Zz_closed_bradenton Artificial Kidney Center

“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: 42154 Based on facility logs, policy and interviews the facility failed to meet the standard of dialysate testing levels in the dialysis machines at least once a year, in 11 machines (Numbers 5, 6, 7, 8, 9, 10, 11, 13, 14, 17, 18) of 23 machines in the facility. Findings included: Review of the facility summary of endotoxin, colony count, of the dialysate (the fluid passing through the dialysis machine used for drawing out toxins from the patient bloodstream) revealed that in September of 2023 there were 2 machines with last samples collected at 705 days (#18) and 719 (#17) days. From March 2024 though July 2024 reviewed cultures there were 9 (#5, #6, #7, #8, #9, #10, #11, #13, #14) machines greater than 365 days. Review of the policy titled, “Microbiological Monitoring of Dialysate” ...Schedule sampling ...microbiological samples will be collected as follows: incenter- A minimum of two machine per month and enough machines so that all machines, including backup equipment, are tested at a minimum of once a year ...the biomedical staff will review the electronic records within the system at a minimum of monthly for creation of the monthly trending reports and to assure samples have been collected, interpreted and action taken in accordance with this policy. During an interview on 09/17/2024 at 2:48 PM the Facility Administrator stated that “water is the heart of dialysis” and confirmed that the dialysate cultures were not performed annually. During an interview on 09/17/2024 at 3:30 PM, the Biomed/Technical Operations Manager of the NW Florida Region identified that they did note in April of 2023 an issue and that they “initiated an action plan.” No evidence of the plan was provided. During an interview on 9/18/2024 at 09:20 AM, the Biomed Technical Operations Manager provided the facility policy for the drawing of dialysate cultures. He further commented that he would be escalating the plan and process of obtaining cultures, and become the point of contact moving forward for the facility. On 9/17/2024 at 09:30 AM an observation of the Backflow preventer on the Dialysis Water Reverse Osmosis system was last inspected on 3/24/2023, and had multiple expired tags present from 2021,2022. The Biomed Technical Operations Manager was informed of the findings.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 42154 Based on the facility policy, standard of care, facility logs, and interviews the facility failed to identify, plan or correct areas of concern related to water cultures testing timeframes greater than 365 days in 11 (numbers 5, 6, 7, 8, 9, 10 , 11, 13, 14, 17, 18) machines out of 24 facility machines. Findings included: Review of the facility policy titled, “Department Operating Guidelines Preventative Maintenance and Task Intervals” ...The purpose of the document is to define acceptable intervals for task completion. This establishes a basis for Quality assessment improvement reporting and response to surveyors regarding evaluation of timely completion of task ...Annual maintenance must be completed in the same calendar month for which it is scheduled. The day of the month is not considered ... The recommendations for routine monitoring mentioned within this section are from the updated 2011 recommendations by Association for the Advancement of Medical Instrumentation (AAMI). The standard dialysis fluid from each dialysis machine within a facility should be tested at least once a year for bacteria and endotoxin, where regular testing is conducted on a different machine each month (machines are tested on a rotation). Regular maintenance of the machines, knowledge of factors that impact dialysis quality, and pathways for corrective measures to be successful are additional keys for effective and safe dialysis. Hemodialysis and Water Quality - PMC (nih.gov) Review of the facility summary of endotoxin, colony count, dialysate (the fluid passing through the dialysis machine used for drawing out toxins from the patient bloodstream) revealed that in September of 2023 there were 2 machines with last samples collected at 705 days and 719 days. and from March 2024 through July 2024 showed that there were 9 machines greater than 365 days. During an interview on 09/17/2024 at 3:30 PM, the Biomed/Technical Operations Manager of the NW Florida Region identified that they did note in April of 2023 an issue and that they “initiated an action plan.” No evidence of the plan was provided. He said that the policy of the facility is that they have to be done within the same month not within 365 days. He confirmed that 365 days is yearly.”