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Institute of Medicine (US) Forum on Medical and Public Health Preparedness for Catastrophic Events. Crisis Standards of Care: Summary of a Workshop Series. Washington (DC): National Academies Press (US); 2010.

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Crisis Standards of Care: Summary of a Workshop Series.

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Legal Issues for Crisis Standards of Care

Legal concerns hover over every issue in disaster planning and crisis standards of care. “Laws absolutely pervade emergency responses at every level of the government,” explained James Hodge, then executive director at Johns Hopkins’ Center for Law and the Public’s Health, one of several legal experts who presented at the four regional workshops. “Laws determine what constitutes a public health or other type of emergency; they help create the infrastructure through which we respond, prevent, and detect these emergencies; they authorize the performance or non-performance of various different actions by a host of different actors; and they flat-out determine the extent of responsibility for potential or actual harms that arise during emergencies.”

Planning ahead to ensure that the legal environment will support an effective, fair, and consistent response is a crucial step in preparing for crisis standards of care during an emergency event. Workshop participants found that this area still needs a significant amount of work.

Legal Liability

Most states have provisions that limit legal liability during emergencies. Ball from South Carolina outlined a number of laws that help limit medical malpractice liability during emergency situations in South Carolina, including the following:

  • Emergency Health Powers Act (44-5-570, (C)(1)): “Any health care provider appointed by [the South Carolina Department of Health & Environmental Control] … must not be held liable for civil damages as a result of medical care … unless the damages result from … circumstances demonstrating a reckless disregard for the consequences.”
  • Medical Malpractice Act (38-79-30): “Volunteer (non-compensated) health care provider … not liable for any civil damage for any act or omission resulting from the rendering of the (medical) services unless … act or omission was the result of … gross negligence or willful misconduct.”

Similar laws exist in most other states. But although these laws represent a good start, they come with one major drawback during crisis standards situations. Raymond Pepe of the Uniform Law Commission (ULC) noted that the laws “by and large immunize ordinary acts of negligence while not immunizing gross negligence or willful disregard of standards of care.” Despite the drawbacks of this limitation, several participants added, it is also necessary to discourage harmful behavior and protect patients from those who do not act in good faith during disaster responses.

Crisis standards contemplated include not offering or discontinuing life-sustaining treatments such as ventilators as part of a broader triage program. “When we willfully and knowingly withdraw or withhold life support, knowing there may be a bad outcome, we tread that line of willful misconduct,” said Cheryl Starling of the California Department of Public Health. Starling and others noted that this is one of the key barriers to getting healthcare providers and facilities to come to the table to discuss crisis standards of care and disaster preparedness.

These issues, she said, make “lawyers run for the hills and refuse to let people even talk about this … because [many people believe] you’re setting yourself up for negligence and willful misconduct.” This fear is especially strong with regard to the most extreme situations that involve the need to discontinue life-sustaining treatment in some patients.

These issues can also make healthcare providers unwilling to act during these emergencies, even with the clearest directions in place by top-level public health administrators. If you can’t solve the legal liability issue, many noted, you can’t get anywhere.

Fortunately, a great deal of work has been done on this issue at both the federal and state levels, creating a reference body of potential options for various localities to explore.

Addressing the Liability Problem

The first question that must be asked when approaching the problem of legal liability, Pepe said, is what legal liability is based on. “An accepted community standard of care grows out of either custom or practice, or it grows out of outcomes-based research which has led to consensus with respect to how to treat certain conditions,” said Pepe. “When you’re dealing with an alternative standard of care, you’re dealing with something fundamentally different. There’s a need to have clear legal recognition that these alternative standards exist and that practitioners are authorized to follow them.”

It is important to note that there is a critical distinction between legal and medical standards of care (Box 13). Starling noted that the term “standard of care” actually comes from a legal setting, not a medical setting, defining the duty to provide a minimum acceptable standard of care. “The medical standard of care may be higher than that, but defining the legal bare-minimum of that standard of care … and analyzing how that will change during emergencies … is a critical issue that requires more work,” Starling said.

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BOX 13

Medical and Legal Standards of Care. Medical Standards of Care: The type and level of medical care required in specific circumstances by professional norms, accreditation or other requirements. Legal Standards of Care: The amount of skill that a medical (more...)

Participants discussed a variety of ways in which the actual legal protections could be achieved.

Deputize Physicians

James Geiling, chief of medical services at the White River Junction VA Medical Center, VT, noted that some states have simply “deputized” physicians during states of emergency, or the federal government can make them federal agents. These actions can be enacted rapidly, and those deputized as state agents receive the state’s “sovereign immunity-type protections” that exist in many jurisdictions.

The complication of this action is that these deputized workers become the legal agents of the state or the federal government, and they must therefore be prepared to perform as the state or federal government mandates, not necessarily what their own healthcare institution or other usual employer might require. That concept can make many healthcare institutions and employers very uncertain, and they may be unwilling to cede that control.

Enact Comprehensive Liability Protection

Other states have taken more nuanced approaches. Virginia has enacted a comprehensive liability protection program that goes into effect if there is a declaration of emergency on behalf of the state government and it has resulted in resource shortages. Critically, the Virginia law does not require a separate act by the legislature to go into effect, but can be put into effect by the governor’s credo.

Montana passed a bill earlier in 2009 “that very much touches altered standards of care in an emergent situation if declared by the governor and protects us and gives us some immunity—and it’s different from the code of practice that we have,” noted Orlando meeting participant Michael Spence of Kalispell Regional Medical Center, MT.

A theme throughout the workshops was the concept of moving up the political chain of command when empowering this kind of legal liability protection, and putting the declaration of the emergency in the hands of a single powerful individual, such as a governor. Colorado, for instance, has draft executive orders that the governor can enact and that provide blanket protections for everything from license issues to who can dispense medicine.

Finding ways to make the standards as consistent and evenly applied as possible will be critical to mitigating liability for providers who are trying to do the right thing. That means, for example, having liability protections that extend not just to doctors and nurses, but to triage officers, resource teams, and all other parties involved in the healthcare process. Persons involved in triage were of particular concern because triage is where many of the most difficult decisions must be made. Participants mentioned the challenge and importance of developing consistency across state lines, and this was also a theme in the 2009 IOM letter report (IOM, 2009).

Credentialing and Scope of Practice

In contemplating the legal ramifications of enacting crisis standards of care, one issue that was raised repeatedly at the workshops was the credentialing of out-of-state healthcare providers. Other means of augmenting the core caregiver community were seen as critical, including expanding the types of care that certain healthcare providers can provide and supporting retired healthcare workers who are interested in volunteering during times of crisis.

Participants discussed the critical importance of having sufficient, qualified personnel during an emergency. Finding ways to expand the size and scope of the caregiver community, while maintaining and supporting a community-based vision for crisis standards of care, was seen as a critical task.

One group that has taken the lead on this work is the Uniform Law Commission, an interstate organization that has done extensive work on the credentialing issue and has developed a draft law—the Uniform Emergency Volunteer Health Practitioners Act—that states can adopt (Box 14). It includes a robust system for the interstate recognition of healthcare licenses.

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BOX 14

Uniform Emergency Volunteer Health Practitioners Act. Helps remove some of the barriers to implementing alternative standards of care Provides a model for promoting interstate cooperation

“It takes the fundamental approach that there is no reason that if your state is affected by a disaster you need to review on a case-by-case basis the credentials of people who are coming in from other states,” said the ULC’s Pepe.

The law limits the scope of medicine that these outside practitioners can practice, but it takes a common-sense approach of smoothing their entry into the disaster response. The idea is that multiple states can adopt the law in its written format.

At the same time, statutes across the country envision expanding scopes of practice temporarily for existing healthcare providers to let them work beyond the boundaries of their traditional expertise. Pharmacists may be asked to administer vaccinations, nurses may be asked to function in the role of nurse practitioners, and emergency medical technicians may be asked to dispense medicine.

Similarly, many states have statutes that allow retired healthcare providers to provide a limited set of services, such as palliative care. These healthcare providers can be a tremendous aid during an emergency, many noted, as long as they are given tasks appropriate to their training and education.

“We polled about 10,000 different perspective volunteers back in 2006,” said Johns Hopkins’ Hodge. “Seventy percent of them, or nearly 70 percent, said that their potential exposure to liability is an important or essential fact in whether or not they’ll actually participate in an emergency.”

The math is simple: Better, clearer legal protections mean more personnel to confront a mass casualty event.

EMTALA and HIPAA

Multiple workshop participants expressed concerns about the impact of federal regulations—specifically, the Emergency Medical Treatment and Labor Act (EMTALA) and the Health Insurance Portability and Accountability Act (HIPAA)—on the ability to respond to a medical disaster (Box 15). EMTALA requires certain hospitals to provide emergency care to all patients, regardless of their ability to pay; patients may not simply be denied care and turned away from the hospital’s doors. HIPAA governs privacy regulations and restricts the sharing of medical information. Compliance with these regulations is a significant concern for hospitals because failure to comply can result in exclusion from the Medicare program.

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BOX 15

EMTALA and HIPAA. EMTALA: The Emergency Medical Treatment and Labor Act was enacted by Congress in 1986 to “ensure public access to emergency services regardless of ability to pay.” The law requires hospitals participating in the Medicare (more...)

“How are you going to triage people to … alternate sites when you have EMTALA regulations in your face?” asked one participant, capturing the concerns of many. “How are you going to transfer people to other facilities when you have HIPAA that’s not going to let you get information back?”

To some extent, these specific concerns are already accounted for in the existing legal system. An apparently less well-known fact about the HIPAA and EMTALA regulations is that, when the HHS Secretary declares a public health emergency and the President declares an emergency or a disaster pursuant to the National Emergencies Act or the Stafford Act, HHS can issue an “1135 waiver” that temporarily suspends sanctions for noncompliance with certain provisions under both HIPAA and EMTALA.2 These waivers have been enacted in the past, and can be put in place quickly (and retroactively) during a disaster setting.

Florida’s Hood, however, cautioned about taking this comfort too far, noting that “many states have laws about medical confidentiality which are stricter than HIPAA.”

Hood and others noted that the 1135 waivers do not impact these more restrictive state-level laws. The recommendation was that states should individually evaluate their laws and put in place emergency orders to remove barriers to emergency response.

Legal Triage

Regardless of what legal rules are in place, or what standards have been agreed to, the legal landscape will be constantly shifting during an emergency, and participants will likely have to adjust their response accordingly.

Johns Hopkins’ Hodge introduced his own concept of “legal triage” to define how healthcare administrators must constantly adjust their operating procedures throughout an emergency to remain consistent with the evolving situation (Hodge and Anderson, 2008; Hodge et al., 2009). “It’s about prioritizing … legal issues in real time to construct a favorable legal environment … that facilitates legitimate public health responses during emergencies,” said Hodge. “Once an emergency has been declared, by design the legal landscape changes…. [I]t changes instantly and it can change drastically, and depending on how it changes, based on the type of emergency that we’re involved with, the legal responsibilities and liability protections and altered standards of care issues come into play.”

Hodge noted that since September 11, 2001, many new laws have been put into place governing emergency response and disaster preparedness. Forty-two states now officially allow for a declaration of disaster, and 26 states specifically define a public health emergency. The peculiarities of how those disasters are declared and what the term “disaster” actually means, legally, varies in nearly every case. Quite often there are different levels of declaration. “Your deployment, your abilities, your authorities, your liabilities, immunities are all dependent upon that level of an emergency,” explained Hodge.

In the midst of a disaster, having a legal team in place that is ready to respond to and interpret those evolving legal standards can be just as important as having the right medical triage and response teams. The message throughout the meetings was that if communities did not take care of the legal issues, much of the other planning would be significantly less effective.

Education and Training

As well-designed and thoughtful as any legal liability protections or other crisis standards laws may be, their effectiveness rests on whether hospital administrators and their legal counsel know they exist.

A theme that emerged from the legal discussions was that the natural reaction at many hospitals is to protect against liability and limit activity, barring clear guidance otherwise. That will likely be the prevailing wisdom in the confusion sure to accompany a true healthcare disaster.

Workshop participants repeatedly observed that significant work was needed to disseminate information about legal liability protections to healthcare providers, even in those states that have tackled the problem head-on.

Copyright © 2010, National Academy of Sciences.
Bookshelf ID: NBK32742

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