Fmc - East Louisville

“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, manufacturers’ instructions for use (IFU) review, and facility policy 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 manufacturers’ IFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 65 patients who received dialysis treatments at the facility. The findings include: Review of 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.” Further review indicated, “12. Fill the venous chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 65% - 75% full.” An undated manufacturer’s IFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors” indicated that during treatment, “c. Maintain fluid level in arterial chamber at approximately 90% full and venous chambers 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.” An observation of the hemodialysis treatment area on 09/29/2025 at 9:58 AM revealed the arterial drip chamber fluid levels were less than (<) 90% full in Stations 1, 2, 7, 12, 15, 16, 17, 18, 19, and 20, and the venous drip chamber fluid levels were greater than (>) 70% full in Stations 1, 2, 7, 9, 11, 12, 13, 15, 16, 17, 18, 19, and 20. An observation of the hemodialysis treatment area on 10/01/2025 at 9:22 AM revealed the arterial drip chamber fluid levels were < 90% full in Stations 1, 2, 5, 10, 11, 12, 14, 15, 16, and 20, and the venous drip chamber fluid levels were > 70% full in Stations 1, 2, 5, 6, 8, 9, 10, 11, 12, 14, 15, 16, and 20. An observation of the hemodialysis treatment area on 10/01/2025 at 9:50 AM revealed the arterial drip chamber fluid levels were < 90% full in Stations 1, 2, 8, 11, 12, 15, 16, and 20, and the venous drip chamber fluid levels were > 70% full in Stations 1, 2, 6, 8, 9, 11, 12, 15, 16, and 20. An observation of the hemodialysis treatment area on 12/12/2025 at 7:50 AM revealed the arterial drip chamber fluid levels were < 90% full in Stations 1, 4, 5, 6, 8, 9, 10, 15, and 16, and the venous drip chamber fluid levels were > 70% full in Stations 1, 3, 4, 5, 6, 7, 8, 9, 10, 13, 14, 15, 16, and 20. During an interview on 12/12/2025 at 7:50 AM, Registered Nurse (RN) #1 stated the chamber fluid levels were not maintained per the bloodline manufacturer’s IFU. During an interview on 12/12/2025 at 8:12 AM, RN #2 stated she was trained to maintain the drip chambers at “half full or 80% [full]” and “to the line [on the chambers].” During an interview on 12/12/2025 at 8:28 AM, the Certified Clinical Hemodialysis Technician stated, “We were taught to save some [space] for the air” in the venous chamber and “at least halfway full” in the arterial chamber. During an interview on 12/12/2025 at 8:44 AM, the Interim Clinical Manager stated staff were expected to follow the bloodline manufacturer’s IFU for the chamber fluid levels. During an interview on 12/12/2025 at 11:08 AM, the Medical Director stated the staff were expected to follow the bloodline manufacturer’s IFU for the chamber fluid levels.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 35949 Based on interview, record review, and facility policy review, the facility failed to monitor patients’ vital signs and/or machine parameters according to the expectations in their policy for 6 (Patients #2, #3, #4, #5, #6, and #7) of 7 sampled patients. Failure to monitor patients’ vital signs and/or machine parameters during dialysis treatments according to the facility’s policy provided an opportunity for changes to the patients’ vital signs, blood flow rate, dialysate flow rate, arterial and/or venous pressures to be unrecognized and unaddressed and negatively impact the care provided to the 65 in-center patients who received dialysis treatments at the facility. The findings include: Review of facility policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, revealed the section titled, “During Treatment,” included, “- 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.” 1. Review of Patient #2’s treatment sheet dated 09/09/2025 revealed machine parameters were not documented for 65 minutes, from 10:03 AM until 11:08 AM and for 64 minutes, from 11:38 AM until 12:42 PM. Review of Patient #2’s treatment sheet dated 09/13/2025 revealed vital signs were not documented for 60 minutes, from 10:00 AM until 11:00 AM, and machine parameters were not documented for 54 minutes, from 10:08 AM until 11:02 AM. Review of Patient #2’s treatment sheet dated 09/27/2025 revealed machine parameters were not documented for 47 minutes, from 10:03 AM until 10:50 AM 2. Review of Patient #3’s treatment sheet dated 09/12/2025 revealed machine parameters were not documented for 47 minutes, from 9:03 AM until 9:50 AM, vital signs were not documented for 61 minutes, from 9:03 AM until 10:04 AM, and machine parameters were not documented for 59 minutes, from 10:04 AM until 11:03 AM. Review of Patient #3’s treatment sheet dated 09/19/2025 revealed machine parameters were not documented for 89 minutes, from 9:32 AM until 11:01 AM. 3. Review of Patient #4’s treatment sheet dated 09/10/2025 revealed machine parameters were not documented for 190 minutes, from 11:25 AM when the treatment was started until 2:33 PM, and vital signs were not documented for 48 minutes, from 1:00 PM until 1:48 PM. Review of Patient #4’s treatment sheet dated 09/15/2025 revealed machine parameters were not documented for 59 minutes, from 2:04 PM until 3:03 PM, and machine parameters were not documented for 72 minutes, from 3:03 PM until the treatment was terminated at 4:15 PM. Review of Patient #4’s treatment sheet dated 09/24/2025 revealed vital signs and machine parameters were not documented for 51 minutes, from 11:42 AM until 12:33 PM. 4. Review of Patient #5’s treatment sheet dated 09/09/2025 revealed vital signs and machine parameters were not documented for 88 minutes, from 1:05 PM until 2:33 PM. 5. Review of Patient #6’s treatment sheet dated 09/10/2025 revealed vital signs and machine parameters were not documented for 80 minutes, from 11:18 AM until 12:38 PM. Patient #6’s treatment sheet dated 09/26/2025 revealed machine parameters were not documented for 47 minutes, from 1:32 PM until 2:19 PM. 6. Review of Patient #7’s treatment sheet dated 09/19/2025 revealed machine parameters were not documented for 54 minutes, from 9:02 AM until 9:56 AM, and the vital signs were not documented for 55 minutes, from 9:02 AM until the treatment was terminated at 9:57 AM. During an interview on 10/01/2025 at 2:40 PM, the Acting Clinic Manager stated vital signs and machine parameters should be documented every 30 to 45 minutes. During an interview on 12/12/2025 at 8:12 AM, Registered Nurse #2 stated she was trained to document vital signs and machine parameters every 30 minutes. During an interview on 12/12/2025 at 8:28 AM, the Certified Clinical Hemodialysis Technician stated that they check the vital signs and machine parameters every 30 minutes. During an interview on 12/12/2025 at 11:08 AM, the Medical Director stated staff were trained and expected to monitor and document vital signs and machine parameters every 30 minutes per the facility’s policy.”