Emergency Preparedness: States Are Planning for Medical Surge, but Could Benefit from Shared Guidance for Allocating Scarce Medical Resources
Released: 2008-07-14T00:00:00

Letter

Background

Federal responsibilities for assisting states in preparing for emergencies include developing national strategies, policies, and guidelines and providing funding to assist states in developing their emergency preparedness plans and programs. A critical element of emergency preparedness is preparing health care systems for medical surge in a mass casualty event, and consideration of hospital capacity, alternate care sites, electronic medical volunteer registries, and altered standards of care is key to this task.

Federal Responsibilities Relating to States’ Preparedness for Medical Surge

DHS is responsible for developing national strategies, policies, and guidelines related to emergency preparedness. Additionally, DHS administers the Homeland Security Grant Program, which currently consists of four programs—the State Homeland Security Program, Urban Areas Security Initiative, Metropolitan Medical Response System, and Citizens Corps Program. While these programs generally award funds to states and municipalities for the prevention and detection of terrorist acts, some funds can be spent on medical response, including medical surge activities.

HHS has the principal responsibility for helping states to prepare for medical surge. In December 2006, PAHPA established ASPR within HHS in order to enhance coordination of public health and medical surge. The act reauthorized and gave ASPR authority over the Hospital Preparedness Program, which provides funds annually to 62 entities—the 50 states, 4 municipalities, 5 U.S. territories, and 3 Freely Associated States of the Pacific—through cooperative agreements in order to strengthen their emergency readiness capabilities. Also, beginning in fiscal year 2009, HHS will require that states provide a 5 percent match to the amount of the federal cooperative agreement funding, through either state funds or in- kind contributions, such as office space or computer support for the program. In 2010 and subsequent years, the matching requirement will increase to 10 percent.

As part of the 2006 Hospital Preparedness Program, ASPR required all cooperative agreement recipients to submit midyear progress reports that include data on 15 sentinel indicators, 13 of which are related to medical surge. For example, one of the sentinel indicators is the number of hospitals that have the capacity to maintain at least one patient with a suspected highly infectious disease in a negative pressure isolation room. PAHPA also gave ASPR authority for the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP). ESAR-VHP supports state-based electronic databases designed to register health care personnel who volunteer to provide medical care in an emergency for the purpose of verifying their credentials. In order to continue to receive Hospital Preparedness Program funds, states must participate in ESAR- VHP by fiscal year 2009. Under PAHPA, HHS is required to link state electronic medical volunteer registries into a national registry.

DOD and VA do not have a federal responsibility in assisting states in planning and preparing for medical surge in a mass casualty event. However, since their hospitals are accredited by the Joint Commission, they are required to participate in at least one annual emergency preparedness exercise with their local community. In addition, because they are part of the local community, they would play a role in planning for and responding to local mass casualty events.

Key Components of Medical Surge in a Mass Casualty Event

According to Homeland Security Presidential Directive 21 (HSPD-21) Public Health and Medical Preparedness, issued in October 2007, mass casualty health care is a critical element of public health and medical preparedness. HSPD-21 is one of a series of executive orders released since September 11, 2001, establishing a national strategy to help protect the nation in the event of terrorist attacks or other catastrophic health events. It states that mass casualty health care capability needs to be different from “day-to-day” public health and medical operations, which “cannot meet the needs created by a catastrophic health event.” It also states that the nation must develop a disaster medical capability that, among other things, is rapid, flexible, sustainable, integrated, and coordinated, and delivers appropriate treatment in the most ethical manner with available capabilities.

The four key components we identified follow: Hospital capacity: Following a mass casualty event, hospitals may need the ability to adequately care for a large number of additional patients. Strategies to increase hospital capacity include deferring elective procedures, applying more stringent triage for admitting patients, discharging patients early with follow-up by home health care personnel, and adding additional beds and equipment in areas of the hospital that are not normally used for inpatient care, such as outpatient examining rooms.

Alternate care sites: A mass casualty event could overwhelm hospitals’ capacity and require the establishment of alternate sites to provide health care services. Alternate care sites deliver medical care outside hospital settings for patients who would normally be treated as inpatients, and triage patients in order to sort those who need critical attention and immediate transport to the hospital from those with less serious injuries. In addition, alternate care sites manage unique considerations that might arise in the context of mass casualty events, including the delivery of chronic care; the distribution of vaccines; or the quarantine, grouping, or sequestration of patients potentially infected with an easily transmissible infectious disease. The development of alternate care sites involves several issues, including the level and scope of medical care to be delivered, the physical infrastructure required, staffing requirements for the delivery of such care, the medical equipment and supplies needed, and the management systems required to integrate such facilities with the overall delivery of health care. Additionally, there are two types of alternate care sites—fixed and mobile. Fixed facilities are nonmedical buildings that, because of their size or proximity to a hospital, can be adapted to provide medical care. Mobile medical facilities are either specialized units with surgical and intensive care capabilities that are based on tractor-trailer platforms or fully equipped hospitals stored in container systems that can be set up quickly.

Electronic medical volunteer registries: In a time of emergency, it can be difficult for state and hospital officials who are organizing a response to use medical volunteers unless they have been preregistered to determine who is qualified to provide medical assistance. For example, immediately after the attacks on September 11, 2001, thousands of people spontaneously arrived in New York City to volunteer their assistance— many of whom volunteered to provide medical assistance to the victims of the attacks. However, authorities were unable to distinguish medically qualified from unqualified volunteers. Generally, an electronic medical volunteer registry would (1) preregister health care volunteers, (2) apply emergency credentialing standards to these registered volunteers, and (3) allow for the verification of the identity, credentials, and qualifications of registered volunteers in an emergency.

Altered standards of care: In a mass casualty event, routine resource shortages would be significantly magnified and hospitals would have limited access to many needed resources, such as health care providers, equipment and supplies, and pharmaceuticals. As a result, it could be necessary to alter standards of medical care in a manner that is different from normal day-to-day circumstances and appropriate to the situation. For example, because of an influx of a large number of patients in a mass casualty event, adequate staffing of health care providers would be hindered by the current shortages of health care providers. Workforce shortages could result in hospitals changing their established standards of care, such as nurse-to-patient care ratios.

The Federal Government Has Provided States with Funding, Guidance, and Other Assistance to Prepare for Medical Surge

The federal government has provided funding, guidance, and other assistance to help states prepare their regional and local health care systems for medical surge in a mass casualty event. From fiscal years 2002 through 2007, the federal government awarded the states about $2.2 billion through ASPR’s Hospital Preparedness Program to support activities to meet their preparedness priorities and goals, including medical surge. Further, the federal government developed, or contracted with experts to develop, guidance that was provided for states to use when preparing for medical surge. In addition, the federal government provided other assistance, such as conferences for states.

Funding to Prepare for Medical Surge

From fiscal years 2002 through 2007, HHS awarded states about $2.2 billion through ASPR’s Hospital Preparedness Program to support activities to strengthen their hospital emergency preparedness capabilities, including medical surge goals and priorities. (See app. III for Hospital Preparedness Program cooperative agreement funding by state.) ASPR’s 2007 Hospital Preparedness Program guidance specifically authorized states to use funds on activities such as the development of a fully operational electronic medical volunteer registry in accordance with ESAR-VHP guidance and the establishment of alternate care sites. We cannot report state-specific funding for four key components—hospital capacity, alternate care sites, electronic medical volunteer registries, and altered standards of care—because state expenditure reports did not disaggregate the dollar amount spent on specific activities related to these components. During fiscal years 2003 through 2007, DHS’s Homeland Security Grant Program also awarded the states funds that were used for a broad variety of emergency preparedness activities and may have included medical surge activities. However, most of these DHS grant funds were not targeted to medical surge activities, and states do not report the dollar amounts spent on these activities.

Guidance to Prepare for Medical Surge

The federal government developed, or contracted with experts to develop, guidance for states to use in preparing for medical surge. DHS developed overarching guidance, including the National Preparedness Guidelines and the Target Capabilities List. The National Preparedness Guidelines describes the tasks needed to prepare for a medical surge response to a mass casualty event, such as a bioterrorist event or natural disaster, and establishes readiness priorities, targets, and metrics to align the efforts of federal, state, local, tribal, private-sector, and nongovernmental entities. The Target Capabilities List provides guidance on building and maintaining capabilities, such as medical surge, that support the National Preparedness Guidelines. The medical surge capability includes activities and critical tasks needed to rapidly and appropriately care for the injured and ill from mass casualty events and to ensure that continuity of care is maintained for non-incident-related injuries or illnesses.

In addition, ASPR provided states with specific guidance related to preparing for medical surge in a mass casualty event, including annual guidance for its Hospital Preparedness Program cooperative agreements, guidance for developing ESAR-VHP-compliant electronic medical volunteer registries, and guidance to develop a hospital bed tracking system. The Hospital Preparedness Program cooperative agreement guidance included activities to assist states in following DHS’s guidelines and meeting its targets. ASPR’s ESAR-VHP guidelines provide states with common definitions, standards, and protocols, which can aid in forming a national network to facilitate the deployment of medical volunteers for any emergency among states. For example, ESAR-VHP registration guidelines categorize medical volunteers by profession, ranging from physicians to mental health counselors. ESAR-VHP guidelines also include four different levels of credentialing based on verification of each volunteer’s qualifications. ASPR provided guidance to states for the Hospital Available Beds for Emergencies and Disasters (HAvBED) system, which is an inpatient bed tracking system designed to allow emergency response entities to know where and what type of additional hospital beds are available, in order to know which hospitals still have capacity to receive patients. HAvBED reports the number of beds vacant/available at the aggregate state level to HHS. To enhance consistency among state- reported data, HAvBED provides standard definitions of beds and data elements each system must incorporate when reporting bed availability during a mass casualty event.

Additionally, HHS worked through AHRQ and contracted with nonfederal entities to develop publications for states to use when preparing for medical surge. For example, AHRQ published the document Mass Medical Care with Scarce Resources: A Community Planning Guide to provide states with information that would help them in their efforts to prepare for medical surge, such as specific circumstances they may face in a mass casualty event. This publication notes that the state may be faced with allocating medical resources during a mass casualty event, such as determining which patients will have access to mechanical ventilation. The publication recommends that the states develop decision-making guidelines on how to allocate these medical resources. The RAND Corporation developed the publication Learning from Experience: The Public Health Response to West Nile Virus, SARS, Monkeypox, and Hepatitis A Outbreaks in the United States, which provides states with information on challenges that they may face in a disease outbreak or bioterrorist attack. AHRQ also published Reopening Shuttered Hospitals to Expand Surge Capacity, which contains an action checklist that can be used by states and local entities to identify organizations that have an interest or responsibility in preparing for medical surge, and to determine what resources each could provide. (See app. III for a list of federal guidance.)

Other Federal Assistance to Prepare for Medical Surge

To support states’ efforts to prepare for medical surge, the federal government also provided other assistance such as conferences and electronic bulletin boards for states to use in preparing for medical surge. States were required to attend annual conferences for Hospital Preparedness Program cooperative agreement recipients, where ASPR provided forums for discussion of medical surge issues. (See app. III for a list of federal conferences.) Additionally, ASPR’s Web site contained links to related published documents, and states were given access to an ASPR- operated electronic bulletin board to communicate with other states on medical surge issues related to the Hospital Preparedness Program. Furthermore, ASPR project officers and CDC subject matter experts were available to provide assistance to states on issues related to medical surge. For example, CDC’s Division of Healthcare Quality Promotion developed cross-sector workshops for local communities to bring their emergency management, medical, and public health officials together to focus on emergency planning issues, such as developing alternate care sites.

Many States Have Made Efforts to Increase Hospital Capacity, Plan for Alternate Care Sites, and Develop Electronic Medical Volunteer Registries, but Fewer Have Planned for Altered Standards of Care

Many states have made efforts related to three of the key components for preparing for medical surge, that is, increasing hospital capacity, planning for alternate care sites, and developing electronic medical volunteer registries, but fewer have implemented the fourth, planning for altered standards of care. More than half of the 50 states were meeting or close to meeting the criteria for the five medical-surge-related sentinel indicators for hospital capacity. In our 20-state review, we found that all were developing bed reporting systems and almost all of the states with DOD and VA hospitals were engaging in various levels of coordination with those hospitals in an effort to expand their hospital capacity. Of the 20 states, 18 reported that they were in the process of selecting alternate care sites that used either fixed or mobile medical facilities. Additionally, 15 of the 20 states had begun registering volunteers in electronic medical volunteer registries. However, only 7 of the 20 states had adopted or were drafting altered standards of care for specific medical interventions to be used in response to a mass casualty event.

All States Were Making Efforts to Expand Hospital Capacity

More than half of the states met or were close to meeting the criteria for the five surge-related sentinel indicators for hospital capacity that we reviewed from the Hospital Preparedness Program 2006 midyear progress reports, the most recent available data at the time of our analysis. (See table 1 for the five sentinel indicators and the associated criteria.) Twenty- four of the states reported that all of their hospitals were participating in the state’s program funded by the ASPR Hospital Preparedness Program, with another 14 states reporting that 90 percent or more of their hospitals were participating. Forty-three of the 50 states have increased their hospital capacity by ensuring that at least one health care facility in each defined region could support initial evaluation and treatment of at least 10 patients at a time (adult and pediatric) in negative pressure isolation within 3 hours of an event. Regarding individual hospitals’ isolation capabilities, 32 of the 50 states met the requirement that all hospitals in the state that participate in the Hospital Preparedness Program be able to maintain at least one suspected highly infectious disease case in negative pressure isolation; another 10 states had that capability in 90 to 99 percent of their participating hospitals. Thirty-seven of the 50 states reported meeting the criteria that within 24 hours of a mass casualty event, their hospitals would be able to add enough beds to provide triage treatment and stabilization for another 500 patients per million population; another 4 states reported that their hospitals could add enough beds for from 400 to 499 patients per million population. Finally, 20 states reported that all their participating hospitals had access to pharmaceutical caches that were sufficient to cover hospital personnel (medical and ancillary), hospital- based emergency first responders, and family members associated with their facilities for a 72-hour period; another 6 states reported that from 90 to 99 percent of their participating hospitals had sufficient pharmaceutical caches. (See app. IV for further information.)

In our further review of 20 states, all 20 states reported that they had developed or were developing bed reporting systems to track their hospital capacity—the first of four key components related to preparing for medical surge. Eighteen of the 20 states reported that they had systems in place that could report the number of available hospital beds within the state. All 18 of these states reported that their systems met ASPR HAvBED standards. For example, in early 2005 one state completed development of a statewide Web-based bed tracking system designed to track the emergency status of all health care facilities. The system has the capacity to present information by individual facility as well as by county. The 2 states that reported that they did not have a system that could meet HAvBED requirements said that they would meet the requirements by August 8, 2008.

Our review also found that of the 10 states with DOD hospitals, 9 reported coordinating with DOD hospitals to plan for emergency preparedness and increase hospital capacity. For example, in one state DOD hospital officials served on state-level emergency preparedness committees and participated in training and exercises. The remaining state said it could not report whether the DOD hospitals participated in such activities because these activities were coordinated at the local level. Eight of the 10 states also reported that DOD hospitals in their state would accept civilian patients in the event of a mass casualty event if resources were available. The 2 remaining states did not know whether their DOD hospitals would accept civilian patients, although one of these states said that there had been discussions about this possibility between the state and DOD.

Of the 19 states that have VA hospitals, all reported that at least some of the VA hospitals took part in the states’ hospital preparedness programs or were included in planning and exercises for medical surge. For example, VA hospitals in one state were participating in state, regional, and local planning for emergency preparedness along with other hospitals in an effort to increase surge capacity and come closer to the state’s goal of 500 beds for every 1 million population, a VA official said. In another state, a VA hospital was planning with state emergency preparedness officials and DOD hospitals to prepare for any mass casualty event that could occur during a major public event taking place in the state later that year. VA officials stated that individual hospitals cannot precommit resources— specific numbers of beds and assets—for planning purposes, but can accept nonveteran patients and provide personnel, equipment, and supplies on a case-by-case basis during a mass casualty event. Twelve of the 19 states reported that VA hospitals would accept or were likely to accept nonveteran patients in the event of a medical surge if space were available and veterans’ needs had been met. Four of the 19 states reported that their VA hospitals would not accept nonveteran patients in the event of a medical surge, 2 states reported that they did not know if the VA hospitals would accept nonveteran patients, and 1 state reported that some of its VA hospitals would take nonveteran patients and others would not.

In planning to increase hospital capacity, most of the 20 states we surveyed reported that they used federal guidance and technical assistance. Eleven states reported that they used ASPR’s Hospital Preparedness Program cooperative agreement guidance, and 9 states used ASPR’s Medical Surge Capacity and Capabilities Handbook. Three states also reported that they used CDC’s Public Health Emergency Preparedness Program cooperative agreement guidance. In addition, 2 states reported that they consulted with ASPR project officers when planning for hospital capacity.

Eighteen States Were Selecting Alternate Care Sites

Eighteen of the 20 states reported that they were in the process of selecting alternate care sites, and the 2 remaining states reported that they were in the early planning stages in determining how to select sites. Of the 18 states, 10 reported that they had also developed plans for equipping and staffing some of the sites. For example, one state had developed standards and guidance for counties to use when implementing fixed alternate care sites and had stockpiled supplies and equipment for these sites. The counties were responsible for identifying and operating these sites. According to state officials, while most counties were still identifying fixed sites, some counties had established memorandums of understanding with various facilities, including churches, schools, military facilities, and shopping malls. In addition, the state purchased three state-run mobile medical facilities, each with 200 beds, which were stored in the northern, central, and southern parts of the state. Another state, which expects significant transportation difficulties during a natural disaster, had acquired six mobile medical tent facilities of either 20 or 50 beds that were stored at hospital facilities across the state. This state also planned to identify fixed facility alternate care sites, which would provide medical services to people who could not take care of themselves at home but did not need to be in a hospital. Each of these fixed sites was expected to serve 1,000 casualties. One of the 2 states that were in the early planning stages was helping local communities formalize site selection agreements, and the second state had drafted guidance for alternate care sites that was expected to be released early in 2008.

Most states reported using AHRQ guidance when planning for alternate care sites. For example, 18 states reported that they used AHRQ’s guidance, such as Rocky Mountain Regional Care Model for Bioterrorist Events, Alternate Care Site Selection Tool, and Reopening Shuttered Hospitals to Expand Surge Capacity. A few states used other federal guidance, such as DHS’s National Incident Management System and National Disaster Management System guidance, when planning alternate care sites. Five states also reported that they used DOD guidance when planning alternate care sites, including DOD’s Modular Emergency Medical System.

Fifteen States Had Begun Registering Volunteers in Electronic Medical Volunteer Registries

Fifteen of the 20 states reported that they had begun registering medical volunteers and identifying their medical professions in an electronic registry, and the remaining 5 states were developing their electronic registries and had not registered any volunteers. For 2006, ESAR-VHP guidance identified seven categories of health care professionals ranging from physicians to mental health counselors that should be included in the states’ registries. Of the 15 states that reported that they had begun registering volunteers, 3 states had registered volunteers in more than eight categories, 3 states had registered volunteers in five to seven categories, and the remaining 9 states had registered volunteers in four or fewer categories, often concentrating on nurses. Officials from 4 of the 5 remaining states that had not begun registering volunteers reported that they anticipated registering volunteers by the spring or summer of 2008. An official from the other state reported that state officials did not know when they would begin to register volunteers.

Of the 15 states that reported they were registering volunteers, 12 reported they had begun to verify the volunteers’ medical qualifications, though few had conducted the verification to assign volunteers to the highest level, Level 1. If a volunteer is assigned to Level 4, it means that the state has not verified any medical qualifications, such as licenses or certifications in medical subspecialties. Three of the 15 states had registered volunteers solely at Level 4. Seven of the 12 states had credentialed some volunteers no higher than Level 3, meaning they had verified the licenses of some of the volunteers. For example, one state had verified the credentials and assigned all of its 1,498 registered volunteers at Level 3. Another 3 of the 12 states had assigned volunteers to no higher than Level 2, meaning these states had conducted additional verification of medical qualifications, such as degrees. For example, one state had assigned its registered volunteer nurses at Level 2. The remaining 2 states had assigned a small number of volunteers at Level 1. For example, one state had assigned 2 of 955 volunteers at Level 1. At Level 1, all of a volunteer’s medical qualifications, which identify their skills and capabilities, have been verified and the volunteer is ready to provide care in any setting, including a hospital.

Nineteen of the 20 states reported that they used ASPR’s ESAR-VHP Interim Technical and Policy Guidelines, Standards, and Definitions when developing registries. Eight of the 20 states also reported that they used information obtained from the annual ESAR-VHP conferences to help develop their volunteer medical registry systems.

Seven of the 20 States Were Planning for Altered Standards of Medical Care

In our 20-state review of efforts related to the fourth key component, we found that 7 states had adopted or were drafting altered standards of care for specific medical issues. Three of the 7 states had adopted some altered standards of care guidelines. For example, one state had prepared a standard of care for the allocation of ventilators in an avian influenza pandemic, which one state official reported would also be applicable during other types of emergencies. Another state issued guidelines in February 2008 for allocating scarce medical resources in a mass casualty event that call for suspending or relaxing state laws covering medical care and for explicit rationing of health care to save the most lives, and require that the same allocation guidelines be used across the state. For example, during a mass casualty event in this state, hospitals could ignore their nurse-patient ratios and nurses could be assigned to jobs outside their specific area of expertise. In addition, nonlicensed individuals, or retired health care providers whose licenses had lapsed, could be recruited to provide emergency care. For example, a nonmedical hospital employee who had experience as a military medic could get an emergency credential to stitch up wounds or start intravenous lines. According to an official, the state had not completed all of the guidelines for allocation of scarce resources that it planned to develop. The state recently convened a panel of ethicists and providers to address which specific categories of patients would receive scarce resources, such as vaccines and ventilators, when shortages existed.

Of the 13 states that had not adopted or drafted altered standards of care, 11 states were beginning discussions with state stakeholders, such as medical professionals and lawyers, related to altered standards of care, and 2 states had not addressed the issue. One state reported that its state health department planned to establish an ethics advisory board to begin discussion on altered standards of care guidelines. Another state had developed a “white paper” discussing the need for an altered standards of care initiative and planned to fund a symposium to discuss this initiative.

Six of the seven states that had adopted or were drafting altered standards of care guidelines reported using AHRQ documents, such as Altered Standards of Care in Mass Casualty Events and Mass Medical Care with Scarce Resources: A Community Planning Guide. Officials from one state reported that they had also used CDC documents and the federal government’s pandemic influenza Web site when planning for altered standards of care.

States Reported Concerns Related to All Four Key Components When Preparing for Medical Surge

While the Hospital Preparedness Program has been operating since 2002, state officials in the 20 states we surveyed reported that they faced continuing challenges in preparing for medical surge in a mass casualty event. Even though many states have made efforts to increase hospital capacity, provide care at alternate care sites, identify and use medical volunteers, and develop appropriate altered standards of care, they expressed concerns related to all four of these key components of medical surge. State officials also noted concerns related to programmatic and regulatory issues involved in preparing for medical surge in a mass casualty event.

Hospital Capacity Concerns

State officials raised several concerns related to their ability to increase hospital capacity, including maintaining adequate staffing levels during mass casualty events, a problem that was more acute in rural communities. While 19 of 20 states we surveyed reported that they could increase numbers of hospital beds in a mass casualty event, some state officials were concerned about staffing these beds because of current shortages in medical professionals, including nurses and physicians. Some state officials reported that their states faced problems in increasing hospital capacity because many of their rural areas had no hospital or small numbers of medical providers. For example, officials from a largely rural state reported that in many of the state’s medically underserved areas hospitals currently have vacant beds because they cannot hire medical professionals to staff them. In addition, these officials reported that because their hospitals did not provide pediatric intensive care or burn care services and instead transferred these patients to neighboring states, the state might not be able to provide these services during a mass casualty event.

State officials also reported that as time passed and no mass casualty events occurred, increasing hospital capacity for a mass casualty event seemed to be a waning priority for hospital chief executive officers. State officials reported that it was difficult to continue to engage private-sector hospital chief executive officers in emergency preparedness activities at a time when these hospitals were facing day-to-day financial problems. For example, officials from one state reported that hospitals in the state were consolidating and closing, and officials from another state reported that fewer hospitals were applying for ASPR Hospital Preparedness Program funds. Officials from two other states reported that progress in preparing emergency plans had slowed, especially for the smaller rural facilities, because the Hospital Preparedness Program allows states to use these funds to hire staff to assist with emergency planning but prohibits hospitals from doing so. According to officials from one of these states, hospital staff have had limited time to spend on emergency planning activities because they must first attend to the operational needs of the hospital.

Alternate Care Site Concerns

Some state officials reported that it was difficult to identify appropriate fixed facilities for alternate care sites. Officials from two states reported that some small, rural communities had few facilities that would be large enough to house an alternate care site. Officials from some states also reported that some of the facilities that could be used as alternate care sites had already been allocated for other emergency uses, such as emergency shelters.

State officials also reported concerns about reimbursement for medical services provided at alternate care sites, which are not accredited health care facilities. During the response to Hurricane Katrina, the Secretary of HHS waived a number of statutory and regulatory requirements related to medical care, and this waiver allowed for reimbursement of medical care provided in alternate care sites. However, officials from several states said that hospitals would prefer to know ahead of time under what circumstances they would receive reimbursement from the Centers for Medicare & Medicaid Services (CMS) for medical care provided in alternate care sites during a mass casualty event. State officials said that having such information would make planning and exercising easier and more realistic. CMS officials told us it would be very difficult to provide specific guidance that would apply to all medical surge events and that the agency preferred to issue guidance on a case-by-case basis following visits to alternate care sites by CMS or Joint Commission officials during the emergency. For example, after Hurricane Katrina, CMS officials visited alternate care sites and the Secretary of HHS relaxed reimbursement requirements for medical care provided in a hospital parking lot, the convention center, and a department store.

State officials also told us they were unclear how certain federal laws and regulations that relate to medical care—specifically, the privacy rule issued by HHS under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Emergency Medical Treatment and Labor Act (EMTALA)—would apply in a mass casualty event, especially if the care were provided in an alternate care site and not a hospital. EMTALA requires hospital emergency rooms at Medicare-participating hospitals to screen and treat for emergency medical conditions all individuals who seek treatment. The HIPAA privacy rule prohibits the unauthorized disclosure of individually identifiable health information by health care providers and certain other entities. The Social Security Act authorizes the Secretary of HHS to waive EMTALA and certain requirements under the HIPAA privacy rule during national emergencies, such as a mass casualty event. Federal guidance published in 2006 describes circumstances where provisions related to emergency treatment and privacy protections were temporarily suspended. AHRQ’s publication Providing Mass Medical Care with Scarce Resources: A Community Planning Guide states that requiring hospitals to adhere to EMTALA requirements during a mass casualty event could be unworkable because of the large number of casualties. It notes that during Hurricane Katrina, HHS temporarily suspended the application of EMTALA in affected regions. This allowed hospitals to provide individuals’ medical screening examination at, or transfer them to, alternate care sites, such as a convention center and department store. During Hurricane Katrina, HHS also temporarily relaxed the sanctions and penalties arising from noncompliance with certain provisions of the HIPAA privacy rule, including the requirements to obtain a patient’s agreement to speak with family members or friends. HHS provided details of these waivers on its Hurricane Katrina Web site.

Electronic Medical Volunteer Registry Concerns

Some states reported that medical volunteers might be reluctant to join a state electronic medical volunteer registry if it is used to create a national medical volunteer registry. PAHPA requires ASPR to use the state-based registries to create a national database. According to state officials, some volunteers do not want to be part of a national database because they are concerned that they might be required to provide services outside their own state. Officials from one state reported that since PAHPA was enacted, recruiting of medical volunteers was more difficult and that the federal government should clarify whether national deployment is a possibility. ASPR officials said that they would not deploy medical volunteers nationally without working through the states.

Finally, some states expressed concerns about coordination among programs that recruit medical volunteers for emergency response. Officials from one state reported that federal volunteer registration requirements for the Medical Reserve Corps (MRC) and the ESAR-VHP programs had not been coordinated, resulting in duplication of effort for volunteers. For example, the volunteers registered in the MRC units in that state also were expected by the state to register in the state electronic medical volunteer registry. Officials from a second state reported that a volunteer for one program that recruits medical volunteers is often a potential volunteer for another such program, which could result in volunteers being double-counted. For example, an emergency medical technician registered in the electronic medical volunteer registry may also volunteer for an MRC unit, a Disaster Medical Assistance Team (DMAT), and the American Red Cross. This may cause staffing problems in the event of an emergency when more than one volunteer program is activated.

Altered Standards of Care Concerns

Some state officials reported that they had not begun work on altered standards of care guidelines, or had not completed drafting guidelines, because of the difficulty of addressing the medical, ethical, and legal issues involved. For example, HHS estimates that in a severe influenza pandemic almost 10 million people would require hospitalization, which would exceed the current capacity of U.S. hospitals and necessitate difficult choices regarding rationing of resources. HHS also estimates that almost 1.5 million of these people would require care in an intensive care unit and about 740,000 people would require mechanical ventilation. Even with additional stockpiles of ventilators, there would likely not be a sufficient supply to meet the need. Since some patients could not be put on a ventilator, and others would be removed from the ventilator, standards of care would have to be altered and providers would need to determine which patients would receive them. In addition, some state officials reported that medical volunteers are concerned about liability issues in a mass casualty event. Specifically, state officials reported that hospitals and medical providers might be reluctant to provide care during a mass casualty event, when resources would be scarce and not all patients would be able to receive care consistent with established standards. According to these officials, these providers could be subject to liability if decisions they made about altering standards of care resulted in negative outcomes. For example, allowing staff to work outside the scope of their practice, such as allowing nurses to diagnose and write medical orders, could place these individuals at risk of liability.

While some states reported using AHRQ’s Mass Medical Care with Scarce Resources: A Community Planning Guide to assist them as they developed altered standards of care guidelines, some states also reported that they needed additional assistance. States said that to develop altered standards of care guidelines they must conduct activities such as collecting and reviewing published guidance and convening experts to discuss how to address the medical, ethical, and legal issues that could arise during a mass casualty event. Four states reported that, when developing their own guidelines on the allocation of ventilators, they were using guidance from another state. This state estimated that a severe influenza pandemic would require nearly nine times the state’s current capacity for intensive care beds and almost three times its current ventilator capacity, which would require the state to address the rationing of ventilators. In March 2006 the state convened a workgroup to consider clinical and ethical issues in the allocation of mechanical ventilators in an influenza pandemic. The state issued guidelines on the rationing of ventilators that include both a process and an evaluation tool to determine which patients should receive mechanical ventilation. The guidelines note that the application of this process and evaluation tool could result in withdrawing a ventilator from one patient to give it to another who is more likely to survive—a scenario that does not explicitly exist under established standards of care. Additionally, some states suggested that the federal government could help their efforts in several ways, such as by convening medical, public health, and legal experts to address the complex issues associated with allocating scarce resources during a mass casualty event, or by developing demonstration projects to reveal best practices employed by the various states. Recently, the Task Force for Mass Critical Care, consisting of medical experts from both the public and the private sectors, provided guidelines for allocating scarce critical care resources in a mass casualty event that have the potential to assist states in drafting their own guidelines. The task force’s guidelines, which were published in a medical journal in May 2008, provide a process for triaging patients that includes three components—inclusion criteria, exclusion criteria, and prioritization of care. The exclusion criteria include patients with a high risk of death, little likelihood of long-term survival, and a corresponding low likelihood of benefit from critical care resources. When patients meet the exclusion criteria, critical care resources may be reallocated to patients more likely to survive.

Other Programmatic and Regulatory Concerns

Many state officials raised concerns about other federal programmatic and regulatory challenges, such as program funding cycles, decreased federal funding for hospital emergency preparedness, and new requirements for state matching funds. State officials reported that ASPR’s Hospital Preparedness Program’s single-year funding cycles had made planning and operating state emergency preparedness programs challenging, in part because it is difficult to plan and implement program activities in a single year. One state official suggested that using a 3-year funding cycle for the Hospital Preparedness Program would allow for long-term planning with more realistic work plans. It would also allow for more time for program development and less time spent on program administration. ASPR officials said that they were aware of the concern and were considering a transition to a multiyear funding cycle beginning in 2009. Another concern expressed by some state officials was that federal funding for ASPR’s Hospital Preparedness Program had decreased while program requirements had increased, making it difficult for states to plan for maintenance of emergency preparedness systems, meet new requirements, and replace expired supplies. Hospital Preparedness Program funds decreased about 18 percent from fiscal year 2004 to fiscal year 2007. Finally, many state officials were concerned about the new requirement for matching funds. Beginning in fiscal year 2009, states that want to receive ASPR’s Hospital Preparedness Program funds will have to match 5 percent of the federal funds with either state funds or in-kind contributions.

Conclusions

Though states have begun planning for medical surge in a mass casualty event, only 3 of the 20 states in our review have developed and adopted guidelines for using altered standards of care. HHS has provided broad guidance that establishes a framework and principles for states to use when developing their specific guidelines for altered standards of care. However, because of the difficulty in addressing the related medical, ethical, and legal issues, many states are only beginning to develop such guidelines for use when there are not enough resources, such as ventilators, to care for all affected patients. In a mass casualty event, such guidelines would be a critical resource for medical providers who may have to make repeated life-or-death decisions about which patients get or lose access to these resources—decisions that are not typically made in routine circumstances. Additionally, these guidelines could help address medical providers’ concerns about ethics and liability that may ensue when negative outcomes are associated with their decisions. In its role of assisting states’ efforts to plan for medical surge, HHS has not collected altered standards of care guidelines that some states and medical experts have developed and made them available to other states. Once a mass casualty event occurs, difficult choices will have to be made, and the more fully the issues raised by such choices are discussed prior to making them, the greater the potential for the choices to be ethically sound and generally accepted.

Recommendation for Executive Action

To further assist states in determining how they will allocate scarce medical resources in a mass casualty event, we recommend that the Secretary of HHS ensure that the department serve as a clearinghouse for sharing among the states altered standards of care guidelines that have been developed by individual states or medical experts.

Agency Comments and Our Evaluation

We requested comments on a draft of this report from HHS, DHS, DOD, and VA. These agencies’ comments are reprinted in appendixes V, VI, VII, and VIII, respectively.

In commenting on this draft, HHS said our report was a fair representation of the progress that has been made to improve medical surge capacity. HHS was silent regarding our recommendation that the department serve as a clearinghouse for sharing among the states altered standards of care guidelines developed by individual states or medical experts. HHS provided technical comments, which we incorporated where appropriate.

In commenting on this draft, DHS concurred with our findings and raised two issues. With regard to the phrase “altered standards of care,” DHS said that the definition of standard of care implies that the standard does not change but “rather it is the type, or level, of care that is altered,” and that this distinction highlights the need to prepare the public “for a different look to health care” in a mass casualty incident. We agree that efforts to inform the public would be beneficial because of the need for enhanced public awareness about how medical care might be delivered in an emergency, but our report focused on addressing states’ concerns about the medical, ethical, and legal issues involved in drafting altered standards of care guidelines. DHS also characterized our recommendation as calling for “passive guidance” and suggested that HHS may need to explore the possibility of producing guidance to direct states’ discussion on rationing of scarce resources. However, we believe a clearinghouse role is more appropriate for HHS than a directive role because the delivery of medical care is a state, local, and private function.

DOD concurred with our findings and conclusions. VA concurred with our findings and said that inconsistencies from state to state regarding VA medical centers’ stance toward treating nonveterans in an emergency stem from the centers’ varying capabilities to provide emergency medical treatment. VA said, for example, that not all medical centers provide emergency services or have the same level of emergency supplies. Nevertheless, VA confirmed its authority to provide care in emergency situations and specifically acknowledged that it is authorized to provide emergency care to nonveterans on a humanitarian basis. Finally, VA also highlighted its federal role in responding to disasters under Emergency Support Function #8, the Robert T. Stafford Disaster Relief and Emergency Assistance Act, and the National Response Framework, which was beyond the scope of our report.

As arranged with your offices, unless you release its contents earlier, we plan no further distribution of this report until 30 days after its issuance date. At that time, we will send copies of this report to the Secretary of HHS and other interested parties. We will also make copies available to others on request. In addition, the report will be available at no charge on the GAO Web site at http://www.gao.gov.

If you or your staffs have any questions about this report or need additional information, please contact me at (202) 512-7114 or bascettac@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. Major contributors to this report were Karen Doran, Assistant Director; Jeffrey Mayhew; Roseanne Price; Lois Shoemaker; and Cherie’ Starck.

Appendix I: Fifteen Hospital Preparedness Program 2006 Sentinel Indicators

2. Total number of participating hospitals statewide.

4. Number of beds statewide, above the current daily staffed bed capacity, that awardee is capable of surging beyond within 5. Number of participating hospitals statewide that have access to pharmaceutical caches sufficient to cover hospital personnel (medical and ancillary), hospital-based emergency first responders and family members associated with their facilities for a 72-hour period. 6. Number of participating hospitals statewide that have the capacity to maintain at least one suspected highly infectious disease 7. Number of awardees’ defined regions that have regional facilities to support the initial evaluation and treatment of at least 10 adult and pediatric patients at a time in negative pressure isolation within 3 hours post-event. 8. Number of ambulatory and nonambulatory persons that can be decontaminated within a 3-hour period, statewide. 9. Number of health care personnel, statewide, trained through competency-based programs. 10. Number of hospital lab personnel, statewide, trained in the protocols for referral of clinical samples and associated information. 11. Functional state-based ESAR-VHP system in place that allows qualified, competent volunteer health care professionals to register for work in hospitals or other facilities during an emergency situation. 12. Number of volunteer health professionals by discipline and credentialing level currently registered in the state-based ESAR-VHP system. 13. Number of drills conducted during the fiscal year 2006 budget period that included hospital personnel, equipment, or facilities. 14. Number of tabletop exercises conducted during the fiscal year 2006 budget period that included hospital personnel, equipment, or facilities. 15. Number of functional exercises conducted during the fiscal year 2006 budget period that included hospital personnel, equipment, or facilities.

The five sentinel indicators that were analyzed in this report for hospital capacity are 2, 4, 5, 6, and 7.

Appendix II: Scope and Methodology

To determine what assistance the federal government has provided to help states prepare their regional and local health care systems for medical surge in a mass casualty event, particularly related to four key components—hospital capacity, alternate care sites, electronic medical volunteer registries, and altered standards of care—we reviewed and analyzed national strategic planning documents and identified links among federal policy documents on emergency preparedness. We also reviewed and analyzed studies and reports related to medical surge capacity issued by the Congressional Research Service, the Department of Health and Human Services’ (HHS) Office of Inspector General, the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), the Office of the Assistant Secretary for Preparedness and Response (ASPR), the Joint Commission, and other experts. In addition, we obtained and reviewed documents from ASPR to determine the amount of funds awarded to states through its Hospital Preparedness Program’s cooperative agreements. We did not review funding documents from the Department of Homeland Security’s (DHS) Homeland Security Grant Program because the agency does not track the dollar amount spent on medical surge activities. We interviewed officials from ASPR, CDC, and DHS to identify and document criteria and guidance given to state and local entities to plan for medical surge and to learn how federal funds were awarded and utilized.

To determine what states have done to prepare for medical surge in a mass casualty event, particularly related to four key components, we obtained and analyzed the 2006 and 2007 ASPR Hospital Preparedness Program cooperative agreement applications and 2006 midyear progress reports (the most current available information—generally effective through March 2007—at the time of our data collection) for the 50 states. We also reviewed the 15 sentinel indicators for the Hospital Preparedness Program. We analyzed the 5 medical-surge-related sentinel indicators for which criteria to evaluate performance were identified and which were reported by the states in their 2006 midyear progress reports. Although ASPR’s 2006 guidance for these reports does not provide specific criteria with which to evaluate performance on these indicators, we identified criteria to analyze the data provided for 5 of them from either ASPR’s previous program guidance or DHS’s Target Capabilities List, which includes requirements related to preparing for medical surge. All 5 of the medical-surge-related sentinel indicators we analyzed were related to one of the four key components—hospital capacity. See appendix I for a list of the 15 sentinel indicators. In addition, we obtained and reviewed 20 states’ emergency preparedness planning documents relating to medical surge and interviewed state officials from these states regarding their activities related to hospital capacity, alternate care sites, electronic medical volunteer registries, and altered standards of care. We also interviewed these state officials to determine what federal guidance or tools they used and to identify the Department of Defense (DOD) and the Department of Veterans Affairs (VA) hospitals’ participation in state planning. Finally, we obtained and reviewed DOD and VA policies and interviewed officials to further understand their policies regarding participation with state and local entities in emergency preparedness planning and responding to mass casualty events.

To determine what concerns states identified as they prepared for medical surge in a mass casualty event, we interviewed emergency preparedness officials from the 20 states and focused our questions on their efforts related to four key components of medical surge we identified. We also asked what further assistance states might need from the federal government to help prepare their health care systems for medical surge.

We did not validate the sentinel indicator data the 50 states reported to ASPR; however, if data for specific indicators were missing or obviously incorrect (e.g., a percentage was greater than 100 percent), we contacted state officials for clarification. We did not examine the accuracy of other self-reported information contained in the midyear progress reports or Hospital Preparedness Program applications from the 20 states we reviewed. During interviews with officials from the 20 states, we discussed the completeness of information provided in their progress reports and applications about four key components related to preparing for medical surge. For each interview, we used a question set that contained open- ended questions. The state emergency preparedness officials we interviewed provided varying levels of detail to answer our questions. Thus our information from these interviews is illustrative and is intended to provide a general description of what the 20 states have done to prepare for medical surge in a mass casualty event and is not generalizable to all 50 states. We conducted our work from May 2007 through May 2008 in accordance with generally accepted government auditing standards.

Appendix III: Hospital Preparedness Program Funding and Medical Surge Guidance and Conferences

Tables 2, 3, and 4 provide information on ASPR’s Hospital Preparedness Program funding and on guidance and other assistance for states to use in preparing for medical surge.

Appendix IV: Data for the Five Surge-Related Sentinel Indicators for Hospital Capacity from the Hospital Preparedness Program

Figures 1 through 5 provide data for the five surge-related sentinel indicators for hospital capacity from ASPR’s Hospital Preparedness Program 2006 midyear progress reports.

Appendix V: Comments from the Department of Health and Human Services

Appendix VI: Comments from the Department of Homeland Security

Appendix VII: Comments from the Department of Defense

Appendix VIII: Comments from the Department of Veterans Affairs