Davita Somerset County 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: 42178 Based upon observation, review of agency policies, and staff interview, it was determined the facility failed to ensure preventative maintenance of equipment for one (1) of one (1) observation (OBS1). Findings included: Review of Agency policy on 9/18/25 at approximately 1:30pm revealed: “Biomed Equipment Management, Policy: 2-01-09...TITLE: PREVENTIVE MAINTENANCE SCHEDULES FOR EQUIPMENT ... POLICY: 1. Preventative maintenance (PM) schedules must be made in accordance with the manufacturer ’ s recommendation for all equipment used to perform a patient treatment. A copy of the equipment PM schedule will be filed in the appropriate Equipment Maintenance Manual...4. All miscellaneous equipment will receive PM performed by trained Biomed teammate or outside vendor per manufacturer ’ s recommendations. Examples of miscellaneous equipment may include, but are not limited to: suction machines, oxygen concentrators, scales, infusion pumps, bicarb mixers and acid dissolution systems. If a specific checklist is developed and used for PM of miscellaneous equipment, it will be reviewed and approved by the Group Biomedical Director (GBD) or Biomedical Operations Manager (BOM)...” Observation conducted on September 16, 2025, at approximately 8:30am of dialysis treatment floor equipment revealed: Baxter intravenous (IV) pump number 9080157FA with a label documenting last date inspected 6/7/23, 2 years, 2 months and 9 days have passed since the last inspection. Infusystems IV pump 62069878 with a label documenting inspection due 8/2/25, 1 month and 14 days have passed since inspection due. Oxygen concentrator N223968DS with a label documenting inspection due 11/11/22, 2 years, 10 months, and 6 days have passed since inspection due. Interview with Facility Administrator on 9/16/25 at approximately 8:45am confirmed that preventative maintenance is performed annually on equipment by third party company. Interview conducted with Facility Administrator, Manager of Clinical Services and Regional Operating Director on 9/18/25 at approximately 2:00pm confirmed the above findings.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 42178 Based on review of facility policies/procedure, medical records (MR), and employee interviews, the facility failed to follow its policy for monitoring vital signs and safety checks and reporting and/or documenting abnormal findings for two (2) of seven (7) MR reviewed (MR 1 & 3). Findings included: “...Policy: 1-03-08...TITLE: PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT ...INTRADIALYTIC DATA COLLECTION/ASSESSMENT ...9. Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a... iii. Non-nocturnal treatments are completed at least every thirty (30) minutes...10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed...13. All findings, interventions and patient response will be documented in the patient’s medical record...” Review of medical records on 9/17/25 between approximately 1:00pm and 4:00pm revealed the following: MR 1, Start of Care at facility: 8/1/25, dates reviewed: 9/1/25-9/12/25. Treatment record dated 9/8/25: included blood pressure reading during treatment at 1:03pm. The next blood pressure reading was obtained at 1:50pm, 47 minutes later. MR 3, Start of Care at facility: 10/11/22, dates reviewed: 7/7/25-9/16/25. Treatment record dated 9/11/25: included blood pressure reading during treatment at 7:00am. The next blood pressure reading was obtained at 8:02am, 62 minutes later. Interview conducted with Facility Administrator, Manager of Clinical Services and Regional Operating Director on 9/18/25 at approximately 2:00pm confirmed the above findings.”

“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: 42178 Based on review of facility policies/procedure, medical records (MR), and employee interviews, the facility failed to ensure the blood flow rate (BFR) and/or the dialysate flow rate (DFR) was administered per physician order for for four (4) of seven (7) MR reviewed (MR 1, 2, 4 & 5). Findings included: “...Policy: 1-03-08...TITLE: PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT ...INTRADIALYTIC DATA COLLECTION/ASSESSMENT ...9. Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a... iii. Non-nocturnal treatments are completed at least every thirty (30) minutes...10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed...13. All findings, interventions and patient response will be documented in the patient’s medical record...” Review of medical records on 9/17/25 between approximately 1:00pm and 4:00pm revealed the following: MR 1, Start of Care at facility: 8/1/25, dates reviewed: 9/1/25-9/12/25. Order reads in part the following: Blood Flow Rate (BFR): 300mL/min; Dialysate Flow Rate (DFR): 600mL/min. On 9/1/25, DFR was recorded to be administered at 500mL/min for the entirety of the tratment starting at 10:14am and ending at 1:14pm. No documentation to reflect reason DFR run at rate different than ordered. On 9/5/25 BFR was recorded to be administered at 350mL/min from 12:02pm to the end of treatment at 2:32pm. No documentation to reflect reason BFR run at rate different than ordered. MR 2, Start of Care at facility: 3/1/22, dates reviewed: 9/3/25-9/11/25. Order reads in part the following: Dialysate Flow Rate (DFR): 600mL/min. On 9/5/25, DFR was recorded to be administered at 300mL/min for the entirety of the tratment starting at 5:53am and ending at 8:55am. No documentation to reflect reason DFR ran at rate different than ordered. MR 4, Start of Care at facility: 5/20/23, dates reviewed: 9/2/25-9/13/25. Order reads in part the following: Dialysate Flow Rate (DFR): 800mL/min. On 9/6/25, DFR was recorded to be administered at 600mL/min from 10:01am and ending at 11:54am. No documentation to reflect reason DFR run at rate different than ordered. MR 5, Start of Care at facility: 10/12/24, dates reviewed: 8/26/25-9/13/25. Order reads in part the following: Blood Flow Rate (BFR): 350mL/min. On 8/30/25 BFR was recorded to be administered at 325mL/min from 9:03am to 11:03am. No documentation to reflect reason BFR run at rate different than ordered Interview conducted with Facility Administrator, Manager of Clinical Services and Regional Operating Director on 9/18/25 at approximately 2:00pm confirmed the above findings.”