Fmc Bma East Charlotte

“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: 32003 Based on NCBON position statement review, policy review, and staff interview, the facility staff failed to validate heparin prepared by a technician for 1 of 2 observations. The findings include: Review on June 4, 2025 of the position statement from the NCBON revised September 2021 revealed, “ ... 2. May assist the licensed nurse with the administration of heparin, lidocaine, and normal saline, provided there is an established written protocol which limits the delegation to the competent UAP (dialysis technician). Review on June 6, 2025 of the facility’s policy, “North Carolina State Specific: Heparin Administration by Patient Care Technicians” published February 25, 2025 revealed, “ ...Validation Process [space] To validate heparin dose: The Licensed Nurse will watch the PCT draw up heparin into the syringe based on the information on the medication label. ...” Observation of June 5, 2025 at 9:35 AM revealed, PCT #1 obtained two syringes from the “nurse must validate” basket in the medication room. The technician then went to dialysis station #5 with the intent to administer the solution to Patient #16 as a CVC post-treatment. Observation of the two syringes revealed, the nursing staff did not validated the solution and dosage. Interview on June 5, 2025 at 9:40 AM with Nurse #1 revealed PCT #1 drew up the solution without validation from a nurse.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 32003 Based on review of the RO log, review of facility signage, observation of the RO display module, and staff interviews, the facility staff failed to ensure weekly heat disinfections were performed for 1 of 1 RO system for 1 of 2 months reviewed (May 2025). The findings include: Review on June 4, 2025 at about 1:45 PM of the RO log revealed, technical issues with the water softener were identified May 12, 2025 through May 17, 2025 (6-days). From May 19, 2025 through May 21, 2025 (3-days) and May 28, 2025, issues were identified with the verification of the last heat disinfection. Review revealed with each instance, the Biomedical Technician(s) were notified of the technical issues. Review on June 4, 2025 at about 2:30 PM signage posted on the RO system had no effective date and revealed, “What to do when there is a heat disinfection failure on the [brand] RO Displaying W-02-52-03 Warning: Heat disinfection stopped...1...2...3...PLEASE PLACE A WORK ORDER IN [management system] TO DOCUMENT THE PATIENT TREATMENT DELAY AND NOTIFY TECHNICAL!...” Observation on June 4, 2025 at about 2:30 PM of the display panel on the RO system revealed, the last heat disinfection occurred May 11, 2025 and the last chemical disinfection occurred May 20, 2025. Interview on June 4, 2025 at about 2:30 PM with the ATOM revealed, heat disinfection should occur every Sunday and chemical disinfection should occur once a month. Interview revealed two (2) heat disinfections were not performed (May 18, 2025 and May 25, 2025) and no work order was entered into [management system] for the technical issue. Telephone interview on June 6, 2025 at 12:52 PM with the Medical Director revealed, heat disinfection for the RO system was an organizational expectation and knowledge of the technical issue would not be provided to him until the next facility-level quality meeting.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 32003 Based on policy review, observation, and staff interview, the facility staff failed to ensure a face mask was not covering the eyes of a patient during dialysis treatment for 1 of 1 patient (Pt #12). The findings include: Review on June 6, 2025 of the facility’s policy, “Patient Assessment and Monitoring” revised May 5, 2023 revealed, “Purpose...Responsibility...Definitions...Delegation ...Data Collection ...Pre-Treatment ...During Treatment ...[space] General Observation/Mental Status [space] ...Ensure each patient’s face is visible and uncovered. Patients may not wear sunglasses or sleeping masks without medical documentation confirming a photosensitivity condition ...” Observation on June 5, 2025 from 8:30 AM to 10:05 AM (95-minutes) revealed, Patient #12 was located dialysis station #27 and the eyes were covered with a yellow face mask. At 9:00 AM, 10:00 AM, and 10:32 AM, PCT #2 was at the chairside and manually entered blood pressure, pulse rates, and BFR/DFR. Observation revealed the technician did not ask the patient to lift up or remove the face mask so that visualization of the patient’s eyes could occur. Open medical record review on June 5, 2025 revealed, Patient #12 was admitted to the in-center facility and had no documented photosensitivity condition. Interview on June 6, 2025 at about 10:20 AM with the Clinical Manager revealed, Patient #12 had no documented photosensitivity condition. NC00228023”