5
Assessing the Capacity of the Public Health Infrastructure

OVERVIEW

A strong public health system is an integral component of bioterrorism defense. Even if the contents of our biodefense arsenal were sufficient to treat any and all disease caused by a bioterrorist agent, we would still need a rapid detection and response system for the delivery of therapeutics or prophylaxis to all exposed individuals. However, there are many critical gaps in the public health infrastructure and many lessons to be learned from our response to the recent anthrax events. These gaps exist at every level—federal, state, and local—and in nearly every realm of public health, from federal laboratory diagnostic capacity to local first responder education.

The anthrax outbreak was a relatively small-scale situation. Had we experienced a massive release, the CDC and Laboratory Response Network (LRN) would have been stretched beyond capacity. Consequently, the CDC is developing more consolidated bioterrorism guidelines and recommendations to aid the federal-level response and strengthen the LRN. Local and community level bioterrorism response preparedness is equally important. Indeed, distribution to the site of the event, for example, will likely not be a problem. The greater challenge will be distributing it within the community once it arrives at its destination. There is a very strong and urgent need to strengthen local public health capacity, not just in terms of available resources but also, and perhaps more importantly, trained and organized personnel. The U.S. public health work force consists of about half a million people, most of whom have never received any formal public health training. It is essential that this work force be well-prepared and understand their role in a bioterrorism emergency. Local capacity building



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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary 5 Assessing the Capacity of the Public Health Infrastructure OVERVIEW A strong public health system is an integral component of bioterrorism defense. Even if the contents of our biodefense arsenal were sufficient to treat any and all disease caused by a bioterrorist agent, we would still need a rapid detection and response system for the delivery of therapeutics or prophylaxis to all exposed individuals. However, there are many critical gaps in the public health infrastructure and many lessons to be learned from our response to the recent anthrax events. These gaps exist at every level—federal, state, and local—and in nearly every realm of public health, from federal laboratory diagnostic capacity to local first responder education. The anthrax outbreak was a relatively small-scale situation. Had we experienced a massive release, the CDC and Laboratory Response Network (LRN) would have been stretched beyond capacity. Consequently, the CDC is developing more consolidated bioterrorism guidelines and recommendations to aid the federal-level response and strengthen the LRN. Local and community level bioterrorism response preparedness is equally important. Indeed, distribution to the site of the event, for example, will likely not be a problem. The greater challenge will be distributing it within the community once it arrives at its destination. There is a very strong and urgent need to strengthen local public health capacity, not just in terms of available resources but also, and perhaps more importantly, trained and organized personnel. The U.S. public health work force consists of about half a million people, most of whom have never received any formal public health training. It is essential that this work force be well-prepared and understand their role in a bioterrorism emergency. Local capacity building

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary will probably also require recruiting more expertise, which requires both money and time. Local medical care surge capacity—including personnel, training, space, supplies, and equipment—must be strengthened. Hospitals are nowhere near being prepared to take on the tens to hundreds of thousands of mass casualties expected in the event of a large bioterrorist event. Equally important is the frontline health care responder who will likely be the one to sound the alarm. To this end, first responders must be adequately trained to recognize the symptoms of the various bioterrorist infectious agents. Real-time response role-playing exercises based on probable biological attack scenarios would be helpful in such planning. Coordinating bioterrorism operational planning among jurisdictions, including with every hospital, will be a significant challenge since state level health departments have limited leverage to make this happen. One suggestion is to apply a model plan to be disseminated to local jurisdictions where it can then be adopted and exercised. It was recommended that jurisdictions share best practice information and new systems be integrated with systems that are already in place. LESSONS BEING LEARNED: THE CHALLENGES AND OPPORTUNITIES Julie L. Gerberding,* M.D., M.P.H. Acting Deputy Director, National Center for Infectious Diseases, Centers for Disease Control and Prevention We are learning many lessons from the recent anthrax events. By reviewing the behind-the-scenes processes as the investigation unfolded, we can identify conspicuous gaps and evaluate what needs to be done to strengthen our biodefense response capabilities. The response to the recent events can be divided into overlapping stages. The first stage was initial detection of the threat and the immediate response to what was happening. This included case detection by astute clinicians, presumptive laboratory diagnoses, and evaluation of suspicious powders. Laboratory confirmation rapidly ensued, both in laboratories within the LRN and at CDC. One of the strengths of our response was the rapid deployment of personnel, antimicrobials, and other assets in response to requests from state and local health departments, which occurred within hours of detection or confirmation of events. In the next stage, full-scale investigation and prevention interventions were priorities. This included post-exposure prophylaxis, building closure, environmental sampling and criminal investigation in addition to traditional epidemi- *   This statement reflects the professional view of the author and should not be construed as an official position of the Centers for Disease Control and Prevention.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary ologic and clinical evaluation. Interim guidance and recommendations were developed nearly in sync with these activities. We were very careful to label these recommendations “interim,” knowing that we would probably update or consolidate them as more information and data became available. The current stage of response is that of recovery and regrouping. Priorities now include optimizing post-exposure prophylaxis, promoting adherence, monitoring the short and long-term safety of the prevention interventions, building remediation, and recalling personnel and assets back to CDC. Re-entry is a very important component of the current stage of response. In other words, coping with the transition from a crisis state to a more proactive and reflective state. This includes considering ways to improve adherence to the sixty-day antimicrobial therapy, evaluating treatment, and understanding the overall impact and cost of this situation. Evidence-based guidelines and recommendations also are being developed. Most importantly, input is being sought from a variety of consultants to identify strengths of the response as well as gaps that require action to improve our capacity to respond to future events. There are several lessons to be learned regarding the CDC and federal response in particular: In terms of competency, we need new paradigms and skills at CDC. Forensic epidemiology is a new discipline for us; one that requires new perspectives and investigative methods. Working side-by-side with the FBI and other law enforcement agencies is something we have done before but certainly not on this scale or with this degree of ongoing involvement. We must learn to make adaptive decisions, that is decisions that must be made in real time with very little data and that require an experimental approach. Inducing explanations or policy decisions from immediate situations, instead of from the more extensive databases that normally frame most public health decisions, learning from new information, adjusting guidelines and policies in response, and building the science as one moves forward are necessary parts of this process. We need enhanced environmental microbiology expertise. Most of the investigations, including those that are still ongoing, are highly focused on environmental evaluation. Evidence-based air, water, and surface sampling strategies, risk assessment, decontamination methods, and re-entry criteria are needed for B. anthracis and other potential agents of bioterrorism. We must be able to quickly access expertise in a range of specialized fields, such as small particle physics, ventilation systems, and building engineering. Response capacity must be expanded. For example, laboratory capacity must be sufficient to support a large-scale event. The CDC intramural laboratory response was outstanding. Extramural public health laboratories, including those in the Laboratory Response Network, were similarly challenged and also performed extraordinarily well. Laboratorians rose to the occasion, and a number of

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary surge capacity needs were identified and fairly quickly met. Measures that were taken during the response include: CDC expanded the BSL-3 space so that anthrax typing could continue simultaneously with ongoing diagnostic studies. CDC created a new Level A laboratory in less than 72 hours that processed 600 environmental specimens per shift. On the first day of full-scale operation, the new lab processed 1,000 samples. CDC implemented a new integrated data management system which coordinated all of the laboratory results from the many participating laboratories across the center and linked with relevant patient data at CDC. Thus, we could enter a single data set and find both laboratory and clinical information about specific patients. This was a ground-breaking accomplishment which greatly facilitated daily laboratory coordination. To date, at CDC we have processed about 5,400 anthrax-related specimens, and there is still more work to be done. The number of specimens managed outside CDC exceeds 70,000. Nevertheless, this was a relatively small-scale situation. Had it been a massive release, we would have been stretched beyond capacity. Collaboration is essential. The CDC has a great deal of experience with collaboration, but we have never had to collaborate with so many partners for so long and so intensely. Key partners included state and local health departments, clinicians, health care facilities and organizations, and numerous federal agencies including other agencies in DHHS, the FBI, U.S. Postal Service, EPA, DoD, USAMRIID, and the U.S. State Department. Coordination is crucial; an effective response depends on knowing who is in charge. All layers of government and public health must be synchronized to make this kind of collaborative effort work, but how should this effort be coordinated? Internally, the CDC Emergency Operations Center was supported by a series of teams, such as environmental, postal, clinical, information technology, communications, the personnel team, the telephone hot line team, etc., that were led by senior personnel. Field investigations in each locale were directed by an on-site senior field team leader and co-leader who were linked to a corresponding support team at CDC. The operations center facilitated information flow from the field teams to decision-makers and deployment of resources and personnel to support the field teams and implement decisions. Coordinating activity outside of the CDC was especially challenging. The National Security Council (NSC), the Office of Homeland Security, DHHS, governors, and health commissioners all played important roles in coordinating CDC’s response. Communication is key. Our communications capacity was not the strength of this investigation, to say the least. We did field hundreds of phone calls during the peak times of this investigation and provided a great deal of information to those who needed it most, including critical partners in the investigation. Im-

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary mediately after the attack in New York and Washington, DC, there was almost no communication from CDC because we were operating under federal emergency response management plans. But as the investigation unfolded, we were allowed to carefully communicate a limited amount of information. Later, it became clear that more information from CDC was desperately needed, but by then we were in a reactive phase where we were trying to catch up with information needs. Clearly, a proactive information management plan is a critical priority for future response efforts. Consultation is also very important, so that we can learn as we go forward. For example, we have conducted nine consultations at CDC to solicit input from experts about how we can improve our response capacity. These have included partners from affected areas, clinicians, professional organizations, communications experts, research scientists, environmental scientists, and many others with relevant expertise. Future meetings are planned to examine other aspects of the federal response, such as how to scale up for other scenarios and how to use new detection systems to rapidly identify an event. THE RESPONSE INFRASTRUCTURE: INVESTIGATING THE ANTHRAX ATTACKS Bradley Perkins,* M.D. Division of Bacterial and Mycotic Diseases Centers for Disease Control and Prevention From October 4 to November 2, 2001, the first ten confirmed cases of inhalational anthrax caused by intentional release of Bacillus anthracis were identified in the United States. Epidemiologic investigation indicated that the outbreak—in the District of Columbia, Florida, New Jersey, and New York—resulted from intentional delivery of B. anthracis spores through mailed letters or packages. These are the first U.S. cases of intentional inhalational anthrax that we know about and the first inhalational cases in the U.S. since 1976; only eighteen other cases have been reported through the last century. The median age of patients was 56 years (range 43 to 73 years) which, in contrast to cutaneous cases, is slightly older than expected. Seventy percent of the cases were male and, except for one, all were known or believed to have processed, handled, or received letters containing B. anthracis spores. The median incubation period of the first six cases (i.e., known cases) from the time of exposure to onset of symptoms was 4 days (range 4 to 6 days). At initial presentation, symptoms included fever or chills (n=10), sweats (n=7), fatigue or malaise (n=10), minimal or nonproductive cough (n=9), dysp- *   The information provided in this paper reflects the professional view of the author and should not be construed as an official position of the U.S. Department of Health and Human Services or the Centers for Disease Control and Prevention.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary nea (n=8), and nausea or vomiting (n=9). The drenching sweats and the extent of fatigue, malaise and GI symptoms were quite dramatic and unlike what had been reported in previous literature, although some of the Sverdlovsk autopsy data showed GI symptoms in a number of the inhalational cases. On the other hand, the laboratory tests were not very remarkable. The median white blood cell count was only moderately elevated at 9.8 x 103 /mm3 (range 7.5–13.3), often with increased neutrophils and band forms. Nine patients had elevated serum transaminase levels, and six were hypoxic. All 10 patients had abnormal chest X-rays; abnormalities included infiltrates (n=7), pleural effusion (n=8), and mediastinal widening (seven patients). Importantly, the mediastinal widening was a fairly subtle feature that was missed on a couple of initial interpretations. The pleural effusions were hemorrhagic pleural effusions which were recurrent and a predominant feature of the clinical illness. Computed tomography of the chest was performed on eight patients, and mediastinal lymphadenopathy was present in seven. With multidrug antibiotic regimens and supportive care, survival of patients (60%) was markedly higher (<15%) than previously reported. Two of the deaths were probably due partly to the fact that patients did not receive antibiotics or appropriate antibiotics when they came for medical attention. For most cases, the infection was identified from blood cultures. Positive CSF cultures were remarkable in terms of the number and the striking morphology of B. anthracis; and on blood agar, they reached confluent growth in about 6 hours, which again is remarkable. Blood cultures grew for all patients whose cultures were tested prior to receiving antibiotics. The three patients who did not have positive cultures had all been treated with antibiotics; their diagnosis was made instead by a combination of immunohistochemical staining for the capsule and cell wall of B. anthracis, DNA for B. anthracis or, in one case, a serology that showed a four-fold rise for anti-PA IgG. Importantly, the diagnosis was based on specimens from the pleural cavity, pleural biopsy, transbronchial biopsies, and actual cytology blocks from pleural fluid. The eleventh inhalational anthrax case, which was not included in the above summary data, was a 94-year old Connecticut woman who was admitted on November 16. She had a 3- to- 5-day prodromal illness that was fairly vague in its manifestations and was complicated by the fact that some people were attributing her illness to depression as a result of a recent death of a friend. Although her chest X-ray was within normal limits, blood cultures obtained on the day of admission grew gram-positive rods and, over the next several days, clinical progression was rather remarkable with development of bilateral bloody pleural effusions, hypotension requiring vasopressor support, intubation and then death. Although mediastinal adenopathy had not been detected on her admission chest X-ray (probably because of dehydration), it was present at the time of autopsy. Also at the time of autopsy, her gross and microscopic findings were consistent with inhalational anthrax.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary THE CENTERS FOR DISEASE CONTROL BIOTERRORISM INVESTIGATION Kevin Yeskey,* M.D. Acting Director of Emergency and Environmental Health Services, Centers for Disease Control and Prevention The bioterrorism program at the CDC began in 1999. The program had two initial components: an intramural capacity development component intended to enhance CDC’s bioterrorism response capacity and an extramural cooperative agreement program that served to develop state and local public health preparedness for a bioterrorist event. CDC’s intramural activities included hiring of subject matter experts in priority areas of bioterrorism; expanding and enhancing the laboratory capacity to handle biological and chemical agents; development of specific communications technologies using the Internet; enhancing CDC’s surveillance and epidemiology capacity; and developing and managing the National Pharmaceutical Stockpile. The extramural cooperative agreement is a five-year program that has four focus areas: preparedness and planning; surveillance and epidemiology; laboratory capacity; and communications. Every state has received funding for at least one component of the cooperative agreement, but not all states received funding for each component. In the preparedness focus area, sites receiving funding have begun to develop public health bioterrorism preparedness plans. In the epidemiology and surveillance focus area, states have hired personnel to enhance their bioterrorism surveillance and reporting capacity. Additionally, several special projects have been initiated that utilize alternative sources for surveillance, such as medical examiners and poison control centers. State and some municipal health department laboratories have developed the capacity to provide initial screening for several of the biological agents most likely to be used as biological weapons. These labs are part of the Laboratory Response Network that enables them to have access to a secure communications system, order reagents, receive new protocols, obtain proficiency testing, and receive training from the CDC. One of the main communications activity of the cooperative agreement is the Health Alert Network (HAN). The HAN offers a means to provide rapid communication to health departments via high speed Internet access. Another, more secure, communications system is the Epidemic Information Exchange (Epi-X). This system offers a more secure mechanism to communicate to a more directed audience. There have been challenges in the development of the CDC bioterrorism program and the recent response to the terrorist events since September 11, 2001. In the area of preparedness, activity must extend beyond the creation of a *   The information provided in this paper reflects the professional view of the author and not an official position of the U.S. Department of Health and Human Services or the Centers for Disease Control and Prevention.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary written response plan. Preparedness involves assessment of a community’s vulnerabilities, resources, and threats. Bringing all concerned parties to the assessment process is one of the main challenges facing public health responders. Clinical providers, treatment facilities, and first responders must develop integrated and coordinated preparedness plans. Inclusion of non-traditional public health partners, such as law enforcement, is essential to this process. Surveillance challenges include the implementation of “real-time” surveillance methodologies that are not as labor intensive as those used during the response to the anthrax incidents. Laboratory challenges include expanding the screening capacity for biologic and chemical agents to the local level. Additional challenges include having the capacity for accurate field-testing to assess hoaxes at the scene of an event, rather than performing all testing at the state health laboratory, which often overloads them. Specimen transport can also be difficult as some air couriers refused to transport environmentally contaminated samples during the recent anthrax incidents. Communications challenges include providing accurate information on a timely schedule. Field teams must also have standardized pre-developed data management tools so that others who need to evaluate these data can easily access data gathered in the field. VA CAPABILITY TO ENHANCE THE MEDICAL RESPONSE TO A DOMESTIC BIOLOGICAL THREAT Kristi L. Koenig,* M.D., FACEP National Director, Emergency Management Strategic Healthcare Group (EMSHG) Veterans Health Administration Department of Veterans Affairs VA Missions and Organization The Department of Veterans Affairs (VA) is a cabinet-level department that has the care of veterans as its primary mission. VA manages and controls the vast medical care assets of the largest integrated healthcare system in the country. Currently, VA has 163 medical centers nationwide, in addition to approximately 450 community-based outpatient clinics, 130 nursing homes, 73 home care programs, and 206 counseling centers. VA personnel across the nation include about 15,000 physicians and more than 1,000 dentists, 58,000 nurses, 36,000 pharmacists, and 130,000 ancillary staff. Thus, VA is the federal presence in the local community, with facilities and personnel in virtually every neighborhood in the country. *   The information provided in this paper reflects the professional view of the author and should not be construed as an official position of the U.S. Department of Veterans Affairs.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary VA is composed of three Administrations: Veterans Health Administration (VHA), Veterans Benefits Administration, and National Cemetery Administration. VHA is the largest of the three administrations and has four statutory missions. In addition to its primary mission of “medical care,” VHA has affiliations with most of the nation’s teaching institutions (Education Mission) and a vast research program (Research Mission). It is the so-called “Fourth Mission” or Contingency Support that is least known. The executive agent for the Fourth Mission is the Emergency Management Strategic Healthcare Group (EMSHG). EMSHG is currently authorized 86 FTEs that include a headquarters staff of 24 and 62 out-based personnel consisting of District Managers, Area Emergency Managers (AEMs), and Management Assistants located at field offices throughout the nation. AEMs serve as liaisons to VHA’s 22 Veterans Integrated Service Networks (VISNs) by providing emergency consultation and support in the development and implementation of VISN and VA medical center emergency management plans. Comprehensive Emergency Management (CEM) Programs Emergency Management Missions EMSHG coordinates emergency management programs that ensure health care for eligible veterans, military personnel, and the public through the Federal Response Plan and the National Disaster Medical System (NDMS) during Department of Defense (DoD) contingencies, national security emergencies, and disasters. VHA’s Fourth Mission consists of the following six functions: VA Contingencies DoD Contingencies Federal Response Plan National Disaster Medical System (NDMS) Radiological Hazards Continuity of Operations/Continuity of Government EMSHG plans and coordinates VA’s role as the primary backup to DoD during war or national emergencies. It responds to taskings received by VA under the Federal Response Plan and Federal Radiological Emergency Response Plan to provide support to veterans and non-veterans alike. EMSHG also supports VA’s continuity of operations plans through maintenance of relocation sites, and operates the VHA’s Emergency Operations Center. VA, via EMSHG, assists in the implementation of the NDMS to supplement state and local medical resources in the event of a major domestic disaster or emergency. EMSHG’s AEMs provide support for VA healthcare facilities designated as Federal Coordinating Hospitals

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary for NDMS. Additional information on VA’s role in emergency management can be found on the EMSHG website at www.va.gov/emshg. VA Role in Bioterrorism VA’s primary focus is the protection of its own veteran patients and staff. In addition, Presidential Decision Directive (PDD) 62 directs VA to support the Department of Health and Human Services (DHHS) in providing adequate stockpiles of pharmaceuticals and training of personnel in civilian NDMS hospitals. VAMC Preparedness VA uses an all-hazard, CEM approach. The four phases of CEM—mitigation, preparedness, response, and recovery—are incorporated into each emergency management plan. This approach is consistent with that required by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Standards for hospitals across the country as of January 2001. EMSHG contributed significant content to the 2001 JCAHO Environment of Care Standards on Emergency Management and has been invited to develop training standards for JCAHO surveyors. Counterterrorism funding and preparations are part of the overall all-hazard, CEM approach. Under CEM, a hazard vulnerability analysis is performed in each location with assistance from the EMSHG AEMs assigned to VAMCs throughout the country. This approach provides the flexibility to meet any contingency. For example, a pandemic influenza event would have essentially the same effects on the healthcare infrastructure as biological terrorism with a contagious agent such as smallpox or pneumonic plague. While the bioterrorism event would be unique in terms of the involvement of law enforcement, VA facilities use an Incident Management System for all emergencies that coordinates all appropriate participants both within a VA facility and from outside agencies such as law enforcement. VA has a robust exercise and training program (> 400 exercises per year) that includes specific attention to bioterrorism as part of its comprehensive approach. Presidential Decision Directive 62 VA supports the Department of Health and Human Services (DHHS) in two roles under Presidential Decision Directive (PDD) 62:1) management of pharmaceutical stockpiles, and 2) training of personnel working in civilian NDMS hospitals. VA procures, rotates and manages four pharmaceutical caches for the DHHS Office of Emergency Preparedness’ (OEP) National Medical Response Teams (NMRT). These caches are mostly geared towards management of

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary chemical casualties. In addition, VA manages a “Special Event” cache that is staged at National Security “high-risk” events upon request. Through its Prime Vendor System, VA also purchases the contents of the CDC’s National Pharmaceutical Stockpile. These stockpiles are larger than the NMRT caches and contain equipment and antibiotics suitable for treatment of biological terrorism casualties. At the end of FY2001, OEP transferred $832,000 to VA EMSHG to begin training of NDMS hospital personnel. The first part of the project will be to perform a “needs assessment.” VA already has a robust education and training program. One example is the partnership between VA and Soldier Biological Chemical Command (SBCCOM) that resulted in hosting the Domestic Preparedness Program Hospital Provider Course at more than 40 VA facilities across the country last fiscal year. Federal Response Plan (FRP) When the President declares a disaster, the Federal Response Plan (FRP) is activated. VA provides personnel, pharmaceuticals and supplies upon request from DHHS under Emergency Support Function ESF #8: Health and Medical Services. In fact, since the FRP was promulgated by the Federal Emergency Management Agency (FEMA) in 1992, VA’s assistance has been requested in every major disaster that has occurred in the United States, its territories or possessions. More than 1,000 clinical personnel have been deployed along with large quantities of supplies. In addition to providing resources for presidentially declared disasters, VA has provided emergency managers to assist with the staging of medical personnel and supplies at sites of various “high-threat events” (e.g., NATO 50, Olympics, Inauguration, Papal Visit, and Economic Summit of the Eight). Disaster Emergency Medical Personnel System (DEMPS) DEMPS is a nationwide registry or database of full-time VA employees who wish to volunteer to deploy if needed to assist with a disaster. The database is maintained at EMSHG headquarters and is currently being populated. Skills, professional qualifications and credentials, and documentation of appropriate training are being collected. Some volunteers have special training in the management of terrorist attacks. VA Unique Resources In addition to its national infrastructure with personnel and facilities across the nation, VA has several other unique resources.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary gaged, who could speak with authority and credibility. People stopped calling in and the situation de-escalated. Public Health Communication A critical deficit in our plan exists in the area of public and media communications. The original national plan included an Internet backbone, hardware, secure websites, curriculum, distance learning, public information, and media programs. Most of the money, however, went to just putting computers on health officers’ desks. In fifteen California jurisdictions, the health officers didn’t have computers. The main reason we didn’t have a functional public information program in these recent episodes is that we ran out of money in that focus area. This is despite the fact that a successful response depends almost completely on what you tell the public. This also suggests a problem with priorities. Building Capacity My state faces a projected 20 percent budget shortfall this year. Since public health is not traditionally considered to be a part of the public safety system, it is not exempted from these cuts as other functions are. The threat of bioterrorism should and must change that. You do not see cuts in fire departments, and you should not see them in public health. There is some hope that this message is getting across. One issue related to the overwhelming demand placed on diagnostic laboratories is that the majority of the tests they performed involved hoaxes. This is partly due to the fact that the original model for biologic incidents is identical to a HAZMAT response to chemical exposures. As a result we wasted a lot of energy doing work on non-credible threats. However, this did illustrate the flexibility and capacity of the existing laboratory network. It showed the potential to take on such problems without much modification. The problem with our response, however, was that most of the testing was done at expensive and very sophisticated Level B laboratories rather than conducting initial screening at Level A laboratories. The very large capacity of Level A laboratories could not be used effectively. We had not fully thought about the need for that much Level A capacity. We met the demand by using more sophisticated laboratories. A Level A lab, for example, was set up at CDC. There are a lot of labs that could fulfill this role. There is also the issue of registration to handle special agents. Out of probably 2,500 clinical labs in California that can culture anthrax, there are no more than approximately half-a-dozen registered to handle it for analysis. We need to work out a way so that screening tests can be performed without sending the samples to Level B labs. Level C laboratories are needed at the state or regional level to perform the sophisticated confirmation now limited to CDC or USAMRIID. Money is part of the issue, but also workforce availability. It is very hard to find and hire people

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary with the requisite skills. One thing that has been very helpful has been the CDC Emerging Infectious Disease Fellowship Program which has assigned individuals to work with us in our labs. Expanding Level C laboratories could also help in the transfer of applied research from biotech partners to the public health network. I happen to be an Army Reserve officer and Commander of one of two small infectious disease teams that have been organized into something called Consequence Management Medical Response Teams. This is another of the many federal assets that need to be recognized and woven into our bioterrorism defense net. Learning Lessons Finally, we have not given enough attention to “war games” and exercises. Those that have been conducted, for example, Dark Winter and TOPOFF, revealed vulnerabilities and were very sobering to participants and observers. Recognizing and responding to those vulnerabilities, we should conduct realworld exercise that drill down to the local response. Different variations should be tried in two or three settings. Not only would we learn a lot, we would get local responders involved in the learning process. If the real thing happens, we will be much better prepared to respond. U.S. PUBLIC HEALTH SERVICE OFFICE OF EMERGENCY PREPAREDNESS Donald C. Wetter,* P.A.-C., M.P.H. United States Public Health Service There was much valuable information shared in many areas during the meeting at the IOM. While briefly mentioned on occasion during the conference, the topic of surge capacity of hospitals and other medical institutions during a biological terrorism incident needs more emphasis. This includes hospital bed capacity, alternate care facility use, medical provider staffing, medical logistics and operations to name but a few areas. Laboratory capacity, public health information, vaccines, etc. were important aspects of the discussion regarding preparedness for and response to bioterrorism. This planning is incomplete without fully integrating the community that is caring for the victims of these attacks. The assumption for this discussion is that there would be a large number of patients presenting to the healthcare system. It is difficult to define the term “large” in the context of bioterrorism because even an incident with relatively few patients ill from a bioterrorism agent could also create thousands of “worriedwell” individuals presenting to a hospital. With this in mind, the healthcare system *   The information provided in this paper reflects the professional view of the author and should not be construed as an official position of the United States Public Health Service.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary must be able to respond to all individuals seeking care. The current financial state of US hospitals has decreased the likelihood that a significant number of beds will be available for a sudden increase in patients. Staff shortages and closure of hospitals or sections of some facilities create a daily marginal surge capability. The issue of staffing is not only numbers; it remains education on bioterrorism issues. Again, due to the strain on the current medical system, it is difficult to fund training for hospital staff. Competition for staff time because of the rapid pace of increasing medical knowledge also lowers the probability that a hospital or practice manager will choose terrorism for staff education over other more commonly seen diseases. Though most emergency services use some Incident Command System (ICS), it appears that many hospitals and public health agencies are not familiar with the system or at least do not wish to adopt it. In the complex operations of terrorism response, it is essential that the healthcare institutions coordinate with the rest of the community emergency management and use some form of ICS. As discussed throughout this meeting communications and coordination are vitally important. This was reinforced to me after my six-week assignment at the New York City Emergency Operations Center during the World Trade Center incident, anthrax investigation, and American Airlines 587 crash. Finally, the issue of funding emergency response to a biological event needs to be addressed. The Federal Emergency Management Agency is tasked with the lead in consequence management for a terrorist incident. While FEMA took the lead for the World Trade Center and much of the response funding, the agency did not do so for the bioterrorism response of the anthrax event. The policy regarding this part of disaster management is unclear. FEMA funded some states in their response to the West Nile virus, but to this date, not to the anthrax attack. Hospitals and health departments will possibly need access to additional funds to respond properly to bioterrorism events. ASSESSING STATE AND TERRITORIAL HEALTH DEPARTMENTS James (Jerry) Gibson, M.D., M.P.H. Director of Disease Control, South Carolina Department of Health and Environmental Control and immediate past president of the Council of State and Territorial Epidemiologists I will state my perceptions of the preparedness of state and local public health departments to detect, investigate, and respond to potential bioterrorist attacks and threats of such attacks. I am making one fundamental assumption that I believe most of us share here: that a major long-term goal in building an effective response to bioterrorist attacks is to re-build the American public

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary health infectious disease control capacity which suffers currently from at least thirty years of deferred maintenance. This disease control capacity is congruent with the acute infectious disease control infrastructure, which consists of trained organized people, communication systems and laboratories. The state of disarray of these systems is summarized well in the Institute of Medicine’s 1988 report The Future of Public Health. I have seven points to make, and then six recommendations. First, public health organization and capability are highly varied across the 51 state and 3,000 local health departments of the United States. Some are strong, but many are very weak, some of those large population centers. However, the need to respond well to a bioterrorist threat is present in all jurisdictions. Therefore, there exist critical disparities in needed capability. Our preparedness building cannot ignore the weak departments. Second, the public health system is very fragmented in many states. Local health departments are separate from the state health department, which has little leverage to improve them. Often they communicate minimally, and working in partnership is difficult. Third, our task for bioterrorism preparedness is to build complex human systems that must work right the first time they are challenged. That is difficult: people are less consistent than vaccines. It implies to me that the bioterrorism response systems must be integral parts of the regular infectious disease surveillance and control systems if they are to be exercised regularly, and perform when needed. Fourth, in the end, public health response capacity is trained people. Local health departments in particular are very short of these. Thus capacity building requires recurring funds to hire people, not a one-time capitol investment. There is no way around this need. Fifth, to plan, organize, hire staff and train them takes time. Even in the private sector it takes time, and the ability of state and local health departments to adapt to urgent circumstances and speed up operations is also highly variable. Thus finding ways to help state bureaucracies develop a sense of urgency, while still maintaining their programs for HIV/AIDS, family planning, diabetes mellitus, vital statistics, etc., is essential. The key implication of this fact is that the speed at which health departments can absorb new funds is limited; capacity building does not happen overnight. Sixth, “planning is an unnatural process….”. Getting a bioterrorism operational plan, integrated with key partners, in every county and city (not to mention every hospital) is a major challenge. Health departments have limited leverage to assure it happens. Thus this critical process of assuring local bioterrorism preparedness planning will take substantial resources. Seventh, the most important point, most state health departments are very dependent on federal grant funds to operate their programs. In the state of South Carolina, about 38% of the integrated health department’s (state and the 46

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary counties) budget comes from federal cooperative agreements; another 38% is earned from Medicaid and other sources, and thus is not available for bioterrorism preparedness. Essentially all the discretionary funds are federal. Therefore, I would like to propose six principles by which new federal bioterrorism grants be allocated to state and local health departments. These principles come from a new document from the Association of State and Territorial Health Officials (ASTHO) Anti-terrorism Task Force. Such grants should provide for state flexibility of use. Funds should be routed in such a way that their use for public health is assured, but beyond that the state should have the discretion to spend them where they are most needed. Also, states should have the authority in emergencies to redirect federal grant funds and federally funded staff to areas of critical need, without penalties. This process should avoid cumbersome multiple layers of permission seeking from the granting agency. Funding should be based primarily on state need rather than be competitive. Given the wide range of state capabilities, competitive funding will only make the strong stronger and leave the weak as vulnerable as before. Funding budgets must be multi-year, to allow for the time needed for states to absorb funds. Funding will have to continue to some extent long-term, since new staff are an essential part of preparedness. State and local health departments should be required to plan and submit funding proposals together, so that planning and implementation can be coordinated. Likewise, the grant process should require coordination and communication between public health and other agencies receiving bioterrorism funds. A mechanism is needed for state and local health departments to share best practices and ideas that work rapidly. Possible a series of ongoing emailbased surveys of innovative ideas could help do this. New information, communication or surveillance systems should be built on or be integrated with existing systems such as NEDSS, HAN and Epi-X. I was also asked to give my first three priorities for action to build state and local public health response capability to a bioterrorist attack. These are: Make federal cooperative agreement funds available to all states to be used primarily to build city/county public health capability for disease surveillance and investigation. In many states, what is likely to work best is to hire surveillance and epidemiology mentor/trainers on a regional basis to train, support and work with local-level infectious disease control staff to build active surveillance. These regional bioterrorism epidemiology staff can also promote local liaison between key participants and preparedness planning. Provide good educational materials and methods of dissemination by state health departments for primary care clinician education on detection, reporting, clinical care, and infection control of the first-line and also second-line bioter-

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary rorist agents. The dissemination should be via grants to states and large city public health departments, because the optimal method of disseminating and reinforcing the messages will vary locally and must be determined locally. A major purpose of such education programs should be to build relationships between state/local health departments and clinicians. Provide sufficient funds to complete the national, state-based system of electronic infectious disease surveillance (NEDSS) which has been begun. This is a very challenging task and will take several years to complete, test, de-bug, and optimize. It will also require significant recurrent costs for maintenance. COUNTERING BIOTERRORISM THREATS: LOCAL PUBLIC HEALTH PERSPECTIVES Thomas L. Milne Executive Director National Association of County and City Health Officials In most communities, it is typically a local or state public health department that responds when there is a diagnosis of even a single case of a serious infectious disease. A significant outbreak often results also in the mobilization of resources from the Centers for Disease Control and Prevention. Fortunately, local, state and federal public health efforts have successfully contained most outbreaks of infectious disease in recent years to a relatively small number of cases. The growing concern that an intentionally caused event involving a biological agent could occur in this country have prompted many activities directed toward increasing public health preparedness. Local public health agencies, along with the National Association of County and City Health Officials in Washington, DC, have been engaged in bioterrorism preparedness work since 1999, in partnership with CDC, representatives of state health departments, and representatives of local boards of health. Local health officials urge that the following principles and factors guide the work ahead: Principles There is significant likelihood that terrorism events involving biological agents will occur. Such events will take place in communities and will affect people living in communities. While state and national level preparedness is important, it is very important that communities be prepared as well, with preparedness plans and necessary capacities to respond in place. Preparedness plans, to be effective, must be developed through broad collaboration including all significant stakeholders in communities, including hospitals, emergency responders, fire, law enforcement, public health, physicians, and elected officials.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary There is a significant under-investment in public health, particularly at the local level, where capacities have been declining in recent years. Virtually no local public health agency, regardless of size and level of budget, has the full range of capacities needed to assure an adequate public health response to bioterrorism events. Significant resources are needed from the federal government to assure that the local and state infrastructure is adequate to the tasks required. Investment in public health preparedness for bioterrorism will have multiple benefits because the capacities and competencies required are directly applicable to the general daily responsibilities of public health departments at the local and state levels. Local Public Health Infrastructure There is no such thing as a consistent local public health system. There are approximately 3,000 local public health departments in the U.S. Most are small and serve small populations. The median size health department employs 13 staff while the mean size is 67 employees. About 70 percent of local health departments serve populations of 50,000 or smaller. Most are agencies of local government, with county health departments the most common form. However, in 16 states (primarily in the east and southeast U.S.), local health departments are mostly or entirely local offices of the state department of health. About 160 counties in the country have no form of local public health services. Services, authorities, and staffing levels vary widely among health departments, and no two are the same. The increased and much needed emphasis on public health preparedness should prompt discussions of the need to build a more consistent system of local public health, assuring that the necessary capacities and competencies are available to serve all residents of the country. Strategies to address this need should begin with local and state initiatives and, only if and where needed, include federal mandates. Needed Capacities The capacities needed to assure adequate local (and State) public health preparedness include the following: A workforce of adequate size and with adequate training. Adequate public health laboratory capacity. Increased epidemiology capacity including significantly upgraded surveillance systems. Information systems which are secure, continually updated, and highly accessible to local and state public health officials.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary Communications systems which are secure, offer redundancy, and provide full time high speed access to information systems. Federal, state and local laws and policies which fully support the emergency powers needed by public health officials to respond fully and quickly to bio-events and other public health emergencies. Capacity to participate in community preparedness planning, which includes the testing and practice of such plans. Financing Needed An absolute funding level needed to assure local public health preparedness cannot be defined, especially given the many shortcomings associated with the lack of consistency among local health departments nationally. It has been estimated that between $835 million and $1.3 billion are needed annually for five years to develop a fully prepared local and state public health system. Clearly, such federal investment would need to be continued at a maintenance level once the system has been built. Accountability Accountability for expenditures and outcomes is an essential aspect of the large investment necessary to build a fully prepared system of local and state health departments. Financial accountability measures should assure that states maintain their current levels of support for state and local public health activities. The gains achieved in capacities and competencies should be documented and compared against a set of standards. The National Public Health Performance Standards Program has been developed and is scheduled for implementation in 2002. That program may provide a basis for mandated performance once federal funding has been assured and is in place. PUBLIC HEALTH PRIORITIES FOR RESPONDING TO BIOTERRORISM Ruth L. Berkelman, M.D. Department of Epidemiology Rollins School of Public Health, Emory University Senator Frist challenged us at the beginning of this workshop to articulate better to the public what is meant by the term public health infrastructure; he challenged us to explain clearly and in lay language why public health infrastructure is critical to bioterrorism preparedness. We have not fully addressed this concern the past two days, and we need to accept this challenge and share with people what we mean by “public health infrastructure,” in a way that everyone understands.

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary We need to assure our communities that a good public health infrastructure will provide them with nurses, doctors, and others who are trained in public health—experts who make it their business to know what is happening in terms of health in their community, such as whether there is an epidemic of influenza in the community, or a meningitis outbreak at a local high school or a bioterrorism attack—experts who know what to do to protect their community when public health threats such as these occur. The public needs to know that professionals in public health are in place that can investigate problems and provide guidance to individual doctors and other healthcare providers in their community. Public health professionals also work with schools, industry and the general public to protect the community. They assure that families are safe from epidemics and other threats to their health, that vaccines and antibiotics are available to the whole community and can be administered and/or distributed as necessary to protect the community’s health. We need to talk to the community in concrete terms about public health infrastructure and protection of public health, just as we do with fire and police protection. I want to turn now to six issues related to bioterrorism preparedness that have emerged in the discussions the past two days. These are not comprehensive, but they do represent priorities for public health preparedness. First, there is a need to strengthen the local and state public health departments. In the context of this forum, there is a great deal of overlap between the public health infrastructure and bioterrorism preparedness. They are not identical, but public health infrastructure is required to assure bioterrorism preparedness. This means, in part, an infusion of resources and trained personnel. At the same time, there is a need to examine the current organization of public health departments. Jerry Gibson described the striking disparities among local health departments. There may be a part-time nurse with 1 or 2 clinics a week for a community of 4,000 people; there may be no one available for emergencies. The state of Georgia has 19 health districts and 159 health departments. Each state is going to have to look at its needs and decide how best to proceed. Is Georgia, for example, better off working with the 19 districts or the 159 departments, or is yet another balance needed? Perhaps some of those departments should be consolidated for the purpose of preparedness for bioterrorism. As new resources are appropriated for use by local and state public health departments, a reexamination of the existing organizations may be helpful to assure that their use is efficient and effective for preparedness for bioterrorism and other major public health threats. A second issue is disease detection and the need to strengthen surveillance. There currently is great interest in syndromic surveillance as a tool for early detection of bioterrorist events. We need to explore these systems further—systems based on pharmaceutical data, 911 calls, clinic visits, and so forth—to de-

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary termine the diseases, syndromes, and conditions for which they might be important, and those for which they are not. Rigorous evaluation will be needed. While syndromic surveillance may prove useful for some health alerts, the traditional system of having a doctor, infection control practitioner, or other health professional know what to be alert to, and who to call when they are concerned will remain fundamental. For example, it is unlikely that a system utilizing emergency department visits and based on ICD codes for fever and rash will substitute for a well-trained health care provider for the early detection of smallpox. Ed Eitzen from the Department of Defense said one of the most important defensive measures we can take is training of the healthcare provider. We need to assure education of physicians and other healthcare providers and strengthen the liaison between public health agencies and the healthcare community. A third issue is vaccine development and procurement. The number of companies producing vaccines has declined dramatically in the past two decades, and the production of some important vaccines like the one for adenovirus was curtailed although the vaccine was still needed. There has been relatively little incentive for companies to produce new classes of antibiotics. Who is responsible for ensuring that the American public has the vaccines and antimicrobial agents that they need? What agency? There needs to be a clear mandate defining responsibilities in this realm. A fourth issue is surge capacity. Renu Gupta raised the important need to look at the possibility of having/using reserve expertise in the private sector. We need to utilize both industry and academia during times of need both for their expertise and their surge capacity. During the anthrax crisis, they came forward and offered their help, but it was difficult for public health agencies to harness these resources. It is far more difficult to organize volunteers in the midst of a crisis if there has not been advance planning. It is likely that in the wake of the terrorist attack, private industry and academia will be even more inclined to participate in such planning today than before the terrorist attacks. One example of the need was the shortage of surge capacity in the laboratory during the recent anthrax incident. We should take steps to avoid the situation where CDC needs to conduct Level A lab analysis for anthrax, and states may be back-logged to a degree that could jeopardize public health. A fifth issue is the need for interdisciplinary groups to work on applied research questions in the area of bioterrorism. Applied research to answer simple questions sometimes falls through the cracks. Although this may be due to lack of resources, sometimes it may be due to the lack of clarity as to who is responsible for defining and conducting needed research that does not fit with one specific field of scientific inquiry. Yet, applied research on such issues as the potential for dissemination of anthrax powder through handling of envelopes and on decontamination following release of anthrax powder can be critical. Establishing interdisciplinary groups to determine research needs and to implement the needed research may be useful. It is good to hear of CDC’s plan to conduct

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Biological Threats and Terrorism: Assessing the Science and Response Capabilities - Workshop Summary meetings in the coming weeks to establish an applied research agenda for anthrax, meetings which will include experts from a variety of scientific fields and who represent both the public and private sector. The final issue I want to address today is the necessity for the intelligence community and the scientific community to work together. The intelligence community needs to inform scientists, but scientists need to help the intelligence community, too. When a scientist is disaffected, the intelligence community may need to be alerted; when a scientist is discovered by other scientists to be conducting work that may inadvertently lead to adverse consequences and where the risk is deemed greater than the potential benefit, the scientific community needs to stand collectively against such work. We also need to think about cross-training between the intelligence community and the public health community. We in public health have been hearing about the importance of documenting the chain of custody of samples for forensic purposes, and many have not understood the term “chain of custody”; public health professionals may need some training in forensic sciences to better understand the needs of that community. Also, the intelligence community may need training in public health concerns. The FBI may want to consider having some of its experts trained in the Epidemic Intelligence Service (EIS) at the CDC. The Department of Defense has had people trained in EIS for several years, and that has been quite beneficial.