151.45 Electrical safety
All appliances, instruments and
installations shall be tested before
use to determine compliance with
grounding, current leakage, and other
device safety requirements to ensure
protection of patients and employes. A
program of routine maintenance shall
be effectively enforced to ensure that
all electrical receptacles and plugs,
wires, and connectors are safe. If an
appliance requiring three-wire
circuitry for grounding is attached to
a two-wire outlet, the adaptor plug
pigtail shall be attached to a
ground.
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Observations:
Based on review of facility documents, observation and staff interview (EMP), it was determined the facility failed to ensure the contracted biomedical service completed routine maintenance on electrical equipment used for patient care in the Emergency Department (ED).
Findings include:
Review on July 24, 2025, of the facility's "Biomedical Equipment Management" policy, no review date, revealed "Policy: All mechanical and electrical patient care equipment will be evaluated prior to use based on maintenance requirements. All incoming and existing equipment meeting the evaluation criteria are included in the medical equipment management program. An inventory of equipment included in the program and equipment maintenance records documenting all maintenance on equipment is kept in the Maintenance Department office. Procedure: All biomedical equipment is evaluated on use, function, maintenance requirements and equipment history. All biomedical equipment found to defective / not operating correctly will be evaluated by Maintenance Department staff. Minor repairs that do not require specialized knowledge or repairs that do not require certification shall be performed by the Maintenance Department staff. Any device that requires specialized knowledge to perform repairs will [sic] sent to qualified service locations for repairs ..."
Review on July 24, 2025, of the facility's "Biomedical Engineering Services Contract" dated December 1, 1996, for the period November 1, 2024, to October 31, 2025, revealed "...Agreement between [name of contracted Biomedical Engineering Services] desires to provide Biomedical Engineering services to the Client and whereas the Client desires to contract with the [Name] to provide Biomedical Engineering Services for routine preventive maintenance and emergency repairing ..."
Observation of the Emergency Department (ED) on July 24, 2025, at approximately 1100 revealed cardiac monitors in ED bays one through eight had preventative maintenance (PM) stickers dated with a completion date of April 2024 and due October 2024. Further observation revealed a Glidescope (an instrument used to visualize the vocal cords for airway management such as placing a breathing tube) in bay 7 with a PM sticker due January 2025.
An interview with EMP10 confirmed the above findings and revealed preventative maintenance is performed by [name of contracted Biomedical Engineering Services]. EMP10 revealed they were unsure if PMs were recently completed and it is possible the tags peeled off.
An interview with EMP2 on July 24, 2025, at approximately 1515 revealed the facility has a contract [name of contracted Biomedical Engineering Services] for PM to include all equipment in the hospital.
A request was made of EMP10 on July 24, 2025, for the facility's preventative maintenance tracking log. None was provided.
Interview with EMP1 and EMP2 on July 24, 2025, revealed the facility does not have preventative maintenance tracking logs.
| | Plan of Correction - To be completed: 09/05/2025
1) EMHS' Biomedical vendor was on-site from July 28th - July 31st completing the required biomedical services and electrical checks on all of EMHS' equipment.
2) Facilities Services Staff will review and/or revise the Biomedical Equipment Managment Policy.
3) All Facilities Services Staff will review the Biomedical Equipment Managment Policy and any revisions and be required to sign off on the policy review.
4) The Biomedical Engineering Services Contract will be reviewed with the Facilities Services Manager. The covered items list will be reviewed and updated to reflect current service dates and future service dates.
5) A Biomedical Engineering Services Review calendar will be established to identify annual biosafety checks and review for contract compliance.
6) Any non-compliance with the contract will be addressed by the Facilities Services Manager and the CEO.
7) This plan of correction will be monitored by the CEO for compliance. Any issues of staff non-compliance will be addressed following EMHS' progressive discipline policy.
8) The policy review, staff review, and implementation of the services review calendar will be completed on or before 9/5/2025.
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