o Hospital facilities, supplies and equipment must be maintained to ensure an acceptable level of safety and quality.
o A hospital may adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk-based assessment by qualified personnel, unless:
• Other Federal or state law; or hospital Conditions of Participation (CoPs) require adherence to manufacturer’s recommendations and/or set specific requirements. For example, all imaging/radiologic equipment must be maintained per manufacturer’s recommendations; or
• The equipment is a medical laser device; or
• New equipment without a sufficient amount of maintenance history has been acquired.
• Hospitals electing to adjust facility or medical equipment maintenance must develop policies and procedures and maintain documentation supporting their Alternate Equipment Management (AEM) program. They must adhere strictly to the AEM activities and/or frequencies they establish.