Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on June 27, 2022 through June 30, 2022, Fresenius Medicare Care Greater Northeast, 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 conducted on June 27, 2022 through June 30, 2022, Fresenius Medical Care Greater Northeast, 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(a)(1) STANDARD
IC-WEAR GLOVES/HAND HYGIENE
Name - Component - 00
Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.
Observations:
Based upon observation, policy and procedure review, and an interview with the facility administrator, it was determined the facility failed to ensure hand hygiene and donning of new gloves during initiation of graft/fistula and preparation of the hemodialysis machine for one (1) of three (3) observations (Observations #3)
Findings include:
A review of policy "Hand Hygiene" was reviewed on 6/29/22 at approximately 1:00 PM and states, "Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content...Hands will be..Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water when...Before and after direct contact with patients, entering and leaving the treatment area, before performing any invasive procedure such as vascular access cannulation or administration of parenteral medication, immediately after removing gloves..., after contact with inanimate objects near the patient."
A review of policy "Access Assessment and Cannulation" was reviewed on 6/29/22 at approximately 1:00 PM and states, "Assessment of the Vascular Access, Ask...Look, Listen.. Feel...Remove gloves and perform hand hygiene. Don new gloves..."
Observation of the treatment area was conducted on 6/28/22 from approximately 9:40 AM through 12:05 PM.
Observation #3. On 6/28/22 at approximately 11:43 AM, Patient Care Tech (PCT) #3 at station 9, was observed assessing patient's access site. PCT then left patient's treatment area to use Myron Meter. PCT was then observed putting on new gloves without performing hand hygiene and touching patient's machine. PCT then left patient's area to change gloves again without performing hand hygiene. This was then repeated an additional three (3) times without performing hand hygiene. In addition, when PCT initiated treatment at station 9 the PCT then changed gloves again without performing hand hygiene and touched station 10's machine.
An interview with the facility administrator and director of operations on 6/29/22 at approximately 2:00 PM confirmed the above findings.
Plan of Correction:In-servicing will be completed by July 15, 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 improved compliance is observed the audits will then be completed 2 times/week for 2 weeks. If 100% compliance is maintained after the 2 weeks, the audits will be completed monthly following the QAI program. A POC specific auditing 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 for ongoing guidance and sustained compliance.
Completion date: August 5, 2022
494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.
Observations:
Based on a review of the daily machine disinfection log, facility policy and an interview with the biomedical technician and administrator, the facility failed to ensure that weekly Chemical Rinse (bleach) disinfection was performed according to the machine manufacturer guidelines and completed according to facility policy for eight (8) out of twenty-three (23) hemodialysis machines reviewed for the month of April 2022.
Review of facility policy was conducted on 6/29/22 at approximately 12:00 PM revealed, Policy "Hemodialysis Machines: Acid Clean, Chemical Rinse and Heat Disinfection" states, "Manufacturer's instructions for use must be followed. The following defines the minimum dialysis machine cleaning and disinfection requirements. The frequency and duration of system cleaning and disinfection will be scheduled to maintain microbiological contamination to conform with company policy and procedures....Chemical Rinse must be performed at a minimum of weekly (every 7 days)..."
A review of machine disinfection logs was conducted on 6/27/22 at approximately 1:30 PM.
The following eight (8) machines did not have a Chemical (bleach) rinse from 4/12/22-4/26/22 (total of 14 days) : 2TOS-114607, 111520, 115085, 115072, 115052, 114901, 114843, 114794.
An interview was conducted with the biomedical technician supervisor, facility administrator, and director of operations on 6/28/22 at approximatley 2 PM confirmed the above findings.
Plan of Correction:To ensure compliance, the CM or designee will re-educate all the DPC staff on:
- Hemodialysis Machines: Acid Clean, Chemical Rinse and Heat Disinfection
The meeting will review that all hemodialysis machines must be cleaned and disinfected internally per policy based on the Manufacturer's Instructions for Use. The meeting will also reinforce that documentation of the cleaning, chemical rinse and heat disinfection must be entered on the machine disinfection log upon completion.
In-servicing will be completed by July 15, 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 improved compliance is observed the audits will then be completed 2 times/week for 2 weeks. If 100% compliance is maintained after the 2 weeks, the audits will be completed monthly following the QAI program. A POC specific auditing 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 for ongoing guidance and sustained compliance.
Completion date: August 5, 2022
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