Given the interest and news surrounding the Centers for Medicare & Medicaid Services' (CMS') adoption of the 2012 editions of the National Fire Protection Association’s (NFPA’s) Life Safety Code (LSC) and Health Care Facilities Code, it is easy to lose track of some other recent regulatory changes.
Among these is CMS’ updated and expanded equipment inventory and Hospital Equipment Maintenance Requirements, which contains requirements and survey guidance on the conditions under which an organization can choose not to follow manufacturer’s recommendations.
A sea change
The hospital equipment maintenance requirements and related survey guidance are contained within CMS Survey & Certification (S&C) Group letter (S&C: 14-07-Hospital), released Dec. 20, 2013. It also requires what to most facilities will be an expansion of their equipment inventories to include all equipment.
While the new requirements applied to both utility systems and medical equipment, the CMS letter was a sea change in the requirements for hospital utility equipment inventories as well as inspection, testing and maintenance (ITM) practices.
The revised CMS approach introduced an alternate equipment management (AEM) program for those hospitals that wish to deviate from following the manufacturer’s recommendations.
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“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,” CMS states. The Appendix A interpretive guidelines provided further guidance intended to be followed by surveyors during CMS surveys.
In a nutshell, health care facilities must follow all required ITM activities and frequencies mandated by applicable rules, regulations, codes and standards. In addition, they must follow the equipment manufacturer’s recommendations unless they are permitted to deviate by the S&C letter; establish and follow a fully compliant, written risk-based AEM program; complete the full AEM inclusion risk assessment; and consider (and document) the extent to which they deviate from the manufacturer’s recommendations.
Some hospitals initially decided to simply follow the manufacturer’s recommendations in order to avoid the paperwork associated with an AEM program. Then, after they looked at some of the manufacturer’s recommendations, they realized that it would be better to establish the AEM program to cover some of their equipment ITM processes.
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The CMS letter requires that organizations follow the manufacturer’s recommendations when there is “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” that the alteration of maintenance activities or frequency would be safe. CMS did not define what it meant by “sufficient maintenance history” within the document.
For equipment that does not have ITM activities and/or frequencies in accordance with the manufacturer's recommendations, CMS states, “The AEM program must be based on generally accepted standards of practice for facility or medical equipment maintenance.” CMS then referenced both the American National Standards Institute/Association for the Advancement of Medical Instrumentation EQ 56:1999/(R) 2008, Recommended Practice for a Medical Equipment Management Program, and the American Society for Healthcare Engineering (ASHE) 2009 book, Maintenance Management for Health Care Facilities, as two acceptable documents for that purpose. Both publications are available through their respective organizations’ websites.
The new requirements mean changes to some current utility maintenance management processes as laid out in a health care facility’s existing plans, policies or procedures (PPPs).
The new [expanded] equipment inventory requirements and some other changed requirements within the S&C letter necessitated modifications to many health care facility utility systems' management plans. Most organizations include utility inventory equipment control language and related requirements within their utility systems' management plans.
As an example, code-mandated or NFPA standard-mandated ITM requirements exclude certain equipment from even being considered for AEM. The S&C letter states, “Other CoPs [Conditions of Participation] require adherence to manufacturer’s recommendations and/or set specific standards.” As an example, the letter states that “LSC requirements incorporated by reference at 42 CFR 482.41(b) [have] some provisions that are pertinent to equipment maintenance, and compliance with these requirements [is] assessed on federal surveys.”
The changes likely will require additional risk assessments based upon, for example, the CMS critical equipment/Joint Commission high-risk equipment definitions and related requirements. The outcomes of these activities can affect some existing processes.
The recently adopted 2012 edition of NFPA 99, Health Care Facilities Code, has new building utility system risk categories defined within Chapter 4 that also now need to be taken into consideration.
Unfortunately, there is not a clear match between the CMS critical equipment/Joint Commission high-risk equipment and any of the NFPA 99-2012 risk categories. However, it appears that NFPA 99-2012 Category 1 building systems also would have to be considered CMS critical equipment/Joint Commission high-risk equipment because it “is likely to” is stronger than “a risk of” in the following examples:
- NFPA 99-2012 Category 1 building systems appear to be riskier than CMS critical equipment/Joint Commission high-risk equipment: “Facility systems in which failure of such equipment or system is likely to cause major injury or death of patients or caregivers … . ”
- CMS “critical equipment” and the Joint Commission “high-risk equipment” are equivalent in the CMS critical equipment phrase: “ … physical plant equipment for which there is a risk of serious injury or death to a patient or staff person should the equipment fail … ”; and the Joint Commission high-risk equipment phrase: “Any device or components of building utility systems for which there is a risk of serious injury or death to a patient or staff person if the device or component fails. High-risk equipment includes life-support equipment.”
- NFPA 99-2012 Category 2 building systems would be noncritical (not high-risk) based on the following definition: “Facility systems in which failure of such equipment or system is likely to cause minor injury to patients or caregivers … .”
The CMS requirements stipulate a level of program-effectiveness process management that probably necessitates new or modified PPPs and perhaps also changes to existing forms.
AEM risk assessments
The S&C letter states, “In determining whether or not it is safe to include equipment in the AEM program, the hospital must take into account the typical health and safety risks associated with the equipment’s use. A hospital is expected to identify any equipment in its AEM program which is ‘critical equipment,’ i.e., biomedical or physical plant equipment for which there is a risk of serious injury or death to a patient or staff person should the equipment fail. The guidance in Appendix A discusses the types of factors to be considered when hospitals make these determinations. Generally, multiple factors must be considered, since different types of equipment present different combinations of severity of potential harm and likelihood of failure. Note that the risk may vary for the same type of equipment, depending on the patient care setting within the hospital where it is used.”
Whether equipment is critical (Joint Commission “high-risk”) equipment is one of the tests. It may even be the most important factor to consider, but it is not the only factor. Within the State Operations Manual, Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, A-0724 (Rev.); Interpretive Guidelines §482.41(c)(2), CMS states that factors for a hospital 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 equipment failure or malfunction — would failure or malfunction of the equipment hospitalwide or in a particular setting be likely to cause harm to a patient or a staff person? How serious is the harm likely to be? How widespread is the harm likely to be?
- Information, if available, on the manufacturer’s equipment maintenance recommendations, including the rationale for the manufacturer’s 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 the manufacturer’s instructions? If the manufacturer’s instructions are not available in the hospital, how does the hospital assess whether the AEM uses appropriate maintenance strategies? How readily can the hospital validate the effectiveness of AEM methods for particular equipment? For example, can the hospital explain how it ensures no reduction in the quality of the performance of biomedical equipment subjected to alternate maintenance methods?
- 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 (for AEM-inclusion decisions) are generally different from the more commonly used historical, utility risk assessment factors used by hospitals.
Much of this information is covered in more detail within the 2015 ASHE Annual Conference white paper, “Alternate Equipment Management (AEM) Program Compliance.” Hospital facility managers also should review a copy of both the S&C letter and its Appendix A. HFM
David Stymiest, PE, CHFM, CHSP, FASHE, is a senior consultant at Smith Seckman Reid, Nashville, Tenn. He can be reached at DStymiest@SSR-inc.com.