Davita General Butler Dialysis

“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: 35949 Based on observation, interview, manufacturer’s instructions for use (IFU) review, and facility policy review, the facility failed to follow the bloodline manufacturer’s IFU by not maintaining the arterial and venous drip chamber fluid levels at 3/4 full during 4 of 4 observations. Failure to follow the manufacturer’s IFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 19 patients who received dialysis treatments at the facility. The findings include: Review of facility policy, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised 04/2024, indicated, “9 e. The arterial and venous drip chamber levels should be observed and adjusted as needed.” Review of the manufacturer’s IFU, “Nipro Instructions for Use ...Nipro Set ® Blood Tubing Set,” revealed the section titled, “General Warnings and Precautions,” included, “10. Maintain drip chamber fluid levels at 3/4 full to help prevent drip chamber evacuation, causing possible air embolus. Full drip chamber levels can result in stagnation of blood in the upper portions of the drip chamber, resulting in clotting.” Further review indicated, “Dialysis Treatment Precautions: 1. Before initiating dialysis treatment, check the following: a. Drip chambers are in the upright position and have the fluid level at ¾ full.” and “3. b. Periodically check fluid level in drip chamber and adjust if required.” Observation of the hemodialysis treatment area on 07/28/2025 at 11:12 AM revealed the arterial drip chamber fluid levels were less than 3/4 full in Stations 1, 2, 3, 5, and 6 and greater than 3/4 full in Stations 1, 2, 5, and 6. Observation of the hemodialysis treatment area on 07/29/2025 at 8:06 AM revealed the arterial drip chamber fluid levels were less than 3/4 full in Stations 2, 3, 4, 5, and 6 and greater than 3/4 full in Stations 2, 4, and 5. Observation of the hemodialysis treatment area on 07/29/2025 at 8:26 AM revealed the arterial drip chamber fluid levels were less than 3/4 full in Stations 2, 3, 4, 5, 6, and 7 and greater than 3/4 full in Stations 2, 4, and 5. Observation of the hemodialysis treatment area on 07/29/2025 at 9:10 AM revealed the arterial drip chamber fluid levels were less than 3/4 full in Stations 2, 3, 4, 5, 6, and 7 and greater than 3/4 full in Stations 2, 3, and 5. During an interview on 07/29/2025 at 9:11 AM with Certified Clinical Hemodialysis Technician (CCHT) #3 and Registered Nurse (RN) #1, they stated the drip chambers should be “3/4 full.” CCHT #3 and RN #1 confirmed the drip chamber fluid levels were not maintained according to the manufacturer’s IFU. During a concurrent interview in the treatment area with the Facility Administrator after reviewing the manufacturer’s IFU, the Facility Administrator confirmed the drip chamber fluid levels were not maintained according to the manufacturer’s IFU. During an interview on 07/31/2025 at 11:52 AM, the Medical Director confirmed the facility staff were expected to follow the manufacturer’s IFU for maintaining the drip chamber fluid levels during dialysis treatment.”

“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: 35949 Based on interview, record review, and facility policy review, the facility failed to follow the individualized medication prescription as prescribed by the medical provider for 2 (Patient #4 and Patient #5) of 5 sampled patients. Failure to follow the medical providers’ medication prescription had the potential to negatively impact the effectiveness of the prescribed medication for the 19 patients who received dialysis treatments at the facility. The findings included: Review of facility policy, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised 04/2024, revealed, “3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by the licensed nurse withing one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model, b. treatment time, c. Target weight, d. UFR [ultrafiltration rate] and Max [maximum] UFR, e. UF [ultrafiltration] Profiling, f. Blood flow rate, g. Dialysate flow rate, h. All accesses evaluated, i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings, j. Heparinization (intradialytic infusion setting).” Review of facility policy, “Medication Policy,” revised 10/2022, revealed, “9. Medications are administered as prescribed and then documented in the patient’s medical record. No medications are given without an order from the physician or non-physician practitioner (NPP). Medication orders must include the patient name, drug name, dose, route, frequency, date and time the order was received.” Review of Patient #4’s treatment sheet dated 07/11/2025 revealed a prescribed hourly infusion of 1 milliliters (ml) of heparin with a prescribed stop time of 60 minutes before the end of the treatment. Patient #4’s treatment sheet indicated the heparin infusion ended at 11:41 AM, and the treatment was terminated 47 minutes later at 12:28 PM. There was no rationale documented why the hourly infusion of heparin was not terminated 60 minutes before the end of the treatment. Review of Patient #4’s treatment sheet dated 07/14/2025 revealed a prescribed hourly infusion of 1 ml of heparin with a prescribed stop time of 60 minutes before the end of the treatment. Patient #4’s treatment sheet indicated the heparin infusion ended at 12:48 PM, and the treatment was terminated 14 minutes before, at 12:34 PM. There was no rationale documented why the hourly infusion of heparin was not terminated 60 minutes before the end of the treatment. Review of Patient #5’s treatment sheet dated 07/22/2025 revealed a prescribed hourly infusion of 1 ml of heparin with a prescribed stop time of 60 minutes before the end of the treatment. Patient #5’s treatment sheet indicated the heparin infusion ended at 10:33 AM, and the treatment was terminated 45 minutes later, at 11:18 AM. There was no rationale documented why the hourly infusion of heparin was not terminated 60 minutes before the end of the treatment. During an interview on 07/29/2025 at 1:30 PM, the Facility Administrator confirmed the heparin infusion administration was not reflected accurately on the flowsheets to indicate the hourly infusion was terminated 60 minutes prior to the end of the treatment per the physicians’ orders. During an interview on 07/31/2025 at 9:35 AM, Certified Clinical Hemodialysis Technician (CCHT) #4 confirmed she was trained and expected to follow the physicians’ orders and confirmed the hourly heparin infusion stop times indicated on the treatment sheets was “confusing.” During an interview on 07/31/2025 at 9:52 AM, Registered Nurse (RN) #2 reviewed the treatment sheets regarding the heparin hourly infusion. RN #2 confirmed the dialysis machine was programmed prior to initiation of dialysis treatment to stop 60 minutes before the treatment end time. RN #2 confirmed she was trained and expected to follow physicians’ orders. During an interview on 07/31/2025 at 11:52 AM, the Medical Director confirmed the staff were trained and expected to follow the physicians’ orders for the administration of the hourly heparin infusion.”

“QAPI-INDICATOR-NUTRITIONAL STATUS CFR(s): 494.110(a)(2)(ii) The program must include, but not be limited to, the following: (ii) Nutritional status. This Standard is not met as evidenced by: 35949 Based on interview, Quality Assurance and Performance Improvement (QAPI) meeting minutes review, and facility policy review, the facility failed to identify underperformance in 1 of 1 quality indicator areas related to albumin levels below 4.0. Failure to identify underperformance and develop and implement an action plan had the potential to miss opportunities to improve albumin levels in the 19 patients who received dialysis treatments at the facility. The findings included: Review of facility policy, “Continuous Quality Improvement Program,” revised 04/2021, revealed, “7. The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: Patient Safety, including Review [sic] of sentinel events, Review of trends of adverse patient occurrences including falls and blood loss, Review of product, equipment, or medication notices or recalls, Infection Control, including Incidence [sic] of infections, Vaccination rates for Hepatitis B, Influenza, and Pneumococcal, Adequacy of Dialysis (Kt/V), Nutritional Status (Albumin), Mineral Metabolism and Renal Bone Disease, Anemia Management, Vascular Access, Growth and Capacity, Mortality - review of deaths, Hospitalizations and Emergency Ambulance Transfers, Patient Satisfaction and Grievances, including KDQOL [Kidney Disease Quality of Life], other indicators as reflected in the Facility Health Record application. 8. Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained.” Review of the QAPI meeting minutes from 06/17/2025 and 07/29/2025 revealed an action plan was not developed or implemented related to albumin laboratory values less than 4.0 and exceeding the United States threshold of 49.3% established by the Centers for Medicare and Medicaid Services and indicated on the Dialysis Facility Report for Fiscal Year 2025, Table 9, when 13 of 19 patients had albumin values less than 4.0 in two of the last three months resulting in a percentage of 68%; 18.7% above the threshold indicating underperformance. During an interview on 07/31/2025 at 9:55 AM, the Manager of Clinical Services stated the underperformance of the albumin levels was not identified as a data-driven focus area in QAPI, and an action plan was not developed and/or implemented. During an interview on 07/31/2025 at 11:34 AM, the Registered Dietician stated she was aware of the Centers for Medicare and Medicaid Services (CMS) mandated threshold for albumin values <4.0 but was not aware that the QAPI was not reflecting the correct threshold value and was not triggering for an action plan to be developed and implemented. During an interview on 07/31/2025 at 11:52 AM, the Medical Director confirmed QAPI should trigger for an action plan based on the established CMS thresholds.”