Wednesday, January 25, 2012

Compliance News: CMS Hospital Equipment Maintenance Requirements Clarified



By Dean Samet, CHSP



Hospitals are expected to maintain equipment inventories and documentation of their maintenance activities. Federal or state laws and regulations may require that equipment maintenance activities be performed in accordance with the manufacturer’s recommendations, or may establish other maintenance requirements. In such instances, hospitals must be in compliance with the most stringent maintenance requirements mandated. Absent such mandated requirements, the Centers for Medicare & Medicaid Services (CMS) is allowing hospitals to follow one of the following: The manufacturer’s recommended maintenance schedule; to schedule more frequent maintenance than the manufacturer recommends; or, in some cases of non-critical equipment, to schedule less frequent equipment maintenance than the manufacturer calls for.


In a December 2, 2011 Memorandum (Ref: S&C: 12-07-Hospital), CMS provided a clarification for hospital equipment maintenance requirements. In their memorandum summary they stated the following:

A) Alternate equipment maintenance schedules permitted in some instances: Hospitals may adjust maintenance, inspection, and testing frequencies for some facility and medical equipment below those recommended by the manufacturer, based on an assessment by qualified personnel of the risk to patient and staff health and safety.

  -   Manufacturer-recommended maintenance frequency is required for:

    1. All equipment critical to patient health and safety*; and
    2. Any new equipment until a sufficient amount of maintenance history has been acquired.

B) Alternative equipment maintenance methods are not permitted**: Hospitals must continue to follow the manufacturer’s recommended techniques for maintaining equipment, even if the hospitals alter the frequency of maintenance activities.

* At a minimum, critical equipment includes, but is not limited to, life-support devices, key resuscitation devices, critical monitoring devices, equipment used for radiologic imaging, and other devices whose failure may result in serious injury to or death of patients or staff.

**Maintenance strategies are various methodologies for determining the most efficient and effective application of maintenance activities. There are several maintenance strategies including Preventive, Predictive, Reactive, and Reliability-Centered, which can be used to determine the appropriate frequency for maintenance, inspection, and testing of equipment based upon acceptable risk to patient health and safety.

Section 482.41(c)(2) of the CMS Conditions of Participation, Interpretive Guidelines & Survey Process, requires that hospital facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. It is important to remember that although the hospital may elect to adjust the frequency of some maintenance activities below those recommended by the manufacturer, the content of the recommended maintenance activities must not be substituted or eliminated.

Note: The above memorandum updates the guidance in Appendix A of the State Operations Manual related to hospital facility and medical equipment.

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