Initial Comments:
Based on the findings of an onsite unannounced recertification survey conducted on September 19, 2022 through September 21, 2022, BMA of Northeastern Philadelphia 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 recertification survey conducted on September 19, 2022 through September 21, 2022, BMA of Northeastern Philadelphia was identified 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:
494.30 STANDARD
IC-SANITARY ENVIRONMENT
Name - Component - 00
The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.
Observations:
Based on observations (OBS) of the in-center dialysis area and an interview with the clinical manager, the facility failed to remove expired medications and supplies from the medication cart located next to the nurses' station and failed to maintain a clean medication refrigerator for two (2) of two (2) observations: OBS #1 and OBS #2.
Findings include:
OBS #1 of the in-center medication refrigerator conducted on September 19, 2022 from 10:00 AM until approximately 10:15 AM found several pieces of black debris located at the bottom of the medication refrigerator, below the last shelf.
OBS #2 of the in-center medication cart located next to the nurses' station conducted on September 19, 2022 from 10:50 AM until approximately 11:20 AM found the following expired medications and supplies: Jamar Disposable Monofilament LOPS (foot screening tool used to test sensation), Quantity = 19, LOT #Q0815GS, had an expiration date of 08/15/2020; Lokelma (Sodium Zirconium Cyclosilicate) for Oral Suspension (used for treating high potassium levels), Quantity = 8 packets, LOT #W0400024A, had an expiration date of 05/31/2022; Nitrostat (used to relieve chest pain), 100 Tablet bottle, LOT #AG6080, had an expiration date of 06/30/2021; Becton-Dickinson Safety-Lok 1 ml syringes, Quantity = 14 syringes, LOT#7090828, had an expiration date of 06/30/2022.
An interview with the director of operations, clinical manager and education coordinator conducted on September 21, 2022 starting at 12:15 PM confirmed the above findings.
Plan of Correction:For immediate compliance all expired items found at the time of the survey were removed and discarded on September 21, 2022, by the clinic manager (CM). The black debris found in the in-center medication refrigerator was removed and the refrigerator was cleaned.
For ongoing compliance, the CM or designee will in-service all DPC staff on the following policy:
- Expiration Dates Sterile Supplies
Emphasis will be placed on ensuring that all medications and supplies, including Jamar Monofilament foot screening tools, Lokelma, Nitrostat, and syringes, are all within the current date for use. The meeting reviewed that medications and supplies must be within a current date for expiration. The meeting will also review that stock must be rotated First In – First Out when restocking. The meeting will reinforce that staff must check the expiration date of medications and supplies before using them.
The inservice will be completed by September 29, 2022, and the education records will be on file in the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A Plan of Correction (POC) audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM 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: October 28, 2022
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 on observations occurring on September 19, 2022, September 20, 2022 and September 21, 2022, a review of infection control policies, and an interview with the clinical manager, the facility staff did not adhere to infection control practices by failing to perform COVID-19 screenings for visitors upon entry to the facility for three (3) of three (3) observations occurring on September 19, 2022, September 20, 2022 and September 21, 2022: OBS #1, OBS #2, and OBS #3.
Findings include:
A review of CMS memo QSO-20-36-ESRD on September 21, 2022 at 3:00 PM states:
"Visitor Screening: Facilities should encourage visitors to be aware of signs and symptoms consistent with COVID-19 and not enter the facility if they have such signs and symptoms. Screen all visitors entering the healthcare facility for symptoms consistent with COVID-19 or exposure to others with SARS-CoV-2 infection ..."
A review, on September 21, 2022 at approximately 11:00 AM, of Fresenius Kidney Care (FKC) Policy Titled "Guidance on Dialyzing and Infection Control Practices During a COVID-19 Endemic in FKC Dialysis Clinics (Reference Number: 64147, Published 06/09/2022), Section on Patient, Visitor, Staff, Physician and Physician Extender Screening (page 5) states "Regardless of COVID-19 vaccination and/or booster status, all patients, visitors, staff, physicians, and physician extenders entering an FKC dialysis clinic must be screened for ongoing signs and symptoms of COVID-19 disease."
Observation #1 occurred on September 19, 2022 whereby two (2) Department of Health (DOH) Health Care Nurse (HCN) Surveyors entered the lobby of clinic, found no personnel at the reception area, knocked on the door to the treatment area (Door #1) and were greeted by a FKC clinic employee who released a lock to a second door (Door #2) leading to the inside of the clinic. Both HCN Surveyors were permitted to enter through Door #2 without any COVID-19 screening being conducted before or after entry through Door #2, nor throughout anytime of the day while the HCN Surveyors were on site.
Observation #2 occurred on September 20, 2022 whereby two (2) DOH Health Care Nurse (HCN) Surveyors entered the lobby of clinic and knocked on the door leading to the inside of the clinic (Door #2). Door #2 was opened by a FKC clinic employee. Both HCN Surveyors were permitted to enter through Door #2 without any COVID-19 screening being conducted before or after entry through Door #2, nor throughout anytime of the day while the HCN Surveyors were on site.
Observation #3 occurred on September 21, 2022 whereby two (2) DOH Health Care Nurse (HCN) Surveyors entered the lobby of clinic and knocked on the door leading to the inside of the clinic (Door #2). Door #2 was opened by a FKC clinic employee. Both HCN Surveyors were permitted to enter through Door #2 without any COVID-19 screening being conducted before or after entry through Door #2, nor throughout anytime of the day while the HCN Surveyors were on site.
An interview with the Director of Operations, Clinical Manager and Education Coordinator conducted on September 21, 2022 starting at 12:15 PM confirmed the above findings.
Plan of Correction:For ongoing compliance, the CM or designee re-educated all the DPC staff on the following policy:
- Guidance on Dialyzing and Infection Control Practices During a Covid-19 Endemic in FKC Dialysis Clinics
The meeting reinforced the importance of ensuring that all staff, physicians, physician extenders, patients, and visitors, including any surveyors, are screened for covid upon entering the facility per policy. Documentation of the screening must be recorded on the Covid Screening tool.
The in-servicing of staff will be completed by September 29, 2022. Documentation of the training will be on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly 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 CM 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: October 28, 2022
|