Usrc Zuni 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 directions for use (DFU) review, and facility policy review, the facility failed to follow the bloodline manufacturer’s DFU during dialysis treatments by not maintaining the arterial drip and venous drip chamber fluid levels at 3/4 full during 2 of 2 observation days. Failure to follow the bloodline manufacturer’s DFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 99 patients who received in-center dialysis treatments at the facility. Findings included: The facility’s policy titled, “Priming the Extracorporeal Circuit (CombiSet, NiproSet and Streamline Bloodlines),” revised 07/2024, indicated, “18. Once priming is complete, clamp arterial and venous bloodlines. Aseptically connect patient ends together to prepare for recirculation of the extracorporeal circuit. Unclamp arterial and venous patient end bloodlines. Fill venous drip chamber 65-75% (CombiSet) or 3/4 (NiproSet) full by loosening the side arm tubing cap, tighten cap and clamp the venous monitoring line.” Additional review indicated, “Note: Ensure arterial and venous chamber levels are maintained throughout the dialysis treatment as described in the priming procedure above.” The manufacturer’s DFU titled, “Nipro Instructions for Use ...Nipro Set ® Blood Tubing Set,” indicated, “General Warnings and Precautions: 10. Maintain drip chamber fluid levels at ¾ 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 09/16/2024 at 10:00 AM, revealed the arterial and venous drip chamber fluid levels were greater than (>) 3/4 full in Stations 2, 3, 4, 6, 7, 11, 12, 15, 18, 19, 22, 23, 26, 27, and 30. Observation of the hemodialysis treatment area on 09/16/2024 at 10:45 AM, revealed the arterial and venous drip chamber fluid levels were > 3/4 full in Stations 3, 4, 7, 11, 12, 15, 18, 19, 22, 23, 26, 27, and 30. Observation of the hemodialysis treatment area on 09/19/2024 at 10:20 AM, revealed the arterial and venous drip chamber fluid levels were > 3/4 full in Stations 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 16, 17, 20, 21, 22, 23, 24, 25, 26, and 27. Observation of the hemodialysis treatment area on 09/19/2024 at 10:45 AM, with the Facility Administrator, revealed the arterial and venous drip chamber fluid levels were > 3/4 full in Stations 1, 2, 3, 6, 7, 9, 10, 11, 12, 16, 17, 19, 20, 21, 22, 23, 24, 25, 26, and 27. During an interview on 09/19/2024 at 10:44 AM, the Facility Administrator reviewed the manufacturer’s DFU and acknowledged the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. The Facility Administrator stated the staff were trained to fill the drip chambers “at the line [on the machine]” or “3/4 full.” During an interview on 09/19/2024 at 11:10 AM, the Medical Director confirmed the staff should follow the manufacturer’s DFU for the drip chamber fluid levels. During an interview on 09/19/2024 at 11:23 AM, Registered Nurse #3 stated the drip chamber fluid levels should be filled “this much [showing fingers separated by approximately one inch].” During an interview on 09/19/2024 at 11:40 AM, Certified Clinical Hemodialysis Technician #6 stated the drip chambers should be filled “at the line on the machine.””