Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on April 29, 2023, Fresenius Kidney Care of Reading, 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 April 29, 2023, Fresenius Kidney Care of Reading, was identified to have the following standard level deficiencies and was 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:
494.30(a)(1)(i) STANDARD
IC-HBV-VACCINATE PTS/STAFF
Name - Component - 00
Hepatitis B Vaccination
Vaccinate all susceptible patients and staff members against hepatitis B.
Observations:
Based on personnel file review, policy and procedure review, and an interview with the administrator, it was determined the ESRD failed to determine Hepatitis B Susceptibility for staff for two (2) out of five (5) personnel files (PF) reviewed (PF#1 and PF#2.)
Findings include:
Review of policy "Employee Requirements For Testing and Vaccination For Hepatitis B" on 4/19/2023 states "...Prior to vaccine administration, draw the Hepatitis B antibody (anti-HBs) to determine susceptibility..."
Review of PF#1 (Date of Hire 10/19/2020) on 4/18/2023 at approximately 10:50 AM revealed no screening for Hepatitis B antibodies to determine susceptibility.
Review of PF#2 (Date of Hire 9/20/2021) on 4/18/2023 at approximately 11:15 AM revealed no screening for Hepatitis B antibodies to determine susceptibility.
An interview with the facility administrator on 4/19/2023 at approximately 3:15 PM confirmed the above findings.
Plan of Correction:
V 126
For ongoing compliance all employees' files will be reviewed for their Hepatitis status.
Staff who are noted to be susceptible will be re-offered the Hepatitis B vaccine. If they refuse, a declination will be signed and placed in their employee file. The audit of the employee files will be completed by May 12, 2023.
The Director of Operations (DO) or designee re-educated the CM on the following policy:
- Employee Requirements for Testing and Vaccination for Hepatitis B
Emphasis will be placed on ensuring that all new employees are offered the Hepatitis B vaccination upon hire. If the staff consents to the vaccination, a Hepatitis B antibody should be drawn if the staff are not able to show previous Hepatitis B results. It the employee refuses the vaccination or has antibodies > 10, a declination will be signed and placed in their employee file.
The in-servicing by the DO will be completed by May 10, 2023, with documentation of the training on file at the facility.
The CM or designee will perform Hepatitis B audits of all newly hired staff within two weeks of the start date. The CM will report the findings of the new hire audit at the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A plan of correction (POC) audit tool will be used for the audits.
Issues of non-compliance will be re-education and counseling by the DO.
Sustained compliance will be monitored by the QAPI committee.
Completion Date: June 14, 2023
494.30(b)(1) STANDARD
IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P
Name - Component - 00
The facility must-
(1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit;
Observations:
Based upon review of ESRD infection control audits, policy and procedure review, and an interview with the facility administrator, it was determined the ESRD failed to ensure infection control practice monitoring for in-center hemodialysis for six (6) out of six (6) months of ESRD infection control audits reviewed (October 2022-March 2023).
Findings include:
Review of Policy "Quality Assessment and Performance Improvement Program" on 3/19/2023 at approximately 2:00 PM states "...elements to be reviewed will include...infection surveillance...an effective and successful review of the QAPI meeting and program activities will include:...review of the results of required self audits...."
Review of the ESRD's infection control audit checklists on 4/19/2023 at approximately 10:45 AM revealed no documentation of incenter hemodialysis infection control practice monitoring between October 2022-March 2023.
An interview with the facility administator on 4/19/2023 at approximately 3:15 PM confirmed the above findings.
Plan of Correction:V 142
To ensure compliance the DO or designee will in-service the Interdisciplinary Team (IDT) members on policy:
- Quality Assessment and Performance Improvement Program
The meeting will focus on ensuring that the Quality Assessment and Performance Improvement (QAPI) committee follows the schedule for the completion of all workbook audits. This includes the monthly infection control (IC) practice monitoring with documentation in the QAPI workbook. The importance of review and trending of the IC audits will also be covered in the meeting.
The inservice will be completed by May 10, 2023, and the education records will be on file in the facility.
The DO or designee will perform monthly QAPI audits for four (4) months. At that time if compliance is observed, the audits will then be completed per the QAPI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The DO will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: June 14, 2022
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based upon Personnel File (PF) review, ESRD policy and procedure review, and an interview with the ESRD administrator, it was determined the Medical Director failed to ensure Employee Tuberculosis Testing was conducted according to ESRD policy for two (2) out of five (5) PF's reviewed (PF#1 and PF#2).
Review of ESRD policy "Employee Tuberculosis Testing" on 4/19/2023 at approximately 2:00 PM states "...TB testing using the two-step tuberculin skin test (TST) method is required upon hire."
Review of PF#1 (Date of Hire 10/19/2020) on 4/18/2023 at approximately 10:50 AM revealed no documentation of a two-step tuberculin skin test (TST) screening (PF contained a one-step tuberculin skin test (TST) screening).
Review of PF#2 (Date of Hire 9/20/2021) on 4/18/2023 at approximately 11:15 AM revealed no documentation of a two-step tuberculin skin test (TST) screening.
An interview with the facility administrator on 4/19/2023 at approximately 3:15 PM confirmed the above findings.
Plan of Correction:V 715
For ongoing compliance all employees' files will be reviewed for their tuberculosis status. If their medical record does not have evidence of a two-step PPD completed upon hire, a two-step PPD will be administered. Documentation of the PPD test with the results will be available in the employees' personnel file. The audit of the employee files will be completed by May 12, 2023.
By May 10, 2023, the DO and the CM will meet with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the following policy:
- Employee Tuberculosis Testing
The Medical Director will be informed at the meeting with the DO and CM that the CM has received re-education of the above policy with the focus on the importance of ensuring that all new employees receive a two-step tuberculin skin test upon hire. The training will also review the importance of ensuring that there is documentation of the testing in the employee's personnel file.
The inservice will be completed by May 10, 2023, with documentation on file at the facility.
The CM or designee will perform audits of all newly hired staff within two weeks of the start date. The CM will report the findings of the new hire TB audit at the monthly QAPI schedule. A POC audit tool will be used for the audits. Issues of non-compliance will be re-education and counseling by the DO.
Sustained compliance will be monitored by the QAPI committee.
Completion Date: June 14, 2023
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