This is the accessible text file for GAO report number GAO-04-360R entitled 'HHS Bioterrorism Preparedness Programs: States Reported Progress but Fell Short of Program Goals for 2002' which was released on February 10, 2004. This text file was formatted by the U.S. General Accounting Office (GAO) to be accessible to users with visual impairments, as part of a longer term project to improve GAO products' accessibility. Every attempt has been made to maintain the structural and data integrity of the original printed product. Accessibility features, such as text descriptions of tables, consecutively numbered footnotes placed at the end of the file, and the text of agency comment letters, are provided but may not exactly duplicate the presentation or format of the printed version. The portable document format (PDF) file is an exact electronic replica of the printed version. We welcome your feedback. Please E-mail your comments regarding the contents or accessibility features of this document to Webmaster@gao.gov. This is a work of the U.S. government and is not subject to copyright protection in the United States. It may be reproduced and distributed in its entirety without further permission from GAO. Because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately. February 10, 2004: Congressional Committees: Subject: HHS Bioterrorism Preparedness Programs: States Reported Progress but Fell Short of Program Goals for 2002: The anthrax incidents during the fall of 2001 raised concerns about the nation's ability to respond to bioterrorist events and other public health threats. The incidents strained the public health system, including surveillance[Footnote 1] and laboratory workforce capacities, at the state and local levels.[Footnote 2] Several months after the incidents, the Congress appropriated funds to strengthen state and local bioterrorism preparedness.[Footnote 3] The Department of Health and Human Services' (HHS) Centers for Disease Control and Prevention (CDC) and Health Resources and Services Administration (HRSA) distributed the funds in 2002 through two cooperative agreement programs with state, municipal, and territorial governments.[Footnote 4] To strengthen preparedness, the two cooperative agreement programs-- CDC's Public Health Preparedness and Response for Bioterrorism Program and HRSA's National Bioterrorism Hospital Preparedness Program-- require participants to complete specific activities designed to build public health and health care capacities. The 2002 cooperative agreements for both programs ended on August 30, 2003. For the 2002 cooperative agreements, CDC's and HRSA's programs distributed approximately $918 million and approximately $125 million, respectively.[Footnote 5] The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 directs us to report on federal programs that support preparedness efforts at the state and local levels.[Footnote 6] We have previously reported on state and local efforts and hospital preparedness.[Footnote 7] As agreed with the committees of jurisdiction, for this report, we examined the extent to which states completed 2002 cooperative agreement requirements and whether states identified any factors that hindered implementation of CDC's program and HRSA's program. In this report, we use the term "state" to refer to the 50 states, the District of Columbia, New York City, Chicago, and Los Angeles County. Enclosure I contains the information we provided during our January 14, 2004 briefing of your staff. To determine the extent to which states had completed program requirements, we relied primarily on the cooperative agreement progress reports that CDC and HRSA required the states to submit. We checked the data for internal consistency as well as consistency with other sources and determined that they were adequate for our purposes. We reviewed semi-annual progress reports submitted by the states, covering the period through August 30, 2003, for CDC's program and through July 1, 2003, for HRSA's program.[Footnote 8] For a number of reasons, we use broad categories to describe the degree of progress states have made in completing requirements. These reasons include: CDC and HRSA changed the reporting formats over the course of the agreements, states had varying interpretations of what constituted completion of the requirements, and the final reports do not reflect follow-up by CDC and HRSA to clarify states' responses. We also interviewed officials and reviewed relevant documents from CDC, HRSA, and HHS's Office of the Assistant Secretary for Public Health Emergency Preparedness. We also interviewed officials from 10 states, 1 local health department within each of these states, and 2 major metropolitan areas directly funded by CDC and HRSA.[Footnote 9] The program participants are not identified in this report because of the sensitive nature of the issue. In addition, we interviewed representatives and reviewed documents from the Association of State and Territorial Health Officials and the American Hospital Association and its affiliates. We reviewed documents from the National Association of County and City Health Officials, the Council of State and Territorial Epidemiologists, and the Association of Public Health Laboratories. We performed our work from June 2003 through February 2004 in accordance with generally accepted government auditing standards. Results: States reported progress toward the CDC program's goal of strengthening public health preparedness, but identified factors that hindered them from meeting all of CDC's 2002 cooperative agreement requirements. All states reported progress in developing the capacities CDC considers critical for public health preparedness, but no state completed all program requirements. Some of the 14 requirements that CDC considers critical benchmarks of preparedness were more likely to be completed than others. Four critical benchmarks were met by most of the states. These benchmarks included the establishment of a bioterrorism advisory committee and coverage of 90 percent of the state's population by the Health Alert Network--a nationwide program designed to ensure communication capacity at all state and local health departments. Two critical benchmarks were met by few of the states: development of a statewide response plan and development of a regional response plan. The remaining eight critical benchmarks were met by around half the states. These benchmarks included assessment of emergency preparedness and response capabilities, development of a system that can receive and evaluate urgent disease reports at all times, and development of an interim Strategic National Stockpile[Footnote 10] plan. In addition, state and local officials reported three main factors that hindered their ability to complete all of CDC's requirements: (1) redirection of resources to the National Smallpox Vaccination Program,[Footnote 11] (2) difficulties in increasing personnel as a result of state and local budget deficits, and (3) delays caused by state and local management practices, such as contracting and hiring procedures. Similarly, states reported progress toward the HRSA program's goal of strengthening hospital preparedness but identified factors that have hindered their efforts to complete all of HRSA's 2002 program requirements. While no state has completed all of HRSA's requirements- -to conduct needs assessments, to meet three critical benchmarks of hospital preparedness, and to address priority issues--states have until March 31, 2004, to complete most of them. No state reported completing all components of its needs assessment. Almost all states reported that they had met two of the three critical benchmarks: designation of a coordinator for hospital preparedness planning and establishment of a hospital preparedness planning committee. No state reported meeting the third benchmark--development of a plan for the hospitals in the state to respond to an epidemic involving at least 500 patients. States reported varying degrees of progress in addressing the priority issues that HRSA required them to address, such as receipt and distribution of medications and vaccines, personal protection of health care workers, quarantine capacity, and communications. State officials expressed concern that HRSA funding was insufficient for states to meet the requirements of the 2002 program. Similarly, hospital representatives reported that redirection of resources to the National Smallpox Vaccination Program and delays caused by lengthy contracting processes for distributing funds from the state to the hospitals hindered efforts to implement the program. In summary, although the states' progress fell short of 2002 program goals, CDC's and HRSA's cooperative agreement programs have enabled states to make much needed improvements in the public health and health care capacities critical for preparedness. States are more prepared now than they were prior to these programs, but much remains to be accomplished. Agency Comments: We provided a draft of this report to HHS. HHS informed us that it had no comment on the draft report but provided technical comments, which we incorporated where appropriate. We are sending copies of this report to the Secretary of HHS, the Director of CDC, the Administrator of HRSA, and other interested officials. We will also provide copies to others upon request. In addition, the report will be available at no charge on the GAO Web site at http://www.gao.gov. If you or your staff have any questions or need additional information, please contact me at (202) 512-7119. Another contact and key contributors are listed in enclosure III. Janet Heinrich: Director, Health Care--Public Health Issues: Signed by Janet Heinrich: Enclosures - 3: List of Committees: The Honorable Judd Gregg: Chairman: The Honorable Edward M. Kennedy: Ranking Minority Member: Committee on Health, Education, Labor, and Pensions: United States Senate: The Honorable Ted Stevens: Chairman: The Honorable Robert C. Byrd: Ranking Minority Member: Committee on Appropriations: United States Senate: The Honorable W.J. "Billy" Tauzin: Chairman: The Honorable John D. Dingell: Ranking Minority Member: Committee on Energy and Commerce: House of Representatives: The Honorable C.W. Bill Young: Chairman: The Honorable David R. Obey: Ranking Minority Member: Committee on Appropriations: House of Representatives: Enclosure 1: [See PDF for slideshow] [End of slideshow] CDC Focus Areas, Critical Capacities, and Critical Benchmarks (2002): To strengthen public health preparedness, CDC identified focus areas for states to improve their public health capacity. Within each focus area, CDC identified the specific capacities that are critical for states to be prepared to respond to a bioterrorist event or other public health emergency. To guide states in building these critical capacities, CDC specified a number of requirements for the 2002 cooperative agreements, and designated some of them as critical benchmarks. Table 1 lists the focus areas and their associated critical capacities and critical benchmarks. Table 1: CDC Focus Areas, Critical Capacities, and Critical Benchmarks for the 2002 Cooperative Agreements: Focus area: Focus area A; Critical capacity: Preparedness Planning and Readiness Assessment; Critical capacity #1: To establish a process for strategic leadership, direction, coordination, and assessment of activities to ensure state and local readiness, interagency collaboration, and preparedness for bioterrorism, other outbreaks of infectious disease, and other public health threats and emergencies; Critical benchmark: Critical benchmark #1: Designate an executive director of the bioterrorism preparedness and response program; Critical benchmark #2: Establish a bioterrorism advisory committee. Critical capacity #2: To conduct integrated assessments of public health system capacities related to bioterrorism, other infectious disease outbreaks, and other public health threats and emergencies to aid and improve planning, coordination, and implementation; Critical benchmark: Critical benchmark #3: Assessment of emergency preparedness and response capabilities; Critical benchmark #4: Assessment of statutes, regulations, and ordinances that provide for credentialing, licensure, and delegation of authority for executing emergency public health measures. Critical capacity #3: To respond to emergencies caused by bioterrorism, other infectious disease outbreaks, and other public health threats and emergencies through the development and exercise of a comprehensive public health emergency preparedness and response plan; Critical benchmark: Critical benchmark #5: Development of a statewide response plan and provisions for exercising the plan; Critical benchmark #6: Development of regional response plans. Critical capacity #4: To ensure that state, local, and regional preparedness for and response to bioterrorism, other infectious outbreaks, and other public health threats and emergencies are effectively coordinated with federal response assets; Critical benchmark: Critical benchmark #7: Develop an interim plan to receive and manage items from the Strategic National Stockpile (SNS). Critical capacity #5: To effectively manage the CDC SNS, should it be deployed--translating SNS plans into firm preparations, periodic testing of SNS preparedness, and periodic training for entities and individuals that are part of SNS preparedness; Critical benchmark: No critical benchmarks were identified for 2002 cooperative agreements. Focus area: Focus area B; Critical capacity: Surveillance and Epidemiology Capacity; Critical capacity #6: To rapidly detect a terrorist event through a highly functioning, mandatory reportable disease surveillance system, as evidenced by ongoing timely and complete reporting by providers and laboratories, especially of illnesses and conditions possibly resulting from bioterrorism, other infectious disease outbreaks, and other public health threats and emergencies; Critical benchmark: Critical benchmark #8: Develop a system to receive and evaluate urgent disease reports on a 24-hour-per-day, 7-day-per-week basis. Critical capacity #7: To rapidly and effectively investigate and respond to a potential terrorist event as evidenced by a comprehensive and exercised epidemiologic response plan that addresses surge capacity, delivery of mass prophylaxis and immunizations, and pre-event development of specific epidemiologic investigation and response needs; Critical benchmark: Critical benchmark #9: Assess current epidemiologic capacity and achieve the goal of at least one epidemiologist for each metropolitan statistical area. Critical capacity #8: To rapidly and effectively investigate and respond to a potential terrorist event, as evidenced by ongoing effective state and local response to naturally occurring individual cases of urgent public health importance, outbreaks of disease, and emergency public health interventions such as emergency chemoprophylaxis or immunization activities; Critical benchmark: No critical benchmarks were identified for 2002 cooperative agreements. Focus area: Focus area C; Critical capacity: Laboratory Capacity-- Biologic Agents; Critical capacity #9: To develop and implement a statewide program to provide rapid and effective laboratory services in support of the response to bioterrorism, other infectious disease outbreaks, and other public health threats and emergencies; Critical benchmark: Critical benchmark #10: Develop a plan to improve working relationships and communication between clinical labs and higher level Laboratory Response Network (LRN)[A] labs. Critical capacity #10: As an LRN member, to ensure adequate and secure laboratory facilities, reagents, and equipment to rapidly detect and correctly identify biological agents likely to be used in a bioterrorist incident; Critical benchmark: No critical benchmarks were identified for 2002 cooperative agreements. Focus area: Focus area D; Critical capacity: Laboratory Capacity-- Chemical Agents; Critical capacity: No critical capacities/benchmarks were identified for 2002 cooperative agreements; Critical benchmark: Focus area: Focus area E; Critical capacity: Health Alert Network/ Communications and Information Technology. Critical capacity #11: To ensure effective communications connectivity among public health departments, health care organizations, law enforcement organizations, public officials, and others by: (a) continuous, high-speed connectivity to the Internet; (b) routine use of e-mail for notification of alerts and other critical communication; and (c) a directory of public health participants (including primary clinical personnel), their roles, and contact information covering all jurisdictions; Critical benchmark: Critical benchmark #11: Ensure that 90 percent of the population is covered by the Health Alert Network; Critical benchmark #12: Develop a communications system that provides a 24-hour-per-day, 7-day-per-week flow of critical health information. Critical capacity #12: To ensure a method of emergency communication for participants in public health emergency response that is fully redundant with e-mail; Critical benchmark: No critical benchmarks were identified for 2002 cooperative agreements. Critical capacity #13: To ensure the ongoing protection of critical data and information systems and capabilities for continuity of operations; Critical benchmark: No critical benchmarks were identified for 2002 cooperative agreements. Critical capacity #14: To ensure secure electronic exchange of clinical, laboratory, environmental, and other public health information in standard formats between the computer systems of public health partners; Critical benchmark: No critical benchmarks were identified for 2002 cooperative agreements. Focus area: Focus area F; Critical capacity: Risk Communication and Health Information Dissemination. Critical capacity #15: To provide needed health/risk information to the public and key partners during a terrorism event by establishing critical baseline information about the current communication needs and barriers within individual communities, and identifying effective channels of communication for reaching the general public and special populations during public health threats and emergencies; Critical benchmark: Critical benchmark #13: Develop an interim plan for risk communication and information dissemination. Focus area: Focus area G; Critical capacity: Education and Training; Critical capacity #16: To ensure the delivery of appropriate education and training to key public health professionals, infectious disease specialists, emergency department personnel, and other health care providers in preparedness for and response to bioterrorism, other infectious disease outbreaks, and other public health threats and emergencies, either directly or through the use (where possible) of existing curricula and other sources, including schools of public health and medicine, academic health centers, CDC training networks, and other providers; Critical capacity #16: To ensure the delivery of appropriate education and training to key public health professionals, infectious disease specialists, emergency department personnel, and other health care providers in preparedness for and response to bioterrorism, other infectious disease outbreaks, and other public health threats and emergencies, either directly or through the use (where possible) of existing curricula and other sources, including schools of public health and medicine, academic health centers, CDC training networks, and other providers; Critical benchmark: Critical benchmark #14: Prepare a timeline to assess training needs. Source: CDC. [A] CDC established the LRN to maintain state-of-the-art capabilities for biological agent identification and characterization. The LRN is a multilevel system designed to link state and local public health laboratories with advanced capacity clinical, military, veterinary, agricultural, water, and food-testing laboratories. [End of table] Enclosure III: GAO Contact and Staff Acknowledgments: GAO Contact: Michele Orza, (202) 512-6970: Acknowledgments: The following staff members made important contributions to this work: Angela: Choy, Chad Davenport, Maria Hewitt, Krister Friday, and Nkeruka Okonmah. (290293): FOOTNOTES [1] Public health surveillance uses systems that provide for the ongoing collection, analysis, and dissemination of health-related data to identify, prevent, and control disease. [2] See U.S. General Accounting Office, Bioterrorism: Public Health Response to Anthrax Incidents of 2001, GAO-04-152 (Washington, D.C.: Oct. 15, 2003). [3] Department of Defense and Emergency Supplemental Appropriations for Recovery from and Response to Terrorist Attacks on the United States Act, Pub. L. No. 107-117, 115 Stat. 2230, 2314 (2002), and the Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act of Fiscal Year 2002, Pub. L. No. 107-116, 115 Stat. 2186, 2198. [4] A cooperative agreement is used as a mechanism to provide financial support when substantial interaction is expected between the executive agency and a state, local government, or other recipient carrying out the funded activity. Under their programs, CDC and HRSA made funding available to the following: all 50 states; the District of Columbia; the country's three largest municipalities (New York City, Chicago, and Los Angeles County); the territories of American Samoa, Guam, and the U.S. Virgin Islands; and the commonwealths of the Northern Mariana Islands and Puerto Rico. CDC also made funding available to the republics of Palau and the Marshall Islands and the Federated States of Micronesia. [5] In 2003, the Congress appropriated additional funds for bioterrorism preparedness. Consolidated Appropriations Resolution, 2003, Pub. L. No. 108-7, Division G, Title II, 117 Stat. 11, 322. HHS renewed the cooperative agreements for the period of August 31, 2003 through August 30, 2004. CDC's and HRSA's programs distributed about $870 million and about $498 million, respectively. [6] Pub. L. No. 107-188, ยง 157, 116 Stat. 594, 633 (2002). [7] U.S. General Accounting Office, Bioterrorism: Preparedness Varied across State and Local Jurisdictions, GAO-03-373 (Washington, D.C.: Apr. 7, 2003), and Hospital Preparedness: Most Urban Hospitals Have Emergency Plans but Lack Certain Capacities for Bioterrorism Response, GAO-03-924 (Washington, D.C.: Aug. 6, 2003). [8] The final progress report for one state was missing for the CDC program. HRSA did not require states to complete some of the requirements until March 31, 2004. [9] We selected these program participants in order to provide a range of population sizes, geographic locations, and experience with responding to disasters and conducting large drills and exercises. Each of the 10 local health departments in our sample serves a major metropolitan area within a state. [10] The Strategic National Stockpile, formerly the National Pharmaceutical Stockpile, is a repository of pharmaceuticals and medical supplies that can be delivered to the site of a biological or other attack. [11] In December 2002, HHS directed states to offer smallpox vaccination to public health and health care workers; however, additional funds ($100 million) were not made available to carry out the vaccinations until May 2003. For more information on the National Smallpox Vaccination Program, see U.S. General Accounting Office, Smallpox Vaccination: Implementation of National Program Faces Challenges, GAO-03-578 (Washington, D.C.: Apr. 30, 2003).