Fresenius Kidney Care Opelousas St. Landry

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 14442 Based on policy review, observations, and interview, the dialysis facility failed to ensure that it follows standard infection control precautions for cleaning and disinfection of the dialysis station. This deficient practice was evidenced by failing to ensure the dialysis station was completely vacated by the patient before staff cleaned and disinfected the dialysis machine. Findings: Review of the facility Cleaning and Disinfection of the Dialysis Station policy revealed, in part: Definition: Dialysis Station. Area including the dialysis machine. Vacating the Machine: To prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection of the station and set up for the next patient. Observations of cleaning and disinfection of the dialysis station on 01/08/2024 at 11:38 a.m. revealed S3RN cleaned and disinfected the hemodialysis machine while Patient #1 was seated in the station treatment chair. In an interview on 01/10/2024 at 9:49 a.m., S2Clinic Manager confirmed the patient should completely vacate the dialysis station before staff begin cleaning and disinfection of the dialysis machine.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 14442 Based on record reviews and interviews, the dialysis facility failed to ensure staff follow manufacturer instructions for accurately documenting pH verification of the Fresenius 2008T Bluestar hemodialysis machine for 1 (#1) of 1 sampled patient. Findings: Review of the facility Biomedical Support Services TSB-Regulatory Guidance for Using the 2008 Independent Conductivity and pH document revealed, in part: Purpose: Recent advancement in the dialysis machines’ technology now incorporates an independent verification of conductivity and pH, no longer requiring staff to use an external means of verification as outlined below. Machine Instructions For Use: The latest 2008T Bluestar functional software version 2.72 or later now incorporates a method for the machine to independently verify conductivity and pH when used in accordance with the machine instruction for use and using the bibag disposable. Determining Independent Verifications: If the machine is using a bibag disposable, the machine will independently verify both conductivity and pH. Documentation: A new pH pass/fail (p/f) field was added to the machine set up screen to allow staff using machines enabled with Bluestar software and bibag systems to enter a pass/fail in the independent pH field as displayed on the machine. Review of Patient #1’s Treatment Sheets dated 12/20/2023, 12/22/2023, 12/24/2023, and 12/29/2023 revealed the Machine Setup pH pass/fail (p/f) section was blank. Further review revealed the pH (numerical) section had 7.0 documented. In an interview on 01/09/2024 at 2:31 p.m., S5ATOM confirmed Patient #1’s hemodialysis machine was a 2008T Bluestar machine and used a bibag disposable. S5ATOM confirmed staff should document pass or fail (p/f) in the independent pH field. S5ATOM confirmed the pH numerical section was for pH strips which the facility did not use with the 2008T Bluestar machine and bibag system. In an interview on 01/10/2024 at 9:36 a.m., S2Clinic Manager confirmed staff should document either pass or fail (p/f) in the pH section. S2Clinic Manager confirmed staff did not use pH strips and should not have documented 7.0 in the pH numerical section.”

“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: 14442 Based on record reviews and interview, the dialysis facility failed to ensure the patient’s dialysis prescription for dialysis flow rate was delivered as ordered by the physician for 1 (#1) of 1 sampled patient. Findings: Review of the facility Pre-Treatment Safety Checks Procedure revealed, in part: Pre-Dialysis Safety Checks: Verify the following elements by two direct patient care staff members prior to treatment initiation: Dialysate flow rate. After Patient is Seated: The clinician initiating treatment must verify the prescribed set up matches the patient: Prescription: Dialysate flow rate. Review of the facility Auto Flow Dialysate policy revealed, in part: Auto Flow Rate: Depending on the auto flow rate selected the dialysate flow rate will be either 1.5 or 2.0 times the blood flow rate. The dialysate flow rate will change when the user changes the blood flow rate. The following details the approximate transition points where the dialysate flow will change. Blood Flow Rate using Auto Flow 1.5. Blood Flow Rate 316 - 416. Dialysate Flow Rate 600. Review of Patient #1’s Hemodialysis Orders revealed, in part: BFR 350 mL/min and DFR Auto Flow 1.5. Review of Patient #1’s Treatment Sheet dated 12/31/2023 revealed BFR 350 mL/min and DFR 800 mL/min for the entire treatment. Review of Patient #1’s Treatment Sheet dated 01/08/2024 revealed BFR 350 mL/min and DFR 700 mL/min for first 1 hour 53 minutes treatment. The patient received 4 hours of dialysis treatment. In an interview on 01/10/2024 at 10:44 a.m., S2Clinic Manager confirmed Patient #1’s dialysis flow rate was not delivered as ordered by the physician on 12/31/2023 and 01/08/2024. S2Clinic Manager confirmed Patient #1’s dialysate flow rate should had been 600 mL/min.”