o A CAH 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, unless:
• Other Federal or state law, or CAH Conditions of Participation (CoPs) require adherence to manufacturer’s recommendations and/or set specific requirements. For example, the National Fire Protection Association (NFPA) Life Safety Code (LSC) requirements incorporated by reference at 42 CFR 485.623(d) have some provisions pertinent to equipment maintenance, and compliance with these requirements is assessed on Federal surveys; or
• The equipment is imaging/radiologic equipment or a medical laser device; or
• New equipment without a sufficient amount of maintenance history has been acquired.
• CAHs 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.
• CAHs must be able to demonstrate that qualified personnel, whether employees or contractors, are making the decisions to place equipment in the AEM program, performing the risk-based assessments, establishing the alternate equipment maintenance requirements, managing the AEM program, and performing the maintenance in strict accordance with the AEM policies and procedures.