Dialysis Center of East Providence

“MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ CFR(s): 494.40(a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1. 7.2.2 Sample collection Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers. This Standard is not met as evidenced by: 46715 Based on record review and staff interview it has been determined that the facility failed to ensure that dialysate (a specially formulated solution to remove waste products and excess fluid from the blood when the kidneys are not functioning properly) samples were collected from at least two dialysis machines monthly and from enough machines so that each machine was tested once per year for 2 of 24 machines reviewed, machine #s 5 and 6. Findings are as follows: Review of a facility policy titled, “Microbiological testing: Dialysate” dated 2/5/2024 states in part, “...Machine Dialysate Testing Frequency: All dialysis machines must be tested: for bacteria and endotoxin. Scheduled so as each machine is sampled within a calendar year. Minimum of 2 machines each calendar month...” Review of a dialysate and endotoxin schedule for 2024 revealed that machine #s 5 and 6 are to be tested in January of every calendar year. Review of the “Environmental Testing Results” from January of 2024 through June of 2025 revealed that the last date that machine #s 5 and 6 were tested for bacteria and endotoxins was 1/8/2024, indicating that they are 6 months overdue for annual testing. Surveyor observation on 7/9/2025 at approximately 11:15 AM revealed a patient was undergoing dialysis treatment on machine #5. During a surveyor interview on 7/10/2025 at approximately 10:00 AM with the Facility Technical Manager, he acknowledged that both machine #s 5 and 6 were not tested annually per the facility policy and the regulation. Additionally, he revealed that samples had been taken from both machines for dialysate testing after it was brought to the facility’s attention by the surveyor. During a surveyor interview on 7/10/2025 at 10:15 AM with the Clinic Manager, she revealed that she would expect every machine to be tested annually per the regulation and the facility policy. During a surveyor observation on 7/10/2025 at 10:40 AM of the treatment room revealed both machine #s 5 and 6 were in the dialysis treatment room to be used. 47279”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 47279 Based on surveyor observation and staff interview, it has been determined that the facility failed to be maintained to provide dialysis patients and staff with a safe and functioning treatment environment. Findings are as follows: Surveyor observation on 7/9/2025 at approximately 2:30 PM of the patient treatment area in the presence of the Clinic Manager and the Clinical Regulatory Manager, revealed the following: - A large glass window panel with spiderwebbed cracks throughout - A double bay sink with tape over the basins. During a surveyor interview immediately following the above observations with the Clinic Manager and the Clinical Regulatory Manager, they acknowledged the cracked glass window panel and that the sink had tape over the basins. Additionally, the Clinic Manager indicated the window has been in that condition for a while, but she did not realize it was the glass that was cracked and thought that it was only the film that covered the glass that was damaged. Further, she revealed the sink has been out of service for a while because of a plumbing issue that has been unresolved. Furthermore, they were unable to provide evidence that the facility maintained a safe and functioning treatment environment for the patients and staff.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 46715 Based on surveyor observation and staff interview it has been determined that the facility failed to ensure that the building is maintained to ensure the safety of patients and staff, relative to the access to the patient treatment area being restricted to authorized personnel only for 1 of 1 patient treatment room. Findings are as follows: During a surveyor observation on 7/8/2025 at approximately 8:45 AM during the initial flash tour of the facility revealed the Clinic Manager entering the treatment room through double doors. Further observation revealed that she entered through the left-sided door that was unlocked. During an interview directly following the above observation the Clinic Manager acknowledged that there are locks on the doors leading to the treatment room, however, she revealed that the lock for the left door has been broken for a while. During a surveyor observation on 7/8/2025 at approximately 11:00 AM the left door leading to the patient treatment room was noted to be propped open. Additionally, neither the receptionist nor any other staff were present in the front office or immediate vicinity. During subsequent surveyor observations from 7/8/2025 through 7/10/2025 revealed the left door that leads to the patient treatment room was left unlocked and accessible. During a surveyor interview on 7/9/2025 at approximately 2:30 PM with the Clinic Manager and the Clinical Regulatory Manager they acknowledged that the broken lock of the left door allowed access to the patient treatment area by unauthorized personnel. 47279”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) 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. This Standard is not met as evidenced by: 47279 Based on surveyor observation and staff interview, it has been determined that the facility failed to ensure that the water filtration and distribution equipment was properly maintained for the water and dialysate (a specially formulated solution to remove waste products and excess fluid from the blood when the kidneys are not functioning properly) treatment systems including the Reverse Osmosis (RO) machine (a water purification system that uses a semi-permeable membrane to remove contaminants from water used in dialysis treatments) and components of the dialysate storage tank and water pump. Findings are as follows: 1a. During a surveyor observation on 7/8/2025 at approximately 8:45 AM of the water treatment area, in the presence of the Clinic Manager and the Facility Technical Manager (FTM), revealed the following: - Clear fluid leaking from the regulator (a component of the RO machine) and dripping on the floor below, forming a puddle - An accumulation of a crystallized white substance approximately the size of a grapefruit noted in two separate areas of components of the dialysate storage and distribution system including the piping attached to the storage tank and the piping of the distribution system leading to the patient treatment center During a surveyor interview immediately following the above observations with the FTM in the presence of the Clinic Manager, he acknowledged the leaking regulator and build-up of white substances and indicated he was aware of both but had yet to address them. 1b. During a surveyor observation on 7/10/2025 at approximately 8:30 AM of the water treatment area, in the presence of the FTM, revealed one of the two water pumps that propel water into the water treatment and distribution system was noted to be leaking. During a surveyor interview immediately following the above observation with the FTM, he acknowledged the leaking water pump. During a surveyor interview on 7/10/2025 at approximately 1:00 PM with the Clinic Manager, in the presence of the FTM and Clinical Regulatory Manager, they were unable to provide evidence that the facility properly maintained all components of the water filtration and distribution system and dialysate storage and distribution system.”