Sanford Tom and Frances Leach Bismarck Dialysis

“BACT OF H20-MAXIMUM & ACTION LEVELS CFR(s): 494.40(a) 4.1.2 Bacteriology of water: max & action levels Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for reuse, shall contain a total viable microbial count lower than 200 CFU/mL and an endotoxin concentration lower than 2 EU/mL The action level for the total viable microbial count in the product water shall be 50 CFU/mL, and the action level for the endotoxin concentration shall be 1 EU/mL. If those action levels are observed in the product water, corrective measures shall promptly be taken to reduce the levels. This Standard is not met as evidenced by: 20497 Based on policy review, record review, and staff interview, the facility failed to repeat culture testing for 1 of 4 months (November) in 2024 when the product water culture exceeded allowable levels. Failure to repeat culture testing when reaching the action level limited the facility’s ability to ensure safe product water for use in dialysis treatments. Findings include: Review of the policy “Water System Testing - Dialysis Enterprise” occurred on 12/17/24. This policy, dated 03/07/24, stated, “. . . Testing for Bacterial Contamination of the Water System 1. Allowable levels: Compoment [sic] . . . Total viable bacteria count . . . Action Level . . . 50 CFU/ml [colony forming units per milliliter] . . . 5. Assessment of Results: Utilize the algorithm to assess the results of the testing. . . .” The undated algorithm stated, “Review dialysate and water culture results > Results 50-199 CFU/ml > Notify Manager > Review culture and disinfection logs > disinfect machine or water system > Redraw sample . . .” Review of 2024 water system culture records occurred on 12/17/24. The 11/06/24 report for Pre Loop 2 TP11, collected 11/04/24, stated, “. . . Culture Result 50 cfu/ml Action limit reached - action required . . .” Review of the 2024 culture tracking records occurred on 12/17/24. The 11/04/24 record showed an entry of <50 cfu/ml for Pre Loop 2 (TP11). The facility failed to accurately document the culture result for Pre Loop 2 (TP11) in November 2024. Upon request on 12/17/24, the facility failed to provide evidence of redrawing a sample for a follow up culture of Pre Loop 2 (TP11). During interview on 12/17/24 at 4:10 p.m., an administrative staff member (#1) confirmed the facility failed to recognize the action limit was reached for Pre Loop 2 (TP11) in November 2024 and failed to re-culture Pre Loop 2 (TP11).”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 20497 Based on policy review, record review, and staff interview, the facility failed to test the dialysis treatment water for free chlorine, chloramine, or total chlorine at least every four hours each patient treatment day for 1 of 26 treatment days (11/04/24) reviewed in November 2024. Failure to test for free chlorine, chloramine, or total chlorine every four hours each day of patient treatments limited the facility’s ability to ensure safe dialysis treatment water. Findings include: Review of the policy “Water Testing Chlorine - Dialysis Enterprise” occurred on 12/17/24. This policy, dated 12/14/21, stated, “. . . Policy: . . . Total chlorine is checked before each patient shift or minimum of every four hours. . . .” Reviewed on 12/17/24, the November 2024 chlorine testing record showed the facility tested for chlorine on 11/04/24 at 1105 (11:05 a.m.) and next at 1640 (4:40 p.m.) - 5 hours and 35 minutes after the last test. The bottom of the form included instructions stating, “. . . (Chlorine MUST be checked a minimum of every 4 hours) . . .” During interview on 12/17/24 at 4:10 p.m., an administrative staff member (#1) confirmed staff had not checked the water system for chlorine every four hours on 11/04/24.”