Biosurveillance: Nonfederal Capabilities Should Be Considered in Creating a National Biosurveillance Strategy
Published: 2011-10-31T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The nation is at risk for a catastrophic biological event. The Implementing Recommendations of the 9/11 Commission Act directed GAO to report on biosurveillance--to help detect and respond to such events--at multiple jurisdictional levels. In June 2010, GAO recommended that the National Security Staff lead the development of a national biosurveillance strategy, which is now under development. This report focuses on nonfederal jurisdictions, which own many of the resources that support a national capability. It discusses (1) federal support for state and local biosurveillance; (2) state and local challenges; (3) federal support and challenges for tribal and insular areas and (4) federal assessments of nonfederal capabilities. To conduct this work, GAO interviewed select federal-agency, jurisdiction, and association officials and reviewed relevant documents. To collect information on federal efforts and challenges, we also sent standardized questionnaires to seven states and two cities.
section_title: What GAO Found
paragraphs: The federal government has efforts to support health preparedness that state and city officials identified as critical to their biosurveillance capabilities. The efforts these officials identified fell into four categories: (1) grants and cooperative agreements, (2) nonfinancial technical and material assistance, (3) guidance, and (4) information sharing. Within each of the categories, the officials identified specific federal efforts that were essential to their biosurveillance activities. For example, public-health officials described cooperative agreements from the Centers for Disease Control and Prevention that provided resources for disease investigation, as well as guidance on federal priorities. However, as with our June 2010 findings about federal biosurveillance, in the absence of a national strategy, these efforts are not coordinated or targeted at ensuring effective and efficient national biosurveillance capabilities. Because the resources that constitute a national biosurveillance capability are largely owned by nonfederal entities, a national strategy that considers how to leverage nonfederal efforts could improve efforts to build and maintain a national biosurveillance capability. State and city officials identified common challenges to developing and maintaining their biosurveillance capabilities: (1) state policies that restrict hiring, travel, and training in response to budget constraints; (2) ensuring adequate workforce, training, and systems; and (3) the lack of strategic planning and leadership to support long-term investment in cross-cutting core capabilities, integrated biosurveillance, and effective partnerships. A national biosurveillance strategy that considers planning and leadership challenges at all levels of the biosurveillance enterprise may help partners across the enterprise find shared solutions for an effective national biosurveillance capability. The federal government provides some resources to help control disease in humans and animals in tribal and insular areas, but there are no specific efforts to ensure these areas can contribute to a national biosurveillance capability. Resources include cooperative agreements, disease-specific funding, training, and technical assistance. Surveillance capacity varies among tribes and insular areas, but common challenges include limited health infrastructure including human- and animal-health professionals and systems. The federal government has not conducted a comprehensive assessment of state and local jurisdictions' ability to contribute to a national biosurveillance capability, as called for in presidential directive. According to federal, state, and local officials, the magnitude and complexity of such an assessment is a challenge. Until it conducts such an assessment, the federal government will lack key information to support a national biosurveillance capability. A national strategy like the one we previously recommended--one capable of guiding federal agencies and its key stakeholders to systematically identify gaps, resources to address those gaps, and investment priorities--would benefit from an assessment of jurisdictions' baseline capabilities and critical gaps across the entire biosurveillance enterprise.
section_title: What GAO Recommends
paragraphs: GAO recommends that the National Security Staff ensure the strategy considers (1) existing federal efforts, (2) challenges, and (3) assessment of nonfederal capabilities. GAO provided a draft of this report to the National Security Staff, and the federal, state and city officials who contributed information. The National Security Staff acknowledged the accuracy of the report, but did not comment on the recommendation.

section_title: Letter
paragraphs: A catastrophic biological event, such as a terrorist attack with a weapon  of mass destruction or a naturally occurring pandemic, could cause  thousands of casualties or more, weaken the economy, damage public  morale and confidence, and threaten national security. Effective  preparation for, detection of, and response to a major biological event  requires effective pre- and postdisaster coordination and cooperation  among different federal agencies, levels of government, nongovernmental  organizations, and the private sector. Timely detection of signs of unusual  and potentially dangerous disease is a first step in an effective response  to a natural, accidental, or intentional outbreak of a biological event of  national concern.
Although the United States has numerous surveillance programs and  systems at various levels of government and in the private sector to  monitor disease, these programs and systems were developed separately  for a variety of mission objectives, and as such are relatively  uncoordinated. We reported in June 2010 that federal biosurveillance  efforts were dispersed across many federal agencies, but no federal  entity had responsibility and authority for coordinating activities to help  ensure timely detection and situational awareness for disease outbreaks  with potentially catastrophic consequences. We also reported that the  responsibility and capacity for collecting most information and carrying out  most health-monitoring activities resides within state and local  jurisdictions or with private-sector entities—such as hospitals and other  private health-care providers. The federal government generally cannot  compel state and local jurisdictions or private-sector entities to provide  information or resources to support federal biosurveillance efforts.  Instead, individual federal agencies, in pursuit of their missions, attempt  to build relationships and offer incentives—like grants—to encourage  voluntary cooperation with specific federal efforts.
In October 2007, Homeland Security Presidential Directive-21 (HSPD-21)  articulated a vision for protecting the nation from catastrophic disease  outbreaks in humans that included a call for a national biosurveillance  capability that enhances the timeliness of detection and the quality of  situational awareness for response. The national biosurveillance  capability described in HSPD-21 relies on, among other things, (1) strong  clinician awareness and laboratory diagnostic capacity; (2) a national  “common operating picture” that provides a comprehensive picture of the  health of communities and the associated threat environment by  incorporating information from human health, animal health, agricultural,  meteorological, environmental, intelligence, and other data; and (3) a  nationwide epidemiologic surveillance system that is robust enough to  identify specific disease incidence and prevalence and flexible enough to  tailor analyses to new syndromes and emerging diseases. In calling for  such a national capability, HSPD-21 reflects the centrality of state and  local resources in supporting the capability, stating that state and local  government officials should be involved in system design and that the  capability should be principally aimed at enhancing the capabilities of  state and local governments.
In June 2010, we reported that although the federal government has  undertaken some potentially useful steps for supporting a national  biosurveillance capability, there is no unifying framework for integrating   dispersed capabilities and responsibilities and no entity with authority to  guide the implementation of a national effort that encompasses all  stakeholders with biosurveillance responsibilities. We recommended that  the National Security Staff designate a focal point to develop a national  biosurveillance strategy. According to National Security Staff officials,  they have designated a Sub-Interagency Policy Committee, which they  said serves as the focal point for an ongoing effort to develop the national  biosurveillance strategy.
GAO-10-645, Biosurveillance: Efforts to  Develop a National Biosurveillance Capability  Need a Strategy and a Designated Leader,  (June 30, 2010)
1.  In the absence of a national biosurveillance strategy, what federal  efforts support state and local jurisdictions’ biosurveillance  capabilities?   2.  What challenges, if any, have selected state and local jurisdictions  faced in building and maintaining biosurveillance capabilities?  3.  How does the federal government support tribal and insular  participation in a national biosurveillance capability and what  challenges does it face?   4.  To what extent has the federal government assessed nonfederal  jurisdictions’ capacity to contribute to a national biosurveillance  capability?
To address our objectives, we reviewed key legislation and presidential  directives related to biosurveillance, including the Homeland Security Act  of 2002, the Public Health Security and Bioterrorism Preparedness and  Response Act of 2002, the Pandemic and All-Hazards Preparedness Act  of 2006, and Homeland Security Presidential Directives (HSPD) 9, 10,  and 21. This report focuses on surveillance efforts for zoonoses— diseases that can be transferred between animals and humans—and  other emerging infectious diseases with the potential to cause  catastrophic human health effects. At the federal level, we consulted  officials at the Departments of Agriculture (USDA), Homeland Security  (DHS), Health and Human Services (HHS), and the Interior (DOI), which  have key missions, statutory responsibilities, directives, or programmatic  objectives for biosurveillance activities within the scope of this report,  including protecting human and animal health and national security. We  also discussed biosurveillance at the state and city level with officials from  the Department of Justice’s Federal Bureau of Investigation.
To provide perspectives on the federal efforts that support state  biosurveillance capabilities and the challenges officials face building and  maintaining those capabilities, we selected a nongeneralizable sample of  seven states based on a variety of factors that might affect  biosurveillance efforts—including the structure of a state’s public health  system, its geography, and its amount and type of agriculture. The states  selected were Utah, Colorado, New Jersey, California, Delaware, North  Carolina, and Mississippi. In each of these states, we interviewed three  groups of officials: (1) officials in public-health departments, (2) officials in  state agriculture departments, and (3) officials in various departments that  included wildlife infectious-disease control and monitoring in their  missions. We also interviewed public-health officials with responsibility for  human infectious-disease control and monitoring in two cities with an  increased risk of bioterrorism—New York City and Washington, D.C.— that received direct funding from federal agencies to support  preparedness capabilities. Among other things, we discussed the federal  efforts that support their biosurveillance capabilities and the challenges  they face in building and maintaining biosurveillance capabilities.
We analyzed the information collected during state and city interviews  and developed follow-up questionnaires to confirm and enhance  information from the interviews about the federal programs and initiatives  that support state and local biosurveillance capabilities and the  challenges officials face. We sent follow-up questionnaires to public  health departments in all seven states and two cities and to agriculture  and wildlife officials in the seven states. Within each public-health  department, we sent separate questionnaires to laboratory and  epidemiology officials. In total, we distributed 32 questionnaires and  received 27 responses. Of the 27 respondents, 7 were epidemiologists, 7  were public health laboratory officials, 6 were state agriculture officials,  and 7 were state wildlife officials. All of the public-health, agriculture, and  wildlife departments represented by the 27 respondents had also been  represented in our initial interviews. However, in some cases the lead  official who responded to the questionnaire had not attended the  interview.
The questionnaires had a section on federal support for state and local  biosurveillance capabilities and a section on challenges. The content of  the federal-support section varied for human-health and animal-health  respondents, but the challenges section was the same for both. We  asked respondents to consider federal-support efforts and challenges  over the last 2 years. Because the states and cities in this review were  not selected in a probability sample, neither the information derived from  interviews with officials nor the questionnaire responses are generalizable  across the 50 states or the tens of thousands of localities in the United  States. Rather, both the interviews and the questionnaire results offer  some perspective on the value of select federal activities and challenges  faced by a group of state and city officials who are actively engaged in  efforts to detect and respond to major disease events. In addition,  although we interviewed officials responsible for public-health emergency  management in most state public-health departments that we visited, we  did not administer follow-up questionnaires to the officials responsible for  planning and preparing for emergency response, because their response  focus was generally not central to our scope. Because this report focuses  on detection of and situational awareness of potentially catastrophic  zoonotic and emerging infectious-disease events, certain federal efforts  that federal agencies consider important for supporting state and local  preparedness may not have been identified by state and city officials  during our interviews and follow-up questionnaires.
To consider the relationship between our findings at the nonfederal level  and our previous findings at the federal level about building and  maintaining a national biosurveillance capability, we reviewed our June  2010 findings about the centrality of nonfederal capabilities to a  biosurveillance enterprise. We also reviewed our June 2010 findings  about the purpose of a national biosurveillance strategy and the benefits it  could provide for guiding the effort to support a national biosurveillance  capability. We determined that because the federal government relies on  nonfederal resources to support a national biosurveillance capability, our  June 2010 findings about using the strategy to determine how to leverage  resources, weigh the costs and benefits of investments, and define roles  and responsibilities were particularly germane to the federal government’s  efforts to partner with nonfederal biosurveillance enterprise partners to  support a national biosurveillance capability.
To understand how the federal government supports biosurveillance in  tribal and insular areas, we consulted officials from HHS’s Indian Health  Service (IHS); HHS’s Centers for Disease Control and Prevention’s  (CDC) Office of State, Tribal, Local and Territorial Support; CDC’s Office  of Surveillance, Epidemiology, and Laboratory Services, CDC’s National  Center for Emerging and Zoonotic Infectious Diseases, USDA’s Office of  Tribal Relations; USDA’s Animal and Plant Health Inspection Service;  DOI’s Bureau of Indian Affairs; and DOI’s Office of Insular Affairs, which  have responsibility for working with tribal or insular councils and  governments, generally, or on health-related matters. In addition, to  develop additional context about health infrastructure and surveillance in  insular areas, we interviewed representatives from the Pacific Island  Health Officers Association (PIHOA), an association that works in the  U.S.-Affiliated Pacific Islands to provide regional healthcare solutions and  strengthen crosscutting public-health infrastructure.
To evaluate the extent to which the federal government has assessed  nonfederal jurisdictions’ capacity to contribute to a national  biosurveillance capability, we reviewed relevant presidential directives  and federal-agency documents, along with our prior work and  recommendations on building and maintaining a national biosurveillance  capability, for criteria. We determined that such an assessment is called  for in HSPD-10 and CDC’s National Biosurveillance Strategy for Human  Health and is a critical activity for developing an effective national  strategy containing the elements we advocated in prior work on national  strategies. To determine what types of assessment activities had been  undertaken and whether an enterprisewide assessment of nonfederal  biosurveillance capabilities had been conducted, we reviewed relevant  assessments and federal documents. We also interviewed federal  officials at all five federal departments previously listed, officials in each of  the seven states, officials in the two cities, and officials at 10 professional  and research institutions that include public health, animal health, or  laboratories in their missions about assessment efforts, to determine  whether they had participated in or had any familiarity with an  enterprisewide assessment of nonfederal capabilities. More detailed  information about our scope and methods appears in appendix I.
We conducted this performance audit from August 2010 to October 2011  in accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
subsections: section_title: Background
subsections: section_title: Biosurveillance in Brief
paragraphs: As shown in figure 1, biosurveillance is a concept that emerged in  response to increased concern about biological threats from emerging  infectious diseases and bioterrorism. Biosurveillance is carried out by and  depends on a wide range of dispersed entities, including state, tribal,  local, and insular jurisdictions. As we reported in June 2010, because of  the vast array of activities and entities associated with effective  biosurveillance, ongoing interagency and intergovernmental collaboration  is crucial.
The backbone of biosurveillance is traditional disease-surveillance  systems. Traditional disease-surveillance systems are designed to collect  information on the health of humans and animals to support a variety of  public-welfare and economic goals. These systems support  biosurveillance efforts by recording national health and disease trends  and providing specific information about the scope and projection of  outbreaks to inform response. State and local public-health   agencies have the authority and responsibility for carrying out most  public-health actions, including disease surveillance and response to  public-health emergencies in their jurisdictions. State laws or  regulations mandate disease reporting at the state and local level, bu state-based systems are coordinated at the national level by a voluntary  set of reporting criteria and case definitions. For example, the mainst traditional disease surveillance in humans is the National Notifiable  Diseases Surveillance System, through which state public-health  departments voluntarily report their notifiable disease data to CDC. The  National Notifiable Disease List includes those diseases that CDC and  state public-health officials have identified as posing a serious public- health risk for which case reports would help inform prevention and  control efforts. Diseases on the nationally notifiable list range from  sexually transmitted diseases, such as Human Immunodeficiency Virus  and syphilis, to potential bioterrorism agents, such as anthrax and  tularemia.
Similarly, to help protect the nation’s agricultural sector, USDA has  routine reporting systems and disease-specific surveillance programs,  which rely on state-collected data, for domesticated animals and some  wildlife that can provide information to support the early detection goal of  biosurveillance. Many states have a statutory or regulatory list of diseases  that animal-health officials are required to report to the state departments  of agriculture. State animal-health officials obtain information on the  presence of specific, confirmed clinical diseases in the United States from  multiple sources—including veterinary laboratories, public-health  laboratories, and veterinarians—and report this information to USDA’s  National Animal Health Reporting System (NAHRS). This system is  designed to provide data from state animal-health departments on the  presence or absence of confirmed World Organization for Animal Health  reportable diseases in specific commercial livestock, poultry, and  aquaculture species in the United States.
For wildlife, USDA’s Animal and Plant Health Inspections Service’s  Wildlife Services division is charged with conducting surveillance of  wildlife to detect zoonotic or other diseases that may pose threats to  agriculture. The division’s National Wildlife Disease Program is charged  with conducting routine surveillance for targeted diseases and responding  to mortality and morbidity events, particularly those occurring near  humans or livestock. The program has wildlife disease biologists in most  states that work to coordinate with state, local, and tribal officials to  conduct surveillance and respond to events. In addition, DOI’s U.S.  Geological Survey’s (USGS) National Wildlife Health Center is charged  with addressing wildlife disease throughout the United States. This center  provides disease diagnosis, field investigation, disease management and  research, and training. It also maintains a database on disease findings in  wild animals and on wildlife mortality events, although there is currently  no national reporting system for wildlife diseases.
Recognizing that human and animal diseases are interconnected, several organizations—including the American  Medical Association, the American Veterinary  Medical Association, USDA, and HHS—have  taken steps to support the One Health  concept, which is a worldwide strategy for  expanding interdisciplinary collaboration and  communications in all aspects of health care  for humans and animals.
Disease-reporting systems help professionals to recognize unusual  disease signals and analyze their meaning, but generally have inherent  limitations that affect the speed with which their results can be  determined, communicated, and acted upon. Many surveillance programs  incorporate other methods of surveillance that have the potential to  augment and enhance the detection and situational-awareness benefits  of traditional disease reporting. For example, syndromic surveillance uses  health-related data collected before diagnosis to look for signals or  clusters of similar illnesses that might indicate an outbreak. An example  of syndromic surveillance data is prediagnostic health-related information  like patients’ chief complaints recorded by hospital emergency room staff.  However, we reported in September 2004 and November 2008 that the  ability of syndromic surveillance to more-rapidly detect emerging diseases  or bioterror events has not yet been demonstrated. Another method  used in disease surveillance efforts is sentinel surveillance, in which  practitioners monitor for specific disease events in a targeted subset  rather than an entire population. Sentinel surveillance can also promote  early detection, for example by monitoring sentinel chicken flocks and   testing for the presence of antibodies to arboviruses, such as West Nile  virus, which could be spread by mosquitoes to humans.
Numerous federal, state, local, and private-sector entities with  responsibility for monitoring animal and human health have roles to play  both in supporting traditional surveillance activities and in designing  systems to focus specifically on enhancing detection and situational  awareness.
section_title: Biosurveillance Roles and Responsibilities in Nonfederal Jurisdictions
paragraphs: Conducting biosurveillance is a shared responsibility among multiple  local, state, and federal agencies, as well as among professionals across  various disciplines in state, tribal, local, and insular jurisdictions. However,  there is variation in organization and structure among public-health,  animal-health, and wildlife functions at the state, tribal, local, and insular  levels. For example, as shown in figure 2, a state’s public-health structure  may or may not be centralized.
On the other hand, livestock and poultry health is largely centralized  within state departments of agriculture, relying on accredited veterinarians  across the state for detection. By contrast, wildlife disease surveillance  largely lacks structure entirely and is dependent upon chance  observations of unusual numbers of sick or dead wildlife, or both, being  observed and reported to state or local wildlife agencies. The exception is  USDA’s National Wildlife Disease Program, which coordinates national  surveillance and reporting of targeted diseases that may pose threats to  human health or agricultural resources.
Some of the nonfederal partners with key responsibilities in the  biosurveillance enterprise are presented in table 1.
Tribal Jurisdictions. As of October 2010, there were 565 federally  recognized tribes—340 in the continental United States and 225 in  Alaska. Federally recognized Indian tribes are Native American groups  eligible for the special programs and services provided by the United  States to Indians because of their status as Indians. Under the Indian  Self-Determination and Education Assistance Act, as amended, federally  recognized Indian tribes can enter into self-determination contracts or  self-governance compacts with the federal government to take over  administration of certain federal programs for Indians previously  administered on their behalf by the Department of the Interior or HHS.
The Bureau of Indian Affairs, within DOI, and the IHS, within HHS, are the  primary agencies that operate Indian programs within those two  departments. IHS is charged with providing health care to the  approximately 1.9 million American Indians and Alaska Natives who are  members or descendants of federally recognized tribes. These services  are provided at federally or tribally operated health-care facilities, which  receive IHS funding and are located in 12 geographic regions overseen  by IHS area offices. These IHS-funded facilities vary in the services that  they provide. For example, some facilities offer comprehensive hospital  services, while others offer only primary-care services. Although  American Indian tribes are sovereign entities, IHS facilities follow disease- reporting regulations and use disease-reporting channels for the state in  which tribal patients geographically reside. For example, tribal patients  who live within the boundaries of Utah, New Mexico, or Arizona could use  the same IHS facility in Shiprock, New Mexico. If a patient whose tribal  residence is geographically located in Arizona presents at the Shiprock  facility with a disease that the state of Arizona has designated as  reportable, IHS would report it to Arizona public health officials. Tribes  that manage their own health services use the national notifiable disease  reporting system.
Land-based agricultural resources are vital to the economic and social  welfare of many tribes. The Intertribal Agriculture Council is an  organization of tribal agriculture producers and conducts programs  designed to further the goal of improving tribal agriculture by promoting  the Indian use of Indian resources through contracts and cooperative  agreements with federal agencies.
Insular Jurisdictions. The United States has strategic and economic  pacts with two jurisdictions in the Atlantic Ocean and six in the Pacific  Basin. These jurisdictions are together referred to as insular areas and  include the territories of American Samoa, Guam, and the U.S. Virgin  Islands; the commonwealths of the Northern Mariana Islands and Puerto  Rico; and the freely associated states of the Federated States of  Micronesia, the Republic of the Marshall Islands, and the Republic of  Palau. The pacts with the insular areas include the provision of federal  assistance which, for example, can include funding to support public- health preparedness efforts, such as building and maintaining basic  public-health capabilities.
According to CDC, some of the world’s most  destructive diseases are vector-borne—that  is they are transmitted to humans and  animals by vectors such as ticks, mosquitoes,  or fleas. CDC also contends the United  States is at a greater risk than ever from  vector-borne diseases—such as West Nile  virus, Lyme disease, dengue fever, chikungunya, and Rocky Mountain spotted  fever—due to globalization and climate  change. separate public-health laboratory—play a dual role in providing both  clinical and public-health laboratory services in their own jurisdictions.  The laboratories in this network have limited testing capabilities, though,  and often medical officials must send specimens to Hawaii, the U.S.  mainland, or Australia for additional testing.
CDC officials said that the Pacific insular areas present a challenge to  global disease spread and detection, because the region has experienced  outbreaks of emerging infectious disease and has lower detection  capacity. According to CDC officials, in the age of routine air travel and  with the rights granted to foreign nationals of some Pacific insular areas  under the Compacts of Free Association, the risk of insular residents  traveling to U.S. territories, Hawaii, and the mainland with undiagnosed  and potentially dangerous infectious diseases is troublesome.  Additionally, according to DOI officials, issues surrounding international  travel create challenges to ensuring timely response to disease outbreak  events in insular areas.
USDA operates disease-eradication and investigation activities, export  certification, and surveillance actions in most U.S. insular areas. In  addition, USDA’s National Wildlife Disease Program has an office in  Hawaii that supports activities to conduct surveillance for and respond to  outbreaks of disease in wildlife that pose threats to human health and  agricultural resources.
DOI’s USGS National Wildlife Health Center, located in Madison,  Wisconsin, assists state and federal agencies with wildlife health-related  issues and has a Honolulu Field Station, which is staffed by a wildlife  disease specialist and three biological technicians. The Honolulu Field  Station was established to serve state and federal agencies in Hawaii and  the Pacific, including the insular areas. The Honolulu Field Station  provides training to biologists regarding response to unusual wildlife  mortalities and performs laboratory and field investigations to determine  the cause of death in wildlife.
section_title: Humans, Livestock, Wildlife, and the Spread of Zoonotic Diseases
paragraphs: About 75 percent of the new diseases that have affected humans over the  past 10 years are zoonotic and have been caused by pathogens  originating from an animal. Many of these diseases have the potential to  spread through various means over long distances and to become global  problems. As shown in figure 3, these emerging and reemerging diseases  transmit between animals—including livestock and wildlife—and humans.  In some cases, disease transmission is direct, in others the animals act  as intermediate or accidental hosts, while in others transmission occurs  via arthropod—for example, mosquitoes or ticks—vectors. Examples of  such emerging and zoonotic diseases include: West Nile virus, H1N1,  SARS, avian influenza, and rabies. Potential bioterrorism threats also  include the use of zoonotic diseases as weapons of mass destruction,  such as anthrax, plague, tularemia, and brucellosis.
Habitat loss and human encroachment on rural and wildlife environments  are bringing populations of humans and animals, both farmed and wild,  into closer and more-frequent contact. Increasingly, wildlife are involved  in the transmission of diseases to people, pets, and livestock, and  managing wildlife vectors is an integral part of efforts to control the spr of zoonotic diseases. Diseases among wildlife can also provide early  warnings of environmental damage, bioterrorism, and other risks to  human health. DOI’s USGS National Wildlife Health Center, which is the  only federal laboratory in the United States dedicated to wildlife disease  investigation, focuses on developing methods to reduce or eliminate the  transmission of diseases among wildlife, domestic animals, and humans.
section_title: We Previously Recommended That the National Security Staff Develop a National Biosurveillance Strategy
subsections: section_title: Brucellosis and Feral Swine
paragraphs: In June 2010, we reported that while some high-level biodefense  strategies have been developed, there is no broad, integrated national  strategy that encompasses all stakeholders with biosurveillance  responsibilities that can be used to guide the systematic identification of  risk, assessment of resources needed to address those risks, and the  prioritization and allocation of investment across the entire biosurveillance  enterprise. We found that the decision makers responsible for developing  a national biosurveillance capability are spread across multiple agencies  and departments, and rely on support from state and local authorities. We  noted that our prior work on complex undertakings like biosurveillance  can benefit from strategic oversight mechanisms, such as a focal point  and a national strategy, to coordinate and lead efforts across the multiple  federal departments with biosurveillance responsibilities. We  recommended that the Homeland Security Council, which was  established to serve as a mechanism for ensuring coordination of federal  homeland security–related activities and development of homeland- security policies, should direct the National Security Staff to establish a  focal point and charge this focal point with the responsibility for  developing a national biosurveillance strategy.
Hunting feral swine is a popular sport among  hunters, and also serves as a population  control method which wildlife agencies  support, but there are more than 24 diseases  that people can get from feral swine.  While  most of these diseases are spread by eating  undercooked meat, the germs that cause  swine brucellosis are spread by swine  through birthing fluids and semen.  People  become exposed to the germs through  contact with an infected swine’s blood, fluids,  or tissues (such as muscles, testicles, liver, or  other organs).  Domestic swine are also  threatened by brucellosis through contact  with infected feral swine.
In August 2011, the National Security Staff reported that it had created a  biosurveillance Sub-Interagency Policy Committee, under the guidan the Domestic Resilience Group, to serve as a focal point in order to  coordinate the development of a National Strategy for Biosurveillance.  They said the strategy, and the implementation guidance to it, will define  the overall purpose of the U.S. government biosurveillance effort, and w pay particular attention to the assignment of roles and responsibilities.  These efforts are the first steps taken to address the findings in our June  2010 report.
section_title: Absent a Strategy and Biosurveillance- Specific Capability Efforts, Existing Federal Activities Help Support State and Local Capabilities
paragraphs: In the absence of a national biosurveillance strategy, the federal  government has some efforts, including emergency preparedness,  disease-specific surveillance, and laboratory enhancement programs, that  provide resources and information that state and city officials say are  critical to their efforts to build and maintain capabilities. The federal  programs and initiatives that officials identified during interviews as useful  for supporting their biosurveillance capabilities generally fell into four  categories, which respondents to our follow-up questionnaire ranked in  descending order of importance as follows: (1) grants and cooperative  agreements, (2) nonfinancial technical and material assistance, (3)  guidance, and (4) information sharing. As we reported in June 2010,  about federal biosurveillance activities, without a strategic approach to  build and maintain a national biosurveillance capability, these efforts  continue to be uncoordinated and not specifically targeted at ensuring the  most-effective and efficient biosurveillance capability.
subsections: section_title: Federal Grants and Cooperative Agreements Provide Essential Support for State and Local Biosurveillance Capabilities
paragraphs: Nearly all—26 of 27—of the questionnaire respondents identified grants  and cooperative agreements as the most important type of federal  assistance they receive. During interviews, state and local officials in  multiple agriculture, public-health, and wildlife departments said that they  are completely or largely dependent on federal funding for  biosurveillance-related activities and that their biosurveillance capabilities  would be limited without these federal grants and cooperative  agreements.
State and city officials we interviewed noted that grants and cooperative  agreements generally serve a dual purpose in that they both provide  guidance on federal priorities, goals, and objectives and provide financial  support to pursue those priorities. For example, when we asked public- health officials about the federal efforts that support their capabilities, five  of nine public-health departments cited the guidance on planning and  federal priorities that they receive in conjunction with the Public Health  Emergency Preparedness (PHEP) cooperative agreement. At the same  time, six of nine public-health departments we interviewed cited PHEP   funding as critical for supporting their capability resources, such as  additional staff to increase investigation and diagnostic capacity, and for  building and maintaining those capabilities identified as priorities. Officials  from one public-health department said that the funding they receive for  PHEP and another CDC cooperative agreement—Epidemiology  Laboratory and Capacity for Infectious Diseases (ELC)—pays the salaries  of 70 percent of their communicable-disease staff, including the salaries  of their scientists, researchers, physicians, and data analysts. Moreover,  these officials said the federal cooperative agreements enable the  department to conduct outbreak investigations that were not possible  before PHEP and ELC funding was available. Similarly, laboratory  officials in one state we visited said that the cooperative agreements  enable the department to pay for additional public-health positions,  training, and laboratory testing efforts and equipment, and without the  cooperative agreements, their laboratory testing capacity would be  considerably reduced.
A National Biosurveillance Capability: A  national biosurveillance capability is the  combination of capabilities of all jurisdictions  and entities that constitute the biosurveillance  enterprise working in concert to achieve the  timely detection and situational awareness  goals of biosurveillance, particularly for  potentially catastrophic biological events.
In interviews, agriculture officials in five of seven states said that their  departments depend on federal funding to conduct surveillance efforts.  For example, officials from three of the states said federal grants and  cooperative agreements enable their departments to, among other things,  collect and test specimens and purchase equipment for surveillance  efforts. Similarly, wildlife officials from four states we interviewed said that  their dependence on federal funding dictates priorities for certain  surveillance efforts—such as the funding for avian influenza and chronic  wasting disease surveillance efforts—and they would likely not conduct  active surveillance efforts like these without federal support. In follow-up  questionnaires, we asked officials to identify the federal grants and  cooperative agreements that were essential to their core biosurveillance  capabilities. Table 2 shows the federal grants and cooperative  agreements most commonly identified as essential to their core   biosurveillance capabilities by the 27 officials who responded to our  questionnaire, by group. For more information on questionnaire results,  see appendix III.
Respondents to our follow-up questionnaire ranked nonfinancial technical  and material assistance as the second-most important type of federal  support for building and maintaining biosurveillance capabilities.  According to state and local officials, the nonfinancial assistance efforts  they identified help to, among other things, support biosurveillance  capacity by improving state and local capacity to identify and diagnose  diseases. For example, state public-health, agriculture, and wildlife  officials said that training opportunities sponsored by the federal  government help enhance and standardize their laboratory testing  methods, epidemiological investigations, and specimen-collection  procedures, which helps state and local officials develop more efficient  and effective disease diagnostic capabilities. In addition, in interviews,  officials from both public health and agriculture said that the chance to  work together on concrete projects like avian influenza planning and  surveillance projects gave them an ongoing reason to communicate and  collaborate.
Public-health officials from five of nine public health departments we  visited said, in interviews, that they rely on CDC’s subject-matter  expertise to either guide their efforts during an event—such as the 2009  H1N1 outbreak—or to answer questions about a specific investigation.  Moreover, public-health officials in three of seven states said that without  this and other types of nonfinancial assistance, their department would  not be able to conduct as many investigations and the efficiency with  which they could diagnose a disease would decrease. In addition, public- health officials from one state said the ability to get CDC’s help confirming  results and to send specimens with unusual characteristics, which are  difficult to identify, increases the state’s laboratory capacity and improves  the efficiency with which the state can diagnose an unusual disease.
Similarly, agriculture officials we interviewed in one state said if they did  not have the National Veterinary Services Laboratory (NVSL) to provide  confirmation for unusual disease samples, they would be less prepared to  handle disease outbreaks. Finally, wildlife officials from one state said  working in the field with federal officials to trap animals and collect  samples has enhanced their relationships with federal officials, their  knowledge of new sampling procedures and surveillance data  management, and their ability to work with USDA officials during the grant  process. In follow-up questionnaires, we asked officials to identify the  federal nonfinancial and technical assistance efforts that were essential to  their core biosurveillance capabilities. Table 3 shows the federal  nonfinancial and technical assistance efforts most commonly identified as  essential to their core biosurveillance capabilities by the 27 officials who  responded to our questionnaire, by group. For more information on  questionnaire results, see appendix III.
The category of federal assistance ranked third overall in importance by  state and city questionnaire respondents is guidance. Additionally, during  our site visits, the majority of state and city officials we interviewed—16 of  23—said the primary source of federal guidance related to biosurveillance  accompanies federal grants and cooperative agreements and serves the  purpose of shaping programmatic goals, objectives, and priorities. For  example, the public-health epidemiologists and laboratory director for one  city said that the detailed capability guidance that accompanied the most  recent round of PHEP funding helped the city perform a gap analysis, the  results of which will serve as a planning guide over the next 5 years. In  addition, four of nine public-health departments we spoke with discussed  guidance that supports their efforts to build and maintain biosurveillance  capabilities by supporting specific activities that constitute their  capabilities, for example, guidance regarding standardized case  definitions, disease-reporting requirements, and sampling procedures for  unusual or emerging disease agents. Public-health officials in one state  we visited said that guidance on standardization is essential to ensure  states are able to move information to CDC more efficiently, and without  standardization it would be difficult to exchange information with their  partners. Similarly, agriculture officials in one state we visited said federal  sampling standards help interpret information about disease occurrence  in other states, because the significance of results is uniform nationwide.  These officials said that without this guidance, they would need to  develop protocols state-by-state to interpret results, which would lead to a  loss of efficiency in animal diagnostic laboratory protocols and  interpretation of results.
In follow-up questionnaires, we asked respondents to characterize the  various types of guidance, which had previously been identified in  interviews, as very useful, moderately useful, somewhat useful, or not  useful in supporting their biosurveillance capabilities. Table 4 shows the  sources of federal guidance the 27 officials who responded to our  questionnaire—by group—most commonly identified as very useful for  supporting biosurveillance capabilities. For more information on  questionnaire results, see appendix III.
Information-sharing tools and analytical products was the category ranked  fourth in importance by our 27 questionnaire respondents. In interviews,  officials said that without the knowledge they gain through these tools and  products they would lack critical information about emerging-disease  situations in neighboring states and throughout the nation. For example,  public-health officials in one state noted that they would lack context  about a health situation in their state without the knowledge they gain  through these systems and reports about incidents in neighboring states  and throughout the nation. In addition, they said these tools are useful in  helping them to better understand baselines for various diseases they  observe in their own jurisdictions. Public-health officials in another state  we interviewed noted that without the information provided by PulseNet,  their ability to detect foodborne outbreaks would be diminished.
Southeastern Cooperative Wildlife  Disease Study (SCWDS)
The wildlife agencies of 19 states (shaded on  map) and Puerto Rico and the U.S.  Geological Survey of DOI fund regional  wildlife research and service projects through SCWDS, and USDA’s Veterinary  Services provides support for national and  international surveillance activities where  diseases may spread among wildlife and  livestock.  SCWDS provides wildlife-disease  expertise to state and federal agencies  responsible for wildlife and domestic livestock  resources.  SCWDS aims to detect causes of  illness and death in wildlife, characterize the  effect of diseases and parasites upon wild  animal populations, identify disease  interrelationships between wildlife and  domestic livestock, and determine the role of  wildlife in transmission of human diseases.
Likewise, agriculture officials we interviewed in one state said without the  compiled information that federal agencies share with them—for example,  disease data on USDA’s Veterinary Service Laboratory Submissions  website—they would be operating blindly and would need to spend time  contacting other states to know what is happening outside their borders.  They said this information is particularly useful when it comes to animal  movement across state lines, so that they are aware of those diseases of  concern in different areas of the country. Similarly, wildlife officials from  one state said that the information shared by federal agencies provides  awareness of disease threats in their state and information about how to  respond if they encounter the disease in question. They said that the lack  of this information could delay the state’s detection of a potentially  devastating disease, because outbreak signals—like animal die-offs  would have to trigger an investigation in their state—before they had any  awareness of looming disease threats. In follow-up questionnaires, we  asked officials to identify the types of information sharing tools and  analytical products that were essential to their core biosurveillance  capabilities. Table 5 shows the types of information sharing tools and  analytical products most commonly identified as essential to their core  biosurveillance capabilities by the 27 officials who responded to our  questionnaire, by group. For more information on questionnaire results,  see appendix III.
In June 2010, when we recommended that the National Security Staff  lead the development of a national biosurveillance strategy, we noted that  an effective national biosurveillance strategy could help identify the  resources currently being used to support a biosurveillance capability,  additional resources that may be needed, and opportunities for leveraging  resources. Although not generalizable to the whole biosurveillance  enterprise, our findings suggest that there are existing federal resources  that nonfederal officials find essential to their efforts and could provide a  starting point for considering how to leverage nonfederal resources.
Because the resources that constitute a national biosurveillance capability  are largely owned by nonfederal entities, a national strategy that  considers how to leverage existing efforts and resources in federal, state,  tribal, local, and insular jurisdictions could improve efforts to build and  maintain a national biosurveillance capability.
section_title: State and Local Officials Reported Challenges Related to State Policies, Core Capability Resources, and Planning and Leadership to Support Biosurveillance Capabilities
paragraphs: State and city officials we spoke with reported a variety of challenges in  building and maintaining biosurveillance capabilities. These challenges  generally fell into three different groups: (1) state policies enacted in  response to fiscal constraints, (2) obtaining and maintaining resources to  support capabilities, and (3) leadership and planning challenges. In the  follow-up questionnaire, we asked respondents how challenges identified  in the interviews affect their capabilities and to rank the top three  challenges they face. For each challenge respondents identified facing,  we asked them to indicate whether or not the current combination of  resources, leadership, and planning in their jurisdictions were adequate to  address that challenge. The challenges reported here are only those that  respondents indicated are not currently adequately addressed. For  additional information about questionnaire results related to challenges,  see appendix IV.
subsections: section_title: State Policies May Constrain Hiring, Travel, and Information Technology, Even When Federal Funding Is Available
paragraphs: One set of challenges that state and city officials described to us had to  do with the state and local budget crises and the policies states have put  in place to respond to this challenge. Specifically, in interviews with state  public-health, agriculture, and wildlife departments, multiple officials  reported barriers that state policies presented for building and maintaining  a biosurveillance capability. Among these barriers were (1) an inability to  use federal funding for new positions because of state hiring restrictions,  (2) an inability to attend national trainings and conferences (even when  federal travel funding is available) because of state travel restrictions, and  (3) an inability to participate in training and other online forums sponsored  by federal agencies and professional associations because of state  restrictions on when and how they can use information technology in their  offices.
In follow-up questionnaires, 20 of 27 respondents identified these kinds of  state policies as a challenge to building and maintaining biosurveillance  capability. One respondent who ranked this kind of challenge among the  top three challenges noted that state policies on hiring require the use of  contractors rather than full-time equivalent personnel. As a consequence,  the respondent noted, the knowledge accrued through the course of on- the-job training leaves the agency when a given contract ends.
Although federal agencies who work to help support capabilities in state  and local jurisdictions have limited ability to directly affect state policies,  CDC officials say they are aware of the issue and agree that it is a  challenge—in some cases severely hampering states’ ability to move  forward with capability building. The CDC officials said they have  discussed the issue with their state and local partners as part of a larger  effort to explore various funding options to help better support capability  building.
section_title: State and City Officials Report Concerns about Resources
paragraphs: A second set of challenges reflected general concerns about the  resources that support biosurveillance capabilities, such as appropriately  trained personnel, systems, and equipment. Nineteen of 27 respondents  to our follow-up questionnaires reported facing workforce shortages  among skilled professionals—epidemiologists, informaticians,  statisticians, laboratory staff, animal-health staff, or animal-disease  specialists. One respondent who rated this particular challenge among  the top three noted that noncompetitive salaries had resulted in lack of  interest in positions and high turnover. As a consequence, according to  the respondent, investments in training yield lower returns and quality of  the overall workforce is affected.
Sixteen of 27 questionnaire respondents reported problems with training  availability. A state wildlife official who rated training availability as the top  current challenge noted that without proper training, staff in the field—who  often have duties other than disease surveillance—lack an understanding  of the importance of surveillance and reporting, as well as knowledge of  the techniques to carry it out. Fourteen of 27 questionnaire respondents  indicated issues with workforce competency—hiring and retaining  professionals with adequate training and education. One of the  respondents that rated this challenge among the top three noted that  without properly trained staff to support them, initiatives languish. She  also noted that the need for the few skilled personnel to provide on-the- job training and education consumes time and affects workflow.
Fifteen of 27 questionnaire respondents reported that keeping up with  ongoing systems maintenance and enhancement needs has been  challenging. One respondent who rated ongoing systems maintenance  and enhancement among the top three challenges said that public-health  informatics, including state-of-the-art database systems and effective  electronic linkages, are critical to surveillance, but place demands on  resources to attract and maintain public-health informatics expertise and  support database applications. Thirteen of 27 questionnaire respondents  reported challenges maintaining adequate laboratory capacity. One  laboratory official who ranked this among the top three challenges stated  that many at the public-health lab are nearing retirement and it has been  difficult to attract and retain younger laboratory scientists to work in public  health.
section_title: State and City Officials Report Leadership and Planning Challenges That Could Be Considered in a National Biosurveillance Strategy
paragraphs: The third set of challenges state and city officials that we interviewed  reported included (1) difficulty planning for longer-term capability-building  efforts because of uncertainty from year to year about whether project  funds would be available; (2) difficulty planning to invest in basic  capabilities for multiple disease threats because federal funding has  focused on specific diseases rather than strategically building core  capabilities; (3) limited leadership and planning—at all levels of the  biosurveillance enterprise—to support regional and integrated disease  data-surveillance approaches; and (4) differing priorities and other  partnership issues. Many of the challenges that state and city officials  identified are similar to issues we reported regarding biosurveillance at  the federal level. We noted that many of the challenges like these that  face the biosurveillance enterprise are complex, inherent to building  capabilities that cross traditional boundaries, and not easily resolved. We  recommended in June 2010 that a leadership mechanism, such as a focal  point, and a strategy could help define the scope of the problems to be  addressed, in turn leading to specific objectives and activities for tackling  those problems, better allocation and management of resources, and  clarification of roles and responsibilities.
In our follow-up questionnaires, by far the single most-commonly reported  challenge was funding instability and insecurity, with 25 of 27  questionnaire respondents identifying it as a challenge that has not been  adequately addressed. Among those, 23 ranked it as one of the top three  challenges and 16 of those ranked it as their top challenge. In interviews,  officials in both the human- and animal-health communities noted that  they receive little or no support from state budgets for surveillance  activities, leaving them largely reliant on federal funding for this type of  activity. Moreover, two agriculture officials noted that it is difficult for  states to develop long-term plans for building and maintaining capabilities  because they do not know how much funding they will receive from year  to year. For example, three of the nine visits we made to state public- health departments occurred near the application deadline for the new  PHEP cooperative agreements. All three sets of public health officials  reported receiving news of a last minute reduction in funding—which  according to CDC officials equaled 12 percent—that resulted in the need  to significantly revise their PHEP application and accompanying plan for  building and maintaining capabilities, in a short time frame.
In interviews, agriculture officials in three of the seven states we visited  said they receive little or no funding in their state budgets to support  biosurveillance activities and depend on federal funding, which they say  has been decreasing. Because of the decreases in funding, the  agriculture officials from one state said that their department has  decreased its staff level by half over the past 6 years, and these officials  noted that without federal funding the department’s biosurveillance  capabilities would be minimal. Likewise, wildlife officials in five of the  seven states we visited said that they receive little or no funding for  surveillance from their state budgets and rely on federal programs to  support surveillance.
Federal officials agreed that funding insecurity and instability is a serious  challenge affecting states’ ability to plan for and execute capability- building efforts. In October 2010, CDC’s Advisory Committee to the  Director—recognizing much of CDC’s effect results from the funds it  provides state, tribal, local, and territorial public-health departments— charged its State, Tribal, Local and Territorial Workgroup to produce  recommendations to maximize resources and develop capacity  throughout this nonfederal community. A subworkgroup was created  specifically to consider issues arising from the fiscal challenges facing  states and localities.
According to CDC officials, the workgroup has discussed moving  cooperative agreements like PHEP and ELC to a 2-year cycle to give  state and local public-health departments more time to work within state- imposed restrictions, but they cannot make such a change without  legislative action. In addition, CDC officials stated that they attempt to  communicate budget decisions to their nonfederal partners in a timely  manner. For example, they said that they provided guidance to PHEP  applicants to help them plan around funding uncertainty by  communicating the minimum funding available and advising them to plan  for the next fiscal year using the current year’s funding level with the  expectation that it will likely be reduced. However, these officials also  noted that when federal agencies have to operate on a continuing  resolution, it restricts their ability to plan and obligate funds, which in turn  can result in reductions and delays in funding activities at the state and  local level.
An official from DOI’s USGS National Wildlife Health Center also  attributed funding instability and insecurity to the annual appropriations  cycle, because federal agencies also do not know what the budget will be  from year to year. Like CDC officials, he said that multiyear appropriations  would allow for more long-term planning. USDA officials also  acknowledged that their nonfederal partners face challenges planning for  and developing capabilities because of funding uncertainty. Officials from  USDA’s Animal and Plant Health Inspection Service’s Veterinary Services  said they are working to streamline the cooperative agreement process to  provide additional flexibility to the states by producing fewer but broader  agreements that would allow the states to better prioritize their needs.
Twenty-one of the 27 state and city officials who responded to our follow- up questionnaire reported that the common federal approach of funding  capabilities in response to specific diseases or initiatives—for example,  West Nile virus—limited their ability to develop core capabilities that could  provide surveillance capacity that cut across health threats and for  emerging-disease threats. Along these lines, one of the respondents who  rated this challenge among the top three said that broad-based  surveillance activities are crucial for detecting new and emerging  diseases, but funding targeted for specific diseases does not allow for  focus on a broad range of causes of morbidity and mortality.
Federal officials agreed that the disease-specific nature of funding is a  challenge to states’ ability to invest in core capabilities. CDC officials said  this long-standing issue stems from the way CDC receives funding, which  is disease-specific and, in turn, awarded to the states that way. According  to officials, funding authorized under the Patient Protection and Affordable  Care Act (PPACA) has recently offered some authority for flexible  biosurveillance capability investments. For example, they said the  PPACA program supports additional epidemiologists and laboratory  support staff and infrastructure improvements, among other things, at the  state and local level. Additionally, CDC officials noted that the all-hazards  nature of PHEP grants supports states’ ability to invest in crosscutting  core capabilities.
An official from DOI’s USGS National Wildlife Health Center similarly  noted that the structure of funding is a challenge for agencies at all levels,  and said he would like to see more broad-based funding to allow for long- term investments to retain and develop capacity to address disease  issues. USDA officials also acknowledge that stovepiped, or disease- specific, funding presents a challenge for their nonfederal partners when  planning for and investing in crosscutting capabilities. Within USDA’s  Animal and Plant Health Inspection Service, officials from Veterinary  Services said that they are moving away from funding disease- and  program-specific items and toward a new funding approach, intended to  reduce stovepiping and provide for additional flexibility. USDA’s Wildlife  Services officials also find stovepiped funding challenging, but said that  they have little control over the issue.
In interviews and follow-up questionnaires, city and state officials also  reported challenges with the leadership and planning for integrated  biosurveillance approaches. Sixteen of 27 respondents to our follow-up  questionnaires reported a lack of leadership and mechanisms to support  regional approaches to disease surveillance. Similarly, 17 of 27  respondents reported that integrating information across disease domains  is a challenge because of a lack of leadership and mechanisms to  facilitate information sharing and data integration among public-health,  agriculture, and wildlife disease-control functions. One respondent who  ranked integrating human and animal surveillance information among the  top three challenges said that the lack of leadership and mechanisms to  do so is a barrier to effective and efficient disease response.
Federal agencies with biosurveillance roles have acknowledged that  attention to integrated biosurveillance approaches is needed. In response  to HSPD-21, CDC created the National Biosurveillance Strategy for  Human Health, collaborating with federal and nonfederal partners, to  provide a foundation for a long-term effort to improve a nationwide  capability to manage human health–related data and information. The  strategy lays out six priority areas for attention to address critical gaps  and opportunities for improvement. Among the six is integrated  biosurveillance, about which the strategy states that, because the  responsibility for public health is shared across multiple levels of  government, professional practice, and scientific disciplines, the timely  exchange of reliable and actionable information is essential. Although the  strategy includes goals for enhancing integration of human-health data,  these goals have not yet been the central focus of implementation plans  for the strategy. However, according to CDC officials, the efforts to  establish objectives for enhancing management of human-health  information as part of the strategy has been important for larger HHS  efforts, such as implementing the National Health Security Strategy.  Officials also said these activities are important to the efforts the National  Security Staff has underway to guide the biosurveillance enterprise. In  addition, CDC officials stated that the BioSense program is being  redesigned to improve the ability for jurisdictions to share data with each  other during specific events, which could foster more regional data  sharing.
An official from DOI’s USGS National Wildlife Health Center said it would  be helpful to have a national strategy or framework to guide all of those  involved in wildlife health to respond in a coordinated, appropriate, and  proportionate way to wildlife disease issues. In addition, he said the  framework is needed to outline the shared responsibilities related to  threat detection and assessment, policy development, and management  actions. According to the official, DOI plans to begin working on such a  framework for wildlife surveillance with its partners in the near future.  USDA officials also acknowledged that nonfederal partners have faced  challenges with leadership and planning for integrated biosurveillance  approaches. USDA officials from Animal and Plant Health Inspection  Service’s Wildlife Services said they could enhance the integration of  biosurveillance capacities for their nonfederal partners by providing  access to their existing networks. However, the officials said they would  need a source of funding for the increased efforts required to meet the  needs of nonfederal partners. Officials from Veterinary Services stated  that to address integration challenges, they try to engage their nonfederal  partners in planning activities, but are looking to the National Security  Staff’s work on the national biosurveillance strategy to help address larger  challenges.
Some challenges identified by state and local officials reflected an  opportunity for better partnerships between the federal and the state and  local governments. Fourteen of 27 respondents to our follow-up  questionnaires indicated that competing federal priorities present  challenges. For example, in one interview, state officials said that grant  guidance can be contradictory with regards to funding streams, and one  grant may recommend focusing on a certain priority and then other grants  recommend other priorities that do not complement the other grant’s  guidance. In addition, 12 of 27 questionnaire respondents reported having  vague or insufficient guidance. In interviews, state and local officials who  identified this issue noted that there is no user-friendly central repository  of best practices for maintaining and enhancing capabilities and that  guidance lacks concrete examples for things like developing state  planning documents or fostering integrated biosurveillance efforts. Finally,  12 of 27 questionnaire respondents reported federalism challenges, such  as conflict between national and local priorities, philosophies, and  approaches to conducting biosurveillance. For example, in an interview,  public-health officials in one state told us that they have to spend valuable  time and resources convincing their federal partners not to overreact to  electronic laboratory results of disease that are considered dangerous,  such as plague, but are also endemic in low levels within their  jurisdictions  Officials from CDC stated that they are aware of these kinds of  challenges facing their nonfederal partners and of the need to improve  federal and nonfederal coordination among programs. These officials said  states may have different priorities than those at the federal level due the  need to balance their state responsibilities to address health concerns of  the state with their other activities conducted with varying federal  agencies and programs. According to the officials, they are committed—in  national strategy efforts—to building on current capabilities at all levels of  government and will take into consideration the issues and challenges  states experience in working with their federal biosurveillance partners.  They also noted that as they developed guidance for PHEP recipients for  the most recent round of cooperative agreements—Public Health  Preparedness Capabilities: National Standards for State and Local  Planning—they involved approximately 200 stakeholders and experts to  help public-health departments better organize their work and determine  whether they have the resources to build and sustain all the capabilities.  Additionally, they said that they attempted to ensure that their nonfederal  partners do not experience continual shifts in PHEP priorities by  implementing a new process for reviewing and approving proposed  changes to PHEP guidance.
They also described several efforts to coordinate grant guidance within  CDC and with other federal partners to improve effectiveness and reduce  conflicting activities or redundant reporting. Among these efforts were  multiple workgroups and other activities to engage with federal and  nonfederal partners, as well as a Memorandum of Understanding with  multiple federal departments that fund preparedness activities. According  to CDC officials, the memorandum establishes a formal framework that  supports joint federal planning and better coordinates emergency public  health and health care preparedness consistent with national strategies  and priorities.
An official from DOI’s USGS National Wildlife Health Center agrees that  partners throughout the biosurveillance enterprise experience federalism  challenges. He said that a national strategy or framework that clearly  outlines roles and responsibilities could help alleviate these issues. USDA  officials also acknowledged that their nonfederal partners have faced  these kinds of challenges. Officials from USDA Animal and Plant Health  Inspection Service’s Wildlife Services said that they recently created a  plan to achieve a more unified cross-program approach to addressing  wildlife-disease issues that will affect the agency and its stakeholders.  These officials stated that enhanced integration of the USDA resources,  expertise, personnel, and infrastructure needed to address issues of  wildlife-disease surveillance—among other things—should help their  nonfederal partners to mitigate this challenge. Officials from Veterinary  Services stated that to address federalism challenges, they seek to  proactively engage their nonfederal partners in planning activities, but are  looking to the National Security Staff’s work on the national  biosurveillance strategy to help address the larger challenge.
In our June 2010 report, we called for a national strategy that could begin  to address the difficult but critical issues of who pays for biosurveillance  capabilities and how a national capability will be sustained in the future.  Our findings about the challenges with planning and investing in core  capabilities, while not generalizable to all nonfederal jurisdictions, suggest  that there may be some common issues with the structure of funding that  affect longer-term planning and investments in core biosurveillance  capabilities. We also reported in June 2010 that clarifying the numerous  governmental and private-sector entities’ roles and responsibilities for  leading, partnering, or supporting biosurveillance activities could help  ensure timely disease detection and situational awareness across  multiple domains. Our findings similarly suggest that there may be some  common issues with promoting integrated biosurveillance approaches at  the nonfederal level. As part of a national biosurveillance strategy,  considering challenges like these may help partners across the enterprise  find shared solutions as they strive to build and maintain an integrated  national biosurveillance capability.
section_title: Federal Agencies Provide Some Support, but Biosurveillance Capabilities in Tribal and Insular Areas Are Limited by Resources and Infrastructure
paragraphs: As with the state and local jurisdictions, the federal government does not  have efforts designed specifically to build and maintain tribal or insular  biosurveillance capabilities to support a national biosurveillance  capability. However, tribal and insular jurisdictions also receive certain  cooperative agreements and technical assistance that federal officials say  can help support biosurveillance capacity. At the same time, federal  officials reported that limited resources and infrastructure in tribal and  insular jurisdictions present challenges to building their capacity.
subsections: section_title: Federal Agencies Have Provided Financial and Technical Assistance That Can Support Tribal and Insular Capabilities
paragraphs: According to federal and professional association officials that work with  tribal and insular jurisdictions, federal agencies provide disease-specific  funding and cooperative agreements, as well as training and technical  assistance, to support public-health and animal-health surveillance  capacity.
Insular areas are eligible for the PHEP and ELC cooperative agreements  from CDC. PHEP funds public-health preparedness projects in American  Samoa, Guam, U.S. Virgin Islands, Northern Mariana Islands, Puerto  Rico, Federated States of Micronesia, Republic of the Marshall Islands,  and Republic of Palau. In addition, ELC—which builds epidemiological  and laboratory capacity—is awarded to Puerto Rico and the Republic of  Palau.
According to officials from PIHOA, federal agencies also provide  specimen testing for Pacific insular areas—which have no reference  laboratory capacity of their own—for disease agents that the islands’  clinical laboratory network is not equipped or certified to handle. PIHOA  developed the Regional Lab Initiative for the transportation of human  specimens, and PIHOA serves as a steward for the specimen  transportation network by negotiating specimen-transportation contracts  with commercial airlines, developing shipping standards for laboratory  specimens, and overseeing the Regional Lab Initiative budget. PIHOA  officials said that federal funding for this initiative is critical to enable  Pacific insular areas to transport specimens for testing to those  laboratories with greater capabilities.
According to CDC officials, their Division of Global Migration and  Quarantine also works with the insular areas to enhance crosscutting  public-health initiatives, with a focus on disease surveillance and help  public-health departments tie into various CDC programs. For example,  the division has been working with Guam since late 2009 to move  towards electronic data sharing of health information to improve  timeliness and response to catastrophic events, including better linkages  to the National Notifiable Disease Surveillance System. During a 2010  mumps outbreak in Guam and the Federated States of Micronesia, the  division also played a coordination role and facilitated the shipment of lab  specimens. Officials said that the Guam mumps outbreak helped identify  gaps in their surveillance capacity, and the division followed up with  targeted training to address the gaps. The division is also working to  enhance the quality of American Samoa's public-health records to  enhance its ability to submit electronic public-health data into the World  Health Organization’s syndromic surveillance system for the Pacific  Islands region.
For animal health in the insular areas, USDA has employees and offices  in some insular areas. USDA Veterinary Medical Officers in the field  interact with producers, respond to reports of potential Foreign Animal  Diseases, help administer disease eradication and control and  surveillance activities, and assist with export certification out of these  field-office sites. DOI provides diagnostic service to determine causes of  mortality in wildlife. For example, in American Samoa and Palau, DOI  performs necropsy surveys of free-ranging wildlife (both terrestrial and  marine) to determine the cause of death. The agency reported that all bird  carcasses necropsied are routinely tested for avian influenza. The  agency also reported that the ability to ship samples from American  Samoa and Palau to Honolulu, Hawaii, has allowed the agency to gain a  greater understanding of causes of wildlife mortality in those regions. In  case of catastrophic mortality, DOI officials said the agency would  probably send someone out to the area to provide on-site assistance and  collaborate with local agencies to deal with the issue and resolve it to its  logical conclusion. For example, DOI officials have offered response  assistance to Palau to help with unusual poultry mortality events in efforts  to effect early detection of avian influenza. DOI also provides annual  workshops to agencies to communicate findings and provide on-site  training on wildlife disease response.
Tribal nations are not eligible for PHEP or ELC funding, but CDC advises  states to include tribes in their required all-hazards public-health  capability planning for PHEP funding. In addition, IHS has cooperative  agreements with Tribal Epidemiology Centers, to support local public  health and provide data analyses for the tribes. As shown in figure 4,  there are 12 Tribal Epidemiology Centers located around the country. The  12 Tribal Epidemiology Centers typically serve 30-100 tribes in their  region. Officials from IHS said that the Tribal Epidemiology Centers may  offer a foundation for building tribal biosurveillance capabilities. However,  biosurveillance is not the primary job or mission of the epidemiology  centers. The priorities of the centers are driven by the needs of the tribes,  and the centers help the tribes create a structure for intervention to  prevent the major conditions affecting the tribal population.
Federal agencies also provide technical assistance and training to tribal  jurisdictions. The Office for State, Tribal, Local and Territorial Support  within CDC provides training and technical assistance to improve data  and surveillance standards in tribal areas and work to foster public-health  workforce development in tribal areas. In addition, IHS provides, without  charge, software for automated electronic surveillance that can be  implemented by IHS, tribal, and Urban American Indian and Alaska  Native sites to help with automated reporting and information sharing.  The initial project, IHS’s Influenza Awareness System, focused on  influenza-like illness, but according to IHS officials is currently expanding  to include other notifiable diseases. IHS also provides technical  assistance to tribes, sometimes through the Tribal Epidemiology Centers,  and also provides some training, which is available to any American  Indian or Alaska Native. The primary focus of the training is not  biosurveillance but basic public-health functions, but federal officials who  work with these jurisdictions say that any effort to build public-health  infrastructure increases biosurveillance capabilities over their existing  levels.
Additionally, according to USDA officials, tribes can participate in the  same disease-control and eradication programs (such as tuberculosis,  brucellosis, scrapie, and chronic wasting disease) as states through  grants and cooperative agreements. These officials said these  cooperative agreements increase tribes’ biosurveillance capability,  particularly with tribes that have more-robust existing infrastructure, like  Navajo Nation, which has a full-time veterinarian. USDA officials with  responsibility for wildlife said they also provide cooperative agreements  and training to support tribal wildlife disease surveillance.
section_title: Federal Working Groups and Outreach Efforts Can Help Support Biosurveillance Capabilities
paragraphs: To help build public-health and animal-health surveillance capacity,  federal agencies have also created working groups and other outreach  efforts to tribal and insular jurisdictions. For example, the Office for State,  Tribal, Local and Territorial Support within CDC works with health  departments to increase public-health capacity through a working group  that helps build capacity across jurisdictions, for example between tribes  and corresponding state or local health departments. CDC has developed  Pacific working groups to address various issues in the Pacific insular  areas, such as the Public Health Preparedness and Response Working  Group and an epidemiology working group. According to officials, these  working groups help coordinate activities between various CDC  departments and the Pacific insular areas.
USDA’s Native American Program Coordinator serves as a tribal liaison,  providing assistance to tribes and has developed a relationship with the  large land-owning tribes that participate in its programs. The officials said  that the tribal liaison has built this relationship over the years by attending  the Intertribal Agriculture Council’s Meetings, a gathering of tribal  agriculture producers. They noted that because of the tribal liaison’s  continuous outreach, they believe that the tribes know whom to call if  unusual animal disease symptoms appear in animals on their lands.
section_title: Federal Agencies Face Unique Challenges Supporting Tribal and Insular Jurisdictions
subsections: section_title: USDA’s Traceability Program
paragraphs: Federal officials, as well as officials from professional associations like  the Council of State and Tribal Epidemiologists and PIHOA described  infrastructure and demographic challenges they face in helping to build  biosurveillance capabilities in tribal and insular jurisdictions. For example,  CDC officials said that, overall, there is a low capacity to detect and report  diseases in both tribal and insular jurisdictions, and that better assurance  for detection of potentially catastrophic signs would require enhancement  of basic systems and public-health functions. HHS officials said that  tribes, insular areas, and states face similar public-health infrastructure  challenges, but the challenges are more severe in tribal and insular  areas. For example, IHS and CDC officials said some tribes have serious  public-health infrastructure limitations—for example, some have minimal  or no functioning health-department structure—so officials said the idea of  building biosurveillance capabilities is not a realistic pursuit in these  areas.
USDA and DOI officials also reported capacity challenges—such as few  veterinary and wildlife personnel on the ground in tribal and insular  areas—that limit biosurveillance capabilities. Additionally, officials said  that the federal cooperative agreements offered by federal agencies do  not always provide for the infrastructure enhancement needed for tribal  and insular areas, because they assume a basic level of capacity that  these jurisdictions often do not have. However, USDA, DOI, and HHS  officials also cautioned that despite the limited infrastructure in some of  the tribal and insular areas, it would not be practical from a cost-benefit  standpoint to invest in complete biosurveillance systems for every tribe  and insular area. For example, for small tribal nations and insular areas it  may not make sense to expect them to support and maintain separate  laboratory facilities, especially when there are other nearby state  resources available that could support testing for those populations.
Along the same lines, HHS officials said that tribes and their federal and  state partners have historically faced disease-reporting challenges. CDC  officials noted that as sovereign nations, tribes typically prefer to work  directly with federal agencies, rather than state governments, but  because of the nature of public health, it often makes sense for tribes and  states to share data or conduct joint investigations with the states. CDC  officials said that data sharing between tribes in states is challenging,  because tribes may have limited public-health capacity. The officials said  that Tribal Epidemiology Centers offer some promise for facilitating  information sharing, but some states have been reluctant to share health  data with Tribal Epidemiology Centers, because until recently they lacked  public-health authority—a legal designation that governs the ability of  governmental entities to collect, receive, and share data for public-health  purposes under the Health Insurance Portability and Accountability Act of  1996 (HIPAA). Tribal Epidemiology Centers are operated by nonprofit  organizations that typically had no legal health authority to handle such  data. However, in 2010, PPACA designated these centers public-health  authorities under HIPAA. This provision allows the IHS-funded Tribal  Epidemiology Centers to access federal and state data sets for research  purposes, just as state health departments do. However, these centers  still are nonprofit organizations that are competitively selected on a  periodic basis and there is no guarantee that the entire nation will  continue to have center coverage. HHS officials said the designation of  the centers as public-health authorities will likely facilitate more sharing  among states and tribes, but it is a relatively new development, so it is too  soon to determine the effect.
Federal officials also reported facing demographic and logistical  challenges in working with tribal nations. Complications in data collection  and reporting arise from the nature of tribal boundaries and populations.  Specifically, tribes are not defined by geographic boundaries, tribal  members may not live on tribal lands, and tribal lands may cross state  boundaries. Officials also said population size and geography vary for  tribes and many tribes are in remote locations, including about half of the  more than 500 federally recognized tribes located in Alaska. An official  from IHS noted that, in general, tribal communities do not have  populations large enough to justify building complete, individual  surveillance programs and that tribes generally do not have infrastructure  or resources to support such an effort.
According to USDA officials, every tribe has a different relationship with  the state it is located in and with the federal government. Some tribes  have direct relationships with the state agriculture department because  most tribes do not have veterinarians. In some cases, the states may take  care of the surveillance needs for a tribe, and in other cases, the tribes  may have their own surveillance capacity. In general, tribes do not have  funding to establish and maintain laboratories. Tribes typically use the  state labs that are part of the National Animal Health Laboratory Network  (NAHLN), the facilities at Plum Island, the Ames, Iowa lab, or state labs  that are not part of NAHLN. (For more information about laboratories, see  app. II.) DOI officials said that tribes are interested in wildlife management  and disease surveillance, but do not have the resources, as tribes need to  build capabilities at the most basic level—like wildlife biologists and  management expertise.
Federal agencies, as well as association officials, reported similar  resource, demographic, and logistical challenges in insular areas.  Officials at the Council of State and Territorial Epidemiologists, PIHOA,  and CDC said the Pacific insular areas are challenged in identifying  disease outbreaks and emerging diseases. According to PIHOA officials,  this is due to workforce shortages for doctors, nurses, epidemiologists,  and laboratory officials, and the limited laboratory capacity on the islands.  Although the islands can currently depend on laboratories outside Pacific  insular areas to conduct testing, and there are currently initiatives and  programs in place to improve laboratory capacity on the islands, it may  take several days to detect a disease.
CDC officials said timely reporting cannot be ensured in the Pacific  insular areas and there is limited ability to build public-health  infrastructure in the territories. For example, they said the public-health  systems will have to transition to more formal mechanisms of information  sharing, because currently events trigger regional partners to respond in  an ad hoc and unsystematic way. To address some of these challenges,  PIHOA developed the Public Health Infrastructure Initiative, partially  funded by CDC’s National Public Health Improvement Initiative, which is  supported by PPACA’s Prevention and Public Health Fund, to help  improve Pacific insular areas’ public-health systems at every level.  Through this initiative, PIHOA is working with Pacific insular areas  officials to develop public-health curricula to improve the epidemiological  and surveillance capabilities of the islands.
According to DOI officials, aside from Guam, insular areas in the Pacific  region have little to no existing veterinary capacity to deal with animal or  zoonotic diseases. DOI officials said they would like to get more wildlife  disease data from places like Guam and the Commonwealth of the  Northern Mariana Islands, but the lack of reliable in-territory contacts  there has made it difficult to establish those relationships.
section_title: The Federal Government Has Not Comprehensively Assessed Nonfederal Biosurveillance Capabilities
paragraphs: Various federal agencies and professional associations with public-health  missions have assessed some aspects of nonfederal biosurveillance  capabilities, such as the evaluation of laboratory, epidemiology,  surveillance, and other capacities, but the federal government has not  systematically or comprehensively assessed state and local governments’  ability to contribute to a national biosurveillance capability. An  assessment of capabilities that support biosurveillance is called for in  HSPD-10, which states that the United States requires a periodic  assessment that identifies gaps or vulnerabilities in our biodefense  capabilities—of which surveillance and detection is a key part—to guide  prioritization of federal investments. We have previously reported that a  national biosurveillance capability depends upon participation from  nonfederal jurisdictions and that few of the resources required to support  the capability are wholly owned by the federal government. Therefore,  assessing the baseline and identifying investment needs for a national  biosurveillance capability necessarily involves assessing nonfederal  entities’ ability to support a national capability.
No federal, state, local, or association official we spoke to was able to  identify a systematic approach—planned or underway—to assessing  state and local biosurveillance capabilities and identifying strengths,  weaknesses, and gaps across the biosurveillance enterprise. However,  certain aspects of public-health capabilities have been assessed by  federal agencies and professional associations. For example, CDC’s  most-recent round of guidance associated with the PHEP cooperative  agreements has begun to define elements, priorities, resource  considerations, and metrics for building and assessing public-health  surveillance, epidemiology, and laboratory capabilities. According to CDC  officials, these national standards are designed to assist states and  localities in self-assessing their ability to address the prioritized planning  resource elements of each capability and then to assess their ability to  demonstrate the functions and tasks within each capability. CDC officials  stated that this self-assessment enables states and localities to identify  their gaps in preparedness, determine their specific jurisdictional goals  and priorities, develop plans for building and sustaining capabilities, and  prioritize preparedness investments. CDC officials noted that these data  and data collected through the ELC could, with the right attention and  resources, offer an opportunity to provide more-cohesive information for a  national assessment in the future.
In addition, for the past 4 years the Association of Public Health  Laboratories has conducted an assessment of the District of Columbia  and the 50 state public-health laboratories’ capacity to respond to biologi- cal, chemical, radiological, and other threats, such as pandemic influenza.  Similarly, the Council of State and Territorial Epidemiologists has  conducted four assessments since 2001 to assess the epidemiology  capacity of state, local, and territorial health departments in the United  States. Further, CDC funded a survey of state, local, and territorial  syndromic surveillance capabilities that was conducted by the  International Society of Disease Surveillance.
According to several federal and state officials, a comprehensive  assessment of the biosurveillance enterprise may identify a baseline  status, strengths, weaknesses, and gaps across the biosurveillance  enterprise and improve the nation’s ability to conduct biosurveillance, but  state officials also noted that states would need additional funding to  overcome any gaps identified by a federal assessment. For example,  officials from one federal agency said that a comprehensive assessment  of state and local biosurveillance capabilities would help identify  vulnerabilities in the enterprise, assess needs, and help target resources  to those areas. Similarly, another federal official who oversees programs  for tribal entities noted that knowing more about tribes’ strengths,  weaknesses, and gaps would enable their division to better understand  where they need to provide additional assistance or focus resources  during an event.
State officials we interviewed also discussed how a national assessment  could identify best practices in biosurveillance and inform states and  federal resource decisionmaking. For example, public health officials from  one state said that information about the capability needed to support a  national biosurveillance capability would be helpful to support lessons  learned and identify best practices. Similarly, wildlife officials from one  state said they lack knowledge about the types of wildlife surveillance  conducted by other states and other states’ baseline capabilities. They  said an assessment of capabilities could determine how their efforts  compare to other states, which would provide information to state  decision makers to guide resource decisions. According to public-health  officials from another state, some gaps in biosurveillance are already  fairly well understood—such as electronic lab reporting and workforce  sufficiency. These officials said that a formalized national assessment  would bring these gaps to the attention of federal agencies and hoped  that federal agencies would address these gaps with additional funding,  guidelines, and the prioritization of investments.
Although federal, state, and local officials we interviewed generally  agreed that a comprehensive national assessment may improve the  nation’s ability to conduct biosurveillance, all the officials we interviewed  acknowledged that such an assessment would be a complex undertaking.  Federal, state, and local officials said the size, variability, and complexity  of the biosurveillance enterprise—including federal, state, and local  biosurveillance efforts—make it difficult to define precisely what should be  measured and identifying the most appropriate assessment participants  would be difficult. For example, public-health officials from one state said  it would be important to identify definitions and create measurements with  which to evaluate capacities, otherwise it would be difficult to maintain a  narrow scope for the assessment. They also noted that the development  of this type of assessment would require the input of multiple  stakeholders. Other officials also noted that it may be difficult to identify  the most appropriate parties to provide information for the assessment.  For example, agriculture officials from one state said that identifying the  most appropriate person to complete the assessment would be difficult,  because a state veterinarian will have a different perspective from  someone who regularly works in the field. The difficulty in conducting a  comprehensive national assessment is exacerbated not only by the  magnitude of the undertaking—assessing the capabilities of the states,  tribes, insular areas, and the tens of thousands of localities in the United  States—but also by the lack of a clear mission and a vision for the  desired end state of a national biosurveillance capability. In our June  2010 strategy recommendation, we noted that the National Security Staff  and its focal point should define the mission and desired end state.
Until it conducts an assessment of nonfederal biosurveillance capabilities,  the federal government will continue to lack key information about the  baseline status, strengths, weaknesses, and gaps across the  biosurveillance enterprise to guide development and maintenance of a  national biosurveillance capability. Officials we interviewed at all levels, as  well as federal guidance and directives like HSPD-21, acknowledge that a  national biosurveillance capability necessarily rests on the cumulative  capabilities of state and local agencies that constitute a large portion of  the biosurveillance enterprise. A national strategy like the one we  recommended in June 2010—one capable of guiding federal agencies  and its key stakeholders to systematically identify risks, resources to  address those risks, and investment priorities—may be better positioned  to guide development and maintenance of the capability if it takes into  account the particular challenges and opportunities inherent in partnering  with nonfederal jurisdictions such as state, tribal, local, and insular  governments. Moreover, efforts to build the capability would benefit from  a framework that facilitates assessment of nonfederal jurisdictions’  baseline capabilities and critical gaps across the entire biosurveillance  enterprise.
section_title: Conclusions
paragraphs: A key component of preparedness for a potentially catastrophic biological  event is the ability to detect a dangerous pathogen early and assess its  potential spread and effect. Experts have noted, and our reviews of both  federal and nonfederal government biosurveillance activities confirm, that  the federal government has undertaken numerous efforts to support  timely detection and situational awareness for potentially catastrophic  biological events, but these efforts are not well integrated. As we reported  in June 2010, current efforts lack a unifying framework and structure for  integrating dispersed capabilities and responsibilities across the  biosurveillance enterprise. Further we noted that without this unifying  framework, it will be difficult to create an integrated approach to building  and sustaining a national biosurveillance capability as envisioned in  HSPD-21.
Officials at all levels of government, as well as HSPD-21’s vision of a  national biosurveillance capability, acknowledge that state and local  capabilities are at the heart of the biosurveillance enterprise. According to  federal, state, and local officials, early detection of potentially serious  disease indications nearly always occurs first at the local level, making  the personnel, training, systems, and equipment that support detection at  the state and local level a cornerstone of our nation’s biodefense posture.  Therefore, to be most effective, a national biosurveillance strategy like the  one we recommended in June 2010—one capable of guiding federal  agencies and their key stakeholders to systematically identify risks,  resources to address those risks, and investment priorities—would  address the particular challenges and opportunities inherent in partnering  with state and local jurisdictions. Moreover, efforts to build the capability  would benefit from a framework that facilitates assessment of  jurisdictions’ baseline capabilities and critical gaps across the entire  biosurveillance enterprise.
section_title: Recommendations for Executive Action
paragraphs: In order to help build and maintain a national biosurveillance capability in  a manner that accounts for the particular challenges and opportunities of  reliance on state and local partnerships, we recommend the Homeland  Security Council direct the National Security Staff to take the following  action as part of its implementation of our previous recommendation for a  national biosurveillance strategy:    Ensure that the national biosurveillance strategy (1) incorporates a  means to leverage existing efforts that support nonfederal  biosurveillance capabilities, (2) considers challenges that nonfederal  jurisdictions face in building and maintaining biosurveillance  capabilities, and (3) includes a framework to develop a baseline and  gap assessment of nonfederal jurisdictions’ biosurveillance  capabilities.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report for review to the National Security Staff,  DHS, HHS, DOI, USDA, the Department of Justice; and the state and city  officials who contributed to our review. The National Security Staff  acknowledged the accuracy of the information contained in the report but  did not comment on the recommendation. DHS provided a written  response to the draft report, which is summarized below and presented in  its entirety in appendix V of this report. USDA provided an oral response  that is summarized below. DHS, HHS, DOI, USDA, the Department of  Justice, the North Carolina Division of Public Health, and the Utah  Department of Agriculture and Food provided technical comments, which  we incorporated where appropriate.
In written comments, DHS concurred with our findings. DHS noted that its  National Biosurveillance Integration Center has key biosurveillance roles  and responsibilities, and stated that to support the Center’s mission, DHS  is working with the National Security Staff on the Sub-Interagency Policy  Committee on Biosurveillance. DHS further stated that it understands the  importance of and supports the inclusion of nonfederal biosurveillance  resources in the National Biosurveillance Strategy under development.
In oral comments, USDA concurred with our findings and  recommendations. Overall,. Specifically, USDA’s Animal and Plant Health  Inspection Service’s Veterinary Services and Wildlife Services supported  our recommendation to leverage support, consider challenges, and  develop a framework to understand the current capacity and conduct a  needs assessment for nonfederal identities to conduct biosurveillance  activities. USDA stated that it will continue to work with the National  Security Staff in development of the National Biosurveillance Strategy.  USDA noted that its Animal and Plant Health Inspection Service has an  established national program—the National Wildlife Disease Program— that is currently available to provide the infrastructure and leadership  necessary to implement these recommendations, and should be  incorporated into an integrated system. USDA noted that the program has  a history of providing leadership for national surveillance during various  outbreaks, which demonstrates its overall abilities to develop and  maintain broad local, state, tribal and private efforts to conduct targeted  biosurveillance activities.
We are sending copies of this report to the Special Assistant to the  President for National Security Affairs; the Attorney General; the  Secretaries of Homeland Security, Health Human and Services,  Agriculture, and the Interior; and interested congressional committees.  The report is also available at no charge on GAO’s website at  http://www.gao.gov.
If you or your staff have any questions about this report please contact  me at (202) 512-8777 or jenkinswo@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made major contributions to  this report are listed in appendix VI.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: To address our objectives, we reviewed key legislation and presidential  directives related to biosurveillance, including the Homeland Security Act  of 2002; the Public Health Security and Bioterrorism Preparedness and  Response Act of 2002; the Pandemic and All Hazards Preparedness Act  of 2006; and Homeland Security Presidential Directives (HSPD) 9, 10,  and 21. This report focuses on surveillance efforts for zoonoses— diseases affecting animals and humans—and other emerging infectious  diseases with the potential to cause catastrophic human-health effects.
Our work issued in June 2010 on biosurveillance efforts at the federal  level explored surveillance for the following biosurveillance domains:  human health, animal health, plant health, food, and the environment  (specifically, air and water). Given further complexity arising from the  number of and variation among states, localities, tribes, and insular areas,  we narrowed the disease scope for this report. We focused on zoonotic  disease agents, because of the particular threats associated with them  and because threats from zoonotic disease agents clearly illustrate the  potential benefits of an integrated biosurveillance capability. Given the  focus on surveillance for zoonoses and other emerging infectious  diseases in humans, certain federal efforts—for example, the Department  of Homeland Security’s air-monitoring system BioWatch—are not  discussed. Similarly, certain types of waterborne, foodborne, plant, or  animal diseases—for example Foot and Mouth Disease—that could have  devastating economic consequences or dire human-health effects are not  the focus of this report.
At the federal level, we consulted officials at the Departments of  Agriculture, Homeland Security, Health and Human Services, and the  Interior, which have key missions, statutory responsibilities, directives, or  programmatic objectives for biosurveillance activities within the scope of  this report, including protecting human and animal health and national  security. We also discussed biosurveillance issues at the state and city  level with officials from the Department of Justice’s Federal Bureau of  Investigation.
To develop background on and contextual understanding of the federal  efforts that support state biosurveillance capabilities and the challenges  officials face building and maintaining those capabilities, we interviewed  officials from 10 professional associations and research organizations  and asked for recommendations on factors to consider when selecting  states for site visits. We interviewed officials from the following  organizations:      Council of State and Territorial Epidemiologists,    Trust for America’s Health,    National Association of State Public Health Veterinarians,    American Phytopathological Society,    Association of Public Health Laboratories,    U.S. Animal Health Association,    American Association of Veterinary Laboratory Diagnosticians,    Association of State and Territorial Health Officials, and    OneHealth.
International Society for Disease Surveillance,  On the basis of information collected during interviews with officials from  professional associations and research organizations and a review of  published reports and studies, we identified several factors that could be  associated with variability in approaches, philosophies, and challenges  faced by states in conducting biosurveillance. We selected seven states  for site visits with the dual goals of capturing variation on each of these  factors and accounting for each in commonalities identified across the  states we visited. The factors we identified and their application to our site  selection are shown in table 6.
Application of factor to selection  We visited coastal states in the eastern and western United States, as well  as noncoastal states. We also visited states with large urban populations and  states with more rural populations. In addition, we visited at least one state  that has an international border.  We visited at least one state with a centralized public-health structure, at  least one with a decentralized public-health structure, at least one with a  shared or mixed relationship, and at least one with no local public-health  departments.  We visited at least one state identified by professional association officials as  having strong public-health capabilities as a result of leadership and political  will, connections between public and animal health or attention to health  security as a public-health and national-security issue. We also visited at  least one state that the professional association officials identified as part of  a group of states that had chronically struggled with resource issues.  According to association officials we interviewed, the extent to which a state  has agricultural interest has a bearing on its animal-health resources and  programs. We visited at least one state with a large industry presence for  one or more of the following types of agriculture: commercial fishing,  chickens, turkey, hogs, and cattle.  In 2007 and 2008, the Association of State and Territorial Health Officials  surveyed the states for their State-by-State Profile of Public Health. As part  of that effort, the association asked states to select from a list indicating their  top five priorities. Within the list were two priorities particularly relevant to  health preparedness generally and biosurveillance capabilities specifically.  Respectively these are: (1) assuring preparedness for a health emergency  and (2) focusing on early detection or population-protection measures. We  selected at least one state that selected neither of the priorities and at least  one state that selected one or both. There were no states that selected  priority (2) but did not select priority (1) in our sample.
The states selected were California, Colorado, Delaware, Mississippi,  New Jersey, North Carolina, and Utah. In every state, we interviewed  three groups of officials:   1.  Officials in public-health departments, including state epidemiologists,  who had responsibility for infectious-disease control, disease  monitoring, and emergency response in humans.  2.  Officials, generally including the state veterinarian, in state agriculture  departments who had responsibility for infectious-disease control and  monitoring in livestock and poultry.   3.  Officials in various departments that included wildlife infectious- disease control and monitoring in their missions. For example, one of  these was a State Department of Wildlife and Fisheries.
We also interviewed public-health officials with responsibility for human  infectious-disease control and monitoring in two cities with an increased  risk of bioterrorism—New York City and Washington, D.C.—that received  direct funding from federal agencies to support preparedness capabilities.
We analyzed the information collected during state and city interviews  and developed follow-up questionnaires to confirm and enhance  information from the interviews about the federal programs and initiatives  that support state and local biosurveillance capabilities and the  challenges officials face. We sent follow-up questionnaires to public- health departments in all seven states and two cities and to agriculture  and wildlife officials in the seven states. Within each public-health  department, we sent separate questionnaires to laboratory and  epidemiology officials. In total, we distributed 32 questionnaires and  received 27 responses. Of the 27 respondents, 7 were epidemiologists, 7  were public-health laboratory officials, 6 were state agriculture officials,  and 7 were state wildlife officials. All of the public-health, agriculture, and  wildlife departments represented by the 27 respondents had also been  represented in our initial interviews. However, in 7 cases—6 laboratory  directors and 1 state veterinarian—the lead officials to whom we directed  the questionnaire had not been present at the initial interviews. We  pretested the public-health questionnaire with a laboratory official who  was not at the original interviews in order to ensue the questions could be  understood outside of the context of the interview.
Each questionnaire had two sections: one on federal support to states  and cities and one on challenges faced by states and cities. The content  of the federal support section varied for human-health and animal-health  respondents, but the challenges section was the same for both human-  and animal-health respondents. The specific federal programs and  challenges we asked about were based on initial interviews with the  different groups of respondents. We asked respondents to consider  federal efforts over the last 2 years. Because the states and cities in this  report were not selected in a probability sample, neither the information  derived from interviews with officials nor the questionnaire responses are  generalizable across the 50 states or the tens of thousands of localities in  the United States. Rather, both the interviews and the questionnaire  results offer some perspective on the value of select federal activities to,  and challenges faced by, a group of state officials who are actively  engaged in efforts to detect and respond to major disease events. In  addition, although we interviewed officials responsible for public-health  emergency management in most state public-health departments that we  visited, we did not administer follow-up questionnaires to the officials  responsible for planning and preparing for emergency response, because  their response focus was generally not central to our scope. Because this  report focuses on detection of and situational awareness of potentially  catastrophic zoonotic and emerging infectious-disease events, certain  federal efforts that federal agencies consider important in supporting state  and local preparedness may not have been identified by state and city  officials during our interviews and follow-up questionnaires.
To consider the relationship between our findings at the nonfederal level  and our previous findings at the federal level about building and  maintaining a national biosurveillance capability, we reviewed our June  2010 findings about the centrality of nonfederal capabilities to a  biosurveillance enterprise. We also reviewed our June 2010 findings  about the purpose of a national biosurveillance strategy and the benefits it  could provide for guiding the effort to support a national biosurveillance  capability. We determined that because the federal government relies on  nonfederal resources to support a national biosurveillance capability, our  June 2010 findings about using the strategy to determine how to leverage  resources, weigh the costs and benefits of investments, and define roles  and responsibilities were particularly germane to the federal government’s  efforts to partner with nonfederal biosurveillance enterprise partners to  support a national biosurveillance capability.
To understand how the federal government supports biosurveillance in  tribal and insular areas, we consulted officials from components of federal  departments with responsibility for working with tribal or insular councils  and governments, generally, or on health-related matters. These  included: the Department of Health and Human Services’s Indian Health  Service; the Department of Health and Human Services’s Centers for  Disease Control and Prevention’s (CDC) Office of State, Tribal, Local and  Territorial Support; CDC’s Office of Surveillance, Epidemiology, and  Laboratory Services, CDC’s National Center for Emerging and Zoonotic  Infectious Diseases, the Department of Agriculture’s Office of Tribal  Relations and the Department of Agriculture’s Animal and Plant Health  Inspection Service; the Department of the Interior’s Bureau of Indian  Affairs; and the Department of the Interior’s Office of Insular Affairs. In  addition, to develop additional background and context about health  infrastructure and surveillance in insular areas, we interviewed  representatives from the Pacific Island Health Officers Association  (PIHOA), which works in the U.S.-Affiliated Pacific Islands to strengthen  crosscutting public-health infrastructure, including health-workforce  development, quality assurance, health data systems, public-health  planning, and public-health laboratories. The findings in this report about  insular areas focus on the U.S.-Affiliated Pacific Islands. With the  exception of Puerto Rico and the U.S. Virgin Islands, all commonwealths,  territories, possessions, and freely associated states of the United States  fall within the U.S.-Affiliated Pacific Islands.
To evaluate the extent to which the federal government has assessed  nonfederal governments’ capacity to contribute to a national  biosurveillance capability, we reviewed relevant presidential directives  and federal-agency documents like the National Biosurveillance Strategy  for Human Health, along with our prior work and recommendations on  building and maintaining a national biosurveillance capability. We  determined that such assessment is called for in HSPD-10 and CDC’s  National Biosurveillance Strategy for Human Health and is a critical  activity for developing an effective national strategy containing the  elements we advocated in prior work on national strategies. To  determine what types of assessment activities had been undertaken and  whether an enterprisewide assessment of biosurveillance of nonfederal  capabilities had been conducted, we reviewed relevant assessments and  federal documents like the Council of State and Territorial  Epidemiologist’s 2009 National Assessment of Epidemiology Capacity  and CDC’s Public Health Preparedness series. In addition, we  interviewed federal officials at all five federal departments, state officials  in each of the seven states, city officials in the two cities, and officials at  10 professional and research institutions that include public health, animal  health, or laboratories in their missions about assessment efforts,  including whether they had participated in or had any familiarity with an  enterprisewide assessment of nonfederal capabilities.
We conducted this performance audit from August 2010 to October 2011  in accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
section_title: Appendix II: Laboratories, Laboratory Networks, and Their Roles in Biosurveillance
paragraphs: Public-health and animal-health laboratories serve a critical role in both  initial detection and ongoing situational awareness of biological events.
section_title: Appendix III: Responses to Follow-Up Questionnaire Concerning Federal Programs and Initiatives That May Support Nonfederal Biosurveillance Capabilities
paragraphs: This appendix contains the results of our follow-up questionnaire for each  of the four categories of federal programs and initiatives that state and  city officials identified during interviews. Presented below are the  questions and response totals to the follow-up questionnaires we sent to  (1) state and city public-health epidemiology officials (called the  Epidemiology group in this appendix), (2) state and city public-health  laboratory officials (the Laboratory group), (3) state agriculture officials  (the Agriculture group), and (4) state wildlife officials (the Wildlife group)  by group, and descriptions of the federal programs and initiatives listed.
Supports Capability Enhancement: Without  this support, core functions are adequately  maintained, but enhanced biosurveillance  methods and mechanisms cannot be built or  maintained.
The content of the questionnaire varied for the different respondent  groups. For example, public-health officials (the Epidemiology and  Laboratory groups) were asked about some information sharing and  analytical products, whereas animal-health officials (the Agriculture and  Wildlife groups) were asked about others. This was based on earlier  interviews with these different groups of officials. Of the 27 officials who  responded to these questionnaires, 7 were from the Epidemiology group,  7 were from the Laboratory group, 6 were from the Agriculture group, and  7 were from the Wildlife group. For more detail on the method by which  these questionnaires were administered, see appendix I.
section_title: Appendix IV: Responses to Follow-Up Questionnaire Concerning Challenges State and Local Officials May Face in Building and Maintaining Biosurveillance Capabilities
paragraphs: Table 16 shows the results of our follow-up questionnaire for the question  concerning challenges that state and local officials may face in building  and maintaining biosurveillance capabilities. Presented below are the  question and response totals to the follow-up questionnaires we sent to  (1) state and city public-health epidemiology officials, (2) state and city  public-health laboratory officials, (3) state agriculture officials, and (4)  state wildlife officials by group, and descriptions for the challenges  identified.
Question: How do you classify the following challenges as they currently  pertain to your area of responsibility?
section_title: Appendix V: Comments from the Department of Homeland Security
section_title: Appendix VI: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Edward George, Assistant  Director; Amanda Jones Bartine; Michelle Cooper; Kathryn Godfrey;  Susanna Kuebler; and Heather Romani made significant contributions to  the work. Tina Cheng assisted with graphic design. Amanda Miller and  Russ Burnett assisted with design, methodology, and analysis. Stuart  Kaufman assisted with design and administration of the follow-up  questionnaire. Tracey King provided legal support. Linda Miller provided  communications expertise.