Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on September 27, 2022 through September 30, 2022, Fresenius Medical Care at Nazareth 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 September 27, 2022 through September 30, 2022, Fresenius Medical Care at Nazareth 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 supplies from the emergency box and failed to maintain a clean area designated only for clean and unused equipment and supplies, and medications for two (2) of two (2) observations.
Findings include:
Observation #1, conducted on September 27, 2022 at approximately 10:40 AM, of a counter area in the in-center treatment area, located across from Stations 4 and 5, found that there was a broken drawer front sitting on a counter that was designated and labeled as a clean area. The first drawer below the counter was without a drawer front.
Observation #2, conducted in the in-center treatment area on September 27, 2022 at approximately 1:00 PM found the following expired supply in the emergency box: 2 boxes of non-woven sterile 4x4 sponges, lot #76567, with a use by date of 03/2022.
An interview with the director of operations and the clinical manager conducted on September 30, 2022 starting at 11:30 AM confirmed the above findings.
Plan of Correction:V 111
For immediate compliance all expired supplies found at the time of the survey were removed and discarded on September 30, 2022, by the Clinic Manager (CM). At the same time, the biomedical technician (BMT) contacted a repair person to have the broken drawer repaired.
For ongoing compliance, the CM or designee will in-service all direct patient care (DPC) staff on the following policy:
- Expiration Dates Sterile Supplies
Emphasis will be placed on ensuring that all medications and supplies, including sterile 4x4's, are all within the current date for use. The meeting reviewed that medications and supplies must follow the manufacture's direction for use (MDU) and 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 meeting also reviewed that the BMT and CM must be notified when any part of the physical plant needs repair.
The in-servicing of staff will be completed by October 7, 2022, with documentation of the training on file at 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 Performance and 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: November 8. 2022
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 observations (OBS) of the clinical area, facility policies, and an interview with the clinical manager, the facility failed to follow its policy regarding donning (putting on) and doffing (taking off) gloves, and hand hygiene during the dialysis procedure for three (3) of fifteen (15) observations. OBS#1, OBS#2, and OBS#3.
Findings include:
On September 30, 2022 at 10:30 AM, a review of Facility Policy, " Changing the Catheter Dressing Procedure, " Reference Number 45664, Published 05/02/022 states: " ...Perform hand hygiene, don clean gloves, inspect and remove the old dressing, discard dressing, and remove gloves. Perform hand hygiene. "
On September 30, 2022 at 10:35 AM, a review of Facility Policy, " Initiation and Termination of Treatment Using a Central Venous Catheter (CVC), " Reference Number 47265, Published 07/05/2022 states, " Hand hygiene must be performed per policy: " Hand Hygiene " to prevent transmission of pathogenic microorganisms. Aseptic technique must be followed to prevent infection. "
On September 30, 2022 at 10:40 AM, a review of Facility Policy, " Access Assessment and Cannulation, " Reference number 45178, Published 07/05/2022 states, " Prior to treatment ...wash hands and don PPE: gloves ....,listen for bruit ...., clean stethoscope after assessing a patient ....., remove gloves and perform hand hygiene. Don new gloves. "
On September 30, 2022 at 10:45 AM, a review of Facility Policy, " Hand Hygiene, " Reference Number 47664, Published 11/04/2019 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. "
On September 30, 2022 at 10:50 AM, a review of Facility Policy, " Hand Hygiene Procedure, Reference Number 47665, Published 09/26/2018 states, " If gloves are worn, remove and discard in appropriate waste contained. Expose the skin for decontamination. Apply alcohol-based hand rub to the palm of one hand .... "
Observation (OBS) of the treatment area was conducted on September 27, 2022 from 9:00 AM to approximately 1:30 PM.
OBS#1 Station #15: Prior to initiation of dialysis with a central venous catheter, PF#4 connected syringes to the central venous catheter ports, then removed and replaced gloves without performing hand hygiene, touched the computer screen, removed the syringes, and connected the blood lines without changing gloves.
OBS#2 Station #15: In preparation for central venous catheter exit site care, after removing and discarding the central line dressing, PF#4 changed gloves without performing hand hygiene, then proceeded to clean the central venous catheter exit site.
OBS#3 Station #14: In preparation for accessing an arteriovenous (AV) fistula for initiation of dialysis, PF#4 performed hand hygiene, donned new gloves, reached underneath his/her gown and pulled out a stethoscope to evaluate the AV fistula, returned the stethoscope to beneath his/her gown, and then proceeded to insert the cannulation needles into the fistula without changing gloves and performing hand hygiene. The stethoscope was not cleansed prior to use on the patient.
An interview with the director of operations and clinical manager on September 30, 2022 starting at 11:30 AM confirmed the above findings.
Plan of Correction:The CM or designee re-educated all the direct patient care (DPC) staff on the following policy:
- Changing the Catheter Dressing Procedure
- Initiation and Termination of Treatment Using a Central Venous Catheter (CVC)
- Access Assessment and Cannulation
- Hand Hygiene
- Hand Hygiene Procedure
Special emphasis will be placed on ensuring that hand hygiene is performed per policy at all times. This includes any time gloves are removed, after touching inanimate objects such as computer screens and syringes, after removing the CVC dressing and discarding the dressing and before cleaning the CVC exit site. The meeting will also review the importance of cleaning and disinfection of stethoscopes and performing hand hygiene after listening to the fistula/graft site prior to cannulation.
The in-servicing of staff will be completed by October 7, 2022, with documentation of the training 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: November 8, 2022
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