Observations:
Based on review of facility documents, tour and interview with staff (EMP), it was determined that the facility failed to follow their approved policy for Managing Malfunction Devices in the Operating Room.
Findings include:
A review of facility policy "Managing Malfunction Devices in the Operating Room" dated July 27, 2023, revealed "It is the policy of UPMC to comply with the provisions of Safe Medical Device Act (SMDA) ... D. Malfunctioning Equipment: these include the medical devices that are serviced, inspected, and receive inspection tags by Clinical Engineering. 1. Immediately remove the device from patient use/circulation .."
A tour conducted on June 17, 2024, of operating rooms revealed three booms (equipment used to centralize all surgical support equipment and utility services where there is a need for access to medical gases such as oxygen, nitrogen, and carbon dioxide, electrical power and audio-visual data services) that were previously broken had a break mechanism added while waiting for the arrival of the new replacment booms. Observation noted that if the brake mechanism was not applied the boom could move.
Interview conducted on June 17, 2024 with EMP7 confirmed the booms were broken in 3 of the operating rooms and had been taped and propped to hold them in place so they did not move during surgical procedures. Further interview confirmed that the booms should remain stationary during the procedure unless moved by the staff. If the boom moves then this can be a patient safety concern and an infection control concern.
Interview conducted on June 17, 2024, with EMP1 confirmed that the booms were not working correctly and the operating room continued to be used to provide surgical services.
Interview conducted on June 17, 2024 with EMP 6 revealed that the facility became aware of the problem with the booms in March of 2024.
| | Plan of Correction - To be completed: 07/16/2024
A multidisciplinary team met on June 28, 2024, to discuss the finding and develop a plan of correction. The team included the UPMC Carlisle President, VP Patient Care Services/Chief Nurse Officer, Chief Medical Officer, VP Service Coordination, Director Performance Improvement, Clinical Director Surgical Services, Unit Director – Operating Room, Unit Director – Peri anesthesia, Patient Safety Specialist, Radiology Enterprise Engineers, and Director Regulatory Compliance. The following plan was developed:
- Communication of nonfunctioning surgical equipment will be discussed and reported daily during the morning huddle. The daily huddle includes scheduled staff and nursing leaders. Any malfunctioning equipment will be documented in the daily communication log. The Unit Director or Clinician will initiate the algorithm when appropriate.
- An algorithm was developed to guide the flow of communication and mitigation steps to be followed when equipment required for surgery is not functioning. If the mitigation steps initiated by the front-line leaders do not resolve the concern, the issue will be escalated to the senior administrative team comprised of the President, Chief Nurse Officer, Vice President of Medical Affairs, and the Chair of Surgery.
- The senior administrative team will determine if surgeries can continue. The outcome of the administrative team's review will be communicated immediately to the surgical leaders (Unit Director, Clinicians). All scheduled OR team members will be immediately notified of the final decision by the Unit Director/Clinician.
- Monthly, the Biomedical Engineering department will generate a report of the work request activity from the previous month and share with the Operating Room Unit Director. The team will review the biomed work orders to determine if there are any trends. In addition, the Surgical Services leadership (Unit Director, Clinician) and Biomedical Engineering will perform monthly rounding by performing a walk through in the operating room suite.
|
