Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed from December 14, 2021 to December 17, 2021, Fresenius Medical Care-Logan, 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 from December 14, 2021 to December 17, 2021, Fresenius Medical Care-Logan, was found NOT to be in compliance with the following requirement 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:
494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT
Name - Component - 00
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.
Observations:
Based on an observational tour, and interview with the Administrator the facility did not monitor a sanitary environment to minimize the transmission of infectious agents.
Findings include:
On December 14, 2021 at approximately 10:00 a.m., observation in Supply Room #2, revealed following expired stored items:
- Nine, (9), BD 60 ml syringe, Luer-Lok tip Lot#4181564, expired 6/2019.
2, One, (1), box of 40 BD 60 ml Syringes, Luer-Lok tip Lot#5162777, expired 6/2020.
-Twenty, (20), Disposable Monofilament, (test diabetic foot screens), Lot# P111GS expired 11/15/2021.
-Twenty, (20), Disposable Monofilament, (test diabetic foot screens), Lot# Q0815GS expired 8/15/2020.
On December 14, 2021 at approximately 10:45 a.m., observation on Emergency Cart #1, drawer #3, revealed following expired stored items:
-Twenty (20), 18 G needles, Lot# 6114584, expired 5/31/21.
-Fourteen, (14), Sodium Chloride 10 ml syringes for injection, Lot# 8074714, expired 3/31/2021.
On December 14, 2021 at approximately 10:50 a.m., observation on Emergency Cart #2, drawer #3, revealed following expired stored items:
-One, (1), 14fr Urethral Catheter, lot 6348R21QX, expired on 12/12/2021.
-One, (1), B. Braun IV administration Set Lot# 0061611759, expired 2/28/2021.
On December 15, 2021, in an interview with the Administrator the above findings were confirmed .
Plan of Correction:For immediate compliance all expired items found at the time of the survey were removed and discarded on 12/14/2021 by the bio-medical technician (BMT).
For ongoing compliance, the Clinic Manager (CM) will in-service all direct patient care (DPC) staff on the following policy:
- Storage of Supplies
- Emergency Cart Checklist
Emphasis will be placed on ensuring that all supplies, including those stored in the emergency cart and storeroom, are all within the current date for use. The meeting reviewed that supplies must be rotated First In – First Out when restocking.
The inservice was completed by 12/17/2021 and the education records will be on file in the facility.
The CM and/or designee will conduct daily audits for two (2) weeks. If one hundred percent (100%) compliance is observed, then audits will continue weekly x 2 weeks. If compliance has been sustained audits will continue monthly per Quality Assessment Improvement (QAI) program. A Plan of Correction (POC) specific audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion date: 1/31/2022
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