Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on June 5, 2023, through June 7, 2023, Fresenius Medical Care Abramson 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 5, 2023 through June 7, 2023, Fresenius Medical Care Abramson 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 on review of facility policy, observation (OBS) of treatments performed, and an interview with the acting Clinical Manager, the facility did not ensure that patient care staff remove gloves and performed hand hygiene during accessing of AV fistula for two (2) of three (3) observations (OBS #7 and 8) and during discontinuation of dialysis with an AV fistula for one (1) of two (2) OBS (OBS #10).
Findings include:
A review of facility policy on June 7, 2023, at approximately 1:30 P.M. revealed the following:
Policy #47806 titled "Access Assessment and Cannulation" states, "Assessment of Vascular Access: Prior to treatment, ask the patient to wash access area with soap per hand hygiene procedure. Wash access (per above) if patients unable to clean their access. Wash hands and don PPE... Look... Listen... Feel... Remove gloves and perform hand hygiene. Don new gloves... Perform skin antisepsis on one side at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection... Perform hand hygiene and don new gloves... Insert needle into previously prepped site... Remove gloves. Perform hand hygiene."
Policy # 47664 titled "Hand Hygiene" states, " Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water 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 medications, immediately after removing gloves, after contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled, after contact with inanimate objects near the patient, when moving from a contaminated body site to a clean body site of the same patient, after contact with the dialysis wall box, concentrate, drain or water lines. "
Observation of the treatment area was conducted on June 5, 2023, from approximately 9:15 A.M. to 11:30 A.M. revealed the following:
OBS #10, Station #5 at approximately 9:40 A.M., during discontinuation of dialysis with an AV fistula. Patient Care Technician (PCT) #1 performed hand hygiene and donned gloves, reinfused the extracorporeal circuit and discontinued the blood lines, then removed the needles without performing the required glove change and hand hygiene. The remainder of the procedure was completed by another staff member.
PCT #1 was observed from 9:41 A.M. to 9:55 A.M. as follows: Hand hygiene and donned gloves. Touched dialysis machine at Station #5, set up supplies for discontinuation of dialysis, then touched dialysis machine again. PCT #1 performed hand hygiene and glove change, left the station to attend to another patient. Upon return PCT #1 performed hand hygiene and donned gloves, touched the dialysis machine, and removed the access lines without performing hand hygiene and glove change.
OBS #7, Station #5 at approximately 10:39 A.M., during initiation of dialysis with an AV fistula. PCT #1 performed hand hygiene and donned gloves, cleansed the access site, palpated the cannulation sites, applied antiseptic to the cannulation sites, and inserted the cannulas without performing the required glove changes and hand hygiene during the procedure.
OBS #8, Station #6 at approximately 11:00 A.M., during initiation of dialysis with an AV fistula, PCT #1 performed hand hygiene and donned gloves, cleansed the access site, palpated the cannulation sites, applied antiseptic to the cannulation sites, and inserted the cannulas without performing the required glove changes and hand hygiene during the procedure.
An interview with the acting Clinic Manager on June 7, 2023, at approximately 2:00 P.M. confirmed the above findings.
Plan of Correction:V113
To ensure compliance, the Clinic Manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
- Access Assessment and Cannulation
- Hand Hygiene
Special emphasis will be placed on ensuring that hand hygiene is always performed per policy. This includes after disconnecting the bloodlines and prior to removing the patient's needles. The in-service also reviewed the importance of ensuring that hand hygiene is per policy during access evaluation, cannulation and treatment initiation.
The in-servicing will be completed by June 21, 2023, with documentation of the training on file at the facility.
The CM or designee will perform daily audits on the DPC staff 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: July 28, 2023
494.30(a)(1)(i) STANDARD
IC-IF TO STATION=DISP/DEDICATE OR DISINFECT
Name - Component - 00
Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient.
-- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient.
-- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient's station should be used only for that patient and should not be returned to a common clean area or used on other patients.
Observations:
Based on observations (OBS), review of facility policy, and an interview with the acting Clinic Manger, it was determined the facility failed to ensure that the dialysis station was vacated and disinfected before supplies for another patient were brought to the station for two (2) of nineteen (19) observations made. (OBS #14 and 18).
Findings include:
Review policy of titled " Cleaning and Disinfecting the Dialysis Station " on June 7, 2023, at approximately 2:00 PM states, " Vacating the Machine: To prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection of the station and set up for the next patient. "
Observation in the clinic area on June 5, 2023, from approximately 9:15 A.M. to 11:30 A.M. revealed the following:
OBS #14, Station #5 at approximately 9:45 A.M., while the patient #1 was still in the dialysis chair, PCT #1 was observed partially cleaning the dialysis machine, bringing clean supplies for the next patient to the station and placing the supplies on top of the machine.
OBS #18, Station #7 at approximately 11:15 A.M., while patient #2 was still in the dialysis chair, PCT #1 was observed cleaning the dialysis machine, bringing clean supplies for the next patient to the dialysis station, and placing supplies on top of the machine. After patient #2 left the dialysis station, PCT #1 began setting up the dialysis circuit for the next patient before cleaning the dialysis chair, blood pressure cuff, and other equipment present in the dialysis station.
An interview with the acting Clinic Manager on June 7, 2023, at approximately 2:00 PM confirmed the above findings.
Plan of Correction:V 116
To ensure compliance, the CM or designee re-educated all the DPC staff on the following policy:
- Cleaning and Disinfecting the Dialysis Station
Special emphasis will be placed on ensuring that the dialysis station, including the machine and other items such as the blood pressure (BP) cuff, must not be cleaned or disinfected prior to the patient exiting the dialysis station. The meeting also reviewed that clean supplies may not be brought into the station until it has been cleaned and disinfected after the patient leaves.
The in-servicing will be completed by June 21, 2023, with documentation of the training on file at the facility.
The CM or designee will perform daily audits on the DPC staff 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 QAI 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: July 28, 2023
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