Assessing the Capacity of the Public Health Infrastructure
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
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-
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
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-
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-
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.
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
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.
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:
Federal Response Plan
National Disaster Medical System (NDMS)
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
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.
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
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.
There are robust research and education programs with affiliations with most of the country’s medical schools.
Telemedicine or telehealth is another resource that might be especially useful in a bioterrorism event with a contagious agent so that experts could view patients from a distance.
The Prime Vendor System allows economic and efficient purchase of pharmaceuticals and supplies.
National alerting and communications systems are in place and routinely tested.
VA also has extensive expertise in the identification and treatment of victims experiencing Post Traumatic Stress Disorder and counts large numbers of stress counselors among its assets.
EMSHG Technical Advisory Committee
In July of 2000, EMSHG formed a Technical Advisory Committee (TAC). The TAC is a multidisciplinary group of internal VA leaders and emergency management experts from federal partner agencies such as DHHS, FEMA, DoD, CDC, and the Federal Bureau of Investigation. The first goal of the TAC was to advise on preparing VA medical centers for any type of weapons of mass destruction threat.
The TAC was divided into the following task forces: Organizational Support; Basic Training; Decontamination and Personal Protective Equipment; Accessing Stockpiles; Surveillance; Quarantine; VA’s Role in the Local Community; and Research and Assessment.
Emergency Management Academy
In the fall of 2001, EMSHG initiated the Emergency Management Academy (EMA). The EMA has a focus on emergency management and healthcare. Target audiences will be trained using web-based technology, satellite videoconference, and hands-on sessions. A knowledge management library is posted on the EMSHG website as part of the EMA. VA is capable of granting continuing medical education credits. Accreditation is provided not only for VA personnel, but also for attendees at the annual NDMS conference and other major disasterrelated conferences and programs.
One of the major issues that our nation faces is the lack of surge capacity. This is due in large part to the influence of managed care and the resultant shift to ambulatory services and decreases in in-patient beds. The national nursing
shortage contributes to this lack of excess patient care capacity. Further, if we have a concurrent overseas conflict and U.S. disaster, reservists will be mobilized further draining the health care system. While we currently count beds to assess capacity, beds are no longer a good surrogate marker. We need to develop methods to assess patient care capacity and explore creative solutions to the lack of surge capacity.
VA is the largest national integrated healthcare system with facilities and personnel across the country. The initial response to any disaster is local—it will take some time before state and federal resources can be mobilized. Therefore, VA is uniquely positioned to assist with both local and federal counterterrorism efforts. While our primary focus remains protection of our ability to care for veterans, VA also provides the federal medical presence in the local community since we are “in and of that community.”
THE PROGRESS, PRIORITIES, AND CONCERNS OF PUBLIC HEALTH LABORATORIES
Mary J. R. Gilchrist, Ph.D.
Director, University of Iowa Hygienic Laboratory
President, Association of Public Health Laboratories
The Laboratory Response Network (LRN) was instituted in 1999 in preparation for the U.S. response to bioterrorism. The LRN consists of public health laboratories that form linkages to the private hospital, clinical, and referral laboratories, which refer isolates to the public health laboratories for confirmation of identity of suspect microorganisms. The system was not fully operational when the October anthrax events began but, even so, it functioned relatively well. One can only guess at the difficulties that would have occurred without the embryonic phase of the LRN. Human illness was limited so the system was not fully tested for dealing with a large outbreak of disease. However, it did appear to work even though training had not been widely and intensively administered to the local laboratories. In several cases the isolates of Bacillus anthracis were presumptively identified at the local laboratory and referred to the state lab for full identification. It is apparent that without widespread knowledge of the diagnosis of illness, some of these cases might have been missed completely.
Because the event played out over several weeks in the form of envelopes being delivered to offices, the primary challenge to the public health laboratories was to rule out other suspect powders. At the peak, the public health laboratories in the LRN were testing over 1,200 powders per day. These were those powders that were deemed a credible threat by the law enforcement community so it is likely that some ten-fold or greater numbers were evaluated and rejected as non-
credible threats. Even following this filter by law enforcement, the impact of the public health laboratory testing was significant. If you assume that 5 to 10 people were exposed to each of the credible threats, on average, then 6,000 to 12,000 people per day were saved from fear and/or the need for prophylaxis. In some states the management of the program was smooth and in others capacity was exceeded and turnaround time prolonged. Obviously fine-tuning is necessary. The good news is that the private laboratories rapidly became motivated to learn to test for bioterrorism agents and that public health laboratories developed greater ties with the emergency management community so that the next event can be more readily managed even if it involves greater numbers of human illnesses.
A full evaluation of the testing capacity of the LRN should be conducted. The CDC has been collecting data that should be subjected to scrutiny and projections made about future capacity. The various types of tests should be scaled for their relative effort. With the chain of custody and evidence documentation procedures that we used at University Hygienic Laboratory (UHL), as well as the complex packaging, the suspect powders were extremely labor intensive. Environmental and nasal swabs were more easy to open and required no evidence documentation but the environmental swabs had more spore formers to evaluate than did nasal swabs. An approximation of relative effort for powders:environmental swabs:nasal swabs would be 10:4:1. Thus, if a facility claims to have conducted a large number of tests, the relative effort demands of the various types of tests should be considered. Most of the 1,200 tests cited in the paragraph above were powders but a few facilities also reported swab samples.
After the events of October and November have played out, a full assessment of the LRN is indicated. Evidently, it will be imperative to provide realtime communication of testing capacity throughout the system. This would allow for redistribution of effort where needed, to identify sites not at capacity that could relieve those exceeding capacity. Originally, a proposal for a protected website to perform this function was entertained but not implemented due to concerns about security. If a website cannot be adequately secure, the rapid development of an alternative is strongly recommended.
The testing of samples during the fall bioterrorism outbreak was primarily conducted using conventional methods, culture and staining. These tests are relatively accurate but speed is often important and the culture requires 2–3 days to produce a final result. More rapid tests are being adopted. Many states have purchased advanced instrumentation for real time amplification (PCR-type) testing, for example, Smartcyclers, Lightcyclers, and ABI 5700 or 7700 TaqMan devices. The reagents for use with these devices are being produced at CDC. The proficiency tests to confirm the adequacy of the reagents and devices were underway in many states when the anthrax outbreak began. The CDC should be recognized for its prescience in developing these assays and supported in furthering this cause. The rapid identification of organisms is very important and should be advanced. Reagent production should be supported fully so that it is
adequate and timely. Manufacture, storage, and distribution of reagents should be protected from other types of terrorism by consideration of off-site locations and stockpiles. States should have redundancy in instrumentation so that when an instrument fails, there is backup testing capacity available. The validity of the tests should be fully demonstrated. FDA approval should be sought so that specimens from humans can be fully evaluated in a rapid fashion.
Smallpox diagnosis should be part of the system available for PCR-type testing in the states. The specimen would be decontaminated prior to testing, obviating the need for BSL-4 facilities, so safety is not a limiting issue in states where BSL-2/3 facilities are available. Although it is true that most true cases of smallpox may be readily identifiable clinically, there will be skin rashes that cannot be ruled out. Moreover, it is possible that atypical rashes may not occur in those who were previously vaccinated, as we encountered in the atypical measles cases of the latter part of the last century. Rapid specific etiologic identification will minimize panic and preclude excess use of limited supplies of vaccine. We must have widely dispersed capability for rapid diagnosis. The bioterrorism events of the last two months have fully demonstrated the accuracy of this imperative.
The advent of bioterrorism this fall allowed the recognition of other needs. Security of the laboratory building became a priority in Iowa when the “Ames” strain was said to be the cause of the first case of anthrax. The media stated that the organism was “man made” in a laboratory in Iowa. The National Guard visited the UHL that evening and they stayed to guard our building for several weeks. Our building is a multiuse building that was built in 1917 to serve as a tuberculosis sanitarium. There are many security challenges that we face as we prepare to bridge the interval preceding occupancy of the new building that we seek. Security arrangements range in the other state public health laboratories from sophisticated in California to minimal in other states. The CDC has reinforced its security following the events of September 11 when it was closed due to the threat of terrorism. It remains a potential target for future events and should duplicate functions elsewhere whenever they constitute a critical path. Public health laboratories should be subject to critical infrastructure protection not unlike transportation and energy structures.
Among the needs that we recognize are specimen transport and communications capability enhancements. To fulfill these needs, courier systems and communication devices, respectively, are now recognized as critical. Finally, safety remains an issue in many laboratories. Although Biosafety Level 3 laboratories are present, or being planned and built in most state public health laboratories, they may not be situated in close approximation to all areas where they are needed. Optimized safety facilities will decrease turnaround time and maximize surge capacity.
Among the problems that were recognized during the last two months were those of communication between the Level A (hospital or clinical laboratories) and the Level B/C (public health laboratories). The National Laboratory System
(NLS) is the concept currently under consideration for implementation to link public health and private laboratories. It is being evaluated in four states that are employing prototype methods to form these linkages. Prior to September 11, 2001, many private laboratories were not convinced of the need for bioterrorism training. Thus, such training was shunned when it was offered. Now, the laboratory community is anxious for training and for linkages. The National Laboratory System (NLS) should be fully implemented throughout the U.S. When implemented, it will provide reciprocal communications links, feedback of results to the private laboratories and of needs to the public health laboratories.
The LRN should be linked with other laboratory networks that have complementary functions. The veterinary diagnostic laboratories in the states have recently formed a network with the National Veterinary Services Laboratory (NVSL) at the hub. This veterinary laboratory network is comparable to its human diagnostic counterpart, the LRN with the CDC at the hub. Linkages between the two networks would facilitate the efforts of both networks. Zoonotic microbial agents that are familiar to veterinarians and their laboratory communities cause many primary bioterrorism disease threats, e.g., anthrax, tularemia, plague, and brucellosis. Indeed, if used by terrorists the organisms may strike both humans and animals. For these reasons, greater linkages between human and veterinary laboratories are strongly indicated. Other potential linkages would include those with military, food, and environmental and international labs. Many of these linkages are already being discussed. Funding and organizational planning will breathe life into the linkages and make them function.
Chemical terrorism laboratory capacity should be distributed widely throughout the states. At present there are only some five states that have such funding and are developing capacity. None of these are in the plains states so Iowa would not be well served should there be a chemical terrorism event. It would be particularly problematic should air traffic be simultaneously shut down and no specimen delivery could occur. The bioterrorism events of the past two months have definitely taught us that laboratory capacity should be widely distributed and under local control. Similarly, testing for chemical terrorism must not be limited to a few sites.
With some $8 million annually, the CDC administers funding and coordination of the LRN. Although these limited funds were instrumental in supporting the planning and organizational phase, they are inadequate for the operational phase of the LRN. The amount being distributed to the states is inadequate to fully fund laboratories that must continue routine operations and also sustain efforts directed at identification of bioterrorism agents. The UHL is currently receiving $100,000 per year for its bioterrorism grant. This amount is insufficient to support a sustained effort and would strain the capabilities of the current staff beyond the breaking point. Federal funding should be enhanced so that the system can operate smoothly.
The concept of “dual use” should be widely celebrated. The PCR instrument at UHL that was purchased with bioterrorism funding is also used for detection of West Nile Virus, whooping cough and a host of other agents. Our staff members work on detection of other agents during times of quiescence in bioterrorism. They must do so to retain full proficiency in identification of all agents. It is not possible to be proficient at identification of bioterrorism agents unless one can identify all other agents. The government should embrace the concept of “dual use” as necessary as well as economical. The emergence of infectious diseases occurs either naturally or intentionally and the means of emergence cannot be ascertained before the agent is detected and identified. From time to time, governmental agencies drift toward compartmentalizing funding and restricting dual use as though it were an evil. In truth, it is an inevitable, necessary and highly laudable use of funding.
A major concern to the bioterrorism response community is the prospect of false positive and false negative tests that may be produced by devices currently owned or being sold to first responders and to citizens. The “Smart Ticket” is a hand held device originally used around military bases to continuously monitor air for presence of incoming agents. When used in this fashion and backed up by confirmatory tests, it has worked adequately. However, in recent years it was purchased by the first responder communities for delivery of instantaneous results. Unfortunately, the device gave false positive signals in numerous instances. These false positive signals may have subsequently depleted capacity to manage real events. Organisms such as Bacillus subtilis and Bacillus cereus, present in soil and dust, are common sources of false positive signals. Bacillus thuringiensis, the agent used on vegetables as an insecticide, is also a source of false positive signals. Testing some green peppers with the “Smart Ticket” led to the fear that foods were contaminated with B. anthracis spores in at least one incident. Not only are false positive results a problem with this device. Unfortunately, the device requires as many as 10,000 spores to yield a positive result. Thus, it also may cause many false negative results. The CDC published an admonition against the use of the “Smart Tickets” for decision-making. Stronger constraints against the use of the device should be considered.
An ominous situation may be at hand with regard to a new group of test devices. There are several new devices being marketed for home testing. One is potentially hazardous to health. It involves a growth medium said to be selective for Bacillus anthracis that also claims to provide some indication of the identity of the species. Although one might argue that the isolation of the anthrax bacillus would be rare and thus the device not hazardous, it remains to be proven that the device would not grow other hazardous organisms. The device has a sticker warning the curious that an anthrax culture is in progress but this is not a convincing safety element. Of greater concern than safety, perhaps, is the potential for production of false positive results that will confound the public health community and unduly deplete resources. Testing devices should be regulated
even when they are not for use on human clinical specimens. If these devices are not regulated, test results may mislead investigators and divert attention from critical needs. Worse, the results may lead to unprotected exposures to hazardous agents, followed by disease and death.
Although not fully functional, the LRN was a relative success story during the last two months. This fact should not cause us to conclude that the LRN has been fully tested for functionality in upcoming bioterrorism attacks. The LRN was not subjected to the greater stresses that it would have to endure if/when there is an event involving large numbers of ill individuals. Post event evaluation of the LRN should be conducted to ensure that weaknesses are identified and repaired and strengths are amplified and systematized. The Association of Public Health Laboratories is currently composing a questionnaire to distribute to the public health laboratory community to identify unmet needs that were identified during the fall anthrax outbreak. Good planning should be based on credible data. Funding should follow the need for a better system and should support areas of greatest need.
THE ROLE OF THE CENTERS FOR PUBLIC HEALTH PREPAREDNESS
Stephen S. Morse, Ph.D.
Mailman School of Public Health
The public health system is at the forefront of our defenses against bioterrorism, as it is against infectious diseases in general. As demonstrated by the recent anthrax events, the first indication of an attack may well be the appearance in emergency rooms or doctors’ offices of people sick with an unexpected illness. Conceptually, many of the steps that the public health system needs to take in order to strengthen our national biodefense are very similar to what needs to be done to prepare for an unexpected, naturally occurring outbreak of infectious disease (call it “emerging infections plus”). Not only is public health an important component of biodefense, it may perhaps be the only component in the earliest phases of a response to a bioterrorist attack. Sustaining this capacity between crises poses a difficult but essential challenge to recognizing early warnings and saving as many lives as possible. The U.S. public health work force consists of about half a million people, many of whom have never actually had any formal training in public health. Ensuring that the entire work force is well-prepared and understands its role in an emergency is an important need.
Showing great foresight in this regard, last year the CDC set up a new program (through a cooperative agreement with the Association of Schools of Public Health) to build a network of centers for public health preparedness that links academe and public health practice. The goal was to develop competency-based
curricula in public health that would be appropriate to local needs and could also serve as models for national replication and national testing. It is also a goal to provide materials through technology-supported learning, which means that the information should be available on the web or by other means such that people can access it at any time for training purposes.
Currently, there are seven academic centers in the system. Columbia University was one of the first academic centers in the system to receive funding; Columbia’s center at the Mailman School of Public Health is partnered with the New York City Department of Health to focus on emergency preparedness, including bioterrorism and infectious disease preparedness. Members of the center include people with public health backgrounds as well as specialists in curriculum and distance learning. Development of the preparedness plan required initially looking at already existing preparedness plans for New York City to see how they could be revised and strengthened. Dr. Kristine Gebbie (a Center member) and her colleagues at the Columbia University School of Nursing had developed a set of emergency preparedness competencies for public health, to serve as a basis for developing training. The core competencies for public health workers include such fundamental items as “describe the public health role in emergency response” and “describe the agency chain of command in an emergency.” Focus groups and discussions with the health department had indicated that all employees could benefit from a general orientation to emergency preparedness, keyed to these competencies. The next step was to work with the city’s health department to develop a competency-based training program, with a specific portion of the workforce, as an example.
The first training program was designed (by a curriculum team led by Dr. Marita K. Murrman) for public health nurses in school health. There are about 800 New York City school nurses who represent a large pool of professional, clinically trained people that could assist in an emergency. Their first primary emergency role is opening and staffing Red Cross shelters. In fact, this is exactly what happened after September 11. After a pilot run in June, the training program (given in conjunction with the American Red Cross) had been completed by late August, and a number of the nurses who participated in it were called in to staff shelters or volunteer in other capacities. Because they had received this type of training, they said they were able to hit the ground running.
Since September 11, the Center has continued to work closely with New York City on identifying continuing preparedness and education needs and, in response to their request, helping to evaluate the city’s response to the disaster. The Center also provided the city, as well as CDC, with a database of faculty members of the School of Public Health who could help the city in an emergency or help elsewhere if surge capacity is needed. We have also been working with the New York Presbyterian hospital system, which has thirty-one units and covers about one-quarter of the patients in the greater New York City area, to develop improved surveillance and plans for enhancing the interface between
public health and the hospital system. Recognizing that public and provider education is a key need, the Center developed training programs on bioterrorism response for clinicians (coordinated by Dr. Robyn Gershon, in partnership with the New York Academy of Medicine, the state medical society and other organizations) and provided lay language information through community forum presentations and the School’s website. There are continuing needs in these areas, as well as in the closely related area of hospital preparedness, which the Center is continuing to address.
Shortly before September 11, we met with the Office of Emergency Management (OEM) of New York City. We learned that the incident command side of emergency response—fire, police, FEMA, FBI, etc.—speak a very different language than does the public health community. The discussions with OEM suggested that it would be useful to train their first responders not only in terms of core competencies but also to orient them to the role of public health in general (as well as doing the reciprocal task with the public health community, to help bridge these cultural and vocabulary differences). Currently, the Center is developing content for this purpose.
For further information, the Columbia University’s Center for Public Health Preparedness website (http://cpmcnet.columbia.edu/dept/sph/CPHP/index.html) provides information on the Center’s programs and links to other websites. Further information on CDC’s overall network of Centers for Public Health Preparedness can be found on the CDC website: http://www.phppo.cdc.gov/owpp/centersforPHP.asp.
THE ROLE OF COORDINATED INFORMATION DISSEMINATION: THE CASCADE SYSTEM IN THE UNITED KINGDOM
John Simpson, M.B.B.S., M.F.P.H.M.
Head of Emergency Planning Co-ordination Unit
Department of Health, United Kingdom
In 1994 some issues concerning the provision of timely information for healthcare professionals developed in the U.K., particularly after the notice of a vaccine withdrawal appeared in the media before the Department of Health’s official information to doctors was delivered. It was decided by the then Chief Medical Officer that a system should be set up to enable urgent messages cascade down to all doctors and other relevant health professionals in a timely manner. Before 1994 messages were sent in the form of a Chief Medical Officer letter by first class (next day) post.
This system originally used, and which to a considerable extent still is used, is a closed computer network system called EPINET which was developed by the Public Health Laboratory Service (PHLS). This system was developed for trans-
fer of communicable disease notification information and outbreak intelligence. The Chief Medical Officer’s office was connected to the system which allowed a message to be sent to all Directors of Public Health and Consultants in Communicable Disease in local Health Authorities. The Health Authority could then, by using either a courier system or fax (when available) send copies of the letter to hospitals and General Practitioner (family physician) surgeries. A simplified structural diagram of the Health Service in England is appended in Figure 5-1.
It was decided that there would be two levels of urgency for messages, 6 hours (immediate) and 24 hours (urgent). The time frame was from receipt of the message from the Health Authority to the delivery to the end user (hospital or surgery). The system was found to be useful by end users and many general practitioners who did not have a fax machine were encouraged to buy one by the scheme.
The system is used particularly for notifications of pharmaceutical withdrawals, changes in policy, notification of important new scientific/medical information, urgent notification of new/changed procedures or the need for increased vigilance for certain diseases.
An audit of the system showed that the messages were regarded by end users as useful and timely, and that decisions taken about what messages should be sent by the Chief Medical Officer’s office were good. It was also commented that the immediate system should only be used when really necessary, and that some messages should be sent out by the districts at local discretion as they may not directly affect their locality. There were also comments about poor dissemination in hospitals to front-line staff and from general practitioners to community staff and suggestions on how to improve this were taken up.
Over the years as technology has improved virtually all Health Authorities also receive an e-mailed copy over the NHS net e-mail system, a secure e-mail system (or in a few cases Internet e-mail) as well. These messages can then be e-mailed by the local Health Authority via the NHS net to Hospitals and GP surgeries who are on the system or by fax if they are not (all UK GPs, except for a very few, now have a fax). Also, if a message is only thought relevant for a certain group, e.g., public health doctors, it can be marked for their attention only. Interestingly, some of these messages have been sent pre-public announcement and there has been little leaking, which has made Central Government comfortable with the system. Since September 11, the system has been used to tell the service to urgently review major incident plans and disseminate protocols for “white powder” incidents and to point out where useful information on deliberate biological and chemical release can be found on the world-wide web. For important messages, the CMO often still sends an urgent letter by post to backup the information sent by the system.
STATE AND LOCAL NEEDS FOR RESPONDING TO BIOTERRORISM
Michael S. Ascher,* M.D., FACP
Office of Public Health Preparedness
Office of the Secretary
U.S. Department of Health and Human Services
Until recently, I was the lead medical officer for the State of California focussing on bioterrorism, and I will speak today from that perspective. One thing we have learned from California’s many disasters is that all disasters are basically the same. Fire, flood, earthquakes—they all require the same set of skills. I thought this would not apply to public health emergencies, but I have become convinced that the logistics of responding to a smallpox outbreak or disbursing antibiotics or dispatching firefighters is almost the same. It involves different people, but the same questions: Where do you get the people? How do they get to the scene? What happens to them when they get there? How do you refresh them? How do you feed them?
Managing the Response
This suggests my first point, which is fairly simple. Someone should develop standardized instant management system “modules” for the public health response to bioterrorism. It should be modeled on things that worked well in the past, every jurisdiction should operate by the same rules, and the response elements should be vertically integrated.
The importance of the latter can be illustrated by the Oakland fire. One reason it became a full-blown disaster was that Oakland had not joined the standardized incident management system. When the fire started, there were fire trucks and men within easy distance who could have come in to help. But their radios were not compatible with Oakland’s, and they couldn’t attach their hoses to Oakland’s fire hydrants.
A similar logistical problem is that the plans for the drug stockpiles do not extend down to the local jurisdiction. California has 61 health officers, some with larger jurisdictions than many states. But no one has determined their needs or capabilities—found out what kind of hydrants they have.
Local capacity can be vitally important. In the recent anthrax episode, there were so many instances of suspected exposures that the FBI wasn’t able to determine which were credible. But we were able to get local health officers en-
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.
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
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.
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
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
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
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-
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
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:
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.
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.
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.
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.
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 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.
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-
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
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.