Dialysis Center of Johnston

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 41729 Based on surveyor observation and staff interview, it has been determined that the facility failed to ensure that the brine tank (a part of the water softening system that holds a concentrated solution to remove hard minerals such as calcium and magnesium) was filled at least halfway with salt pellets at the time of the observation. Findings are as follows: During a surveyor observation on 8/12/2025 at 8:25 AM of the water treatment room in the presence of Charge Nurse, Staff A, the brine tank was observed to have salt pellets below the halfway mark. Additional observation revealed the water in the tank was above the salt pellets and brown particles were floating in the tank. During a surveyor interview immediately following the above-mentioned observation with Staff A, she acknowledged that the salt pellets were not at least halfway up the tank, as required, and confirmed the presence of brown particles floating in the tank. During an additional surveyor observation on 8/13/2025 at 8:30 AM of the water treatment room in the presence of the Facility Technical Manager, the brine tank was observed to have salt pellets above the halfway mark of the tank. During a surveyor interview immediately following the above-mentioned observation with the Facility Technical Manager, he acknowledged the salt pellets were filled above the halfway mark and indicated that it should not have been at the level observed. During a surveyor interview on 8/13/2025 at 9:50 AM with the Clinic Manager, she was unable to provide evidence that the softener brine tank salt pellets were maintained a level of at least half the tank, as required.”

“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: 41729 46715 Based on record review, surveyor observation, 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 4 of 23 machines reviewed, machine #s 18, 19, 22, and 23. 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 the “Dialysate machine Sampling schedule” revealed the following: - machine #18 is due in September - machine #19 is due in October - machine #22 is due in November - machine #23 is due in December Review of the “Environmental Testing Results” from January of 2024 through August of 2025 revealed that the last date that machine #s 18, 19, and 23, were tested for bacteria and endotoxins was on 3/7/2024, indicating that they are overdue for their annual testing. During a surveyor observation on 8/13/2025 at approximately 12:45 PM revealed patients undergoing dialysis treatments on machine #s 18, 19, and 22. Additional observation revealed that machine #23 was off the treatment floor and not in use. During a surveyor interview on 8/13/2025 at approximately 12:40 PM with the Facility Technical Manager, he acknowledged that machine #s 18, 19, 22, and 23 had not been tested annually, per the regulation. During a surveyor interview on 8/13/2025 at 12:50 PM with the Clinic Manager, she revealed that she would expect every machine to be tested annually, per the regulation.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 41729 Based on record review and staff interview, it has been determined that the facility failed to ensure that staff follow the hemodialysis (HD, a procedure where a dialysis machine and a special filter called an artificial kidney, or a dialyzer, are used to clean the blood) prescription when administering HD treatment for 1 of 8 patients reviewed, Patient ID #8. Findings are as follows: Record review revealed Patient ID #8 was admitted to the facility in June of 2025 with a diagnosis including, but not limited to, end stage renal disease (when the kidneys have significantly lost their ability to filter waste and excess fluid from the body) and is dialysis dependent. Record review of the patient’s current dialysis prescription order dated 8/11/2025 revealed a blood flow rate (BFR, the speed that the patient’s blood is moving through the dialysis tubing) of 400 milliliter/minute (ml/min). Record review of a HD treatment flowsheet dated 8/2/2025 revealed a dialysis prescription for a BFR of 400 ml/min. Record review of the above-mentioned flowsheet revealed the patient received his/her dialysis on 8/2/2025 with a BFR of 450 ml/min instead of 400 ml/min, as ordered, for the duration of his/her treatment. Further record review failed to reveal evidence that the physician was notified that the patient did not receive his/her dialysis treatment, as ordered, or a rationale as to why the BFR was adjusted. During a surveyor interview on 8/13/2025 at 9:59 AM with the Clinic Manager, she acknowledged that the patient’s BFR had not been followed, as ordered. Additionally, she was unable to provide evidence of a rationale as to why the BFR was adjusted.”