Emergency Preparedness
State Efforts to Plan for Medical Surge Could Benefit from Shared Guidance for Allocating Scarce Medical Resources
Gao ID: GAO-10-381T January 25, 2010
Potential terrorist attacks and the possibility of naturally occurring disease outbreaks have raised concerns about the "surge capacity" of the nation's health care systems to respond to mass casualty events. The statement GAO is issuing today summarizes a June 2008 report, Emergency Preparedness: States Are Planning for Medical Surge, but Could Benefit from Shared Guidance for Allocating Scare Medical Resources (GAO-08-668). In that report, GAO was asked to examine the assistance the federal government had provided to help states prepare for medical surge and what states had done to prepare for medical surge. To do this GAO reviewed documents from the 50 states and federal agencies and interviewed officials from a judgmental sample of 20 states and from federal agencies, as well as emergency preparedness experts.
In its June 2008 report, which is summarized in this statement, GAO found that following a mass casualty event that could involve thousands, or even tens of thousands, of injured or ill victims, health care systems would need the ability to "surge," that is, to adequately care for a large number of patients or patients with unusual medical needs. The federal government has provided funding, guidance, and other assistance to help states prepare for medical surge in a mass casualty event. From fiscal years 2002 to 2007, the federal government awarded the states about $2.2 billion through HHS's Office of the Assistant Secretary for Preparedness and Response's Hospital Preparedness Program to support activities to meet their preparedness priorities and goals, including medical surge. Further, the federal government provided guidance for states to use when preparing for medical surge, including Reopening Shuttered Hospitals to Expand Surge Capacity, which contains a checklist that states can use to identify entities that could provide more resources during a medical surge. Based on a review of state emergency preparedness documents and interviews with 20 state emergency preparedness officials, GAO found that many states had made efforts related to three of the four key components of medical surge that GAO had identified--increasing hospital capacity, identifying alternate care sites, and registering medical volunteers. But fewer had implemented the fourth: planning for altering established standards of care. More than half of the 50 states had met or were close to meeting the criteria for the five medical-surge-related sentinel indicators for hospital capacity reported in the Hospital Preparedness Program's 2006 midyear progress reports. In a 20-state review, GAO found that ? all 20 were developing bed reporting systems and most were coordinating with military and veterans hospitals to expand hospital capacity, ? 18 were selecting various facilities for alternate care sites, ? 15 had begun electronic registering of medical volunteers, and ? fewer of the states--7 of the 20--were planning for altered standards of medical care to be used in response to a mass casualty event. State officials in GAO's 20-state review reported that they faced challenges relating to all four key components in preparing for medical surge. For example, some states reported concerns related to maintaining adequate staffing levels to increase hospital capacity. According to some state officials, volunteers were concerned that if state registries became part of a national database they might be required to provide services outside their own state. Some states reported that they had not begun work on or completed altered standards of care guidelines due to the difficulty of addressing the medical, ethical, and legal issues involved in making life-or-death decisions about which patients would get access to scarce resources. While most of the states that had adopted or were drafting altered standards of care guidelines reported using federal guidance as they developed these guidelines, some states also reported that they needed additional assistance.
GAO-10-381T, Emergency Preparedness: State Efforts to Plan for Medical Surge Could Benefit from Shared Guidance for Allocating Scarce Medical Resources
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Testimony:
Before the Subcommittee on Management, Investigations, and Oversight,
Committee on Homeland Security, House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 11:00 a.m. EST:
Monday, January 25, 2010:
Emergency Preparedness:
State Efforts to Plan for Medical Surge Could Benefit from Shared
Guidance for Allocating Scarce Medical Resources:
Statement of Cynthia A. Bascetta:
Director, Health Care:
Held in Danville, PA:
GAO-10-381T:
GAO Highlights:
Highlights of GAO-10-381T, a testimony before the Subcommittee on
Management, Investigations, and Oversight, Committee on Homeland
Security, House of Representatives.
Why GAO Did This Study:
Potential terrorist attacks and the possibility of naturally occurring
disease outbreaks have raised concerns about the ’surge capacity“ of
the nation‘s health care systems to respond to mass casualty events.
The statement GAO is issuing today summarizes a June 2008 report,
Emergency Preparedness: States Are Planning for Medical Surge, but
Could Benefit from Shared Guidance for Allocating Scare Medical
Resources (GAO-08-668). In that report, GAO was asked to examine the
assistance the federal government had provided to help states prepare
for medical surge and what states had done to prepare for medical
surge. To do this GAO reviewed documents from the 50 states and
federal agencies and interviewed officials from a judgmental sample of
20 states and from federal agencies, as well as emergency preparedness
experts.
What GAO Found:
In its June 2008 report, which is summarized in this statement, GAO
found that following a mass casualty event that could involve
thousands, or even tens of thousands, of injured or ill victims,
health care systems would need the ability to ’surge,“ that is, to
adequately care for a large number of patients or patients with
unusual medical needs. The federal government has provided funding,
guidance, and other assistance to help states prepare for medical
surge in a mass casualty event. From fiscal years 2002 to 2007, the
federal government awarded the states about $2.2 billion through HHS‘s
Office of the Assistant Secretary for Preparedness and Response‘s
Hospital Preparedness Program to support activities to meet their
preparedness priorities and goals, including medical surge. Further,
the federal government provided guidance for states to use when
preparing for medical surge, including Reopening Shuttered Hospitals
to Expand Surge Capacity, which contains a checklist that states can
use to identify entities that could provide more resources during a
medical surge.
Based on a review of state emergency preparedness documents and
interviews with 20 state emergency preparedness officials, GAO found
that many states had made efforts related to three of the four key
components of medical surge that GAO had identified”increasing
hospital capacity, identifying alternate care sites, and registering
medical volunteers. But fewer had implemented the fourth: planning for
altering established standards of care. More than half of the 50
states had met or were close to meeting the criteria for the five
medical-surge-related sentinel indicators for hospital capacity
reported in the Hospital Preparedness Program‘s 2006 midyear progress
reports. In a 20-state review, GAO found that:
* all 20 were developing bed reporting systems and most were
coordinating with military and veterans hospitals to expand hospital
capacity,
* 18 were selecting various facilities for alternate care sites,
* 15 had begun electronic registering of medical volunteers, and,
* fewer of the states”7 of the 20”were planning for altered standards
of medical care to be used in response to a mass casualty event.
State officials in GAO‘s 20-state review reported that they faced
challenges relating to all four key components in preparing for
medical surge. For example, some states reported concerns related to
maintaining adequate staffing levels to increase hospital capacity.
According to some state officials, volunteers were concerned that if
state registries became part of a national database they might be
required to provide services outside their own state. Some states
reported that they had not begun work on or completed altered
standards of care guidelines due to the difficulty of addressing the
medical, ethical, and legal issues involved in making life-or-death
decisions about which patients would get access to scarce resources.
While most of the states that had adopted or were drafting altered
standards of care guidelines reported using federal guidance as they
developed these guidelines, some states also reported that they needed
additional assistance.
What GAO Recommends:
In the June 2008 report GAO recommended that the Secretary of the
Department of Health and Human Services (HHS) ensure that the
department serves as a clearinghouse for sharing among the states
altered standards of care guidelines developed by individual states or
medical experts. HHS was silent on GAO‘s recommendation but has since
reported taking steps to design such a clearinghouse. HHS and the
departments of Homeland Security, Defense, and Veterans Affairs
concurred with GAO‘s findings.
View [hyperlink, http://www.gao.gov/products/GAO-10-381T or key
components. For more information, contact Cynthia A. Bascetta at (202)
512-7114 or bascettac@gao.gov.
[End of section]
Mr. Chairman and Members of the Subcommittee:
I am pleased to be here today to discuss our work examining both the
federal assistance provided to states and the states' own efforts to
help build the "surge capacity" of the nation's health care system to
respond to mass casualty events. The September 11, 2001, terrorist
attacks on the World Trade Center and the Pentagon, the anthrax
incidents during the fall of 2001, and the H1N1 influenza pandemic of
2009 have raised public awareness and concern about the ability of the
nation's health care systems[Footnote 1] to respond to bioterrorism
[Footnote 2] and other mass casualty events.[Footnote 3] In a mass
casualty event the ability of local or regional health care systems to
deliver services consistent with established standards of care
[Footnote 4] could be compromised, at least in the short term, because
the volume of patients would far exceed the available hospital beds,
medical personnel, pharmaceuticals, equipment, and supplies. The
nation's health care system was tested by last year's H1N1 pandemic
and may be challenged to respond to a large-scale public health
emergency if there is a resurgence of the H1N1 influenza virus or some
other strain of influenza in 2010.
Following a mass casualty event, health care systems would need the
ability to "surge," that is, to adequately care for a large number of
patients or patients with unusual or highly specialized medical needs.
Providing such care would require the allocation of scarce resources
and could occur outside of hospitals and other normal health care
delivery sites. Through literature reviews and interviews with experts
and professional associations, we identified four key components
related to preparing for medical surge in a mass casualty event: (1)
increasing hospital capacity, including beds, workforce, equipment,
and supplies; (2) identifying and operating alternate care sites
[Footnote 5] when hospital capacity is overwhelmed; (3) registering
and credentialing volunteer medical professionals; and (4) planning
for appropriate altered standards of care[Footnote 6] in order to save
the most lives in a mass casualty event.
Federal and state entities both play roles in preparing for emergency
preparedness. The Department of Homeland Security (DHS) has the
overall federal responsibility under the Homeland Security Act of 2002
for managing national emergency preparedness.[Footnote 7] In December
2006, the Congress passed the Pandemic and All-Hazards Preparedness
Act (PAHPA). PAHPA designated the Secretary of Health and Human
Services as the lead official for all federal public health and
medical responses to public health emergencies, including medical
surge.[Footnote 8] Under the federal plan for responding to
emergencies,[Footnote 9] states have responsibility for producing
emergency preparedness plans in coordination with regional and local
entities, and both DHS and the Department of Health and Human Services
(HHS) are responsible for supporting their efforts. In addition, the
Department of Defense (DOD) and the Department of Veterans Affairs
(VA) are expected to assist state and local entities in emergencies. A
DOD directive authorizes local military hospitals to coordinate with
state and local entities to plan for emergency preparedness, and DOD
hospitals are authorized to accept civilian patients in a mass
casualty event.[Footnote 10] VA policies and procedures allow VA
hospitals to participate in state and local emergency planning, and by
statute VA may provide medical care to nonveterans in a mass casualty
event.
My statement today is based largely on our June 2008 report entitled
Emergency Preparedness: States Are Planning for Medical Surge, but
Could Benefit from Shared Guidance for Allocating Scare Medical
Resources[Footnote 11] and includes some updated information. In the
June 2008 report, we examined the following questions: (1) What
assistance has the federal government provided to help states prepare
their regional and local health care systems for medical surge in a
mass casualty event? (2) What have states done to prepare for medical
surge in a mass casualty event? (3) What concerns have states
identified as they prepare for medical surge in a mass casualty event?
In carrying out the work for our June 2008 report examining what
assistance the federal government provided to states to help them
prepare their regional and local health care systems for medical surge
in a mass casualty event, we reviewed and analyzed national strategic
planning documents. We also analyzed reports related to medical surge
capacity issued by various entities, including the Agency for
Healthcare Research and Quality (AHRQ), Centers for Disease Control
and Prevention (CDC), Office of the Assistant Secretary for
Preparedness and Response (ASPR), and the Joint Commission.[Footnote
12] 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 also interviewed
officials from ASPR, CDC, and DHS to identify and document criteria
and guidance given to states to plan for medical surge. To determine
what states had done to prepare for medical surge in a mass casualty
event, 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 at
the time of our data collection for the June 2008 report[Footnote 13])
for the 50 states.[Footnote 14] We also reviewed the 15 sentinel
indicators from these reports.[Footnote 15] Although ASPR's 2006
guidance for these midyear progress reports did not provide specific
criteria with which to evaluate recipients' performance on these
sentinel indicators, we identified criteria to analyze the data
provided for 5 of the indicators related to one of four key
components--hospital capacity--from either ASPR's previous program
guidance or DHS guidance.[Footnote 16] In addition, we obtained and
reviewed 20 states' emergency preparedness planning documents relating
to medical surge and interviewed officials from these states
responsible for planning for medical surge. We selected the 20 states
by identifying 2 states from each of the 10 HHS geographic regions--
one with the most ASPR Hospital Preparedness Program funding and one
with the least funding. These selection criteria allowed us to take
into account population (program funding was awarded using a formula
including, in part, population), geographic dispersion, and different
geographic risk factors, such as the potential for hurricanes,
tornadoes, or earthquakes. We obtained and reviewed DOD and VA
policies and interviewed officials regarding their participation with
state and local entities in emergency preparedness planning and
response. To determine what concerns states identified as they
prepared for medical surge, we interviewed emergency preparedness
officials from the 20 states on their efforts related to four key
components. We also asked what further assistance states might need
from the federal government to help prepare their health care systems
for medical surge. The information from these interviews is intended
to provide a general description of what the 20 states have done to
prepare for medical surge and is not generalizable to all 50 states.
We conducted the performance audit for the June 2008 report from May
2007 through May 2008, and updated certain information on the status
of HHS's actions to respond to our recommendations by interviewing an
HHS official, in accordance with generally accepted government
auditing standards. Those standards require that we plan and perform
the audit to obtain sufficient, appropriate evidence to provide a
reasonable basis for our findings and conclusions based on our audit
objectives. We believe that the evidence obtained provides a
reasonable basis for our findings and conclusions based on our audit
objectives. A detailed explanation of our methodology is included in
our June 2008 report.
In brief, we found that the federal government provided funding,
guidance, and other assistance to help states prepare for medical
surge in a mass casualty event. From fiscal years 2002 to 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, we reported that the federal government developed, or
contracted with experts to develop, guidance that was provided for
states to use when preparing for medical surge and that ASPR project
officers and CDC subject matter experts were available to provide
assistance to states on issues related to medical surge. In reporting
on state activities, we found that many states had made efforts
related to three of the key components of medical surge, that is,
increasing hospital capacity, planning for alternate care sites, and
developing electronic medical volunteer registries, but fewer had
addressed the fourth component, planning for altered standards of
care. For example, in our 20-state review, we found that all were
developing bed reporting systems to increase hospital capacity and 18
reported that they were in the process of selecting alternate care
sites that used either fixed or mobile medical facilities. However,
fewer of the states--7 of the 20--had adopted or were drafting altered
standards of medical care to be used in response to a mass casualty
event. In reporting on concerns states identified as they prepared for
medical surge, we found that state officials in the 20 states we
surveyed reported that they continued to face challenges related to
all four key components of medical surge. For example, some states
reported that although they could increase numbers of hospital beds in
a mass casualty event, they were concerned about staffing those beds
because of current shortages in medical professionals, and some states
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 in making life-or-death decisions in advance of a disaster
about which patients would get or lose access to scarce resources.
To further assist states in determining how they will allocate scarce
medical resources in a mass casualty event, we recommended 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. In
commenting on a draft of our report in May 2008, HHS, DHS, DOD, and VA
concurred with our findings. HHS was silent regarding our
recommendation. However, in October 2009, an HHS official reported
that the agency was designing a Web portal to serve as a clearinghouse
on preparedness and response, with an emphasis on the allocation of
scarce medical resources, in part as a result of GAO's recommendation.
In January 2010, an HHS official reported that efforts to design and
develop the Web portal were continuing.
The Federal Government Has Provided States with Funding, Guidance, and
Other Assistance to Prepare for Medical Surge:
In June 2008, we reported that from fiscal years 2002 through 2007,
HHS awarded states about $2.2 billion through ASPR's Hospital
Preparedness Program[Footnote 17] to support activities to strengthen
their hospital emergency preparedness capabilities, including medical
surge goals and priorities.[Footnote 18] 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 and the establishment of
alternate care sites. We cannot report state-specific funding for the
four key components of medical surge 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.
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.[Footnote 19] In addition, ASPR provided
states with specific guidance related to preparing for medical surge
in a mass casualty event, such as annual guidance for its Hospital
Preparedness Program cooperative agreements, guidance for developing
electronic medical volunteer registries, and guidance to develop a
hospital bed tracking system. For example, ASPR's electronic medical
volunteer registries 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.
Additionally, we reported that 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 a
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. 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. For example, states were required to
attend annual conferences for Hospital Preparedness Program
cooperative agreement recipients, where ASPR provided forums for
discussion of medical surge issues. 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. A detailed list of
federal guidance and conferences is included in our June 2008 report.
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:
In June 2008 we reported that states were making efforts to expand
hospital capacity. We found that 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,[Footnote 20] the
most recent available data at the time of our analysis for the June
2008 report.[Footnote 21] 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 had 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[Footnote 22] 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 of the 50 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.
We also reported in 2008 that in a 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 Hospital Available
Beds for Emergencies and Disasters (HAvBED) standards.[Footnote 23]
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.[Footnote 24] We also reported that of the 10 states
with DOD hospitals, 9 reported coordinating with DOD hospitals to plan
for emergency preparedness and increase hospital capacity and 8
reported that DOD hospitals in their state would accept civilian
patients in the event of a mass casualty event if resources were
available.[Footnote 25] Additionally, 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.[Footnote 26] 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.[Footnote 27] 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, and 1 state
reported that some of its VA hospitals would take nonveteran patients
and others would not.
We further reported in June 2008 that 18 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.
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. 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.
Our June 2008 report also noted that 15 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. Officials from 4 of the 5 remaining states
that had not begun registering volunteers reported that they
anticipated registering them. 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. At
Level 1, all of a volunteer's medical qualifications, which identify
his or her skills and capabilities, have been verified and the
volunteer is ready to provide care in any setting, including a
hospital.
In our 20-state review of efforts related to the fourth key component,
we reported 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.[Footnote 28] 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
required that the same allocation guidelines be used across the state.
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.
States Reported Concerns Related to All Four Key Components When
Preparing for Medical Surge:
In June 2008, we reported that even though states had 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.
Hospital capacity concerns. We reported that 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,[Footnote 29] 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.
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. Some state officials also reported concerns about
reimbursement for medical services provided at alternate care sites,
which are not accredited health care facilities, and concerns
regarding how certain federal laws and regulations that relate to
medical care would apply during a mass casualty event for care
provided at alternative care sites.
Electronic medical volunteer registry concerns. We reported that 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. Additionally, 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)[Footnote 30] and the electronic medical volunteer
registry programs had not been coordinated, resulting in duplication
of effort for volunteers. 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. 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, in 2005 HHS estimated that in a severe influenza pandemic
almost 10 million people would require hospitalization,[Footnote 31]
which would exceed the current capacity of U.S. hospitals and
necessitate difficult choices regarding rationing of resources.
[Footnote 32] HHS also estimated 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
ventilators, and others would be removed from ventilators, 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, which had 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, requiring the state to address
the rationing of ventilators. In March 2006 the state convened a work
group to consider clinical and ethical issues in the allocation of
mechanical ventilators in an influenza pandemic.[Footnote 33] 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.
In May 2008, 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,[Footnote 34] 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.
Concluding Observations:
In our June 2008 report, we noted that though states had begun
planning for medical surge in a mass casualty event, only 3 of the 20
states in our review had 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 were 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.
Mr. Chairman, this concludes my prepared statement. I would be happy
to answer any questions you or other members of the subcommittee may
have.
Contacts and Acknowledgments:
For further information about this statement, please contact Cynthia
A. Bascetta 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 statement. Karen Doran, Assistant Director,
was a key contributor to this statement.
[End of section]
Footnotes:
[1] By health care systems, we mean both public health and medical
systems, including hospitals.
[2] A bioterrorism attack is the deliberate release of viruses,
bacteria, or other germs (agents) used to cause illness or death in
people, animals, or plants. These agents are typically found in
nature, but it is possible that they could be changed to increase
their ability to cause disease, to make them resistant to current
medicines, or to increase their ability to be spread into the
environment. Biological agents can be spread through the air, through
water, or in food.
[3] A mass casualty event is a public health or medical emergency that
could involve thousands, or even tens of thousands, of injured or ill
victims.
[4] A standard of care is the diagnostic and treatment process that a
provider should follow for a certain type of patient or illness, or
certain clinical circumstances. It is how similarly qualified health
care providers would manage the patient's care under the same or
similar circumstances.
[5] Alternate care sites deliver medical care outside of hospital
settings for patients who would normally be treated as inpatients.
[6] The term "altered standards" generally means a shift to providing
care and allocating scarce equipment, supplies, and personnel in a way
that saves the largest number of lives, in contrast to the traditional
focus of treating the sickest or most injured patients first. For
example, it could mean applying principles of field triage to
determine who gets what kind of care, changing infection control
standards to permit group isolation rather than single-person
isolation units, changing who provides various kinds of care, or
changing privacy and confidentiality protections temporarily.
[7] See Pub. L. No. 107-296, 116 Stat. 2135 (2002).
[8] Pub. L. No. 109-417, §101, 120 Stat. 2831, 2832 (2006) (codified
at 42 U.S.C. § 300hh).
[9] The National Response Framework details the missions, policies,
structures, and responsibilities of federal agencies for coordinating
resource and programmatic support to states, tribes, and other federal
agencies.
[10] DOD Directive 3025.1, Military Support to Civil Authorities §§
4.6.1.2 and 4.5.1 (Jan. 15, 1993).
[11] GAO, Emergency Preparedness: States Are Planning for Medical
Surge, but Could Benefit from Shared Guidance for Allocating Scare
Medical Resources, [hyperlink, http://www.gao.gov/products/GAO-08-668]
(Washington, D.C.: June 13, 2008).
[12] The Joint Commission is an independent, nonprofit organization
that evaluates and accredits more than 15,000 U.S. health care
organizations and programs, including DOD and VA hospitals.
[13] The 2006 program year for the Hospital Preparedness Program was
September 1, 2006, to August 31, 2007. The 2007 program year was
September 1, 2007, to August 8, 2008.
[14] While the Hospital Preparedness Program awards funds annually to
62 entities--the 50 states; 4 municipalities, including the District
of Columbia; 5 U.S. territories; and 3 Freely Associated States of the
Pacific--we limited our review to the 50 states.
[15] Sentinel indicators are smaller component tasks of critical
benchmarks, which measure program capacity-building efforts such as
purchasing equipment and supplies and acquiring personnel. For
example, for the benchmark "Surge Capacity; Beds," one of the sentinel
indicators is the number of additional hospital beds for which a
recipient could make patient care available within 24 hours. ASPR
requires that states report on 15 sentinel indicators.
[16] Two of the 15 indicators--total number of hospitals statewide and
total population statewide--were used as denominators to analyze the 5
indicators.
[17] An additional $218 million was provided to four large
municipalities, five U.S. territories, and three Freely Associated
States of the Pacific for a total of approximately $2.5 billion. Over
the 2-year period, fiscal years 2004 and 2005, HHS also awarded an
additional $200,000 to 48 states for electronic medical volunteer
registries development through this program.
[18] Since January 2006, HHS also had awarded the 62 recipients an
additional $400 million in two phases and a supplement to prepare for
a pandemic influenza outbreak. The funds were awarded to accelerate
their current planning efforts for an influenza pandemic and to
exercise their plans. These funds included $75 million in August 2007
that could be used, in part, to develop pandemic alternate care sites
and to conduct medical surge exercises.
[19] For example, one of the activities is to receive and treat surge
casualties. One of the critical tasks associated with this activity is
to ensure adequacy of medical equipment and supplies in support of
immediate medical response operations and for restocking requested
supplies and equipment.
[20] The 2006 program year was from September 1, 2006, to August 31,
2007; therefore, information provided in the midyear progress reports
was reported as of March 2007.
[21] Four of the states we reviewed provided sentinel indicator
information as of April 2007, one state as of August 2007, and another
state as of September 2007.
[22] Negative pressure isolation rooms maintain a flow of air into the
room to ensure that contaminants and pathogens cannot escape from the
room to other parts of the facility and to protect the health of
workers and other patients.
[23] Among other standards, HAvBED systems are required to report on
seven categories of staffed available beds. The seven bed categories
are intensive care, medical and surgical, burn, pediatric intensive
care, pediatric, psychiatric, and negative pressure isolation. HAvBED
systems are also required to report on emergency department
diversions, decontamination facilities available, and ventilators
available. ASPR allows each state to use Hospital Preparedness Program
funds to develop its own bed tracking system as long as the system
meets HAvBED requirements.
[24] ASPR required all recipients to complete the development of their
bed tracking system by August 8, 2008.
[25] DOD Directive 3025.1, section 4.5.1 authorizes military officials
to take necessary actions to respond to civilian requests for
assistance in emergencies, which may include accepting civilian
patients. This decision can be authorized by DOD or, in cases of
urgent need, by the commander of the local military hospital.
[26] VA is authorized to furnish hospital care or medical services as
a humanitarian service to non-VA beneficiaries in emergency cases. See
38 U.S.C. § 1784; 38 C.F.R. §§ 17.37, 17.43, 17.95, 17.102. VA is also
authorized to provide care and services during certain disasters and
emergencies. See 38 U.S.C. § 1785; 38 C.F.R. § 17.86.
[27] According to a VA General Counsel memorandum (Guidance on
Entering into Mutual Aid Agreements, July 23, 2003), hospitals can
also enter into mutual aid agreements in which VA hospitals and local
entities agree to assist each other during disasters and emergencies.
These agreements often include provisions to accept patients from
other hospitals if the transferring hospital has an overwhelming
number of patients or if the transferring facility does not have the
resources for patients who require specialized medical treatment.
However, these mutual aid agreements must state that the agreement is
limited by certain VA obligations that may take precedence over the
agreement to assist local hospitals during an emergency, such as VA's
obligations under the National Disaster Medical System and its
obligations to assist DOD during a time of war or national emergency.
[28] A ventilator mechanically moves oxygen into and out of the lungs
of a patient who is physically unable to breathe on his or her own, or
whose breathing is insufficient to maintain life.
[29] Officials from the remaining state reported that they did not
know how many beds were available statewide above the current daily
staffed bed capacity.
[30] MRC is a federal program within the U.S. Surgeon General's
Office, which is in HHS. MRC units are community-based and organize
and utilize volunteers to, among other things, prepare for and respond
to emergencies. MRC volunteers include medical and public health
professionals as well as other community members, such as interpreters
and legal advisers.
[31] By comparison, seasonal influenza in the United States generally
results in 200,000 hospitalizations annually.
[32] Department of Health and Human Services, HHS Pandemic Influenza
Plan (Washington, D.C., November 2005).
[33] The group brought together experts in law, medicine, policy
making, and ethics with representatives from medical facilities and
city, county, and state government.
[34] The task force included officials from DHS, HHS, ASPR, CDC, DOD,
and VA. See Asha V. Devereaux et al., "Definitive Care for the
Critically Ill During a Disaster: A Framework for Allocation of Scarce
Resources in Mass Critical Care: From a Task Force for Mass Critical
Care Summit Meeting, January 26 to 27, 2007, Chicago, Il.," Chest
(2008): 133, 51-66.
[End of section]
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