Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed on June4, 2025, DCI Renal Services of Pittsburgh, LLC 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 June 4, 2025, DCI Renal Services of Pittsburgh, Llc was found not to be in 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. As a result of the survey, one (1) Conditions for Coverage, and 1 standard level deficiencies were cited.
Plan of Correction:
494.100 CONDITION
CFC-CARE AT HOME
Name - Component - 00
Observations:
Based on direct observations (OBS), review of Centers for Medicare and Medicaid Services end-stage renal disease, review of facility policy/procedure, review of medical records (MR) and an interview with the clinic nurse manager and home therapy nurse manager it was determined that the clinical staff failed to demonstrate compliance with facility policy/procedure for the testing of "Product water used to prepare dialysate or concentrates from powder at a dialysis facility..." The facility must meet testing and other requirements of ANSI/AAMI RD52:2004... to ensure that the water and dialysate are within the AAMI limits (V595).
This CONDITION is not met as evidenced under the following standards:
(Cross Reference)
The facility failed to demonstrate compliance with Centers for Medicare and Medicaid Services end-stage renal disease and facility policy/procedure for the testing of Product water.
V595 - 494.100 (c)(1)(v)(B) requirements of ANSI/AAMI RD52:2004.
The cumulative effect of these systematic problems identified resulted in the ESRD's inability to ensure the provision of quality healthcare in a safe environment.
Plan of Correction:Water Check RC Residual Chlorine strips to be thrown away and the RPC-Ultra-Low total Chlorine strips will be used per NxStage guidelines. This will be completed by 6/6/2025.
In-service will be done with all home therapy staff on the requirement to use the RPC- Ultra Low Total Chlorine Strips as per NxStage guidelines. This will be completed no later than 6/10/2025.
Home Therapy Staff will be in-serviced on the use of the NxStage Checklist which includes steps to be sure the appropriate strips will be used for testing. A picture of the correct strips will also be on the checklist. The checklist will be completed and signed by the home therapy nurse and then given to the nurse manager for review and verification. This will be completed prior to the start of training. The checklists will be kept in a binder with the water and dialysate samples. This will be completed by 6/10/2025.
Staff will follow Policy and Procedure 508- Ultra Low Total Chlorine Testing on NxStage Pureflow to test for chloramines. The patient will be trained by the home therapy nurse to use the RPC- Ultra Low Chlorine strips as well. This will be completed each time a new batch of dialysate is made. Audits will be done via a checklist prior to new training. This will be complete by 6/10/2025.
The Home Therapy Nurse Manager will monitor staff compliance by auditing the next two new start home hemodialysis training sessions. The Home Therapy Manager will ensure the RPC Ultra-Low Total Chlorine test strips are used and that the checklist and documentation is complete.
494.100(c)(1)(v) STANDARD
H-MEET RD52:2004
Name - Component - 00
The facility must meet testing and other requirements of ANSI/AAMI RD52:2004. In addition, bacteriological and endotoxin testing must be performed on a quarterly, or more frequent basis as needed, to ensure that the water and dialysate are within the AAMI limits.
Observations:
Based on facility policy's, medical record reviews (MRs), observations (OBS) and an interview with the home therapy nurse manager, the facility failed to ensure product water testing was conducted per facility policy by utilization of Ultra Low Total Chlorine Testing strips for home hemodialysis patient treatments for one (1) of one (1) home hemodialysis medical records (MR) reviewed (MR# 1 and OBS#1).
Findings include:
A review was conducted of facility policy's on June 3, 2025 at approximately 11:00 a.m.
"Policy Number: 507; Water and Dialysate Evaluation and Testing Guidelines for PureFlow SL... TAG - 595; Sample - Product Water; Frequency - Each batch, prior to use of batch; Test Performed; Analysis of chlorine/chloramines levels to ensure the AAMI and manufacturere's specifications are met."
A review of "Policy number 508.0... Title: Ultra Low Total Chlorine Testing on NxStage PureFlow SL... 1. When the Batch is almost complete... the control panel displays "check chloramines remove orange line..."
MR review conducted on 6-3-25 at approximately 10:00 am revealed:
MR#1(home hemodialysis patient in training): date range of: 5-19-25 through 6-2-25 contained documentation of completed dialysis treatments received/performed on the following dates: 6-2-25; 5-29-25; 5-28-25; 5-27-25; 5-23-25; 5-22-25; 5-21-25 and 5-19-25.
OBS#1; date 6/3/25 at approximately 9:30 am: EMP20 provided surveyor with "Residual Chlorine (Watercheck RC) testing strips for residual chlorine in rinse water" Lot# 2408322021. Expiration date: 2/2027. EMP states "I used the residual testing strips to test for presence of chlorine since May 19, 2025(first treatment date) for every treatment the patient had through today(6/3/25)." Dates of treatments noted in afformentioned statement.
An interview with the facility nurse manager, facility educator and home therapy nurse manager on June 3, 2025 at approximately 12:30 p.m. confirmed the above findings.
Plan of Correction:Water Check RC Residual Chlorine strips to be thrown away and Ultra-Low total Chlorine strips by RPC to be used per NxStage guidelines. This will be completed by 6/6/2025.
Inservice will be done with all home therapy staff on the requirement to use the RPC- Ultra Low Total Chlorine Strips as per NxStage guidelines. This will be completed no later than 6/10/2025.
Home Therapy Staff will be in-serviced on the use of the NxStage Checklist which includes steps to be sure the appropriate strips will be used for testing. A picture of the correct strips will also be on the checklist. The checklist will be completed and signed by the home therapy nurse and then given to the nurse manager for review and verification. This will be completed prior to the start of training. The checklists will be kept in a binder with the water and dialysate samples. This will be completed by 6/10/2025.
Staff will follow Policy and Procedure 508- Ultra Low Total Chlorine Testing on NxStage Pureflow to test for chloramines. The patient will be trained by the Home therapy nurse to use the RPC- Ultra Low Chlorine strips as well. This will be completed each time a new batch of dialysate is made. Audits will be done via a checklist prior to new training. This will be complete by 6/10/2025.
The Home Therapy Nurse Manager will monitor staff compliance by auditing the next two new start home hemodialysis training sessions. The Home Therapy Manager will ensure the RPC Ultra-Low Total Chlorine test strips are used and that the checklist and documentation is complete.
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