Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on 5/3/24, DCI Renal Care Group of Pittsburgh was found to be in compliance with the requirements of 42 CFR, Part 494.62 Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on 5/3/24, DCI Renal Care Group of Pittsburgh was found to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.70(a)(12) STANDARD
PR-RECEIVE SERVICES OUTLINED IN POC
Name - Component - 00
The patient has the right to-
(12) Receive the necessary services outlined in the patient plan of care described in §494.90;
Observations:
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.
Plan of Correction:1. All clinical staff will be retrained by the Nurse Manager or Designee by 5/31/2024 on the facility's "Policy 501: Administration and Use Of Intravenous Heparin" with emphasis on ensuring the proper dose of 1:1000 Heparin to be given during the treatment is properly labeled and infusing at the ordered physician's rate. This should be confirmed by ensuring the Heparin pump is on (the Heparin tab on the screen will be green on the machine) and this can also be documented in Darwin Direct by checking the box that the Heparin Pump is "On." This will be verified at the beginning of the treatment when a Licensed Professional verifies the dialysis prescription in Darwin Direct. The amount of heparin administered will be documented at the end of the treatment
2. Nurse Manager or Designee will ensure that all clinical staff review and sign acknowledgement of understanding of policies. Upon completion of training and understanding of policies, acknowledgement will be placed in facility's education manual or each employee's personnel file.
3. Staff signed the acknowledgement of understanding of this policy and process on May 1st, 2024. Everything was presented to DOH Surveyor the following morning and prior to the Exit Interview to show that we have already started the process for correcting this problem.
4. Initially, Nurse Manager and/or Nurse Educator will audit each flow sheet where Heparin was used on a daily basis for two (2) weeks to ensure that staff are properly initiating Heparin according to the policy at the start of the treatment and the physician orders. If the standards are met, the staff will be observed weekly for two (2) weeks to ensure that the staff are properly initiating Heparin and verifying that the Heparin is on at the start of the treatment. If the standards are met, the staff will be observed monthly for three (3) months. If those standards are met, the staff will be observed quarterly for two (2) quarters. All audit results will be reviewed at monthly QAPI meetings.
494.110(b) STANDARD
QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE
Name - Component - 00
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.
Observations:
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.
Plan of Correction:1. All members of the IDT Team will be review the facility's "Policy 800: Quality Assessment Performance Improvement (QAPI)" with emphasis on ensuring the facility measures, analyzes, and tracks quality indicators throughout each month then discuss whether they are met or not met during the QAPI meeting. If not met, there must be evidenced that a root cause analysis was performed on the outlier, reviewed, and discussed with the Medical Director during the meeting. This all will be documented in the QAPI Meeting Minutes.
2. Specifically, Hospitalization/Mortality Rates were reviewed for the months of October 2023 to December 2023 with one (1) Death in October and one (1) in November. Both months lacked documentation and lacked evidence that a root cause analysis was performed.
3. Moving forward, we will discuss in detail the Hospitalization/Mortality Rates each month. If there are no deaths, this will be documented in our monthly QAPI Meeting Minutes. If there is a death or multiple deaths in the month, then a root cause analysis will be performed by the Nurse Manager to determine if it is dialysis related. The finding will be presented during our QAPI Meeting and documented in our monthly QAPI Meeting Minutes.
4. In addition to the above, the Nurse Manager and/or Nurse Educator will audit the QAPI Meeting Minutes monthly for the next twelve (12) months to ensure that all deaths even if there are none for the month are reviewed, investigated, discussed, and documented on each month.
494.150(c)(1) STANDARD
MD RESP-DEVELOP, REVIEW & APPROVE P&P
Name - Component - 00
The medical director must-
(1) Participate in the development, periodic review and approval of a "patient care policies and procedures manual" for the facility;
Observations:
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 ] 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 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.
Plan of Correction:1. All clinical staff will be retrained by the Nurse Manager or Designee by 5/31/2024 on the facility's "Policy 500: Use of Multiple Dose Vials" with emphasis on ensuring that when a multi-dose vial has been opened, the vial should be dated, initialed, and discarded within 28 days unless the manufacturer's guidelines specifies a shorter or longer date.
2. Policy 500: Use of Multiple Dose Vials was updated on May 6th, 2024 reflecting the change from 30 days to 28 days. The policy was presented, reviewed, and adopted by Governing Body on Thursday, May 16th, 2024, which is reflected in the Governing Body Minutes.
3. Nurse Manager or Designee will ensure that all clinical staff review and sign acknowledgement of understanding the policies. In addition to the policy, we will place a white/dry erase board on the medication refrigerator labeled "Multi-dose Medication Expiration Log." This list has some of the most common medications with the how many days the medication is viable along with the 1st date the vial was opened and the date the vial expires. This is an additional step to labeling the vial itself. Upon completion of training and understanding of policies, acknowledgement will be placed in facility's education manual or each employee's personnel file.
4. Initially, Nurse Manager and/or Charge Nurse/RN will observe and initial the white board weekly on a Friday prior to the next week to ensure all multi-dose vials are properly disposed of on or prior to the expiration date. The Nurse Manager or Designee will audit the white board to ensure multi-dose vials are properly disposed of weekly for two (2) weeks then monthly for two (2) months. If the standards are met, the white board will be observed quarterly for one (1) month to ensure that multi-dose policies are disposed of per CDC and manufacturer recommendations. All audit results will be reviewed at monthly QAPI meetings.
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