Dci North Versailles

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 46886 Based on interviews with staff (EMP), medical record reviews (MR), and patient care observations (OBS) the facility failed to provide medications as described in the plan of care for one (1) of five (5) prescription verification observations. (OBS4) Findings included: During a dialysis prescription verification observation (OBS4) for MR5 conducted on 5/1/24 at approximately 11:45 am with EMP1 (Clinical Manager) it was noted that 1000 units/hour of heparin were to be infusing as listed on the dialysis prescription but the patient did not have a heparin infusion running. A review of MR5 ’ s 5/1/24 Hemodialysis Flowsheet on 5/1/24 at approximately 3:00 pm revealed a treatment plan which included an hourly infusion of 1000 units of heparin (blood thinner) during dialysis. The patient ’ s treatment start time was listed as 10:25 am. As of OBS4 at 11:45 am the patient failed to receive approximately 1000 units of hourly heparin as per the treatment plan. The above finding was reviewed with EMP1 (Clinical Manager) and EMP2 (Administrator) during an interview on 5/1/24 at approximately 3:00 pm.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 46886 Based on a review of the facility quality assessment and improvement program meeting minutes (QA), discharge summary checklists, and an interview with the clinical manager, the facility did not review and evaluate the root causes of patient mortality, then develop an improvement plan for two (2) of four (4) QAs reviewed. (QAs 1 and 2) Findings include: A 5/3/24 review of agency policy titled Quality Assessment and Performance Improvement (QAPI) revealed: “ Policy ...The dialysis facility must measure, analyze, and track quality indicators ...The following list represents the minimum elements required by CMS and DCI to be reported/tracked ...Deaths ...” A review of the QAPI program meeting minutes from October 2023 to December 2023 (QAs) was conducted on 5/3/24 at approximately 1:00 pm with EMP1, Clinical Manager. Two patient deaths were noted within the period reviewed. QA1: Meeting minutes dated 11/16/23 read: “ ...Hospitalizations/Mortality rate ...Mortality rate ...1 CTB this month. One patient death was reported in the meeting minutes but no evidence of a patient mortality root cause analysis. QA2: Meeting Minutes dated 12/21/23 which reviewed November data read: “ ...Hospitalizations/Mortality Rates ...Mortality rate ...1 CTB this month. EMP1 presented surveyor with Discharge Summary Checklist noting a patient death with a discharge date of 11/7/23. One patient death was reported in the meeting minutes but no evidence of a patient mortality root cause analysis was noted review within meeting minutes. Lack of evidence to support that QAPI program reviewed patient mortality root cause was reviewed with the clinical manager, EMP1, on 5/3/24 at approximately 1:00 pm.”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 46886 Based on interviews with staff (EMP), medical record reviews (MR), reviews of policies and on site observations (OBS), the facility failed to maintain a medication procedure which was up to date with the current standard of practice for one (1) of five (5) MRs reviewed. (MR5) Findings included: A review of CDC recommendations for Injection Safety and Multi-dose Vials on 5/3/24 at approximately 4:30 pm revealed: “Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. In addition, the United States Pharmacopeia (USP) General Chapter 797 [16 <https://www.cdc.gov/injectionsafety/providers/references.html>] recommends the following for multi-dose vials of sterile pharmaceuticals: If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Refer to package insert and/or manufacturer expiration date to determine the beyond-use-date. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used ... “ Source: CDC website <https://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html> Last Reviewed: June 20, 2019 During a medication preparation observation of injectable heparin (OBS1) for MR5 conducted on 5/1/24 at approximately 11:45 am EMP1 (Clinical Manager) stated that multi-dose medication vials were to be discarded within “ 30 days “ of the date opened. A review of facility policy titled Procedure No: 500 ...Use of Multiple dose Vials on 5/1/24 at approximately 4:00 pm revealed: “ Policy ...2. When a multi-dose vial has been opened ...the vial should be dated, initialed and discarded within 30 days, unless the manufacturer specifies a shorter date for that opened vial ... “ A review of the package insert for Heparin Sodium on 5/3/24 at approximately 10:30 am revealed no specified beyond use date, therefore per CDC guidelines the vial should be discarded 28 days after opening. The current facility procedure of discarding multi-dose heparin sodium at 30 days after opening does not comply with the CDC guidelines for Injection Safety and Multi-dose vials. The finding was reviewed with EMP1 (Clinical Manager) and EMP2 (Administrator) on 5/1/24 at approximately 3:00 pm.”