Fresenius Medical Care Cheraw

“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: 35949 Based on observation, interview, and facility policy review, the facility failed to ensure all environmental surfaces in the dialysis treatment stations were or could be disinfected at the end of each dialysis treatment during 3 of 3 observations. This failure had the potential to affect 80 patients who received dialysis treatments at the facility. Findings included: 1. An observation of the hemodialysis treatment area on 03/18/2025 at 9:50 AM revealed Certified Clinical Hemodialysis Technician (CCHT) #8 failed to disinfect the sanitizer bottle and bracket attached to the hemodialysis machine while disinfecting Station 19. An observation of the hemodialysis treatment area on 03/18/2025 at 10:20 AM revealed CCHT #11 failed to disinfect the sanitizer bottle and bracket attached to the hemodialysis machine while disinfecting Station 10. During an interview on 03/18/2025 at 10:25 AM, CCHT #11 stated he did not disinfect the sanitizer bottle and bracket. CCHT #11 stated he was trained and expected to disinfect all surfaces in the treatment station. During an interview on 03/18/2025 at 10:27 AM, CCHT #8 stated she did not disinfect the sanitizer bottle and bracket. CCHT #8 stated she was trained and expected to disinfect all surfaces in the treatment station. During an interview on 03/18/2025 at 10:28 AM, the Clinical Manager (CM) stated staff were trained and expected to disinfect “everything” in the dialysis treatment stations after each dialysis treatment. 2. An observation of the hemodialysis treatment area on 03/19/2025 at 11:55 AM revealed tape and tape adhesive residue on the chairside tables of each dialysis chair in all 28 hemodialysis stations and on an additional chair stored near the supply room door. During an interview on 03/19/2025 at 3:28 PM, Registered Nurse (RN) #5 acknowledged the chairside tables were unable to be thoroughly disinfected due to the tape and tape adhesive residue. During an interview on 03/19/2025 at 3:30 PM, Certified Clinical Hemodialysis Technician (CCHT) #7 acknowledged the chairside tables were unable to be thoroughly disinfected due to the tape and tape adhesive residue. During an interview on 03/19/2025 at 3:35 PM, the Clinical Manager (CM) acknowledged the chairside tables were unable to be thoroughly disinfected due to the tape and tape adhesive residue. During an interview on 03/20/2025 at 10:28 AM, the Medical Director confirmed staff should disinfect all environmental surfaces in the dialysis treatment stations. A facility policy titled, “Cleaning and Disinfection of the Dialysis Station,” published 11/02/2020, indicated, “Background: The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses.” The policy also indicated “Definition,” “Dialysis Station,” and “Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment, patient training, and/or patient clinic visits. Equipment in the dialysis station may include (but is not limited to) the following: - Dialysis machine/cycler and attachments such as IV [intravenous] pole, BP [blood pressure] cuff and hand sanitizer/holder, organizer - Chair/bed - [Brand name hemodialysis system] - Individual television and remote.””

“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, facility policy review, review of manufacturer’s instructions for use (IFU), and interviews, the facility failed to maintain arterial drip chamber fluid levels at 85% to 95% full and venous drip chamber fluid levels at 65% to 75% full during 3 of 3 observations. This failure had the potential to affect 80 patients who received dialysis treatments at the facility. Findings included: An observation of the hemodialysis treatment area on 03/17/2025 at 9:28 AM revealed the arterial drip chamber fluid levels were less than (<) 85% full in Stations 3, 4, 7, 8, 9, 13, 14, 17, 19, 20, 22, 23, 26, 27, and 28, and the venous drip chamber fluid levels were greater than (>) 75% full in Stations 2, 3, 4, 6, 7, 8, 9, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 23, 25, 26, 27, and 28. An observation of the hemodialysis treatment area on 03/19/2025 at 8:44 AM revealed the arterial drip chamber fluid levels were < 85% full in Stations 6, 7, 8, 9, 10, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 26, 27, and 28, and the venous drip chamber fluid levels were > 75% full in Stations 3, 4, 6, 8, 9, 10, 12, 13, 14, 15, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, and 28. An observation of the hemodialysis treatment area on 03/19/2025 at 11:37 AM revealed the arterial drip chamber fluid levels were < 85% full in Stations 2, 6, 8, 9, 10, 12, 13, 21, 22, 23, 26, and 28, and the venous drip chamber fluid levels were > 75% full in Stations 2, 6, 8, 9, 10, 12, 13, 16, 17, 18, 21, 23, 24, 25, 26, and 28. A facility policy titled, “Initiation of Treatment Using an Arteriovenous Graft or Fistula and [Brand name] Dialyzer,” published 05/26/2024, indicated, “Final Machine Verification - Prior to starting the blood pump, verify the following... 5. The arterial chamber is 85-95% full, and venous chamber is 65-75% full. ...” The manufacturer’s IFU titled, “[Brand name] Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors,” indicated, “...2. During Treatment a. Periodically check the extracorporeal [out of the body] circuit for any evidence of possible Separation [sic] or leaks. b. Maintain fluid level in pre-pump arterial chamber at 85 to 95% full, post-pump arterial and venous chambers at 65 to 75% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air Leaks [sic] will also cause the chamber levels to fluctuate.” During an interview on 03/19/2025 at 11:40 AM, Certified Clinical Hemodialysis Technician (CCHT) #7 stated “three quarters” full when asked the required level of blood in the arterial and venous drip chambers. CCHT #7 confirmed the arterial and venous drip chamber fluid levels were not maintained according to the manufacturer’s IFU. During an interview on 03/19/2025 at 11:44 AM, the Clinical Manager (CM) stated “full to three quarters” full when asked the required level of blood in the arterial and venous drip chambers. The CM reviewed the manufacturer’s IFU and confirmed the arterial and venous drip chamber fluid levels were not maintained according to the IFU. During an interview on 03/20/2025 at 10:28 AM, the Medical Director confirmed the staff should follow the manufacturer’s IFU.”