Fmc- Wayne County

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 35697 Based on record review, interview, and facility policy review, the facility failed to ensure a patient event involving 1 (Patient #1) of 7 sampled patients was reported and failed to call the local fire department in accordance with facility policies when 1 of 15 dialysis machines malfunctioned during treatment and produced smoke and a burning smell. Findings included: A facility policy titled, “Fire Drill,” dated 08/02/2017, indicated, “Basic Fire Training” included “Flames may not be the only indication of a fire in the dialysis facility [sic] a potential fire may smolder behind walls, in electrical outlets or wiring, or in equipment before actual flames appear. Staff should immediately remove patients and staff from the location and call the local fire department when any of the following signs are present: - Burning smell - Smoke.” A facility policy titled, “Patient Safety Event Reporting and Documentation,” dated 02/06/2023, indicated, “Medical Devices in use during a patient event shall be sequestered until further review. Additional investigation may be necessary to determine if the medical device may have caused or contributed to the patient event.” The policy revealed, “If ...” “Device failed, malfunctioned, a potential safety hazard is discovered, or staff expressed dissatisfaction with a produce.” “Then ....” “Notify Technical Services - Submit a [Facility Name] Product Compliant Form.” Patient #1’s “Treatment Sheet for Facility,” dated 09/14/2022, revealed the patient’s treatment was discontinued early due to the patient’s dialysis machine started smoking. The treatment sheet revealed the patient was immediately disconnected from the machine and their chair was pulled away from the machine. The treatment sheet revealed the machine was pulled from use and a work order was placed. During an interview with Biomedical Technician (Biomed Tech) #3 and the Clinic Manager on 10/23/2024 at 1:10 PM, the Clinic Manager stated that (for the incident on 09/14/2022) they did not call the fire department as per the facility policy; they stopped Patient #1’s treatment and pulled the machine from the treatment area. Biomed Tech #3 confirmed that there was a burning smell and smoke coming from the machine. The Clinic Manager stated they did not file an incident report. During an interview on 10/24/2024 at 9:40 AM, Registered Nurse (RN) #7 stated she remembered taking care of Patient #1 on 09/14/2022. RN #7 stated that she remembered there was a burning smell and smoke coming from the patient’s machine. RN #7 stated that neither she nor anyone else from the facility called the fire department or emergency services. During an interview on 10/24/2024 at 11:00 AM, the Staff Nephrologist stated that he was present at the facility during the incident on 09/14/2022. The Staff Nephrologist stated by the time he entered the treatment area the staff had already moved the machine. The Staff Nephrologist stated that he was not aware if the fire department had been called, nor was he sure if an incident report was filed.”