Davita Honesdale Dialysis Center

“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: 19122 Based on review of facility policy/procedure, observation, review of medical records and personnel file documentation, and based on interview with biomedical staff (Employees #5 and #6) and the administrator (Employee #10), the facility failed to ensure three (3) of three (3) facility staff notified biomedical staff prior to the initiation of the hemodialysis (HD) treatment on August 20, 2024 that a warning message was displayed regarding a hemodialysis (HD) machine component. (Employees #2, #3 and #8) Findings include: On August 20, 2024 at approximately 1:50 PM, review of facility policy 2-02-08C, titled “B Braun Avitum AG Dialysis Fluid Filter Diacap Ultra Replacement”, revealed the following under “Notes”: The dialysis fluid filter, Diacap, must be changed at the latest when the following warning window is displayed on the screen: Check the DF Filter. Check the life-time data on the service record. Do you want to continue with an expired filter? Are you sure? If yes, press the key “Cancel”. The use of a Diacap filter is not to exceed 150 therapies or 900 operating hours. The warning window appears when 60 operating hours or 10 therapies remain. During observation of the hemodialysis treatment area on August 20, 2024 at approximately 9:29 AM, HD machine #10 displayed the following yellow alert/statement during the HD treatment for patient #5: Continue with expired filter. During interview conducted on August 20, 2024 at approximately 12:25 PM, the biomedical staff members (Employees #5 and #6) reported the following: Facility staff are to notify biomedical staff when the warning message is first displayed. The yellow alert displayed on HD machine #10 indicates the Diacap filter may have expired prior to the initiation of the HD treatment on 08/20/2024. Facility staff did not provide notification prior to initiation of 08/20/2024 HD treatment that the Diacap filter for HD machine #10 was approaching expiration. Patient #5: On August 22, 2024 at approximately 9:35 AM, review of the medical record revealed the following as documented on the “Treatment Details Report” dated 08/20/2024: -The HD machine prescription settings were verified by the registered nurse (RN-Employee #8) and the patient care technician (PCT-Employee #3) -The HD treatment was initiated by the PCT (Employee #2) at 6:04 AM. On August 20, 2024 at approximately 9:45 AM, review of “ESRD Survey Worksheet: Personnel File Review” form documentation revealed the following: Employee #2: The date of hire of the Certified Clinical Hemodialysis Technician (CCHT) was 08/29/2022. Employee #3: The date of hire of the PCT was 07/10/2023. Employee #8: The date of hire of the RN was 05/21/2021. During interview conducted on August 22, 2024 at approximately 12:20 PM, the administrator reported the CCHT (Employee #2) confirmed the Diacap expiration warning message was displayed on HD machine #10 during the week prior to the 08/20/2024 HD treatment and that Employee #2 forgot to notify biomedical staff the Diacap filter for HD machine #10 was approaching expiration. The administrator confirmed Employees #2, #3 and #8 failed to notify biomedical staff of the approaching expiration of the Diacap filter for HD machine #10 prior to the initiation of the HD treatment on 08/20/2024.”