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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>Now this resource is supported by the <a href="http://emergency.cdc.gov/">Centers for Disease Control and Prevention</a> (CDC).</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 It was current when produced and may now be outdated. Archive material is no longer maintained, and some links may not work.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>"Worst Practices"</h3>
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<p>Before presenting guidelines and "best practices," it is necessary to emphasize the danger of laboratories ignoring or not knowing protocols and procedures. Every expert who was interviewed for this chapter or who attended the Stakeholder Meeting in April 2004, pointed to "worst practices" he or she had encountered in his or her experience with sentinel, reference, and national laboratories, or as a public health official. This ignorance or lack of information on the part of a public or private laboratory or first responder group—particularly in a time of crisis—could result in casualties.</p>
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<p>Examples of "worst practices" that have been encountered by experts include:</p>
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<ul>
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<li>Laboratories purchasing reagents not approved by the CDC from private companies instead of obtaining them from the LRN.</li>
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<li>Private (for-profit) laboratories claiming that they had the ability to carry out environmental assessments and/or to test "white powders".</li>
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<li>HAZMAT teams or first responders bringing environmental samples to sentinel laboratories or bringing untested materials through reference laboratory doors.</li>
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<li>Labs growing a known select agent or pathogen in vitro but not reporting it to the CDC for days or weeks. In one case, a strain of monkeypox was not reported for 12 days because the laboratory, which was well-equipped and had highly trained staff, assumed it could handle it "on its own".</li>
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</ul>
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<h3>Best Practices, Recommendations, and Guidance for Reference and National Laboratories</h3>
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<p>Based on the gaps and shortfalls identified above, and on the input from SMEs and our independent research, we propose the following set of best practices to form the basis of a preliminary guideline for laboratory emergency preparedness. As the needs, requirements, and functions of sentinel labs differ from those of reference and national labs, we have separated our recommendations into two sections.</p>
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<p>Best practices for reference and national laboratory capacity include:</p>
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<h4>Personnel</h4>
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<ol>
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<li>Staff practiced and proficient in the use of LRN protocols, use of LRN reagents, and BSL-3 practices and procedures (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</li>
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<li>As an ideal target, at least two doctoral-level scientists on staff with laboratory medicine experience, although this is not necessarily realistic and will vary from State to State, depending on size and population (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</li>
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<li>At least one full-time information technology specialist to manage laboratory information systems (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</li>
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<li>At least three laboratorians able to perform Real-time PCR, Time-Resolved Fluorescence, and confirmatory testing of bacterial Category A select agents.</li>
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<li>Consultants from other confirmatory labs. Written agreements should be made by State labs to address surge capacity needs (not just for BT, but also for epidemics), to allow the samples to move out of State, and to ensure sufficient numbers of qualified microbiologists trained to perform BSL-3 procedures should an emergency occur (personal communications with Barbara Johnson; James Snyder, Ph.D.).</li>
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<li>Mutual aid agreements between neighboring States should be implemented (personal communication with Barbara Johnson). The CDC has Memoranda of Agreement (MOA) with States, which could potentially be used to provide an appropriate legal framework for such documents.</li>
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<li>The CDC can detail out laboratorians on a short-term basis to fill critical needs (personal communication with Barbara Johnson).</li>
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<li>A Statewide vaccination program should be considered for all first responders and laboratory staff potentially coming into contact with select agents, including maintenance staff.</li>
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</ol>
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<h4>Funding</h4>
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<ol>
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<li>Long-term funding for personnel should be provided in order to attract qualified candidates (personal communications with Scott Becker; Mary Gilchrist, Ph.D.; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</li>
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<li>Long-term funding for BSL-3 and BSL-4 research and development also should be provided in order to ensure the availability of appropriate laboratory space for surge capacity during a BT event (personal communications with George Ludwig, Ph.D.; Mark Wolcott, Ph.D.).</li>
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<li>States should contribute a minimum of 40% of laboratory budgets to ensure proper capacity (<a href="devmodap5a.htm#trust">Trust for America's Health 2003</a>).</li>
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<li>Funding must go both into upgrading labs to the BSL-3 level and into sustaining labs that have upgraded to BSL-3 standards so that they do not go unused at that level simply because they cannot afford the maintenance (personal communications with George Ludwig, Ph.D.; Mark Wolcott, Ph.D.). The LRN should work with States to tie its funding to satisfactory proficiency testing results (personal communication with Richard Kellogg).</li>
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<li>Zoonotic agents should factor into Federal funding considerations for smaller, more agricultural States (e.g., Iowa) (personal communication with Mary Gilchrist, Ph.D.).</li>
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<li>Federal oversight—or at a minimum, clear guidance—should be required for State funds to ensure that public health monies are allocated judiciously to State public health labs, veterinary labs, agricultural labs, and forensics labs based upon need (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</li>
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</ol>
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<h4>Facilities/Biosecurity</h4>
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<p>Ideally, each State should have at least two reference laboratories with dedicated BSL-3 or BSL-2/3 facilities (<a href="devmodap5a.htm#campbell">Campbell 2002</a>) that meet standards consistent with those published in the 4th edition of Biosafety in Microbiological and Biomedical Laboratories (personal communications with Barbara Johnson; Richard Kellogg; James Snyder, Ph.D.). One reference laboratory may be sufficient for some States.</p>
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<ol>
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<li>All reference laboratories should meet Select Agent requirements. Implementation of the Select Agent requirements should be focused on improved personnel identification measures and sophisticated control measures that extend beyond locks (personal communication with Barbara Johnson).</li>
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<li>Laboratories must have autoclaves on-site for waste disposal.</li>
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<li>In order to cooperate effectively with law-enforcement, national labs and select reference labs must have the appropriate security, tamper-proof materials, and tight login entry abilities. Reagents should be computer-based, including order, receipt, lot, quantity, date opened, and amount used, so that when a laboratorian mixes a reagent, he/she knows exactly where it came from and how to troubleshoot any problems (personal communication with Barbara Johnson). A Clinical Laboratory Improvement Amendment (CLIA) requirement already exists for labs to maintain a record of reagents as part of their quality control documentation, but this requirement would be enhanced if its implementation could be computer-based.</li>
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<li>4. To aid in the processing of unusual or excessive environmental samples, a triage area should be set up in a separate building from the lab, to prevent non-biological or unknown samples from crossing the laboratory threshold. If funding permits, this area would provide a dedicated facility to handle chemical and radiological samples, and possibly explosive samples, in addition to diverse biological samples.</li>
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</ol>
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<h4>Clinical Laboratory Connectivity</h4>
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<ol>
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<li>Each State should have a complete list of all clinical and diagnostic laboratories located in the State (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</li>
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<li>Each State should distribute contact lists and algorithms to each hospital laboratory and private laboratory (including physicians' offices and commercial laboratories) within the State. These lists should include locations of State and Federal laboratories with 24-hour/7-day contact information.</li>
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<li>3. State and local public health laboratories should consider participation in the Public Health Informatics Institute's collaborative program to establish requirements for a public health LIMS.</li>
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<li>4. Laboratories should ensure that their uses of information technology are HIPAA-compliant.</li>
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</ol>
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<h4>Equipment/Supplies</h4>
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<p>Equipment should be for dual-use for personnel to achieve proficiency with procedures and to maximize use of limited space (personal communications with Scott Becker; Mary Gilchrist, Ph.D.; Rosemary Humes; Richard Kellogg; Chris Mangal; Jim Pearson, M.D.; Ann Willey, J.D., Ph.D., February 27, 2004).</p>
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<ol>
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<li>Laboratories should, at a minimum, have the following equipment: BSC Type IIB (full or partial exhaust), Phase Contrast microscope, Fluorescence Microscope, Real-time PCR unit, centrifuge, incubator, -70°C freezer, and water bath (Florida Department of Health 2002). HAZMAT team, WMD-CSTs, and military rapid response units can play a support role to the LRN with their mobile RT-PCR units. They can rapidly deploy to the site of an event and provide preliminary field testing in the case of a BT event (personal communication with James Snyder, Ph.D.). However, the field equipment currently used by such teams and mobile labs—in particular, handheld devices for testing environmental samples—has a high yield of false positives, and all samples tested in the field will need to be retested by confirmatory labs for definitive rule-out or rule-in results.</li>
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<li>A more comprehensive stockpile of reagents should be made available from the LRN for select agent testing.</li>
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</ol>
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<h4>Transportation/Courier Services</h4>
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<ol>
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<li>Arrangements and agreements should be made with State courier systems to ensure sustained and timely delivery of isolates to reference laboratories. Efforts should be made to ensure delivery from a sentinel laboratory to a reference laboratory within a few hours of notification that a potential BT agent has been isolated.</li>
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<li>If existing courier and transportation services are unable to provide quick and reliable delivery of potential agents, alternate delivery methods should be put in place in advance to be deployed only in the event of an emergency. One possibility is an agreement with National Guard forces (<a href="devmodap5a.htm#mothershead">Mothershead, Tonat, and Koenig, 2002</a>).</li>
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<li>Only bonded or authorized Statewide and national couriers with the appropriate training should be employed for the transport of ambiguous samples or select agents. Law enforcement may also be brought in as a courier (and custodian) if a sample is confirmed as being of a BT nature or is otherwise associated with criminal intent.</li>
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</ol>
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<h4>Training</h4>
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<ol>
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<li>At least one full-time State laboratory training coordinator should be present in each State (<a href="devmodap5a.htm#campbell">Campbell, 2002</a>).</li>
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<li>At least one full-time BT State training coordinator should be present in each State (<a href="devmodap5a.htm#aphl">APHL, 2003</a>).</li>
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<li>At least one simulation exercise that involves at a minimum one Category A surrogate agent should be conducted each year. Exercise assessments should be based on laboratory readiness and capability from intake prioritization, identification and confirmatory tests results, and the reporting of results via the LRN Web site.</li>
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<li>Regular training courses and tabletop exercises involving laboratories and using surrogate agents should supplement the simulation described above (personal communication with Richard Kellogg).</li>
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<li>More BSL-3 training should be implemented. Labs also need to identify trained staff who can act as instructors in select facilities (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</li>
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<li>CDC-sanctioned BT training should be exempt from SAP and U.S.DA restrictions.</li>
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<li>The CDC should develop a basic laminated reference manual for specific tests for suspect agents that can be distributed to all LRN reference labs and possibly another version made available to sentinel labs. (The information for such a manual is already available on the LRN Web site, but sentinel laboratories do not have online access to this restricted, private site.) An online version of this manual that can be downloaded to a personal digital assistant should be developed concurrently with the laminated reference guide (personal communication with Barbara Johnson). Funding is not currently allocated for this activity; however, the process is relatively inexpensive and a combination of LRN and Federal funds potentially could be used.</li>
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<li>Reference labs should participate in Statewide training programs with other first responders as well as law enforcement agencies, to address joint emergency response protocols, State and local chain-of-custody requirements, and State and local ICS, and to build mutual trust and personal relationships between the different emergency response communities.</li>
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</ol>
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<h4>Interagency Communications</h4>
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<ol>
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<li>Reference laboratories should identify and communicate with other relevant local, State, and Federal groups, including other public health organizations, civil support teams, HAZMAT teams, law enforcement agencies, and other local first responders; State emergency management agencies, environmental agencies, and State National Guard Bureaus; and the Department of Defense, FBI, and the Federal Emergency Management Agency (FEMA).</li>
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<li>State public health departments should also establish their own independent networks. Iowa has taken steps to set up a regional support system for testing isolates with other North-Central States (North Dakota, South Dakota, Nebraska, Kansas, Minnesota, Missouri, Wisconsin, Illinois, Indiana, and Michigan). Their goal is to be prepared to act alone if necessary, but to be able to act in concert if possible. They are creating lists of what each health department specializes in according to testing capabilities, facilities, and personnel (personal communication with Mary Gilchrist, Ph.D.).</li>
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<li>Notification algorithms should be available to all reference laboratories and should be activated and verified on a quarterly basis.</li>
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<li>The LRN should integrate veterinary laboratory testing into its matrix (personal communication with Mary Gilchrist, Ph.D.). </li>
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<li>Interagency integration of data should be attempted between the LRN, the FDA's Food Emergency Response Network, and the Veterinary Diagnostics Laboratory's new network, as well as other parallel emergent networks (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</li>
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<li>The national labs should work with the LRN to establish general acceptance of multiple assay protocols and procedures that meet specific performance criteria (personal communications with George Ludwig, Ph.D.; Mark Wolcott, Ph.D.).</li>
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<li>All reference labs should be familiar with the Incident Command System and with their local chain-of-custody requirements.</li>
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</ol>
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<a id="Guidelines" name="Guidelines"></a>
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<h3>Best Practices, Recommendations, and Guidance for Sentinel Laboratories</h3>
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<p>A core best practice for sentinel labs is to ensure that they only handle clinical samples and under no circumstances accept environmental samples or mixed samples for testing. Such samples should be referred immediately to the closest confirmatory reference lab. Similarly, if a clinical sample cannot be conclusively ruled out, it should also be referred to the appropriate State public health laboratory for further testing. The core reasons for this critical best practice are discussed in "<a href="devmodel5.htm#Sample">Handling an Unknown Sample</a>," above; the greatest concern is that a clinical facility might become contaminated and not only put a patient population at risk, but also require lengthy decontamination procedures.</p>
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<p>Other best practices for sentinel laboratories are recognizing potential BT agents for referral; identifying the closest reference laboratory prior to an event; retaining the chain-of-custody and becoming familiar with law enforcement requirements and protocols; understanding both routine and crisis shipping procedures and having a list of authorized couriers in a format that is readily accessible; participating in State-run exercises; and enrolling in the new College of American Pathologists (CAP) Lab Preparedness Survey proficiency testing program, if feasible, or in training programs developed by the National Laboratory Training Network (NLTN). Specific details on sentinel lab best practices are discussed below.</p>
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<h4>Personnel</h4>
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<p>In the event of a BT attack, personnel who are certified in routine testing should be available to assist with shift work to provide surge capacity to reference laboratories for routine tests such as TB or HIV, which the confirmatory labs will not be able to handle in addition to their rule-in BT testing (personal communications with Scott Becker; Rosemary Humes; Chris Mangal; Jim Pearson, M.D.).</p>
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<p>When they encounter a suspicious agent, clinical laboratorians should be freed of the restraints of requiring a physician order to initiate investigatory testing. Federal funding should support this enhancement to BT preparedness, to avoid insurance conundrums. Such funding would have the ancillary benefit of contributing to an active surveillance program of random high threat agent screening on suspicious diagnoses—for example, a certain small percentage of patients presenting with "fever of unknown origin" and respiratory symptoms would be automatically screened, with the cost deferred to a Federal surveillance budget, and patient information protected by HIPAA (personal communication with Bettina Stopford, R.N., Director, Public Health and Medical Emergency Preparedness, Science Applications International Corporation, Justice and Security Solutions Group, March 2004). This is akin to other syndromic surveillance programs currently in effect across the United States and specifically in cities such as New York, where sentinel lab personnel play a significant role.</p>
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<h4>Funding</h4>
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<p>Many private laboratories are for-profit entities that do not—and, some experts argue, should not—receive State (or Federal) funds. Other hospital labs and small local public health labs require State funds, particularly for investments such as supplemental training, information technology upgrades, and specialized equipment. Such laboratory funding could be contingent on specific qualification criteria and appropriate time-bound performance measures or on proficiency testing performance. "Public" annual report cards submitted to the Governor could allow problems to be addressed at the State level with labs being held accountable for the funding they request (personal communication with Richard Kellogg, LRN Coordinator, Centers for Disease Control and Prevention).</p>
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<p>Several experts suggest that alternative funding mechanisms should be considered for BT funds. As discussed previously, the short-term nature of most BT funding has caused significant human resources issues for labs seeking to attract quality personnel. One notable exception is New York State, which has managed to circumvent some of the short-term funding issues by channeling all funds through a not-for-profit corporation, founded 20 years ago, that receives funds on behalf of the New York State Public Health Department. BT funds are awarded to the nonprofit corporation and segregated from other State funds. New York is in its fourth year of such BT funds, and is not constrained by a short-term focus. The employment of quality personnel is contingent only on the life of the grant to the not-for-profit corporation (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004).</p>
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<h4>Facilities/Biosecurity</h4>
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<p>As most sentinel labs do not have BSL-3 capabilities and do not have the necessary waste disposal and containment equipment in place, their best biosecurity practice will be to clearly understand and apply the LRN "rule-out or refer" concept of operations. Sentinel labs with access to funding should not spend monies building BSL-3 facilities or acquiring specialized autoclaves or other containment and disposal equipment; as they only perform rule-out testing, they do not require such investments. Sentinel labs must have contingency plans for maintaining control of and protecting evidence in the event they encounter a select agent and must establish a clear and documentable procedure for chain-of-custody that meets law enforcement standards (personal communication with Barbara Johnson).</p>
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<p>Sentinel labs are exempt from the Select Agent requirements (42 CFR 73) (personal communication with Barbara Johnson). Per these requirements, however, they will only remain exempt if they transfer or destroy any select agent they encounter within seven calendar days after identification has been confirmed unless otherwise directed by the FBI or by another law enforcement agency and following consultation with the HHS Secretary (<a href="devmodap5a.htm#hhs02">HHS, 2002</a>).</p>
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<h4>Clinical Laboratory Connectivity</h4>
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<p>Internet connectivity should be a significant priority for sentinel labs, to allow better training, better communication with both State public health departments and Federal agencies, better reporting during a crisis or for syndromic surveillance purposes, and better tracking of patients.</p>
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<p>Sentinel labs should establish Internet connectivity and ensure that they comply with HIPAA regulations concerning patient confidentiality and the secure transmission of any individually identifiable health data.</p>
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<p>"Online" labs should enroll in Statewide healthcare provider networks so that State public health labs have current and accurate data on their capabilities and needs (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004).</p>
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<h4>Equipment/Supplies</h4>
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<p>The routine testing carried out by sentinel labs is not equipment-intensive, and therefore, as noted above, additional equipment should not be a primary concern for those labs, particularly those dependent on State funds for their daily operations (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004).</p>
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<p>As frequently as possible, equipment should be for dual-use purposes to maximize use of limited space and ensure that personnel achieve sufficient proficiency with procedures to avoid attempting to master new equipment during a crisis (personal communications with Scott Becker; Mary Gilchrist, Ph.D.; Rosemary Humes; 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). The only caveat would be that sentinel labs must remain mindful of FAR clauses governing the private use of public funds, as discussed previously.</p>
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<h4>Transportation/Courier Services</h4>
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<p>Sentinel lab personnel must know about packaging and shipping of suspect samples and about alternative transportation methods in a crisis. Each lab should have a reference document or manual on these topics. This information can be downloaded from the CDC or ASM Web sites, and also can be provided via mail or fax by State Public Health Labs (personal communication with Barbara Johnson).</p>
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<p>Sentinel and private labs should also ensure that they use only authorized couriers for the transfer of suspect clinical samples to reference labs. An authorized courier is either a HAZMAT or first responder unit with the appropriate experience or a bonded courier who is trained to handle potentially infectious substances. Certain national couriers, such as FedEx, also are specifically equipped to handle select agent samples. If there is any suspicion that a sample might be a BT agent, law enforcement agents may be called in to act as both the custodian and the courier for the sample, depending on chain-of-custody requirements. Sentinel labs should never entrust a sample to a local, unproven courier.</p>
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<h4>Training</h4>
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<p>To be able to provide routine testing surge capacity in support of State public health laboratories during an emergency, sentinel lab staff should receive training to perform non-BT testing that falls outside their regular routine. They should be trained in standard testing protocols, since Select Agent regulations prohibit them from engaging in BSL-3 work at their regular (sentinel) lab, and certification is laboratory-specific (<a href="devmodap5a.htm#gao">U.S. General Accounting Office 2001</a>; personal communication with James Snyder, Ph.D.).</p>
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<p>Representatives from sentinel labs can and should participate in meetings and exercises organized by State public health labs, and should also be familiar with their local law enforcement, HAZMAT, and WMD-CST points of contact. In addition, "Adopt-a-Lab" programs can allow local and regional meetings of representatives from sentinel labs to discuss new concepts and requirements, testing procedures, and general emergency preparedness challenges. These meetings can include reference labs as well. Louisville, KY, has implemented this program very successfully for labs within a 50-mile radius (personal communication with James Snyder, Ph.D.).</p>
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<p>Where funds allow, sentinel laboratory staff should be provided with basic IT training and education about online emergency communication protocols, as well as related HIPAA regulations.</p>
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<h4>Interagency Communications</h4>
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<p>On a related issue, sentinel labs must have the capability of receiving both routine and emergency guidance either through E-mail or, if the lab is not online, through broadcast fax (personal communication with Ann Willey, J.D., Ph.D., February 27, 2004).</p>
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<p>Both sentinel and reference labs should establish communication lines with veterinary resources, environmental organizations, and food laboratories within their State, in order to maximize their ability to troubleshoot in a crisis and to share general laboratory best practices and lessons learned (e.g., with respect to zoonotics or food-borne illnesses) (personal communication with Mary Gilchrist, Ph.D.).</p>
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<h3>Guideline for Building the Model: Applicability of Best Practices</h3>
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<p>The best practices discussed above serve as a gold standard for sentinel, reference, and national laboratories and should be used as guidelines, rather than as a mandate, to ensure laboratory preparedness and ensure sufficient capacity should a BT event occur. Below, we answer several outstanding questions about our recommended best practices.</p>
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<h4>Adaptability—Are these best practices suitable for use in any region?</h4>
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<p>The best practices outlined above are suitable for use in any region.</p>
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<h4>Throughput. How many victims of a biological attack will these best practices aid?</h4>
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<p>It is difficult to quantify how many victims would be aided by instituting the recommended best practices; however, it is certain that these practices would reduce the time from occurrence of a BT event to detection, significantly decreasing morbidity and mortality.</p>
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<p>Capacity calculations are realistic for clinical samples. For example, approximately 60 clinical samples per BSC can be tested and reported within a 12-hour period assuming a high index of suspicion for a particular agent and dependent on the experience of the laboratorian performing the testing. (<a href="devmodap5a.htm#fdoh">Florida Department of Health, 2002</a>) However, measuring the capacity of laboratories to handle environmental samples is quite difficult and no model currently exists to accurately assess environmental testing capacity. Suggestions that environmental samples take twice as long to process as clinical samples can be misleading, as environmental samples can differ dramatically (e.g., a swipe vs. a phone booth). Building a model to assist with these calculations would be challenging, but worth exploring.</p>
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<h4>Cost—How much will it cost regions to implement the best practices?</h4>
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<p>Based on government grade scales (GS) 13-15, the starting salary for a Ph.D.-level scientist ranges from $65,000 to $90,000 per year depending upon experience. The starting salary for an Information Technology Specialist is approximately $35,000 to $55,000 per year.</p>
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<p>Conversion of BSL-2 suites into BSL-3 suites and construction of new BSL-3 suites can be very costly. Remodeling of existing facilities may cost in excess of $500,000 and construction of new facilities may cost a minimum of $1.5 million.</p>
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<p>Costs to meet minimum equipment requirements:</p>
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<ol>
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<li>Phase Contrast Microscope $2,000 + </li>
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<li>Fluorescence Microscope $2,000 +</li>
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<li>RT-PCR unit (e.g., Smart Cycler II) $30,000 +</li>
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<li>Centrifuge</li>
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<li>* (benchtop or microcentrifuge) $2,000 +</li>
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<li>* (floor model) $7,000 + </li>
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<li>Incubator (0.6 cu. ft. benchtop) $800 + </li>
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<li>70°C freezer (7 cu. ft.) $7,000 + </li>
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<li>Water bath (10L capacity) $800 + </li>
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</ol>
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<p>Costs for transportation and courier services are difficult to enumerate as special agreements may need to be made. These services are not federally funded and many States must cut budgets for these services because of financial constraints.</p>
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<p>The salary for a full-time laboratory coordinator or a full-time BT State training coordinator is approximately $35,000-$70,000, depending on location and experience.</p>
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<p>While the LRN currently funds proficiency testing for reference labs, the sources of funding for annual exercises and for proficiency testing for sentinel labs will vary and merit further consideration.</p>
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<p>Institution of the best practices would cost more than most labs can afford.</p>
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<h4>Operational Impact. What are the operational considerations of using these best practices?</h4>
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<p>The operational impact would be significant. During the anthrax crisis in October, 2001, laboratories reported a major negative impact for testing both BT and routine non-BT isolates. Enacting the recommended best practices would help reduce the capacity burden placed on already overwhelmed laboratories. Institution of mutual aid agreements, prior arrangements for transportation and courier services, and training recommendations would also positively affect operational impact. </p>
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<h4>Training—What level of training do these best practices require?</h4>
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<p>Several levels of training are required if best practices are instituted. For sentinel laboratories, training should be coordinated by the State laboratory training coordinator and should be offered regionally within the State. Training for sentinel laboratories should include recognition of select agents, procedures used to rule out potential BT agents, activation of a notification algorithm, appropriate waste disposal, and shipping regulations. Proficiency testing also should be addressed. Training must be offered on a regular basis to ensure that newly hired laboratorians are trained properly. Annual refresher courses are recommended.</p>
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<p>The NLTN is a good resource for sentinel laboratories. The network was created jointly by APHL and CDC and provides continuing education for laboratorians performing clinical, public health, and environmental laboratory testing. Training resources developed for BT by the NLTN include: Webcasts, sentinel laboratory protocols, a calendar of NLTN training seminars, and other useful links. NLTN training seminars are held frequently and in different locations. The seminars are offered gratis or for a nominal fee (e.g., $10.00).</p>
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<p>For reference and national laboratories, training is handled primarily through the LRN and includes instruction-based training as well as practical exercises and proficiency testing. A State-based laboratory training coordinator is necessary, however, to provide supplemental training and refresher courses.</p>
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<h4>Resources. Do the practices build on existing practices/infrastructure? Are there available resources to implement the practices?</h4>
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<p>Most of these recommended practices build on existing practices and infrastructures, including those recommendations for personnel, clinical laboratory connectivity, and training. However, existing infrastructure is not apparent for transportation/courier services and is lacking in the areas of facilities/biosecurity and equipment/supplies.</p>
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<h4>Morbidity and Mortality—What impact will these practices have on saving lives?</h4>
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<p>These practices will significantly decrease morbidity and mortality, as the time from occurrence of an event to its detection will be greatly reduced. The best practices protect laboratorians and their immediate environment from contamination and rapid identification of the responsible BT agent will ensure that antimicrobial therapy and other treatment measures can be optimized, which will benefit the general public. Rapid identification will allow epidemiologists and other emergency management personnel to make quick decisions and optimize their response based upon the mode of transmission, incubation period, and treatment options for the identified agent.</p>
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<p>As an additional benefit, dual-use technologies and overall improvements that would be made to public health facilities should result in decreased morbidity and mortality from other infectious diseases.</p>
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<h4>Evidence-based Practice versus Theory—Is there a body of professional research supporting these practices or are they theoretical?</h4>
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<p>These practices are supported by decades of research with BT agents and facility requirements for handling these agents. Notification call-lists, or algorithms, are used and activated on a regular basis by many emergency responder groups. This practice should transfer well to public health agencies. Proficiency testing has been widely used for years as a measure of laboratory performance, although BT agents were not incorporated into testing programs until recently.</p>
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<p>The LRN has been in existence since 1999 and there has been a significant amount of research aimed at establishing such a network. The decentralized nature of the LRN is similar to the PulseNet project established to identify food-borne illness outbreaks. Regional, rather than State-based, projects have been less successful in their ability to respond in a timely fashion and State boundaries are a natural catchment for funding, training and transportation/courier services. In addition, the LRN has added practical experience, due to its involvement during the anthrax crisis in October 2001.</p>
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<h4>Regulatory Compliance—Do the practices comply with existing regulations or do they require a regulatory change?</h4>
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<p>At this time, the main existing regulation for reference and national laboratories in regard to testing BT agents is the Select Agent Regulation, 42 CFR 73.0. All clinical and diagnostic laboratories do, however, undergo general annual inspections and must be in compliance with regulations established by agencies such as CLIA or CAP. FAR and HIPAA regulations also apply to specific laboratory activities, as does the Patriot Act.</p>
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<p>The LRN has no regulatory powers and cannot penalize reference laboratories that perform poorly. There is currently no accountability for funding allocation or time-bounded performance measures. These practices do require a regulatory change in order to promote responsibility and accountability.</p>
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<p>Lastly, experts recommend the establishment of Federal guidelines and regulations for handheld devices used for environmental testing in the field, similar to the guidelines and regulations currently in existence for devices to test clinical samples (which must receive Federal certification).</p>
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<a id="Future" name="Future"></a>
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<h3>Future Research Needs</h3>
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<p>We identified several research areas that lie beyond the scope of this chapter but warrant urgent and in-depth exploration:</p>
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<p><strong><em>A better definition of environmental capacity</em>.</strong> What are the relevant variables? Measuring the capacity of different laboratories to handle environmental (vs. clinical) samples is not simple. No model currently exists to accurately assess environmental testing capacity. The calculations of time and quantity are complex. Variables include whether the potential agent is known or suspected, the types of materials being sampled, laboratorian experience testing reliability of assays, whether new assays are being developed or are available, availability of equipment, options for secure transport, etc. Building a model to assist with these calculations would be challenging, but certainly worth pursuing.</p>
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<p><strong><em>A guideline for handheld devices</em>.</strong> What types of devices should first responders use and not use, and when should they use them? Handheld devices for clinical specimens currently must be nationally certified, but there is no Federal certification program or regulation for environmental devices. This research should include an exploration of the current state-of-the-art in handheld devices, and a delineation of core criteria for development, testing, and selection by both Federal agencies and State and local governments.</p>
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<p><strong><em>A guideline for staffing the workforce at confirmatory labs</em>.</strong> What is the appropriate mix of skills, experience, and academic requirements that will allow a confirmatory
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lab to adequately support response and development? What variations exist (or
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should exist) from State to State?</p>
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<p><strong><em>An analysis of laboratory capacity to handle chemical, radiological, or explosive samples</em>.</strong> How do the capabilities and requirements differ from BT, and where do they overlap?</p>
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<p><strong><em>An analysis of how better to integrate EPA labs, FDA labs, and veterinary labs into the emergency preparedness and response discussions and plans of both reference labs and sentinel labs</em>.</strong></p>
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<p><strong><em>A national guideline for chain-of-custody issues</em>.</strong> Current chain-of-custody protocols differ from State to State and even from jurisdiction to jurisdiction within States, causing tremendous confusion as to how to handle unknown or suspect samples.</p>
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<p><strong><em>A proposal to build a primary and secondary educational curriculum focused on laboratory disciplines</em>.</strong> Fewer and fewer students are showing an interest in pursuing careers as microbiologists or medical technicians, which is causing a shortage of classically trained staff at public health laboratories nationwide. By contrast, careers in forensics and nursing have become popular due to television shows and sustained public relations campaigns. How can careers in biological and laboratory sciences be similarly popularized? What is the best approach to inculcate an interest in these disciplines at a young age?</p>
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<p class="size2"><a href="devmodel1.htm#Contents">Return to Contents</a><br />
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<a href="devmodacro.htm">Proceed to Next Section</a></p>
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