Department of Defense Serum Repository
Encyclopedia
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
.
, 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 25000 square feet (2,322.6 m²) facility in Silver Spring
, Maryland
. In recent years, the DoDSR has grown by approximately 1.9-2.3 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.
, 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
The first officially articulated purpose of the DoDSR is found in a 1991 WRAIR
solicitation for the management of the precursor to the DoDSR:
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 School of Hygiene and 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
A subsequent DoD Directive, DoDD 6490.02E, expanded authorized uses of the DoDSR slightly:
requested the Armed Forces Epidemiological Board (AFEB) address three questions related to the mission and operation of the DoDSR:
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.
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 .
(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.
under a no-bid
or "sole-source" contract 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.
Due to storage constraints, approximately 5.5 million specimens from two walk-in freezers were placed into "high-density" configuration in 2006, and additional reconfiguration may be required. The current operations contract calls for the contractor to
"adjust the storage configurations of specimens in one or more freezers to accommodate high-density, boxed specimen storage" as required.
, Minnesota
.
In 2008, the DoDSR procured a specialized freezer truck to transport specimens to the DoDSR, and solicited a bid for more frequent transport of specimens to the repository
.
database referred to as the Defense Medical Surveillance System (DMSS) , which serves as the "sole link" to the DoDSR inventory. Serum specimens are identified by a unique specimen identification number, which for the majority of specimens are linked to the Social Security Number
of the donor , and the date the specimen was obtained.
In addition to inventory data, DMSS also integrates select medical outcomes data available through the Military Health System
(MHS), including International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9CM) diagnosis
codes, Current Procedural Terminology
(CPT) codes, and other pertinent administrating data from inpatient and outpatient encountered provided directly by the MHS or through Tricare
managed care
services.
Active duty
component service members (unlike service members in the Reserve components), are entitled to free (or nearly free) health care for the duration of their military service, the details of which are captured electronically in DMSS. The active duty component thus constitutes a cohort where health events can be assessed longitudinally with minimal ascertainment bias. Over half of the specimens in the DoDSR are traceable to service members who have been on active duty, and 75% of active duty service members have provided three or more longitudinal specimens.
Limited additional health and personnel data linked to DoDSR specimens include records of immunizations, overseas deployments, military assignment data, and records from pre- and post-deployment health assessments.
administrative and clinical data exist which are not integrated into DMSS. These include:
Recent AFHSC solicitations have requested additional staff to address these data shortfalls.
operates the AFIP Tissue Repository, which contains approximately 3 million case files and associated paraffin blocks, microscopic glass slides, and formalin-fixed tissue specimens from pathologic examinations occurring throughout the Military Health System. Thousands of cases are added to the repository each year. With the disestablishment of the AFIP under Base Realignment and Closure
, management of the Tissue Repository was to have been transferred to the Uniformed Services University of the Health Sciences
. However, Public Law 110-181 Section 722 directed the President to establish a Joint Pathology Center, which would subsume responsibility for the AFIP Tissue Repository. A Joint Pathology Center Working Group Concept of Operations stated that:
In its review of the JPC Working Group Concept of Operations, the Defense Health Board emphasized that:
Despite the utility of linking AFIP Tissue Repository specimens to longitudinal pre-diagnostic serum available in the DoDSR, no formal linkage of the AFIP Tissue Repository inventory has yet been made to DMSS or to the DoDSR. No estimate is yet available on the potential commercial value of such a formal linkage.
.
DNA
Repository (also known as the Repository of Specimen Samples for the Identification of Remains) which articulates a mechanism for donors to request the destruction of their specimens following separation from service.
study, originally commissioned in 2006 by USACHPPM
was published in its entirety on Wikileaks
. The leaked documents included a justification for the $500,000 contract cost, directly authorized by former Surgeon General of the United States Army Kevin C. Kiley
on August 4 2006, which stated the study and its 12 month timetable for delivery was necessary
Despite the leaked study draft's publication date of May 2008, at the time of the leak and outbreak in May 2009, RAND listed the study as a "current project", noting in its description that "the threat of an emerging human pandemic [has] highlighted the importance of a comprehensive U.S. Armed Forces health surveillance architecture". Around the time of the leaked documents' appearance on Wikileaks, the lead author of the unpublished RAND
study published an op-ed piece in the Baltimore Sun
describing the control of the outbreak a concern of "national security", and highlighting the need to "marshal the best... institutional strengths... to prevent, detect and respond effectively to this latest infectious disease".
Serum repository
A serum repository is a facility which stores frozen serum for future retrieval and study. Examples of serum repositories include the NHANES serum repository and the Department of Defense Serum Repository...
operated by the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
Department of Defense
United States Department of Defense
The United States Department of Defense is the U.S...
containing over 50,000,000 human serum
Blood serum
In blood, the serum is the component that is neither a blood cell nor a clotting factor; it is the blood plasma with the fibrinogens removed...
specimens, collected primarily from applicants to and members of the United States Uniformed Services
Uniformed services of the United States
The United States has seven federal uniformed services that commission officers as defined by Title 10, and subsequently structured and organized by Title 10, Title 14, Title 33 and Title 42 of the United States Code.-Uniformed services:...
.
The DoDSR is located in Silver Spring
Silver Spring, Maryland
Silver Spring is an unincorporated area and census-designated place in Montgomery County, Maryland, United States. It had a population of 71,452 at the 2010 census, making it the fourth most populous place in Maryland, after Baltimore, Columbia, and Germantown.The urbanized, oldest, and...
, Maryland
Maryland
Maryland is a U.S. state located in the Mid Atlantic region of the United States, bordering Virginia, West Virginia, and the District of Columbia to its south and west; Pennsylvania to its north; and Delaware to its east...
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
United States Army Center for Health Promotion and Preventive Medicine
The United States Army Center for Health Promotion and Preventive Medicine — known as USACHPPM or CHPPM — is a United States Army center headquartered at Aberdeen Proving Ground, Maryland, United States...
(USACHPPM), itself evolved from the Johns Hopkins School of Hygiene and Public Health
Johns Hopkins Bloomberg School of Public Health
The Johns Hopkins Bloomberg School of Public Health is part of Johns Hopkins University in Baltimore, Maryland, United States...
. The DoDSR traces its origins to 1985 and the beginnings of the United States Armed Forces
United States armed forces
The United States Armed Forces are the military forces of the United States. They consist of the Army, Navy, Marine Corps, Air Force, and Coast Guard.The United States has a strong tradition of civilian control of the military...
HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
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
Walter Reed Army Institute of Research
This article is about the U.S. Army medical research institute . Otherwise, see Walter Reed .The Walter Reed Army Institute of Research is the largest biomedical research facility administered by the U.S. Department of Defense...
(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
Multiple sclerosis
Multiple sclerosis is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms...
, schizophrenia
Schizophrenia
Schizophrenia is a mental disorder characterized by a disintegration of thought processes and of emotional responsiveness. It most commonly manifests itself as auditory hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and it is accompanied by significant social...
, autoimmune diseases and cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
.
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 virusVirus
A virus is a small infectious agent that can replicate only inside the living cells of organisms. Viruses infect all types of organisms, from animals and plants to bacteria and archaea...
, subsequently known as Human Immunodeficiency Virus
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
(HIV). Early laboratory testing was performed via contracted private laboratories. Screening soon expanded to all civilian applicants processed at Military Entrance Processing Stations
United States Military Entrance Processing Command
The United States Military Entrance Processing Command is a Major Command of the Department of Defense, which screens and processes applicants into the United States Armed Forces...
. A condition of some early laboratory testing contracts specified that remnant serum were to remain in frozen storage. In 1989, the Army
United States Army
The United States Army is the main branch of the United States Armed Forces responsible for land-based military operations. It is the largest and oldest established branch of the U.S. military, and is one of seven U.S. uniformed services...
’s Walter Reed Army Institute of Research
Walter Reed Army Institute of Research
This article is about the U.S. Army medical research institute . Otherwise, see Walter Reed .The Walter Reed Army Institute of Research is the largest biomedical research facility administered by the U.S. Department of Defense...
(WRAIR) awarded a contract to McKesson
McKesson
McKesson Corporation is the largest health care company in the world, with sales of $106.6 billion in 2009.McKesson is based in the United States and distributes health care systems, medical supplies and pharmaceutical products...
to consolidate and store accumulated residual serum specimens at a single facility, established in proximity to WRAIR in Rockville
Rockville, Maryland
Rockville is the county seat of Montgomery County, Maryland, United States. It is a major incorporated city in the central part of Montgomery County and forms part of the Baltimore-Washington Metropolitan Area. The 2010 U.S...
, Maryland
Maryland
Maryland is a U.S. state located in the Mid Atlantic region of the United States, bordering Virginia, West Virginia, and the District of Columbia to its south and west; Pennsylvania to its north; and Delaware to its east...
. The HIV Research Program (established by Congressional Direction in 1986) , under the WRAIR Division of Retrovirology, established the Walter Reed
Walter Reed
Major Walter Reed, M.D., was a U.S. Army physician who in 1900 led the team that postulated and confirmed the theory that yellow fever is transmitted by a particular mosquito species, rather than by direct contact...
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 25000 square feet (2,322.6 m²) facility in Silver Spring
Silver Spring, Maryland
Silver Spring is an unincorporated area and census-designated place in Montgomery County, Maryland, United States. It had a population of 71,452 at the 2010 census, making it the fourth most populous place in Maryland, after Baltimore, Columbia, and Germantown.The urbanized, oldest, and...
, Maryland
Maryland
Maryland is a U.S. state located in the Mid Atlantic region of the United States, bordering Virginia, West Virginia, and the District of Columbia to its south and west; Pennsylvania to its north; and Delaware to its east...
. In recent years, the DoDSR has grown by approximately 1.9-2.3 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.
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 WarGulf War
The Persian Gulf War , commonly referred to as simply the Gulf War, was a war waged by a U.N.-authorized coalition force from 34 nations led by the United States, against Iraq in response to Iraq's invasion and annexation of Kuwait.The war is also known under other names, such as the First Gulf...
, including claims by many service members of adverse health outcomes
Gulf War syndrome
Gulf War syndrome or Gulf War illness describes a medical condition that affected veterans and civilians who were near conflicts during or downwind of chemical weapons depot demolition, after the 1991 Gulf War. A wide range of acute and chronic symptoms have included fatigue, musculoskeletal...
, 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
Assistant Secretary of Defense for Health Affairs
The Assistant Secretary of Defense for Health Affairs is chartered under United States Department of Defense Directive 5136.1 in 1994. This DoDD states that the ASD is the principal advisor to the U.S...
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
Walter Reed Army Institute of Research
This article is about the U.S. Army medical research institute . Otherwise, see Walter Reed .The Walter Reed Army Institute of Research is the largest biomedical research facility administered by the U.S. Department of Defense...
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
Walter Reed Army Institute of Research
This article is about the U.S. Army medical research institute . Otherwise, see Walter Reed .The Walter Reed Army Institute of Research is the largest biomedical research facility administered by the U.S. Department of Defense...
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
Walter Reed Army Institute of Research
This article is about the U.S. Army medical research institute . Otherwise, see Walter Reed .The Walter Reed Army Institute of Research is the largest biomedical research facility administered by the U.S. Department of Defense...
to a newly-formed subordinate command of the United States Army Medical Command
United States Army Medical Command
The U.S. Army Medical Command is a major command of the U.S. Army that provides command and control of the Army's fixed-facility medical, dental, and veterinary treatment facilities, providing preventive care, medical research and development and training institutions.MEDCOM is commanded by the...
, the United States Army Center for Health Promotion and Preventive Medicine
United States Army Center for Health Promotion and Preventive Medicine
The United States Army Center for Health Promotion and Preventive Medicine — known as USACHPPM or CHPPM — is a United States Army center headquartered at Aberdeen Proving Ground, Maryland, United States...
(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
World War II
World War II, or the Second World War , was a global conflict lasting from 1939 to 1945, involving most of the world's nations—including all of the great powers—eventually forming two opposing military alliances: the Allies and the Axis...
at the Johns Hopkins School of Hygiene, now the Johns Hopkins School of Hygiene and Public Health
Johns Hopkins Bloomberg School of Public Health
The Johns Hopkins Bloomberg School of Public Health is part of Johns Hopkins University in Baltimore, Maryland, United States...
. The change in custody was accompanied by an increased emphasis on the epidemiologic
Epidemiology
Epidemiology is the study of health-event, health-characteristic, or health-determinant patterns in a population. It is the cornerstone method of public health research, and helps inform policy decisions and evidence-based medicine by identifying risk factors for disease and targets for preventive...
, public health
Public health
Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals" . It is concerned with threats to health based on population health...
and health surveillance
Clinical surveillance
Clinical surveillance refers to the surveillance of health data about a clinical syndrome that has a significant impact on public health, which is then used to drive decisions about health policy and health education...
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 AffairsAssistant Secretary of Defense for Health Affairs
The Assistant Secretary of Defense for Health Affairs is chartered under United States Department of Defense Directive 5136.1 in 1994. This DoDD states that the ASD is the principal advisor to the U.S...
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.
Location
The DoDSR facility is located in 25283 square feet (2,348.9 m²) of leased commercial space in a 90000 square feet (8,361.3 m²) 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
Holy Cross Hospital (Silver Spring)
Holy Cross Hospital is a large hospital in Silver Spring, Maryland. The hospital, the second largest in Maryland, was founded in 1963 by the Sisters of the Holy Cross. There are over 1,200 doctors in the hospital.- History :...
, and Comcast
Comcast
Comcast Corporation is the largest cable operator, home Internet service provider, and fourth largest home telephone service provider in the United States, providing cable television, broadband Internet, and telephone service to both residential and commercial customers in 39 states and the...
, 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
Fort George G. Meade
Fort George G. Meade is a United States Army installation that includes the Defense Information School, the United States Army Field Band, and the headquarters of United States Cyber Command, the National Security Agency, and the Defense Courier Service...
, Maryland
Maryland
Maryland is a U.S. state located in the Mid Atlantic region of the United States, bordering Virginia, West Virginia, and the District of Columbia to its south and west; Pennsylvania to its north; and Delaware to its east...
) was considered as early as 2005 .
Considerations under BRAC
Although AFHCS maintains technical and computing facilities supporting the DoDSR at the Walter Reed Army Medical CenterWalter Reed Army Medical Center
The Walter Reed Army Medical Center was the United States Army's flagship medical center until 2011. Located on 113 acres in Washington, D.C., it served more than 150,000 active and retired personnel from all branches of the military...
(WRAMC), Washington, D.C.
Washington, D.C.
Washington, D.C., formally the District of Columbia and commonly referred to as Washington, "the District", or simply D.C., is the capital of the United States. On July 16, 1790, the United States Congress approved the creation of a permanent national capital as permitted by the U.S. Constitution....
and is subject to realignment under the recommendations of the Base Realignment and Closure
Base Realignment and Closure
Base Realignment and Closure is a process of the United States federal government directed at the administration and operation of the Armed Forces, used by the United States Department of Defense and Congress to close excess military installations and realign the total asset inventory to reduce...
(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 ScientificThermo Fisher Scientific
Thermo Fisher Scientific is a large life sciences supply company that was created in 2006 by the merger of Thermo Electron and Fisher Scientific.-Predecessors and merger:...
under a no-bid
No-bid contract
The term "no-bid contract" is a popular phrase for what is officially known as a "sole source contract". A sole source contract implies that there is only one person or company that can provide the contractual services needed, and any attempt to obtain bids would only result in one person or...
or "sole-source" contract 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
Fisher Scientific
Fisher Scientific International, Inc. was a biotechnology company that provided products and services to the global scientific research and United States clinical laboratory markets...
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 30 feet (9.1 m) x 30 feet x 10 high , whose interiors are maintained at -30°C by pairs of compressors.Serum Storage
The majority of serum specimens are stored inside the walk-in freezers in cardboard boxes, approximately 6 x 18 x 3.5 inches (88.9 mm) in size, each containing 308 specimens, and each consisting of approximately 2.5 mL of frozen serum The cardboard boxes are sequentially numbered and labeled, and stored on metal shelving units within the walk-in freezers for ready accessibility and retrieval.Due to storage constraints, approximately 5.5 million specimens from two walk-in freezers were placed into "high-density" configuration in 2006, and additional reconfiguration may be required. The current operations contract calls for the contractor to
"adjust the storage configurations of specimens in one or more freezers to accommodate high-density, boxed specimen storage" as required.
Transportation of Specimens to the DoDSR
The majority of specimens are received quarterly in frozen form, following completion of all HIV testing. Shipments arrive in pallets transported in a freezer truck from the major contracted testing laboratory, ViroMed, which is located in MinnetonkaMinnetonka, Minnesota
As of the census of 2000, there were 51,301 people, 21,393 households, and 14,097 families residing in the city. The population density was 1,893.0 persons per square mile . There were 22,228 housing units at an average density of 818.9 per square mile...
, Minnesota
Minnesota
Minnesota is a U.S. state located in the Midwestern United States. The twelfth largest state of the U.S., it is the twenty-first most populous, with 5.3 million residents. Minnesota was carved out of the eastern half of the Minnesota Territory and admitted to the Union as the thirty-second state...
.
In 2008, the DoDSR procured a specialized freezer truck to transport specimens to the DoDSR, and solicited a bid for more frequent transport of specimens to the repository
.
Data Linkages
DoDSR inventory data and related information are stored in an OracleOracle Database
The Oracle Database is an object-relational database management system produced and marketed by Oracle Corporation....
database referred to as the Defense Medical Surveillance System (DMSS) , which serves as the "sole link" to the DoDSR inventory. Serum specimens are identified by a unique specimen identification number, which for the majority of specimens are linked to the Social Security Number
Social Security number
In the United States, a Social Security number is a nine-digit number issued to U.S. citizens, permanent residents, and temporary residents under section 205 of the Social Security Act, codified as . The number is issued to an individual by the Social Security Administration, an independent...
of the donor , and the date the specimen was obtained.
In addition to inventory data, DMSS also integrates select medical outcomes data available through the Military Health System
Military Health System
The Military Health System is the enterprise within the United States Department of Defense responsible for providing health care to active duty and retired U.S. Military personnel and their dependents...
(MHS), including International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9CM) diagnosis
Diagnosis
Diagnosis is the identification of the nature and cause of anything. Diagnosis is used in many different disciplines with variations in the use of logics, analytics, and experience to determine the cause and effect relationships...
codes, Current Procedural Terminology
Current Procedural Terminology
The Current Procedural Terminology code set is maintained by the American Medical Association through the CPT Editorial Panel. The CPT code set describes medical, surgical, and diagnostic services and is designed to communicate uniform information about medical services and procedures among...
(CPT) codes, and other pertinent administrating data from inpatient and outpatient encountered provided directly by the MHS or through Tricare
TRICARE
TRICARE, formerly known as the Civilian Health and Medical Program of the Uniformed Services , is a health care program of the United States Department of Defense Military Health System. TRICARE provides civilian health benefits for military personnel, military retirees, and their dependents,...
managed care
Managed care
...intended to reduce unnecessary health care costs through a variety of mechanisms, including: economic incentives for physicians and patients to select less costly forms of care; programs for reviewing the medical necessity of specific services; increased beneficiary cost sharing; controls on...
services.
Active duty
Active duty
Active duty refers to a full-time occupation as part of a military force, as opposed to reserve duty.-Pakistan:The Pakistan Armed Forces are one of the largest active service forces in the world with almost 610,000 full time personnel due to the complex and volatile nature of Pakistan's...
component service members (unlike service members in the Reserve components), are entitled to free (or nearly free) health care for the duration of their military service, the details of which are captured electronically in DMSS. The active duty component thus constitutes a cohort where health events can be assessed longitudinally with minimal ascertainment bias. Over half of the specimens in the DoDSR are traceable to service members who have been on active duty, and 75% of active duty service members have provided three or more longitudinal specimens.
Limited additional health and personnel data linked to DoDSR specimens include records of immunizations, overseas deployments, military assignment data, and records from pre- and post-deployment health assessments.
Links to Other Available Data
Significant additional MHSMilitary Health System
The Military Health System is the enterprise within the United States Department of Defense responsible for providing health care to active duty and retired U.S. Military personnel and their dependents...
administrative and clinical data exist which are not integrated into DMSS. These include:
- Records of pharmaceuticals dispensed at MHSMilitary Health SystemThe Military Health System is the enterprise within the United States Department of Defense responsible for providing health care to active duty and retired U.S. Military personnel and their dependents...
outpatient pharmacies and through the outsourced civilian retail and mail-order pharmacy, available through the DoD Pharmacoeconomics Center's (PEC) Pharmacy Data Transaction Service (PDTS). - Records of Health Level 7 (HL7) coded results of microbiology, chemistry, and hematology laboratory tests, available through the MHS.
- Family history, risk factor data, available through the MHSMilitary Health SystemThe Military Health System is the enterprise within the United States Department of Defense responsible for providing health care to active duty and retired U.S. Military personnel and their dependents...
Armed Forces Health Longitudinal Technology ApplicationArmed Forces Health Longitudinal Technology ApplicationThe Armed Forces Health Longitudinal Technology Application is the electronic health record system used by medical providers of the U.S. Department of Defense since its initial implementation in January 2004. It is a services-wide medical and dental information management system...
(AHLTA) Electronic Medical RecordElectronic medical recordAn electronic medical record is a computerized medical record created in an organization that delivers care, such as a hospital or physician's office...
system. - Information on confirmed cancer diagnoses available in the Automated Central Tumor Registry (ACTUR).
Recent AFHSC solicitations have requested additional staff to address these data shortfalls.
Linkages to Other DoD Biological Repositories
The Department of Defense, through the Armed Forces Institute of PathologyArmed Forces Institute of Pathology
The Armed Forces Institute of Pathology was a US government institution concerned with diagnostic consultation, education, and research in the medical specialty of pathology. It was founded in 1862 as the Army Medical Museum and was located in Washington, DC on the grounds of the Walter Reed Army...
operates the AFIP Tissue Repository, which contains approximately 3 million case files and associated paraffin blocks, microscopic glass slides, and formalin-fixed tissue specimens from pathologic examinations occurring throughout the Military Health System. Thousands of cases are added to the repository each year. With the disestablishment of the AFIP under Base Realignment and Closure
Base Realignment and Closure
Base Realignment and Closure is a process of the United States federal government directed at the administration and operation of the Armed Forces, used by the United States Department of Defense and Congress to close excess military installations and realign the total asset inventory to reduce...
, management of the Tissue Repository was to have been transferred to the Uniformed Services University of the Health Sciences
Uniformed Services University of the Health Sciences
The Uniformed Services University of the Health Sciences is a health science university run by the U.S. federal government. The primary mission of the school is to prepare graduates for service to the U.S. at home and abroad in the medical corps....
. However, Public Law 110-181 Section 722 directed the President to establish a Joint Pathology Center, which would subsume responsibility for the AFIP Tissue Repository. A Joint Pathology Center Working Group Concept of Operations stated that:
"The JPC... will provide maintenance/modernization of the Tissue Repository in support of the mission of the DoD and other federal agencies."
In its review of the JPC Working Group Concept of Operations, the Defense Health Board emphasized that:
"Every effort must be pursued to guarantee that the Tissue Repository is preserved, implements world-class modernization, and is utilized appropriately. A recent independent report by Asterand (Detroit, MI) submitted to Uniformed Services University of the Health Sciences found the repository to have a commercial value of $3.0-$3.6 Billion..."
Despite the utility of linking AFIP Tissue Repository specimens to longitudinal pre-diagnostic serum available in the DoDSR, no formal linkage of the AFIP Tissue Repository inventory has yet been made to DMSS or to the DoDSR. No estimate is yet available on the potential commercial value of such a formal linkage.
Permitted Uses of DoDSR Specimens
Requests for access to DoDSR specimens are governed by guidelines developed by the Armed Forces Health Surveillance Center. According to guidelines, " [t]he Director of the repository is solely responsible for authorizing releases of specimens from the repository."Research
DoDSR specimens may only be released to principal investigators outside the Department of Defense for purposes of medical research if the proposed study has "a coinvestigator who is assigned to the Department of Defense and is knowledgeable, responsible, and accountable for all aspects of the study’s design and execution (including data management, analysis, interpretation, and reporting of results)."Clinical Care
Serum from the DoDSR may be requested by clinicians within the Military Health System to aid diagnosis and guide clinical management. Serum may also be released to clinicians outside the Military Health System provided a physician in the Military Health System in the same specialty as the requestor validates the clinical relevance of the requested use prior to the release of any serum.Criminal Investigations
Serum specimens from the DoDSR may be used for criminal investigations and prosecutions if directed by the Assistant Secretary of Defense for Health AffairsAssistant Secretary of Defense for Health Affairs
The Assistant Secretary of Defense for Health Affairs is chartered under United States Department of Defense Directive 5136.1 in 1994. This DoDD states that the ASD is the principal advisor to the U.S...
.
Informed Consent
DoDSR specimens are collected without informed consent, and specimen donors are not informed of the use of their specimens in subsequent studies. Specimens retrieved by the DoDSR for use in external research studies are, with rare exceptions, deidentified prior to being sent to outside investigators.Genetic Testing
A 1996 memorandum specifically stated that DoDSR specimens collected for pre- and post-deployment health surveillance "will not be used for any genetics related testing".Civilian and Beneficiary Serum
As a result of clinically-indicated HIV testing performed on civilians and family beneficiaries at Military Treatment Facilities (eligible for health care within the Military Health System), approximately 900,000 serum specimens from individuals not directly affiliated with the Uniformed Services through application or service are also stored in the DoDSR. In Privacy Act documentation, DoD acknowledges that the AFHSC maintains "...specimen collections (remaining serum from blood samples) from which serologic tests can be performed..." from categories of individuals which include "Department of Defense military personnel (active and reserve) and their family members...".Destruction of Specimens
DoDSR guidelines are silent as to whether a mechanism exists for specimen donors to request destruction or removal of their specimens from the repository. In Privacy Act documentation, DoD states that "[r]ecords are destroyed when no longer needed for reference and for conducting business", but no formal mechanism is articulated for the destruction or specimens. This is in contrast to the Armed Forces Institute of PathologyArmed Forces Institute of Pathology
The Armed Forces Institute of Pathology was a US government institution concerned with diagnostic consultation, education, and research in the medical specialty of pathology. It was founded in 1862 as the Army Medical Museum and was located in Washington, DC on the grounds of the Walter Reed Army...
DNA
DNA
Deoxyribonucleic acid is a nucleic acid that contains the genetic instructions used in the development and functioning of all known living organisms . The DNA segments that carry this genetic information are called genes, but other DNA sequences have structural purposes, or are involved in...
Repository (also known as the Repository of Specimen Samples for the Identification of Remains) which articulates a mechanism for donors to request the destruction of their specimens following separation from service.
RAND Study on the Role of the DoDSR in Pandemic Influenza Preparedness
On May 1, 2009, during the early stages of the 2009 H1N1 flu outbreak, an unpublished RANDRAND
RAND Corporation is a nonprofit global policy think tank first formed to offer research and analysis to the United States armed forces by Douglas Aircraft Company. It is currently financed by the U.S. government and private endowment, corporations including the healthcare industry, universities...
study, originally commissioned in 2006 by USACHPPM
United States Army Center for Health Promotion and Preventive Medicine
The United States Army Center for Health Promotion and Preventive Medicine — known as USACHPPM or CHPPM — is a United States Army center headquartered at Aberdeen Proving Ground, Maryland, United States...
was published in its entirety on Wikileaks
Wikileaks
WikiLeaks is an international self-described not-for-profit organisation that publishes submissions of private, secret, and classified media from anonymous news sources, news leaks, and whistleblowers. Its website, launched in 2006 under The Sunshine Press organisation, claimed a database of more...
. The leaked documents included a justification for the $500,000 contract cost, directly authorized by former Surgeon General of the United States Army Kevin C. Kiley
Kevin C. Kiley
Major General Kevin C. Kiley was the 41st Surgeon General of the United States Army and commander of the U.S. Army Medical Command, Fort Sam Houston, Texas. He was commander of Walter Reed Army Medical Center and North Atlantic Regional Medical Command twice, from 2002 to 2004, and as acting...
on August 4 2006, which stated the study and its 12 month timetable for delivery was necessary
"...to describe the current and future capabilities of the Department of Defense Serum Repository to assist with the early identification and response to an influenza pandemic. Adequate resources are not available in-house to perform these analyses in sufficient time to prepare for a pandemic...."
Despite the leaked study draft's publication date of May 2008, at the time of the leak and outbreak in May 2009, RAND listed the study as a "current project", noting in its description that "the threat of an emerging human pandemic [has] highlighted the importance of a comprehensive U.S. Armed Forces health surveillance architecture". Around the time of the leaked documents' appearance on Wikileaks, the lead author of the unpublished RAND
RAND
RAND Corporation is a nonprofit global policy think tank first formed to offer research and analysis to the United States armed forces by Douglas Aircraft Company. It is currently financed by the U.S. government and private endowment, corporations including the healthcare industry, universities...
study published an op-ed piece in the Baltimore Sun
The Baltimore Sun
The Baltimore Sun is the U.S. state of Maryland’s largest general circulation daily newspaper and provides coverage of local and regional news, events, issues, people, and industries....
describing the control of the outbreak a concern of "national security", and highlighting the need to "marshal the best... institutional strengths... to prevent, detect and respond effectively to this latest infectious disease".
See also
- Other biological repositories: UK BiobankUK BiobankUK Biobank is a large long-term biobank study in the United Kingdom which is investigating the respective contributions of genetic predisposition and environmental exposure to the development of disease...
, NHANESNational Health and Nutrition Examination SurveyThe National Health and Nutrition Examination Survey is a survey research program conducted by the National Center for Health Statistics to asses the health and nutritional status of adults and children in the United States, and to track changes over time. The survey combines interviews and...
, DeCODEDecode GeneticsdeCODE genetics, Inc. is a biopharmaceutical company based in Reykjavík, Iceland. The company was founded in 1996 to identify human genes associated with common diseases using population studies, and apply the knowledge gained to guide the development of candidate drugs... - Biobanking: BiobankBiobankA biobank is a cryogenic storage facility used to archive biological samples for use in research and experiments. Ranging in size from individual refrigerators to warehouses, biobanks are maintained by institutions such as hospitals, universities, nonprofit organizations, and pharmaceutical...