Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on April 2, 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 on April 2, 2025, DCI Renal Services of Pittsburgh, Llc was found to have the following standard level deficiency that was 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:
494.40(a) STANDARD
ENVIRONMENT-SECURE & RESTRICTED
Name - Component - 00
8 Environment: secure & restricted
The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system.
Observations:
Based on an escorted faciity tour, observations, review of facility Quality Assessment Performance Improvement (QAPI) Peer Review On-Site Corporate survey dated 5/28/24, and an interview with the clinic manager and chief technician; the facility failed to maintain the integrity of the reverse osmosis (RO) holding tank and the water treatment area for two (2) of two (2) observations(OBS) (OBS #1 & OBS#2) and the facility failed to ensure the storage room, treatment area, patients and staff were secured from unauthorized access.
Findings included:
An escorted facility tour conducted on 3/31/25 at approximately 10:15 a.m revealed the following: Surveyor was escorted by clinical nurse manager to the lower level of the facility via stairwell. Surveyor was escorted outside to the staff parking lot via an exit door at bottom of stairwell to continue tour. Upon completion of outside staff parking area and supply delivery area, surveyor proceeded back to same door that was exited. Surveyor noted a numerical code lock outside of exit door. Surveyor did not type in a code for re-entry. Surveyor was able to gain entry by turning knob of door and pulling open. Upon re-entry clinical nurse manager was able to open exit door from outside of facility without entering a code in the keypad. Biomed employee confirmed the "lock was not engaging".
The unsecured door gives access to storage area with supplies and acid/dialysate solution that are stored in large holding tanks. Individuals gaining entry through unlocked door also had immediate access to stairwell that leads to upper floor with treatment unit access to patients and staff allowing for unauthorized access.
Interview with clinic manager and biomed technician confirmed above findings. Clinic manager states "We had an elevator repairman that was here I believe last Thursday and must have unlocked door then. It's a habit to just enter my code and open the door. I did not check to see if the door locked or not."
OBS #1 completed by surveyor on 3/31/25 at approximately 10:25 AM revealed an active water leak from the RO holding tank. Floor directly under the tank had a puddle of water measuring approximately two feet in diameter. Clinic manager states "We know about it and have a ticket in to fix the drip. The drip is coming from the top pipe. If you look close you can see it drip. I believe when our corporate auditor was here they are the ones who brought it to the previous facility manager's attention."
OBS#2 completed 3/31/25 at approximately 10:25 AM revealed an active water leak from a microfilter connection. Puddle of water under filter approximately 12 inches in diameter. Clinic manager states "I didn't notice that before."
An interview conducted with the Chief Technician on 3/31/25 at approximately 12:10 PM confirmed the above findings. "Yeah, we knew about the RO holding tank leak back in May of 2024, I think, that's when the internal audit was done. The other leak is new."
Plan of Correction:Initially, the door was locked and the key secured by the technical manager. Nurse Manager and/or Designee will monitor employee exit doors twice daily for (2) two weeks to ensure that the employee entrance doors are closed and locked. If standards are met, Nurse Manager or Designee will monitor the employee entrance doors on a weekly basis for two (2) weeks. If standards are met, the Nurse Manager or Designee will monitor the employee exit doors monthly. The audit results will be documented on audit forms and presented at the monthly QAPI meetings. In addition, the daily task of monitoring the employee exit doors will be added to the daily assignment sheet and assigned to a staff member each day.
All but one water leak was repaired by 4/2/2025. We have attempted twice to repair this leak but does not hold. The Corporate technician was consulted on April 22, 2025, regarding recurrent leak and will be offering guidance on proper solution to repair leak. Corporate technician has been in contact with tank manufacturer, and they are working on a solution. The tank will be repaired immediately following receival of repair parts. Additionally, the technical manager will contact the vendor for details for RO holding tank replacement. Beginning on 4/28/2025 the RO tank and water connections will be audited for leaks daily by technical staff or designee. If a new leak is found, the technical department and nurse manager will be notified, and a work order will be entered into the Technical Module. Audit results will be noted on the audit tool and Tech Module requests and repairs will be reported to GB/QAPI monthly by Technical Manager.
494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS
Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.
Observations:
Based on review of policy, National Kidney Foundation (NKF) Guidelines, observation (OBS), and staff (EMP) interview, the facility failed to ensure two (2) of two (2) patients with an arteriovenous fistula (AVF) washed their access prior to disinfection and initiation of dialysis. (OBS#1 and OBS#2)
Findings:
Review of facility policy on 4/1/25, at approximately12:45 p.m. revealed: "Vascular Access Disinfectant Policy... Procedure NO:125... date issued: 2/12/2025... Policy... 2. Pateitns should was their hands and access with antibacterial soap and water prior to staff disinfection of access; if the patient is unable to complete this step, staff must complete this step at chairside..." "Procedure... Option 1 (preferred)... Chlorhexadine [antiseptic] is a 30 second contact time with a 1 minute dry time..."
According to NKF Guidelines, "Tips for Everyday Care of Your AV Fistula or Graft Prevent Infection ... Wash your access site before every dialysis treatment. Your dialysis center has hand washing sinks and antimicrobial soap." Retrieved from https://www.kidney.org/sites/default/files/11-50-0216_va.pdf
OBS#1 on treatment floor on 4/1/25 at approximately 11:05 a.m. revealed patient walk to station 10 without first washing his/her access in facility sink. EMP10 wiped the patient's AVF with a "Chloraprep Antiseptic Towelette", inserted both needles, and initiated dialysis. Interview with EMP9 (dialysis technician) and EMP2 (registered nurse) after the observation confirmed the patient did not wash their access in the sink.
OBS#2 on treatment floor on 4/1/25 at approximately 11:40 a.m. revealed patient walk to the dialysis station without first washing his/her access in the facility's sink. EMP3 wiped the patient's AVF with a "Chloraprep Antiseptic Towelette", inserted both needles, and initiated dialysis. Interview with EMP3 (registered nurse) after the observation confirmed the patient did not wash their access in the sink.
Plan of Correction:The Nurse Manager and/or designee will ensure all staff are in-serviced on policy & procedures 102, 103, 104, 105, 106- Insertion of Access Needles. Staff education will emphasize the requirement for patients to wash access prior to treatment and if patients are unable to wash access, staff will wash access at chairside. Evidence of the policy review will be documented in each employee's file. This education will be done by 4/24/2025. The Nurse Manager and/or designee will educate the patients regarding the necessity for them to wash their arm access upon entry to the dialysis unit prior to cannulation. A log will be kept ensuring all patients have been educated and shown return demonstration of appropriate washing technique. Once 100% of patients have demonstrated understanding, evidence of the patient education provided will be documented in the patients' charts. This education will be done by 4/25/2025. Beginning the week of 4/28 2025, the Nurse Manager, Nurse Educator, and/or designee will audit the patients washing their arm accesses at the sink prior to cannulation. For any patients unable to wash their arm access at the sinks, staff will be audited on cleaning of access at chairside. Auditing and observations will be performed daily each shift weekly for four weeks or until 100%, with re-education provided when indicators are not met. At this point the audit will continue once per month for six months, and then quarterly for the remainder of the calendar year. All audit findings will be reported to the Governing body at monthly meetings for review, oversight and subsequent recommendations as needed. Documentation of audit results will be found in the Governing Body Meeting minutes.
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