Military Health
DOD's Vaccine Healthcare Centers Network Gao ID: GAO-07-787R June 29, 2007Members of the military have long been required to receive immunizations. The Department of Defense (DOD) estimates that over 2.2 million servicemembers receive at least one mandatory immunization annually. Immunizations are provided through the administration of vaccines, which contain "antigens" or parts of a specific virus or bacterium that are used to trigger an immune response to protect the body from disease. DOD's immunization requirements vary depending on several factors, such as a servicemember's branch of military service, location, age, and type of personnel, such as newly enlisted recruits, those conducting high-risk travel, and reserve forces. No immunization is completely safe. Like all individuals, servicemembers may experience side-effects as a result of their immunizations, known as adverse events. Most adverse events consist of relatively mild reactions, such as swelling near the site of the immunization. However, a small number of individuals may experience more severe reactions, such as some servicemembers who received the anthrax and smallpox vaccines. Some servicemembers who received these vaccines experienced severe reactions such as migraines, heart problems, and the onset of diseases including diabetes and multiple sclerosis. Since then, the adverse events associated with these vaccines have caused concern among members of Congress about the safety of some mandatory immunizations. In response to three congressional directives, DOD established the Vaccine Healthcare Centers (VHC) Network in September 2001 with initial funding provided by the Department of Health and Human Services' (HHS) Centers for Disease Control and Prevention (CDC). The purpose of the VHC Network is to meet the health care needs of servicemembers receiving mandatory immunizations. DOD placed the VHC Network under the command of the Army Surgeon General. However, neither DOD nor the Army provided the VHC Network with a mission statement. As a result, VHC Network officials defined their own mission. In addition, since 2001, the VHC Network--which is not included in DOD's long-term budget planning--has relied upon funding provided on an annual basis from a variety of sources. Its lack of both a recognized mission and a specified funding source caused uncertainty among VHC Network officials about its future existence and organizational structure. Two recent laws--the National Defense Authorization Act for Fiscal Year 2006 and the National Defense Authorization Act for Fiscal Year 2007--contained provisions that required us to examine several issues related to the VHC Network. In response, and after consultation with the committees of jurisdiction, this report describes (1) the efforts the VHC Network is undertaking to address the needs of servicemembers arising from mandatory military immunizations and (2) how DOD has supported the mission of the VHC Network.
The VHC Network supports the health care needs of servicemembers that may arise from military immunizations in three ways. First, it offers clinical support. For example, it provides clinical care to servicemembers experiencing potential adverse events, and, in cases where the patient is not located near a regional VHC site, it may remotely coordinate the patient's care with the other providers directly involved in the patient's treatment. Second, the VHC Network conducts research to improve the safe administration of vaccines and the prevention, identification, and treatment of adverse events. Third, it educates servicemembers and military health care staff on adverse events. For example, the VHC Network makes information available by conducting briefings and posting training materials on a Web site. In general, DOD and CDC officials said that they consider the VHC Network's contributions important, particularly in the area of clinical care. However, several DOD officials, including DOD medical staff members, added that its educational efforts may not be reaching enough military health care providers who remain unaware, for example, of some adverse events and the role of the VHC Network. DOD's December 2006 decisions, including the plan to place the VHC Network under the command of the Military Vaccine Office (MILVAX), will give the VHC Network recognition as a formal entity within DOD's command structure and an established mission within DOD, and have the potential to provide access to a more stable source of funding, when they are implemented in fiscal year 2008. According to VHC Network officials, the absence of such a mission and a place in DOD's long-range budget has made it difficult to plan strategically, develop and maintain regional VHC sites, and attract and retain staff. Under DOD's new plan, the Army, Air Force, and Navy will each provide funding for the VHC Network. In addition, there will be opportunities for all the services to provide input into decisions regarding the activities of the VHC Network. VHC Network officials stated that they hope that DOD's decisions will provide opportunities for the VHC Network to plan for and accomplish its mission with greater predictability.
GAO-07-787R, Military Health: DOD's Vaccine Healthcare Centers Network
This is the accessible text file for GAO report number GAO-07-787R
entitled 'Military Health: DOD's Vaccine Healthcare Centers Network'
which was released on June 29, 2007.
This text file was formatted by the U.S. Government Accountability
Office (GAO) to be accessible to users with visual impairments, as part
of a longer term project to improve GAO products' accessibility. Every
attempt has been made to maintain the structural and data integrity of
the original printed product. Accessibility features, such as text
descriptions of tables, consecutively numbered footnotes placed at the
end of the file, and the text of agency comment letters, are provided
but may not exactly duplicate the presentation or format of the printed
version. The portable document format (PDF) file is an exact electronic
replica of the printed version. We welcome your feedback. Please E-mail
your comments regarding the contents or accessibility features of this
document to Webmaster@gao.gov.
This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed
in its entirety without further permission from GAO. Because this work
may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this
material separately.
June 29, 2007:
The Honorable Carl Levin:
Chairman:
The Honorable John McCain:
Ranking Member:
Committee on Armed Services:
United States Senate:
The Honorable Ike Skelton:
Chairman:
The Honorable Duncan L. Hunter:
Ranking Member:
Committee on Armed Services:
House of Representatives:
Subject: Military Health: DOD's Vaccine Healthcare Centers Network:
Members of the military have long been required to receive
immunizations.[Footnote 1] The Department of Defense (DOD) estimates
that over 2.2 million servicemembers[Footnote 2] receive at least one
mandatory immunization annually. Immunizations are provided through the
administration of vaccines, which contain "antigens" or parts of a
specific virus or bacterium that are used to trigger an immune response
to protect the body from disease. DOD's immunization requirements vary
depending on several factors, such as a servicemember's branch of
military service, location, age, and type of personnel, such as newly
enlisted recruits, those conducting high-risk travel, and reserve
forces.
No immunization is completely safe. Like all individuals,
servicemembers may experience side-effects as a result of their
immunizations, known as adverse events. Most adverse events consist of
relatively mild reactions, such as swelling near the site of the
immunization. However, a small number of individuals may experience
more severe reactions, such as some servicemembers who received the
anthrax and smallpox vaccines. DOD made these vaccines mandatory
starting in 1998 and 2002, respectively, out of concern that these
pathogens could be used as biological weapons.[Footnote 3] Some
servicemembers who received these vaccines experienced severe reactions
such as migraines, heart problems, and the onset of diseases including
diabetes and multiple sclerosis. Since then, the adverse events
associated with these vaccines have caused concern among members of
Congress about the safety of some mandatory immunizations.
In response to three congressional directives, DOD established the
Vaccine Healthcare Centers (VHC) Network in September 2001 with initial
funding provided by the Department of Health and Human Services' (HHS)
Centers for Disease Control and Prevention (CDC).[Footnote 4] The
purpose of the VHC Network is to meet the health care needs of
servicemembers receiving mandatory immunizations. This includes
educating servicemembers about how to prevent adverse events and
diagnosing and treating those with severe reactions. In September 2001,
the National VHC--or headquarters--opened at Walter Reed Army Medical
Center in Washington, D.C., along with a regional VHC site in the same
location. By 2003, three more regional VHCs had opened at the Womack
Army Medical Center at Fort Bragg in North Carolina, the Wilford Hall
Medical Center at Lackland Air Force Base in Texas, and the Portsmouth
Naval Medical Center in Virginia.
DOD placed the VHC Network under the command of the Army Surgeon
General. However, neither DOD nor the Army provided the VHC Network
with a mission statement. As a result, VHC Network officials defined
their own mission. In addition, since 2001, the VHC Network--which is
not included in DOD's long-term budget planning--has relied upon
funding provided on an annual basis from a variety of sources. Its lack
of both a recognized mission and a specified funding source caused
uncertainty among VHC Network officials about its future existence and
organizational structure. However, in December 2006, DOD made several
decisions regarding the VHC Network. These decisions, which become
effective in fiscal year 2008, address the VHC Network's funding and
mission and transfer it to the command of the Military Vaccine Office
(MILVAX), which oversees military immunization policies across DOD.
Two recent laws--the National Defense Authorization Act for Fiscal Year
2006 and the National Defense Authorization Act for Fiscal Year 2007--
contained provisions that required us to examine several issues related
to the VHC Network.[Footnote 5] In response, and after consultation
with the committees of jurisdiction, this report describes (1) the
efforts the VHC Network is undertaking to address the needs of
servicemembers arising from mandatory military immunizations and (2)
how DOD has supported the mission of the VHC Network.
To describe the efforts the VHC Network is undertaking to address the
needs of servicemembers,[Footnote 6] we interviewed officials from the
National VHC, and from each of the four regional VHCs, on the VHC
Network activities. We also interviewed DOD officials at the Office of
the Assistant Secretary of Defense for Health Affairs, the Defense
Health Board, the DOD Center for Deployment Health Research, the Army
Medical Research and Materiel Command, the Preventive Medicine
Residency Training Program of the Uniformed Services University of the
Health Sciences, and the Offices of the Surgeon General for the Army,
Air Force, and Navy to obtain their perspectives on the mission and
activities of the VHC Network. In addition, we interviewed officials
from MILVAX to obtain information on immunization policies and related
requirements and to understand its relationship with the VHC Network.
We also interviewed two providers--one in the Army and another in the
Air Force--who have treated servicemembers experiencing adverse events,
and a Navy nurse familiar with immunizations. During our interviews, we
also obtained information regarding the education and assistance the
VHC Network offers military and civilian health care providers and the
services that it provides to family members and others, such as DOD
contractors, receiving immunizations. Finally, we spoke to CDC
officials to understand how the role CDC plays in monitoring adverse
events among the civilian population compares to the VHC Network's role
in the military. We obtained and analyzed relevant documentation and
data on the VHC Network's activities from the entities we contacted.
To determine how DOD has supported the mission of the VHC Network, we
interviewed officials at the Assistant Secretary of Defense for Health
Affairs, MILVAX, the Offices of the Surgeon General for the Army, Air
Force, and Navy, and the VHC Network. We also obtained budgetary
information concerning the VHC Network, including funding sources, from
fiscal year 2001 through fiscal year 2006. In addition, we reviewed VHC
Network staffing levels during April 2007. We supplemented this work
with interviews with CDC officials to obtain information on the funding
CDC provided to help launch the VHC Network in 2001. To assess the
reliability of the VHC Network's information on regional staffing,
clinical support mechanisms, and educational resources, we talked with
agency officials about their data collection and quality control
procedures and reviewed relevant documentation. We determined that the
data were sufficiently reliable for the purposes of this report. We
performed our work from June 2006 through May 2007, in accordance with
generally accepted government auditing standards.
Results in Brief:
The VHC Network supports the health care needs of servicemembers that
may arise from military immunizations in three ways. First, it offers
clinical support. For example, it provides clinical care to
servicemembers experiencing potential adverse events, and, in cases
where the patient is not located near a regional VHC site, it may
remotely coordinate the patient's care with the other providers
directly involved in the patient's treatment. Second, the VHC Network
conducts research to improve the safe administration of vaccines and
the prevention, identification, and treatment of adverse events. Third,
it educates servicemembers and military health care staff on adverse
events. For example, the VHC Network makes information available by
conducting briefings and posting training materials on a Web site. In
general, DOD and CDC officials said that they consider the VHC
Network's contributions important, particularly in the area of clinical
care. However, several DOD officials, including DOD medical staff
members, added that its educational efforts may not be reaching enough
military health care providers who remain unaware, for example, of some
adverse events and the role of the VHC Network.
DOD's December 2006 decisions, including the plan to place the VHC
Network under the command of MILVAX, will give the VHC Network
recognition as a formal entity within DOD's command structure and an
established mission within DOD, and have the potential to provide
access to a more stable source of funding, when they are implemented in
fiscal year 2008. According to VHC Network officials, the absence of
such a mission and a place in DOD's long-range budget has made it
difficult to plan strategically, develop and maintain regional VHC
sites, and attract and retain staff. Under DOD's new plan, the Army,
Air Force, and Navy will each provide funding for the VHC Network. In
addition, there will be opportunities for all the services to provide
input into decisions regarding the activities of the VHC Network. VHC
Network officials stated that they hope that DOD's decisions will
provide opportunities for the VHC Network to plan for and accomplish
its mission with greater predictability.
We provided a draft of this report to DOD and HHS. We received written
comments from DOD stating that it concurred with our findings. HHS
provided technical comments, which we incorporated as appropriate.
Background:
The human body generally tolerates immunizations without significant
side effects and most immunized individuals require no treatment.
Reactions at or near the injection site, such as redness, itching, and
swelling, are not unusual among those experiencing adverse events. Less
common reactions are systemic events that affect the entire body, such
as fever, chills, or nausea. Instances of severe adverse events are
rare. Officials from the VHC Network and CDC estimate that between 1
and 2 percent of immunized individuals may experience severe adverse
events, which could result in disability or death. Some of these events
may occur coincidentally following immunization, while others may truly
be caused by immunization. The fact that an adverse event occurred
following immunization is not conclusive evidence that the event was
caused by a vaccine. A comprehensive evaluation of the patient's
condition may be necessary to make this determination, and may be
followed by treatment or exemption[Footnote 7] from further doses of a
vaccine.[Footnote 8]
The VHC Network is currently overseen by the Army's North Atlantic
Regional Medical Command (NARMC), which operates under the Army Surgeon
General. As of April 2007, the VHC Network had 40 staff. Fourteen of
them work for the National VHC in medical, educational, and
administrative capacities. The remaining 26 staff members worked for
the regional VHCs (see table 1).
Table 1: Regional VHC Staff Distribution, as of April 2007:
Medical personnel; Walter Reed VHC: 4; Fort Bragg VHC: 3; Portsmouth
VHC: 3; Wilford Hall VHC: 4; Total: 14.
Support staff; Walter Reed VHC: 5; Fort Bragg VHC: 3; Portsmouth VHC:
2; Wilford Hall VHC: 2; Total: 12.
Total; Walter Reed VHC: 9; Fort Bragg VHC: 6; Portsmouth VHC: 5;
Wilford Hall VHC: 6; Total: 26.
Source: The VHC Network.
Note: Medical personnel include the medical director, nurse
practitioners, and health educators. Support staff include the patient
service coordinator and other administrative support.
[End of table]
The Office of the Secretary of Defense designated the Army as the
executive agent[Footnote 9] for the DOD-wide military immunization
program. The Army, through the Office of the Army Surgeon General,
established MILVAX to coordinate efforts in immunization services for
all DOD components.[Footnote 10] Specifically, MILVAX is charged with
delivering education, enhancing scientific understanding, promoting
quality, and helping to develop and coordinate military immunization
programs for all DOD services worldwide. For example, MILVAX provides
information related to military immunization requirements through such
vehicles as Immunization University, an online source of guidelines and
training materials for those administering military immunizations. In
addition, MILVAX monitors databases maintained by each of the military
services that track the administration of vaccines and health of
servicemembers before and after immunization to identify patterns in
symptoms that might indicate adverse events. MILVAX is also responsible
for ensuring adherence to standards applicable to the proper shipping
and handling of some temperature-sensitive immunization products.
In January 2006, DOD required that, at a minimum, more than 75 percent
of servicemembers must be rated as "fully medically ready." To meet
this requirement, among other things, servicemembers must receive all
immunizations that, depending on their particular circumstances, are
required of them.[Footnote 11] Most immunizations involve injections,
and some require multiple doses. Table 2 shows vaccines generally
required for servicemembers.
Table 2: Vaccines Generally Required for Servicemembers (2006):
Population segment: Trainees; Vaccine: Diphtheria, hepatitis A,
hepatitis B, influenza, measles, meningococcal disease, mumps,
pertussis, poliovirus, rubella, tetanus, varicella, yellow fever.
Population segment: Routine during career (both active duty and
reserves); Vaccine: Diphtheria, hepatitis A, influenza, pertussis,
tetanus.
Population segment: Individualized based on deployment or travel to
high-risk areas; Vaccine: Anthrax, hepatitis B, Japanese encephalitis,
meningococcal disease, smallpox, typhoid, yellow fever.
Population segment: Individualized based on occupational or personal
needs; Vaccine: Haemophilus influenzae type b, hepatitis B,
meningococcal disease, pneumococcal disease, rabies, varicella.
Source: DOD.
Note: Immunization policy varies among military services, based on
individual needs.
[End of table]
The VHC Network Provides Clinical Support, Performs Research, and
Offers Education to Address Servicemembers' Needs:
The VHC Network undertakes a variety of activities to support the needs
of servicemembers who receive immunizations. We have grouped these
activities into three categories--clinical support, research, and
education. By focusing on these activities, the VHC Network attempts to
prevent, identify, and treat adverse events.
The VHC Network Offers Clinical Support:
The VHC Network offers clinical support to servicemembers, health care
providers, and others, such as family members. Such support is
available in person to servicemembers and others who visit the VHC
Network's regional locations. Clinical support is also provided by
telephone--servicemembers, and others with clinical questions, may call
the DOD Vaccine Clinical Call Center, which is operated by the VHC
Network. This center is available 24 hours a day, 7 days a week.
According to its officials, the VHC Network has responded to at least
1,700 calls made to its call center, from June 2004--when the call
center first became operational--through March 2007. The VHC Network
also provides clinical support through its Web site, which contains a
link that allows for confidential e-mail communication. Through this
link, according to VHC Network officials, 146 inquiries have been
addressed from August 2005, when the link became operational, through
March 2007.[Footnote 12] Through these venues, the VHC Network provides
the following clinical support.
Providing clinical care: The VHC Network treats servicemembers
experiencing potential adverse events, particularly in instances where
symptoms have been persistent, nonresponsive to previous treatment, and
debilitating. VHC Network physicians may serve as primary care
providers, providing in-person care, for patients at the regional VHCs.
For patients at other locations, the VHC Network may serve as the long-
distance case manager. In such cases, VHC Network physicians use
telemedicine to remotely coordinate a patient's care with their primary
care providers, by telephone or through the Internet. Regardless of
whether patient care is provided directly or remotely, it may include
diagnostic assessments, such as performing physical examinations,
evaluating the results of laboratory tests, consulting with current and
past healthcare providers, conducting comprehensive interviews
regarding past health history with patients and family members, and
providing necessary treatment. Depending on the patient's needs, the
VHC Network may also make referrals to other health care providers for
subspecialty care, and engage in long-term follow-up of the patient's
progress. According to VHC Network officials, from September 2001, when
the VHC Network was created, through mid-April 2007, the VHC Network
has provided clinical treatment to about 2,400 servicemembers.
Responding to immunization-related questions: The VHC Network staff
answer questions from servicemembers and their families, providers, and
others. The questions may be general or unique to a patient's
individual situation, and involve topics such as the following:
* Safe administration of vaccines to prevent adverse events: For
example, should servicemembers be immunized if they have a history of
certain allergies or when they are taking a specific prescription
medication?
* Identification of potential adverse events: For example, could
symptoms of vertigo, or short-term memory loss be related to a recent
immunization?
* Safe practices after immunization: For example, are there precautions
a servicemember should take after receiving certain vaccines, such as
the smallpox vaccine, where there is a risk that the virus from the
vaccination site may be transferred and infect family members or others
with whom the servicemember has close contact?
Providing clinical input to administrative decisions: Because of its
clinical expertise in adverse events following immunization, the VHC
Network provides input in certain administrative decisions involving
the longer-term health care needs of those who have experienced adverse
events as a result of mandatory immunizations. For example, it assists
servicemembers in obtaining medical exemptions from further
immunizations, to avoid future severe reactions. In other situations,
it supports patients who are no longer on active duty in obtaining
military health care benefits so they may be treated for symptoms
associated with adverse events. For example, it helps members of the
reserves with establishing their eligibility for military health care
benefits by providing documentation on the link between their symptoms
and the mandatory immunizations they received while on active
duty.[Footnote 13]
Many of the DOD officials, military health care staff, and CDC
officials we interviewed considered the VHC Network's clinical support
efforts both important and unique. For example, several indicated that
the VHC Network is uniquely positioned in the military to care for
those experiencing adverse events, because of the staff's expertise in
immunology and their continuous exposure to and familiarity with such
cases.[Footnote 14] In addition, MILVAX officials told us that the VHC
Network's regional sites provide a single point of access to
coordinated medical care for servicemembers experiencing adverse
events. As a result, these officials told us that servicemembers
benefit greatly because they do not have to go through a lengthy
process of seeing several providers before being diagnosed and treated.
The VHC Network Conducts Research to Improve Vaccine Safety:
The VHC Network conducts research to improve DOD's ability to identify,
treat, and prevent adverse events related to immunizations. The VHC
Network uses information it gathers through its clinical support
activities and supplements that information with medical literature
reviews and joint efforts with other entities with an interest in
military immunizations. For example, the VHC Network regularly
coordinates with MILVAX in researching possible adverse events and
related trends. Through its routine review of military immunization
databases, MILVAX may identify a trend in certain symptoms and ask the
VHC Network to investigate the cause. The two entities may also
collaborate in their research activities, such as a recent study of the
flu vaccine that compared the safety of the injectable vaccine to that
of the nasal spray vaccine. The VHC Network also engages in research
projects with other entities such as CDC and universities, covering
topics such as immunologic responses to anthrax immunization and
postimmunization chronic fatigue syndrome. Through these research
efforts, the VHC Network aims to improve vaccine safety by the
following:
Safely administering vaccines: As a result of its research on possible
causes of adverse events, the VHC Network created a screening form to
capture servicemembers' health histories, prior to immunization. Health
care staff administering vaccines may use these forms to identify any
potential vaccine-related risks. As a result of the information
provided, they may give the servicemember a different vaccine dosage
than others receive or a medical exemption from the vaccine.
Identifying and treating potential adverse events: According to VHC
Network officials, the VHC Network, through its clinical experience and
related evaluation and research work, facilitates the discovery of new
vaccine-related adverse events, particularly rare ones, which may not
be as readily identified by database research and analysis. For
example, VHC Network officials told us that they determined that
inflammation of the heart may be caused by the smallpox vaccine and
that they disseminated that information throughout the military medical
community through presentations, the VHC Network's Web site, and other
means. Without this information, the chest pains some servicemembers
experience may not be associated by providers with the immunization and
instead may be misdiagnosed as a different heart ailment. In addition,
the VHC Network provides tools on its and MILVAX's Web sites to further
assist military providers in properly diagnosing and treating adverse
events. For example, the VHC Network has created clinical definitions
for six additional adverse events not previously characterized, such as
new onset of headaches, muscle pain, chronic fatigue, and autoimmune
disorders, in order to help providers identify such symptoms as
possible adverse events. In addition, the VHC Network provides clinical
guidelines to further assist providers in their diagnosis and care of
adverse events.
Many officials at MILVAX, other DOD entities with an interest in
military health care research, and CDC told us that they believe that
the VHC Network has made important contributions to research. For
example, MILVAX officials cited the VHC Network's role in the
investigation of the causes of death of three servicemembers after
receiving multiple immunizations, including the smallpox vaccine, the
VHC Network's study of the possible genetic predisposition to adverse
events, and its work on the association between inflammation of the
heart and the smallpox vaccine.
The VHC Network Educates Servicemembers, Providers, and Others about
Adverse Events and VHC Resources:
The VHC Network has a number of activities to educate servicemembers,
providers, and other military health care staff about adverse events,
the role of the VHC Network, and the resources it provides. The VHC
Network uses a variety of approaches, including the following:
Presentations: The VHC Network staff make various presentations about
vaccine-related adverse events and the role of the VHC Network. The VHC
Network estimates that in 2006 it conducted 810 presentations. For
example, VHC Network staff conducted briefings at the Soldier Readiness
Processing program, which prepares servicemembers for deployment, at
the four VHC locations. These briefings accounted for almost 30 percent
of all presentations and reached about 20,000 servicemembers. Other
presentations involved briefings at mass immunization sites, family
support group meetings, and various orientation sessions, for example,
for new hospital staff at military medical centers including the four
VHC sites. VHC Network staff also participated in health fairs and
conferences.
Printed material: The VHC Network publishes the Immunization Tool Kit,
a booklet that contains vaccine-related information on matters such as
the safe administration of immunizations, possible adverse events, and
sources of additional information targeted to military and civilian
health care providers. Almost 78,800 copies of the Immunization Tool
Kit have been distributed since it was first published in 2001, through
March 2007.
Web resources: The VHC Network offers educational resources on its Web
site such as Project Immune Readiness, a distance learning tool that
targets military health care staff administering immunizations, but is
also available to anyone interested in learning more about vaccines.
Among other things, the tool uses educational modules to teach health
care staff how to prevent and recognize adverse events. For example, in
2005, 2,060 people completed 7,779 of these modules.
Collaborative efforts: The VHC Network and MILVAX regularly collaborate
in education efforts. For example, MILVAX reviews new material to be
included in the VHC Network's Project Immune Readiness, such as
guidance on the proper handling and storage of vaccines. In addition, a
representative of the Uniformed Services University of the Health
Sciences, which provides training on public health in the military,
told us that VHC Network staff have assisted in developing its
preventive medicine training.
While many DOD officials and medical staff we contacted acknowledged
the contributions of the VHC Network in education, several said that
they do not believe that enough military healthcare providers are being
reached. Specifically, we were told that many providers are still
unaware of the VHC Network, its role, and the potential links between
certain symptoms and adverse events, which, in turn, affects their
ability to not only provide proper diagnosis and treatment, but also to
educate those being immunized.[Footnote 15] According to DOD officials
with whom we spoke, the nature of DOD's organization, with its
continuous rotation and restructuring of personnel, creates a challenge
for the VHC Network to effectively reach out to every targeted audience.
Recent Decisions by DOD Have the Potential to Provide Greater Stability
to the VHC Network:
In December 2006, DOD made decisions addressing matters regarding the
VHC Network, including its organizational status, mission, and funding.
VHC Network officials stated that the unpredictability of the VHC
Network's budget from one year to the next had affected facility
development and staff retention, and compromised the VHC Network's
ability to provide services and to accomplish its mission. DOD's recent
decision to place the VHC Network under the command of MILVAX,
beginning in fiscal year 2008, provides recognition of the VHC
Network's status and mission, in addition to offering the potential for
more funding security through access to DOD's long-term budget planning
process.
Uncertainties in DOD's Commitment to the VHC Network Had Affected Its
Status, Mission, and Funding:
Since its establishment in 2001, the VHC Network had been operating
under the command of the Army. Although the VHC Network officials
defined their own mission, they did not undertake the steps necessary
to establish a recognized mission within DOD. The VHC Network also
sought, but never obtained, the oversight of a DOD executive agent,
which would have provided it with a defined mission within the agency.
In addition, the structural and financial support for the VHC Network
was not formalized. Although the VHC Network was initially designed to
serve the Army, Air Force, and Navy, officials from the Air Force and
Navy told us that they did not contribute to formulating the mission
and activities of the VHC Network regional sites located at their bases
and, consequently, they had little incentive to financially support the
VHC Network's activities and mission.
The VHC Network had not been included in the military's long-term
budget planning, which, VHC Network officials stated, limited their
ability to strategically plan to accomplish their mission. VHC Network
budget requests were submitted to the Army annually beginning in fiscal
year 2002; however, the VHC Network was never incorporated into the
Army's budget. Similarly, although requests were submitted for
inclusion in DOD's 5-year budgets,[Footnote 16] prepared in fiscal
years 2004 and 2006, the VHC Network's costs were not included in the 5-
year budgets.
The VHC Network obtained funding from a variety of sources, relying
primarily on funds provided by the Army Surgeon General on a year-by-
year basis from fiscal year 2002 through fiscal year 2006. During this
period, the Army Surgeon General provided the VHC Network approximately
$21.1 million from its allocated Global War on Terrorism (GWOT)
funds.[Footnote 17] In addition, for fiscal years 2005 and 2006, NARMC
provided approximately $177,000 to support VHC Network activities not
covered by GWOT funds. About $5.5 million from the Defense Health
Program appropriation was directed to be spent on the VHC Network, as
outlined in conference agreements for fiscal years 2003 and
2006.[Footnote 18] For fiscal years 2003 through 2006, MILVAX provided
funding for activities such as VHC Network educational efforts and the
operation of the DOD Vaccine Clinical Call Center. Table 3 shows the
VHC Network's sources of funding for fiscal years 2002-2006.
Table 3: Funding Sources for VHC Network Activities, Fiscal Years 2002-
2006:
Financial support (dollars in millions): GWOT--Army Surgeon General;
Fiscal year 2002: $5.200; Fiscal year 2003: $1.920; Fiscal year 2004:
$5.640; Fiscal year 2005: $5.551; Fiscal year 2006: $2.874; Total:
$21.185.
Financial support (dollars in millions): NARMC; Fiscal year 2002:
[Empty]; Fiscal year 2003: [Empty]; Fiscal year 2004: [Empty]; Fiscal
year 2005: 0.117; Fiscal year 2006: 0.060; Total: 0.177.
Financial support (dollars in millions): Defense Health Program
Appropriations[A]; Fiscal year 2002: [Empty]; Fiscal year 2003: 2.543;
Fiscal year 2004: [Empty]; Fiscal year 2005: [Empty]; Fiscal year 2006:
2.970; Total: 5.513.
Financial support (dollars in millions): MILVAX; Fiscal year 2002:
[Empty]; Fiscal year 2003: 0.444; Fiscal year 2004: 0.623; Fiscal year
2005: 0.610; Fiscal year 2006: 0.366; Total: 2.043.
Financial support (dollars in millions): Total; Fiscal year 2002:
$5.200; Fiscal year 2003: $4.907; Fiscal year 2004: $6.263; Fiscal year
2005: $6.278; Fiscal year 2006: $6.270; Total: $28.918.
Source: DOD.
Notes: Since February 2006, the VHC Network also received over $2.3
million in grants and awards from DOD and the National Institutes of
Health for various projects. The Army, Air Force, and Navy have also
provided facility space and utilities for the VHC regional sites
located at their bases.
[A] The conference reports accompanying DOD's Appropriations Acts for
Fiscal Years 2003 and 2006 contained funding tables indicating that a
total of about $5.5 million was to be spent on the VHC Network for
those years. See H.R. Conf. Rep. No. 107-732, at 323 (2002)
(accompanying Pub. L. No. 107-248) and H.R. Conf. Rep. No. 109-359, at
454 (2005) (accompanying Pub. L. No. 109-148).
[End of table]
Although the total annual funding for the VHC Network has been fairly
consistent from year to year,[Footnote 19] according to VHC Network
officials, its exclusion from the Army's and DOD's budget projections
complicated their ability to plan to provide services. For example,
using fiscal year 2003 funds, the VHC Network built a regional site in
Landstuhl, Germany.[Footnote 20] The facility, costing approximately
$500,000, was completed in 2004. However, it was never occupied as a
VHC regional site because the Army's 5-year budget projections for
fiscal years 2006 to 2011 did not include funds to operate it. In
addition, the Army wanted to clarify the mission of the VHC Network
before it agreed to the VHC Network's expansion. The Army used the
facility for other purposes.
In addition, VHC Network officials stated that the lack of reliable
funding made it difficult to plan for staffing. For example, although
Air Force and Navy personnel were utilizing services provided by the
Wilford Hall and Portsmouth regional VHC sites, the Army considered
closing these two regional VHCs in 2006, because of the absence of
budgetary support from the Air Force and Navy. In particular, VHC
Network officials noted that the uncertainty surrounding the future of
the Portsmouth regional VHC made it difficult to recruit and retain
staff there. The position of medical director at the Portsmouth site
had been vacant since April 2004, when the site's last medical director
resigned, citing funding uncertainty as part of her reason for
resigning.[Footnote 21] By December 2006, when DOD made decisions
addressing the mission and funding of the VHC Network, the Portsmouth
VHC had been unable to recruit replacements for vacant staff positions,
in part, because it could not ensure that the positions would exist in
the upcoming year.
DOD's Decisions Could Make the VHC Network's Status, Mission, and
Funding More Predictable:
DOD addressed the challenges facing the VHC Network in December 2006.
After deliberations and unanimous agreement from the Army, Air Force,
and Navy, DOD finalized decisions that will take effect in fiscal year
2008 regarding the VHC Network's mission, status, and funding.[Footnote
22] DOD's decisions provided recognition of the VHC Network's mission
and place within DOD's command structure, and have the potential to
provide access to more predictable funding. Its decisions included (1)
placing the VHC Network under the command of MILVAX, (2) funding the
VHC Network through contributions from each of the services, (3)
formalizing Army, Air Force, and Navy input into and oversight of the
VHC Network's mission and activities, and (4) providing outcomes
oversight through an independent panel and a program review scheduled
for 2010.
DOD provided the VHC Network clear organizational status through the
decision to transfer it from NARMC's command to MILVAX. This will
enable the VHC Network to share in the benefits afforded to MILVAX as a
program operating under an executive agent. In addition, DOD concluded
that all three services will periodically be asked to provide input
into decisions concerning the VHC Network's activities, making each
service a stakeholder in the success of the VHC Network's mission.
DOD also made several decisions that support the VHC Network's mission.
For example, it concluded that the mission developed by the VHC Network
was appropriate and that the VHC Network should continue with its
current activities, including maintaining its network structure of a
headquarters and regional sites. MILVAX and VHC Network officials are
currently working together, with input from the services, to revise
MILVAX's mission to include VHC Network activities. In addition, DOD
decided that it would provide oversight of the VHC Network through an
independent expert panel, which will conduct a program review in 2010.
A MILVAX official stated that being within the MILVAX command may also
provide the VHC Network additional opportunities to accomplish its
mission. For example, MILVAX has a staff of 18 analysts in the United
States and abroad who could assist in publicizing the VHC Network's
services to clinicians and other military personnel. This official
suggested that greater visibility may help ensure that those in need of
the VHC Network's services know how to access them, which may be
especially important considering the reintroduction of the mandatory
anthrax immunization and DOD's January 2006 directive to achieve a
higher level of medical readiness, partly through immunizing
servicemembers.
DOD also took several actions to address the VHC Network funding
concerns. While DOD's decision to place the VHC Network under MILVAX
does not guarantee funding for the VHC Network, MILVAX's position as a
program operating under an executive agent ensures that the VHC Network
will be included in budget planning. With MILVAX's new responsibility
for the VHC Network's mission and activities, the VHC Network's budget
will be included within MILVAX's request for inclusion in DOD's 5-year
internal budget projections, beginning with fiscal year 2008. In
addition, DOD decided that the Army, Air Force, and Navy will share
responsibility for funding the VHC Network. VHC Network officials told
us that they hope that the changes in funding will provide the VHC
Network with additional security and facilitate VHC Network officials'
ability to plan activities.
Agency Comments:
We provided a draft of this report to DOD and HHS. In its written
comments, DOD said that it concurred with our findings. DOD's written
comments are reprinted in enclosure I. HHS provided technical comments,
which we incorporated as appropriate.
-----
We are sending copies of this report to the Secretary of Defense and
other interested parties. In addition, this report will be available at
no charge on GAO's Web site at http://www.gao.gov. We will also make
copies available to others upon request. If you or your staff members
have any questions about this report, please contact me at (202) 512-
7114 or crossem@gao.gov. Contact points for our Offices of
Congressional Relations and Public Affairs may be found on the last
page of this report. GAO staff who made major contributions to this
report are listed in enclosure II.
Signed by:
Marcia Crosse:
Director, Health Care:
Enclosures - 2:
[End of section]
Enclosure 1:
Comments from the Department of Defense:
[See PDF for image]
[End of figure]
Health Affairs:
The Assistant Secretary Of Defense:
1200 Defense Pentagon: Washington, DC 20301-1200:
JUN 14 2007:
Ms. Marcia Crosse: Director, Health Care: U.S. Government
Accountability Office: 441 G Street, N.W. Washington, DC 20548:
Dear Ms. Crosse:
This is the Department of Defense (DoD) response to the GAO draft
report, GAO-07-787R, `Military Health: DoD's Vaccine Healthcare Centers
Network,' dated May 22, 2007 (GAO Code 290549).
Thank you for the opportunity to review the Draft Report and provide
comments. I concur with the report's findings and results.
My points of contact on this audit are Dr. Michael Kilpatrick
(Functional) at (703) 578-2675 and Mr. Gunther Zimmerman (Audit
Liaison) at (703) 681-3492.
Sincerely,
Signed by:
S. Ward Casscells, MD
[End of section]
Enclosure II:
GAO Contact and Staff Acknowledgments:
GAO Contact:
Marcia Crosse at (202) 512-7114 or crossem@gao.gov:
Acknowledgments:
Geraldine Redican-Bigott, Assistant Director; Adrienne Griffin;
TaNaisha Lee; Pauline Seretakis; and Margaret Weber made key
contributions to this report.
(290549):
[End of section]
FOOTNOTES
[1] The military first mandated immunizations in 1777, when General
George Washington required troops to receive the smallpox vaccine.
Since then, the smallpox vaccine has been given to members of the
military during major conflicts including the Civil War, World War I,
World War II, the Korean War, and the Vietnam War. The smallpox
immunization requirement was suspended in 1990 and was subsequently
reinstated for certain personnel in 2002.
[2] For the purposes of this report, we use the term "servicemembers"
to include all members of the military, including active duty, reserve,
and National Guard servicemembers. In addition to servicemembers, DOD
may require others to receive immunizations, such as DOD contractors
and family members who accompany service members to military locations.
[3] The military suspended the use of the anthrax vaccine in October
2004, in response to a court order that expressed concern regarding the
administrative process by which the Food and Drug Administration (FDA)
approved the vaccine for its use. The court subsequently modified this
order, which allowed the military to begin to offer the anthrax vaccine
on a voluntary basis in April 2005. In December of 2005, FDA determined
that the vaccine protected against all routes of exposure to anthrax
spores, including inhalation. In October 2006, after the court order
had expired, DOD announced that it was resuming mandatory vaccination
for certain personnel and issued a memorandum that designated which
personnel would be required to receive the immunization and which
servicemembers would be eligible to receive it on a voluntary basis.
[4] The first directive was contained in the conference report
accompanying the Consolidated Appropriations Act for Fiscal Year 2000.
Congress directed the National Institutes of Health, CDC, and DOD to
conduct a collaborative study on the safety and efficacy of vaccines
used against biological agents. See H.R. Conf. Rep. 106-479, at 727
(1999). The second directive was contained in section 751 of the
National Defense Authorization Act for Fiscal Year 2001. This provision
required DOD to establish a system for monitoring adverse reactions to
the anthrax vaccine and to establish guidelines under which
servicemembers could obtain access to a treatment facility for
expedited treatment and follow up of adverse events. See Pub. L. No.
106-398 App., § 751, 114 Stat. 1654, 1654A-193 (2000) (codified at 10
U.S.C. § 1110). The third directive called for the continued study of
the anthrax vaccine by CDC and was provided in the Consolidated
Appropriations Act for Fiscal Year 2001, Pub. L. No. 106-554 App., 114
Stat. 2763, 2763A-25 (2000). Congress indicated in a report
accompanying the 2001 appropriation law that the establishment of the
VHC Network would, among other things, facilitate data collection and
training. See H.R. Conf. Rep. No. 106-1033, at 166 (2000).
[5] See Pub. L. No. 109-163, § 736, 119 Stat. 3136, 3356 and Pub. L.
No. 109-364, § 737(a), 120 Stat. 2083, 2302 (2006).
[6] We consider the efforts of the VHC Network to address the needs of
those receiving the anthrax immunization under both mandatory and
voluntary circumstances to be within the scope of this report.
[7] Under current DOD-wide policy, servicemembers may receive a
temporary (lasting up to 365 days) or permanent medical exemption from
immunizations from appropriate medical personnel, based on factors such
as preexisting immunity, severe reactions to prior vaccination, or
pregnancy, and still be considered medically ready for deployment.
[8] For some vaccines, such as the anthrax immunization, immunity is
achieved after the administration of multiple doses of vaccine.
[9] An executive agent in DOD provides defined levels of support for
operational missions or other activities that provide support to two or
more DOD services. According to DOD Directive 5101.1, an executive
agent is the head of a DOD component to whom the Secretary or Deputy
Secretary of Defense has assigned specific responsibilities, functions,
and authorities. There are 10 medical programs operating under
executive agents in DOD; the Army is the executive agent for 9 of those
programs.
[10] Programs, such as MILVAX, that operate under an executive agent
have separate and identifiable lines in DOD's internal budget process.
[11] Medical readiness requires that service members are fit and ready
to deploy. For example, active service members are required to have an
annual dental examination, pass an annual health assessment, and be
tested for human immunodeficiency virus within the previous 24 months,
in addition to receiving their mandatory immunizations.
[12] In addition, according to VHC Network officials, the VHC Network
has also responded to e-mails outside of the secure link.
[13] Most members of the reserves are not enrolled in a military health
care insurance program when they are not on active duty. However, they
may be eligible for military health care benefits or health care
provided by the Department of Veterans Affairs, for service-related
injuries or illness incurred or aggravated while on active duty.
[14] Providers at the regional VHCs are civilians and do not rotate
among facilities.
[15] For example, according to CDC's Morbidity and Mortality Weekly
Report of May 18, 2007, a child of a servicemember who received the
smallpox vaccine experienced a life-threatening reaction to his
father's immunization. (http://www.cdc.gov/mmwr/preview/mmwrhtml/
mm5619a4.htm, downloaded on May 18, 2007.) Such a reaction can occur
from close physical contact with people who have recently received this
vaccine. Greater awareness of adverse events and their prevention among
servicemembers and military health care staff could help prevent such
incidents.
[16] The Five-Year Defense Program budget is prepared on a biannual
basis, 2 years in advance of the 5-year period and is meant for long-
range DOD planning.
[17] GWOT funds support military operations to combat terrorism
worldwide. Congress has been appropriating GWOT funds since 2001,
through both annual appropriations and supplemental appropriations.
Each service allocates its share of GWOT funds among its various
functions. Only the Army has used GWOT funds to support the VHC
Network.
[18] The conference reports accompanying DOD's Appropriations Acts for
Fiscal Years 2003 and 2006 contained funding tables indicating that a
total of about $5.5 million was to be spent on the VHC Network for
those years. See H.R. Conf. Rep. No. 107-732, at 323 (2002)
(accompanying Pub. L. No. 107-248) and H.R. Conf. Rep. No. 109-359, at
454 (2005) (accompanying Pub. L. No. 109-148).
[19] The VHC Network's fiscal year 2007 budget of $6.105 million is
funded through contributions from each of the services: the Air Force
and Navy provided approximately $1.6 million each, the Army provided
approximately $2.5 million, and the balance--approximately $0.3
million--will be available through NARMC's GWOT allocations.
[20] Landstuhl Regional Medical Center in Germany is the primary
medical treatment center for casualties of U.S. operations within
Europe, Southwest Asia, and the Middle East.
[21] The Wilford Hall medical director currently serves as the
Portsmouth medical director.
[22] The National Defense Authorization Act for Fiscal Year 2007
prohibited DOD from downsizing or restructuring the VHC Network during
fiscal year 2007. See Pub. L. No. 109-364, § 737(b), 120 Stat. 2083,
2302-03 (2006).
