The Department of Defense Serum Repository (also referred to as the DoD Serum Repository or simply DoDSR) is a biological repository operated by the United States Department of Defense containing over 50,000,000 human serum specimens, collected primarily from applicants to and members of the United States Uniformed Services.
The DoDSR is located in Silver Spring, Maryland and is operated by the Armed Forces Health Surveillance Center (AFHSC), a subordinate of the United States Army Center for Health Promotion and Preventive Medicine (USACHPPM), itself evolved from the Johns Hopkins School of Hygiene and Public Health. The DoDSR traces its origins to 1985 and the beginnings of the United States Armed Forces HIV screening program (originally referred to as the HTLV-III screening program), when serum remaining after periodic laboratory testing of service members was retained first by the Walter Reed Army Institute of Research (WRAIR), then later systematically archived in the Army/Navy Serum Repository, the precursor to the DoDSR.
Today the DoDSR is among the largest serum repositories in the world, in terms of numbers of individuals represented, number of longitudinal specimens stored per individual, and total quantity of serum. The majority of specimens are linked to detailed medical and personnel data, creating a valuable resource for retrospective research and public health surveillance. The DoDSR's longitudinal serum, collected systematically from a large population, has enabled major contributions to understanding the etiology of many health conditions not otherwise amenable to prospective study, including multiple sclerosis, schizophrenia, autoimmune diseases and cancer.
History The earliest serum housed in the DoDSR was collected through the Armed Forces' HLTV-III screening program, implemented in 1985 in response to the emergence of a new human virus, subsequently known as Human Immunodeficiency Virus (HIV). Early laboratory testing was performed via contracted private laboratories. Screening soon expanded to all civilian applicants processed at Military Entrance Processing Stations. A condition of some early laboratory testing contracts specified that remnant serum were to remain in frozen storage. In 1989, the Army's Walter Reed Army Institute of Research (WRAIR) awarded a contract to McKesson to consolidate and store accumulated residual serum specimens at a single facility, established in proximity to WRAIR in Rockville, Maryland. The HIV Research Program (established by Congressional Direction in 1986), under the WRAIR Division of Retrovirology, established the Walter Reed Army Serum Repository, which would evolve to become the Army/Navy Serum Repository in 1989. In 2001, the repository inventory was moved to its current location, a facility in Silver Spring, Maryland. In recent years, the DoDSR has grown by approximately 1.9RAND, p.44.-2.3 million specimens annually. By 2007, the DoDSR inventory had grown to over 44 million specimens, and by the end of 2009, over 50,000,000 specimens.
Growth of the DoDSR Inventory
HIV Seronegative Specimens The DoDSR, along with its precursor repositories, were designated as the ultimate storage facility for all serologically negative HIV specimens obtained through military HIV testing programs. Growing initially through the routine screening of all civilian applicants, and then through the continued screening of retained military personnel (at approximate two year intervals), by 1990 the DoDSR inventory had grown to contain over six million serum specimens, and by 1996 over 17 million specimens. Standardized processes in place at the contracted military HIV testing laboratories ensured efficient management of the growing inventory, permitting the DoDSR to enforce standards in specimen labelling, configuration, and shipment of specimens which facilitated their physical integration into the DoDSR inventory. Contracts for HIV testing, negotiated by the individual military services, covered all specimens shipped from Military Treatment Facilities for HIV testing within the United States; for this reason unless specifically removed, serum from military beneficiaries (i.e. spouses and children) would also find their way into the DoDSR inventory.
Addition of Pre- and Post-Deployment Specimens Prompted by experiences in the aftermath of the Persian Gulf War, including claims by many service members of adverse health outcomes, the December, 1995 deployment of U.S. service members to Bosnia was accompanied by increased emphasis on health surveillance. A 1996 Assistant Secretary of Defense for Health Affairs memorandum mandated the collection of pre- and post-deployment serum specimens from deploying service members, and their integration into the DoDSR. The policy also directed that specimens collected for HIV surveillance could suffice. Although a small number of specimens were collected directly for health surveillance outside of existing HIV testing channels, specimens collected in this manner suffered from lack of standardization. By 1999, the Assistant Secretary of Defense issued modified instructions, which directed that the requirement for pre- and post-deployment specimens be satisfied by HIV testing. Initially, an HIV specimen was required to be collected prior to deployment if none had been collected in the year prior.
Concerns over the adequacy of specimens collected for this purpose, including findings of the Rhode Island Gulf War Commission, contributed to public concern over the adequacy of existing serum collection practices. The FY2005 Defense Authorization Act called on the Department of Defense to perform
[a]n assessment of whether there is a need for changes to regulations and standards for drawing blood samples for effective tracking and health surveillance of the medical conditions of personnel before deployment, upon the end of a deployment, and for a followup period of appropriate length.
Additionally, this legislation required DoD to change its policies to require collection of an HIV specimen within 120 days pre-deployment and 30 days post-deployment. This change was later rescinded in conjunction with the later recommendations of the Armed Forces Epidemiological Board, to permit a sample collected within the year prior to deployment to meet requirements. Despite the many changes in policies, the large numbers of service members deploying in support of Operations Iraqi Freedom and Enduring Freedom have led to a moderate increase in the rate of specimen acquisition and growth of the DoDSR inventory.
Evolution of the DoDSR Mission and Custody The DoDSR has evolved from a research-affiliated repository limited to storing HIV seronegative specimens, to a repository serving a broad health surveillance mission for which it was not originally intended.
The first officially articulated purpose of the DoDSR is found in a 1991 WRAIR solicitation for the management of the precursor to the DoDSR:
Sera repository operations are required for retrospective studies in support of current and future retroviral research efforts ... Analysis of these sera will be very important.
The WRAIR solicitation anticipated as-needed specimen retrieval of up to 5,000 specimens per year.
In 1995, responsibility and custody of the DoDSR inventory and its associated database was transferred from WRAIR to a newly formed subordinate command of the United States Army Medical Command, the United States Army Center for Health Promotion and Preventive Medicine (USACHPPM). USACHPPM, or simply CHPPM, itself evolved from the U.S. Army Industrial Hygiene Laboratory, which was initially established in 1942 at the beginning of World War II at the Johns Hopkins School of Hygiene, now the Johns Hopkins Bloomberg School of Public Health. The change in custody was accompanied by an increased emphasis on the epidemiologic, public health and health surveillance utility of DoDSR specimens.
A DoD Instruction issued in 1997, since rescinded, described the purpose of the DoDSR as being for
medical surveillance for clinical diagnosis and epidemiological studies. The repository shall be used exclusively for the identification, prevention, and control of diseases associated with operational deployments of military personnel.
A subsequent DoD Directive, DoDD 6490.02E, expanded authorized uses of the DoDSR slightly:
There shall be a Department of Defense Serum Repository for medical surveillance for clinical diagnosis and epidemiological studies. The repository shall be used for the identification, prevention, and control of diseases associated with military service.
Rationale for Current Practices Responding to concerns outlined in the FY2005 Defense Authorization Act , the Assistant Secretary of Defense for Health Affairs requested the Armed Forces Epidemiological Board (AFEB) address three questions related to the mission and operation of the DoDSR:
Is there a sound basis for the continued routine collection of sera pre- and post-deployment for clinical care reasons, public health surveillance or research purposes in order to examine the effects of deployment on health? Should any other biological specimens be collected for clinical care reasons, public health surveillance, or research purposes? Are there any valid reasons to change the time frames of specimens of collected biological specimens either pre- or post-deployment for clinical care reasons, public health surveillance, or research purposes?
The AFEB study determined that there was sound basis for the continued collection of serum, but recommending the additional collection of white blood cells in addition to serum. The AFEB study also recommended that the DoD establish an oversight panel be created to govern access to the specimens. Neither recommendation has yet been acted on.
Present DoDSR
Location
The DoDSR facility is located in of leased commercial space in a building located at 11800 Tech Road, Silver Spring, Maryland. The leased space was acquired through a ten-year lease managed by the General Services Administration (GSA) which expires October 1, 2010.
The commercial facility is shared with two other major tenants: Holy Cross Hospital, and Comcast, whose continued occupancy precludes contiguous expansion of the DoDSR inventory. Due to space constraints at the existing facility, relocation of the DoDSR inventory to another location in the Baltimore - National Capital region (including Ft. Meade, Maryland) was considered as early as 2005.FedBizOpps.gov, 2005.
Considerations under BRAC Although AFHCS maintains technical and computing facilities supporting the DoDSR at the Walter Reed Army Medical Center (WRAMC), Washington, D.C. and is subject to realignment under the recommendations of the Base Realignment and Closure (BRAC) Commission, published BRAC recommendations do not specify a location to which the facilities must relocate. Relocation of the WRAMC AFHSC facilities are necessary by September 15, 2011.
Contracted Operation The DoDSR is operated by Thermo Fisher Scientific under a no-bid or "sole-source" contractFedBizOpps.gov, 2006. awarded in 2006. An earlier no-bid contract was awarded to Cryonix in 2005, although Cryonix was later incorporated under Thermo Electron Corporation's Biorepository Services division. Thermo Electron subsequently merged with Fisher Scientific in 2006. Thermo Fisher's Fisher BioServices business currently holds the contract.
Freezer Equipment The DoDSR consists of 15 large walk-in freezers, each approximately x 30 feet x 10 high, whose interiors are maintained at -30 °C by pairs of compressors.
Serum Storage