Children’s Hospital Boston - 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: 31240 Based on review of Water Testing Logs, the Water Room Flow Chart and staff interview, the dialysis unit failed to ensure that corrective measures were promptly taken to reduce the levels of abnormally high culture results in the water obtained from one port (BS-2) in the water system. Findings include: Review of the facility’s Dialysis Unit Water System Microbiology Testing Process Flow Chart, dated 2019, indicated the following: * If sampling results are greater than (>) 50 colony forming units per milliliter (CFU/ml) in the first test, then retest immediately. Review of the Dialysis Water System Testing Results, dated 9/11/23, indicated a post-sanitization testing result of 82 CFU/ml from port BS-2. Further review of test results failed to indicate that immediate retesting was completed from this port as required. During an interview on 2/14/24 at 1:00 P.M., the Senior Director of Hospital Engineering said that a resample was not obtained in September 2023 when the CFU count was > 50 CFU/ml from port BS-2. He said there was no action plan put in place to investigate and correct the issue.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 31240 Based on record review and interview, the dialysis unit failed to ensure the dialysis treatment order was delivered as prescribed relative to Dialysate Flow Rate (DFR)-the measurement of how fast the dialysate solution flows in milliliters per minute [ml/min]) to draw toxins from the patient’s blood during the process of dialysis, for 1 patient (#3), out of total sample of 5 patients. Findings include: Patient #3 was admitted to the facility in March 2023 with End Stage Renal Dialysis requiring hemodialysis treatments. Review of a Physician’s order, dated 1/31/24, indicated the DFR was to be delivered at a rate of 0. Review of 9 Hemodialysis Flowsheets, dated 1/31/24 through 2/14/24, indicated the DFR had not been delivered as prescribed on 1 of 9 Hemodialysis Flowsheets. *2/1/24-The DFR was delivered at a rate of 300, not 0 as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 2/15/24, the Clinical Coordinator said that Patient #3 came in on 1/31/24 for an extra treatment, just for ultrafiltration. She said the staff must follow the physician’s order for DFR, and if not followed as ordered, then staff should document why the change was made. She said after reviewing Patient #3’s clinical record that there was no documentation that staff clarified with the physician to change the DFR rate from 0 to 300. She said that Patient #3 is usually prescribed a DFR of 300 when receiving an extra treatment for ultrafiltration, but the staff should have clarified the order with the prescriber to make any changes.”

“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: 37349 Based on interview, Dialysis Water System Testing Results, and Quality Assurance and Performance Improvement (QAPI) meeting minute review, the dialysis unit failed to identify that an action level water culture result of 82 CFU, had not been acted upon, to ensure the safe delivery of dialysis quality water for dialysis treatment. Findings include: Review of the Dialysis Unit Description and Scope of Service, effective 5/1/21, included the following: * The Dialysis Unit participates in collection of data related to program and hospital quality improvement focus may include the following examples: Medical record review, Patient and family satisfaction assessment, Patient Access, Hospital wide audits, Core Metrics, Program based quality measures and Patient and Family satisfaction via Press Ganey. * Program specific Quality Improvement (QI) initiatives include: Dialysis QAI measures as outlined by the Centers for Medicare and Medicaid Services (CMS), including but not limited to : Dialysis Adequacy, Nutritional Status, Mineral Metabolism, Anemia Management, Vascular Access, Medical Injuries and Medical Errors, Patient Satisfaction and Grievances, Infection Control, Vaccinations, Health Outcomes, Nursing Quality Measures. Review of the facility’s Dialysis Unit Water System Microbiology Testing Process Flow Chart, dated 2019, indicated the following: * If sampling results are greater than (>) 50 colony forming units per milliliter (CFU/ml) in the first test, then retest immediately. Review of the Dialysis Water System Testing Results, dated 9/11/23, indicated a post-sanitization testing result of 82 CFU/ml from port BS-2. Further review of the test results indicated no further testing was obtained from this port as required. During an interview on 2/14/24 at 1:00 P.M., the Senior Director of Hospital Engineering said that a resample was not obtained in September 2023 when the bacteria count was > 50 CPU/ml from port BS-2. He said there was no action plan put in place to investigate and correct the issue. Review of the QAPI meeting minutes, dated 10/13/23, for water testing results reviewed, failed to indicate the lab result from port BS-2 was above action level and failed to identify that immediate retesting had not occurred. There was no action plan in place to investigate and correct the issue. During an interview on 2/15/24 at 11:45 A.M., the Director of Patient Services, Kidney Programs said the action level and missed retesting should have been reported at the QAPI meeting.”