HospitalInspections.org

Based on review of facility documentation and staff interviews (EMP), it was determined that the facility failed to follow its policy and manufacturer guidelines for the preventative maintance (PM) of 25 medical devices.

Findings include:

Review of the Butler Memorial Hospital Policy C.E.001- Medical Equipment Management Plan, revised January 2006, revealed, "PURPOSE: The Medical Equipment Management Plan (MEMP) establishes and maintains a program to promote the safe and effective use of medical equipment. Clinical Engineering has responsibility for equipment designated as medical devices* and is responsible for administering the records of equipment included in the MEMP. ... * Medical devices are defined as those which are intended to be used for diagnostic, therapeutic or monitoring care provided to the patient ... C. Maintenance Activities The facility utilizes maintenance strategies including, but not limited to, predictive interval based, corrective and metered, based on manufacturers' recommendations. Definitions: ... 2. Planned Maintenance: consists of a documented visual inspection, electrical safety testing, performance verification including alarms if applicable, and cleaning as required: may also include calibration and replacement of parts or consumables (PM kits, filters, batteries, etc.), specific to device as required per manufacturer. ... 5. Life Support Equipment: consists of devices intended to sustain life and whose failure to perform its primary function when used according to manufacturers' instructions and clinical protocol, is expected to result in imminent death in the absence of immediate intervention (see Appendix A, Life Support Equipment). ... Appendix A: Life Support Equipment A life support equipment list has been established by Butler Health System. Life Support Equipment will be inspected and maintained per the Manufacturers recommended maintenance strategies. A 100% PM completion rate will be maintained for items designated as Life Support Equipment. ... Items designated as Life Support include the following: A. Anesthesia Machine ..."

1. Review of facility documentation dated November 16, 2016, revealed, "2. Monthly Planned and Corrective Maintenance Reports (attached) a. Planned Maintenance ...3) Device Not Available: None this period 4) Can Not Locate: None this period 5) Pending PM service to Date: 28. ..." Further review of the documentation revealed an attachment titled "Pending PM Service." The "Pending PM Service" attachment revealed 28 items with PM past due dates, ranging from December 2015 through October 2016. The list of the items included but was not limited to: Pulse Oximeter, Telemetry Transmitter, Oral Thermometer, Anesthesia Vaporizer, Gas Anesthetic Monitor, Sequential Compression Device, Ablation Laser, PCA Pump, Multi Channel ECG, Multi Parameter Monitor, Anesthesia Machine, Full Field Direct Digital Mammography and Anesthesia Vaporizer. (** On November 18, 2016, the number of pending PMs was clarified with EMP2 as 25, with no change in the aforementioned listing of identified items)

2. On November 17, 2016, at approximately 1:50 PM, when asked if the items listed on the "Pending PM Service" list were all currently in use, EMP2 stated, "As far as I know." When additionally asked if facility policy defined how long after an item was past due for PM it was removed from service, EMP2 stated, "It doesn't. I guess ideally the machine should shut down."

3. On November 17, 2016, at approximately 2:00 PM, EMP2 confirmed that the dates listed on the "Pending PM Service" list were based on manufacturer recommendations stating, "That is what those dates would be. ... Yes. They are all overdue."

4. On November 17, 2016, at approximately 2:10 PM, when asked if any items had ever been taken out of service due to as past due PM, EMP2 stated, "I don't think so. You would have to locate it first."

5. On November 18, 2016, at 11:08 AM, EMP2 confirmed that an item can go a year past the PM due date without being marked as not found or retired from the system.