Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on August 21, 2023, through August 25, 2023, Renal Care Group - Wynnewood Dialysis 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 August 21, 2023, through August 25, 2023, Renal Care Group - Wynnewood Dialysis 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 staff observations (OBS) in the treatment area, facility policy and procedure review, and an interview with the Facility Administrator, the facility failed to ensure hand hygiene and donning of new gloves during central venous catheter (CVC) exit site care for two (2) of two (2) observations (OBS # 1 and 3), during initiation of dialysis with a CVC for three (3) of three (3) observations (OBS # 1, 2, and 3), and during access of the AV (arterial venous) fistula or graft for initiation of dialysis for three (3) of three (3) observations (OBS #4, 5, and 6).
Findings include:
Review of facility policy titled "Central Venous Catheter Dressing Change" on August 25, 2023, at approximately 9:00 A.M. states, "Removal Of The Old Dressing: Action: 3. Perform hand hygiene. 4. Don gloves. 5. Inspect and remove old dressing... 7. Discard dressing and remove gloves. Perform hand hygiene. Cleaning The Catheter Exit Site: Action: 1. Perform hand hygiene and don clean gloves..."
Review of facility policy titled "Access Assessment and Cannulation" on August 25, 2023, at approximately 9:00 A.M. states, "Assessment of Vascular Access: 2. Wash hands and don PPE... 7. Feel: Pulse...Thrill... 9. Remove gloves and perform hand hygiene. Don new gloves... Skin Disinfection: 1. Disinfect cannulation site... Needle Placement Procedure: 1. Perform hand hygiene and don clean gloves... 5. Insert needle into previously prepped site..."
Review of facility policy titled "Hand Hygiene" on August 25, 2023, at approximately 9:00 A.M. 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... before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications... immediately after removing gloves... after contact with inanimate objects near the patient... when moving from a contaminated body site to a clean body site of the same patient."
Observation in the treatment area conducted on August 21, 2023, from approximately 9:45 A.M. to 12:00 P.M., and August 24, 2023, from 9:45 A.M. to 11:30 A.M. revealed the following:
OBS #1 on August 21, 2023, at approximately 11:27 A.M. at Station #23, PCT (patient care technician) #2 was observed completing CVC exit site care and did not perform hand hygiene and don new gloves prior to initiating dialysis with the CVC.
OBS #2 on August 21, 2023, at approximately 11:36 A.M. at Station #7, PCT #1 was observed completing CVC exit site care and did not perform hand hygiene and don new gloves prior to initiating dialysis with the CVC.
OBS #3 on August 21, 2023, at approximately 11:44 A.M. at Station #17, during CVC exit site care, RN #1 was observed performing hand hygiene and donning clean gloves, then taping a small bag for trash to the side of the dialysis chair. RN #1 removed the old CVC dressing and initiated cleaning of the CVC exit site without performing hand hygiene and donning new gloves. RN #1 was then observed initiating dialysis with the CVC without performing hand hygiene before donning new gloves. RN #1 did not perform hand hygiene before donning new gloves when the procedure was completed and before touching the dialysis machine.
OBS #4 on August 21, 2023, at approximately 10:13 A.M. at Station #2, PCT #3 was observed initiating dialysis with a vascular access. PCT #3 cleansed the skin, palpated the access site, and attempted to insert the needle without performing hand hygiene and donning new gloves after touching the patient's arm. PCT #3 was unsuccessful inserting the needle on the first attempt. PCT #3 removed the needle and applied a pressure bandage. At approximately 10:23 A.M. PCT #3 performed hand hygiene and donned new gloves, removed the pressure bandage, and inserted the needle without cleansing the site and performing hand hygiene and donning new gloves.
OBS #5 on August 21, 2023, at approximately 10:28 A.M. at Station #24, PCT #4 was observed initiating dialysis with a vascular access. PCT #4 cleansed the patient's arm, palpated the site, and inserted the needle without performing hand hygiene and donning new gloves after touching the patient's arm.
OBS #6 on August 21, 2023, at approximately 11:00 A.M. at Station #19, RN #1 was observed initiating dialysis with a vascular access. RN #1 performed hand hygiene and donned clean gloves, touched the dialysis machine, cleansed the patient's arm, palpated the site, and inserted the needles, without performing hand hygiene and donning new gloves after touching the dialysis machine and the patient's arm.
Interview with the Facility Administrator on August 24, 2023, at approximately 3:00 P.M. confirmed the above findings.
Plan of Correction:The Clinical Manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
Hand Hygiene
Hand Hygiene Procedure
Changing the Catheter Dressing Procedure
Initiation of Treatment Using a Central Venous Catheter and Optiflux® Single Use Ebeam Dialyzer
Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux® Single Use Ebeam Dialyzer
Access Assessment and Cannulation
Special emphasis will be placed on ensuring hand hygiene and glove changes in between tasks to prevent cross contamination.
This includes after removal of the old CVC dressing, prior to initiation of CVC exit site care, after CVC exit site care is performed and after touching contaminated surfaces. Ensuring staff adherence using aseptic technique and clean gloves are donned prior to access site skin disinfection and cannulation. The meeting will also review the importance of not touching
cannulation sites after skin disinfection and importance of performing hand hygiene any time gloves are removed, before donning
new gloves and in between contact with the hemodialysis machine, after touching patient's arm and before making the aseptic connection to prevent cross contamination.
The in-servicing of staff will be completed by 9/18/23, 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 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: 10/19/23
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 observations (OBS) and an interview with the facility staff, the facility failed to remove expired supplies from the emergency cart for one (1) of one (1) observations. (OBS # 1)
Findings include:
Observation of the equipment/ supplies within the facility's emergency cart was conducted on August 24, 2023, at approximately 2:00PM revealing:
OBS #1:
Twenty-one (21) B. Braun 24 hour Safe Day IV (intravenous) administration sets, 15 drops per ml (milliliter) expired May 31, 2023.
Five (5) Cardinal Health Transparent Dressing 4 x 4.75 inches expired July 31, 2023.
Four (4) Dora 15 G (gauge) x 25 fixed wing with back eye AV (arterio-venous) fistula needle set expired January 4, 2023.
An interview with the facility administrator on August 24, 2023, at approximately 3:00 P.M. confirmed the above the findings.
Plan of Correction:For immediate compliance, on 8/25/23 the expired supplies within the facility's emergency cart including the twenty one (21) B. Braun 24 hour Safe Day IV administration sets, five (5) cardinal health transparent dressing and four (4) Dora 15 G (gauge) x 25 fixed wing with back eye fistula needle set were discarded.
To ensure ongoing compliance, the Clinical Manager (CM) or designee will in-service all DPC staff on the following policies:
Storage of Supplies
Emergency Medications, Equipment and Supplies
The meeting will focus on ensuring that all supplies, including supplies stored in the emergency cart that are available for use are current and have not exceeded their expiration date. Facility will ensure the emergency cart will contain all the necessary equipment and supplies in the event of an emergency.
In servicing will be completed by 9/18/23. All training documentation is on file at the facility.
The CM or designee will perform weekly audits for 4 weeks. The Governing Body will determine on-going frequency of the
audits based on compliance. Once compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC specific 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: 10/19/23
494.80(a)(2) STANDARD
PA-ASSESS B/P, FLUID MANAGEMENT NEEDS
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
Blood pressure, and fluid management needs.
Observations:
Based upon review of policy, medical records (MR), and an interview with facility staff, it was determined that the dialysis facility failed to ensure in-center hemodialysis patient assessments, including blood pressures, were assessed and documented at minimum every 45 minutes, while on hemodialysis as per facility policy for four (4) of eight (8) in-center hemodialysis Medical Records reviewed (MR#1, 2, 3, and 5).
Findings include:
Review of facility policy titled " Patient Assessment and Monitoring " on August 24, 2023, at approximately 2:30 P.M. states, " During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations ... "
A review of MR conducted on August 22, 2023, from approximately 9:30 A.M. to 2:30 P.M. and August 23, 2023, from approximately 9:30 A.M. to 3:30 P.M. revealed the following:
MR#1, start of care June 16, 2023: Treatment records from August 2, 2023, through August 21, 2023, revealed the following:
August 18, 2023, between 11:30 A.M. and 12:18 P.M., 48 minutes between monitoring.
MR#2, start of care November 15, 2019: Treatment records from August 4, 2023, through August 21, 2023, revealed the following:
August 4, 2023, between 5:41 A.M. and 6:31 A.M., 50 minutes between monitoring.
August 14, 2023, between 6:37 A.M. and 7:29 A.M., 52 minutes between monitoring.
MR #3, start of care June 16, 2022: Treatment records from July 25, 2023, through August 19, 2023, revealed the following:
August 1, 2023, between 7:02 A.M. and 8:02 A.M., 60 minutes between monitoring.
MR#5, start of care March 23, 2015: Treatment records from August 4, 2023, through August 21, 2023, revealed the following:
August 4, 2023, between 12:01 P.M. and 1:05 P.M., 65 minutes between monitoring.
An interview with EMP#1 on 12/2/2022 at approximately 2:00 PM confirmed the above findings.
An interview with the facility administrator on August 24, 2023, at approximately 3:00 P.M. confirmed the above findings.
Plan of Correction:The Clinical Manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
Patient Assessment and Monitoring
Special emphasis will be placed on timeliness of monitoring and documentation of safety checks and vital signs including blood pressure and pulse rate. Ensuring patient monitoring and documentation is completed every 30 minutes or more as needed, not
exceeding 45 minutes.
The in-servicing of staff will be completed by 9/18/23, with documentation of the training on file at the facility.
The CM or designee will perform daily audits of 10% of patient treatment sheets utilizing a developed Plan of Correction Auditing tool to verify adherence to policy and procedure related to timeliness of patient monitoring for 2 weeks.
If compliance is noted, the audits will be completed 2 times/week for 2 weeks. 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: 10/19/23
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