Compliance News: CMS Changes Hospital Equipment Maintenance Requirements
CMS recently issued Survey & Certification Letter S&C:14-07-Hospital, which changed the requirements for hospital equipment maintenance. The new requirements apply to utility systems equipment as well as medical equipment. The CMS letter can be found at http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-07.pdf, and hospital facility directors should obtain and review a copy of it. That letter also includes as Appendix A the interpretive guidelines that are intended to be used by CMS surveyors in interpreting the new rules.
This topic was negotiated for several years as accreditors and ASHE strived to align the previous CMS requirements that maintenance was to be solely in accordance with manufacturer requirements with the broader TJC approach that permitted hospital experience and other parameters to be factored into maintenance decisions. The final decision is a mix between the two approaches and requires that TJC-accredited hospitals make some changes to their approach as well.
Reflecting the TJC changes, there are two new elements of performance that will take effect on July 1, 2014: EC.02.04.03 EP24 for medical equipment and EC.02.05.05 EP6 for utility systems equipment. The May 2014 issue of EOC News includes a Clarifications and Expectations article by TJC Director of Engineering George Mills entitled “Implementing a Robust Equipment Maintenance Program.” Besides presenting the two new EPs listed above, the article also includes a 12-item checklist “Is Your Equipment Maintenance Program Defensible?” We recommend that the TJC checklist, which contains content that can also serve as a robust equipment maintenance tracer, should be obtained and reviewed by all hospital directors, managers and supervisors responsible for equipment maintenance – both utility systems equipment and medical equipment.
The revised CMS approach introduces an Alternate Equipment Management (AEM) program for those hospitals that intend to deviate from simply following manufacturer’s recommendations. CMS stated “The determination of whether it is safe to perform facility or medical equipment maintenance in an alternate manner must be made by qualified personnel, regardless of whether they are hospital employees or contractors” and also stated that the qualifications it expects within the Appendix A interpretive guidelines: “In the case of facility equipment, a Healthcare Facility Management professional (facility manager, director of facilities, vice president of facilities) would be considered qualified. The hospital must maintain records of the qualifications of hospital personnel who make decisions on placing equipment in an AEM program, and must be able to demonstrate how they assure contracted personnel making such decisions are qualified.”
Another change to be aware of is the CMS requirements regarding new equipment that is not eligible for placement in an AEM program, which CMS identified as “new equipment for which sufficient maintenance history, either based on the hospital’s own or its contractor’s records, or available publicly from nationally recognized sources, is not available to support a risk-based determination.” CMS also stated “new equipment must be maintained in accordance with manufacturer recommendations until a sufficient amount of maintenance history has been acquired to determine whether the alteration of maintenance activities or frequency would be safe. If a hospital later transitions the equipment to a risk-based maintenance regimen different than the manufacturers’ recommendations, the hospital must maintain evidence that it has first evaluated the maintenance track record, risks, and tested the alternate regimen.”