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<p><strong>You Are Here:</strong> <span class="crumb_link"><a href="/" class="crumb_link">AHRQ Archive Home</a> > <a href="/prep/" class="crumb_link">Public Health Preparedness Archive</a> > <a href="." class="crumb_link">Development of Models for Emergency Preparedness</a> > Chapter 5 (continued)</span></p>
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<td height="30px"><span class="title"><a name="h1" id="h1"></a>Development of Models for Emergency Preparedness </span></td>
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<td><div id="centerContent"><p><strong>Public Health Emergency Preparedness</strong></p> <div class="headnote">
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<p>This resource was part of AHRQ's Public Health Emergency Preparedness program, which was discontinued on June 30, 2011, in a realignment of Federal efforts.</p>
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<p>This information is for reference purposes only. It was current when produced and may now be outdated. Archive material is no longer maintained, and some links may not work. Persons with disabilities having difficulty accessing this information should contact us at: <a href="https://info.ahrq.gov/">https://info.ahrq.gov</a>. Let us know the nature of the problem, the Web address of what you want, and your contact information. </p>
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<p>Please go to <a href="https://www.ahrq.gov/">www.ahrq.gov</a> for current information.</p></div>
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<h3>Facilities/Biosecurity</h3>
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<p>There is significant consensus among experts that, in spite of improvements over the past few years, the laboratory surge capacity in the United States in the event of multiple BT events—or even a single but widespread event—is almost nonexistent. This is one of the central challenges that the LRN is specifically designed to address, and it has made significant progress.</p>
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<p>A primary constraint for responding to a BT event is laboratory space. This is due not only to the equipment required to evaluate, test, and handle suspect samples, but also to the huge diversity of samples brought in during a crisis—ranging from compact swipes to entire pieces of furniture. A significant related concern is that, during an event, dedication of laboratory space for BT testing will severely inhibit the ability of a laboratory to perform its normal operations. Surge capacity must be sufficient not only to respond to a crisis, but to incorporate a laboratory's routine daily load. The notion of a triage area, discussed above, should be considered for future funding for all reference and national laboratories.</p>
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<p>Space constraint is an important factor when calculating laboratory capacity and is the greatest limiting factor to throughput for both, not just for sentinel labs and, but also for reference labs. Capacity calculations, however, may be inadequate, particularly for environmental testing. They may not take into consideration "outlying" worst-case scenarios. For example, the capacity (personnel, equipment, and time) during the anthrax crisis to handle the receipt of the phone booth for testing at the Hygienic Laboratory at the University of Iowa cannot be compared to the capacity to test a clinical sample or an environmental swipe (personal communication with Mary Gilchrist, Ph.D.).</p>
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<p>Capacity calculations for such a diversity of environmental samples are quite complex. Relevant variables include whether the potential agent is known; types of materials being sampled; laboratorian experience testing different types of samples; reliability of assays; whether new assays are being developed or are currently available; availability of equipment; options for secure transport; etc. In this context, using models that build on laboratory capacity for clinical samples—which has been attempted by some States—is not recommended, since environmental sampling and testing is vastly different from testing clinical specimens.</p>
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<p>The issue of environmental testing in and of itself has not been adequately resolved in most States. Who should do the testing both at the time of a suspect incident and post-cleanup to verify that proper remediation has been effected? Should reference labs be using CDC-provided reagents for this purpose? These are examples of important questions that remain unanswered. In New York City, following the anthrax attacks, a whole cottage industry sprang up of groups who claimed to have the ability to conduct environmental assessments. Currently in New York, only five to seven labs are permitted to do environmental anthrax testing, and only two (the New York City and New York State public health laboratories) can handle "white powders.". Other labs may only do swipes (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004). </p>
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<p>Some experts have argued that a solution might be to allow more laboratories to become proficient at testing environmental samples. However, validated protocols and procedures do not currently exist, and more research is needed to create standardized methods for processing environmental samples. As discussed above, first responders, sentinel labs, and State public health labs must have a clear understanding of the LRN's "rule-out or refer" concept of operations and of current chain-of-custody mandates and requirements. BSL-3 operations require moderate to high security, which is normally unavailable in sentinel laboratories (<a href="devmodap5a.htm#hhc02">HHS 2002</a>). Reference laboratories, on the other hand, are registered with the LRN and, as such, are required to possess select agent certification, have moderate to high security, and have a dedicated BSL-3 suite or BSL-2/3 suite (<a href="devmodap5a.htm#cdc">CDC, 2005</a>).</p>
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<p>At the level of national and DoD labs, facilities are also insufficient. DoD labs are contracting out, rather than increasing the capacity of their own laboratories, even for routine testing missions. This means that in the event of a national crisis, such as what followed 9/11 and the anthrax mailings—when, for security reasons, contractors cannot be utilized for certain functions and all testing for DoD purposes has to be carried out by U.S. AMRIID (and, to some extent, the Naval Medical Research Center)—these labs would be overwhelmed. In addition, the national labs are the only ones with equipment and trained staff for high levels of Select Agent and environmental testing, and they will be
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for the foreseeable future. Therefore, expanding the capacity of the DoD labs is essential. Even at the routine research and development level, more space is required in both DoD and national labs. Lastly, the amount of BSL-3 and BSL-4 space for carrying out the research that is required for diagnostics, therapeutics, and vaccines is lacking, a fact that is recognized throughout the Federal government (personal communications with George Ludwig, Ph.D., Chief, Diagnostic Systems Division, U.S. Army Medical Research Institute of Infectious Diseases; Mark Wolcott, Ph.D., Chief, Special Pathogens and Field Operations and Training Branches, U.S. Army Medical Research Institute of Infectious Diseases.)</p>
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<p>A final biosecurity concern, discussed below, is waste disposal for sentinel labs. Alternative medical waste disposals are available specifically for BT agents. Since it is unlikely that sentinel labs will deliberately propagate unusual pathogens—rather, they will only encounter them under extraordinary circumstances—most specimens would go through the standard waste stream. This is a serious issue that most States have not addressed either separately or as part of a holistic biosecurity strategy (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004). Simply installing specialized autoclaves in sentinel labs is a suboptimal solution, since such autoclaves would be difficult for these labs to maintain.</p>
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<h3>Clinical Laboratory Connectivity</h3>
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<p>The electronic reporting mechanisms for moving information quickly and effectively between sentinel labs and public health labs are not well established. Many public health labs have connectivity neither within the lab itself or nor with external partners. While integrated information system solutions have been discussed, few have been developed or implemented. Most reference labs do not have robust enough lab information management systems to be able to capture or cross-reference data from multiple streams and matrices. This is especially problematic when the labs are dealing with different sample types in different carriers— air, water, waste, tabletops, dirt, etc. At the same time, raw data cannot be simply transferred to CDC, because of the risk of duplication, misinterpretation, and acceptance without validation. Transferring data to CDC also bypasses the State public health personnel who have primary responsibility for dealing with those data and the LRN procedures for reporting data (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.). The CDC has provided funds for data systems that provide interconnectivity among State labs, but many of these systems are not yet implemented.</p>
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<p>As a result, Web-based reporting systems usually have been created on the fly during crisis situations—as happened during events surrounding both West Nile Virus and Severe Acute Respiratory Syndrome (SARS)—and these systems are both limited and stovepiped. As data cannot be transferred electronically in real-time, it is frequently provided by telephone, which often leads to mistakes in transcription or interpretation. Even outside of a crisis, this lack of integrated connectivity is problematic. For example, most State labs are not aware of important and relevant research going on in the private sector (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</p>
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<p>Several issues arise from a dearth of information technology resources at many sentinel labs. For example, New York State has 270 sentinel labs outside of New York City, but only one third of these ( roughly 80 labs) have Internet connectivity. This means that 66 percent of sentinel labs are not connected to the State Public Health Department electronically. A Health Resources and Services Administration (HRSA) grant has allowed the State to provide hospitals with electronic capabilities—namely, hardware, software, and staff training—but not all private labs have benefited. According to public health officials, however, the lack of Internet connectivity is not a funding issue, but rather a problem of both management and organizational culture (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004).</p>
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<p>The lack of Internet connectivity creates serious information management problems on many levels. These are particularly critical in crisis situations, as was illustrated during the evolution of the West Nile Virus outbreaks (personal communications with George Ludwig, Ph.D.; Mark Wolcott, Ph.D.). On a more basic and routine level, being "offline" prevents sentinel labs from enrolling in Statewide healthcare provider networks, so State public health facilities do not have current information on critical laboratory capabilities or deficits (e.g. assay or containment capabilities) for many of their laboratories. Labs that do have Internet connectivity can update their data regularly via a secure Web-based profile instrument (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004). Even labs with connectivity experience information management problems with respect to resources such as the CDC's National Electronic Disease Surveillance System and Health Alert Network, because they are unaware of the timelines and steps being performed to implement these systems (personal communication with Mary Gilchrist, Ph.D.).</p>
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<p>Connectivity becomes an even greater issue when you include not only the sentinel labs that are doing the rule-out testing, but also the physician's office labs that are handling routine clinical specimens. For example, there are 70,000 physicians licensed in New York State alone (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004). Layered upon these concerns are HHS regulations that address the requirements of the Federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) and govern patient privacy. HIPAA regulations stipulate that any sensitive patient information—specifically, individually identifiable health information transferred via the Internet be sent only through a secure connection, and regulations also exist that govern the types of information that can be transferred. Therefore, sentinel lab Internet connectivity is not sufficient in and of itself to ensure full functionality, particularly in a sensitive crisis situation. Investment in information protection software and secure servers or encryption tools is also necessary. It should be noted that these HIPAA regulations also govern the appropriate uses of fax and voice communications for the transmission of individually identifiable patient health information (<a href="devmodap5a.htm#hhs05">HHS, 2005</a>).</p>
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<p>Several organizations are taking active steps to combat laboratory connectivity gaps. With funds from The Robert Wood Johnson Foundation, the Public Health Informatics Institute has launched several successful initiatives, including a new collaboration with State and local public health laboratories to develop a "comprehensive requirements document for public health laboratory information management systems" (LIMS). This project also received funding from APHL based on their 2002-2005 strategic plan. The project began in November 2003 and completion is anticipated for June 2004. So far, 26 State and local public health laboratories are participating. This project also builds on ongoing national standards efforts, including the Public Health Information Network and the National Health Information Infrastructure (NHII) (<a href="devmodap5a.htm#phii">Public Health Informatics Institute 2003</a>).</p>
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<h3>Equipment/Supplies</h3>
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<p>While the equipment used both for routine activities and for select agent testing is increasingly sophisticated and effective, many steps still remain to improve laboratory capacity to respond to a BT event. Concerns range from equipment used by first responders to procedures in sentinel labs to a universal shortage of reagents used in reference and national labs. These issues require a variety of remedial approaches, and are discussed in greater detail below.</p>
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<p>Most experts concur that a primary requirement for laboratory equipment (and BT emergency response equipment) is that it must, wherever possible, have dual-use applications. When equipment is purchased and dedicated solely to BT use rather than to dual-use or all-hazards purposes, the likelihood increases that laboratorians will be unfamiliar with it during an event. If personnel do not gain practical experience, time will be lost during an event while laboratorians familiarize themselves with the equipment (personal communications with Scott Becker; Rosemary Humes; Mary Gilchrist, PhD.; Richard Kellogg, LRN Coordinator, Centers for Disease Control and Prevention; Chris Mangal; Jim Pearson, M.D.; Ann Willey, J.D., Ph.D., February 27, 2004). Equipment not used in everyday practice also takes up valuable space in laboratories that already suffer spatial limitations.</p>
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<p>Biosafety concerns, reviewed above, are also important when evaluating laboratory equipment and supplies. Specific equipment requirements for different BSL levels are discussed above. An additional biosafety constraint that tends to be specific to clinical laboratories is that while many of them have autoclaves on site, they do not use them for viable organisms and instead send these offsite for disposal. This is an important security and safety issue when working with potential BT agents and is discussed further in the Transportation section below (personal communication with James Snyder, Ph.D.).</p>
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<p>Laboratorians have a number of concerns about the devices employed for field testing. Experts feel that these technologies should address the differing needs of first responders, laboratorians, and clinicians and the need to carry out both clinical and environmental testing (personal communication with Mary Gilchrist, Ph.D.). A more focused evaluation of the current research and development is urgently needed along with an acknowledgement of the importance of evaluating long-term investments concurrently with short-term solutions. Rapid pathogen or agent identification tools for first responders and first receivers will enable them to implement lifesaving medical actions and make rapid treatment decisions based on more than just presenting signs and symptoms, which may be vague and cause delays in patient care and responder protection. Many experts also recommend the establishment of Federal guidelines and regulations for these devices, including baseline tests for each type of instrument.</p>
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<p>A final concern in this area is that laboratorians require a pristine sample that is also large enough to meet testing demands. Samples frequently are "used up" in the field, leaving none for the definitive, gold-standard tests performed in the confirmatory laboratory. Many experts have suggested that first responders need more guidance on the appropriate use and limitations of handheld devices, as well as clearer direction for proper collection and processing of samples. This training will vary depend on the nature of the field equipment developed, vetted, and utilized in the future; protocols for the correct handling of samples will be universal.</p>
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<p>Finally, in terms of supplies, a significant problem cited by many experts is the current shortage of lab reagents for confirmatory labs. These reagents generally are provided by the LRN to participating laboratories, but supply is not sufficient. During the ricin scare in the summer of 2003, many labs could not obtain the reagents they requested from the CDC. One expert noted that the LRN is currently unable to meet even daily (routine) reagent requests. Some experts suggested the need to establish a national stockpile of lab reagents, similar to the current stockpiles of prophylactics and vaccines.</p>
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<h3>Transportation/Courier Services</h3>
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<p>A major gap in preparedness relates to the challenge of distinguishing a routine clinical specimen from a select agent or engineered pathogen before testing is completed. Public health providers send a clinical specimen on a patient suspected of having an infectious disease to a sentinel lab. If that specimen is found to be unusual, it is immediately sent to a public health reference lab. Most such samples are generally sent via the United States Postal Service (USPS) or via overnight courier (e.g., FedEx), depending on what is being sent. Delivery time thus ranges from roughly 24 hours to 2-3 days (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004).</p>
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<p>In the case of a BT agent, law enforcement agents may be responsible for taking over transport of the sample. There is currently significant confusion at the level of sentinel labs as to which transportation system they should use if a specimen is ambiguous. At a minimum, such as specimen should be labeled as an infectious substance and packaged accordingly. To remedy this shortfall, certain States (e.g., New York) are implementing State-wide training programs for sentinel labs, public health departments, and local hospitals concerning the packaging and shipping of ambiguous specimens (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004). This training is critical to ensure that sentinel laboratories (as well as first responders) use appropriate, authorized, trained couriers in the event of a potential BT attack or when encountering infectious disease agents.</p>
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<p>At the State level, bonded couriers whose services are not available to the public are specifically trained in the handling of potentially infectious substances. Sentinel labs must be aware of who these couriers are, so they do not give a suspect sample to the local entrepreneurial courier service who does not have adequate proficiency in handling such materials. There also are inconsistencies in the ways in which couriers interpret Federal regulations. For example, Virginia's State Public Health Lab has stopped using FedEx because of concerns about this issue.</p>
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<p>Many States, have no mechanism for regular and timely delivery of isolate samples, even just from a hospital to a lab. If delivery is reliant solely on air travel, it will be paralyzed in the case of a broader terrorism emergency—and yet very few States have thought through alternative delivery vehicles for crisis response (personal communications with Mary Gilchrist, Ph.D.; Barbara Johnson, Director, Center for Biosecurity, STRA, Science Applications International Corporation; Ann Willey, J.D., Ph.D., February 27, 2004). Information to guide such thinking can be downloaded from the ASM and CDC Web sites, and specific packaging and air transport guidelines have been developed by the International Air Transport Association and appear on their Web site as well (http://www.iata.org).</p>
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<a id="Training" name="Training"></a>
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<h3>Training</h3>
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<p>A fundamental training issue is the ability to detect BT agents and to distinguish them from routine clinical samples. Most laboratories, especially hospital and physician office laboratories, are unlikely to recognize BT agents without prompting from clinicians. Currently, most sentinel laboratories have not introduced algorithms into everyday practice that would aid in detecting potential BT agents. Guidelines for such algorithms are available on both the ASM and the CDC Web sites. State public health departments frequently offer training by providing periodic updates on emerging diseases such as SARS, the avian flu, monkeypox, or West Nile Virus, as well as more general training materials (written by their staff) that are intended to supplement materials available from other sources, such as the CDC or LRN (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004).</p>
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<p>Training in the correct use of specialized laboratory equipment currently falls short of what would be necessary during a BT event. It should be noted that some select agents can be worked up at BSL-2, depending on the procedure being performed, and most clinical samples also can initially be handled under BSL-2 conditions. Though actual testing practices for BT agents are widely used for less potentially lethal agents, BT agents require use of a BSC hood and special personal protective equipment to prevent both self-contamination and environmental contamination.</p>
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<p>Other special precautions, such as preventing aerosols and appropriately disposing of biological waste materials, must also be considered. All sentinel labs and most reference labs are equipped and funded, and their staff trained, for clinical diagnostics, not for environmental testing. Staff at many reference laboratories lack full understanding of how to carry out environmental testing—both at the pre-analytical level (what information to collect) and at the collection level (what collection method to employ—wet swabs or high efficiency particulate air socks, for example) (personal communications with Scott Becker; Rosemary Humes; Richard Kellogg; Chris Mangal; Jim Pearson, M.D.). </p>
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<p>During the 2001 anthrax attacks, many labs were unexpectedly thrust into that environmental role. Staff at many labs inadvertently contaminated their environment with anthrax spores, making them seem incompetent—which, ultimately, led to overall under-utilization of the reference laboratories during the crisis, the over-utilization of national laboratories, and to a shortfall in the U.S. capacity to respond (personal communications with George Ludwig, Ph.D.; Mark Wolcott, Ph.D.). A salient problem is that clinical laboratories simply do not have the necessary protocols to follow for processing environmental samples—and should not do so under any circumstances.</p>
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<p>The challenges present in training State public health staff to handle unknown environmental samples in unusual contingencies can have deleterious consequences in any biological agent crisis, however small and localized. If a State identifies a suspect agent and the Governor says "test it," but the State labs don't have the methods, reagents, people, or training to carry out the testing, the consequences can be grave for both containment and decontamination. If a new pandemic (such as SARS) hits, and staff know what personal protective equipment to wear but not how to remove it afterwards, they can inadvertently contribute to the transmission of the disease (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.; James Snyder, Ph.D.).</p>
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<p>Many States have statewide proficiency testing requirements. The LRN also regularly performs proficiency training with reference labs, and their overall training support to States is excellent. Kentucky, for example, has taken strong advantage of LRN training sessions, which have included training for packaging and shipping isolates, similar to what has been provided in the State of New York by its Public Health Department (personal communications with James Snyder, Ph.D.; Ann Willey, J.D., Ph.D., February 27, 2004).</p>
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<p>Overall, many experts point to the need for sustained, Statewide education and training for potential BT events as part of a regular, inclusive routine. If laboratorians are not used to working with certain types of equipment and following specific protocols in the course of their daily work, they will not be able to perform competently in a time of crisis. An outbreak or emergency is not the time to train. Training sessions and educational programs for a BT event should include representatives not only from State and local labs, but also HAZMAT teams, first responders, and environmental labs. (New CDC chemical terrorism funding for all 50 States should help bring first responder communities together with laboratorians as well.) </p>
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<p>These sessions also should include an overview of the Incident Command System for that State, as many sentinel and reference laboratory staff members do not have a clear understanding of ICS. The more inclusive the Statewide programs, the more likely different stakeholders will be to perform better individually, work better collectively and understand each other's roles in a crisis. </p>
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<p>An expert from Iowa's State public health lab has noted that monthly meetings are held in her State that promote training and contribute to building trust between the different constituents (personal communication with Mary Gilchrist, Ph.D.). Such training will have the ancillary benefit of lessening the burden on public health laboratories—many of which are already under-funded and carry a large load of day-to-day activities—in the event of a crisis, as other receivers and responders will have a better understanding of when to refer a sample.</p>
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<p>A related challenge, which is as much cultural as it is technical, is to train personnel to operate in a "law enforcement" context—rather than in a clinical context—in the case of a BT event. Public health personnel, and in particular laboratory personnel, are not accustomed to dealing routinely with matters involving criminal investigations, although they are trained to handle samples requiring chain-of-custody (with potential criminal charges), and they also are occasionally called upon to testify (personal communication with Barbara Johnson). </p>
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<p>The core challenge is providing laboratorians with an understanding of the law enforcement investigative process (to include ICS and the hierarchy of relationships, e.g., HAZMAT to WMD-CST to State Criminal Investigation to local police to FBI). Similarly, law enforcement organizations are sometimes uninformed about the realities of dealing with specific agents and organisms, and about the related routine requirements for laboratorians (personal communication with Barbara Johnson).</p>
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<p>Though most investigative matters would not directly affect laboratorians, matters such as chain-of-custody and the proper shipment of isolates need to be addressed in the laboratory through continued—and possibly increased—training. A better mutual understanding of protocol could help resolve the tension between the laboratory's ability to carry out collaborative research and its need to lock down evidentiary material in the case of ambiguous agents. </p>
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<p>Several experts have suggested that regular joint exercises, which already take place in several States (e.g., Iowa), are one of the best ways to deepen the mutual understanding between laboratorians and law enforcement (personal communication with Barbara Johnson). This is particularly important since there are no set national procedures for chain of custody, which varies widely from State to State, and even between jurisdictions within States.</p>
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<p>Finally, addressing their training and retention issues, several State public health officials have pointed to a dearth in information technology experience among their personnel. Many microbiologists and laboratory technicians have little or no experience working with complex information systems. At the same time, recruiting IT staff is challenging for State public health labs for the funding and salary reasons discussed above. An APHL expert has suggested that a basic understanding of laboratory IT issues, requirements, and procedures should be integrated into any instruction that laboratory personnel receive both academically and in the laboratory.</p>
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<h3>Interagency Communications</h3>
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<p>Although communication mechanisms and plans among State, local, Federal, defense, and LRN laboratories in the event of a crisis exist, details are sensitive and not public. The resilience of these mechanisms and plans remains largely untested and, in the opinion of many experts, questionable. This is one of the most significant and potentially detrimental gaps in laboratory emergency preparedness (personal communications with George Ludwig, Ph.D.; Mark Wolcott, Ph.D.).</p>
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<p>Agency-specific parochialism is at least partially responsible and is difficult to overcome, because everyone wants to maintain their funding and status (personal communications with George Ludwig, Ph.D.; Mark Wolcott, Ph.D.). In that context, the environment for open and complete sharing needs to evolve. Changes need to be made at the State level in the area of oversight, which has a direct impact on both communications and funding. Food programs, agricultural diagnostic programs, and public health lab programs are all administered very differently at the State level, and yet they compete for funds (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.). An interagency communication matrix that gives one agency more political muscle than another can be damaging
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to the public health infrastructure.</p>
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<p>Even at the Federal level, emergency communication protocols are lacking. During the anthrax episodes of 2001, there was no formal Incident Command process between the U. S. Department of Justice (DOJ) and U.S.AMRIID because U.S.AMRIID's usual mandate is research and development, not emergency response (personal communications with George Ludwig, Ph.D.; Mark Wolcott, Ph.D.). </p>
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<p>Progress has been made in this area but most experts concur that much work remains. In addition, and somewhat surprisingly, the EPA has no current funding for BT activities. This issue is causing significant debate in laboratory circles, particularly due to the concerns over the handling of environmental samples. One expert also noted that some attempts at the State level to be included in Federal working groups were ignored, even though the State public health laboratories are expected to be major players in the event of a BT attack.</p>
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<p>The LRN and the national and defense labs share routine information frequently. Many LRN assays were evolved from DoD models, although LRN assays were developed specifically to ensure that standardized testing methods would be followed. The LRN and DoD labs at the national level may use different protocols for assays, because the level of testing may differ between DoD and the CDC (personal communications with George Ludwig, Ph.D.; Mark Wolcott, Ph.D.). </p>
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<p>In addition, there is no Federal guidance on environmental samples. The CDC, EPA, DoD, and Congress have yet to agree on procedural or funding issues, aside from the very limited Biowatch environmental surveillance project, which is focused exclusively on the passive monitoring of select urban areas (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</p>
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<p>In the context of interagency collaboration on surveillance, experts also point to the controversial USPS Biohazard Detection System (BDS), set up in the aftermath of the anthrax mailings and aimed at providing a "scientifically valid approach" to detecting threats in the mail. The automated system is designed to shut down all operations if a biological agent is detected. However, following testing in 15 pilot sites, the USPS halted further deployment of the machines in April 2004 after several sorting lines yielded "non-determinant" (inconclusive) test results (U.S. Postal Service, 2004). As with Biowatch, experts are concerned about the high incidence of false positives, particularly if the program spans all 283 main USPS mail processing and distribution plants.</p>
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<p>Lastly, HRSA has had little involvement with States to assist with sentinel lab connectivity or other sentinel lab capacity issues. As a result, the guidance and support of the State Cooperative Agreement are not reaching sentinel labs (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</p>
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