Chapter 5. Laboratory Capacity

Background

A biological attack could rapidly overburden State and local public health systems. Initial detection of an event would likely take place at the local level in clinical settings, such as emergency rooms, physicians' offices, and walk-in clinics, and in the field through the intervention of hazardous materials (HAZMAT) groups, National Guard Weapons of Mass Destruction Civil Support Teams (WMD-CSTs), and local first responders. To reasonably contain these casualties and reduce the time from a bioterrorism (BT) event to its detection, health professionals need the most applicable training, facilities, personal protective equipment, and tools to enhance their ability to diagnose diseases caused by BT agents, rapidly inform public health authorities of such events, and treat individual patients.

Laboratories play a critical role in the response to any bioterrorist (BT) event, as the timeliness, accuracy, and security of lab diagnostics will have a direct impact on the containment and mitigation of an incident and on the clinical treatment of victims. Surge capacity at the local, State, and Federal levels, however, remains alarmingly insufficient. There also is a profound dichotomy between the likely local nature of an initial response to the discovery of a suspect agent and the quality of the training, facilities, connectivity, and equipment in local "sentinel" labs. In addition, coordination of preparedness activities between Federal agencies, public health departments, and local labs still presents numerous challenges. Laboratory surge capacity issues urgently need to be addressed at the local, State, and national levels.

This section on laboratory capacity was reviewed at a meeting of subject matter experts (SMEs) at an Agency for Healthcare Research and Quality-sponsored stakeholder forum held in the Washington, D.C., area in April 2004. The section was revised based on comments at that meeting. Many of the experts also had further input, as noted throughout the section.

The primary audience for this set of guidelines and best practices is intended to be healthcare emergency planners at the Federal, State, and local levels. However, the analysis of gaps and shortfalls, as well as the recommendations and suggested best practices, include information pertinent to first responders, microbiologists, laboratory technicians, clinicians, laboratory directors, law enforcement, and State, local, and Federal agencies involved in either emergency response or allocation of BT funds.

These guidelines are provided in support of the Agency for Healthcare Research and Quality's (AHRQ) Bioterrorism Initiative at the U.S. Department of Health and Human Services (HHS). In light of the specific focus on agents of biological terrorism, an examination of emergency response protocols and laboratory standard operating procedures for terrorism involving chemical, radiological, nuclear, or explosive agents falls beyond the scope of this analysis and is recommended as an area for future research at the conclusion of our chapter.

Whereas there is considerable overlap among guidelines in areas such as personal protective equipment, the procedures and equipment vary significantly in a laboratory context. Nonetheless, certain elements of our analysis—such as procedures for handling and triaging unknown environmental samples; connectivity and laboratory IT and communication capabilities; and interagency communication—do have some relevance to preparedness and response targeted at other (non-biological) forms of terrorism, and may be useful to emergency planners in a broader context

Lastly, defining the term "capacity" appropriately in the context of laboratory BT response poses significant challenges. This chapter includes a discussion of the lack of a current model for measuring and evaluating an individual laboratory's capacity to triage, handle, process, and refer environmental samples (as opposed to clinical samples), and provides a list of variables that would factor into the development of such a model.

The guidelines and best practices provided below are thus better articulated as "Laboratory Capabilities", as this term encompasses all of the factors that influence and determine capacity, as well as other critical issues that govern emergency preparedness and response.

Biosafety in Laboratories

The primary purpose of biosafety in the laboratory is containment—to reduce or prevent exposure of laboratorians, others in the immediate area, and the surrounding environment to potentially hazardous agents. There are four biosafety levels (BSL): BSL-1 (lowest), BSL-2, BSL-3, and BSL-4 (highest) (U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health, 1999).

BSL-1, the lowest biosafety level, is only suitable for work with non-pathogenic organisms and is used in undergraduate and secondary education laboratories. It therefore will not be included in this report.

BSL-2 practices, safety equipment, and facility design support work with clinical and diagnostic agents of moderate risk that are present in the community and are associated with varying levels of disease severity. Using good microbiological techniques, these agents can be handled safely for activities conducted on the open bench, provided the potential for producing splashes and aerosols is low. Even though organisms routinely manipulated at BSL-2 conditions are not known to be transmissible by the aerosol route, procedures that have potential for producing splashes or aerosols should be performed under a biosafety cabinet, and appropriate personal protective equipment—e.g., face cover, gloves, gown—should be utilized. BSL-2 conditions are appropriate when the presence of an agent may be unknown.

BSL-3 practices are employed in clinical, diagnostic, research, or production facilities in which indigenous or exotic agents with potential for respiratory transmission are handled that may cause serious or potentially lethal disease. This level is also appropriate for procedures that may produce aerosols or require high concentrations of agents normally manipulated under BSL-2 conditions. At this level, more emphasis is placed upon using primary barriers (e.g., personal protective equipment, biosafety cabinet [BSC]) and secondary barriers (e.g., controlled access, special air ventilation systems) to prevent contamination of personnel and the surrounding environment.

BSL-4 practices are appropriate when working with dangerous and exotic agents that pose a significant individual risk of life-threatening disease that may be transmitted by the aerosol route and for which no known treatment or vaccine exists.

There are currently only four operational BSL-4 laboratory suites in the United States: at the Centers for Disease Control and Prevention (CDC) in Atlanta; at the United States Army Medical Research Institute for Infectious Diseases (U.S.AMRIID) at Fort Detrick in Frederick, MD; at the Southwest Foundation for Biomedical Research in San Antonio; and at the University of Texas at Galveston. A small BSL-4 facility exists on the National Institutes of Health (NIH) campus in Bethesda, MD, but it is currently being operated only at a BSL-3 level for research on important emerging infectious diseases (National Institute of Allergy and Infectious Diseases, 2004). Therefore, BSL-4 facilities will not be covered in depth in this report.

An exception to these defined levels can be found in the 4th edition of Biosafety in Microbiological and Biomedical Laboratories, which allows that some existing facilities may not have all the features that are recommended for BSL-3. Under these circumstances, BSL-2 laboratories may achieve an acceptable level of safety to conduct routine BSL-3 procedures provided that the exhaust air is discharged to the outdoors, the ventilation is balanced to provide directional airflow into the room (negative pressure), access to the laboratory is restricted while work is in progress, and the standard microbiological practices, special practices, and safety equipment for BSL-3 are rigorously followed. This practice may be prohibitive, however, as an existing BSL-2 facility must be dedicated exclusively to BSL-3 until work is completed and the facility has been appropriately decontaminated.

In general, three elements of containment determine which biosafety level is recommended for specific agents: laboratory practices and techniques, safety equipment, and facility design. Laboratory practices and techniques comprise the standard microbiological practices used to manipulate microorganisms. Safety equipment, which acts as the primary barrier against select agents, includes BSCs, enclosed containers for transporting agents, personal protective equipment, and safety centrifuges. Facility design is considered a secondary barrier and includes controlled access, interior surfaces designed for easy cleaning and decontamination, and special air ventilation systems.

Most agents can be manipulated at more than one biosafety level, depending on the specific procedure being performed. For instance, procedures for isolating and identifying Yersinia pestis can be performed safely at BSL-2; however, manipulations that may produce aerosols, such as those required for antimicrobial susceptibility testing, should be performed at BSL-3.

The Laboratory Response Network

The Laboratory Response Network (LRN) was established in 1999 through the primary collaborative efforts of the CDC, the Association of Public Health Laboratories (APHL), and the Federal Bureau of Investigation (FBI). The LRN was established following a mandate from Congress aimed at protecting the United States from biological and chemical terrorism events, both by standardizing laboratory procedures across States and by formalizing a network of labs to respond to both overt and covert events.

One of the primary goals of the LRN is to develop validated, national standard operating procedures for testing and referring potential BT agents, in order to accelerate the identification of these organisms in the event of a BT attack. Other functions of the LRN include providing reagents to confirmatory labs; disseminating information and communications (both routine and crisis) through broadcast E-mails; standardizing training; administering proficiency testing for reference labs; compiling a directory of reference labs, including emergency contact information; and more.

Prior to the establishment of the LRN, standard operating procedures varied from facility to facility among the nation's public health, hospital, physician's office, and private laboratories, rendering a coordinated response virtually impossible, and increasing the risk of improper handling of high-risk samples.

Within the LRN, there are now three hierarchical laboratory levels. Laboratories occupy a level based upon training, facilities, equipment, and availability of secure Internet access. Most hospital and small city/county health department laboratories are classified as sentinel laboratories (formerly known as "Level A" laboratories). At this lowest level of the hierarchy, these laboratories have the ability to access widely available testing protocols to rule out BT agents.

The American Society for Microbiology (ASM) originally developed and wrote the Sentinel Level Laboratory Protocols, which were reviewed by CDC representatives and are posted on several Web sites, including the ASM Web site and CDC Web site. If the laboratory is unable to rule out a specimen, it is referred to the next higher level, a reference laboratory (also known as a confirmatory laboratory, and formerly known as a "Level B" or "Level C" laboratory), for further testing to either rule out or rule in the specimen. Reference laboratories represent larger metropolitan city/county health departments, State Public Health Department Laboratories, and some military laboratories.

Unlike sentinel laboratories, reference laboratories have access to secure LRN Web site information that provides advanced testing protocols and also allows laboratories to order special standardized reagents—which are necessary to perform these procedures—directly from the LRN. National laboratories (formerly known as "Level D" laboratories) are comprised of the CDC and U.S.AMRIID laboratories. National laboratories operate at the most sophisticated level of engineering and safety measures and can perform high-level characterization of BT agents, provide confirmatory testing, and archive agents (Centers for Disease Control and Prevention 2005; Heatherley 2002; personal communication with Richard Kellogg, LRN Coordinator, Centers for Disease Control and Prevention).

All U.S. laboratories that perform microbiology testing are part of the LRN, since laboratories are required to report and refer select agents to State public health departments as a matter of routine practice. However, sentinel laboratories are not officially registered with the LRN as they only access basic protocols that are widely available for ruling out specimens. Reference laboratories are required to meet certain facility requirements in order to be registered with the LRN and to obtain secure Internet access to advanced protocols and standardized reagents.

Reference and national laboratories must also be in compliance with the Select Agent Regulation, 42 Code of Federal Regulations (CFR) 73.0. This regulation establishes requirements for the possession, use, and transfer of select agents and toxins as listed in § 73.4 and § 73.5. Requirements address registration of select agents, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, recordkeeping, inspections, and notifications.

The Select Agent Regulation also provides specific criminal and civil penalties for violation of the regulations set forth (U.S. Department of Health & Human Services 2002). Compliance with this regulation also requires compliance with the U.S. Department of Agriculture (U.S.DA) regulation (9 CFR 121) for those overlapping select agents that not only infect humans, but also are known animal pathogens (e.g., Francisella tularensis), and therefore fall under the auspices of both U.S.DA and HHS.

While the LRN provides periodic training sessions and updates via secure Internet access, distributes funding to States, and implements proficiency testing with reference laboratories, it has no regulatory powers. As such, laboratories are not held accountable to the LRN for allocation of funds or time-bounded performance measures, such as results of proficiency testing challenges (personal communication with Richard Kellogg, LRN Coordinator, Centers for Disease Control and Prevention).

Gaps in Emergency Preparedness and Laboratory Capacity

In order to assess the gaps and shortfalls in laboratory capacity and identify best practices, Science Applications International Corporation engaged in an extensive review of laboratory materials and conducted research through open sources. We also interviewed a number of SMEs to cull specific stories and experiences from those "on the front lines" of laboratory management and defense. We asked a number of SMEs from different communities in the emergency response and laboratory spectrum to review an early draft of this chapter (March 2004).

Finally, we organized a meeting of "stakeholders" from these communities (April 2004) to discuss the gaps, shortfalls, best practices, and recommendations contained herein and to provide further guidelines for discussion and analysis. A summary list of SMEs is provided in Chapter 1, Appendix A.

The criteria used to assess hospital, private, military, public health, and State laboratories are as follows (Association of Public Health Laboratories, 2003):

• Personnel.
• Funding.
• Facilities/biosecurity.
• Clinical laboratory connectivity.
• Equipment/supplies.
• Transportation/courier services.
• Training.
• Interagency communications.

It is nearly universally acknowledged that covert biological events will be detected initially at the local level. In that context, it is particularly important to assess the preparedness of sentinel laboratories (formerly Level A), which carry the responsibility of recognizing, ruling out, or referring potential BT agents.

Sentinel labs are comprised of hospital, physician's office, and walk-in clinical laboratories, as well as private laboratories, and are equipped and trained only to handle clinical samples. They are not equipped to triage unknown or mixed samples and have little or no surge capacity in the case of an unusually large influx of clinical specimens from hospitals or clinics. In this context, their understanding of when and how to rapidly and properly isolate and refer suspect samples to confirmatory labs will be critical. Many sentinel labs also require improvements in their connectivity and emergency communications capabilities and in their staff's clear understanding of courier constraints and chain-of-custody requirements.

Reference and national laboratories face the challenge of having to rely largely on their own resources in the immediate aftermath of a biological incident. There are external surge capacity resources at the national level—primarily of a military nature—including deployable public health laboratories, Mobile Analytical Labs (MALs), Dismounted Analytical Labs, Biological Integrated Detection Systems, and Analytical Lab Systems. However, these external resources would require time to deploy; therefore laboratories cannot expect additional resources to arrive for at least 36-48 hours.

Additionally, mobile field laboratories such as WMD-CST MALs are focused on rapid field identification. Although they could provide a first evaluation, they are not suitable for confirmatory purposes. Thus the overall surge capacity they provide in support of reference and national labs remains modest at best.

In the event of a BT attack, no State or even national lab will have the surge capacity to meet the requirements of a sharp increase in incoming samples. Some experts have suggested that a solution might be to admit more private labs to the LRN as reference labs.

According to one researcher, allowing just one or two private labs per State to act as reference labs (under the "control" of the LRN) would be sufficient to provide adequate surge capacity to respond to a local BT incident. This expansion of reference laboratory capabilities currently would be at the discretion of each individual State (personal communication with James Snyder, Ph.D., Department of Pathology, Division of Laboratory Medicine, University of Louisville School of Medicine). Most stakeholders and experts, however, caution against admitting private or clinical laboratories to reference lab status, because of concerns over the potential misuse (for private gain) of reagents and protocols designated specifically and uniquely for reference testing.

Specific regulations exist prohibiting the private use of detection assays not approved by the U.S. Food and Drug Administration (FDA) for in vitro diagnostic use of clinical samples (personal communication with Richard Kellogg, LRN Coordinator, Centers for Disease Control and Prevention).

Before a sample arrives at a reference laboratory, it will frequently be handled and possibly tested by a HAZMAT group or WMD-CST. If a suspicious substance such as a white powder is discovered by a private citizen or if an accident triggers the spill of a noxious substance, 911 will be called and, generally, both the local Fire Department and a HAZMAT team will be deployed to the scene. Hazardous Materials Technicians are certified to handle equipment to contain, transport, and conduct basic field testing on biological materials.

If there is any suspicion that the agent is of a terrorist nature, the State's Incident Command System (ICS) will go into effect and the Incident Commander will call in an initial response team from the State WMD-CST, who have a mobile field lab as well as capabilities for decontamination, emergency communications, operations, reach-back, and preliminary medical care. WMD-CSTs are trained to handle WMD and related materials; they are authorized by Congress, certified by the Department of Defense (DoD), and fall under the authority of the State's Governor (California National Guard, 2000; U.S. Northern Command, Joint Task Force Civil Support, n.d.).

Like the military mobile labs, neither the HAZMAT teams nor the WMD-CSTs have the equipment or training to conclusively determine the precise nature of an agent or conduct definitive rule-out or rule-in testing. They would not serve as definitive laboratories to provide final confirmation of pathogens. A discussion of the current gaps and shortfalls in field testing (and specifically, the current uses of handheld devices) appears in the "Funding" section below. Any sample that is processed initially by a team in the field must be sent to the closest LRN lab for confirmatory testing and potential referral to a national lab or to law enforcement.

With this background, the following gaps and shortfalls cause great concern in the public health community and among laboratorians and should form the core of an urgent remediation strategy.

Handling an Unknown Sample

Many experts feel that the most salient gap in laboratory emergency preparedness is the inability of many laboratories to handle an unknown sample. Environmental samples are of particular concern, for several reasons. Locally, sentinel and private laboratories simply are not equipped to handle them and should not handle them (see discussion below). At the State level, many public health laboratories have equipment and space constraints, which curtail their ability to accept certain environmental samples.

One illustrative example is that of a State public health lab that received an entire phone booth for testing, in the aftermath of the October 2001 anthrax mailings. Another example from the same timeframe is U.S.AMRIID, which received rugs as well as numerous pieces of furniture, as well as thousands of smaller, more manageable samples. All in all, U.S.AMRIID received close to 30,000 samples in less than nine months, and conducted more than 260,000 assays, growing from a 7-person to an 80-person lab.

Sometimes the problem is more complex. A major concern for State public health laboratories is the unknown status of environmental samples delivered to their doorstep. One expert recalls that he once received a stainless steel tube from first responders who had x-rayed it to ensure that no explosives were present, and were requesting that the tube be opened and sampled for potential BT agents. When laboratorians opened the container, a noxious green gas escaped—and even though the tube had been opened in a biosafety cabinet, the building had to be evacuated and emergency management personnel had to respond to the scene.

There are numerous other examples of labs receiving samples from the field with requests for biological testing when they potentially contain chemical, radiological, or explosive materials as well or when the biological nature of the sample (animal, clinical, environmental, food-borne, water-borne, etc.) is undetermined. Field screening will not always flag these complexities. Receiving an unknown sample directly into a laboratory area from the field is simply not advisable.

Some experts have proposed a concrete solution to this gap for reference and national labs, which is to have a triage area in a separate building from the lab through which all samples must pass before entering the laboratory. Ideally, in addition to essential HAZMAT and biological agent triage capabilities, this area would provide a dedicated facility to handle chemical, radiological, and explosive samples—including, if possible, an explosive containment room and chemical hoods to handle nefarious gasses. It is clear that the latter facilities will be unrealistic for many reference labs, particularly in smaller States.

As a further alternative, experts have suggested the implementation of equivalent mobile units, to be used for testing in the field. A central challenge would be securing funding for such facilities, a topic that merits further and urgent exploration. The Department of Homeland Security has indicated its willingness to fund three or four prototypes of triage areas, potentially under the auspices of the Environmental Protection Agency (EPA), but concrete action has not yet been taken on this front. The FBI and FDA have some prototypes of mobile units, but their effectiveness is still insufficiently tested or proven.

In addition, some State public health laboratories, as well as national labs spanning the CBRNE spectrum—e.g., the U.S. Army Edgewood Chemical Biological Center, Lawrence Livermore National Laboratory, and U.S.AMRIID—are beginning to develop protocols for unknown samples. The emerging guidelines focus first on the field screening process (for which current gaps and shortfalls are discussed below) and then on how to handle the sample safely once it arrives at the lab, without contaminating or killing lab staff.

In general, sentinel labs should never receive or test environmental samples. While currently no Federal regulation governs environmental sampling in a hospital/clinic/private laboratory, both SMEs and groups such as APHL and the LRN all strongly discourage it. Sentinel labs should not accept or handle such samples for several reasons.

First, the exclusive focus of patient care centers (physicians’ offices, hospitals, or clinics) should be to treat their patient population.

Second, there is a strong possibility of contamination that would extend to the healthcare facility and endanger the lives of hospitalized patients, who already are at high risk of infection due to compromised immune systems. At the time of the anthrax crisis, there were many examples of State public health labs— all of which were allegedly prepared to handle "white powders"— that contaminated their facilities, and in some cases took several months to fully decontaminate. Sentinel lab staff are not trained nor are the labs equipped to handle environmental samples, including "white powders", and in some States (e.g., New York) are prohibited from doing so (personal communication with Ann Willey, J.D., Ph.D., Director of Policy and Planning, Wadsworth Center, February 27, 2004).

Third, environmental samples are "unknown" and may contain a mixture of biological, chemical, radiological, or explosive agents. Such samples simply cannot be processed and tested in a healthcare facility with a patient population. Finally, sentinel labs do not have Select Agent status, and therefore cannot process a sample suspected of containing a select agent.

Environmental samples usually will be collected (and sometimes triaged and field-tested) by HAZMAT teams, WMD-CSTs, or local first responders. Following this initial handling, and assuming the sample is not determined to be chemical, explosive, or radiological, it should be taken by these teams (or transported via an authorized courier) to the closest reference lab. EPA labs, veterinary labs, and FDA labs currently play a smaller role in this general emergency response, although they are proactive in the case of zoonotics, food-borne illnesses, and infectious diseases.

Many experts feel strongly that these labs should be integrated into the response plans of sentinel and reference labs and included in training exercises for BT events (personal communication with Mary Gilchrist, Ph.D., Vice President for Research, Hygienic Laboratory, University of Iowa); this area is recommended for further research below. For a flowchart of the pathway for handling both environmental and clinical samples in both routine and crisis scenarios, select Chapter 5, Appendix B: Model for Laboratory Capacity and BT Response Planning.

A problem that plagued many first responders and sentinel labs during the 2001 anthrax attacks was not knowing where to send a suspect sample or how to handle a non-clinical sample. Many State laboratories had insufficient funding to be "open and on-call" 24 hours a day, 7 days a week. The reaction of first responders who found a suspicious substance was to contact private labs for testing after hours, because State labs were not open (personal communication with James Snyder, Ph.D.).

Fortunately, this situation has changed fairly significantly over the several years. All State public health labs now have 24/7 "call", so that a sample can be brought in at any time. Sentinel labs also now know who to call if they are "first receivers" of an unknown sample, and to what number they must redirect first responders who report a suspicious substance or specimen. More inclusive State-level training programs, meetings, and exercises will help States further increase awareness of emergency protocols and contact numbers among first responders, sentinel labs, and LRN reference labs.

Personnel

Shortage of personnel is one of the most significant gaps in laboratory preparedness at all levels. Clinical microbiologists certified by the American College of Microbiology (ACM) and other classically trained microbiologists have the necessary knowledge, skills, and abilities to use standardized protocols to rule out, identify, and perform further testing of BT agents. However, the United States is currently experiencing a shortfall in the number of ACM-certified and/or classically trained personnel working in clinical laboratories (personal communication with James Snyder, Ph.D.).

Perhaps of even greater concern for future requirements is that fewer and fewer qualified personnel are entering the field of microbiology or taking the coursework at the undergraduate university level. Neither universities nor the Federal government have addressed this issue. An interest in science needs to be inculcated in students beginning in grade school (personal communications with Scott Becker, Executive Director, Association of Public Health Laboratories; Rosemary Humes, MS, MT (ASCP) SM, Director, Infectious Disease Programs, Association of Public Health Laboratories; Chris Mangal, Program Manager, Emergency Preparedness and Response, Association of Public Health Laboratories; Jim Pearson, M.D., Association of Public Health Laboratories, Virginia State Laboratory.

While a discussion of the specific incentives and academic curricula lies beyond the scope of this chapter, a recommendation for future research is made in "Future Research Needs".

Compounding this shortfall, State public health laboratories are currently experiencing a significant retention problem, due largely to their low pay rates. State labs are able to recruit quality entry-level employees to whom they provide extensive and generally high-quality training. However, many of these entry-level employees move on after only two or three years with a State lab to more lucrative careers in private labs or with contractors (personal communication with James Snyder, Ph.D.).

State labs thus experience tremendous turnover, because they cannot meet their salary requirements. They lose the staff they have spent time and money training before they are able to get a return on their investment in the form of staff productivity (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.). State labs become a "training ground" for entry-level microbiologists and laboratory technicians. This revolving door phenomenon is costly to the labs. In addition, lower salaries mean that they have difficulty attracting "career" mid-level employees and quality senior staff.

Short-term BT funding also creates a significant challenge for those in charge of hiring personnel for public health laboratories at the State and local levels. In most States, allocations are made annually or for the duration of a specific grant. Appropriately trained and skilled microbiologists seeking permanent career opportunities will be unlikely to accept a position at these labs if they know that their job may be eliminated a year or even a few months later. This, in addition to the deficit in the number of classically trained microbiologists and medical technicians entering the field, makes it increasingly difficult for public health laboratories to attract personnel.

Other personnel such as laboratory technicians, chemists, security guards, and IT specialists are also difficult to hire and retain because of these funding constraints (personal communications with Scott Becker; Mary Gilchrist, Ph.D.; Rosemary Humes, MS, MT (ASCP) SM,; Chris Mangal; Jim Pearson, M.D.; Ann Willey, J.D., Ph.D., February 27, 2004).

A final hiring and retention issue that primarily afflicts sentinel labs but can be an issue for some reference and State public health labs is geography. The pool of specialists is already small. If he/she can choose, a qualified microbiologist, lab tech, security guard, or IT specialist is more likely to go to an urban area with an agreeable climate than to a remote or unpleasantly cold location (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004).

Another personnel issue that has a direct impact on laboratory capacity to respond to a BT event is the issue of vaccines for laboratory staff. The CDC has a program in place to recommend vaccinations, and States can access this information through the CDC, although not all States do.

Some States also use Investigational New Drugs (IND) vaccines, which require special training to administer. Currently the only two Select Agent vaccines that are available are for smallpox and anthrax. U.S.AMRIID does not have the funds to develop other INDs, a process that is very expensive—e.g., a single assay simply to test a vaccine for potency every two years costs $70,000.

In terms of obtaining and administering vaccines, it is often difficult for sentinel labs to convince State public health labs that they need to vaccinate their staff, even though the latter are included in emergency response plans and require protection. Healthcare, first responder, and laboratory personnel are vaccinated selectively, based on criteria determined by each State. In Iowa, for example, physicians, nurses, and smallpox response teams are vaccinated, but emergency management technicians and laboratorians are not. This is a serious potential impediment to lab capacity in a BT event and is an issue that State health emergency planners must address urgently as part of their general preparedness strategy; each State should execute a plan articulating who is to be vaccinated prior to an event.

In addition to the microbiologists and technicians working in the labs, ancillary personnel such as maintenance staff should be considered for vaccination, as they are responsible for maintaining BSCs and other potentially tainted equipment.

A discussion of vaccines for the general U.S. population is beyond the scope of this chapter. Experts do note, however, that such a program is unlikely in the short term due to serious liability issues for the DoD. It is an issue that is being (and will need to be) handled at the White House level.

Other gaps and shortfalls related to personnel issues are discussed in the "Training" section below.

Funding

The primary concerns with BT funding are that it is short-term, often too generalized, and frequently thrown at projects or technologies that are neither validated nor effective. Short-term funding has serious implications for personnel recruitment and retention, as discussed above. It also has an impact on a laboratory's ability to conduct proper maintenance of its specialized facilities, a critical component of biosafety. While most BT funding is allocated to general preparedness activities, oversight of such funding is still focus-area-specific. Federal funding also is allocated primarily to human services and does not factor in important related activities, such as environmental laboratory concerns or veterinary issues related to zoonotic agents. As a result, for example, States that have smaller human populations but larger animal populations are not receiving commensurate funding for their biosecurity activities (personal communication with Mary Gilchrist, Ph.D.).

Funding problems also exist with private labs that currently compete for State monies or, if they are for profit, must abide by strict Federal Acquisition Regulations (FAR) and restrictions concerning private use of public funds. Even though private labs are not public health entities, their role is sufficiently significant that they are unquestionably part of the overall public health response mechanism. A funding model to be considered might be Federal funding earmarked for smaller or not-for-profit labs, a recommendation that also applies to veterinary labs and food labs, most of which do not currently receive specially-allocated Federal funds (personal communication with James Snyder, Ph.D.).

Another salient problem is that funding has been thrown at technologies or equipment that can aggravate a crisis situation rather than remediate it. An excellent example is field testing, where—from the confirmatory laboratory perspective—current approaches generate additional costs in both time and equipment. Specifically, the handheld devices that are in widespread use to test environmental samples are notorious for giving false positive results and are considered inadequate and unreliable by laboratorians. Although HHS has never endorsed these devices as a reliable way of providing definitive agent identification, other agencies that do not fall under HHS, as well as many first responders, still support their use.

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