032607 Avondale Dialysis (Fmc)

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 52534 Based on document review and interview, it was determined that the facility failed to ensure state law was followed regarding safety checks being performed every 30 minutes for (3) of (6) treatments for Patient #4. Failure to monitor patients every 30 minutes during dialysis treatment has the potential risk of patient harm if staff do not recognize and provide necessary interventions for problems patients may experience during treatment. Findings include: Arizona Administrative Code requires: “...R9-10-1018. Dialysis Services ...E. An administrator of an outpatient treatment center that is authorized to provide dialysis services shall ensure that for a patient receiving dialysis services:...7. The patient:...e. Is monitored by a personnel member while receiving dialysis at least once every 30 minutes ...” The facility policy titled “Patient Assessment and Monitoring” requires “...during Treatment ...Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations ....” Patient #4 ’ s medical record review on 07/21/2025 revealed: Treatment sheet dated 07/17/2025 08:44 to 09:22 vital signs 38 minutes apart Treatment sheet dated 07/10/2025 09:00 to 09:42 vital signs 42 minutes apart Treatment sheet dated 07/05/2025 10:01 to 10:40 vital signs 38 minutes apart Employees #1, 2, and 5 confirmed on 07/21/2025 that Patient #4 did not have safety checks performed every 30 minutes according to facility policy.”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 52534 Based on document review, observation, and interview it was determined that the facility failed to ensure staff appropriately disinfected (2) of (6) patients (Patients #12 and 13) vascular access prior to cannulation which has the potential risk of blood stream infection and vascular access infection if the site is not disinfected properly. Findings include: The facility policy titled “Access Assessment and Cannulation” requires “...Disinfect cannulation site as follows using any of the disinfectants below: 70% isopropyl alcohol pad: using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating ....” Observation on 07/21/2025 revealed Employee #28 cleaning Patient #13 ’ s vascular access for cannulation. Employee #11 disinfected the arterial site using isopropyl alcohol for 22 seconds, and then disinfected the venous site with isopropyl alcohol for 35 seconds. Observation on 07/22/2025 revealed Employee #25 cleaning Patient #12 ’ s vascular access for cannulation. Employee #11 disinfected the arterial site using isopropyl alcohol for 29 seconds, and then disinfected the venous site with isopropyl alcohol for 22 seconds. Employee #1 confirmed on 07/22/2025 that Employees #25 and 28 did not disinfect Patients #12 and 13 ’ s vascular access according to facility policy.”

“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: 52534 Based on document review and interview, it was determined that the facility failed to ensure biomedical technical staff accurately documented in the dialysis equipment maintenance records and performed annual preventive maintenance as required in the manufacturer’s directions for use (DFU) which has the potential for patient injury or harm if dialysis machines are not maintained and normal operation is not verified. Findings include: The document titled “2008T Machine Operator’s Manual” referenced preventive maintenance in the “”2008T Hemodialysis System Preventive Maintenance Procedures” document as follows. The document titled “2008T HEMODIALYSIS SYSTEM PREVENTIVE MAINTENANCE PROCEDURES” requires: “...Preventive Maintenance for the 2008T Hemodialysis System...Scheduled maintenance is performed based on timed intervals or number of hours a machine is operated, whichever comes first. The time and hours intervals are as follows: ...Machines without...with Extended Life Pump Components...Six (6) months...Annually or after 4000 hours of operation...Failure to install, operate and maintain this equipment according to the manufacturer’s instructions may cause injury or death to the patient or the operator...Included in the Preventive Maintenance procedures are tests to verify normal machine operation....” The document titled “Action Plan System Logs 09/23/2024” revealed “...Summary of Outliers / Findings ... Machine hours documented incorrectly for multiple machines for the last year .... Actions Planned ...Will monitor hours documentation on all preventative maintenance for machines for the next 3 months - ATOM ...Update #1 (12/18/2024) Machine hour logging is on-going and improving. Will continue to monitor for a year .... Update #2 (01/17/2025) No new machine hour discrepancies found ... Update #3 (02/25/2025) No new machine hours discrepancies found ... Resolved 02/25/2025 The “FKC EQUIPMENT RECORD” for preventive maintenance and work orders for the last 12 months for dialysis machines was reviewed and found to have discrepancies in record keeping for tracking machine hours and corresponding maintenance during the Action Plan and following the resolution of the Action Plan. The following dialysis machine records contained inaccurate documentation of hours in operation and that preventive maintenance was not performed within the manufacturer’s DFU. Dialysis machine 02T0S249515 01/21/2025: clock hours 22,000 01/27/2025: clock hours 21,591 01/15/2025: clock hours 22,675 Dialysis machine 02T0S249561 11/21/2024: clock hours 21,000 01/27/2025: clock hours 20,758 02/24/2025: clock hours 21,078 02/24/2025: clock hours 22,000 05/08/2025: clock hours 23,000 07/14/2025: clock hours 22,989 Dialysis machine 02T0S251622 11/21/2024: clock hours 21,000 01/27/2025: clock hours 20,629 02/24/2025: clock hours 21,077 02/24/2025: clock hours 22,000 03/11/2025: clock hours 21,056 05/08/2025: clock hours 23,000 07/07/2025: clock hours 22,659 Dialysis machine 02T0S251623 11/21/2024: clock hours 21,000 01/27/2025: clock hours 19,860 05/08/2025: clock hours 23,000 07/14/2025: clock hours 22,030 Dialysis machine 02T0S251628 10/08/2024: clock hours 18,470 10/08/2024: clock hours 18,470 11/21/2024: clock hours 21,000 01/27/2025: clock hours 19,938 04/18/2025: clock hours 22,803 04/18/2025: clock hours 22,360 05/11/2025: clock hours 23,000 07/14/2025: clock hours 22,407 Dialysis machine 02T0S251630 03/11/2025: clock hours 22,866 04/18/2025: clock hours 22,360 Dialysis machine 02T0S251631 10/04/2024: clock hours 20,695 10/03/2024: clock hours 20,055 04/18/2025: clock hours 22,360 04/18/2025: clock hours 22,803 Dialysis machine 02T0S251632 04/18/2025: clock hours 23,294 05/08/2025: clock hours 23,000 Dialysis machine 02T0S251635 11/07/2024: clock hours 21,235 11/21/2024: clock hours 21,000 Dialysis machine 02T0S251661 11/21/2024: clock hours 21,000 12/14/2024: clock hours 20,506 01/27/2025: clock hours 22,351 03/11/2025: clock hours 21,874 Dialysis machine 02T0S251663 11/21/2024: clock hours 21,000 12/14/2024: clock hours 20,748 Dialysis machine 02T0S251672 01/27/2025: clock hours 22,310 03/11/2025: clock hours 22,168 Dialysis machine 92T0S235813 11/21/2024: clock hours 21,000 01/23/2025: clock hours 22,000 01/27/2025: clock hours 21,745 Dialysis machine 92T0S236029 11/21/2024: clock hours 21,000 01/23/2025: clock hours 22,115 01/27/2025: clock hours 21,920 01/15/2025: clock hours 22,675 Employees #2, 32, and 33 confirmed on 07/21/2025 that clock hours used to determine timeframes for performing dialysis machine preventive maintenance were not logged accurately in the facility equipment record, making it difficult to determine if the DFU for machine maintenance was followed. Employee #1 confirmed on 07/22/2025 that the inaccurate hours persisted during the Action Plan and following the resolution date of the Action Plan.”