted on 9/7/18, it was determined that the facility failed to ensure the implementation of policies and procedures for the provision of a verifiable record system for controlled drugs. Findings include: Reference: Facility policy titled Control and Accountability of Controlled Dangerous Substances (CDS) states, "Procedure ... 1. It is the responsibility of all staff that handle CDS drugs to accurately administer, count and document their use." 1. Review of CDS accountability in six (6) medical records (Medical Records #2 through #7) revealed the following discrepancies: a. The administration of Midazolam 2mg is recorded on the anesthesia record, dated 8/28/18, in Medical Record #2. The corresponding Controlled Substance Record lacks evidence of administration of Midazolam to this patient. b. The administration of Fentanyl 100 mcg is recorded on the anesthesia record, dated 8/28/18, in Medical Record #2. The administration of 50 mcg and destruction of 150 mcg of Fentanyl is recorded on the corresponding Controlled Substance Record. c. The administration of Versed 4 mg is recorded on the Peripheral Nerve Blockade record, dated 6/8/18, in Medical Record #3. The administration of 4 mg and wastage of 4 mg of Versed is recorded on the corresponding Controlled Substance Record. d. The administration of Fentanyl 150 mcg is STATE FORM 6899 LGDO11 If continuation sheet 8 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2306 Continued From page 8 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A2306 recorded on the Peripheral Nerve Blockade record, dated 6/8/18, in Medical Record #3. The administration of 100 mcg of Fentanyl is recorded on the Anesthesia Record, for a total of 250 mcg. The administration of a total of 350 mcg of Fentanyl and wastage of 50 mcg, for a total of 400 mcg is recorded on the corresponding Controlled Substance Record. e. The administration of Fentanyl 200 mcg is recorded on the Peripheral Nerve Blockade record, dated 6/20/18, in Medical Record #7. The administration of 200 mcg of Fentanyl is recorded on the Anesthesia Record, for a total administration of 400 mcg. The administration of a total of 500 mcg of Fentanyl is recorded on the corresponding Controlled Substance Record. 2. These findings were confirmed by Staff #2. A2320 8:43A-9.3(b)(7)(iii) PHARMACEUTICAL SVCS: A2320 POLICIES & PROCEDURES The facility's policies and procedures for the control of drugs subject to the Controlled Dangerous Substances Acts and amendments thereto shall include, but not be limited to, in all areas of the facility where drugs are dispensed, administered or stored, procedures for the intentional wasting of controlled drugs, including the disposition of partial doses, and for documentation, including the signature of a second person who shall witness the disposition. This REQUIREMENT is not met as evidenced by: STATE FORM 6899 LGDO11 If continuation sheet 9 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2320 Continued From page 9 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A2320 Based on document review conducted on 9/7/18, it was determined that the facility failed to ensure the implementation of policies and procedures addressing the intentional wasting of partial doses of vials/ampules of controlled drugs. Finding include: Reference #1: Facility policy titled Control and Accountability of Controlled Dangerous Substances (CDS) states, "Procedure ...II.1. All CDS drugs are maintained and a record of their use is recorded as follows...5. The amount of medication wasted indicated by two (2) signatures ..." Reference #2: Facility policy titled Control and Accountability of Controlled Dangerous Substances (CDS) states, "III.2.4 When the CDS medications are issued they are issued with a CDS inventory sheet to record: ...7. A witness to the wasting of the CDS drug ... 1. Review of Narcotics Controlled Drugs Audit Sheets revealed that almost every entry had two signatures in the "RN/MD Signatures." Two required for BOS, EOS, Waste and received" column, even when there was no documented wastage. By doing this, it is not clear if a person signed because he/she witnessed a waste. a. The signature for the witnessing of intentional wasting of a CDS needs to be specifically for wastage. A witness should not sign if wastage did not occur or was not witnessed. 2. The administration of 0.5 mg and wastage of 1.5 mg of hydromorphone for Patient #1, on 8/24/18 at 10:00 AM, is recorded on the Narcotics Controlled Drugs Audit Sheet. The sheet lacks a STATE FORM 6899 LGDO11 If continuation sheet 10 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC A. BUILDING: ______________________ C 09/07/2018 STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) (X4) ID PREFIX TAG (X3) DATE SURVEY COMPLETED B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION A2320 Continued From page 10 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A2320 witness' signature for wastage. 3. The wastage of 75 mcg of Fentanyl on the Controlled Substance Record, dated 6/15/18, lacks the signature of a witness to the wastage. 4. The wastage of 1 mg of Versed on the Controlled Substance Record, dated 8/4/18, lacks the signature of a witness to the wastage. 5. The wastage of 50 mcg of Fentanyl on the Controlled Substance Record, dated 8/4/18, lacks the signature of a witness to the wastage. 6. The wastage of 50 mcg of Fentanyl on the Controlled Substance Record, dated 8/25/18, lacks the signature of a witness to the wastage. 7. The wastage of 50 mcg of Fentanyl on the Controlled Substance Record, dated 6/8/18, lacks the signature of a witness to the wastage. 8. The wastage of 100 mcg of Fentanyl on the Controlled Substance Record, dated 8/1/18, lacks the signature of a witness to the wastage. 9. The documentation for witnessing wastage on all Controlled Substance Records reviewed included the initials of the person witnessing the waste, not the signature. . A2432 8:43A-9.5(b) PHARMACEUTICAL SVCS: A2432 STORAGE OF DRUGS STATE FORM 6899 LGDO11 If continuation sheet 11 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2432 Continued From page 11 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A2432 All drugs shall be stored under proper conditions, as indicated by the United States Pharmacopoeia, product labeling, and/or package inserts. This REQUIREMENT is not met as evidenced by: Based on observation conducted on 9/7/18, it was determined that the facility failed to ensure that medications are stored in accordance with manufacturers' recommendation. Findings include: Reference #1: The manufacturer's package insert for Succinylcholine states, "Store in refrigerator 36 degrees to 46 degrees Fahrenheit. The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency." Reference #2: The manufacturer's package insert for Rocuronium Bromide states, "Rocuronium bromide should be stored in a refrigerator 2 degrees to 8 degrees C ... Upon removal from refrigeration to room temperature storage conditions, use Rocuronium bromide within 60 days..." Reference #3: Facility policy titled "Storage of Medication" states, "3. ... Medications removed from the refrigerator and left in anesthesia carts, must have an out of refrigerator expiration date per manufacturer's instruction. ..." STATE FORM 6899 LGDO11 If continuation sheet 12 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A2432 Continued From page 12 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A2432 1. At 10:05 AM, one vial of succinylcholine and one vial of Rocuronium bromide, not dated when removed from the refrigerator, were found on the anesthesia cart in OR #1, stored at room temperature. 2. At 10:30 AM, one vial of succinylcholine, not dated when removed from the refrigerator, was found on the anesthesia cart in OR #3, stored at room temperature. A3070 8:43A-12.6(a)(16)(ii) SURG & ANES SVCS: A3070 SURG POL & PROCEDURES Policies and procedures regarding infection prevention and control shall include, but not be limited to, use of aseptic technique and scrub procedures. This REQUIREMENT is not met as evidenced by: Based on observation, staff interview and review of nationally recognized guidelines, it was determined that the facility failed to ensure implementation of aseptic technique in accordance with nationally recognized guidelines and acceptable standards of practice. Findings include: Reference #1: Association of periOperative Registered Nurses (AORN) 2017 Edition Guidelines for Perioperative Practice Guideline for Surgical Attire Recommendation III states, "Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears and facial hair." STATE FORM 6899 LGDO11 If continuation sheet 13 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A3070 Continued From page 13 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A3070 1. Upon interview, Staff #1 stated that the center follows AORN guidelines. 2. The facility policy titled, "Operating Room Attire For Personnel" failed to address covering of facial hair. 3. On 9/7/18 during a tour of the surgical suite, the following was observed: a. At 9:35 AM, in Operating Room (OR) #2, (a restricted area,) Staff #13 was observed scrubbed in for a surgical procedure, wearing a surgical mask that failed to cover his beard and facial hair. b. At 10:25 AM, Staff #13, Staff #15, and Staff #16 were observed cleaning and disinfecting OR #2 between patient procedures. Staff #13, Staff #15, and Staff #16, had facial hair that was not covered. 4. The above findings were confirmed with Staff #2. A4050 8:43A-14.1(a) INFEC PREV & CONTROL: A4050 ADMINISTRATOR'S RESP The administrator,or designee, shall ensure the development and implementation of an infection prevention and control program. This REQUIREMENT is not met as evidenced by: STATE FORM 6899 LGDO11 If continuation sheet 14 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4050 Continued From page 14 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4050 Based on staff interview and document review, it was determined that the facility failed to ensure the development and implementation of an infection prevention and control program. Findings include: 1. A request was made to Staff #1 for the facility's Infection Control Plan. 2. Upon review, the Infection Control Plan was dated 2010 and contained the name of a different facility. 3. Staff #1 confirmed that this was the most current Infection Control Plan and that the name was the previous name of the facility. A4057 8:43A-14.1(b) INFEC PREV & CONTROL: A4057 ADMINISTRATOR'S RESP The administrator shall designate an infection control professional who shall be responsible for the direction, provision, and quality of infection prevention and control services. The designated person shall be responsible for, but not limited to, developing and maintaining written objectives, policies and procedures, an organizational plan, and a quality improvement program for the infection prevention and control service. The infection control professional may be a consultant; however, there must be a health care professional on site that is responsible for the day-to-day activities related to infection control. This REQUIREMENT is not met as evidenced STATE FORM 6899 LGDO11 If continuation sheet 15 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4057 Continued From page 15 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4057 by: Based on staff interviews and document review, it was determined that the facility failed to ensure that its Infection Control program is under the direction of a designated and qualified professional who has training in infection control. Findings include: 1. Upon interview, Staff #1 stated that Staff #3 was the designated day to day infection control nurse. 2. Staff #3's personnel file lacked evidence of additional infection control education and training. 3. The above finding was confirmed by Staff #1 and Staff #2. A4071 8:43A-14.2(b) INFEC PREV & CONTROL: POL & A4071 PROCEDURES The infection control committee, with assistance from each service in the facility, shall develop, implement, and review, every three years or more frequently as necessary, written policies and procedures regarding infection prevention and control. STATE FORM 6899 LGDO11 If continuation sheet 16 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4071 Continued From page 16 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4071 This REQUIREMENT is not met as evidenced by: Based on observation, staff interview, document review, and review of nationally recognized guidelines, it was determined that the facility failed to develop and implement policies for a sanitary surgical environment, in accordance with nationally recognized guidelines. Findings include: Reference: AORN (Association of periOperative Registered Nurses) 2017 Edition, Guidelines for Perioperative Practice, Guideline for Environmental Cleaning Recommendation III states, "A clean environment should be reestablished after the patient is transferred from the area. ...Recommendation III.c.3. states, Items that are used during patient care should be cleaned and disinfected after each patient use, including anesthesia carts..." 1. Upon interview, Staff #1 stated that the center follows AORN guidelines. 2. The facility policy titled, "Cleaning of the Operating Room between cases and the beginning of the day," failed to address cleaning of the anesthesia cart between patient procedures, in accordance with the above AORN reference. 3. On 9/7/18 at 10:25 AM, during observation of a room turnover in OR #2, the following was revealed: a. Staff #13, Staff #15, and Staff #16 were observed cleaning and disinfecting OR #2 between patient procedures. STATE FORM 6899 LGDO11 If continuation sheet 17 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4071 Continued From page 17 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4071 i. Staff #13, Staff #15, and Staff #16 failed to ensure the anesthesia medication preparation area was cleaned and disinfected. ii. Staff #19 was observed preparing medications on the cart, for the next surgical procedure. iii. Upon interview Staff #19 confirmed the OR staff are responsible for cleaning and disinfecting the anesthesia cart at the end of the procedure. A4098 8:43A-14.2(b)(4) INFEC PREV & CONTROL: A4098 POL & PROCEDURES The infection control committee, with assistance from each service in the facility, shall develop, implement, and review, every three years or more frequently as necessary, written policies and procedures regarding infection prevention and control, including, but not limited to, policies and procedures regarding the following: Infection control practices, including universal precautions, in accordance with the Occupational Safety and Health Administration (OSHA) rule 29 CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens, incorporated herein by reference. This REQUIREMENT is not met as evidenced by: A. Based on staff interview and document review, it was determined that the facility failed to ensure that policies and procedures regarding STATE FORM 6899 LGDO11 If continuation sheet 18 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4098 Continued From page 18 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4098 infection prevention and control are reviewed every three (3) years. Findings include: 1. Infection control policies and procedures, provided by Staff #1 for review, lacked evidence that they had been reviewed by the infection control committee within the past three (3) years. 2. Staff #1 confirmed that the policies were out dated and had not been reviewed or revised within the past three (3) years. Staff #1 stated that the policies were last reviewed in 2010. B. Based on observation, staff interview, and review of Occupational Safety and Health Administration (OSHA) regulations, it was determined that the facility failed to transport soiled instruments in accordance with OSHA regulations. Findings include: Reference: OSHA (Occupational Safety and Health Administration) 29 CFR part 1910.1030(d) (2)(xiii) states, "Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping. ... 1910.1030 (d)(2)(xiii)(B) states, "If the outside contamination of the primary container occurs, the primary container shall be placed within a second container which prevents leakage during handling, processing, storage, transport, ..." 1. On 9/7/18 at 10:27 AM, in OR #2, Staff #13 was observed placing a non-leak proof soiled instrument tray on an open cart, covering the cart STATE FORM 6899 LGDO11 If continuation sheet 19 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4098 Continued From page 19 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4098 with a red biohazard bag, and transporting the cart to the decontamination area. 2. Upon interview, Staff #3 confirmed that the container the instruments were in was not a leak proof container. 3. The policy and procedure for transporting soiled instruments was requested from Staff #1 and not received by the end of the survey. A4183 8:43A-14.3(a)(5) INFEC PREV & CONTROL: A4183 INFEC PREV MEASURES Infection prevention activities shall be based on Centers for Disease Control and Prevention Guidelines, and Hospital Infection Control Practices Advisory Committee (that is, HICPAC) recommendations. An exception to the adoption of the following guideline shall be allowed providing that there is a sound infection control rationale based upon scientific research or epidemiologic data. The following published guideline is incorporated herein by reference, as amended and supplemented: Guideline for Hand Hygiene in Health-Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16), published by the Coordinating Center for Health Information and Service, available at http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf and at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr51 16a1.htm. STATE FORM 6899 LGDO11 If continuation sheet 20 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4183 Continued From page 20 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4183 This REQUIREMENT is not met as evidenced by: Based on observation, staff interview, and review of Center for Disease Control and Prevention (CDC) Guidelines and Recommendations, it was determined that the facility failed to ensure that hand hygiene is performed in accordance with CDC Guidelines and recommendations. Findings include: Reference: Guideline for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee[HICPAC] and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the CDC Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16) page 32 states,"Recommendations: 1. Indications for Handwashing and Hand antisepsis. A. When hands are visibly dirty or contaminated with pertinacious material or are visibly soiled with blood or other body fluids, wash hands with either a non-antimicrobial soap and water or an antimicrobial soap and water. B. If hands are not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands in all other clinical situations described in items 1C-J C. Decontaminate hands before having direct contact with patients ... I. Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. J. Decontaminate hands after removing gloves. ..." STATE FORM 6899 LGDO11 If continuation sheet 21 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4183 Continued From page 21 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4183 1. On 9/7/18 at 10:25 AM, Staff #13 and Staff #15 were observed cleaning and disinfecting OR #2 between patient procedures. a. Staff #13 and Staff #15, removed gloves and failed to perform hand hygiene prior to leaving the OR. 2. At 10:39 AM, Staff #17 was observed leaving OR #1, removed his/her shoe covers with his/her ungloved hands, failing to perform hand hygiene prior to exiting the OR suite. Staff #17 then entered the pre-operative area and transported a patient to the OR. 3. The above findings were confirmed by Staff #2. A4190 8:43A-14.4(a)(1) INFEC PREV & A4190 CONTROL:STRILIZATN PT CARE ITEMS Methods for processing reusable medical devices shall conform with the following or revised or later editions, if in effect, incorpated herein by reference: The Association for the Advancement of Medical Instrumentation (AAMI) requirements, "Good Hospital Practice: Steam Sterilization and Sterility Assurance," ST 46. This REQUIREMENT is not met as evidenced STATE FORM 6899 LGDO11 If continuation sheet 22 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4190 Continued From page 22 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4190 by: A. Based on observation, staff interviews and review of facility documents, it was determined that the facility failed to follow acceptable infection control guidelines. Findings include: Reference #1: AAMI guidelines, ST 79, Section 810.3.1, states, "Terminally sterilized items should be allowed to cool to room temperature before handling. Reference #2. Facility policy, Load and Unloading Steam Sterilizer, states, "Unloading Procedures: 5. At the end of the sterilization cycle, allow time for the packs to cool down inside the sterilizer. a. All packs should be inspected for moisture: if wet, the pack should be considered contaminated and completely re-processed." 1. Upon interview, Staff #11 stated that, due to the volume of procedures, trays are not always allowed to dry in the sterilizer before being used for surgical procedures. Reference #3: AAMI guidelines, ST 79, Section 8.4.3, "Inspection," states, "Instruments should be carefully inspected for cleanliness and flaws or damage and dried before packaging." 1. During the unwrapping of two sterilized/processed trays, brown rust like substances were observed on the liner of both trays. a. Upon inspection, five (5) sterilized instruments contained brown rust like stains. 2. The above findings were confirmed with Staff STATE FORM 6899 LGDO11 If continuation sheet 23 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4190 Continued From page 23 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4190 #8, Staff #9, Staff #1 and Staff #2. 3. Upon interview, Staff #5 confirmed that if a tray is opened in the OR, and rust like stains are visible on the white liner, the circulating nurse is notified and he/she makes the decision whether or not to use the instruments for the procedure. 4. On 9/7/18 at 10:43 AM, a staff member, scrubbed in for a surgical procedure, was observed using a cotton swab to clean the lens of a sterile athroscopy scope and camera. a. At 12:15 PM, Staff #5, confirmed that a cotton swab is used to wipe the lens of the arthroscopy scope and camera, to remove any debris or residue. B. Based on observation and staff interview, it was determined that the facility failed to ensure that instruments were cleaned and/or disinfected immediately after use to prevent the formation of biofilm. Findings include: Reference: ST 79, section 6.3 Care and handling of contaminated reusable items at point of use, states, "...To prevent the formation of biofilm, definitive cleaning should occur as soon as possible." 1. Upon interview, Staff #13 stated that the instruments he/she transported into the decontamination room, had not been disinfected immediately after use. 2. This was confirmed with Staff #1 and Staff #2. C. Based on observation and staff interview, it STATE FORM 6899 LGDO11 If continuation sheet 24 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4190 Continued From page 24 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4190 was determined that the facility failed to have manufacturer's instructions for use (IFUs) available for all of the facility instrumentation. Findings include: Reference #1: ST 79, section 7.2.2, Manufacturers' instructions states, "The written instructions of the device manufacturer should always be followed. The manufacturers' instructions should be kept on file and periodically reviewed for updates. If there are no specific instructions available, then the manufacturer should be contacted to provide documentation." 1. Upon request, Staff #8 and Staff #9 were unable to provide the IFUs for all of the instrumentation. This included IFUs for the Miltek (bone cutter forceps) and Konig (bone cutter) manufacturing brands, as well as the Welsh Allen brand for laryngoscope blades. 2. This was confirmed by Staff #1 and Staff #2. Reference #2: CaviWipe Manufacturer's IFU states, "...Cleaning instructions: Use one CaviWipe towelette to completely preclean surface of all gross debris. ...For use as a disinfectant: Use a second CaviWipe towelette to thoroughly wet the surface. Repeated use of the product may be required to ensure that the surface remains visibly wet for 3 minutes..." 1. During a tour of the OR suite, at 9:35 AM, a stretcher was observed in the hallway, outside of OR #2. The stretcher contained a sheet with a wet red stain, approximately 2 inches in diameter. a. Upon interview Staff #12 stated the stretcher was for the patient who was presently having STATE FORM 6899 LGDO11 If continuation sheet 25 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4190 Continued From page 25 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4190 surgery and will be used to transport the patient to the post operating area. b. At 10:19 AM, 44 minutes after the stretcher was initially observed with the wet red stain, this surveyor asked Staff #12 if the stained sheet will be changed. Staff #12 asked Staff #20 to change the sheet. c. Staff #20, removed the sheet and wiped the stretcher with one CaviWipe, failing to use a second CaviWipe towelette to thoroughly wet the surface and disinfect the stretcher. 2. The above finding was confirmed by Staff #12 and Staff #1. D. Based on observation and staff interviews, it was determined that the facility failed to ensure that it adheres to transmission-based precautions. Findings include: Reference: ST 79, section 4.6, Standard/transmission-based precautions states, "Standard/transmission -based precautions are intended to supplement infection prevention and control practices such as washing hands and wearing personal protective equipment to avoid contact with contaminated items, blood, or body fluids. Appropriate PPE must be used to prevent exposure to blood and body fluids." 1. Personal protective equipment (PPE) was not easily accessible for staff in order to avoid exposure to blood-borne pathogens. a. PPE was stored on the opposite wall from the door of the decontamination room, requiring staff STATE FORM 6899 LGDO11 If continuation sheet 26 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4190 Continued From page 26 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4190 to cross through the room in their scrubs to obtain PPE. b. Staff #1 was observed entering the decontamination room without any PPE. E. Based on staff interviews, document review, and review of nationally recognized guidelines, it was determined that the facility failed to ensure that its policy for sterilizer qualification testing is in accordance with The Association for the Advancement of Medical Instrumentation (AAMI) requirements. Findings include: Reference #1: AAMI (Advancement of Medical Instrumentation) ST79: 2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities section 13.8. Qualification testing 13.8.1 General considerations states, "Qualification testing with a BI [Biological Indicator] PCD [Process Challenge Device] should be performed on all sterilizers after sterilizer installation, relocation, malfunctions, major repairs ...for dynamic-air-removal sterilizers, three consecutive cycles should be run, one right after the other, with a PCD...yielding negative results from all test BI's and appropriate readings from all physical monitors and CI's [Chemical Indicators]. In addition, three consecutive Bowie-Dick tests should be run, one after the other with each test result demonstrating sufficient air removal. ...Rationale: Testing in this order presents a greater challenge." Reference #2: Facility policy titled "Monitoring of Sterilization Cycles" states, "Procedure: ...Biological Monitors Wrapped cycles ...3. ...d. STATE FORM 6899 LGDO11 If continuation sheet 27 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4190 Continued From page 27 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4190 Upon installation of a new sterilizer, three (3) consecutive Bowie-Dick tests should be performed followed be three (3) consecutive BI's for each cycle. ..." 1. The facility policy titled "Sterilization Maintenance and Monitoring," is not in accordance with AAMI guidelines referenced above regarding qualification testing of Pre-Vac sterilizers following installation. 2. At 11:30 AM, in the Sterilization Room, the Getinge 633HC Pre-Vac (Pre-Vacuum) Sterilizer was observed without a maintenance sticker or a biomedical sticker. a. Upon interview, Staff #2 indicated that the sterilizer is new. i. Upon review of the sterilization records, Validation testing was performed on the sterilizer on 2/26/18, by the service representative. ii. The qualification testing performed on 2/26/18 revealed the following: - Loads one (1), two (2), three (3) and four (4) were Pre-Vac cycles run at 273 degrees Fahrenheit and contained a Bowie-Dick Test. - Loads five (5) and six (6) were Pre-Vac cycles run at 275 degrees Fahrenheit and contained a BI test pack. iii. For newly installed Pre-Vac sterilizers, AAMI recommends that Qualification testing be performed by running three (3) consecutive cycles containing a BI test pack, followed by three (3) consecutive cycles containing a Bowie-Dick test pack. Testing in this order presents a greater challenge. STATE FORM 6899 LGDO11 If continuation sheet 28 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4190 Continued From page 28 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4190 3. The above finding was confirmed by Staff #2 and Staff #8. F. Based on observation, staff interviews, and review of nationally recognized guidelines, it was determined that the facility failed to ensure adherence to AAMI guidelines for reprocessing instruments. Findings include: Reference: AAMI ST79: 2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities section 8.2 Instruments states, "...b) Instruments should be positioned to allow the sterilant to come in contact with all surfaces. 1. On 9/7/18 at 11:30 AM, in the Sterilization Room in the presence of Staff #1, Staff #2, and Staff #8, during inspection of a sterilized Hand Instrument Tray, a small autoclavable bag containing multiple instruments was observed within the wrapped set. 2. Review of the instrument count sheet for the Hand Tray revealed that there were forty-three (43) loose instruments within the bag. a. Forty-three (43) loose instruments contained within a small autoclavable bag, does not allow for the sterilant to come in contact with all surfaces of each instrument. 3. The above finding was confirmed with Staff #1, Staff #2 and Staff #8. STATE FORM 6899 LGDO11 If continuation sheet 29 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 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 A4215 Continued From page 29 A4215 A4215 8:43A-14.4(g) INFEC PREV & A4215 (X5) COMPLETE DATE CONTROL:STRILIZATN PT CARE ITEMS The manufacturer's instructions for cleaning, testing, disassembly, and sterilization of equipment shall be readily available and followed by employees. This REQUIREMENT is not met as evidenced by: Based on staff interview, it was determined that the facility failed to have manufacturer's instructions for use for the sterilizer. Findings include: Reference #1: ST 79, section 7.2.2, Manufacturers' instructions state: "The written instructions of the device manufacturer should always be followed. The manufacturers' instructions should be kept on file and periodically reviewed for updates. If there are no specific instructions available, then the manufacturer should be contacted to provide documentation." 1. Upon request, Staff #8 and Staff #9 were unable to provide the manual/IFU for the Getinge Sterilizer. 2. This was confirmed by Staff #1 and Staff #2. A4216 8:43A-14.4(g)(1) INFEC PREV & A4216 CONTROL:STRILIZATN PT CARE ITEMS STATE FORM 6899 LGDO11 If continuation sheet 30 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4216 Continued From page 30 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4216 All hinged instruments shall be processed in an open position. This REQUIREMENT is not met as evidenced by: Based on observation, staff interviews, and a review of a facility policy and procedure, it was determined that the facility failed to ensure that hinged instruments are processed in an open position. Findings include: Reference: Facility policy titled, "Use and Sterilization of Patient Care Items Packaging, Count Sheets" states, "...Surgical Instruments ...5. All hinged instruments should be in the open position." 1. On 9/7/18 at 10:05 AM, during a tour of the Instrument Room, in the presence of Staff #1, Staff #2, and Staff #8, eight (8) hinged instruments were found in the closed position, wrapped in sterile peel packages after having been reprocessed. A4218 8:43A-14.4(h) INFEC PREV & A4218 CONTROL:STRILIZATN PT CARE ITEMS Sterilized materials shall be stored, handled and transported to maintain sterility. Package integrity shall be maintained until used. STATE FORM 6899 LGDO11 If continuation sheet 31 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4218 Continued From page 31 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4218 This REQUIREMENT is not met as evidenced by: Based on observation, staff interviews, and review of nationally recognized guidelines, it was determined that the facility failed to ensure that sterilized items are stored to maintain package integrity. Findings include: Reference: AAMI (Association for the Advancement of Medical Instrumentation) ST79: 2107 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, section 11.1.1 states, "Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination. ...Sterile items should be ...4. positioned so that packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised. ...Rationale: ...Compression of packages can force air and microorganisms into the package contents, cause seals to burst, or puncture the packaging, all of which lead to contamination. ...Stacking can result in damage to the wrap caused by undue pressure from the weight." 1. On 9/7/18 at 10:05 AM, in the Instrument Room, the following was observed: a. Multiple peel-packaged instruments were lying flat, stacked on top of each other, compromising the integrity of the package and its contents. b. There was a plastic bin that contained thirty (30) sterile packages of Kidney basins, Iodine cups, and various surgical instruments. STATE FORM 6899 LGDO11 If continuation sheet 32 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4218 Continued From page 32 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4218 i. The sterile packages were crushed, bent, and compressed within the plastic bin. 2. The above findings were confirmed by Staff #1 and Staff #2. A4260 8:43A-14.5(b) INFEC PREV & CONTROL: A4260 CARE/USE OF STERILIZERS The biological indicator shall be applicable for the process used and shall be stored and used in accordance with the manufacturer's recommendations. This REQUIREMENT is not met as evidenced by: Based on observation, staff interview, document review, and review of manufacturer's instructions for use (IFU), it was determined that the facility failed to ensure biological indicators are used in accordance with the manufacturer's instructions. Findings include: Reference: 3M Attest 41382 BI [biological indicator] Manufacturer's IFU states, "Indications for Use ... Use the 3M Attest 41382 Rapid 5 Steam-Plus Test Pack to monitor: 1. 121 degrees C (Celsius) (250 degrees F [Fahrenheit]) gravity steam sterilization cycles; 2. 132 degrees C (270 degrees F) vacuum assisted steam sterilization cycles. ... Precautions ... Do not use the 3M Attest 41382 Rapid 5 Steam-Plus Test Pack to monitor STATE FORM 6899 LGDO11 If continuation sheet 33 of 34 PRINTED: 12/28/2018 FORM APPROVED New Jersey Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: HEALTHPLUS SURGERY CENTER, LLC (X4) ID PREFIX TAG A. BUILDING: ______________________ (X3) DATE SURVEY COMPLETED C 09/07/2018 B. WING _____________________________ 23116 NAME OF PROVIDER OR SUPPLIER (X2) MULTIPLE CONSTRUCTION STREET ADDRESS, CITY, STATE, ZIP CODE 190 MIDLAND AVENUE SADDLE BROOK, NJ 07663 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) A4260 Continued From page 33 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETE DATE A4260 sterilization cycles which it is not designed to challenge: ... " 1. During a tour of the Sterilization Room, a Getinge Model 633HC steam sterilizer was observed. Staff #8 confirmed the sterilizer is used as a Pre-Vac sterilizer. a. On 9/7/18, review of sterilization records dated 8/22/18 and 9/4/18, revealed the following: i. On 8/22/18, load one (1) was processed, using the 3M Attest 41382 BI, in the Pre-Vac cycle at 275 degrees F, with 4 minute exposure time. ii. On 9/4/18, loads one (1) and two (2) were processed, using the 3M Attest 41382 BI, in the Pre-Vac cycle at 275 degrees F, with 4 minute exposure time. 2. Upon review of the IFU for the 3M Attest BI, the 3M Attest 41382 BI is not indicated for Pre-Vac cycles at 275 degrees F. STATE FORM 6899 LGDO11 If continuation sheet 34 of 34 STATE FORM: REVISIT REPORT PROVIDER / SUPPLIER / CLIA / IDENTIFICATION NUMBER 23116 Y1 MULTIPLE CONSTRUCTION A. Building B. Wing DATE OF REVISIT Y2 NAME OF FACILITY STREET ADDRESS, CITY, STATE, ZIP CODE HEALTHPLUS SURGERY CENTER, LLC 190 MIDLAND AVENUE 9/27/2018 Y3 SADDLE BROOK, NJ 07663 This report is completed by a State surveyor to show those deficiencies previously reported that have been corrected and the date such corrective action was accomplished. Each deficiency should be fully identified using either the regulation or LSC provision number and the identification prefix code previously shown on the State Survey Report (prefix codes shown to the left of each requirement on the survey report form). ITEM DATE ITEM Y4 Y5 Y4 ID Prefix Reg. # A1157 8:43A-3.5(a) LSC ID Prefix Reg. # A2306 8:43A-9.3(b)(7)(i) LSC ID Prefix Reg. # A3070 8:43A-12.6(a)(16)(ii) LSC ID Prefix Reg. # A4071 8:43A-14.2(b) LSC ID Prefix Reg. # A4190 8:43A-14.4(a)(1) LSC Correction ID Prefix Completed Reg. # 09/27/2018 LSC Correction ID Prefix Completed Reg. # 09/27/2018 LSC Correction ID Prefix Completed Reg. # 09/27/2018 LSC Correction ID Prefix Completed Reg. # 09/27/2018 LSC Correction ID Prefix Completed Reg. # 09/27/2018 LSC DATE Y5 A2278 8:43A-9.3(b)(4) A2320 8:43A-9.3(b)(7)(iii) A4050 8:43A-14.1(a) A4098 8:43A-14.2(b)(4) A4215 8:43A-14.4(g) ITEM DATE Y4 Y5 Correction ID Prefix Completed Reg. # 09/27/2018 LSC Correction ID Prefix Completed Reg. # 09/27/2018 LSC Correction ID Prefix Completed Reg. # 09/27/2018 LSC Correction ID Prefix Completed Reg. # 09/27/2018 LSC Correction ID Prefix Completed Reg. # 09/27/2018 LSC Correction A2299 8:43A-9.3(b)(7) Completed 09/27/2018 Correction A2432 8:43A-9.5(b) Completed 09/27/2018 Correction A4057 8:43A-14.1(b) Completed 09/27/2018 Correction A4183 8:43A-14.3(a)(5) Completed 09/27/2018 Correction A4216 8:43A-14.4(g)(1) Completed 09/27/2018 REVIEWED BY STATE AGENCY REVIEWED BY (INITIALS) DATE SIGNATURE OF SURVEYOR DATE REVIEWED BY CMS RO REVIEWED BY (INITIALS) DATE TITLE DATE Page 1 of 2 STATE FORM: REVISIT REPORT (11/06) EVENT ID: LGDO12 STATE FORM: REVISIT REPORT PROVIDER / SUPPLIER / CLIA / IDENTIFICATION NUMBER 23116 Y1 MULTIPLE CONSTRUCTION A. Building B. Wing DATE OF REVISIT Y2 NAME OF FACILITY STREET ADDRESS, CITY, STATE, ZIP CODE HEALTHPLUS SURGERY CENTER, LLC 190 MIDLAND AVENUE 9/27/2018 Y3 SADDLE BROOK, NJ 07663 This report is completed by a State surveyor to show those deficiencies previously reported that have been corrected and the date such corrective action was accomplished. Each deficiency should be fully identified using either the regulation or LSC provision number and the identification prefix code previously shown on the State Survey Report (prefix codes shown to the left of each requirement on the survey report form). ITEM DATE ITEM Y4 Y5 Y4 ID Prefix Reg. # A4218 8:43A-14.4(h) LSC Correction ID Prefix Completed Reg. # 09/27/2018 LSC DATE Y5 ITEM DATE Y4 Y5 Correction A4260 8:43A-14.5(b) Completed 09/27/2018 REVIEWED BY STATE AGENCY REVIEWED BY (INITIALS) DATE SIGNATURE OF SURVEYOR DATE REVIEWED BY CMS RO REVIEWED BY (INITIALS) DATE TITLE DATE FOLLOWUP TO SURVEY COMPLETED ON 9/7/2018 CHECK FOR ANY UNCORRECTED DEFICIENCIES. WAS A SUMMARY OF UNCORRECTED DEFICIENCIES (CMS-2567) SENT TO THE FACILITY? Page 2 of 2 STATE FORM: REVISIT REPORT (11/06) EVENT ID: YES LGDO12 NO Surgery Center Plan of Correction V2 @C/W?yj/ Survey Date 9/7/13 4? TAG SYSTEMIC CHANGE MONITORING PLAN RESPONSIBLE REPORTS TO COMPLETION PARTY A1157 All current staff had sterile processing competencies A quarterly audit of competencies will be completed for Director of Administrator Competencies GEN REG: PERSONNEL completed by an outside consultant certi?ed in sterile 100% of the sterile processing staff. Audits will be Nursing IC Committee completed by processing. completed for a period of one year. 0A Committee 9/14/18 Clinical Operations An outside consultant certi?ed in sterile processing will A Clinical Operations Committee will be created and meet on Committee Quarterly audits complete sterile processing competencies for all new a quarterly basis. The CIA committee will report in to the Governing Body 9/26/18 hires within 90 days of hire. Clinical Operations Committee. The Clinical Operations Committee will report to the Governing Body. An outside consultant certi?ed in sterile processing will complete annual competencies for all sterile processing DON will collate data and report to the Administrator, CIA staff. committee, Clinical Operations Committee and Governing Body quarterly. A2278 A new policy on the preparation 8: use of parenteral A medication safety audit tool will be developed. A total of Director of Administrator Policy will be PHARMACEUTICAL SVCS: medications will be developed in conjunction with a 60 random audits will be completed for 6 months. Nursing IC Committee effective 9/26/18. quality consultant pharmacy consultant. Policy will use QA Committee 3' 3:23:23: Of national references. Policy will be approved by the A Clinical Operations Committee will be created and meet on Clinical Operations All staff medications Clinical Operations Committee Governing Body. All a quarterly basis. The DA committee will report in to the Committee providers will be staff, physicians anesthesia providers will be educated Clinical Operations Committee. The Clinical Operations Governing Body educated on the on the policy. Committee will report to the Governing Body. new policies by 9/26/18. All policies procedures will be reviewed annually and approved by the Infection Control Committee, Patient Care Medication audits Committee, Clinical Operations Committee and Governing 10/18-4/19 Body. DON will collate data on a basis and report data to the Administrator and to the (1A committee, Clinical Operations Committee and Governing Body quarterly. A2299 A new policy on the procurement, storage, dispensing, A Controlled Drug Substance (CDS) audit tool will be Director of Administrator Policy will be PHARMACEUTICAL SVCS: administration, intentional wasting disposition of developed. A total of 60 random audits will be Nursing IC Committee effective 9/26/18. Controlled Drug Substances (CDS) will be developed in completed for 6 months. OA Committee 3" Eiisgment? conjunction with a quality consultant 8: pharmacy Clinical Operations All staff storage, consultant. Policy will use federal standards as A Clinical Operations Committee will be created and meet on Committee providers will be dispensing, references. Policy will be approved by the Clinical a quarterly basis. The OA committee will report in to the Governing Body educated on the administratl?m 3? Operations Committee Governing Body. All staff, Clinical Operations Committee. The Clinical Operations new policies by b. :ggogm?ezigi' p:ysicilans anesthesia providers will be educated on Committee will report to the Governing Body. 9/26/18. po icy. Surgery Center Plan of Correction V2 Survey Date 9/7/18 wasting of entire All policies procedures will be reviewed annually and Controlled Drug federal standards as references. Policy will be approved by the Clinical Operations Committee 8: Governing Body. All staff, physicians anesthesia providers will be educated on the policy. A new anesthesia narcotic controlled drug record will be added in addition to the patient anesthesia record. A procedure will be developed in conjunction with the new record to have an end of shift count with the anesthesia a quarterly basis. The DA committee will report in to the Clinical Operations Committee. The Clinical Operations Committee will report to the Governing Body. All policies 81 procedures will be reviewed annually and approved by the infection Control Committee, Patient Care Committee, Clinical Operations Committee and Governing Body. Governing Body contents ?f cos approved by the Infection Control Committee, Patient Care audits 10/ 18-4/19 Ii Committee, Clinical Operations Committee and Governing i Body. DON will collate data on a basis and report data to the Administrator and to the QA committee, Clinical 1 Operations Committee and Governing Body quarterly. A2306 A new medication management policy 81 procedure will A Controlled Drug Substance (CDS) audit tool will be Director of Administrator Policy will be PHARMACEUTICAL SVCS: be developed including a veri?able record system for developed. A total of 60 random audits will be Nursing IC Committee effective 9/26/18. Controlled Drug Substances (CBS). The policy will be completed for 6 months. O.A Committee 3' Exam developed in conjunction with a quality consultant 8: Clinical Operations All staff system for (395 pharmacy consultant. Policy will use federal standards as A Clinical Operations Committee will be created and meet on Committee providers will be references. Policy will be approved by the Clinical a quarterly basis. The DA committee will report in to the Governing Body educated on the Operations Committee Governing Body. All staff, Clinical Operations Committee. The Clinical Operations new policies by physicians anesthesia providers will be educated on Committee will report to the Governing Body. 9/26/18. the policy. All policies 8: procedures will be reviewed annually and Controlled Drug approved by the Infection Control Committee, Patient Care audits 10/18-4/19 Committee, Clinical Operations Committee and Governing Body. DON will collate data on a basis and report data to the Administrator and to the QA committee, Clinical Operations Committee and Governing Body quarterly. A2320 A new medication management policy 8: procedure will A Controlled Drug Substance (CD5) audit tool will be Director of Administrator Policy will be PHARMACEUTNIAL be developed including a procedure for wasting of developed. A total of 60 random audits will be Nursing IC Committee effective 9/26/18. 9? Controlled Drug SubstanceleDS) with a witness. The completed for 6 months. QA Committee a. for wasting . . . . . . . . . . cos with signature policy will be developed In conjunction With a quality Clinical Operations All staff 8: ofwitness consultant pharmacy consultant. Policy will use A Clinical Operations Committee will be created and meet on Committee providers will be educated on the new policies by 9/26/18. Controlled Drug audits 10/18-4/19 New anesthesia narcotic 8t Surgery Center Plan of Correction V2 Survey Date 9/7/18 provider to verify the number of returned COS vials. DON will collate data on a basis and report data to the Administrator and to the QA committee, Clinical Operations Committee and Governing Body quarterly. An anesthesia dose documentation audit tool will be developed. The tool will provide for a 3 way match between controlled drug record will be effective 9/26/ 18. Anesthesia dose documentation the medical record, narcotic count record and the anesthesia audits 10/18-4/19 narcotic controlled drug record. A total of 60 random audits will be completed for 6 months. DON will collate data on a basis and report data to the Administrator and to the OA committee, Clinical Operations Committee and Governing Body quarterly. A2432 A new medication management policy procedure will A medication safety audit tool will be developed. A total of Director of Administrator Policy will be PHARMACEUTICAL SVCS: be developed including a section on storage of 60 random audits will be completed for 6 months. Nursing IC Committee effective 9/26/ 18. STORAGE OF DRUGS medications under proper conditions. The policy will be QA Committee a' developed in conjunction with a quality consultant An infection control committee will be created and meet on Clinical Operations All staff 8: conditions pharmacy consultant. Policy will use federal standards as a quarterly basis. A Clinical Operations Committee will be Committee providers will be references. Policy will be approved by the Clinical created and meet on a quarterly basis. The infection control Governing Body educated on the Operations Committee 8: Governing Body. All staff, committee will report in to the Clinical Operations new policies by physicians anesthesia providers will be educated on Committee. The Clinical Operations Committee will report to 9/26/ 18. the policy. the Governing Body quarterly. Medication audits All policies 81 procedures will be reviewed annually and 10/18-4/ 19 approved by the Infection Control Committee, Patient Care Committee, Clinical Operations Committee and Governing Body. DON will collate data on a basis and report data to the Administrator and to the Infection Control Committee, QA committee, Clinical Operations Committee and Governing Body quarterly. A3070 A dress code policy will be developed in conjunction with A surgical attire audit tool will be developed and monitor Director of Administrator Policy will be SURG 8: ANES SVCS: PEIP a quality consultant. Policy will re?ect AORN compliance with the policies and AORN standards. A total of Nursing IC Committee effective 9/26/18. 3' Fai'ure t? ?53 Perioperative Guidelines for practice regarding surgical 60 random audits will be completed for 6 months. QA Committee attire and facial hair. Policy will be approved by the Clinical operations Staff 8? Clinical Operations Committee 8: Governing Body. All An infection control committee will be created and meet on Committee providers will be staff, physicians anesthesia providers will be educated a quarterly basis. A Clinical Operations Committee will be Governing Body educated on the Surgery Center Plan of Correction V2 Survey Date 9/7/18 1 on the policy. created and meet on a quarterly basis. The infection control new policies by committee will report in to the Clinical Operations 9/25/13. Committee. The Clinical Operations Committee will report to I the Governing Body quarterly. Surgical attire audits 10/18-4/19 All policies procedures will be reviewed annually and approved by the Infection Control Committee, Patient Care i Committee, Clinical Operations Committee and Governing Body. DON will collate data on a basis and report data to the Administrator and to the Infection Control Committee, O.A committee, Clinical Operations Committee and Governing Body quarterly. A4050 An infection control risk assessment will be completed by An infection control audit tool will be developed. The tool Director of Administrator Infection Control INFEC PREV 81 a Certi?ed Infection Control Nurse. Based on the results will include components of the infection control plan based Nursing IC Committee Risk Assessment RESP of the Infection Control Risk Assessment an annual on the risk assessment. At a minimum the tool will address: QA Committee Infection Control 3' SEE. infection control plan will be developed in conjunction environmental cleaning, medication safety, sharps safety and Clinical Operations Plan effective program with a quality consultant and Certi?ed Infection Control injection practices, surgical attire, surgical site infections, Committee 9/26/18 Nurse. Current infection Control policies will be sterilization, Prophylactic antibiotics, compliance with Governing Body reviewed and updated as necessary. Policies will be infection control policies, compliance with AORN standards Infection Control referenced with national practice standards. Any new and hand hygiene. A infection control audit will be Audits 10/18-4/19 policies or oolicy chanees will be approved by the Clinical Operations Committee 8t Governing Body. All staff, physicians 8t anesthesia providers will be educated on the policy. completed for 6 months. Data will be collated on a basis and reported to the Infection Control Committee. An infection control committee will be created and meet on a quarterly basis. A Clinical Operations Committee will be created and meet on a quarterly basis. The infection control committee will report in to the Clinical Operations Committee. The Clinical Operations Committee will report to the Governing Body quarterly. The infection control risk assessment, infection control plan, policies procedures will be reviewed annually and approved by the Infection Control Committee, Patient Care Committee, Clinical Operations Committee and Governing Body. DON will collate data and report to the Administrator, Surgery Center Plan of Correction V2 Survey Date 9/7/ 18 Infection Control Committee, QA committee, Clinical Operations Committee and Governing Body quarterly. A4183 Current infection Control policies will be reviewed and An infection control audit tool will be deveIOped. The tool Director of Administrator Infection Control PREV 3: INFEC updated as necessary in conjunction with a quality will include components of the infection control plan based Nursing IC Committee Policies effective PREV consultant and Certi?ed Infection Control Nurse. Policies on the risk assessment. At a minimum the tool will address: QA Committee 9/26/18 3. Failure to ensure . . . . . . . . . . . . hand hygiene is to be reviewed 8: updated Will include at a minimum: envuonmental cleaning, medication safety, sharps safety and Clinical Operations performed in hand hygiene. Policies will be referenced with national injection practices, surgical attire, surgical site infections, Committee All staff 8: accordance with practice standards. Any new policies or policy changes sterilization, Prophylactic antibiotics, compliance with Governing Body providers will be 5 CDC guidelines will be approved by the Clinical Operations Committee 81. infection control policies, compliance with AORN standards educated on the . Governing Body. All staff, physicians anesthesia and hand hygiene. A infection control audit will be new policies by i providers will be educated on the policy. completed for 6 months. Data will be collated on a 9/26/ 18 I basis and reported to the Infection Control Committee. I An infection control committee will be created and meet on Infection Control a quarterly basis. A Clinical Operations Committee will be Audits 10/18-4/19 created and meet on a quarterly basis. The infection control committee will report in to the Clinical Operations Committee. The Clinical Operations Committee will report to the Governing Body quarterly. All policies procedures will be reviewed annually and approved by the Infection Control Committee, Patient Care Committee, Clinical Operations Committee and Governing Body. DON will collate data and report to the Administrator, Infection Control Committee, QA committee, Clinical Operations Committee and Governing Body quarterly. A4190 Current infection Control policies will be reviewed and A sterilization audit tool will be developed. At a minimum the Director of Administrator Infection Control INFEC PREV updated as necessary in conjunction with a quality tool will address: compliance with facility policies, Nursing IC Committee Policies effective CARE consultant, Certi?ed Infection Control Nurse and compliance with AAMI standards, staff knowledge of facility QA Committee 9/26/18 3' sterile Certi?ed Sterile Processing Consultant. Policies to be policies 8: AAMI standards, staff knowledge and compliance Clinical Operations items in reviewed 8: updated will include at a minimum: with reprocessing items according to manufacturer IFU, staff Committee All staff accordance with transmission based precautions, reprocessing soiled releasing items at room temperature, staff inspection for wet Governing Body providers will be 5779 instruments in accordance with AAMI ST79, immediate packs, rust on instruments, gross debris on clean educated on the b' :sglr?i?lfizereStcool treatment of soiled instruments, following manufacturer instruments, treatment at point of use, use of PPE, new policies by to mom IFU for processing instruments, sterilizer quali?cation availability of PPE, sterilizer quali?cation testing per AAMI 9/26/13 temperature testing, 8: biomedical inspection. Policies will be standards, and biomedical inspection. The sterilization audit before handling referenced with national practice standa rds-AAMl SW9 will be completed for 6 months. Data will be collated on a Infection Control Failure t? ?We? AORN Guidelines. Any new policies or basis and reported to the Infection Control Audits 10/ 18-4/19 for wet packs and . . . . . policy changes will be approved by the Clinical Committee. HealthPIus Surgery Center Plan of Correction V2 Survey Date 9/7/18 approved by the Infection Control Committee, Patient Care Committee, Clinical Operations Committee and Governing Body. DON will collate data and report to the Administrator, Infection Control Committee, QA committee, Clinical Operations Committee, and Governing Body quarterly. i A4098 INFEC PREV 8: 3. Failure to develop 8? review IC policies every 3 years b. Failure to transport soiled instruments in OSHA compliance Current infection Control policies will be reviewed and updated as necessary in conjunction with a quality consultant and Certi?ed Infection Control Nurse. Policies to be reviewed 8; updated will include at a minimum: care of contaminated instruments. Policies will be referenced with national practice standards. Any new policies or policy changes will be approved by the Clinical Operations Committee Governing Body. All staff, physicians 8; anesthesia providers will be educated on the policy. An infection control audit tool will be developed. The tool will include components of the infection control plan based on the risk assessment. At a minimum the tool will address: Environmental cleaning, medication safety, sharps safety and injection practices, surgical attire, surgical site infections, sterilization, Prophylactic antibiotics, compliance with infection control policies, compliance with AORN standards and hand hygiene. A infection control audit will be completed for 6 months. Data will be collated on a basis and reported to the Infection Control Committee. A random audit of 40 cases will be performed on the care, handling transportation of soiled instruments. The audit will look for immediate use of a facility approved surgical instrument foam, and transportation of soiled instruments in compliance with OSHA standards and facility policies. DON will collate results on a basis. Results will be reported to the Infection Control Committee, Quality improvement Committee, Clinical Operations Committee and Governing Body. An infection control committee will be created and meet on a quarterly basis. A Clinical Operations Committee will be created and meet on a quarterly basis. The infection control committee will report in to the Clinical Operations i Committee. The Clinical Operations Committee will report to the Governing Body quarterly. All policies 8: procedures will be reviewed annually and r- approved by the Infection Control Committee, Patient Care Committee, Clinical Operations Committee and Governing Body. DON will collate data and report to the Administrator, Director of Nursing Administrator IC Committee 0A Committee Clinical Operations Committee Governing Body lnfection Control Policies effective 9/26/18 All staff 8: providers will be educated on the new policies by 9/26/18 Infection Control Audits 10/18-4/19 Surgery Center Plan of Correction V2 Survey Date 9/7/18 Infection Control Committee, 0A committee, Clinical Operations Committee and Governing Body quarterly. An infection control committee will be created and meet on a quarterly basis. A Clinical Operations Committee will be created and meet on a quarterly basis. The infection control committee will report in to the Clinical Operations Committee. The Clinical Operations Committee will report to the Governing Body quarterly. All policies 81 procedures will be reviewed annually and A4057 . A staff member will be designated as the onsite infection A log will be created to document the education Director of Administrator Designate IC nurse PREV 3: control professional to work in conjunction with the training activities of the onsite infection control nurse. Nursing IC Committee by 9/21/18 RESP Certi?ed Infection Control Consultant. The onsite activities 8! ?ndings will be reported to the Infection CIA Committee 3' 222:3; train infection control nurse will complete ASC Control Committee. Clinical Operations Medical Director an onsite [cp Infection Prevention Course. Committee sign authority Infection Control nurse will be mentored by Certi?ed Governing Body statement by An authority statement will be signed for the onsite Infection Control Nurse Quality Consultant with APIC 9/21/18 infection control nurse by the medical director. training in infection control. IC nurse complete Ari infection control committee will be created and meet on AORN course by a quarterly basis. A Clinical Operations Committee will be 9/24/18 created and meet on a quarterly basis. The infection control committee will report in to the Clinical Operations IC Nurse start Committee. The Clinical Operations Committee will report to log by the Governing Body quarterly. 11/1/18 DON will collate data and report to the Administrator, Infection Control Committee, QA committee, Clinical Operations Committee and Governing Body quarterly. A4071 Current infection Control policies will be reviewed and An infection control audit tool will be developed. The tool Director of Administrator Infection Control INFEC PREV PM [19:13th as necessary in rnniunction with a quality will include components of the infection control plan based Nursing IC Committee Policies effective a' Fan? dembp 1 consultant and Certi?ed Infection Control Nurse. Policies on the risk assessment. At a minimum the tool will address: OA Committee 1 9/26/18 IC policies . . . . . . . . . . . . Failure to to be rewewed updated Will include at a minimum: envnronmental cleaning, medication safety, sharps safety and Clinical Operations impiement AORN cleaning sanitation of horizontal surfaces and room injection practices, surgical attire, surgical site infections, Committee All staff Guidelines for Ic turnover. Policies will be referenced with national sterilization, Prophylactic antibiotics, compliance with Governing Body providers will be Palm": ?0 practice standards. Any new policies or policy changes infection control policies, compliance with AORN standards educated on the will be approved by the Clinical Operations Committee 8: and hand hygiene. A infection control audit will be new policies by d_ Failure to dean Governing Body. All staff, physicians 8: anesthesia completed for 6 months. Data will be collated on a 9/26/18 disinfect surfaces providers will be educated on the policy. basis and reported to the Infection Control Committee. Infection Control Audits 10/18-4/19 Surgery Center Plan of Correction V2 Survey Date 9/7/18 reprocess items Operations Committee 8: Governing Body. All staff, Biomedical Audits ?We use physicians anesthesia providers will be educated on An infection control committee will be created and meet on 10/18-4/19 d. Failure to maintain . . . . . . . instruments rust the policy. a quarterly ba5is. A Clinical Operations Committee Will be free created and meet on a quarterly basis. The infection control Sterile Processing e. Failure to ensure committee will report in to the Clinical Operations Consultant Audits items Properly Committee. The Clinical Operations Committee will report to 10/ 18-4/19 heme the Governing Body quarterly. sterilization . . . . f. Failure to ensure All DOIICIES procedures will be rewewed annually and instruments are approved by the Infection Control Committee, Patient Care immediately Committee, Clinical Operations Committee and Governing treated at point of Body. use 3. Failure to follow . manufacturer's An audit of equipment being inspected by Biomedical IFU Engineering will be completed for a period of 6 h. Failure to follow months. transmission I i A Certi?ed Sterile Processing Consultant will be onsite for 13p}; easily weekly audits for a period of one month, then biweekly accessible audits for a period of two months, then audits for a 1' Fai'u'e t? ensure period of three months. sterilizer quali?cation testing following DON will collate data and report to the Administrator, installation per infection Control Committee, OA committee, Clinical AAMI guidelines Operations Committee and Governing Body quarterly. k. Failure to ensure sterilizer was biomed inspected I. Failure to ensure adherence to AAMI standards A4215 has contracted with a Sterile Processing A random audit of manufacturer lFU?s for 10 Director of Administrator Manufacturer IFU INFEC PREV 8? consulting company. Four certi?ed sterile processing instruments will be completed for a period of 6 months. Nursing IC Committee for high use items PT CARE managers with extensive experience were onsite for the A sterilization audit tool will be developed. At a minimum the OA Committee received by a' entire week of 9/10/18 and will continue onsite until all tool will address: compliance with facility policies, Clinical Operations 9/14/18 b. Failure to follow manufacturer are immediately available for staff. compliance with AAMI standards, staff knowledge of facility Committee IFU All current staff had sterile processing competencies policies AAMI standards, staff knowledge and compliance Governing Body Contract with One completed by an outside consultant certi?ed in sterile with reprocessing items according to manufacturer IFU. staff Source for IFU processing. releasing items at room temperature, staff inspection for wet effective by Part of the competency process was using correct packs, rust on instruments, gross debris on clean 9/21/13 manufacturer IFU for reprocessing instruments. The instruments, treatment at point of use, use of PPE, Surgery Center Plan of Correction V2 Survey Date 9/7/18 facility will also contract with OneSource to have immediate online access to manufacturer availability of PPE, sterilizer quali?cation testing per AAMI standards, and biomedical inspection. The sterilization audit will be completed for 6 months. Data will be collated on a basis and reported to the Infection Control Committee. A Certi?ed Sterile Processing Consultant will be onsite for weekly audits for a period of one month, then biweekly audits for a period of two months, then audits for a period of three months. An infection control committee will be created and meet on a quarterly basis. A Clinical Operations Committee will be created and meet on a quarterly basis. The infection control committee will report in to the Clinical Operations Committee. The Clinical Operations Committee will report to the Governing Body quarterly. DON will collate data and report to the Administrator, Infection Control Committee, QA committee, Clinical Operations Committee and Governing Body quarterly. Audits of Manufacturer IFU 10/18-4/19 Sterile Processing Consultant Audits 10/13-4/19 A4216 INFEC PREV 8.: ST RILIZATN PT CARE ITEMS a. Failure to process hinged instruments in open position has contracted with a Sterile Processing consulting company. Four certi?ed sterile processing managers with extensive experience were onsite for the entire week of 9/10/18 and will continue onsite until all sterile instrument trays have been opened, refurbished, cleaned and reprocessed. All items will be reprocessed using manufacturer IFU and AAMI ST79. All hinged items will be in the open position. The facility is focusing on high volume instruments since those are reprocessed most frequently. All current staff had sterile processing competencies completed by an outside consultant certi?ed in sterile processing. Part of the competency process was correct reprocessing of hinged instruments. A random audit of 80 hinged instruments will be completed for a period of 6 months. A Certi?ed Sterile Processing Consultant will be onsite for weekly audits for a period of one month, then biweekly audits for a period of two months, then audits for a period of three months. An infection control committee will be created and meet on a quarterly basis. A Clinical Operations Committee will be created and meet on a quarterly basis. The infection control committee will report in to the Clinical Operations Committee. The Clinical Operations Committee will report to the Governing Body quarterly. DON will collate data and report to the Administrator, Infection Control Committee, QA committee, Clinical Director of Nursing Administrator IC Committee QA Committee Clinical Operations Committee Governing Body Audits of Hinged instruments 10/18-4/19 Sterile Processing Consultant Audits 10/18-4/19 Surgery Center Plan of Correction V2 Survey Date 9/7/18 I Operations Committee and Governing Body quarterly. 1 A4218 has contracted with a Sterile Processing A random audit of 80 peel packs 8: instrument trays Director of Administrator Audits of Package INFEC PREV 8: consulting company. Four certi?ed sterile processing will be completed for a period of 6 months to check package Nursing lC Committee Integrity i PT CARE managers with extensive experience were onsite for the integrity. A random audit of 4D peel packs O.A Committee 10/ 18-10/19 a. Failure to ensure . . . . . . . . . . . . I that sterilized entire week of 9/10/18 and Will continue onsrte until all Instrument trays Will be completed for an additional 6 Clinical Operations I items are stored to sterile instrument trays have been opened, refurbished, months to check package integrity. At the end of the one Committee Sterile Processing maintain package cleaned and reprocessed. All items will be reprocessed year of audits the facility will determine if the audits need to Governing Body Consultant Audits Integrity using manufacturer IFU and AAMI $179. All sterile items continue or if a different audit should be conducted on 10/18?4/19 will be stored to maintain package integrity. All current sterile processing. staff had sterile processing competencies completed by i an outside consultant certi?ed in sterile processing. An infection control committee will be created and meet on Part of the competency process was correct storage to a quarterly basis. A Clinical Operations Committee will be maintain package integrity. created and meet on a quarterly basis. The infection control I committee will report in to the Clinical Operations I Committee. The Clinical Operations Committee will report to i the Governing Body quarterly. A Certified Sterile Processing Consultant will be onsite for '5 weekly audits for a period of one month, then biweekly audits for a period of two months, then audits for a period of three months. An infection control committee will be created and meet on i a quarterly basis. A Clinical Operations Committee will be created and meet on a quarterly basis. The infection control committee will report in to the Clinical Operations Committee. The Clinical Operations Committee will report to the Governing Body quarterly. DON will collate data and report to the Administrator, Infection Control Committee, QA committee, Clinical Operations Committee and Governing Body quarterly. A4260 has contracted with a Sterile Processing A random audit of biological indicators in Director of Administrator Sterile Processing INFEC PREV 3! ARE consulting company. Four certi?ed sterile processing accordance with manufacturer instructions will be completed Nursing IC Committee Consultant Audits USE OF managers with extensive experience were onsite for the by the certi?ed sterile processing consultant for a period of 6 QA Committee 10/ 18-4/19 a. Failure magma. indicator entire week of 9/10/18. The consultants worked to reset months. Clinical Operations that is applicable sterile processing time and temperature of cycles and Committee for the process in purchase the appropriate biological indicators for the An infection control committee will be created and meet on Governing Body acmrdance With cycles being used. The sterile processing consultants and a quarterly basis. A Clinical Operations Committee will be EU will continue onsite until all sterile instrument trays have created and meet on a quarterly basis. The infection control Plan of Correction V2 Surgery Center - been opened, refurbished, cleaned and reprocessed. All items will be reprocessed using manufacturer and AAMI 5179. All sterile items will be stored to maintain package integrity. All current staff had sterile processing competencies completed by an outside consultant certi?ed in sterile processing. Part of the competency process was using correct biological indicators in accordance with manufacturer instructions. committee will report in to the Clinical Operations Committee. The Clinical Operations Committee will report to the Governing Body quarterly. A Certi?ed Sterile Processing Consultant will be onsite for weekly audits for a period of one month, then biweekly audits for a period of two months, then audits for a period of three months. An infection control committee will be created and meet on a quarterly basis. A Clinical Operations Committee will be created and meet on a quarterly basis. The infection control committee will report in to the Clinical Operations Committee. The Clinical Operations Committee will report to the Governing Body quarterly. DON will collate data and report to the Administrator, Infection Control Committee, QA committee, Clinical Operations Committee and Governing Bodyr quarterly. Survey Date 9/7/18 i i i' -.- Respectfully Submitted, Administrator Surgery Center DEPARTMENT OF HEALTH PO BOX 358 Philip D. Murphy TRENTON, N.J. 08625-0358 Governor . „ www.nj.gov/health SheilaY. Oliver Shereef M. Elnahal,MD, MBA Lt. Governor Commissioner September 7, 2018 Healthplus Surgery Center, LLC 190 Midland Avenue Saddle Brook, NJ 07663 Via Facsimile: 646-448-9150 RE: Curtailment of Services Order Facility ID# NJ23116 Dear : This letter confirms the telephone call ofSeptember7, 2018 at 3:00 p.m. between you and staff of Health Facility Survey and Field Operations (Survey"), and the Office of Licensing Certificate and Need (DOH), wherein you were ordered to curtail all services at Healthplus Surgery Center, LLC, effective immediately. This order shall remain in place until formally lifted by the Department. This action is being taken based on a recommendation from Survey staff and taken in accordance with N.J.A.C. 8:43E-3.6, during an on-site complaint survey conducted on September 7, 2018, during which deficient practices were identified related to serious breaches of infection control with the sterile processing process and inability to ensure the sterility of the instruments. Please be advised that N.J.A.C. 8:43E-3.4(a)(2) provides for a penalty of $250 per day for each patient admitted in violation of this curtailment order. Please also be advised that you may be subject to other enforcement remedies in addition to the curtailment order. The deficiencies found include, but are not limited to: • Instructions For Use (IFU's) were not available for all instruments. • Biologicals are being used incorrectly and validation testing is not being done correctly. • No competencies completed for 3 staff regarding infection control. • Sterile instruments observed with debris in hinges, rusty and discolored. FORMAL HEARING ™~—_——————^— *- Healthplus Surgery Center, LLC is entitled to a prompt formal hearing at the Office of Administrative law (OAL) to challenge the curtailment. Healthplus Surgery Center, LLC must advise the Department within 30 days of this letter to request an OAL hearing regarding this matter. Please forward your OAL hearing request to: Attention: OAL Hearing Requests Office of Legal and Regulatory Compliance, Room 805 New Jersey State Department of Health P.O. Box 360 Trenton, New Jersey 08625-0360 Corporations are not permitted to represent themselves in OAL proceedings, j Therefore, if Healthplus Surgery Center, LLC is owned by a corporation, representation ! by counsel is required. If Healthplus Surgery Center, LLC requests an OAL hearing regarding this matter, thefacility is further required to submit a written response to each charge specified in this order, which shall accompany your request for a hearing. Please call 609-984-8128 if you have any questions regarding this curtailment. Sincerely, Director Program Compliance Division of Certificate of Need and Licensing New Jersey Department of Health GR/jn Control #AX18013 js^iate of ^efti UcrsEg DEPARTMENT OF HEALTH PO BOX 358 TRENTON, N.J. 08625-0358 Philip D. Murphy Governor www.nj .gov/health Sheila Y. Oliver Shereef M. Elnahal, MD, MBA Lt. Governor Commissioner Healthplus Surgery Center, LLC 190 Midland Avenue Saddle Brook, NJ 07663 VIA FACSIMILE (646) 448-9150 &FIRST CLASS MAIL RE: LIFTING of Curtailment of Services Facility ID# NJ23116 Dear , This will confirm this afternoon's phone call between you and staff of the Office of Program Compliance wherein you were advised that the curtailment of services for Healthplus Surgery Center, LLC, that was imposed on September 7, 2018 was lifted, effective immediately. This action is being taken based on a recommendation from Health Facility Survey and Field Operations, indicating, as of today's revisit, the facility is back in compliance. If you have any questions, you may call , Office of Program Compliance and Health Care Financing at (609) 984-8161. Sincerely, Director Program Compliance Division of Certificate of Need and Licensing GR:lk September 27, 2018 Control #AX18013 i, in? girth; nf CNBEU 3121:5213 DEPARTMENT OF HEALTH PO BOX 367 TRENTON, NJ. 08625-0367 PHILIP D. MURPHY Governor SHEILA Y. OLIVER SHEREEF M. ELNAHAL, MD, MBA Lt. Governor Commissioner September 13, 2018 Administrator Surgery Center, LLC 190 Midland Avenue Saddle Brook, NJ 07663 Re: Complaint Dear?z Thank you for your courtesy and cooperation extended during the complaint investigation conducted on September 7, 2018 by surveyors from the New Jersey Department of Health. Enclosed is the statement of deficiencies; please reply to each deficiency on an item-by-item basis with your Plan of Correction The must include: 1. How you will correct the specific findings cited for each deficiency. 2. What systemic changes will be implemented to ensure that each deficient practice does not recur. 3. How the facility will monitor its corrective actions to ensure that the deficient practice is being corrected and will not recur, is. what program will be put into place to monitor the continued effectiveness of the systemic changes. The plan must identify the individual responsible for monitoring, how and when the monitoring will be conducted, how long and how often monitoring will take place, what the goal is for compliance, and to whom the results will be reported. 4. The date on which each item addressed on the P00 will be corrected. Surgery Center, LLC September 13, 2018 Page 2 5. Do not reference and/or include attachments with your P00. 6. Do not include names of individuals in the P00. Use of titles is acceptable, such as, Administrator, Director of Nursing, Infection Control Practitioner, etc. Please be advised that the P00 will not be accepted for review by this office and will be returned to you if it contains reference to and/or attachments and/or names of individuals. All responses should be numbered to correspond with the number of your deficiency statements. Please sign and date the first page of the deficiency statement with your plan of correction. Return these forms to this office within ten (10) business days of receipt of this letter, to my attention. Any delay or lack of response may jeopardize the licensure of your facility. Please be advised that some or all of the deficiencies cited in the enclosed survey report may be referred to the Office of Program Compliance for imposition of enforcement remedies, including civil penalties. OPC will advise you, at a later date and under separate cover, of any enforcement actions and your appeal rights. Please do not hesitate to contact me, if you have any questions regarding the deficiencies at (609) 292-9900. Sincerely, SHCSE Survey and Certification Errol. (State of DEPARTMENT OF HEALTH PO BOX 367 TRENTON, NJ. 08625-0367 PHILIP D. MURPHY Governor SHEILA Y. OLIVER Lt. Governor SHEREEF M. ELNAHAL, MD. MBA Commissioner October 17, 2018 !!minislralor Surgery Center, LLC 190 Midland Avenue Saddle Brook, NJ 07663 Dear?: Thank you for the courtesy and cooperation extended during the State revisit survey of your facility on September 27, 2018 by surveyors from the New Jersey Department of Health. Enclosed is the revisit report which indicates that the deficiencies identified during the survey of September 7, 2018 were corrected. Should you have questions, please do not hesitate to contact me at (609) 292-9900. Sincerely, SHCSE Survey and Certification Encl.