Centers for Medicare & Medicaid Services (CMS) Tag A-0724 (in CMS State Operations Manual, Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals) contains all CMS requirements and survey guidance for a hospital alternate equipment maintenance (AEM) program. According to CMS, factors to consider when evaluating the risks associated with a particular type of equipment include, but are not limited to:
- How the equipment is used and the likely consequences of failure or malfunction — would failure or malfunction of the equipment hospitalwide or in a certain setting likely cause harm to a patient or a staff person? How widespread and serious would the harm likely be?
- Information, if available, on the manufacturer’s equipment maintenance recommendations, including rationale for the recommendations.
- Maintenance requirements of the equipment: Are they simple or complex? Are the manufacturer’s instructions and procedures available in the hospital and, if so, can the hospital explain how and why it is modifying them? If the instructions are not available in the hospital, how does the hospital assess whether the AEM uses appropriate strategies? How readily can the effectiveness of AEM methods be validated for particular equipment?
- The timely availability of alternate devices or backup systems in the event of equipment failure or malfunction.
- Incident history of identical or very similar equipment.
CMS also states, “Generally multiple factors must be considered, since different types of equipment present different combinations of severity of potential harm and likelihood of failure. The hospital is expected to be able to demonstrate to a surveyor the factors it considered in its risk assessment for equipment placed in its AEM program.”
These risk assessment factors are generally not the same as the more common factors that hospitals have used in the past for utility system risk assessments. Based on CMS Tag A-0724, a new risk assessment framework compliant with the CMS requirements is needed to support any AEM-inclusion decisions.
American Society for Health Care Engineering members can access a template to show how metrics address CMS requirements.