oversight

SARS Outbreak: Improvements to Public Health Capacity Are Needed for Responding to Bioterrorism and Emerging Infectious Diseases

Published by the Government Accountability Office on 2003-05-07.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                          United States General Accounting Office

GAO                       Testimony
                          Before the Subcommittee on Oversight
                          and Investigations, Committee on Energy
                          and Commerce, House of Representatives

For Release on Delivery
Expected at 2:00 p.m.
Wednesday, May 7, 2003    SARS OUTBREAK
                          Improvements to Public
                          Health Capacity Are Needed
                          for Responding to
                          Bioterrorism and Emerging
                          Infectious Diseases
                          Statement of Janet Heinrich
                          Director, Health Care—Public Health Issues




GAO-03-769T
                                                  May 7, 2003


                                                  SARS OUTBREAK

                                                  Improvements to Public Health Capacity
Highlights of GAO-03-769T, testimony
before the Subcommittee on Oversight              Are Needed for Responding to
and Investigations, Committee on Energy
and Commerce, House of Representatives            Bioterrorism and Emerging Infectious
                                                  Diseases

SARS has infected relatively few                  The efforts of public health agencies and health care organizations to
people nationwide, but it has raised              increase their preparedness for major public health threats such as
concerns about preparedness for                   bioterrorism and the worldwide influenza outbreaks known as pandemics
large-scale infectious disease                    have improved the nation’s capacity to respond to SARS and other emerging
outbreaks. The initial response to                infectious disease outbreaks, but gaps in preparedness remain. Specifically,
an outbreak occurs in local
agencies and hospitals, with
                                                  GAO found that there are gaps in disease surveillance systems and
support from state and federal                    laboratory facilities and that there are workforce shortages. The level of
agencies, and can involve disease                 preparedness varied across seven cities GAO visited, with jurisdictions that
surveillance, epidemiologic                       have had multiple prior experiences with public health emergencies being
investigation, health care delivery,              generally more prepared than others. GAO found that planning for regional
and quarantine management.                        coordination was lacking between states. GAO also found that states were
Officials have learned lessons                    developing plans for receiving and distributing medical supplies for
applicable to preparedness for such               emergencies and for mass vaccinations in the event of a public health
outbreaks from experiences with                   emergency.
other major public health threats.

GAO was asked to examine the                      GAO found that most hospitals lack the capacity to respond to large-scale
preparedness of state and local                   infectious disease outbreaks. Most emergency departments have
public health agencies and                        experienced some degree of crowding and therefore in some cases may not
hospitals for responding to a large-              be able to handle a large influx of patients during a potential SARS or other
scale infectious disease outbreak                 infectious disease outbreak. Most hospitals across the country reported
and the relationship of federal and               participating in basic planning activities for such outbreaks. However, few
state planning for an influenza                   hospitals have adequate medical equipment, such as the ventilators that are
pandemic to preparedness for                      often needed for respiratory infections such as SARS, to handle the large
emerging infectious diseases.                     increases in the number of patients that may result.
This testimony is based on
Bioterrorism: Preparedness                        The public health response to outbreaks of emerging infectious diseases
Varied across State and Local                     such as SARS could be improved by the completion of federal and state
Jurisdictions, GAO-03-373 (Apr. 7,                influenza pandemic response plans that address problems related to the
2003); findings from a GAO survey                 purchase, distribution, and administration of supplies of vaccines and
on hospital emergency room                        antiviral drugs during an outbreak. The Centers for Disease Control and
capacity (in Hospital Emergency                   Prevention has provided interim draft guidance to facilitate state plans but
Departments: Crowded Conditions                   has not made the final decisions on plan provisions necessary to mitigate the
Vary among Hospitals and                          effects of potential shortages of vaccines and antiviral drugs in the event of
Communities, GAO-03-460 (Mar.                     an influenza pandemic.
14, 2003)) and on hospital
emergency preparedness; and
information updating Influenza
Pandemic: Plan Needed for
Federal and State Response, GAO-
01-4 (Oct. 27, 2000).


www.gao.gov/cgi-bin/getrpt?GAO-03-769T.

To view the full testimony, including the scope
and methodology, click on the link above.
For more information, contact Janet Heinrich
at (202) 512-7119.
Mr. Chairman and Members of the Subcommittee:

I appreciate the opportunity to be here today to discuss the work we have
done pertaining to the nation’s preparedness to manage major public
health threats, such as the emerging infectious disease known as SARS.1
The initial response to an outbreak of infectious disease would occur at
the local level, with support from state and federal agencies, and could
involve disease surveillance,2 epidemiologic investigation,3 health care
delivery, and quarantine management. The SARS outbreak has not infected
large numbers of individuals in the United States, but it has raised
concerns about the nation’s preparedness to manage these components of
response should it, or other infections, reach large-scale proportions.

Public health officials and health care workers have learned lessons
applicable to preparedness for large-scale infectious disease outbreaks
from experiences with other major public health threats. Because of prior
worldwide influenza outbreaks—known as pandemics4—federal and state
agencies have begun to focus special attention on planning for such
events. Similarly, following the anthrax incidents of fall 2001, the Congress
expressed concern that the nation may not be prepared to respond to a
large-scale bioterrorist event. State and local response agencies and
organizations have recognized the need to strengthen their infrastructure
and capacity to respond to bioterrorism. The improvements they are
making will also strengthen their ability to identify and respond to other
major public health threats, including naturally occurring infectious
disease outbreaks. Planning for a response to bioterrorism and influenza
pandemics targets the public health resources essential for a response to
emerging infectious diseases.

To assist the Subcommittee in its consideration of our nation’s capacity to
respond to a major public health threat such as SARS, my remarks today


1
SARS is the abbreviation for severe acute respiratory syndrome.
2
 Disease surveillance uses systems that provide for the ongoing collection, analysis, and
dissemination of health-related data to identify, prevent, and control disease.
3
 An epidemiologic investigation seeks to determine how a disease is distributed in a
population and the factors that influence or determine this distribution.
4
 Influenza pandemics are worldwide influenza epidemics that can have successive “waves”
of disease and last for up to 3 years. Three pandemics occurred in the twentieth century:
the “Spanish flu” of 1918, which killed at least 20 million people worldwide; the “Asian flu”
of 1957; and the “Hong Kong flu” of 1968.




Page 1                                                                         GAO-03-769T
will focus on (1) the preparedness of state and local public health agencies
for responding to a large-scale infectious disease outbreak, (2) the
preparedness of hospitals for responding to a large-scale infectious
disease outbreak, and (3) the relationship of federal and state planning for
an influenza pandemic to preparedness for emerging infectious diseases.

My testimony today is based largely on our recently released report on
state and local preparedness for a bioterrorist attack.5 For that report, we
conducted site visits to seven cities and their respective state
governments. We also reviewed each state’s spring 2002 applications for
bioterrorism preparedness funding distributed by the Department of
Health and Human Services’ (HHS) Centers for Disease Control and
Prevention (CDC) and Health Resources and Services Administration
(HRSA), and each state’s fall 2002 progress report on the use of that
funding. In addition, I will present some findings from a survey we
conducted on hospital emergency department capacity and emergency
preparedness,6 as well as some information updating our 2000 report on
federal and state planning for an influenza pandemic.7

In summary, while the efforts of public health agencies and health care
organizations to increase their preparedness for major public health
threats such as influenza pandemics and bioterrorism have improved the
nation’s capacity to respond to SARS and other emerging infectious
disease outbreaks, gaps in preparedness remain. Specifically, we found
that there are gaps in disease surveillance systems and laboratory facilities
and that there are workforce shortages. The level of preparedness varied
across cities we visited, with jurisdictions that have had multiple prior
experiences with public health emergencies being generally more
prepared than others. We found that planning for regional coordination
was lacking between states. We also found that states were developing



5
 U.S. General Accounting Office, Bioterrorism: Preparedness Varied across State and
Local Jurisdictions, GAO-03-373 (Washington, D.C.: Apr. 7, 2003).
6
 These findings include those related to emergency department capacity, which we
reported in U.S. General Accounting Office, Hospital Emergency Departments: Crowded
Conditions Vary among Hospitals and Communities, GAO-03-460 (Washington, D.C.:
Mar. 14, 2003) and hospital emergency preparedness for mass casualty incidents from
ongoing work. We did our work on the survey from May 2002 through May 2003 in
accordance with generally accepted government auditing standards.
7
U.S. General Accounting Office, Influenza Pandemic: Plan Needed for Federal and State
Response, GAO-01-4 (Washington, D.C.: Oct. 27, 2000).




Page 2                                                                    GAO-03-769T
             plans for receiving and distributing medical supplies for emergencies and
             for mass vaccinations in the event of a public health emergency.

             We found that most hospitals across the country lack the capacity to
             respond to large-scale infectious disease outbreaks. Most emergency
             departments have experienced some degree of crowding and therefore in
             some cases may not be able to handle a large influx of patients during a
             potential SARS or other infectious disease outbreak. Although most
             hospitals report participating in basic planning activities for such
             outbreaks, few have adequate medical equipment, such as ventilators that
             are often needed for respiratory infections such as SARS, to handle the
             large increases in the number of patients that may result.

             The public health response to outbreaks of emerging infectious diseases
             such as SARS could be improved by the completion of federal and state
             influenza pandemic response plans that address problems related to the
             purchase, distribution, and administration of supplies of vaccines and
             antiviral drugs during an outbreak. CDC has provided interim draft
             guidance to facilitate state plans but has not made the final decisions on
             plan provisions necessary to mitigate the effects of potential shortages of
             vaccines and antiviral drugs in the event of an influenza pandemic.


             SARS is a respiratory illness that has recently been reported principally in
Background   Asia, Europe, and North America. The World Health Organization reported
             on May 5, 2003, that there were an estimated 6,583 probable cases
             reported in 27 countries, including 61 cases in the United States. There
             have been 461 deaths worldwide, none of which have been in the United
             States. Of the 56 probable cases in the United States reported through
             April 30, 2003, 37 (66 percent) were hospitalized, and 2 (4 percent)
             required mechanical ventilation. Symptoms of the disease, which may be
             caused by a previously unrecognized coronavirus,8 can include a fever,
             chills, headache, other body aches, or a dry cough.

             A Canadian official recently reported that more than 60 percent of
             probable SARS cases in Canada, where the bulk of North American cases
             have occurred, resulted from transmission to health care workers and



             8
              The coronavirus is one of a group of viruses that are responsible for some but not all
             common colds. They are so named because their microscopic appearance is that of a virus
             particle surrounded by a crown.




             Page 3                                                                    GAO-03-769T
patients. Canada’s experience with managing the SARS outbreak has
shown that measures used to prevent and control emerging infectious
diseases appear to have been useful in controlling this outbreak. One of
the measures that it has undertaken to control the outbreak is isolating
probable cases in hospitals, including closing two hospitals to new
admissions.9 Other measures include isolating people, either in their
homes or in a hospital, who have had close contact with a SARS patient
and providing educational materials regarding SARS to people who have
traveled to locations of concern.

In order to be adequately prepared for a major public health threat such as
SARS in the United States, state and local public health agencies need to
have several basic capabilities, whether they possess them directly or have
access to them through regional agreements. Public health departments
need to have disease surveillance systems and epidemiologists to detect
clusters of suspicious symptoms or diseases in order to facilitate early
detection of disease and treatment of victims. Laboratories need to have
adequate capacity and necessary staff to test clinical and environmental
samples in order to identify an agent promptly so that proper treatment
can be started and infectious diseases prevented from spreading. All
organizations involved in the response must be able to communicate easily
with one another as events unfold and critical information is acquired,
especially in a large-scale infectious disease outbreak. In addition, plans
that describe how state and local officials would manage and coordinate
an emergency response need to be in place and to have been tested in an
exercise, both at the state and local levels and at the regional level.

Local health care organizations, including hospitals, are generally
responsible for the initial response to a public health emergency. In the
event of a large-scale infectious disease outbreak, hospitals and their
emergency departments would be on the front line, and their personnel
would take on the role of first responders. Because hospital emergency
departments are open 24 hours a day, 7 days a week, exposed individuals
would be likely to seek treatment from the medical staff on duty. Staff
would need to be able to recognize and report any illness patterns or
diagnostic clues that might indicate an unusual infectious disease
outbreak to their state or local health department. Hospitals would need to
have the capacity and staff necessary to treat severely ill patients and limit
the spread of infectious disease. In addition, hospitals would need


9
The two hospitals have since been reopened.




Page 4                                                           GAO-03-769T
adequate stores of equipment and supplies, including medications,
personal protective equipment, quarantine and isolation facilities, and air
handling and filtration equipment.

The federal government also has a role in preparedness for and response
to major public health threats. It becomes involved in investigating the
cause of the disease, as it is doing with SARS. In addition, the federal
government provides funding and resources to state and local entities to
support preparedness and response efforts. CDC’s Public Health
Preparedness and Response for Bioterrorism program provided funding
through cooperative agreements in fiscal year 2002 totaling $918 million to
states and municipalities to improve bioterrorism preparedness and
response, as well as other public health emergency preparedness
activities. HRSA’s Bioterrorism Hospital Preparedness Program provided
funding through cooperative agreements in fiscal year 2002 of
approximately $125 million to states and municipalities to enhance the
capacity of hospitals and associated health care entities to respond to
bioterrorist attacks. In March 2003, HHS announced that the CDC and
HRSA programs would provide funding of approximately $870 million and
$498 million, respectively, for fiscal year 2003. Among the other public
health emergency response resources that the federal government
provides is the Strategic National Stockpile, which contains
pharmaceuticals, antidotes, and medical supplies that can be delivered
anywhere in the United States within 12 hours of the decision to deploy.

Just as was true with the identification of the coronavirus as the likely
causative agent in SARS, deciding which influenza viral strains are
dominant depends on data collected from domestic and international
surveillance systems that identify prevalent strains and characterize their
effect on human health.10 Antiviral drugs and vaccines against influenza are
expected to be in short supply if a pandemic occurs. Antiviral drugs, which
can be used against all forms of viral diseases, have been as effective as
vaccines in preventing illness from influenza and have the advantage of
being available now. HHS assumes shortages of antiviral drugs and
vaccines will occur in a pandemic because demand is expected to exceed
current rates of production. For example, increasing production capacity
of antiviral drugs can take at least 6 to 9 months, according to
manufacturers.



10
 CDC participates in international disease and laboratory surveillance sponsored by the
World Health Organization, which operates in 83 countries.



Page 5                                                                      GAO-03-769T
                           In the cities we visited, state and local officials reported varying levels of
State and Local            public health preparedness to respond to outbreaks of diseases such as
Officials Reported         SARS. They recognized gaps in preparedness elements such as
                           communication and were beginning to address them. Gaps also remained
Varying Levels of          in other preparedness elements that have been more difficult to address,
Public Health              including the disease surveillance and laboratory systems and the
                           response capacity of the workforce. In addition, we found that the level of
Preparedness for           preparedness varied across the cities. Jurisdictions that had multiple prior
Infectious Disease         experiences with public health emergencies were generally more prepared
Outbreaks                  than those with little or no such experience prior to our site visits. We
                           found that planning for regional coordination was lacking between states.
                           In addition, states were working on plans for receiving and distributing the
                           Strategic National Stockpile and for administering mass vaccinations.


Progress Has Been Made     States and local areas were addressing gaps in public health preparedness
in Elements of Public      elements, such as communication, but weaknesses remained in other
Health Preparedness, But   preparedness elements, including the disease surveillance and laboratory
                           systems and the response capacity of the workforce. Gaps in capacity
Gaps Remain                often are not amenable to solution in the short term because either they
                           require additional resources or the solution takes time to implement.

Communication              We found that officials were beginning to address communication
                           problems. For example, six of the seven cities we visited were examining
                           how communication would take place in a public health emergency. Many
                           cities had purchased communication systems that allow officials from
                           different organizations to communicate with one another in real time. In
                           addition, state and local health agencies were working with CDC to build
                           the Health Alert Network (HAN), an information and communication
                           system. The nationwide HAN program has provided funding to establish
                           infrastructure at the local level to improve the collection and transmission
                           of information related to public health preparedness. Goals of the HAN
                           program include providing high-speed Internet connectivity, broadcast
                           capacity for emergency communication, and distance-learning
                           infrastructure for training.

Surveillance Systems and   State and local officials for the cities we visited recognized and were
Laboratory Facilities      attempting to address inadequacies in their surveillance systems and
                           laboratory facilities. Local officials were concerned that their surveillance
                           systems were inadequate to detect a bioterrorist event, and all of the states




                           Page 6                                                           GAO-03-769T
we visited were making efforts to improve their disease surveillance
systems. Six of the cities we visited used a passive surveillance system11 to
detect infectious disease outbreaks.12 However, passive systems may be
inadequate to identify a rapidly spreading outbreak in its earliest and most
manageable stage because, as officials in three states noted, there is
chronic underreporting and a time lag between diagnosis of a condition
and the health department’s receipt of the report. To improve disease
surveillance, six of the states and two of the cities we visited were
developing surveillance systems using electronic databases. Several cities
were also evaluating the use of nontraditional data sources, such as
pharmacy sales, to conduct surveillance.13 Three of the cities we visited
were attempting to improve their surveillance capabilities by
incorporating active surveillance components into their systems.

However, work to improve surveillance systems has proved challenging.
For example, despite initiatives to develop active surveillance systems, the
officials in one city considered event detection to be a weakness in their
system, in part because they did not have authority to access hospital
information systems. In addition, various local public health officials in
other cities reported that they lacked the resources to sustain active
surveillance.

Officials from all of the states we visited reported problems with their
public health laboratory systems and said that they needed to be
upgraded. All states were planning to purchase the equipment necessary



11
  Passive surveillance systems rely on laboratory and hospital staff, physicians, and other
relevant sources to take the initiative to provide data on illnesses to the health department,
where officials analyze and interpret the information as it arrives. In contrast, in an active
disease surveillance system, public health officials contact sources, such as laboratories,
hospitals, and physicians, to obtain information on conditions or diseases in order to
identify cases. Active surveillance can provide more complete detection of disease patterns
than a system that is wholly dependent on voluntary reporting.
12
 Officials in one city told us that although it had no local disease surveillance, its state
maintained a passive disease surveillance system.
13
  This type of active surveillance system in which the public health department obtains
information from such sources as hospitals and pharmacies and conducts ongoing analysis
of the data to search for certain combinations of signs and symptoms, is sometimes
referred to as a syndromic surveillance system. One federal official has stated that research
examining the usefulness of syndromic surveillance needs to continue. See S. Lillibridge,
Disease Surveillance, Bioterrorism, and Homeland Security, Conference Summary and
Proceedings Prepared by the Annapolis Center for Science-Based Public Policy (Annapolis,
Md.: U.S. Medicine Institute for Health Studies, Dec. 4, 2001).




Page 7                                                                            GAO-03-769T
            for rapidly identifying a biological agent. State and local officials in most
            of the areas that we visited told us that the public health laboratory
            systems in their states were stressed, in some cases severely, by the
            sudden and significant increases in workload during the anthrax incidents
            in the fall of 2001. During these incidents, the demand for laboratory
            testing was significant even in states where no anthrax was found and
            affected the ability of the laboratories to perform their routine public
            health functions. Following the incidents, over 70,000 suspected anthrax
            samples were tested in laboratories across the country.

            Officials in the states we visited were working on other solutions to their
            laboratory problems. States were examining various ways to manage peak
            loads, including entering into agreements with other states to provide
            surge capacity, incorporating clinical laboratories into cooperative
            laboratory systems, and purchasing new equipment. One state was
            working to alleviate its laboratory problems by upgrading two local public
            health laboratories to enable them to process samples of more dangerous
            pathogens and by establishing agreements with other states to provide
            backup capacity. Another state reported that it was using the funding from
            CDC to increase the number of pathogens the state laboratory could
            diagnose. The state also reported that it has worked to identify
            laboratories in adjacent states that are capable of being reached within 3
            hours over surface roads. In addition, all of the states reported that their
            laboratory response plans had been revised to cover reporting and sharing
            laboratory results with local public health and law enforcement agencies.

Workforce   At the time of our site visits, shortages in personnel existed in state and
            local public health departments and laboratories and were difficult to
            remedy. Officials from state and local health departments told us that
            staffing shortages were a major concern. Two of the states and cities that
            we visited were particularly concerned that they did not have enough
            epidemiologists to do the appropriate investigations in an emergency. One
            state department of public health we visited had lost approximately one-
            third of its staff because of budget cuts over the past decade. This
            department had been attempting to hire more epidemiologists. Barriers to
            finding and hiring epidemiologists included noncompetitive salaries and a
            general shortage of people with the necessary skills.

            Shortages in laboratory personnel were also cited. Officials in one city
            noted that they had difficulty filling and maintaining laboratory positions.
            People that accepted the positions often left the health department for
            better-paying positions. Increased funding for hiring staff cannot
            necessarily solve these shortages in the near term because for many types


            Page 8                                                           GAO-03-769T
                          of laboratory positions there are not enough trained individuals in the
                          workforce. According to the Association of Public Health Laboratories,
                          training laboratory personnel to provide them with the necessary skills
                          will take time and require a strategy for building the needed workforce.14


Level of Preparedness     We found that the overall level of public health preparedness varied by
Varied across Cities We   city. In the cities we visited, we observed that those cities that had
Visited                   recurring experience with public health emergencies, including those
                          resulting from natural disasters, or with preparation for National Security
                          Special Events, such as political conventions,15 were generally more
                          prepared than cities with little or no such experience. Cities that had dealt
                          with multiple public health emergencies in the past might have been
                          further along because they had learned which organizations and officials
                          need to be involved in preparedness and response efforts and moved to
                          include all pertinent parties in the efforts. Experience with natural
                          disasters raised the awareness of local officials regarding the level of
                          public health emergency preparedness in their cities and the kinds of
                          preparedness problems they needed to address.

                          Even the cities that were better prepared were not strong in all elements.
                          For example, one city reported that communications had been effective
                          during public health emergencies and that the city had an active disease
                          surveillance system. However, officials reported gaps in laboratory
                          capacity. Another one of the better-prepared cities was connected to HAN
                          and the Epidemic Information Exchange (Epi-X),16 and all county
                          emergency management agencies in the state were linked. However, the
                          state did not have written agreements with its neighboring states for
                          responding to a public health emergency.




                          14
                           Association of Public Health Laboratories, “State Public Health Laboratory Bioterrorism
                          Capacity,” Public Health Laboratory Issues in Brief: Bioterrorism Capacity (Washington,
                          D.C.: October 2002).
                          15
                            Presidential Decision Directive 62 created a category of special events called National
                          Security Special Events, which are events of such significance that they warrant greater
                          federal planning and protection than other special events. In addition to major political
                          party conventions, such events include presidential inaugurations.
                          16
                            Epi-X is a secure, Web-based exchange for public health officials to rapidly exchange
                          information on disease outbreaks, exposures to environmental hazards, and other health
                          events as they are identified and investigated.




                          Page 9                                                                        GAO-03-769T
Planning for Regional         Response organization officials were concerned about a lack of planning
Coordination Was Lacking      for regional coordination between states of the public health response to
between States                an infectious disease outbreak. As called for by the guidance for the CDC
                              and HRSA funding, all of the states we visited organized their planning on
                              the basis of regions within their states, assigning local areas to particular
                              regions for planning purposes. A concern for response organization
                              officials was the lack of planning for regional coordination between states.
                              A hospital official in one city we visited said that state lines presented a
                              “real wall” for planning purposes. Hospital officials in one state reported
                              that they had no agreements with other states to share physicians.
                              However, one local official reported that he had been discussing these
                              issues and had drafted mutual aid agreements for hospitals and emergency
                              medical services. Public health officials from several states reported
                              developing working relationships with officials from other states to
                              provide backup laboratory capacity.


States Have Begun             States have begun planning for use of the Strategic National Stockpile.17 To
Planning for Receiving and    determine eligibility for the CDC funding, applicants were required to
Distributing Items from the   develop interim plans to receive and manage items from the stockpile,
                              including mass distribution of antibiotics, vaccines, and medical materiel.
Strategic National            However, having plans for the acceptance of the deliveries from the
Stockpile and for             stockpile is not enough. Plans have to include details about dividing the
Administering Mass            materials that are delivered in large pallets and distributing the
Vaccinations                  medications and vaccines.

                              Of the seven states we visited, five states had completed plans for the
                              receipt and distribution of items from the stockpile. One state that was
                              working on its plan stated that it would be completed in January 2003.
                              Only one state had conducted exercises of its stockpile distribution plan,
                              while the other states were planning to conduct exercises or drills of their
                              plans sometime in 2003.

                              In addition, five states reported on their plans for mass vaccinations and
                              seven states reported on their plans for large-scale administration of
                              smallpox vaccine in response to an outbreak. Some states we visited had
                              completed plans for mass vaccinations, whereas other states were still



                              17
                               HHS is planning to purchase approximately 2,700 ventilators by September 2003 to
                              supplement those now available in the Strategic National Stockpile to enhance
                              preparedness for a potential outbreak of SARS in the United States.




                              Page 10                                                                   GAO-03-769T
                          developing their plans. The mass vaccination plans were generally closely
                          tied to the plans for receiving and administering the stockpile. In addition,
                          two states had completed smallpox response plans, which include plans
                          for administering mass smallpox vaccinations to the general population,
                          whereas four of the other states were drafting plans. The remaining state
                          was discussing such a plan. However, only one of the states we visited has
                          tested in an exercise its plan for conducting mass smallpox vaccinations.


                          We found that most hospitals lack the capacity to respond to large-scale
Most Hospitals Lack       infectious disease outbreaks. Persons with symptoms of infectious disease
Response Capacity         would potentially go to emergency departments for treatment. Most
                          emergency departments across the country have experienced some degree
for Large-Scale           of crowding and therefore in some cases may not be able to handle a large
Infectious Disease        influx of patients during a potential SARS outbreak. In addition, although
                          most hospitals across the country reported participating in basic planning
Outbreaks                 activities for large-scale infectious disease outbreaks, few have acquired
                          the medical equipment resources, such as ventilators, to handle large
                          increases in the number of patients that may result from outbreaks of
                          diseases such as SARS.


Most Emergency            Our survey found that most emergency departments have experienced
Departments Have          some degree of overcrowding.18 Persons with symptoms of infectious
Experienced Some Degree   disease would potentially go to emergency departments for treatment,
                          further stressing these facilities. The problem of overcrowding is much
of Crowding               more pronounced in some hospitals and areas than in others. In general,
                          hospitals that reported the most problems with crowding were in the
                          largest metropolitan statistical areas (MSA) and in the MSAs with high
                          population growth. For example, in fiscal year 2001, hospitals in MSAs
                          with populations of 2.5 million or more had about 162 hours of diversion
                          (an indicator of crowding),19 compared with about 9 hours for hospitals in
                          MSAs with populations of less than 1 million. Also the median number of
                          hours of diversion in fiscal year 2001 for hospitals in MSAs with a high
                          percentage population growth was about five times that for hospitals in
                          MSAs with lower percentage population growth.



                          18
                           GAO-03-460.
                          19
                            Diversions occur when hospitals request that en route ambulances bypass their
                          emergency departments and transport patients that would have been otherwise taken to
                          those emergency departments to other medical facilities.



                          Page 11                                                                  GAO-03-769T
Diversion varies greatly by MSA. Figure 1 shows each MSA and the share
of hospitals within the MSA that reported being on diversion more than 10
percent of the time—or about 2.4 hours or more per day—in fiscal year
2001. Areas with the greatest diversion included Southern California and
parts of the Northeast. Of the 248 MSAs for which data were available,20
171 (69 percent) had no hospitals reporting being on diversion more than
10 percent of the time. By contrast, 53 MSAs (21 percent) had at least one-
quarter of responding hospitals on diversion for more than 10 percent of
the time.




20
 The 248 MSAs include those MSAs for which (1) more than half of hospitals in the MSA
returned surveys and (2) more than half of those hospitals that returned surveys provided
data on diversion hours.




Page 12                                                                     GAO-03-769T
Figure 1: Percentage of Hospitals on Diversion More Than 10 Percent of the Time, by MSA, Fiscal Year 2001




                                        Note: Percentage of hospitals reflects those hospitals that responded to the survey; responses were
                                        not weighted to represent all hospitals in the MSA.
                                        a
                                         MSAs with a response rate of 50 percent or less or MSAs with 50 percent or more of data missing for
                                        responding hospitals. In 12 MSAs, no hospitals responded; these MSAs were excluded from the map.




                                        Page 13                                                                              GAO-03-769T
                            Hospitals in the largest MSAs and in MSAs with high population growth
                            that have reported crowding in emergency departments may have
                            difficulty handling a large influx of patients during a potential SARS
                            outbreak, especially if this outbreak occurred in the winter months when
                            the incidence of influenza is quite high. Thus far, the largest SARS
                            outbreaks worldwide have primarily occurred in areas with dense
                            populations.21


Most Hospitals Reported     At the time of our site visits, we found that hospitals were beginning to
Planning and Training       coordinate with other local response organizations and collaborate with
Efforts, but Fewer Than     each other in local planning efforts. Hospital officials in one city we visited
                            told us that until September 11, 2001, hospitals were not seen as part of a
Half Have Participated in   response to a terrorist event but that city officials had come to realize that
Drills or Exercises         the first responders to a bioterrorism incident could be a hospital’s
                            medical staff. Officials from the state began to emphasize the need for a
                            local approach to hospital preparedness. They said, however, that it was
                            difficult to impress the importance of cooperation on hospitals because
                            hospitals had not seen themselves as part of a local response system. The
                            local government officials were asking them to create plans that integrated
                            the city’s hospitals and addressed such issues as off-site triage of patients
                            and off-site acute care.

                            In our survey of over 2,000 hospitals,22 4 out of 5 hospitals reported having
                            a written emergency response plan for large-scale infectious disease
                            outbreaks. Of the hospitals with emergency response plans, most include a
                            description of how to achieve surge capacity for obtaining additional
                            pharmaceuticals, other supplies, and staff. In addition, almost all hospitals
                            reported participating in community interagency disaster preparedness
                            committees.




                            21
                             These areas include mainland China and the Hong Kong Special Administrative Region
                            within the People’s Republic of China; Singapore; Taiwan; and Toronto, Canada.
                            22
                              Between May and September 2002, we surveyed over 2,000 short-term, nonfederal general
                            medical and surgical hospitals with emergency departments located in metropolitan
                            statistical areas. (See U.S. General Accounting Office, Hospital Emergency Departments:
                            Crowded Conditions Vary among Hospitals and Communities, GAO-03-460 (Washington,
                            D.C.: Mar. 14, 2003) for information on the survey universe and development of the survey.)
                            For the part of the survey that specifically addressed hospital preparedness for mass
                            casualty incidents, we obtained responses from 1,482 hospitals for the third section of the
                            survey addressing emergency preparedness, a response rate of about 73 percent.




                            Page 14                                                                     GAO-03-769T
                           Our survey showed that hospitals have provided training to staff on
                           biological agents, but fewer than half have participated in exercises
                           related to bioterrorism. Most hospitals we surveyed reported providing
                           training about identifying and diagnosing symptoms for the six biological
                           agents identified by the CDC as most likely to be used in a bioterrorist
                           attack. At least 90 percent of hospitals reported providing training for two
                           of these agents—smallpox and anthrax—and approximately three-fourths
                           of hospitals reported providing training about the other four—plague,
                           botulism, tularemia, and hemorrhagic fever viruses.


Most Hospitals Lack        Most hospitals lack adequate equipment, isolation facilities, and staff to
Adequate Equipment,        treat a large increase in the number of patients for an infectious disease
Facilities, and Staff      such as SARS. To prevent transmission of SARS in health care settings,
                           CDC recommends that health care workers use personal protective
Required to Respond to a   equipment, including gowns, gloves, respirators, and protective eyewear.23
Large-Scale Infectious     SARS patients in the United States are being isolated until they are no
Disease Outbreak           longer infectious. CDC estimates that patients require mechanical
                           ventilation in 10 to 20 percent of SARS cases.24

                           In the seven cities we visited, hospital, state, and local officials reported
                           that hospitals needed additional equipment and capital improvements—
                           including medical stockpiles, personal protective equipment, quarantine
                           and isolation facilities, and air handling and filtering equipment—to
                           enhance preparedness. Five of the states we visited reported shortages of
                           hospital medical staff, including nurses and physicians, necessary to
                           increase response capacity in an emergency. One of the states we visited
                           reported that only 11 percent of its hospitals could readily increase their
                           capacity for treating patients with infectious diseases requiring isolation,
                           such as smallpox and SARS. Another state reported that most of its
                           hospitals have little or no capacity for isolating patients diagnosed with or
                           being tested for infectious diseases.

                           According to our hospital survey, availability of medical equipment varied
                           greatly between hospitals, and few hospitals seemed to have adequate



                           23
                             CDC, Interim Domestic Guidance for Management of Exposures to Severe Acute
                           Respiratory Syndrome (SARS) for Healthcare and Other Institutional Settings (Apr. 12,
                           2003), http://www.cdc.gov/ncidod/sars/exposureguidance.htm (downloaded May 5, 2003).
                           24
                            CDC, Frequently Asked Questions: Severe Acute Respiratory Syndrome (SARS),
                           http://www.cdc.gov/ncidod/sars/faq.htm (downloaded May 5, 2003).




                           Page 15                                                                  GAO-03-769T
                        equipment and supplies to handle a large-scale infectious disease
                        outbreak. While most hospitals had, for every 100 staffed beds, at least 1
                        ventilator, 1 personal protective equipment suit, or 1 isolation bed, half of
                        the hospitals had, for every 100 staffed beds, fewer than 6 ventilators, 3 or
                        fewer personal protective equipment suits, and fewer than 4 isolation
                        beds.


                        The completion of final federal influenza pandemic response plans that
Key Federal Decisions   address the problems related to the purchase, distribution, and
for Influenza           administration of supplies of vaccines and antiviral drugs during a
                        pandemic could facilitate the public health response to emerging
Pandemic Planning       infectious disease outbreaks. CDC has provided interim draft guidance to
Could Facilitate        facilitate state plans but has not made the final decisions on plan
                        provisions necessary to mitigate the effects of potential shortages of
Response to             vaccines and antiviral drugs. Until such decisions are made, the timeliness
Emerging Infectious     and adequacy of response efforts may be compromised.
Diseases                In the most recent version of its pandemic influenza planning guidance for
                        states, CDC lists several key federal decisions related to vaccines and
                        antiviral drugs that have not been made. These decisions include
                        determining the amount of vaccines and antiviral drugs that will be
                        purchased at the federal level; the division of responsibility between the
                        public and the private sectors for the purchase, distribution, and
                        administration of vaccines and drugs; and how population groups will be
                        prioritized and targeted to receive limited supplies of vaccines and drugs.
                        In each of these areas, until federal decisions are made, states will not be
                        able to develop strategies consistent with federal action.

                        The interim draft guidance for state pandemic plans says that resources
                        can be expected to be available through federal contracts to purchase
                        influenza vaccine and some antiviral agents, but some state funding may
                        be required. The amounts of antiviral drugs to be purchased and
                        stockpiled are yet to be determined, even though these drugs are available
                        and can potentially be used for both treatment and prevention during a
                        pandemic.

                        CDC has indicated in its interim draft guidance that the policies for
                        purchasing, distributing, and administering vaccines and drugs by the
                        private and public sectors will change during a pandemic, but some
                        decisions necessary to prepare for these expected changes have not been
                        made. During a typical annual influenza response, influenza vaccine and
                        antiviral drug distribution is primarily handled directly by manufacturers


                        Page 16                                                          GAO-03-769T
               through private vendors and pharmacies to health care providers. During a
               pandemic, however, CDC interim draft guidance indicates that many of
               these private-sector responsibilities may be transferred to the public
               sector at the federal, state, or local levels and that priority groups within
               the population would need to be established for receiving limited supplies
               of vaccines and drugs.

               State officials are particularly concerned that a national plan has not been
               issued with final recommendations for how population groups should be
               prioritized to receive vaccines and antiviral drugs. In its interim draft
               guidance, CDC lists eight population groups that should be considered in
               establishing priorities among groups for receiving vaccines and drugs
               during a pandemic. The list includes such groups as health care workers
               and public health personnel involved in the pandemic response, persons
               traditionally considered to be at increased risk of severe influenza illness
               and mortality, and preschool and school-aged children.

               Although state officials acknowledge the need for flexibility in planning
               because many aspects of a pandemic cannot be known in advance, the
               absence of more detail leaves them uncertain about how to plan for the
               use of limited supplies of vaccine and drugs. In our 2000 report on the
               influenza pandemic, we recommended that HHS determine the capability
               of the private and public sectors to produce, distribute, and administer
               vaccines and drugs and complete the national response plan.25 To date,
               only limited progress has been made in addressing these
               recommendations.


               Many actions taken at the state and local level to prepare for a bioterrorist
Concluding     event have enhanced the ability of state and local response agencies and
Observations   organizations to manage an outbreak of an infectious disease such as
               SARS. However, there are significant gaps in public health surveillance
               systems and laboratory capacity, and the number of personnel trained for
               disease detection is insufficient. Most emergency departments across the
               country have experienced some degree of overcrowding. Hospitals have
               begun planning and training efforts to respond to large-scale infectious
               disease outbreaks, but many hospitals lack adequate equipment, medical
               stockpiles, personal protective equipment, and quarantine and isolation
               facilities. Federal and state plans for the purchase, distribution, and


               25
                GAO-01-4.




               Page 17                                                          GAO-03-769T
                    administration of supplies of vaccines and drugs in response to an
                    influenza pandemic have still not been finalized. The lack of these final
                    plans has serious implications for efforts to mobilize the distribution of
                    vaccines and drugs for other infectious disease outbreaks.


                    Mr. Chairman, this completes my prepared statement. I would be happy to
                    respond to any questions you or other Members of the Subcommittee may
                    have at this time.


                    For further information about this testimony, please contact me at (202)
Contact and Staff   512-7119. Robert Copeland, Marcia Crosse, Martin T. Gahart, Deborah
Acknowledgments     Miller, Roseanne Price, and Ann Tynan also made key contributions to this
                    statement.




                    Page 18                                                          GAO-03-769T
Related GAO Products


             Smallpox Vaccination: Implementation of National Program Faces
             Challenges. GAO-03-578. Washington, D.C.: April 30, 2003.

             Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have
             Improved Public Health Response Capacity, but Gaps Remain. GAO-03-
             654T. Washington, D.C.: April 9, 2003.

             Bioterrorism: Preparedness Varied across State and Local Jurisdictions.
             GAO-03-373. Washington, D.C.: April 7, 2003.

             Hospital Emergency Departments: Crowded Conditions Vary among
             Hospitals and Communities. GAO-03-460. Washington, D.C.: March 14,
             2003.

             Homeland Security: New Department Could Improve Coordination but
             Transferring Control of Certain Public Health Programs Raises
             Concerns. GAO-02-954T. Washington, D.C.: July 16, 2002.

             Homeland Security: New Department Could Improve Biomedical R&D
             Coordination but May Disrupt Dual-Purpose Efforts. GAO-02-924T.
             Washington, D.C.: July 9, 2002.

             Homeland Security: New Department Could Improve Coordination but
             May Complicate Priority Setting. GAO-02-893T. Washington, D.C.: June
             28, 2002.

             Homeland Security: New Department Could Improve Coordination but
             May Complicate Public Health Priority Setting. GAO-02-883T.
             Washington, D.C.: June 25, 2002.

             Bioterrorism: The Centers for Disease Control and Prevention’s Role in
             Public Health Protection. GAO-02-235T. Washington, D.C.: November 15,
             2001.

             Bioterrorism: Review of Public Health Preparedness Programs. GAO-02-
             149T. Washington, D.C.: October 10, 2001.

             Bioterrorism: Public Health and Medical Preparedness. GAO-02-141T.
             Washington, D.C.: October 9, 2001.

             Bioterrorism: Coordination and Preparedness. GAO-02-129T.
             Washington, D.C.: October 5, 2001.



             Page 19                                                     GAO-03-769T
           Bioterrorism: Federal Research and Preparedness Activities. GAO-01-
           915. Washington, D.C.: September 28, 2001.

           West Nile Virus Outbreak: Lessons for Public Health Preparedness.
           GAO/HEHS-00-180. Washington, D.C.: September 11, 2000.

           Combating Terrorism: Need for Comprehensive Threat and Risk
           Assessments of Chemical and Biological Attacks. GAO/NSIAD-99-163.
           Washington, D.C.: September 14, 1999.

           Combating Terrorism: Observations on Biological Terrorism and Public
           Health Initiatives. GAO/T-NSIAD-99-112. Washington, D.C.: March 16,
           1999.




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           Page 20                                                     GAO-03-769T
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