Davita Brea Dialysis Center

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 39934 Based on observation, interview, and record review, the facility governing body failed to ensure the staff implemented the written policies and procedures during initiation of treatment for two of five sampled patients (Patients 4 and 5). This failure had potential for Patients 4 and 5 to experience negative health outcomes. Findings: 1. Review of the facility’s P&P titled Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate revised October 2024 showed a manual pH testing must be performed to each patient treatment. If the result is outside acceptable range, do not use the delivery system for patient treatment, label the delivery system and notify the Biomed teammate. On 12/10/25 at 0900 hours, PCT 1 was observed initiating Patient 4 hemodialysis treatment. The following was identified: - PCT 1 disinfected Patient’s 4 left forearm fistula, checked and verified the site with stethoscope. - PCT 1 cannulated Patient 4’s AV fistula with two #15-gauge needles. - PCT 1 connected the two dialysis ports to Patient 4’s AV fistula needles and initiated the treatment. However, PCT 1 was not observed to have checked the dialysate pH level before initiating Patient 4’s treatment. On 12/1025 at 1006 hours, during an interview with PCT 1, PCT 1 verified he did not check the dialysate pH level before he initiated the treatment for Patient 4, and he verified the pH test should be done prior to treatments. 2. Review of the facility’s P&P titled Machine Start up and Priming a Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery System and Streamline Blood Lines for first shift of the day revised April 2025 showed if the dialysis delivery system fails any of the test and the cause cannot be corrected or if it fails subsequent test the dialysis delivery system should not be used for treatments. Review of the complaint intake dated 11/3/2025, showed that on 11/ 28 and 11/29/25 (assumed and needed to be verified dates), the complainant informed RN 2 that the heparin pump on the machine was not working during the treatments. After the treatment, the complainant informed RN 2 to have the other PCT change the machine because the complainant had to go home. However, when the complainant returned the next treatment day the machine with the non-functioning heparin pump was not changed and was used again. Review of Patient 5’s Treatment Details Report from August to December showed the specific dates with no machine heparin pump in use were treatment dates 8/29/25 and 9/1/25. Review the detail report for medication administered on both dates showed an order of heparin pork 800 units/hour, intravenous; via infusion every dialysis treatment, and with a total of 2,400 units administered but without the use of a pump. On 12/10/25 at 1119 hours, during an interview and concurrent record review was conducted with RN 2. RN 2 verified on 8/29/25 and 9/01/25, Machine #20’s heparin pump had a malfunction. RN 2 verified she decided to continue using the same machine even the heparin pump was not working, because the patient’s dialysis treatment was already started, and it would delay the treatment if she would have the dialysis machine changed with a working heparin pump. On 12/10/25 at 1600 hours, during an interview with Facility Administrator, he was informed and verified the above findings.”