Fmc Trussville

“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 disinfected at the end of each dialysis treatment during 2 of 2 observations. This failure had the potential to negatively impact the safety and wellbeing of the 37 current patients who received dialysis treatments at the facility. Findings included: A facility policy titled, “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/2023, indicated, “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 section of the policy titled “Definition” revealed that a “Dialysis Station” was defined as an “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 of a water and dialysate preparation system] - Individual television and remote.” An observation of the hemodialysis treatment area on 07/14/2025 at 10:42 AM revealed Certified Clinical Hemodialysis Technician (CCHT) #5 failed to disinfect the sanitizer bottle and the bracket attached to the side of the dialysis machine while disinfecting Station 11. An observation of the hemodialysis treatment area on 07/14/2025 at 10:45 AM revealed CCHT #4 failed to disinfect the sanitizer bottle and the bracket attached to the side of the dialysis machine while disinfecting Station 8. During an interview on 07/14/2025 at 10:54 AM, CCHT #4 acknowledged she/he was trained and expected to disinfect all surfaces in the treatment stations after each dialysis treatment. During an interview on 07/14/2025 at 10:58 AM, CCHT #5 acknowledged she/he was trained and expected to disinfect all surfaces in the treatment stations after each dialysis treatment. During an interview on 07/14/2025 at 10:59 AM, the Clinical Manager confirmed staff were expected to disinfect all surfaces in the dialysis treatment stations after each dialysis treatment, including the sanitizer bottles and the brackets attached to the sides of the dialysis machines. During an interview on 07/17/2025 at 10:20 AM, the Medical Director confirmed staff were expected to disinfect all surfaces in the dialysis treatment stations after each dialysis treatment, including the sanitizer bottles and the brackets attached to the sides of the dialysis machines.”

“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, interview, manufacturer’s instructions for use (IFU) review, and facility procedure review, the facility failed to follow the bloodline manufacturer’s IFU by not maintaining the arterial drip chamber fluid levels at approximately 90% full and the venous drip chamber fluid levels at approximately 70% full during 4 of 4 observations. Failure to follow the manufacturer’s IFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 37 current patients who received dialysis treatments at the facility. Findings included: A facility procedure titled, “Priming an Optiflux Single Use E-beam Dialyzer,” published 05/05/2025, indicated, “8. Fill the Pre-pump arterial chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 85% - 95% full and tighten cap. Close the clamp on the level adjust line.” Further review indicated, “12. Fill venous chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 65% - 75% full. Tighten cap and close clamp on the level adjust line when chamber is filled.” The manufacturer’s IFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors,” indicated, “During Treatment a. Periodically check the extracorporeal circuit for any evidence of possible separation or leaks. b. Do not allow the access or bloodline connections to be covered with a blanket or clothing during treatment. c. Maintain fluid level in arterial chamber at approximately 90% full and venous chamber at approximately 70% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air leaks will also cause the chamber levels to fluctuate.” Observation of the hemodialysis treatment area on 07/14/2025 at 10:30 AM revealed the arterial drip chamber fluid levels were approximately less than (<) 90% full in Stations 1, 4, 5, 6, 10, 12, 13, 14, 17, 18, 19, and 20, and approximately greater than (>) 70% full in Stations 1, 4, 5, 10, 13, 14, 17, 18, 19, and 20. Observation of the hemodialysis treatment area on 07/16/2025 at 11:37 AM and 11:45 AM revealed the arterial drip chamber fluid levels were approximately < 90% full in Stations 1, 2, 3, 10, 11, 12, 13, 15, 16, 17, 19, and 20, and approximately > 70% full in Stations 1, 2, 3, 7, 9, 10, 11, 12, 13, 15, 16, 17, 19, and 20. Observation of the hemodialysis treatment area on 07/16/2025 at 3:15 PM revealed the arterial drip chamber fluid levels were approximately < 90% full in Stations 2, 4, 8, and 18, and approximately > 70% full in Stations 2, 4, 7, 8, and 18. During an interview on 07/16/2025 at 3:15 PM in the treatment area with the Clinical Manager (CM) after review of the manufacturer’s IFU, the CM confirmed the drip chamber fluid levels were not maintained according to the manufacturer’s IFU. During an interview on 07/16/2025 at 4:15 PM, Registered Nurse (RN) #3 stated the drip chamber fluid levels should be “one third of the way” full. RN #3 confirmed the drip chamber fluid levels were not maintained according to the manufacturer’s IFU. During an interview on 07/16/2025 at 4:39 PM, Certified Clinical Hemodialysis Technician #5 stated the drip chambers should be “at least 80 [percent]” in the venous chamber and “90 [percent] in the arterial chamber. CCHT #5 confirmed the drip chamber fluid levels were not maintained according to the manufacturer’s IFU. During an interview on 07/17/2025 at 10:20 AM, the Medical Director confirmed the facility staff were expected to follow the manufacturer’s IFU for maintaining the drip chamber fluid levels during dialysis treatment and readjust as needed.”