Altered Standards of Care in Mass Casualty Events: Chapter 4

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Chapter 4. The Larger Context: Important Related Issues

The expert panel emphasized that, for health systems and providers to respond effectively to a mass casualty event, a number of important legal, policy, and ethical issues related to altered standards of care must be addressed before such an event occurs. These issues are discussed below.

Authority to Activate Use of Altered Standards of Health and Medical Care

It is important to establish clear authority to activate the use of altered standards of health and medical care. The following questions pertain:

What circumstances will trigger a call for altered standards of care?
Who is authorized to make that call, and at what level (site, community, region, State, or Federal) should the call be made?
Under what legal statutory authority, should the call be made?
Once the call is made, who assumes responsibility for directing emergency actions?
What is the relationship of otherwise autonomous institutions to the incident management system?

Generally, when a decision exceeds the authority of a particular organization or region, responsibility for the decision moves to the next level of decisionmaking and authority. Nonetheless, it is advisable that State and local jurisdictions empower local decisionmakers to act before Federal or other outside assistance arrives. Some decisions may emanate from public officials at higher levels of authority, such as the mayor, governor, or president, whereas clinical decisions will need to come from health and medical professionals closer to the event.

While decisions made by those closer to the event may trigger a move to altered standards of care, policies that support the move to altered standards must be put in place by the highest levels of authority necessary. For example, during a mass casualty event, a hospital may decide that the demand for medical care has exceeded the hospital's ability to provide care under normal standards. This decision will require a move to expanded functions for staff (e.g., nurses may perform some physician duties). In this case the decision to move to altered standards of care emanates from the clinical level. However, it is important that the appropriate higher level of authority has put in place the policies, such as provisions allowing the modification of State scope of practice laws that support the decision and empower the hospital's nurses or other health care staff to provide an expanded level of care.

Examples of existing resources that offer starting points for addressing questions of authority are described in the accompanying exhibits. One is a draft checklist developed by the American Bar Association for State and local government attorneys to prepare for possible disasters (Exhibit 5). Another is the Model State Emergency Health Powers Act (Exhibit 6). A third is draft executive orders developed in Colorado that create a legal framework for an emergency and address a variety of legal issues (Exhibit 7).

Exhibit 5. Draft Checklist for State and Local Government Attorneys to Prepare for Possible Disasters

Questions of authority are addressed by the "Draft Checklist for State and Local Government Attorneys To Prepare for Possible Disasters" prepared by the Task Force on Emergency Management and Homeland Security of the State and Local Government Law Section, American Bar Association (March 2003).

The checklist includes lists of questions pertaining to authority in general, authority for surveillance, and intergovernmental joint powers agreements. It also addresses public information, administrative and fiscal issues, contracting, personnel, and liability.

For more information, go to http://www.abanet.org/statelocal/disaster.pdf (PDF Help)

Exhibit 6. Model State Emergency Health Powers Act

The Model State Emergency Health Powers Act (Model Act) grants specific emergency powers to State governors and public health authorities in the event of a large public health emergency. The Model Act was developed for the Centers for Disease Control by The Center for Law and the Public's Health at Georgetown and Johns Hopkins Universities to ensure an effective response to large-scale emergency health threats while protecting the rights of individuals. It provides a broad set of powers for an entity called the Public Health Authority.

As it may relate to altered standards of care, the Model Act provides that a declaration of an emergency activates the disaster response and recovery aspects of State, local, and interjurisdictional disaster emergency plans. There is no mention of local-level involvement. The Public Health Authority is empowered to take control over facilities (health care and other) and "materials," such as food, fuel, clothing and other commodities, and roads. It may control health care supplies by rationing resources; establishing priority distribution to health care providers, disaster response personnel and mortuary staff; and establishing a general distribution to all others. It may establish and enforce quarantine and other infection control measures.

The following provisions of the Model Act have provoked considerable discussion among public health scholars and practitioners:

Quarantine. "Special Powers" of the Public Health Authority apply to: performing physical examinations, necessary tests, and/or vaccination. Any person refusing examination, tests, or vaccination may be isolated or quarantined. These sections (§601, §603) have been subject to media and public scrutiny. States have designed widely differing solutions. However, the Model act has helped to modernize State laws on quarantine and encourages greater consistency among State laws regarding quarantine provisions.
Liability. Health care providers are not held liable for any civil damages, except in cases where they are found to be negligent in treating or in failing to provide treatment. This includes out-of-State health care providers for whom relevant permits to practice have been waived by the Public Health Authority. The Model Act also explicitly states that except in cases of gross negligence or willful misconduct, the State (and the State and local officials specified in the act) is not liable for any property damage, death, or injury incurred as a result of complying with the Act (§804(a)).
Compelling Provider Participation. The Model Act states (§608(a)) that the Public Health Authority can compel in-State health care providers to assist in vaccination, testing, treatment, or examination of an individual as a licensure condition.
Other Provisions. Other provisions of the Model Act include the use of otherwise protected private medical information, public information obligations, access to mental health services and personnel, compensation for private property (calculated according to nonemergency eminent domain procedures) and reimbursement for health care supplies.

For more information, go to http://www.publichealthlaw.net/Resources/Modellaws.htm (PDF Help)

Exhibit 7. Colorado's Approach to Planning for Disaster Emergencies—Executive Orders

Colorado has chosen to plan for disaster emergencies by using draft executive orders to create a legal framework for an emergency and address a variety of legal issues. These orders are summarized in this exhibit.

Executive Order 0.0 Declaring a State of Disaster Emergency Due to Criminal Acts of Biological Terrorism. This executive order declares a disaster emergency of an epidemic type. The Governor's Expert Emergency Epidemic Response Committee would meet and advise the governor that an emergency exists. The governor would then issue this order, which is good for 30 days and sets the stage for other orders directing specific actions to meet the emergency.
Executive Order 1.1 Ordering Hospitals to Transfer or Cease the Admission of Patients to Respond to the Current Disaster Emergency. In directly authorizing hospitals to cease admissions and transfer patients, this order permits hospitals to determine on their own without central guidance whether they have reached their capacity to examine and treat patients. It further grants immunity from civil or criminal liability to those hospitals, physicians, and emergency service providers who act in good faith to comply with the executive order. The order takes the position that the Emergency Medical Treatment and Labor Act (EMTALA) requirements do not preempt this order.
Executive Order 2.0 Concerning the Procurement and Taking of Certain Medicines and Vaccines Required to Respond to the Current Disaster Emergency. This order authorizes the seizure of certain named drugs from public and private outlets listed in the State's pharmacy statutes, and embargoes the supply of those drugs. At the same time, it exempts from seizure those supplies that certain facilities are required to keep on hand for the chemoprophylaxis of their employees. It provides for keeping records of drugs embargoed and for compensating the outlets at the cessation of the emergency.
Executive Order 3.0 Concerning the Suspension of Certain Statutes and Regulations to Provide for the Rapid Distribution of Medication in Response to the Current Disaster Emergency. This order implements Colorado's Strategic National Stockpile Plan and suspends certain pharmacy statutes to facilitate the rapid distribution of medicines and vaccines in response to an emergency epidemic. The order further authorizes named officials to direct listed health care providers to participate in this effort and explicitly permits the limited participation in that effort by nonmedical personnel. The order is not intended for application in response to a chemical event.
Executive Order 4.0 Concerning the Suspension of Physician and Nurse Licensure Statutes to Respond to the Current Disaster Emergency. This order permits physicians and nurses who hold a license in good standing in another State, or who hold an unrestricted but inactive Colorado license, to practice under the supervision of a Colorado-licensed physician during the emergency, provided they do so without charge to the State or any individual patient or victim. This order would permit more physicians and nurses to be available to treat infected persons during the emergency.
Executive Order 5.0 Concerning the Suspension of Certain Licensure Statutes to Enable More Colorado Licensed Physician Assistants and Emergency Medical Technicians to Assist in Responding to the Current Disaster Emergency. Under normal conditions, physician assistants (PAs) and emergency medical technicians (EMTs) licensed in Colorado can practice only in association with or under the supervision of physicians by prior agreement. This order permits PAs and EMTs to practice under the supervision of any licensed physicians in order to afford treatment to the greatest number of infected individuals. The PAs, EMTs, and physicians involved are granted immunity from civil or criminal liability if they act in good faith to meet the terms of the order.
Executive Order 6.0 Concerning the Isolation and Quarantining of Individuals and Property in Response to the Current Disaster Emergency Epidemic. This order empowers the Colorado Department of Public Health and Environment to establish, maintain, and enforce isolation (of infected individuals) and quarantine of (exposed individuals) as needed to protect the public health in an epidemic situation. It further grants similar powers to local boards of health to combat infectious disease epidemics.
Executive Order 7.0 Ordering Facilities to Transfer or Receive Patients with Mental Illness and Suspending Certain Statutory Provisions to Respond to the Current Disaster Emergency. This order permits the transfer of mentally ill persons from a designated facility to some other facility as necessary to treat them for the infectious disease causing the epidemic. It further specifies requirements related to required services and use of identifying personal information, and provides for immunity from civil or criminal liability for any facility acting in good faith under the order.
Executive Order 8.0 Concerning Suspension of Certain Statutes Pertaining to Death Certificates and Burial Practices in Response to the Current Disaster Emergency. This order suspends the statutory timing requirements for filing death certificates and authorizes the executive director of the Colorado Department of Public Health and Environment to direct the disposition of dead bodies in a manner that will protect the public health.

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Legal and Regulatory Issues

The organization and delivery of health care is highly regulated. In a mass casualty event, it is likely that some provisions for temporary modification of regulatory requirements at all levels of government will be necessary. At the present time, uncertainty about legal issues, particularly liability, may be creating a reluctance to anticipate and plan for a mass casualty event that would require altered health and medical care standards. As mentioned earlier, it is important to establish clear authority to activate altered standards of medical care. Alternatives may include enhancing or modifying a number of laws and regulations pertaining to the delivery of health and medical care in normal conditions.

The level of authority necessary to modify laws and regulations during a mass casualty event will correspond with whether they are Federal, State, regional, or local laws. However, in all cases, it is important to make all providers and institutions aware of the established legal framework and authority to modify laws and regulations, so that responders to a mass casualty event will know which laws do and do not apply in a given situation.

To the extent possible, existing laws and other mechanisms should be used to the fullest and should not impede the process of planning for a mass casualty event. It is therefore important to examine existing State public health laws, licensing/certification laws, interstate emergency management compacts and mutual aid agreements, and other legal and regulatory arrangements to determine the extent to which they meet potential new threats. Any waivers granted are likely to be targeted to the affected area for a temporary and specified period of time. In the case of a mass casualty event involving a communicable agent that moves from region to region, it will be important to have flexibility to extend or expand such waivers.

Some of the Federal, State, and local laws and regulations that govern the delivery of health and medical care under normal conditions may need to be modified or enhanced in the case of a mass casualty event. These include laws to: ensure access to emergency medical care; protect patient privacy and confidentiality of medical information; shield medical providers and other rescuers from lawsuits; govern the development and use of health and medical facilities; and regulate the number of hours health and medical providers can work as well as the conditions in which they work. Relevant laws include but are not limited to the following:

Emergency Medical Treatment and Active Labor Act (EMTALA).
Health Insurance Portability and Accountability Act (HIPAA).
Federal Volunteer Protection Act.
Good Samaritan Law.

Additional types of laws and regulations that relate to the delivery of health and medical care include:

80-hour work week rule for medical residents.
Occupational Safety and Health Administration and other workplace regulations.
Building codes and other facility standards.
Publicly funded health insurance laws (including Medicare, Medicaid, and the State Children's Health Insurance Program).
Laws pertaining to human subject research.
Laws and regulations governing the use and licensure of drugs and devices.

In developing a comprehensive plan for the delivery of health and medical care during a mass casualty event, it is important to consider mechanisms to allow for legal, regulatory, or accreditation adjustments in the following areas:

Liability of providers and institutions for care provided under stress with less than a full complement of resources. The plan may have to provide for "hold harmless" agreements or grant immunity from civil or criminal liability under certain conditions.
Certification and licensing. Although it is important to ensure that providers are qualified, it is also important to have flexibility in granting temporary certification or licenses for physicians, nurses, and others who are inactive, retired, or certified or licensed in other States.
Scope of practice. It may be necessary to grant permission to certain professionals on a temporary and emergency basis to function outside their legal scope of practice or above their level of training.
Institutional autonomy. If organizations and institutions cede their authority in order to participate in a unified incident management system in a crisis, the plan may have to address the legal implications for those organizations.
Facility standards. Standards of care that pertain to space, equipment, and physical facilities may have to be altered in both traditional medical care facilities and alternate care sites that are created in response to the event.
Patient privacy and confidentiality. Provisions of HIPAA and other laws and regulations that require signed releases and other measures to ensure privacy and confidentiality of a patient's medical information may have to be altered.
Documentation of care. Minimally accepted levels of documentation of care provided to an individual may have to be established, both for purposes of patient care quality and as the basis for reimbursement from third-party payers.
Property seizures. Provisions may have to be made to take over property, including facilities, supplies, and equipment, for the delivery of care or to destroy property deemed unsafe.
Provisions for quarantine or mass immunization. In anticipation of a biological event, the plan will have to address the establishment and enforcement of isolation, quarantine, and mass immunization and provisions for release or exception.

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Financial Issues

Preparing for and providing health and medical care during a mass casualty event could result in large financial losses for all involved organizations, if issues surrounding the financing of such preparation and care are not addressed. Concern about financial resources and reimbursement for health and medical care provided during a mass casualty event applies to all providers, organizations, and sites, including governmental and nongovernmental, not for profit and for profit. It includes concern about costs of the following:

Providing care in traditional medical settings, alternate care sites and pre-hospital care settings.
Creating alternate care sites in settings such as schools, neighborhood centers, or hotels.
Training providers.
Staging drills.
Repairing physical plant damage.

One potential source of disaster relief is the Stafford Act (Public Law 93-288). However, financing from the Federal government must be supplemented by funds from other public as well as private organizations. In preparing a comprehensive plan, it may be very valuable for planners to include financial management experts from the participating organizations, such as hospital systems. In addition formal mutual aid agreements or other contracts should be developed in advance to document relationships, expectations, and requirements related to obtaining emergency reimbursements. On the patient side, issues of financial access, such as requiring proof of insurance, apply. This concern is closely related to legal issues of documentation for reimbursement. It is not likely that providers will be able to maintain documentation practices beyond what is considered minimally adequate to support treatment; altered standards of documentation for reimbursement purposes may have to be defined.

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Communicating with the Public

Comprehensive plans for responding to a mass casualty event include strategies for communicating with the public before, during, and after an event.

Prior to the occurrence of a mass casualty event, the goal should be to educate the public about:

Signs and symptoms of chemical, biological, radiological, and other exposures.
Appropriate self-care responses.
Appropriate use of health and medical care.
What to expect from the health care system in the event of a mass casualty incident.

During a mass casualty incident, the goal should be to:

Provide information to the public about the status of the response.
Give consistent messages about when and where to seek care.
Manage expectations regarding the delivery of health and medical care.
Provide guidance on how to obtain information about the status of missing persons.

Following a mass casualty incident, the goal should be to provide ongoing information to the public about:

Signs and symptoms of sequelae of exposure to toxic agents and post-traumatic stress.
Who to call for information.
Where to go for help.

Clear communication with the public is an essential part of a health and medical response to a mass casualty event. In order to deliver clear and appropriate messages before, during, and after a mass casualty event, it is important to consider a number of issues:

Providing consistent and regular messaging, preferably through a single spokesperson with professional (medical) credibility, is highly desirable.
Conveying clinical information requires particular care to assure that a lay audience can understand it.
Distinguishing between political and professional messages is essential.
Making provisions for communication in languages other than English may be necessary.

Strategies for public communication can be built from effective models of risk communication in use today for natural disasters, such as hurricanes and earthquakes. They should reflect and be tied to our long history of civil defense and other preparedness efforts dating as far back as World War II and the Cold War.

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Ensuring an Adequate Supply of Health Care Providers

One of the key components of an effective health and medical care response is ensuring adequate supplies of a broad array of qualified responders and providers who are available and willing to serve in a mass casualty event. This is likely to involve the following:

Recruiting from retired or currently unemployed but qualified volunteer providers within the community and State.
Making use of reserve military medical and nursing providers and other responders, as well as an expanded group of providers, such as veterinarians, dentists and dental auxiliary providers, pharmacists, and health professional students.
Modifying State certification and licensing requirements to allow out-of-State providers to practice on a temporary basis.
Modifying State regulations on a temporary basis to broaden scope of practice standards among various trained providers.
Reallocating providers from nonemergency care and nonemergency sites to emergency response assignments and from unaffected regions to affected regions (this will involve identifying skill sets of each practitioner group [e.g., paramedics, nurse midwives, etc.], so as to optimize reassignment potential).
Creating and training a pool of nonmedical responders to support health and medical care operations.
Making adequate provisions to protect providers (and their families) who serve in mass casualty event situations to ensure their willingness to respond.
Developing systems for the advance registration and credentialing of clinicians to augment health care personnel needs during a mass casualty event.

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Provider Training and Education Programs

Adopting altered standards of care, even temporarily, will have a significant impact on health care delivery operations and therefore on the needs of providers for training and education to serve in those circumstances. Planners should not assume that individual providers will know how to deliver appropriate care in a mass casualty event, but rather should develop or identify training programs to ensure a knowledgeable and systematic, coordinated response effort.

A wide array of preparedness training has been designed and is being delivered throughout the country. Some of the training has been evaluated for effectiveness. In the absence of a national clearinghouse for training for all providers and conditions, it is not possible to provide a complete picture of what is available and effective. General principles that might guide the development and identification of effective training include the following:

Training should be competency based.
Training should be ongoing.
Training should be provided to all responders, including nonmedical personnel and potential community volunteer responders, as well as primary care providers in office and clinic settings.
Training should be based on the doctrine of daily routine, which assumes that providers will do best what they do most often, but anticipate extension and expansion of provider roles.
Training should be provided on a just-in-time basis only where appropriate, especially if it differs from daily routine.
Training should be specific to the role a person is likely to play in a mass casualty event (e.g., clinic nurses and nurse aides may need training in burn care).
Training should be specific to the conditions of performance (type of hazard, type of site) and involve opportunities to practice new skills through simulation and other mechanisms.
Training should be effective, as demonstrated by evaluations and trainee performance.
Training should be made available to all potential traditional and non-traditional providers, including veterinarians, dentists and dental auxiliary providers, pharmacists, and health professional students.

A beginning list of the types of training needed by all responders and providers in pre-hospital, hospital, and alternate care sites includes but is not limited to the following:

General disaster response, including an introduction to altered standards of care and how the move to such standards may affect triage and treatment decisions as well as facility conditions.
Legal and ethical basis for allocating scarce resources in a mass casualty event.
Orientation on how an incident management system would work in a mass casualty event.
How to treat populations with special needs (e.g., children and elderly persons).
How to recognize the signs and symptoms of specific hazards and a trend of similar types of signs and symptoms.
How to treat specific conditions.
How to recognize and manage of the effects of stress on themselves and their patients.

Finally, as components of preparedness training are defined, they should be incorporated into the original training for each provider group. For example, if paramedics are expected to participate in mass immunizations or assist in emergency departments, it would be desirable that they get basics on immunization and sterile technique in their original training.

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Protection of Health Care Providers and Facilities

It is important for planners to consider the following to ensure the protection of health care providers:

Personal protective equipment, prophylaxis, and other protections that enable them to work safely.
Training specific to provider responsibilities and to the nature of the event.
Adequate rotation of staff to prevent burnout and errors due to fatigue.
Freedom from threats of malpractice (see earlier discussion of legal issues).
Mental health support during and following stressful situations (e.g., Critical Incident Stress Management).
Care and support for health care providers' families.

A related concern is to protect the integrity and safety of existing health care facilities (e.g., hospitals, the providers who work there, and the patients who are already under care) at the time a mass casualty event occurs. The protection of alternate care sites created in response to a mass casualty event would also be important. A plan to protect health care facilities might include steps to ensure the following:

Current patients and facility staff do not become secondary victims.
Contaminated victims are not permitted to enter "clean" treatment areas.
Facilities may utilize temporary security procedures, such as lockdowns, to enforce safety.
Decontamination processes in all care settings are adequate.
Noncritically ill patients are safely relocated to other facilities, if needed.

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Caring for Populations with Special Needs

It is essential that plans for the delivery of health and medical care in a mass casualty event address how the special needs of several groups within the general population can be met. These needs may vary from providing for alternate means of decontamination for babies and other nonambulatory persons, to having translators available at intake centers, to providing mental health assessment resources within the health care setting. Involving organizations and services designed to serve groups with special needs under normal conditions may be a successful approach. As mentioned earlier, a victim's underlying medical condition may affect their survivability, and therefore may be considered negatively in triage. In some cases resources may be diverted away from adults to children because of their greater life expectancy.

Populations recognized as having special needs in a mass casualty event include but may not be limited to the following:

Children. The unique physiology and wide variation in physical and cognitive development by age within childhood requires that triage personnel be trained in pediatric triage standards and other pediatric assessment protocols (e.g., JumpSTART); family care and adult care be available in pediatric settings; appropriately-sized supplies, equipment, and medication doses be available; and safe use of decontamination procedures be ensured. Provisions for treating children whose parents are not present and for treating parents who will not leave their children are important considerations.
Persons with physical or cognitive disabilities. As under normal standards of care, provisions to accommodate the special disability-related needs of some persons are important aspects of the organization of care. These are likely to include issues of physical access to and within care sites, alternative and safe decontamination procedures, enhanced communication, and issues involving informed consent.
Persons with preexisting mental health and/or substance abuse problems. Preexisting mental health and substance abuse conditions are known to exacerbate an individual's ability to cope with physical and emotional trauma. Provisions should be made for screening and direction to appropriate services as part of triage or other assessment protocols.
Frail or immunocompromised adults and children. Individuals in these groups who are victims may require adjustments in treatment regimens and special monitoring, but these adjustments will be made within the context of any overriding goal to maximize lives saved.
Non-English speakers. Local and regional planning may have to take into account the need for communication tools in languages other than English. Although printed materials of a general nature may be prepared in advance, printed materials and signs will not be an adequate response for those who cannot read any language. An additional challenge may be present if undocumented individuals fear discovery and reprisal if they come forward for health care in a mass casualty event. Involvement of formal and informal networks, organizations, and media outlets that serve non-English speaking groups is essential.

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Transportation of Patients

Addressing issues related to the transportation of patients during a mass casualty event is also important. Roads may be blocked and the emergency transport system will not be adequate to meet the need. Issues to consider include the following:

Who will accompany patients, since health and medical personnel may be needed elsewhere?
How should all available public and private transport, including public and school buses, taxis, and limousines, be mobilized?
What kind of prior agreements can be established to ensure this mobilization can occur?

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