On December 2, 2011, the Centers for Medicare & Medicaid Services (“CMS”) issued a Program Memorandum (“Memorandum”) clarifying equipment maintenance requirements for hospitals. More specifically, the Memorandum addresses: (1) alternate equipment maintenance schedules that are permitted in some instances; and (2) alternative equipment maintenance methods that are not permitted.
The Medicare condition of participation for hospitals found at 42 CFR 482.41 states that hospital facilities, supplies and equipment must be maintained to ensure an adequate level of safety and quality. The Memorandum issued by CMS seeks to clarify the intent of this regulation by stating when a hospital may deviate from the equipment manufacturer’s recommended maintenance schedule. These clarifications will be published in interpretive guidelines for hospitals found in the State Operations Manual.
In the Memorandum, CMS states that, absent any state or federal laws and regulations to the contrary, a hospital is allowed to deviate from the manufacturer’s recommended maintenance schedule if the equipment is designated as non-critical. CMS does not indicate what constitutes non-critical equipment. It should be pointed out that, even if the hospital is allowed to deviate from the manufacturer’s recommended maintenance schedule, alternative methods on how the hospital inspects the equipment must continue to follow the manufacturer’s recommendations.
If the equipment is critical to patient health and safety, the hospital must follow the manufacturer’s recommended equipment maintenance schedules. Critical equipment is defined as equipment such as life-support devices, key resuscitation devices, critical monitoring devices, equipment used for radiologic imaging and any devices whose failure could result in serious injury or death to patients or staff. CMS does not offer any other guidance on what is considered critical equipment.
The Memorandum also addresses new equipment. For new equipment (critical or non-critical) the manufacturer’s recommended equipment maintenance schedule must be utilized until a sufficient maintenance history has been compiled to justify deviating from the manufacturer’s guidelines.
Regardless of whether the equipment is critical or non-critical, equipment maintenance documentation must be maintained, and the maintenance, inspection and testing of equipment must be performed by qualified personnel. CMS states that “qualified personnel” would include a clinical or biomedical technician or engineer. To ensure efficient, effective and appropriate frequency maintenance, CMS suggests hospitals consider whether the maintenance is preventive, predictive, reactive or reliability-centered and then schedule the activities based upon those criteria and the type of equipment.
The Memorandum can be accessed at:
https://www.cms.gov/Surveycertificationgeninfo/downloads/SCLetter12_07.pdf
If you have questions or concerns regarding the foregoing or would like additional information, please contact your regular Hall Render attorney or Todd Selby at tselby@wp.hallrender.com or317.977.1440; Brian Jent at bjent@wp.hallrender.com or 317.977.1402; or David Bufford at dbufford@wp.hallrender.com or502.568.9368.
