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OR Manager

JULY 1994

Are you complying with equipment standard?

   An overlooked Joint Commission standard can trip up ORs that are un-prepared.  The standard, PL.3 under the Plant, Technology, and Safety Management (PTSM) chapter, requires the hospital to have an equipment management program to control risks (see box at right).
   The Joint Commission expects ORs to comply even though the 1994 Accreditation Manual for Hospitals does not have a specific cross reference to the PTSM standards in the Surgical and Anesthesia Services standards.  Other clinical departments, such as Diagnostic Radiology, do have a specific reference to PL.3.  The PTSM standards are referred to indirectly in the preamble to the new Operative and Other Invasive Procedures chapter.
   Despite this apparent oversight, you need to be ready because the Joint Commission says it is training surveyors to look for medical device compliance in the OR.
   Often, OR managers entrust medical equipment compliance to plant operations, clinical engineering, or the biomedical engineering department.  But if your hospital doesn't have such a department or the department doesn't fully support the OR, you may have to pick up the slack.  Also be

JCAHO equipment management standard

 The Joint Commission's standard for managing equipment in the hospital:
  PL.3."There is an equipment management program designed to assess and control the clinical and physical risks of fixed and portable equipment used for the diagnosis, treatment, monitoring, and care of patients and of other fixed and portable electrically powered equipment."

Specific requirements:

Written criteria identify equipment to be included in the program. Before being used, equipment has to be evaluated for the program, and the evaluation documented.

An inventory is kept of all

 equipment in the program, regardless of ownership or purpose. Each piece of equipment has written procedures for testing and training designed to manage risks.
   The equipment management program used to identify and document equipment problems. When problems are identified, action is taken to resolve them. The actions are documented and evaluated for effectiveness.
   The organization reports device problems in compliance with the Safe Medical Devices Act of 1990.

Source:  1994 Accreditation Manual for Hospitals
aware that other departments, such as diagnostic radiology and central supply, that provide medical equipment to the OR also must meet PL.3.
   For the 1994, the PTSM standards are the same as they have been for the past several years.  But as with all standards,		 the focus is shifting to performance improvement. Hospitals are expected to show not just that they have written policies, documented preventive maintenance, etc, but that they have measured and improved performance.
   In 1995, the chapter will be renamed Management of the Environment of Care and will appear in the reorganized manual under the Organizational Functions section.

  How well is your hospital complying? You need to find out how well your hospital is complying and meeting requirements for the OR. Tips were given by Bruce Barkalow, PhD, a certified clinical engineer and hospital consultant.
  "JCAHO surveyors can come in and ask, 'Where is your inventory list of all medical equipment in the OR? Where are your records for maintenance and calibration? What is your QI plan for medical device safety and utilization?'"
  You may be tempted to tell them the information is kept, say, in biomedical engineering. But that may not be enough. If the hospital is in compliance, you will know how to produce the records, answer questions, and show you understand PL.3.

Questions to test soundness of program
 These are the questions you can ask to find out if your hospital has a sound equipment management program for the OR.
   "If you answer no to any of these questions, find out from the hospital administration which department is primarily charged with overall hospital compliance and discuss the support provided to the OR," advises consultant Bruce Barkalow, PhD:
   1. Does your department have, or is your department provided with, an accurate, updated, and verified medical device equipment list that has the correct name of the device, the manufacturer, model number, serial number, risk or patient care priority code, and last date and next date of inspection?
   2. Do you regularly receive (usually every six months) interpreted 		summary reports of all maintenance and preventive maintenance work on OR equipment? You need not just a computerized list but information about the significance of the information.
   3. For each OR medical device, do you have access to a specific file with any work performed, including warranty work, device ownership, and whether or not the device is electrically powered?
   4. Can you determine for any OR medical device whether it is covered by a service contract or in-house service for inspections, calibration, maintenance, and preventive maintenance?
   5. Do you have a system for determining which OR employee has had training to use which medical devices in the OR?

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