Davita Mukwonago 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: 30177 Based on documentation review, interview, policy review, and manufacturer’s instruction for use (MIFU) review, the facility failed to follow the MIFU and facility policy for Preventative Maintenance of the 12 of 12, 2008T Blue Star Hemodialysis System, (machines used to provide dialysis). Failure to follow the MIFU and the facility policy did not ensure the hemodialysis machines were deemed safe and operational for patient use and had the potential to adversely impact the safety and well-being of the 29 patients receiving in-center hemodialysis treatments at this facility. Findings include: Interview on 07/30/24 at 10:45 AM with the Biomedical Technician during Machine/Equipment/Maintenance review, he/she revealed the facility had 12 hemodialysis machines. The Biomedical Technician was then asked what preventative maintenance is required for the 2008T Blue Star hemodialysis machines. The Biomedical Technician replied that the hemodialysis machines required six months, annual preventative maintenance, an annual electrical safety test, and quarterly diasafe filter change. He/she stated that the biomedical staff are responsible for completing the yearly and semi-annual maintenance, including a documented checklist to verify work completed. Review of facility documentation of the 2008T Blue Star Hemodialysis System machine maintenance for annual and semi-annually (machine maintenance completed at six months and one year) revealed no documentation that hemodialysis machines, 1-10, had undergone semi-annual preventative maintenance within the last two years. In addition, there was no documentation that hemodialysis machines, 1-12, had undergone annual preventative maintenance. During a follow-up interview on 07/30/24 at 3:45 PM, the Biomedical Technician verified the facility was unable to produce the verification checklist documentation for the semi-annual preventative maintenance for machines 1-10 and documentation of annual preventative maintenance for machines 1-12. Review of the facility’s policy titled, “Documentation of Repairs, Maintenance, and Calibration on Equipment,” revision date April 2023 indicated, “ ... All Repairs, maintenance and calibration of equipment will be performed in accordance with the manufacturer’s recommendations and specifications. Each time a preventative maintenance is performed on a piece of equipment, a checklist of the necessary procedures will be filled out and initialed by the Biomed teammate ...This checklist will be completed in addition to each of the other documentation items...” Review of the manufacturer’s DFU titled, “2008T Preventive Maintenance Procedures,” dated 2008-2023 indicated, “Scheduled maintenance is performed based on timed intervals or number of hours a machine is operated, whichever comes first. The time and hour intervals are as follows ...Six (6) months, Annually or after 4000 hours of operation ...””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 30177 Based on observation, interview, and policy review, the facility failed to ensure four of ten patients (Patients (P) 1, P2, P3, and P4) vascular access sites and bloodline connections were visible by staff members throughout the dialysis treatment. The failure to ensure vascular access sites were not covered provides an opportunity for accidental needle dislodgement or a line disconnection to go undetected. Allowing patients to cover access sites and bloodline connections exposed the 29 in-center hemodialysis patients to adverse outcomes. Findings include: Observation on 07/29/24 at 09:45 AM with the Facility Administrator revealed that P1, P2, P3, and P4 access sites and bloodline connections were covered and not visible by staff members. During an interview on 07/29/24 at 12:35 PM, the Facility Administrator confirmed that patients’ access sites and bloodline connections should be uncovered and visible at all times to prevent blood loss from needle dislodgement or bleeding. Review of the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” revised April 2024 revealed, “The vascular access site, blood line connections, and the patient’s face should be visible throughout the dialysis treatment.””