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CMS revisions reflect infectious disease danger and emergency standby power systems


May 1, 2019

As if healthcare facilities didn’t have enough to worry about with the always-changing emergency preparation standards—now CMS is changing the standards again. The revisions come as part of the agency’s updates to Appendix Z of the State Operations Manual, as detailed in its Quality, Safety and Oversight memo QSO19-06-ALL.

New requirements proposed in 2013 by the Department of Health and Human Services (HHS) were adopted by CMS, and hospitals were required to be in compliance by November 2017. The changes to the emergency preparedness requirements were designed to help prevent the disruption of hospital services on a mass scale such as that experienced during disasters like Hurricane Katrina in New Orleans and Hurricane Sandy in New York City.

The passed rule required, among other things, that hospitals track displaced patients, provide care at alternate sites, and handle volunteers.

The CMS adoption of the rule required 17 types of suppliers and providers that rely on Medicare and Medicaid funding to adopt the changes; among them was the mandatory adoption of an “all-hazards” emergency plan, similar to what The Joint Commission had already required for accreditation. The rule required not only hospitals, but smaller healthcare facilities such as ambulatory surgery centers, elder-care facilities, and behavioral health long-term care facilities to adopt changes that would ensure the long-term safety and well-being of their patients during a crisis.

In its latest updates, CMS has made two changes to reflect current trends in healthcare emergency planning.

First, CMS will add “emerging infectious diseases” to the current definition of an all-hazards approach—which, as hospital emergency planners know, is what CMS expects organizations to use when planning.

“In light of events such as the Ebola Virus and Zika, we believe that facilities should consider preparedness and infection prevention within their all-hazards approach, which covers both natural and man-made disasters,” according to the CMS memo. “This addition should be added to your Hazard Vulnerability Assessment (HVA) process.”

U.S. hospitals were caught off guard in October 2014, when Thomas Eric Duncan, a Liberian national who was visiting family in Dallas, became the first confirmed U.S. case of Ebola after he checked into Texas Health Presbyterian Hospital with symptoms. A highly lethal virus that can spread with miniscule exposure to bodily fluids, Ebola had largely only been seen in African countries. In August 2014 alone, an outbreak in West Africa caused more than 27,000 cases and 11,000 deaths.

Duncan later died, and two nurses that had been caring for him at the hospital also contracted Ebola; they were treated and recovered. A Centers for Disease Control and Prevention investigation, as well as complaints from staff at Texas Presbyterian after the Dallas case, found that improper protocols and personal protective equipment (PPE) use were to blame for the exposures. Almost overnight, hospitals and associated medical clinics found themselves overhauling triage protocols, training staff to work with full-body PPE suits, and forming specialized “go teams” ready to treat patients who were suspected to be at high risk for Ebola.

Subsequent cases, as well as current flareups of the Ebola virus in Africa, led CMS to issue the clarifications to alert hospitals that they must prepare once again to deal with this highly infectious disease, should it return to U.S. soil. In addition, diseases such as Zika, the flu, monkeypox, and SARS have emerged in recent years as chronic diseases that could overwhelm the American healthcare system.

“I don’t know that this represents a ton of hardship for folks, and I do know, for at least some folks, the latest directive is fairly straightforward as a function of their emergency preparedness programs, activities, etc.,” said Steven MacArthur, safety consultant with The Greeley Company in Danvers, Massachusetts, in his blog, Mac’s Safety Space. “As we’ve discussed once or twice over the years, emergency preparedness is a journey, it is not a destination.”

In other words, if emerging infectious diseases aren’t already in your emergency plan, then you’re way behind the times. It’s time to update.

Electrical power guidance

Next, the new CMS memo has added guidance to provide additional clarifications related to portable or mobile generators to help facilities plan for power outages. These clarifications recommend that facilities use the “most appropriate” energy source or electrical system based on their all-hazards risks assessment and as required by existing federal or state regulations. Essentially, CMS is saying that it will allow hospitals to rely on portable, temporary generators rather than permanently located power sources for emergencies; some hospitals located in less disaster-prone areas, for example, might not need to bear the cost of installing permanent generators. Regardless of the alternate sources of energy a facility chooses to utilize, CMS says the arrangements must be in accordance with local and state laws, manufacturer requirements, and applicable Life Safety Code® (LSC) requirements.

“If a facility risk assessment determines the best way to maintain temperatures, emergency lighting, fire detection and extinguishing systems and sewage and waste disposal would be through the use of a portable and mobile generator, rather than a permanent generator, then the LSC provisions such as generator testing, maintenance, etc. outlined under the National Fire Protection Association (NFPA) guidelines requirements would not be applicable, except for NFPA 70-National Electrical Code,” CMS said in its explanation of the clarification. “However, the revisions, as the provisions under emergency preparedness themselves, do not take away existing requirements under LSC, physical environment or any other Conditions of Participation that a provider type is subject to (for example to maintain safe and comfortable temperatures).”

The clarification seems to come in the wake of a guideline document released by the Federal Emergency Management Agency (FEMA) in 2014, which was designed to help hospital engineers develop contingency plans to keep the power on when disaster strikes. The 170-page book, Emergency Power Systems for Critical Facilities: A Best Practices Approach to Improving Reliability, is also known as FEMA P-1019 in the industry and is freely available for download.

Coincidentally, the guidelines were published around the same time that the HHS Office of Inspector General released a report criticizing hospital response to Hurricane Sandy.

The report, taken from a survey of 174 Medicare-certified hospitals and 10 site visits to facilities in the tri-state area of New York, New Jersey, and Connecticut, found that facilities were largely unprepared for Sandy, which was a significant hurricane that flooded major metropolitan areas.

“It would seem that a lot of folks reached out to CMS to see if they were going to have to replace portable/mobile generators with the typical generator equipment found in hospitals, and (hooray!) the answer to that question is no, you don’t have to: unless your risk assessment indicates that you should,” wrote MacArthur.

He added that CMS makes it clear that no matter what facilities choose to do, they have to maintain their generators, either themselves or through vendors, in accordance with NFPA 70 (and, presumably, the manufacturers’ instructions for use). NFPA 70 includes the following items:

  • All wiring to each generator unit must be installed in accordance with the requirements of any of the wiring methods in Chapter 3.
  • Generators must be designed and located to minimize the hazards that might cause complete failure due to flooding, fires, icing, and vandalism.
  • Generators must be located so that adequate ventilation is provided.
  • Generators must be located or protected so that sparks cannot reach adjacent combustible material.
  • Generators must be operated, tested, and maintained in accordance with manufacturer, local, and/or state requirements.
  • Extension cords and other temporary wiring devices may not be used with portable generators. (Many facilities have begun to incorporate “plug and play” capabilities where a portable generator can be plugged into the building with pre-installed cords and outlets.)

One of the biggest issues that hospitals in the New York area dealt with during Hurricane Sandy was closed roads, which prevented resupply trucks from getting through to refuel hospital generators. As a result, some hospitals have begun drafting extensive contingency plans, such as parking tanker trucks in their parking lots during weather disasters or signing agreements with fuel stations that allow them to take ownership of the station’s reserves should there be an emergency need.

The CMS clarification appears to be an effort to align with FEMA’s guidelines, which also cover new construction considerations and advice to facilities looking to build with emergency contingencies in mind. As always, planning for contingencies starts with knowing what hazards are likely to strike your area, and CMS appears to be giving facilities more leeway in making planning decisions for themselves depending on the perceived hazards in their areas. For instance, hospitals in earthquake-prone areas may not want to put generators in upper-level floors for fear of them being launched out of windows, whereas underground may not be the best place to store generators and emergency fuel in flood-prone areas.

The latest updates include other clarifications from CMS, such as the following:

  • Additional clarification on safe temperatures (HVAC) in areas deemed necessary to protect patients
  • Elaboration on use of portable generators
  • Clarification on emergency preparedness training for contract-based employees
  • Inclusion of a statement allowing facilities that activate their emergency plan twice in one year to be exempt from the requirement to conduct two exercises annually

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