Indicators

Implementation of crisis standards of care first requires recognition of an actual or impending resource shortfall. Workshop participants noted that many different resources may become scarce at different times, depending on the nature of the disaster and the characteristics of the community and the healthcare facility. The 2009 IOM report listed the following resources as likely to be scarce in a crisis care environment and possibly justifying specific planning and tracking:

• Ventilators and components
• Oxygen and oxygen delivery devices
• Vascular access devices
• Intensive care unit beds
• Healthcare providers, particularly critical care, burn, and surgical/anesthesia staff (nurses and physicians) and respiratory therapists
• Hospitals (due to infrastructure damage or compromise)
• Specialty medications or IV fluids (sedatives/analgesics, specific antibiotics, antivirals, etc.)
• Vasopressors/inotropes
• Medical transportation

Workshop participants emphasized that it was important that health-care facilities be aware of impending shortages so they could take steps to avoid having to implement crisis standards of care. Participants also noted the importance of having situational awareness of the system because the entire network of indicators will provide the most accurate sense of the level of stress on the system. For example, a shortage of ventilators will be compensated by the use of other ventilator processes, in turn making those supplies scarce for their originally specified use. In this way, a small number of significantly scarce resources can cause strain throughout the entire system.

Triggers

To achieve integrated, consistent, and fair care, every participant in the system must be operating with the same understanding of where things stand on the conventional/contingency/crisis scale. In fact, many workshop members indicated the need for multiple triggers operating at different levels and with different time frames.

Speaking of his own experience in New York, David Hoffman from Wyckoff Heights Medical Center said his group identified the need for multiple triggers. “There needs to be a trigger based on the declaration of disaster from government officials if there is a statewide or regional event,” Hoffman suggested. “There needs to be a trigger at an institutional level so that there is the means of communicating to the staff that … a new set of rules applied…. And what we’ve learned from the situation in Katrina … is that there needs to be a factual trigger that can be applied retroactively” to provide legal protection for caregivers.

Some participants believed those triggers should be driven on the scene by frontline staff. “I think those kinds of triggers need to be defined by the people who are on the front lines and will be forced to make those decisions,” said HHS’s Rear Admiral Ann Knebel. “We need to support them and make sure that there is, as much as possible, consistency in terms of the principles that drive what those triggers are.” Knebel said that the trigger point comes when available resources are no longer adequate to support patient demand.

Different states have taken different approaches to determining who should make the decision, some empowering governors and others looking to public health officials to help define the triggers and determine the mechanism for transitioning from normal to crisis standards of care. However, as the 2009 IOM report concluded, working through a framework that begins at the institutional and local levels, the authority to institute crisis standards of care lies with the state. In most states, the state department of health holds this responsibility. Some states have well-defined processes for establishing their protocols, but many others are still in development.

Triage

Once a determination has been made that conventional care standards no longer apply, workshop participants commented, the rapid implementation of an effective triage program should be one of the first goals of any healthcare program. A triage program aims to rapidly screen, evaluate, and sort patients based on their medical status and likely outcome.

Ken Berkowitz from the Veterans Administration National Center for Ethics explained a working model of the VHA Hospitals’ operating protocol during pandemic influenza: “Our tertiary triage protocol is the process of sorting acute care hospital patients into three treatment groups. Initial decisions are based on survivability, and that’s justified by the goal of making optimum use of resources and meeting the goal of overall population health. Second-order decisions for equally prioritized patients are based on a first-come, first-served basis, or if that’s not possible, on a lottery basis. That is justified by the principle of fairness.”

As many participants noted, the triage process outlined in the American College of Chest Physicians work on mass critical care has formed the basis for the protocols developed by the VHA and many of the states (Colorado Department of Public Health and Environment, 2009; Devereaux et al., 2008; IOM, 2009; Minnesota Department of Health, 2008; The Utah Hospitals and Health Systems Association, 2009; VHA, 2008a, 2009a). This triage process includes the use of the Sequential Organ Failure Assessment (SOFA) score for determining triage priorities. The system uses a variety of measures linked to six major organ systems— (1) cardiovascular, (2) coagulation, (3) hepatic, (4) neurological, (5) renal, and (6) respiratory—and is already in use in multiple hospitals. The SOFA scores help triage teams rapidly determine how sick people are, and are relatively easy for hospitals to execute and record. The IOM report’s basic triage process is outlined in Figure 1 and exclusion criteria are described in Box 5.

FIGURE 1

Triage algorithm process. ^aExample exclusion criteria include severe, irreversible organ failure (congestive heart failure, liver failure, etc.), severe neurologic compromise, extremely high or not improving sequential organ failure assessment (SOFA) (more...)

BOX 5

Exclusion Criteria Prompting Possible Reallocation of Life-Saving Interventions. SOFA > 15 SOFA > 5 for >5 d, and with flat or rising trend

Under this triage process, both patients who score too high and too low on the SOFA assessment are not given critical care resources during an emergency: patients who score too high because they will not likely benefit from medical care, and patients who score too low because they will likely survive without substantial care.

Many workshop participants also emphasized that the use of SOFA scores is far from the perfect solution. “From a pragmatic standpoint, on an individual–patient level, to say that this person is getting resources and this person is not based on a one-point difference on a SOFA score … that’s a huge issue and something we think about very carefully,” said Hennepin County Medical Center’s Hick.

Moreover, SOFA scores may not apply to some of the most vulnerable patient groups. Stephen Cantrill, an emergency physician in Colorado, noted that SOFA hasn’t been studied in pediatrics, and is not designed as a predictive tool. Many workshop participants noted that the lack of research on SOFA scores and other potential decision tools in pediatric populations is a significant gap and emphasized that much more research should be done in this area so that it can better inform important policy decisions.

Hick said his hospital had an appeals process whereby a patient’s physician could appeal back to the triage team for a rescoring if a patient’s condition changed.

Alternate Care Facilities

Most surge capacity plans contain some means of providing noncritical care outside of the hospital setting to free up as many hospital beds as possible for more seriously ill patients. This can take the form of either formal, dedicated facilities that are idle most of the time, or of convertible public spaces such as schools, restaurants, houses of worship, or meeting halls. These facilities are important components of a surge plan, but they raise additional questions regarding crisis standards of care because the facilities may have different staffing levels, make greater use of volunteers or providers practicing outside of their duties, and have more limited care capabilities. Although this was not discussed in great detail at the workshops, participants also mentioned a number of additional challenges related to establishing alternate care facilities, including facility licensing and reimbursement.

“We have bought, thanks to a grant, a 250-bed surge-capacity facility…. The beds and everything are in trailers and we can move them to a church hall or to a school gym,” said John Robinson, discussing Baptist Memorial Hospital in northern Mississippi’s approach to prestaged surge capacity.

Others cautioned that, even if adequate additional resources are available, these facilities must be adequately staffed or they will not function. “We’ve got eight very nice tractor-trailer-mounted disaster hospitals,” said North Carolina’s Alson. But “nobody is going to be able to staff them [in a true pandemic]. This is not a hurricane where it’s going to go for 4 or 5 weeks maybe. This is months and it’s going to be in multiple events and you’re going to do it with half your staff eventually.”

Workshop participants considered staffing these facilities with a combination of full-time health care physicians, retired physicians, nurse practitioners, and other providers. Many noted that providing palliative care in a surge facility was one area where retired healthcare workers could provide excellent support during a crisis.

In North Dakota, alternate care facilities will provide such care and be staffed by volunteer providers, according to a presentation by North Dakota’s Wiedrich. He detailed the basic capabilities that alternate care facilities in North Dakota would provide (Box 6).

BOX 6

North Dakota Alternate Care Facility Capabilities. Hydration Nutrition

Rick Hong, medical director for public health preparedness in the Delaware Division of Public Health, discussed the model for alternate care facilities being used in Delaware (Box 7). He detailed how each component of the system would be staffed, and what kinds of treatments would be available in each.

BOX 7

Modular Medical Expansion: An Example from Delaware. The surge program in Delaware is based on a concept called “modular medical expansion.” When developing the program, all the parties involved agreed that simply sending all the patients (more...)

Broadening the Scope: Emergency Medical Services, Community Health, and Other Components of the Health System

One reality driven home by the workshops is that the forces involved in disaster preparedness are almost, by definition, top-heavy. While the regional workshops brought together a wide array of professions—public health officers, physicians, hospital administrators, researchers, nurses, and emergency medical technicians (EMTs), to name but a few—most planning and policy work on crisis standards of care is focused on the hospital or hospital-network level.

The reason is simple: These larger and more sophisticated healthcare networks are often the only ones with the resources to spend on disaster preparedness. Unfortunately, this top-heavy approach runs counter to the actual nature of responses to medical emergencies.

“Most emergency responses are an upside-down pyramid,” noted Kathryn Brinsfield, associate chief medical officer at the Department of Homeland Security (DHS). “Critical care patients are a very small piece of that, and the outpatient care, visiting nurses, all the other places” are crucial.

Emergency Medical Services

One recurring theme throughout the workshops was the critical role that the emergency medical services play in directing emergency response, and the limited extent to which they have been incorporated into planning for crisis standards of care.

During day-to-day operations, EMS systems have a mandate to transport individual patients to the closest available hospital, while providing stabilizing care along the way. But as Leslee Stein-Spencer, a Registered Nurse and manager at the Chicago Fire Department, told the Chicago workshop, that approach won’t work during a mass casualty situation.

In a mass casualty situation, EMTs may be called on to transfer multiple patients at a single time, to provide medicine to limit infection, to triage patients onsite, or to transport only those who meet certain qualifications. EMTs may be asked to operate outside their standard scope of practice, or transport patients to alternate care facilities. But so far, at least in her region, training and preparation have overlooked this critical link (Box 8).

BOX 8

Status of Emergency Medical Services Preparedness in Chicago. Using alternative treatment modalities Creating alternative staffing patterns

Stein-Spencer identified a series of issues that must be addressed in developing the emergency response, including the following:

• Defining credentialing/licensing activities, both local and state
• Determining the trigger for crisis standards and identifying who makes the call: local, regional, state
• Finalizing mutual aid agreements
• Handling the differences between private and public responders
• Ensuring the consistency of care in adjacent communities

Some participants also noted the special challenges that arise in many communities, particularly rural areas, in which EMS units are largely or entirely volunteer.

Resource Availability and Distribution

Workshop participants said that identifying available resources is an essential part of laying the foundation for a sound approach to standards of care. Does a hospital know how many emergency beds or emergency ventilators are available? If not, that kind of resource survey should be among the first orders of business when creating a surge program.

William Fales, associate professor of emergency medicine at Michigan State University’s Kalamazoo Center for Medical Studies, discussed the work of the Great Lakes Healthcare Partnership to identify the resources available for surge care during an emergency situation. They identified and categorized 123 types of resources available in the region, consolidating those resources into a centralized database that could be used in emergencies.

“It’s incumbent on every state and community and planning group to know what your resources are so you can figure out how you’re going to fill and meet that gap,” said Knebel of HHS.

Davis Tornabene of Sarasota Memorial Hospital, FL, described what she learned in the planning process. “When we did our tabletop regarding pan flu some issues came to light … we had really no idea of the state supply of available ventilators, antivirals, things like that,” she said.

Others wondered how hospitals could learn more about available resources in the Strategic National Stockpile, such as the numbers and types of ventilators available during a crisis. Although that information may be classified, there were calls to have at least some basic information shared so hospitals could do facility planning.

A broader point made about resources was the need to ensure a fair and adequate distribution of resources, based on processes that can be upheld even as situations become turbulent. “You need those triggers to determine when you’re going to say [to hospital distributors] that you can’t distribute all your N95 respirators to the hospitals that are paying you the most money,” said HHS’s Knebel. “You have to make sure you distribute them to those people who don’t go to those hospitals, the people who live in the inner cities.”

It is all too easy to imagine hospitals hoarding supplies, or suppliers demanding ever higher prices for the remaining few doses of a particular drug. In Colorado, one workshop participant offered, draft orders were under consideration that would allow the governor to seize supplies from any location and redistribute them to other locations.

When supplies do run out, a number of participants suggested developing guidelines for how to reuse and recycle spent resources. Studies are needed, they suggested, on how long supplies such as surgical masks can be used before being discarded in suboptimal environments. In an environment focused on doing the greatest good for the greatest number, extracting the maximum value from limited supplies is crucial.

Pediatrics and Other At-Risk Populations

If crisis standards of care are to be fair, particular attention must be paid to planning for at-risk populations such as children and older adults, workshop participants noted. The challenges of basic triage multiply in these populations for a variety of reasons. There is less available research on which to base decisions, and the care required may be more specialized so even during non-disaster times there are fewer trained healthcare providers and appropriate resources. There is also the potential that a communications problem or a lack of understanding of the special needs of people with disabilities such as sight or hearing impairments could impact the triage process. In some cases, the decisions are simply more emotional.

“Large-scale pediatric casualties could be more than we could bear,” warned George Foltin, speaking of his work on emergency planning with the New York City Department of Health, at the meeting in the Bronx. When triaging pediatric patients, “we need to think of this sometimes as if we were wartime England. We need to be brave. We need to make correct choices. We need to protect our way of life and we need to focus on our children.” Most hospital settings do not have the specialty equipment or specially trained doctors to provide surge coverage of pediatric patients, Foltin noted. As a result, “The major pediatric center must surge,” he said. “We think that critically ill and injured children are better off at a major center that has [the equipment and expertise] to take care of them, even under less than optimal circumstances, rather than going to a hospital that doesn’t know how to take care of them.”

Children represent 25 percent of the U.S. population, so our failure to plan explicitly for their care represents an acute failure of overall planning.

Children, of course, are not the only ones. In fact, there may be situations where the rest of the population is carrying on as normal even as a special-population care facility is completely overwhelmed. “A perfect example was the [New York City] blackout in 2003,” added Judith Ahronheim, a New York geriatrician. “We were thinking about terrorism, but the largest number of admissions to the hospital was vulnerable elderly people whose electrical appliances had failed.”

Mental health patients are another vulnerable population that deserves special attention and care. Anticipating and responding to those needs is a critical part of maintaining a fair standard of care. The importance of upholding fairness during the development and implementation of crisis standards of care is discussed in greater detail below in the section on Ethical Considerations.

Finally, Phillips, of AHRQ, highlighted pregnant women as another group of vulnerable patients. “We don’t really want pregnant healthy women going into some of the hospitals during pandemic influenza,” said Phillips. But how do we encourage woman to deliver at home in contrast to the broader push for hospital births over the past few decades?

Palliative Care

Ultimately, despite surge capacity, despite stretching resources, and despite best efforts, the implementation of crisis standards of care in a mass casualty event may mean that some patients will not have access to critical care resources.

Workshop participants widely believed that no patient, regardless of the circumstance, should simply be “left to die.” Participants stressed that care is never withdrawn. Patients who are not offered access to critical life-sustaining resources should receive the best available palliative care. Participants also discussed regular reevaluation of patients to see if improving conditions have increased their likelihood of responding to more aggressive treatment using available resources.

These situations “contemplate a context where there will be many, many deaths among people who receive critical care resources, and among those who don’t, so it puts an enormous emphasis on palliative care,” said Tia Powell, director of the Montefiore-Einstein Center for Bioethics in The Bronx, New York.

Despite the obvious need, participants worried that too little had been done to establish protocols and standards for palliative care for those who do not receive life sustaining resources. So much energy is spent worrying about resource allocation for those patients who do receive critical care resources that almost none is left over for those who don’t. “It’s distressing after this many years that there’s still a reluctance to talk about palliative care,” said Knebel from the HHS. Even in healthcare circles, there’s a reluctance to admit that sometimes the best the health-care system can do is to make a patient more comfortable.

“It’s a perfectly acceptable standard of care in the appropriate situation,” said Jan Rhyne of the North Carolina Medical Board, who thought it should not even qualify as a crisis standard of care. “It is a very noble type of care, and I think the hospitals are having a tough time getting that message out right now.”

Workshop participants highlighted the need for extensive work on how patients should be treated if life-sustaining treatment such as ventilator support is not offered or is discontinued. Similarly, caregivers should be taught how to deal with the stress of these situations, and to handle the very real potential mental health challenges of those involved.

“I find that personally, in the circles I travel in [palliative care] is now the new third rail of disaster medicine,” said Inova’s Hanfling. “We can talk somewhat comfortably about this shift in standards of care … but when we talk about palliative care … withdrawing ongoing life support—you know it is really frowned upon and I get a lot of push back.”

The decision to reallocate life-sustaining treatment from one patient in favor of another is a very real, on-the-ground issue in a mass casualty situation. “How do you manage that transition?” asks Minnesota’s Hick. “You’re in the ICU, [the patient is] on the ventilator, and now you extu-bate the person. … Do you keep the patient there? … Do you have a palliative care area you move them to? What kind of support do they have? Those are exactly the kinds of issues we need to think through.”

The scenario is even more basic than that. “There’s virtually no standard protocols for external extubation in the literature now. I mean, there was something in Chest Soundings a few years ago, but there’s very little for non-pandemic standards of how to do it. So that’s just an existing gap, period,” noted Berkowitz from the VHA.

These are not easy issues. In the context of a mass casualty event, palliative care may be given to patients who, in normal situations, would receive aggressive interventions and potentially life-sustaining therapies. Exactly how, where, and when to provide this care—and the preparations that must be made to ensure that care is as good as possible—was an area identified as needing significant research.

Mental Health Care

One area that to date has received little attention is the mental health consequences surrounding some of the hardest decisions contemplated—such as removing ventilator assistance from a patient or ceasing pediatric resuscitations in the field. “One of the things we don’t do very well is understand how [practitioners] are likely to respond,” said Jack Herrmann, senior advisor for public health preparedness at the National Association of County and City Health Officials. “We plan for how we want them to respond, and less for how they do respond.”

The long-term fallout on practitioners and patients will also be great, and multiple participants voiced the need to prepare ahead of time to assist patients and caregivers coping with post-event stress. “When people are going to live in this environment for any period of time, the providers are going to need a lot of support,” said Phillips. “They’re going to have to live with these decisions. And I think that’s something we haven’t paid much attention to.”

“Grief management’s going to be a huge, huge component … not just for the individuals who are falling victim to this, but also to the providers who are not able to provide the kind of care and treatment that they feel is important,” said David Fleming, professor of Clinical Medicine and the Director of the Center for Health Ethics at the University of Missouri School of Medicine. To meet this need, Missouri is developing just-in-time pandemic grief training for managers and supervisors.

Robert Hood, an ethicist at the Florida Department of Health, noted that Johns Hopkins University has a CDC funding allotment to work on ethical issues and mental health preparedness.

The broader population will also face significant mental health issues. “The community is going to have to deal with families having family members die in their homes [when] normally they would have had a hospice provider maybe coming in and helping them. They may not have that kind of support,” noted Phillips. “I think there are a whole lot of implications for the mental health field and mental health providers.”

Training

One challenge that workshop participants consistently noted was the difficulty in effectively training and building relationships across organizational boundaries. Efforts like Levy’s community-based CDC workshops help, but the need was identified to develop opportunities that would build ongoing, hands-on, face-to-face relationships among stakeholders before disaster strikes. That means holding joint training exercises and developing personal relationships so that, when disaster does strike, lines of communication will be open.

Inova’s Hanfling noted that “planned disasters” can often provide a framework for exactly this kind of discussion. Hanfling noted that the 2009 presidential inauguration provided an opportunity for representatives from Maryland, Virginia, and the District of Columbia to sit together in an emergency operations center ready to manage an emergency response. This enabled them to provide information in real time from their respective jurisdictions, and in turn to communicate information back from the emergency operations center.

Ultimately, no major events occurred during the Inauguration that required a community-wide response. But bringing people together to sit at the same actual table and build relationships was seen as a major and significant step forward. “One of the things that, even for communities that are fairly advanced [in their preparedness planning] … is that it is quite interesting when you bring these groups together,” said the CDC’s Levy. “For one, they usually end up realizing that they don’t really know the details of each other’s plans, or they’re making assumptions that turn out to be incorrect, or someone will have a plan and another group didn’t even know they had that plan. Also hospital leaderships, we’ve found, usually haven’t grasped the complexity of the issues that are involved in these types of mass events.”

As these diverse groups are brought together, however, there is a need to mediate the situation and foster a fair discussion. These are difficult issues, and tensions can be high.

“I would encourage everybody to look at having a neutral, outside moderator when you bring your core group together,” said Roy Alson, medical director of disaster services for the North Carolina Office of EMS. “You often have disparate groups who have individual issues, and having somebody who’s neutral to guide the process can get you over some rocks and shoals.”