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Testimony:



Before the Committee on Government Reform, House of Representatives:



United States General Accounting Office:



GAO:



For Release on Delivery Expected at 10:00 a.m.



Wednesday, April 9, 2003:



INFECTIOUS DISEASE OUTBREAKS:



Bioterrorism Preparedness Efforts Have Improved Public Health Response 

Capacity, but Gaps Remain:



Statement of Janet Heinrich:



Director, Health Care--Public Health Issues:



GAO-03-654T:



GAO Highlights:



Highlights of GAO-03-654T, a testimony before the Committee on 

Government Reform, House of Representatives 



Why GAO Did This Study:



Following the bioterrorist events of the fall of 2001, there has been 

concern that the nation may not be prepared to respond to a major 

public health threat, such as the current outbreak of Severe Acute 

Respiratory Syndrome (SARS). Whether a disease outbreak occurs 

naturally or is due to the intentional release of a harmful biological 

agent by a terrorist, much of the initial response would occur at the 

local level, particularly hospitals and their emergency departments. 

Efforts to plan for worldwide influenza pandemics are useful for 

understanding public health preparedness for other large-scale 

outbreaks.



GAO was asked to examine (1) the preparedness of state and local public 

health agencies and organizations 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) 

federal and state efforts to prepare for an influenza pandemic. 



This testimony is based on GAO’s report, Bioterrorism: Preparedness 

Varied across State and Local Jurisdictions, GAO-03-373 (Apr. 7, 2003), 

a survey of hospitals GAO conducted to assess their level of emergency 

preparedness, and information updating GAO’s prior report on federal 

and state planning for an influenza pandemic, Influenza Pandemic: Plan 

Needed for Federal and State Response, GAO-01-4 (Oct. 27, 2000). 



What GAO Found:



The efforts of state and local public health agencies to prepare for a 

bioterrorist attack have improved the nation’s capacity to respond to 

infectious disease outbreaks and other major public health threats, but 

gaps in preparedness remain. GAO found workforce shortages and gaps in 

disease surveillance and laboratory facilities. The level of 

preparedness varied across cities GAO visited.  Jurisdictions that have 

had multiple prior experiences with public health emergencies were 

generally more prepared than others. GAO found that regional planning

was generally lacking between states but that states were developing 

their own plans for receiving and distributing medical supplies for 

emergencies, as well as plans for mass vaccinations in the event of a 

public health emergency. 



GAO found that many hospitals lack the capacity to respond to large-

scale infectious disease outbreaks. Most hospitals across the country 

reported participating in basic planning activities for large-scale 

infectious disease outbreaks and training staff about biological 

agents.  However, most hospitals lack adequate equipment, isolation 

facilities, and staff to treat a large increase in the number of 

patients that may result. 



Federal and state officials have not finalized plans for responding to 

pandemic influenza. These plans do not consistently address problems 

related to the purchase, distribution, and administration of supplies 

of vaccines and antiviral drugs that may be needed during a pandemic. 



www.gao.gov/cgi-bin/getrpt?GAO-03-654T.



To view the full report, including the scope

and methodology, click on the link above.

For more information, contact Janet Heinrich at (202) 512-7119.



[End of section]



Mr. Chairman and Members of the Committee:



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. The initial response to an outbreak of 

infectious disease would occur at the local level, with support from 

the state, whether the outbreak was naturally occurring or due to the 

intentional release of a harmful biological agent by a terrorist. Just 

as in a bioterrorist attack, a naturally occurring outbreak could 

involve public health officials in disease surveillance,[Footnote 1] 

epidemiologic investigation,[Footnote 2] health care delivery, and 

quarantine management. Because of prior worldwide influenza outbreaks-

-known as pandemics[Footnote 3]--federal and state agencies have 

focused special attention on planning how to address such events, and 

these efforts are useful for understanding public health preparedness 

for other large-scale outbreaks. The outbreak of Severe Acute 

Respiratory Syndrome (SARS)[Footnote 4] has not infected large numbers 

of individuals in the United States, but it has raised concerns about 

the nation’s preparedness should it, or other infections, reach 

pandemic proportions.



Following the bioterrorist events of the fall of 2001, Congress 

expressed concern that the nation may not be prepared to respond to a 

major public health threat such as a large-scale outbreak of an 

infectious disease. State and local response agencies and organizations 

have recognized the need to strengthen their infrastructure and 

capacity to respond to a bioterrorist attack. The improvements they are 

making will also strengthen their ability to identify and respond to 

other major public health threats, including naturally occurring large-

scale infectious disease outbreaks. Planning for a response to 

bioterrorism and influenza pandemics targets the public health 

resources essential for a response to other infectious diseases.



To assist the Committee in its consideration of our nation’s capacity 

to respond to a major public health threat, my remarks today 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) federal and state efforts to prepare for an 

influenza pandemic.



My testimony today is based largely on our recently released report on 

state and local preparedness for a bioterrorist attack.[Footnote 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 initial 

findings from a survey we conducted of hospitals to assess their level 

of emergency preparedness, which we will more fully report later, and 

from information updating our 2000 report on federal and state planning 

for an influenza pandemic.[Footnote 6]



In summary, while the efforts of public health agencies and health care 

organizations to prepare for a bioterrorist attack have improved the 

nation’s capacity to respond to infectious disease outbreaks and other 

major public health threats, gaps in preparedness remain. More 

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 regional planning was lacking between states, but states were 

developing their own plans for receiving and distributing medical 

supplies for emergencies, and for mass vaccinations in the event of a 

public health emergency. We found that many hospitals lack the capacity 

to respond to large-scale infectious disease outbreaks. Although most 

hospitals across the country report participating in basic planning 

activities for such outbreaks, few have adequate medical equipment, 

such as ventilators, needed to handle the large increases in the number 

of patients that may result. Federal and state influenza pandemic 

response plans, another component of public health preparedness, are in 

various stages of completion and do not consistently address the 

problems related to the purchase, distribution, and administration of 

supplies of vaccines and antiviral drugs during a pandemic.



Background:



In order to be adequately prepared for a major public health threat, 

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 as 

well as at the regional level.



Local health care organizations, including hospitals, are generally 

responsible for the initial response to a public health emergency, be 

it a bioterrorist attack or a naturally occurring infectious disease 

outbreak. 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 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. 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.



Officials view influenza vaccine as the cornerstone of efforts to 

prevent and control annual influenza outbreaks as well as pandemic 

influenza. Deciding which viral strains to include in the annual 

influenza vaccine depends on data collected from domestic and 

international surveillance systems that identify prevalent strains and 

characterize their effect on human health.[Footnote 7] 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 will occur in a pandemic because demand is 

expected to exceed current rates of production and increasing 

production capacity of antiviral drugs can take at least 6 to 9 months, 

according to manufacturers.



State and Local Officials Reported Varying Levels of Public Health 

Preparedness for Infectious Diseases Outbreaks:



In the cities we visited, state and local officials reported varying 

levels of public health preparedness to respond to an infectious 

disease outbreak. They recognized gaps in preparedness elements such as 

communication and were beginning to address them. Gaps also remained in 

other preparedness elements that have been more difficult to address, 

including the response capacity of the workforce and the disease 

surveillance and laboratory systems. In addition, we found that the 

level of preparedness varied across the cities. Jurisdictions that had 

multiple prior experiences with public health emergencies were 

generally more prepared than those with little or no such experience 

prior to our site visits. We found that regional planning was lacking 

between states. States were working on their own plans for receiving 

and distributing the Strategic National Stockpile and for administering 

mass vaccinations.



Progress Has Been Made in Elements of Public Health Preparedness, But 

Gaps Remain:



States and local areas were addressing gaps in public health 

preparedness elements, such as communication, but weaknesses remained 

in other preparedness elements, including the response capacity of the 

workforce and the disease surveillance and laboratory systems. Gaps in 

capacity 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, including preparedness for a bioterrorism incident. 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 Laboratory Facilities:



State and local officials for the cities we visited recognized and were 

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 we visited were making efforts to improve their 

disease surveillance systems. Six of the cities we visited used a 

passive surveillance system[Footnote 8] to detect infectious disease 

outbreaks.[Footnote 9] 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.[Footnote 10] 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 

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 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 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 were 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 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.[Footnote 11]



Level of Preparedness Varied across Cities We Visited:



We found that the overall level of public health preparedness varied by 

city. In the cities we visited, we observed that those cities that had 

recurring experience with public health emergencies, including those 

resulting from natural disasters, or with preparation for National 

Security Special Events, such as political conventions,[Footnote 12] 

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),[Footnote 13] 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.



Regional Planning Was Lacking between States:



Response organization officials were concerned about a lack of planning 

for regional coordination between states of the public health response 

to 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 Planning for Receiving and Distributing the Strategic 

National Stockpile and for Administering Mass Vaccinations:



States have begun planning for use of the Strategic National Stockpile. 

To determine eligibility for the CDC funding, applicants were required 

to develop interim plans to receive and manage items from the 

stockpile, including mass distribution of antibiotics, vaccines, and 

medical materiel. However, having plans for the acceptance of the 

deliveries from the stockpile is not enough. Plans have to include 

details about dividing the materials that are delivered in large 

pallets and distributing the medications and vaccines.



Of the seven states we visited, five states had completed plans for the 

receipt and distribution of 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 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 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.



Most Hospitals Lack Response Capacity for Large-Scale Infectious 

Disease Outbreaks:



Our recent work shows that progress in improving public health response 

capacity has lagged in hospitals. Although most hospitals across the 

country reported participating in basic planning 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 Hospitals Reported Planning and Training Efforts, but Fewer Than 

Half Have Participated in Drills or Exercises:



At the time of our site visits, we found that hospitals were beginning 

to coordinate with other local response organizations and collaborate 

with 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 response to a terrorist event but that the city 

had come to realize that 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.



According to our survey of over 2,000 hospitals,[Footnote 14] 4 out of 

5 hospitals reported having a written emergency response plan for 

large-scale infectious disease outbreaks. Of these hospitals with 

emergency response plans, most include a description of how to achieve 

surge capacity for obtaining additional pharmaceuticals, other 

supplies, and staff. Almost all hospitals reported participating in 

community interagency disaster preparedness committees.



Our survey showed that hospitals have provided training to staff on 

biological agents, but fewer than half have participated in exercises. 

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. While at least 90 percent of hospitals reported providing 

training for smallpox and anthrax, approximately three-fourths of 

hospitals reported providing training about plague, botulism, 

tularemia, and hemorrhagic fever viruses. Fewer than half the hospitals 

reported participating in drills or exercises related to bioterrorism.



Most Hospitals Lack Adequate Equipment, Facilities, and Staff Required 

to Respond to a Large-Scale Infectious Disease Outbreak:



Most hospitals lack adequate equipment, isolation facilities, and staff 

to treat a large increase in the number of patients for an infectious 

disease such as SARS. To prevent transmission of SARS in health care 

settings, CDC recommends that health care workers use personal 

protective equipment, including gowns, gloves, respirators, and 

protective eyewear.[Footnote 15] SARS patients in the United States are 

being isolated until they are no longer infectious. CDC estimates that 

patients require mechanical ventilation in 10 to 20 percent of SARS 

cases.[Footnote 16]



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 equipment and supplies to handle a large-scale infectious 

disease outbreak. While most hospitals had at least 1 ventilator per 

100 staffed beds, 1 personal protective equipment suit per 100 staffed 

beds, or an isolation bed per 100 staffed beds, half of the hospitals 

had less than 6 ventilators per 100 staffed beds, 3 or fewer personal 

protective equipment suits per 100 staffed beds, and less than 4 

isolation beds per 100 staffed beds.



Officials Have Been Slow to Finalize Plans for Federal and State 

Response to an Influenza Pandemic:



Federal and state influenza pandemic response plans, another important 

component to public health preparedness, are in various stages of 

completion and do not consistently address the problems related to the 

purchase, distribution, and administration of supplies of vaccines and 

antiviral drugs during a pandemic. CDC has provided interim draft 

guidance to facilitate state plans, but final federal decisions 

necessary to mitigate the effects of potential shortages of vaccines 

and antiviral drugs have not been made. Until such decisions are made, 

the timeliness and adequacy of response efforts may be compromised.



Federal and State Pandemic Response Plans Are Not Finalized:



Federal and state officials have not finalized plans for responding to 

pandemic influenza. To foster state and local pandemic planning and 

preparedness, CDC first issued interim planning guidance in draft form 

to all states in 1997, outlining general federal and state planning 

responsibilities. Thirty-four states are actively preparing a pandemic 

response plan, and many are integrating these plans with existing state 

plans to respond to natural or man-made disasters, such as floods or a 

bioterrorist attack. Although to a certain extent planning efforts for 

other emergencies can be used for pandemic response, additional 

planning is important to deal with specific aspects of a pandemic 

response. This includes developing plans to address the large-scale 

emergency needs of an entire population, including mass distribution 

and administration of limited vaccines and drugs, with an uncertain 

amount of available resources.



Key Federal Decisions Are Unresolved:



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 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 theoretically 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 sector 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 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 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.[Footnote 17] To date, only limited progress has been made in 

addressing these recommendations.



Concluding Observations:



Many actions taken at the state and local level to prepare for a 

bioterrorist event have enhanced the ability of state and local 

response agencies and organizations to manage a major public health 

threat, such as a large-scale infectious disease outbreak. However, 

there are significant gaps in public health surveillance systems and 

laboratory capacity, and the number of personnel trained for disease 

detection is insufficient. Hospitals have begun planning and training 

efforts to respond to large-scale infectious disease outbreaks, but 

lack adequate equipment, medical stockpiles, personal protective 

equipment, and quarantine and isolation facilities. Federal and state 

plans for the purchase, distribution, and 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 Committee may have 

at this time.



Contact and Staff Acknowledgments:



For further information about this testimony, please contact me at 

(202) 512-7119. Jennifer Cohen, Robert Copeland, Marcia Crosse, Martin 

T. Gahart, Deborah Miller, Roseanne Price, and Ann Tynan also made key 

contributions to this statement.



FOOTNOTES



[1] Disease surveillance uses systems that provide for the ongoing 

collection, analysis, and dissemination of health-related data to 

identify, prevent, and control disease.



[2] An epidemiologic investigation seeks to determine how a disease is 

distributed in a population and the factors that influence or determine 

this distribution. 



[3] 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.



[4] SARS is a respiratory illness that has recently been reported 

principally in Asia, Europe, and North America. As of April 7, 2003, 

there were an estimated 2,601 cases reported in 19 countries, including 

141 suspected cases in the United States. There have been 98 deaths 

worldwide, none of which have been in the United States. Symptoms of 

the disease, which may be caused by a previously unrecognized 

coronavirus, can include a fever, chills, headache, other body aches, 

or a dry cough. 



[5] U.S. General Accounting Office, Bioterrorism: Preparedness Varied 

across State and Local Jurisdictions, GAO-03-373 (Washington, D.C.: 

Apr. 7, 2003).



[6] U.S. General Accounting Office, Influenza Pandemic: Plan Needed for 

Federal and State Response, GAO-01-4 (Washington, D.C.: Oct. 27, 2000).



[7] CDC participates in international disease and laboratory 

surveillance sponsored by the World Health Organization, which operates 

in 83 countries.



[8] 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.



[9] Officials in one city told us that although it had no local disease 

surveillance, its state maintained a passive disease surveillance 

system.



[10] 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).



[11] Association of Public Health Laboratories, “State Public Health 

Laboratory Bioterrorism Capacity,” Public Health Laboratory Issues in 

Brief: Bioterrorism Capacity (Washington, D.C.: October 2002).



[12] 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.



[13] 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.



[14] Between June and September 2002, we surveyed over 2,000 

nonfederal, short-term, general, medical, adult and children’s 

hospitals with emergency departments located in metropolitan 

statistical areas (see U.S. General Accounting Office, Hospital 

Emergency Department: 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). The 

survey contained three parts, the third of which 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.



[15] CDC, Interim Domestic Guidance for Management of Exposures to 

Severe Acute Respiratory Syndrome (SARS) for Healthcare and Other 

Institutional Settings (Mar. 27, 2003), http://www.cdc.gov/ncidod/

sars/exposureguidance.htm (downloaded Apr. 5, 2003).



[16] CDC, SARS Frequently Asked Questions, http://www.cdc.gov/ncidod/

sars/faq.htm (downloaded Apr. 5, 2003). 



[17] GAO-01-4.