Tri State Dialysis

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 28297 Based on interview, facility document review, and policy review, the facility failed to ensure disinfection of the loop and collection cultures was completed at the “worst case scenario” for two of six months reviewed. The failure to collect cultures at the worse case scenario had the potential for not capturing abnormal cultures and this could affect 18 in-center patients. Findings include: Review of the disinfection and culture collection of the reverse osmosis (RO), loop, and machines revealed the following: For February 2025, the disinfection was completed on 02/18/25 and the cultures were collected on 03/10/25, 20 days later. For March 2025, the disinfection was completed on 03/20/25 and cultures were collected on 04/02/25, only 13 days later. During an interview on 07/01/25 at 11:30 AM the Biomedical Technician confirmed there was not a set time of when the water cultures were collected in relation to the disinfection as long as they were done monthly. He/she did confirm they should be done at the worst case scenario, close to the disinfection process completed monthly. The Biomedical Technician confirmed the cultures collected on March 10, 2025, and April 2, 2025 was not worst case scenario. During an interview on 07/02/25 at 9:40 AM the Medical Director stated the disinfection of the RO, loop and machines completed monthly should be done on a consistent schedule and the cultures should be collected closer to 25-30 days from the last disinfection to capture worst case scenario cultures to detect abnormal findings. Review of the facility’s policy titled, “Water Quality Testing,” revised 07/21/21 indicated, “ ...Water, dialysate cultures and LAL (Limulus Amebocyte Lysate) are collected minimally once per month to ensure dialysis water is within the AAMI standards for bacteria levels ...””

“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: 28297 Based on observations, interview, facility’s policy and procedure review, and manufactures directions for use, the facility failed to follow the facility policy for dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing it through a filter) treatments by not maintaining the arterial drip chambers (a pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at three-fourths full for two of three survey days. Failure to follow the facility policy had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 18 patients receiving dialysis treatments in this facility. Findings include: Observation of the hemodialysis treatment area on 06/30/25 at 9:45 AM revealed the arterial drip chamber was less than 10 % full. Observation on 07/02/25 at 8:35 AM the arterial drip chambers at Station 1 and 3 were less than 25% full. During an interview on 07/02/25 at 8:35 AM Registered Nurse (RN) 1 confirmed the drip chambers were low at Station 1 and 3 and should be at the designated line on the chamber. During an interview on 07/02/25 at 11:45 AM the Registered Nurse Manager confirmed the arterial drip chambers should be to the fill line to prevent air from getting into the extracorporeal system. Review of the facility policy “Fresenius 2008 -T Priming,” revised 04/03/25 indicated, “ ...Thread arterial line to dialyzer ... Fill arterial chamber and clamp arterial monitor once chamber is three-fourths full ...” Review of the undated Manufacture Directions for Use for “Combi Set True Flow Series, Hemodialysis Blood Tubing Set with Priming Set and Transducer Protector,” indicated, “ ...Priming Precautions ...Prime pre-pump arterial chamber 85-95% full ...During treatment ...maintain fluid level in pre-pump arterial chamber at 85-95% full ...””