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Chemical and Biological Defense: Observations on DOD's Plans To Protect U.S. Forces (Testimony, 03/17/98, GAO/T-NSIAD-98-83).

Pursuant to a congressional request, GAO discussed the Department of
Defense's (DOD) continuing efforts to protect U.S. military forces
against chemical and biological weapons, including its plan to inoculate
all U.S. military forces against anthrax.

GAO noted that: (1) in examining DOD's experience in preparing its
forces to defend against potential chemical and biological agent attacks
during the Gulf War, GAO identified numerous problems; (2) specifically,
GAO found: (a) shortages in individual protective equipment; (b)
inadequate chemical and biological agent detection devices; (c)
inadequate command emphasis on chemical and biological capabilities; and
(d) deficiencies in medical personnel training, and supplies; (3) while
many deficiencies noted during the Gulf War remain unaddressed today,
DOD has increasingly acknowledged and accepted the urgency of developing
a capability to deal with the chemical and biological threat to its
forces; (4) both Congress and DOD have acted to provide greater
protection for U.S. forces; (5) their actions have resulted in increased
funding, and the fielding of more and better chemical and biological
defense equipment; (6) DOD must address remaining critical deficiencies
if U.S. forces are to be provided with the resources necessary to better
protect themselves; (7) DOD is now embarking on a major effort to
protect U.S. forces from the threat of the deadly biological agent
anthrax; (8) its program to immunize millions of active and reserve
forces against anthrax, ensuring that each receives the prescribed
vaccinations in the proper time sequence, will be a challenge; and (9)
however, if DOD considers lessons learned from previous, smaller-sized
immunization programs and from the medical record-keeping errors in the
Gulf War and Bosnia in formulating detailed implementation plans, it can
reduce the risks and improve the prospects for successfully managing the
program.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  T-NSIAD-98-83
     TITLE:  Chemical and Biological Defense: Observations on DOD's 
             Plans To Protect U.S. Forces
      DATE:  03/17/98
   SUBJECT:  Military operations
             Biological warfare
             Chemical warfare
             Combat readiness
             Immunization services
             Military personnel
             Hazardous substances
             Medical records
             Defense capabilities
IDENTIFIER:  Persian Gulf War
             Desert Shield
             DOD Operation Joint Endeavor
             Bosnia
             
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Cover
================================================================ COVER


Before the Committee on Veterans' Affairs, U.S.  Senate

For Release on Delivery
Expected at
10:00 a.m., EST
Tuesday,
March 17, 1998

CHEMICAL AND BIOLOGICAL DEFENSE -
OBSERVATIONS ON DOD'S PLANS TO
PROTECT U.S.  FORCES

Statement of Mark E.  Gebicke, Director, Military Operations and
Capabilities Issues, National Security and International Affairs
Division

GAO/T-NSIAD-98-83

GAO/NSIAD-98-83T


(703231)


Abbreviations
=============================================================== ABBREV

  DOD - Department of Defense
  FDA - Food and Drug Administration
  USAMRIID - U.S.  Army Medical Research Institute of
  Infectious Diseases

============================================================ Chapter 0

Mr.  Chairman and Members of the Committee: 

We are pleased to be here today to discuss the Department of
Defense's (DOD) continuing efforts to protect U.S.  military forces
against chemical and biological weapons, including its plan to
inoculate all U.S.  military forces against anthrax.  As we learned
from the Gulf War, U.S.  forces were inadequately prepared for
surviving and operating in a chemically or biologically contaminated
environment.  More recently, we found that deficiencies in medical
record-keeping have hampered the conduct of epidemiological research
to the point that DOD cannot provide precise, accurate, and
conclusive answers regarding the causes of Gulf War veterans'
illness. 

Today, we will first briefly discuss the fundamental shortcomings in
DOD's protection of its forces against chemical and biological
warfare.\1

Then, we will discuss DOD's proposed anthrax immunization program. 


--------------------
\1 Appendix I provides a list of the unclassified GAO reports on
DOD's chemical and biological capabilities.  We have also issued
three classified reports on this topic. 


   SUMMARY
---------------------------------------------------------- Chapter 0:1

In examining DOD's experience in preparing its forces to defend
against potential chemical and biological agent attacks during the
Gulf War, we identified numerous problems.  Specifically, we found
shortages in individual protective equipment, inadequate chemical and
biological agent detection devices, inadequate command emphasis on
chemical and biological capabilities, and deficiencies in medical
personnel training and supplies. 

While many deficiencies noted during the Gulf War remain unaddressed
today, DOD has increasingly acknowledged and accepted the urgency of
developing a capability to deal with the chemical and biological
threat to its forces.  Both the Congress and DOD have acted to
provide greater protection for U.S.  forces.  Their actions have
resulted in increased funding, and the fielding of more and better
chemical and biological defense equipment.  DOD must address
remaining critical deficiencies if U.S.  forces are to be provided
with the resources necessary to better protect themselves.  For
example, DOD needs to decide on major policy and doctrine issues,
improve and increase its capability to detect toxic agents, provide
forces with improved and sufficient numbers of individual protective
equipment, and deal with problems of collective protection and
decontamination. 

DOD is now embarking on a major effort to protect U.S.  forces from
the threat of the deadly biological agent anthrax.  Its program to
immunize millions of active and reserve forces against anthrax,
ensuring that each receives the prescribed vaccinations in the proper
time sequence, will be a challenge.  However, if DOD considers
lessons learned from previous, smaller-sized immunization programs
and from the medical record-keeping errors in the Gulf War and in
Bosnia in formulating detailed implementation plans, it can reduce
the risks and improve the prospects for successfully managing the
program. 


   PROTECTING FORCES AGAINST
   CHEMICAL AND BIOLOGICAL AGENTS
   POSES CONTINUING CHALLENGES
---------------------------------------------------------- Chapter 0:2

In 1996, we reported that military units then designated for early
deployment faced many of the same chemical and biological defense
problems that Gulf War veterans had experienced.\2 During the Gulf
War, units and individuals deployed to the theater without all of the
chemical and biological detection, decontamination, and protective
equipment needed to operate in a contaminated environment.  Some
units did not have sufficient quantities or the needed sizes of
protective clothing, and chemical detector paper, and decontamination
kits in some instances had passed their expiration dates.  While the
6-month Operation Desert Shield buildup time allowed DOD to correct
some of these problems, had chemical or biological weapons been used
during this period, some units might have suffered significant,
unnecessary casualties. 

We further reported that DOD's progress in chemical and biological
research and development was slower than planned, training of Army
and Marine Corps forces was inadequate, there was little evidence
that joint training and exercises included chemical and biological
defense elements, stocks of vaccines for biological agents were in
short supply, and medical units lacked necessary chemical and
biological defense equipment and training.  We believe these
deficiencies were a result of, and would not be corrected without,
changes in emphasis on the part of senior military leadership. 

We have also reviewed DOD's ability to protect critical ports and
airfields overseas.  Although I cannot fully discuss our findings in
this open hearing because of their sensitive nature, I can say that
there are deficiencies in doctrine, policy, equipment, and training
for the defense of critical ports and airfields. 

The Congress and DOD have taken action that has improved U.S. 
forces' ability to survive and operate if chemical and biological
agents are used against them.  For example, DOD has requested and the
Congress has approved increased funding for chemical and biological
defense.  Numerous efforts are currently underway that should provide
our servicemembers with new chemical and biological defense equipment
and capabilities over the next 5 years.  These include the production
and fielding of improved protective masks, body garments, and systems
to better detect biological and chemical agents.  In addition,
several commanders in chief recently increased their emphasis on
various aspects of chemical and biological defense by, for example,
increasing stocks of chemical defense equipment and incorporating
more chemical and biological defense scenarios in major military
exercises. 

Still, DOD must address remaining critical deficiencies that affect
its ability to protect forces from chemical and biological attack. 
DOD's doctrine and policy are inadequate regarding responsibility for
the chemical and biological defense of overseas airfields and ports
critical to the deployment, reinforcement, and logistical support of
U.  S.  forces in the event of a conflict.  As a result, questions
are unresolved regarding the provision of the force structure and
equipment needed to protect these facilities.  Also, unresolved
doctrinal, policy, and equipment questions persist regarding the
return of chemically or biologically contaminated strategic lift
aircraft and ships and the protection of both essential and
nonessential civilians in high-threat areas overseas.  Moreover, DOD
has insufficient quantities of biological agent vaccines to protect
U.S.  forces, and servicemembers deployed in high-threat areas
overseas normally have no biological agent detection capability. 
Also, collective protection facilities and equipment and agent
detection systems are generally insufficient to protect the force. 


--------------------
\2 Chemical and Biological Defense:  Emphasis Remains Insufficient to
Resolve Continuing Problems (GAO/NSIAD-96-103, March 29, 1996). 


   DOD'S PROGRAM TO IMMUNIZE
   FORCES AGAINST ANTHRAX
---------------------------------------------------------- Chapter 0:3

Anthrax is an infectious disease that afflicts certain animals,
especially cattle and sheep.  The anthrax vaccine was licensed by the
Food and Drug Administration (FDA) in 1970 to protect veterinarians,
meat packers, wool workers, and health officials who might come in
contact with anthrax.  (FDA licensure of a vaccine means that it has
been tested and proven to be safe and effective in humans.) The
vaccine has been routinely administered to populations at risk for
several years. 

The Chairman of the Joint Chiefs of Staff considers anthrax to be the
greatest biological weapons threat to U.S.  military forces.  After a
3-year study, the Secretary of Defense concluded that vaccination is
the safest way to protect U.S.  forces against a threat that is
99-percent lethal to unprotected individuals.  Accordingly, in
December 1997, DOD announced plans to vaccinate all U.S.  military
personnel (including active, reserve, and national guard
servicemembers) against the biological warfare agent anthrax.  The
Michigan Biologic Products Institute is under contract with DOD to
supply the vaccine for the DOD immunization program. 

While the vaccine will be centrally procured, administering the
vaccinations will be decentralized at multiple DOD facilities
worldwide.  Initially, DOD planned to begin administering the program
in the summer of 1998 to about 165,000 servicemembers and DOD
mission-essential personnel located in Southwest Asia and Northeast
Asia, which are the areas with the greatest biological warfare threat
from anthrax.  Prior to beginning the immunizations, DOD wanted time
to (1) perform testing of the vaccine to ensure its sterility,
safety, potency, and purity; (2) implement a system to track
personnel who receive the vaccinations; (3) approve plans to
administer the immunizations and inform military personnel of the
program; and (4) have the program reviewed by an independent expert. 
However, DOD accelerated the anthrax vaccination schedule.  In March
1998, DOD began immunizing forces stationed in the Persian Gulf
because of the possibility of hostilities occurring in that region. 
DOD plans to vaccinate the remaining active and reserve force over
the next several years.  In addition, DOD plans to decide whether the
program should be extended to others, such as host nation personnel,
civilian contractors, and dependents. 

In accordance with the FDA licensure regimen for this vaccine, DOD
plans to provide an initial series of three vaccinations at 2-week
intervals, a second series of three vaccinations at 6-month
intervals, and annual booster vaccinations to maintain immunity
against anthrax.  DOD recognizes that immunizing the entire force
with multiple vaccinations will be difficult and involves significant
administrative and logistical issues.  DOD's program will involve
administering anthrax vaccinations to about 2.4 million personnel
around the world--a total of about 14.4 million vaccinations for the
current force.  In addition, personnel entering military service will
also be immunized.  Thus, DOD envisions the program to continue
indefinitely. 


      PERSONNEL DATA SYSTEMS TO
      IDENTIFY SERVICEMEMBERS
      REQUIRING VACCINATIONS MUST
      BE ACCURATE
-------------------------------------------------------- Chapter 0:3.1

To ensure that all servicemembers receive the required vaccinations,
it is important for DOD to have accurate and reliable personnel data
systems showing where all servicemembers are located, especially
those deployed to overseas locations. 

Our work in examining the Operation Joint Endeavor medical
surveillance program in Bosnia surfaced concerns about the accuracy
of the deployment database used for determining which servicemembers
required postdeployment medical assessments.  More specifically, DOD
officials expressed concerns about the accuracy of the DOD-wide
database that was used to identify Air Force and Navy personnel who
deployed to Bosnia.  Air Force officials told us that the Air Force
had supplied information to DOD's database on servicemembers it
planned to deploy but that many of them never deployed and the
database was not corrected.  We were also told that data on
servicemembers assigned to two Navy construction battalions that
deployed to Bosnia did not appear in the database.  DOD officials
told us that they were concerned about the accuracy of the deployment
database and planned to address the problem. 


      SUFFICIENT COMMAND EMPHASIS
      NEEDED TO ENSURE PROGRAM
      IMPLEMENTATION
-------------------------------------------------------- Chapter 0:3.2

Because DOD plans to administer anthrax vaccinations in a
decentralized manner at multiple locations involving both operational
and medical personnel, high-level commanders need to emphasize the
importance of the program to ensure that it is carried out within the
time schedule for administering the vaccinations.  Careful attention
to the administration of vaccines is critical because the
vaccinations must be given at specific intervals over an 18-month
period to achieve maximum protection. 

In the past, a lack of command emphasis hindered DOD's successful
implementation of medical programs.  For example, we found that the
Army had not done many postdeployment medical assessments of active
duty personnel who had deployed to Bosnia.  We also found that
assessments done were, on average, not done within the 30-day time
frame DOD established.  Our work disclosed that it took an average of
98 days to complete the assessments. 

In addition, the Bosnia medical surveillance plan also required
servicemembers to undergo a tuberculin test at about 90 days
following departure from the theater.  Our work disclosed that the
test took an average of 142 days. 

These problems occurred because command officials did not emphasize
the importance of the assessments and medical personnel did not have
the authority to require servicemembers to go to medical clinics for
assessments.  Reliance upon unit commanders to require servicemembers
to get the assessments was not effective for the Bosnia deployment. 


      MEDICAL RECORDS DOCUMENTING
      VACCINATIONS MUST BE
      COMPLETE
-------------------------------------------------------- Chapter 0:3.3

Medical records documenting all care (including vaccinations) for
servicemembers are essential for the delivery of high-quality medical
care.  DOD regulations require documentation in a servicemember's
permanent medical record of all immunizations and visits made to
health units. 

The Presidential Advisory Committee on Persian Gulf War Veterans'
Illnesses and the Institute of Medicine reported problems concerning
the completeness and accuracy of medical record-keeping during the
Gulf War.  Research efforts to determine the causes of what has
become known as veterans' Gulf War illnesses have been hampered by,
among other things, incomplete medical records showing immunizations
and other health services provided to servicemembers while deployed. 
The Institute of Medicine characterized DOD's medical records as
fragmented, disorganized, and incomplete. 

We tested the completeness of medical records for selected active
duty Army servicemembers who had deployed under Operation Joint
Endeavor.  We found that many of the medical records were incomplete
in that they lacked documentation on (1) medical surveillance
assessments conducted, (2) tick-borne encephalitis vaccinations
given, and (3) visits made to in-theater health units.  More
specifically, we found that 19 percent of the postdeployment
in-theater medical assessments and 9 percent of the postdeployment
home unit medical assessments were not documented in the medical
records.  These documentation problems were attributed to the fact
that this was a paper-based system that relied upon servicemembers to
hand carry assessment forms from the theater to their home unit,
which maintained the permanent medical record. 

Regarding the documentation of tick-borne encephalitis vaccine in
Bosnia, servicemembers deploying to regions where the threat of this
disease was prevalent were given the choice of being inoculated with
this investigational drug vaccine.\3 We found that 141 (24 percent)
of the 588 medical records reviewed for servicemembers who had
received the vaccine lacked required documentation. 

Our tests of the completeness of the permanent medical records for
servicemembers' visits made to battalion aid stations in Bosnia
showed similar problems.  Specifically, we found that there was no
documentation in the medical records for 44 (29.3 percent) of the 150
visits we reviewed.  Army officials mentioned that permanent medical
records were still paper-based and that information was subject to
being misfiled or lost.  They also pointed out that servicemembers
had deployed to the theater with only an abstract of their permanent
medical records and that any medical documentation generated in the
theater was to have been routed back to the servicemembers' home
units for inclusion into their medical records. 

DOD officials told us that a solution to these documentation problems
would be the development of a deployable, computerized patient
record.  DOD has a project underway to have a paperless computerized
medical record for every active duty servicemember by fiscal year
2000. 


--------------------
\3 An investigational drug is a new drug or product regulated by FDA
that has not been licensed for general use in the United States. 


      CENTRALIZED DATABASE FOR
      MONITORING PROGRAM
      IMPLEMENTATION MUST BE
      ACCURATE
-------------------------------------------------------- Chapter 0:3.4

Without an adequate centralized monitoring system, DOD will not have
reasonable assurances that the program is being implemented as
planned.  For Operation Joint Endeavor, DOD established a centralized
database to track the services' progress in implementing its medical
surveillance program.  Medical units processing medical assessments
were required to send copies of assessment forms to the DOD office
maintaining the centralized database in the United States. 

In testing the completeness of the centralized database for
in-theater and home unit postdeployment medical assessments conducted
for 618 servicemembers, we found that the database understated the
number of assessments done.  More specifically, it omitted 12 percent
of the in-theater medical assessments and 52 percent of the home unit
medical assessments. 

DOD officials told us that they plan to use a new automated system
for tracking implementation of the anthrax immunization program from
locations around the world.  The automated system is still being
developed. 


      EFFICIENT INVENTORY CONTROLS
      ARE NECESSARY TO ENSURE
      SUFFICIENCY OF VACCINE
      SUPPLY
-------------------------------------------------------- Chapter 0:3.5

To ensure that military personnel will receive vaccinations in a
timely manner and to effectively manage the program, it is important
for DOD to maintain an efficient inventory control system.  This
system is needed to ensure that (1) sufficient supplies of vaccines
will be available at the various worldwide immunization sites; (2)
vaccines that are older than their 1-year shelf life are destroyed;
and (3) records of vaccines received, administered, and destroyed are
kept to allow for monitoring and tracking. 

For the Bosnia deployment, DOD experienced problems in accounting for
the inventory of the tick-borne encephalitis vaccine.  DOD had to
comply with strict FDA regulations regarding its use because it was
still being tested as an investigational new drug.  Regulations
required DOD to fully account for vaccine inventories, including the
number of doses administered and the number of doses destroyed. 

In the spring of 1996, officials from the U.S.  Army Medical Research
Institute of Infectious Diseases (USAMRIID) went to Bosnia to review
the procedures being used to administer the tick-borne encephalitis
vaccine.  These officials found that no record of vaccine disposition
was being maintained and recommended that all vaccination sites
perform a physical inventory and maintain data on vaccines on hand,
used, and destroyed.  USAMRIID officials met with considerable
resistance from some medical personnel responsible for administering
the vaccine about the need to keep proper records.  They told us that
some of the personnel seemed more interested in administering the
vaccine than in keeping necessary records. 

Our work on the Bosnia deployment in 1997 showed that the problems
identified by USAMRIID had not been corrected.  More specifically,
DOD could not account for more than 3,000 (20 percent) of the total
number of doses sent to Bosnia.  Since our report was issued in April
1997, officials from the Office of the Army Surgeon General informed
us that most of the missing doses had been destroyed and only 242
doses remained unaccounted for. 


   CONCLUSIONS
---------------------------------------------------------- Chapter 0:4

In conclusion, we believe that DOD has moved in the right direction
in increasing its emphasis on improving its chemical and biological
defense capabilities.  Increased emphasis by the commanders in chief
in their areas of responsibility, a DOD-wide spending increase
leading to increased numbers of fielded chemical and biological
detection and protective equipment, and planned procurements of
equipment over the next several years will make U.S.  forces better
prepared to deal with chemical and biological weapons than in the
past.  However, greater diligence and more action is needed by DOD to
maintain progress toward achieving a level of protection for our
forces that will enable us to achieve wartime objectives.  This
latest initiative to immunize the forces against anthrax represents a
clear recognition of this threat to U.S.  servicemembers.  But DOD
must overcome past deficiencies in its medical record-keeping
practices and make sure supplies of vaccine are available if this new
program is to be successful.  In this regard, we reiterate that DOD
needs to have the means to (1) identify those servicemembers that
require immunization, (2) ensure sufficient command emphasis to
guarantee that those identified for immunization are immunized, (3)
maintain an accurate medical record of immunizations for each
servicemember, (4) manage large-scale immunizations through accurate
central databases, and (5) ensure that vaccine inventories are
appropriately controlled to ensure that sufficient supplies are on
hand. 


-------------------------------------------------------- Chapter 0:4.1

This concludes my prepared remarks.  We would be happy to respond to
any questions the Committee may have. 

RELATED GAO REPORTS ON CHEMICAL AND BIOLOGICAL DEFENSE

Gulf War Illnesses:  Public and Private Efforts Relating to Exposures
of U.S.  Personnel to Chemical Agents (GAO/NSIAD-98-27, Oct.  15,
1997) . 

Combating Terrorism:  Status of DOD Efforts to Protect Its Forces
Overseas (GAO/NSIAD-97-207, July 21, 1997). 

Gulf War Illnesses:  Improved Monitoring of Clinical Progress and
Reexamination of Research Emphasis Are Needed (GAO/NSIAD-97-163, June
23, 1997). 

Defense Health Care:  Medical Surveillance Improved Since Gulf War,
but Mixed Results in Bosnia (GAO/NSIAD-97-136, May 13, 1997). 

Chemical and Biological Defense:  Emphasis Remains Insufficient to
Resolve Continuing Problems (GAO/NSIAD-96-103, Mar.  29, 1996). 

*** End of document. ***