The role of the federal government in helping to guide and facilitate the development of crisis standards of care was highly debated at the workshops. Some participants worried that a heavy-handed approach from Washington could derail more in-the-trenches attempts to develop plans at the state and local levels and lead to policies that are inconsistent with state and local values and needs. Many participants, however, believed some level of guidance at the federal or national level would be helpful. They saw a range of ways that federal or national leadership could facilitate the development of fair and consistent crisis standards of care policies and protocols, and could help reduce unnecessary duplication of effort.

On the practical end, there was a widespread call for the federal government to perform a role as “chief information coordinator” on the topic of crisis standards of care. “There are people all across the country and states, at county and other facility levels, who really are kind of reinventing the wheel,” said Montefiore’s Powell. They are “starting all over again, trying to do the literature search and figure out what’s going on. It’s an enormous investment of time and manpower across the country when in fact there are scholars who at least have some of that information as ready knowledge.”

Indeed, that insight was demonstrated tangibly at the workshops, where dozens of state and local plans were presented, each of which required huge investments of time and energy to produce, and each of which in many cases ended up with similar conclusions. If a way to index that information in a single location as a resource was established, Powell and others suggested, it would massively improve the efficiency of developing these guidelines throughout the nation.

Federal or national involvement would also provide a level of legal, societal, and practical protection that cannot be achieved at the lower levels of leadership. Many people at the workshops noted that there may be some issues for which federal or national involvement is the only practical choice.

“These are politically explosive issues,” noted Powell. “At every single facility and even at the state level you’ll have people who either don’t want to talk about it or just come up with vague guidelines … because it’s a liability risk.” What’s needed, she suggested, is an acknowledgment at the highest level that the issue is worth talking about, and that the uncomfortable must be confronted. “I think the higher you come from in saying that, the more security there is in believing that will be an acceptable plan.”

Looking at the bigger picture, participants noted that having broad federal guidance could help establish consistency from state to state and region to region. The unfortunate reality is that anything other than national guidance risks running into “border issues” in areas where one region, state, or community butts up against another. A coordinating policy that bridges those gaps and establishes a framework of consistency would be immensely valuable.

Many workshop participants praised the aforementioned work of AHRQ and ASPR to establish the outlines of a framework in their 2005 report, Altered Standards of Care in Mass Casualty Events and 2007 report, Mass Medical Care with Scarce Resources: A Community Planning Guide (AHRQ, 2005; Phillips and Knebel, 2007). These documents, however, only go as far as making broad recommendations about the scope and challenges that should be considered and laying out preliminary implementation considerations. Many workshop participants wanted more.

“We’ve got to start identifying players and start trying to get to some specificity of what that national guidance could look like,” said the ANA’s Peterson. She added that establishing evidence-based research for making decisions about crisis standards of care represents a massive and immediate opportunity for a nationally convening organization. Much of the work on crisis standards of care and emergency response is driven by principles and best guesses; there is little existing evidence about what works and what doesn’t in various situations.

These knowledge gaps extend from treatment protocols to triage to equipment usage. For example, there is little evidence about the use of SOFA scores for predicting outcomes in pediatric or geriatric populations, or about which simple treatments achieve the best outcome at acute care facilities during a pandemic influenza.

All of those things can be known to some extent using historical data on past tragedies or studies in non-disaster scenarios. But the unfortunate reality is that there has been neither the funding nor the initiative to do much direct, evidence-based disaster medical research.

One thing was clear from the workshops: Most participants did not want the federal government dictating the specifics of how to implement policies.

“One can’t get too prescriptive on the actual protocols, for a couple of reasons,” said Kristi Koenig, director of public health preparedness at University of California–Irvine. “One, the solutions are going to vary from community to community. And two, a lot of these are evolving situations, where resources are coming in and getting more scarce throughout.”

But still, the opportunity for the federal government to establish broad principles, roles, and objectives, as it did in a strong first step in the AHRQ documents—and then to take that one step forward by serving as a convening mechanism and research coordinator for multiple parties—is evident. Workshop participants suggested the time is now.

“In the context of the broader picture of healthcare reform, and with a shift in the administration … I’d like to see leadership from the top really help to bring this forward now … on a national level,” said Inova’s Hanfling.

Workshop participants’ call for federal and national leadership to provide practical, more detailed information to advance the development of crisis standards of care protocols, and to facilitate intrastate and interstate consistency, formed the basis for the subsequent Institute of Medicine committee report entitled Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations (IOM, 2009). This letter report, summarized in Appendix B, provides guidance on ethical considerations; community and provider engagement, education, and communication; legal authority and environment; indicators and triggers; and clinical process and operations. The committee calls on states to work to ensure consistency in the implementation of crisis standards of care throughout the state and among neighboring states.

The Department of Defense

One other way that the federal government can lead, many said, is by leveraging its position as a large provider and purchaser of healthcare services. That leadership can come through direct purchasing power; as noted earlier, some believe that provider participation in the Medicare program should be predicated on adequate disaster preparedness and emergency management training. Or it can come from serving as a model for other regions or localities in how to develop crisis standards of care. Wayne Hachey, director of preventive medicine for the Office of the Assistant Secretary of Defense, presented at the Irvine and Orlando workshops.

The Department of Defense is “the largest federal agency with a healthcare system,” Hachey said. “Throughout our DoD guidance, we’ve recognized that we will have to establish alternate standards of care [during an emergency] … and those standards of care will not be consistent with today’s standard.”

“We don’t have a DoD-wide standard,” Hachey explained. “What we’ve told folks is that their standards are going to mirror, at least as a baseline, the standards of the civilian community.”

In other words, the DoD program recognizes that each DoD facility has different staffing, different physical plans, a different population to serve, and different equipment and resources. So rather than forcing a top-down standard, it gives hospital administrators the opportunity to adapt their existing standards to the situation at hand. The only caveat, mentioned above, is that those standards be at or above the level of the surrounding community (Box 12). “Rather than being prescriptive, we gave them essentially rules of engagement in establishing altered standards of care,” said Hachey.

BOX 12

Department of Defense Resource Prioritization Policy. Crisis Standards of Care will be adopted—those standards will be locally determined based on resources, demographics, and prioritization principles It will not close its doors to the beneficiary (more...)

To help create and monitor those standards, each installation within the DoD has a Public Health Emergency Officer with responsibility for advising the station commander during a significant public health emergency. This officer also coordinates with the local community to ensure the military and civilian response plans are integrated. Again, the IOM letter report called on state and local officials to coordinate with DoD facilities in the development and implementation of their standards of care protocols (IOM, 2009).

“When we developed guidelines for prioritizing care … the request from our providers [was] asking for both prescriptive guidance but probably more importantly [was asking] for permission to make those kinds of decisions,” Hachey said. “So we gave them broad guidance, gave them sanction, made sure that they made their decisions transparent … [and] mandated that their standards of care at least as baseline be the same as their local standards of care.”