2014/2015 changes to Environment of Care Standards related to Healthcare Technology Management/Biomedical Engineering for deemed sites.
EC.02.04.01, EP 2 - Inventory must now include all medical equipment.
EC.02.04.01, EP 3 - Evaluate what equipment is high-risk to the patient or staff if they fail to perform correctly. This is equal to the CMS expression "critical equipment".
EC.02.04.01, EP 4 - Keep a record of inspection procedures and inspection frequencies. Hospitals must follow manufacturer recommendations or an alternative plan. The alternative plan can not reduce safety and must be based on standard practices. Joint Commission referred to ANSI/AAMI EQ56 as an example of standard practices. George Mills referenced ANSI/AAMI EQ89 at the AAMI 2015 annual conference in Denver.
EC.02.04.01, EP 5 - The following equipment must be inspected according to manufacturer's recommendation: Medical Laser Devices, Imaging and Radiological devices, Equipment subject to federal or state law, Equipment subject to Medicare Conditions of Participation. A plan more stringent than manufacturer recommendations can be followed. New medical equipment must be inspected according to manufacturer's specifications unless there is enough history to justify a change.
EC.02.04.01, EPs 6, and 7 - Determinations to use AEP must be made by an individual qualified according to HR.01.02.01. The AEP assessment must consider "How the equipment or component is used; consequences of failure, including the seriousness and prevalence of harm; availability of an alternative or a backup in the event that the tool fails or malfunctions; incident history of identical or similar equipment; and maintenance requirements of the equipment."
EC.02.04.03, EP 1 - Safety, Operational and Functional checks must be performed before use of equipment and after major repairs.
EC.02.04.03, EPs 2 and 3 - 100% compliance with the Manufacturer's requirements is required for all high-risk equipment, with included life support equipment.
The above is alignment with CMS code 42 CFR 485.623(b)(1),
Facilities / Utilties - EC.02.05.01, EP 2, EC.02.05.01, EP 3, EC.02.05.01, EP 4, EC.02.05.01, EP 5, EC.02.05.01, EPs 6 and 7, EC.02.05.05, EPs 2 and 3 apply the same or similar rules to utilities and their components.
Other Standards
