9
Air Force Institute for Operational Health San Antonio Avian and Pandemic Influenza Activities

The U.S. Air Force began its global influenza surveillance of U.S. military forces and their families in 1976 under Project Gargle (AFIOH, 2006b). Through this program the Air Force systematically collected febrile respiratory illness (FRI) specimens from clinics and hospitals worldwide. In 1997 these efforts were expanded with the development by the Department of Defense (DoD) of the Global Laboratory-Based Influenza Surveillance Program. At the same time, the Office of the Assistant Secretary of Defense for Health Affairs designated the Surgeon General of the Air Force as the executive agent for DoD influenza surveillance (Bailey, 1999). This policy expanded influenza surveillance and promoted a more DoD-wide approach, including sentinel site surveillance of U.S. military personnel and DoD beneficiaries, DoD global medical research facilities, and non-U.S. military forces.

The organization of the DoD Global Emerging Infections Surveillance and Response System (DoD-GEIS) created a DoD-wide global influenza surveillance network that encompassed and expanded the Air Force’s Project Gargle and the Navy’s population-based surveillance of recruits. A DoD policy, Health Affairs Policy Memo 99-081, was signed, and the Air Force Surgeon General was appointed as the executive agent of the new DoD Global Laboratory-Based Influenza Surveillance Program, with management responsibility given to the Air Force Institute for Operational Health (AFIOH) (AFIOH, 2006b). The AFIOH core program for influenza surveillance is guided by both the Health Affairs Policy Memo 99-081 and the Department of Defense Implementation Plan for Pandemic In-



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9 Air Force Institute for Operational Health San Antonio Avian and Pandemic Influenza Activities T he U.S. Air Force began its global influenza surveillance of U.S. mili- tary forces and their families in 1976 under Project Gargle (AFIOH, 2006b). Through this program the Air Force systematically col- lected febrile respiratory illness (FRI) specimens from clinics and hospitals worldwide. In 1997 these efforts were expanded with the development by the Department of Defense (DoD) of the Global Laboratory-Based Influ- enza Surveillance Program. At the same time, the Office of the Assistant Secretary of Defense for Health Affairs designated the Surgeon General of the Air Force as the executive agent for DoD influenza surveillance (Bailey, 1999). This policy expanded influenza surveillance and promoted a more DoD-wide approach, including sentinel site surveillance of U.S. military personnel and DoD beneficiaries, DoD global medical research facilities, and non-U.S. military forces. The organization of the DoD Global Emerging Infections Surveillance and Response System (DoD-GEIS) created a DoD-wide global influenza surveillance network that encompassed and expanded the Air Force’s Proj- ect Gargle and the Navy’s population-based surveillance of recruits. A DoD policy, Health Affairs Policy Memo -0, was signed, and the Air Force Surgeon General was appointed as the executive agent of the new DoD Global Laboratory-Based Influenza Surveillance Program, with management responsibility given to the Air Force Institute for Operational Health (AFIOH) (AFIOH, 2006b). The AFIOH core program for influenza surveillance is guided by both the Health Affairs Policy Memo -0 and the Department of Defense Implementation Plan for Pandemic In- 

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 REVIEW OF THE DOD-GEIS INFLUENZA PROGRAMS fluenza. DoD-GEIS provided funding, programmatic support, and profes- sional guidance to the Air Force in administering this new program, which then became two-pronged (AFIOH, 2006b, DoD, 2006). One prong was surveillance among U.S. military personnel and DoD medical beneficiaries; the second was surveillance in civilian populations in areas of the world where DoD units were located and which were suited to surveillance and to the providing of support to host country populations and allied countries. AFIOH also contributes to the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) and the Armed Forces Epidemiological Board now known as the Defense Health Board. A site visit team of the Institute of Medicine (IOM) Committee for the Assessment of DoD-GEIS Influenza Surveillance and Response Programs visited AFIOH on March 28-29, 2007.1 A list of the people met and inter- viewed and the itinerary followed can be found at the end of this chapter. MANAGEMENT AND PLANNING While the majority of the avian influenza/pandemic influenza (AI/PI) supplemental funding has been allocated to personnel costs, it does not ap- pear that personnel dedicated to assure quality were added as each section was expanded. The AFIOH laboratory has a rigorous quality-assurance program associated with its College of American Pathologists (CAP) and Clinical Laboratory Improvement Program (CLIP) accreditations. However, the lack of technical expertise in particular areas has limited the effective- ness and sustainability of AFIOH’s expanded AI/PI surveillance and detec- tion program. AFIOH has spent a significant portion of the AI/PI supplemental funds on one-time-only expenditures, and it expects that the increase in capacity, particularly in molecular biology, data management, and added surveillance sites, can be maintained in the future with an annual funding level of ap- proximately equal to one-third of the $4.1 million AFIOH received. The AFIOH program is expecting a move to Wright-Patterson Air Force Base in Dayton, Ohio, by 2011, and personnel involved in the influenza program are aware that this move will be a challenge for their program. The issues that they expect include retaining personnel in San Antonio until the site closes, side-by-side operations for some period of time, the potential need to rebuild the program in Dayton, and the reluctance to make neces- 1 Priorto the committee’s visit to AFIOH, the laboratory staff provided the committee with detailed background information on AFIOH and the pandemic/avian influenza activities it was supporting. These materials were used in the writing of this chapter and are available from the IOM in the Public Access File.

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 AIR FORCE INSTITUTE FOR OPERATIONAL HEALTH SAN ANTONIO sary improvements in the current building or campus. The move and its impact are expected to be a major challenge, and the team at AFIOH is well into planning how to overcome any issues that may arise. Staffing The Air Force Institute for Operational Health (AFIOH) has two divi- sions that deal with the surveillance program for viral and bacterial agents. Staff in these divisions often split their time between the influenza program and other AFIOH research activities. One division focuses on the epidemi- ology of different agents and employs about 24 people. The second division, dealing with laboratory identification, has about 95 people, of whom 23 are responsible for the packing and receiving of samples. Five employees are responsible for customer service, which involves interacting with other laboratories both nationally and internationally. The committee was told that 1.4 million samples are handled annually. The DoD-GEIS-driven program for influenza includes sentinel site sur- veillance among U.S. military personnel and DoD beneficiaries, at DoD global medical research facilities, and among non-U.S. military forces. In addition, influenza surveillance is done on several civilian populations around the world where DoD units are located and local support is con- ducive to such activities. A subset of the above AFIOH staff (33 people in total) is working on influenza-related activities. Many of these 33 people are working on multiple projects, and seven represent AFIOH leadership overseeing all of the projects at the laboratory. Two-thirds (about 22 em- ployees) are part of the base funding derived from DoD-GEIS funds. Nine or ten people are employed through the DoD-GEIS supplemental pro- gram, which is aimed at dealing with the threat posed by a new influenza pandemic. AFIOH is thus charged with expanding the capabilities to do high-throughput screening for influenza and to identify increased disease activity, allowing for an adequate and timely response to a pandemic. Currently, there are 65 sites in 40 countries from which samples can be obtained. The isolation frequency (25 percent) of influenza A and B virus isolates is high and speaks to an effective staff capable in classical isolation methodologies. However, the IOM committee found the capability of staff in modern molecular techniques to be less effective. The lack of cutting edge technical expertise in this area has limited the effectiveness, sustainability, and po- tential of AFIOH’s expanded AI/PI surveillance and detection program. In early 2007, there were major staffing problems in the molecular biology section. The departure of key molecular biology personnel appears to have deprived the entire section of much-needed expertise. Unfortunately, the AFIOH leadership may not be aware that the remaining staff is not up to

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 REVIEW OF THE DOD-GEIS INFLUENZA PROGRAMS date in molecular biologic techniques. The committee felt that this lack of expertise, in combination with the associated challenges identifying and ad- dressing issues of quality in the molecular biology program, despite having standard AFIOH quality assurance protocols on hand, threaten the ef- fectiveness and limit the potential of the section’s influenza surveillance activities. The epidemiology staff is charged with tracking the effectiveness of influenza vaccination and the epidemiological pattern of individuals par- ticipating in the DoD-GEIS influenza surveillance program. It is not clear that the present staff has the experience and the determination to collect the necessary raw data and then to provide compelling epidemiological as- sessments. Specifically, both the laboratory staff and the epidemiology staff need strengthening to reliably and confidently find new pandemic strains or to identify unusual epidemiological situations. The laboratory does not ag- gressively test for non-H1 and non-H3 influenza virus strains and does not proactively solicit samples for timely analysis. We were told that samples from Peru are frequently six months old. The epidemiological surveillance appears to be passive rather than proactive and lags behind in applying modern algorithms. Technology and Information Management Under the fiscal year 2006 AI/PI supplemental funding, three infor- mation management/information technology (IM/IT) analysts are being supported to add and improve capabilities in three principal areas. First, a computer-based sample labeling and tracking system is being put into place to replace the time-consuming and error-prone manual procedures currently used. Second, geographic mapping software is being acquired to provide all stakeholders with interactive access to influenza-like illness (ILI) data from medical treatment facilities. (Even without this capability, a great deal of further analysis should be done with this data; for instance, seeking out trends by geographic region or demographic group, rather than just the current breakdown by military service branch.) Finally, a large centralized database is being set up to collect DoD encounter data: visits, prescriptions, etc. by all active and retired military personnel and their dependents, both at DoD medical treatment facilities and non-DoD facilities. This effort ap- pears to be still in the planning stages, and we would strongly encourage a close coordination with other related DoD-wide efforts, such as the Medical Data Access Real-Time framework, which is used to mine composite health care system data from DoD medical treatment facilities and is coordinated by the Office of the Secretary of Defense Clinical Information Technology Program Office. Data analysis efforts at AFIOH primarily involve the collection, analy-

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 AIR FORCE INSTITUTE FOR OPERATIONAL HEALTH SAN ANTONIO sis, and reporting of ILI activity at DoD military treatment facilities world- wide. Standard Ambulatory Data Registry data is collected on a weekly basis from Air Force sites and on a monthly basis for other service branches. Any site experiencing an increase in respiratory patient visits (defined as more than two standard deviations above the mean) is notified and asked to provide specimen samples. Graphs showing overall ILI activity among each service branch are included in the weekly Influenza Surveillance Update published by AFIOH. In addition, DoD-wide respiratory disease labora- tory data gathered through the composite health care system is collected and uploaded to the Centers for Disease Control and Prevention (CDC) on a weekly basis. The ILI tracking program is systematically connected with a trigger to communicate unusual occurrences of ILI back to participating sites. These communications are critical and allow for real-time responses to clusters of illness as they occur. The AFIOH team has shared its accumulated experience and expertise in shipping and receiving with its sentinel sites and the public in general. This is done through an extensive description of packing protocols that is provided in writing, upon request, and is fully available on the inter- net. Similarly, communications about how to collect nasal washes are excellent. Conclusions Given the demonstrated importance of the AFIOH to the U.S. and WHO programs for identifying influenza vaccine strains, it must be staffed and led by individuals with the best reputations in public health labora- tory virology and respiratory disease epidemiology. The molecular biology capacity of AFIOH cannot be maintained in light of the current lack of ex- pertise in personnel in the molecular biology section and a lack of expertise in molecular biology among the leadership. The lack of expertise hinders this group from fully utilizing the resources at its disposal, and it must be addressed in order to make this program sustainable. Permanent expertise in molecular biology and data management is critical, but short-term advi- sors might be helpful in solving immediate problems. The lack of molecular biology expertise at AFIOH will prevent the accurate presentation of this data to stakeholders such as VRBPAC. This lack of expertise has and will continue to affect the effective functioning of AFIOH in communications. RECOMMENDATION 9-1. AFIOH’s influenza program should em- ploy a strong doctoral-level molecular biologist with demonstrated tech- nical and leadership skills. These should include a strong background in laboratory quality control methods. The program staff should be

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 REVIEW OF THE DOD-GEIS INFLUENZA PROGRAMS well-versed in the data analytic approaches desired by the FDA influ- enza vaccine committee. The laboratory should regularly obtain techni- cal guidance from appropriate sources (e.g., CDC, FDA, academia, and GEIS headquarters) to ensure that it is using state-of-the-art methods and is targeting appropriate specimen sources. SURVEILLANCE The program at AFIOH provides national and international respira- tory disease data from DoD beneficiaries within the U.S. Air Force, Army, Navy, and Coast Guard. Allied nations in areas cooperating with the DoD overseas medical research facilities are also collaborating partners. Surveil- lance is conducted under three areas at AFIOH. The first is surveillance for influenza-like illness (ILI); the second surveillance effort involves the test- ing of samples from enrolled sentinel sites; and the third entails the testing of clinical samples arriving from all over the world for a variety of illness complaints (AFIOH, 2007b). The ILI surveillance program collects clinical data on the number of ILI cases occurring at enrolled surveillance sites. This effort has resulted in near real-time collection of clinical cases meeting the DoD ILI definition across the services. These data are compiled by the epidemiology team at AFIOH, and any sites experiencing an incidence of ILI two standard devia- tions above the average are contacted by AFIOH. The flagship surveillance program for AFIOH is the former Project Gargle (started in 1976), now known simply as sentinel site surveillance. Currently, there are 56 sentinel sites in 34 countries, the majority of which are military and DoD research sites or hospitals overseas (see Figure 9.1) (AFIOH, 2007b). New sites are under consideration for addition. Factors considered in the selection of a sentinel site are the potential for emergence of new strains of influenza virus, the potential for importation of new strains, the impact of an outbreak or novel influenza virus on military operations, and whether an area has high troop concentrations and highly mobile or rapid- response units. Sentinel sites are required to institute an active influenza surveillance and identification program. They submit weekly specimens col- lected from patients meeting the criteria for influenza-like illness (ILI) (i.e., fever of more than 38°C and cough or sore throat) along with a completed influenza surveillance questionnaire to provide an epidemiological profile (AFIOH, 2006a). Passive surveillance is performed at non-sentinel sites; the patients from whom respiratory specimens are collected at those sites do not necessarily meet ILI criteria (i.e., they are not always clinical respira- tory diagnostic specimens). AFIOH provides sentinel sites with a program brochure describing the program, an educational presentation, staff-specific

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189 AIR FORCE INSTITUTE FOR OPERATIONAL HEALTH SAN ANTONIO Figure 9-1 AFIOH sentinel surveillance sites and activities, present and future, 2006-2007. SOURCE: Neville, 2006. educational pamphlets, a guidance sheet, influenza surveillance question- naires, and specimen collection kits. Sites are requested to collect six to ten viral culture specimens per week Figure 9-1 along with case data from patients meeting the ILI case definition. Speci- mens are collected as throat or nasopharyngeal swabs or nasal wash using viral transport medium (MicroTest M4-RT [Remel, Lenexa, KS]). Speci- mens collected from U.S. locations are refrigerated, shipped on gel packs, and received within three to four shipping days. All other specimens are fro- zen at -70°C and shipped on dry ice by a commercial carrier. Upon arrival, specimens are processed in a biosafety level 2 (BSL-2) laboratory (BSL-3 is available) and cultured for isolation of influenza A, influenza B, adenovirus, parainfluenza virus 1, 2, and 3, enterovirus, respiratory syncytial virus, and herpes simplex virus using rhesus monkey K cells. Specimens are cultured for up to 10 days before negative results are reported. All original samples are maintained in the event that they are needed to supply a vaccine seed vi- rus. Only original sample material for growth in eggs is acceptable for vac- cine production. All influenza isolates collected from locations outside the United States and isolates of interest from the United States are subtyped using hemagglutination-inhibition (HI) or reverse transcriptase polymerase chain reaction (RT-PCR) procedures. A sample of these isolates undergoes molecular sequencing at AFIOH to identify significant amino acid changes. Select isolates and all sequence data are sent to the CDC for further subtyp-

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0 REVIEW OF THE DOD-GEIS INFLUENZA PROGRAMS ing and antigenic characterization for detection of variance from the vac- cine component strains. All fiscal year 2006 AFIOH influenza surveillance data, which are to include 120 isolates and 101 original samples, have been shared with CDC and the World Health Organization (WHO). The AI/PI supplemental funding has been used specifically to increase laboratory staffing to test additional incoming samples and to provide shipping supplies and updated educational materials on how to properly ship samples. The AFIOH laboratory is a busy clinical laboratory. Any U.S. military site can submit clinical respiratory specimens to AFIOH. Twenty-three non-sentinel sites have been tested since October 2006 after submitting samples to AFIOH for evaluation and were also included in influenza A and B surveillance. The patients tested in this program do not necessarily meet the DoD case definition for ILI. Conclusions AFIOH’s efforts to pull together surveillance data from all of the ser- vices have been hampered by a lack of cooperation and the inability to col- lect standardized data. These data are valuable for tracking disease clusters and should be analyzed in the largest aggregate group that is possible. The designated reporting agency for surveillance would be able to coordinate information more effectively and efficiently if the data from all participants were received in a timely and fully analyzable manner. This relates to Rec- ommendation 10.1. LABORATORY AFIOH is the central laboratory for the DoD influenza program. It serves as both a clinical and a public health laboratory, generating both active and passive surveillance data. AFIOH occupies a large laboratory building at Brooks City Base, located just south of San Antonio, Tex. The space was built in the 1960s and houses numerous BSL-2 laboratories, a single BSL-3 suite, and office spaces, which are not biohazard-handling spaces. Access to the laboratory space is generally restricted by control of the front door of the building. Additionally, the designated Laboratory Re- sponse Network (LRN) space is controlled and limited to selected employ- ees (14 people total) as is access to the 240-square-foot BSL-3 space in the building (four people total). Other rooms in the building that are designated BSL-2 spaces are identified with prominent biohazard signs. The molecular biology section is currently being remodeled to more closely approximate a useful configuration for the laboratory. At the present time, traffic flow, separation of the steps in the processing of samples, and

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 AIR FORCE INSTITUTE FOR OPERATIONAL HEALTH SAN ANTONIO the essential controls needed to prevent and detect contamination are all lacking. The molecular biology section is housed in two contiguous rooms linked by two doors. Samples from the virology section arrive in the labo- ratory for testing in a fully infectious state. They are inactivated, processed for RT-PCR, and tested (RT-PCR screening, subtyping, and sequencing) in these two rooms. All extracted RNA and any archived products are kept in two ultra-low-temperature freezers in the molecular biology laboratory suite. It is unclear how and where any positive controls for molecular bi- ology tests are stored and handled, including any that are on site for the detection of novel HA and NA subtypes. The volume of incoming packages, with approximately 1.4 million samples arriving annually from multiple laboratories and surveillance sites around the world, presents a major space issue for the laboratory (AFIOH, 2006b). Among the incoming samples are approximately 1,600 submitted annually for influenza A and B detection. Samples for influenza A and B testing flow from the designated shipping and receiving areas to the virol- ogy laboratory, where they are inoculated onto cultures. The shipping and receiving management is outstanding in this laboratory. Classical virological methods are used for the initial detection of influ- enza A viruses in clinical samples. These methods include dual inoculation of shell vials and culture tubes. Viruses are cultured for 24 to 48 hours and then detected with IFA techniques. The isolation rates achieved for the laboratory (approximately 40 percent) would indicate that the staff and the methods used are highly effective. The space and equipment dedicated to the ultra-low-temperature stor- age of samples and viruses for normal storage and archiving is not sufficient for the storage of more than one year’s sample volume. Additionally, there is currently no liquid nitrogen storage in the virology laboratory, which limits long-term storage of cells. The current methods for labeling tubes and tracking samples are inad- equate for the sample volume coming into this laboratory and may intro- duce error into the system. Currently, tube inserts are labeled by hand and a preprinted label is attached to the tube. Two tubes are labeled and a single sample divided between them. These tubes are then placed into cardboard boxes and then into ultra-low-temperature freezers. Conclusions The AFIOH laboratory does well with virus isolation, which is now done in only a few places. This is a valuable service offered by AFIOH and should be supported. However, it is critical that the laboratory work with partners to further maximize the use of valuable samples collected by the DoD influenza program (both original patient samples and virus samples).

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 REVIEW OF THE DOD-GEIS INFLUENZA PROGRAMS There are a variety of organizations which may be able to assist in this, such as the National Institutes of Health (NIH). There is inadequate attention paid to preventing and controlling con- tamination, particularly in the molecular biology section. The potential for contamination was a major concern of the committee, and the refitting that is currently underway will not address this problem. RECOMMENDATION 9-2. In order to minimize potential for con- tamination in the molecular biology section and to improve the data generated by this section, AFIOH should seek expertise in molecular biology techniques and their implementation in a diagnostic laboratory setting. While the sample flow from different international sites appears to be adequate, the present staff has not taken full advantage of modern diag- nostic techniques. For example, in the AFIOH weekly influenza surveil- lance report of March 18-24, 2007, it is suggested that “over 90 percent of the influenza isolates have been molecularly sequenced.” In fact, only the hemagglutinin genes had been sequenced (not the entire viral genome) and most likely only the HA1 portion. Furthermore, state-of-the-art multiplex technologies have not been installed at AFIOH, while some collaborating laboratories overseas (and also domestically) effectively use such techniques in their surveillance efforts. RECOMMENDATION 9-3. AFIOH should consider the expansion of its laboratory capacity to include multi-tasking diagnostic equipment for respiratory diseases. The archival storage of original sample material and virus isolates, an important resource coming from this laboratory, is inadequate. The sample labeling system could easily introduce error, as could the lack of an orderly data management system. The equipment needed for sustaining appropriate archived samples, both from the virology and molecular biology sections, is not sufficient to satisfy anticipated future needs. RECOMMENDATION 9-4. AFIOH should create a sustainable and useful archive of the original patient sample and virus isolate materials in this laboratory to ensure that this national resource can be used to fulfill the missions of the DoD-GEIS AI/PI program. AFIOH’s use of the surveillance and sequencing data is less effective than its surveillance and specimen collection system. Collaborations with other U.S. government and scientific entities could maximize the shared

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 AIR FORCE INSTITUTE FOR OPERATIONAL HEALTH SAN ANTONIO knowledge resulting from the lab’s surveillance activities. For example, rigorous rules should be made as to when and how data are shared with the public as well as with other organizations, such as the NIH and Los Alamos National Laboratory (LANL). The NIH has a major sequencing program of influenza virus isolates, and LANL also has a program and superb expertise for analyzing influenza virus sequence data. Both NIH and LANL have exceptional computational biologists trained in the analysis of evolutionary changes of influenza viruses. RECOMMENDATION 9-5. AFIOH should continue collaborate with both the National Institutes of Health and Los Alamos National Labo- ratory and provide sequencing data and samples when appropriate. AFIOH would also benefit from working with cutting-edge academic collaborators who could be helpful in identifying agents present in sam- ples that have eluded identification by in-house people. For example, the Ganem and deRisi laboratories at University of California, San Francisco (UCSF) and the Lipkin laboratory at Columbia University have developed methodologies for the identification of respiratory agents. Such techniques may allow the identification of agents responsible for mixed infections and possibly result in the identification of new agents responsible for respira- tory infections. Finally, AFIOH is encouraged to share reagents with other interested parties. Such sharing should occur with minimal bureaucratic interference and may be facilitated by asking for nominal fees to offset costs for preparing and shipping reagents and materials. Alternatively, agree- ments similar to cooperative research and development agreements could be initiated with appropriate parties interested in collaborations. RECOMMENDATION 9-6. AFIOH should seek out cutting-edge aca- demic collaborators in order to expand the methodologies available to identify agents responsible for mixed infections, which could possibly result in the identification of new agents responsible for respiratory infections. RESPONSE CAPACITY In the six months since October 1, 2006, only 1,613 samples were processed, resulting in the laboratory isolation of 414 influenza viruses. The relatively low number of processed isolates over a period of six months should allow for a considerable surge capacity should there be need for it. The AFIOH virology laboratory has a documented (February 2007) surge plan to address the increased workload for either unusually severe seasonal influenza or the potential emergence of a human pandemic strain. The two

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 REVIEW OF THE DOD-GEIS INFLUENZA PROGRAMS TABLE 9-1 Summary AFIOH Surge Capacity 8 Hours a Day, 24 Hours a Day, 5 Days a Week 7 Days a Week Traditional RT-PCR 1,300 samples/week 5,000 samples/week Traditional RT-PCR 2,600 samples/week 11,000 samples/week (1 gene target) H5 LRN assay 1,500 samples/week 6,000 samples/week SOURCE: AFIOH, 2007a. pillars of this plan are the stockpiling of approximately 500 frozen R-Mix ReadyCells, which are regularly tested and have been validated to detect influenza in 24 to 48 hours, and the cross-training of all medical labora- tory AFIOH personnel to assist in nasal wash specimen handling, screen- ing, sub-typing, and sequencing. It is stated that this plan will increase the sample throughput threefold, from the present capacity of 300 specimens per day screened with RT-PCR up to 900 specimens per day. It is not clear whether the subtyping or sequencing capacities (100 and 40 specimens per day, respectively) will increase by similar factors. Surge Capacity Under routine conditions, the AFIOH/SDEM Molecular Diagnostics Laboratory is capable of performing molecular screening on 1,300 samples per week (see Table 9-1). AFIOH would perform the FDA-approved LRN Assay for H5 with the capacity to screen 1,500 samples per week (AFIOH, 2007a). Targeting only the gene required to rule in or rule out the strain of interest would allow screening of up to 2,600 samples per week. If the lab transitioned to a 24-hours-a-day, 7-days-a-week opera- tion, the estimated short-term surge capacity would be 11,000 samples per week (AFIOH, 2007a). This would require reassigning of staff from other departments in the laboratory to maintain operations. This large volume of samples would have a major impact on the department that receives and processes specimens. AFIOH has an additional stock of supplies available for a short-term surge and would work with the vendors to have additional supplies delivered overnight if needed. Conclusions The capacity to test additional samples is sustainable; however, with problems in such areas as sample labeling, tracking, and archiving, the in- creased rate of testing will result in increased errors and losses of samples

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 AIR FORCE INSTITUTE FOR OPERATIONAL HEALTH SAN ANTONIO (archiving issues) and thus, potentially, no real ability to increase capacity. Coherent reporting requires the input of consistent, high-quality data. In this case, data coming from a variety of institutes have been difficult to gather and, thus, have not been reported. The currently documented surge plan contains a number of variable factors (e.g., regular vs. round-the-clock work shifts, BSL-2 or BSL-3 op- erations, supply inventories) which will be determined at the time that the need for increased sample rates arises, so as much preparatory work as possible is needed to smooth the final execution. In addition, given the regular turnover in personnel and the large number of opportunities for improvement revealed by previous exercises, AFIOH would benefit from periodic exercises of BSL-3 laboratory procedures similar to those carried out in December 2005. RECOMMENDATION 9-7. AFIOH should continue to conduct pe- riodic training exercises and dry runs in order to further develop and test the surge plan. COLLABORATION AND COORDINATION The AFIOH laboratory is the central laboratory for the DoD influenza program. One of the roles of AFIOH is to collaborate with many sites for the purpose of sample collection (see Box 9-1). This is done adequately and represents a strength of the program. AFIOH collects surveillance data from sentinel sites, drawing on the strategic positions of DoD overseas medical research laboratories, including the Naval Medical Research Center Detachment in Lima (collecting specimens from Argentina, Bolivia, Ecua- dor, Peru, and Colombia), the Armed Forces Research Institute of Medical Sciences in Bangkok (collecting specimens from local residents in Nepal, Thailand, and Vietnam), the U.S. Army Medical Research Unit-Kenya in Nairobi (collected from local residents in Burundi, Cameroon, Uganda, and Kenya), and the U.S. Army Center for Health Promotion and Preven- tive Medicine in Honduras (collecting specimens from local residents in El Salvador, Guatemala, Honduras, and Nicaragua) (AFIOH, 2007b). Most of the overseas medical research laboratories submitted respiratory specimens routinely throughout the 2005-2006 seasonal year. In addition to its collaborations with the DoD overseas facilities, AFIOH provides select isolates and all sequence data to the CDC for fur- ther sub-typing and antigenic characterization for detection of variance from the vaccine component strains (AFIOH, 2007b). All fiscal year 2006 AFIOH influenza surveillance data, which is to include 120 isolates and 101 original samples, have been shared with CDC and WHO. As a result of this information sharing, a unique seed virus from one of the DoD surveillance

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 REVIEW OF THE DOD-GEIS INFLUENZA PROGRAMS BOX 9-1 DoD Influenza Executive Agent Functions Identified by AFIOH Act as the central recipient of influenza virus specimens and influenza labora- tory results from all DoD medical treatment facilities that have clinical virology capability Maintain an archive of global influenza specimens available to CDC for vaccine production considerations Compile DoD lab-based influenza data into periodic and annual summary reports Coordinate influenza surveillance activities with DoD-GEIS and other relevant DoD partners including conducting the annual DoD influenza surveillance coor- dination meeting Coordinate with the Influenza Branch of the CDC for sharing of select isolates considered unique or otherwise warranting further characterization at CDC in the vaccine production process Brief the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) and Defense Health Board (formerly AFEB) on DoD influenza surveil- lance results annually Conduct outreach training and capacity-building for influenza activities Participate in various panels, scientific and policy meetings as subject matter experts sites forwarded to CDC by AFIOH was one of the three 2006-2007 human U.S. seasonal influenza vaccine components. The influenza B/Malaysia-like component was collected from an AFIOH sentinel site during the 2004- 2005 seasonal year. During the 2005-2006 season, CDC requested AFIOH to supply influenza A/H3N2 and influenza B original samples for the up- coming Southern Hemisphere vaccine. Sixty-seven samples were provided, with 15 considered as seed candidates (AFIOH, 2007b). In order to stay connected with the scientific community and to share findings, AFIOH staff also participate in national and international confer- ences, such as the meetings of the Vaccines and Related Biological Products Advisory Committee, the International Conference for Emerging Infectious Diseases, the Asia Pacific Military Medicine Conference, and the Council for State and Territorial Epidemiologists. The staff also routinely publish in scientific journals. In addition, all published sequence data are contributed to the NIH GenBank® genetic sequence database, an annotated collection of all publicly available DNA sequences (AFIOH, 2007b).

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 AIR FORCE INSTITUTE FOR OPERATIONAL HEALTH SAN ANTONIO Conclusions As the designated reporting agent in the DoD-GEIS network for influ- enza surveillance, AFIOH is expected to report in timely and standard ways to maximize the utility of the available data. While the newsletter produced by AFIOH is highly informative and contains excellent information, there is little or no information in the communication about data from sites outside of AFIOH. Communication across several systems to stakeholders, clients, col- laborating institutions, and the scientific community at large can be chal- lenging. Many of the difficulties in reporting across the services are related to difficulties in the surveillance arena. There is a need to streamline and standardize reporting, which could be accomplished through a mandate to provide a standardized data feed to AFIOH. AFIOH has used communica- tion to effectively improve surveillance efforts through improved sample quality (nasal wash instructions) and the submission of samples in a timely manner (shipping instructions). However, there is no real minimum stan- dard for what is needed in either the collection or the reporting of data. The supplemental funding has made it more difficult to create a standard report since many sites are doing their own testing, whereas in the past most of it was done at AFIOH. This means that many laboratories and hospitals are creating their own means of reporting. The value of the surveillance data currently being collected is diminished by an inability to collect it and report it through a single entity. The DoD influenza and respiratory disease surveillance program has evolved in recent years in response to the potential of pandemic influenza. This evolution has highlighted both the strengths and the shortcomings of the current program. In order to better reflect the current functional op- erating structure of DoD influenza and the respiratory disease surveillance program’s chain of accountability, as well as take to advantage of AFIOH’s strengths and minimize the effect of the lab’s current limitations, the execu- tive agency functions should be reexamined. (See the related recommenda- tion in Chapter 10.) RECOMMENDATION 9-8. In conjunction with DoD-GEIS head- quarters, AFIOH should examine the current activities at AFIOH, and strategies for strengthening the AFIOH operations should be identified and supported. REFERENCES AFIOH (Air Force Institute for Operational Health). 2006a. AFIOH influenza surveillance sites: DoD military-based sites (unpublished).

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 REVIEW OF THE DOD-GEIS INFLUENZA PROGRAMS AFIOH. 2006b. The Department of Defense Global Laboratory-Based Influenza Surveillance Program: FY 00 annual report. San Antonio. Department of Defense AFIOH. 2007a. AFIOH surge capacity plan (unpublished). AFIOH. 2007b. DoD-GEIS influenza surveillance and response program: AFIOH site assess- ment. PowerPoint presentation given during IOM team visit to AFIOH, March 2007. Bailey S. 1999. Policy for DoD global, laboratory-based influenza surveillance. Memorandum for Surgeon General of the Army, Surgeon General of the Navy, Surgeon General of the Air Force, Deputy Director for Medical Readiness, J-4, the Joint Staff. U.S. Department of Defense, Health Affairs, Washington, DC, February 3, 1999. On file with the National Academies Public Access Records Office. DoD (Department of Defense, Office of the Assistant Secretary of Defense, and Homeland Defense). 2006. Department of Defense implementation plan for pandemic influenza. Washington, DC: DoD. Neville, C. J. 2006. Global influenza surveillance at Air Force Institute for Operational Health. PowerPoint presentation given at first meeting of the IOM Committee for the Assessment of DoD-GEIS Influenza Surveillance and Response Programs, December 19, Washington, DC.

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 AIR FORCE INSTITUTE FOR OPERATIONAL HEALTH SAN ANTONIO LIST OF CONTACTS DoD-GEIS AFIOH Assessment: San Antonio, Texas Paul Barnicott, Air Force Institute for Operational Health, San Antonio, Texas Roger P. Bracio, Epidemic Outbreak Surveillance, Air Force Institute for Operational Health, San Antonio, Texas Linda C. Canas, Epidemiological Surveillance Division, Air Force Institute for Operational Health, San Antonio, Texas Thomas Leo Cropper, Epidemiology Services Branch, Air Force Institute for Operational Health, San Antonio, Texas Jason Garner, Pandemic Influenza Preparedness, Air Force Institute for Operational Health, Brooks City-Base, Texas Penny Giovanetti, 311th Human Systems Wing, Air Force Institute for Operational Health, San Antonio, Texas Lori E. Henrichs, Epidemiological Surveillance Division, Air Force Institute for Operational Health, San Antonio, Texas Matthew C. Johns, Pandemic Influenza Preparedness, Air Force Institute for Operational Health, Brooks City-Base, Texas Christine Lopez, Pandemic Influenza Preparedness, Air Force Institute for Operational Health, Brooks City-Base, Texas Samuel J.P. Livingstone, Epidemic Outbreak Surveillance Program, Lackland Air Force Base, Texas Elizabeth Macias, Epidemiological Surveillance Division, Air Force Institute for Operational Health, San Antonio, Texas Edwin Matos, Pandemic Influenza Preparedness, Air Force Institute for Operational Health, Brooks City-Base, Texas Candace McCall, Risk Assessment Division, Air Force Institute for Operational Health, San Antonio, Texas Carolyn Miller, Surveillance Directorate, Air Force Institute for Operational Health, San Antonio, Texas James Neville, 311th Human Systems Wing, Air Force Institute for Operational Health, San Antonio, Texas Angela Owens, Risk Assessment Division, Air Force Institute for Operational Health, San Antonio, Texas Leslie M. Pratt, Risk Assessment Division, Air Force Institute for Operational Health, San Antonio, Texas Ronald Rippetoe, Epidemiological Surveillance Division, Air Force Institute for Operational Health, San Antonio, Texas Paul Sjoberg, Epidemiology Services Branch, Air Force Institute for Operational Health, San Antonio, Texas

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00 REVIEW OF THE DOD-GEIS INFLUENZA PROGRAMS Jose Valdez, Pandemic Influenza Preparedness, Air Force Institute for Operational Health, Brooks City-Base, Texas Sue Worthy, Pandemic Influenza Preparedness, Air Force Institute for Operational Health, Brooks City-Base, Texas SCHEDULE OF EVENTS DoD-GEIS AFIOH Assessment San Antonio, Texas Participants: Dr. Carol Cardona Dr. Timothy Germann Dr. Peter Palese Kimberly Weingarten March 28-29, 2007 Wednesday, March , 00 Arrive at Building 180 for AFIOH welcome and 0800 introductions Met by: Col. Paul Barnicott, deputy commander, AFIOH/CV Lt. Col. Candace McCall, division chief, AFIOH/RSR Lt. Col. Paul Sjoberg, branch chief, AFIOH/RSRH Dr. Leo Cropper, Influenza Surveillance Program lead Depart to Building 150 0825 Escorted by: Lt. Col. Paul Sjoberg, branch chief, AFIOH/RSRH Arrive at Building 150 for 311th Human Systems Wing 0830-0900 introductions Met by: Col. Penny Giovanetti, deputy director, 311th HSW Depart to Building 930 0900 Arrive at Building 930 0905-0910 Met by: Col. Carolyn Miller, director, SD Lt. Col. Ronald Rippetoe, division chief, AFIOH/SDE Presentation by IOM team (introduction, goal of the 0910-0930 visit, rules of engagement) AFIOH Briefing—overview of program 0930-1040 Briefed by: Linda Canas, chief virologist, and Dr. Leo Cropper Molecular briefing 1050-1130 Briefed by: Dr. Elizabeth Macias, laboratory director, AFIOH 1200 Depart for lunch

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0 AIR FORCE INSTITUTE FOR OPERATIONAL HEALTH SAN ANTONIO Data-handling efforts (Public Health Information 1400-1430 Management System) Briefed by: Lt Col Sjoberg/ Mr. Edwin Matos Review of the DoD-GEIS Influenza program, projects, 1430-1630 and future plans Interaction with AFIOH team members Thursday, March , 00 Arrive at Building 180 to continue review of the DoD- 0800-1000 GEIS influenza program, projects, and future plans Met by: Lt, Col, Paul Sjoberg, branch chief, AFIOH/RSRH Dr. Leo Cropper, Influenza Surveillance Program lead Visit to Texas Metro Health 1000-1100 1130 Lunch Site visit to Lackland AFB, tour of the EOS Project 1245-1430 Escorted by: Lt. Col. Sjoberg Final review/questions for IOM team/AFIOH 1530-1630 Met by: IOM team Col. Paul Barnicott, deputy commander AFIOH Col. Carolyn Miller, director, SD Lt. Col. Ronald Rippetoe, division chief, AFIOH/SDE Lt. Col. Candace McCall, division chief, AFIOH/RSR Lt. Col. Paul Sjoberg, branch chief, AFIOH/RSRH Dr. Leo Cropper, Influenza Surveillance Program lead Influenza team members

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