Combating Terrorism: Accountability Over Medical Supplies Needs
Further Improvement (30-MAR-01, GAO-01-463).
This report follows up on the status of the corrective actions
taken by agencies to address the internal control weaknesses
cited by GAO in October 1999 that could affect the United States'
ability to effectively respond to chemical or biological
terrorist attacks. GAO found that the agencies have significantly
improved accountability over the medical supplies needed to treat
victims of chemical or biological terrorism. However, ensuring
that supplies are current, accounted for and readily available
depends in large part on successful collaboration with other
entities. Until the Centers for Disease Control and Prevention
(CDC) and the Office for Emergency Preparedness (OEP) formalize
ad hoc arrangements with other entities covering the storage,
management, stock rotation and transporting of supplies, they run
the risk that, in the event of a chemical or biological attack,
the appropriate supplies will be unavailable. Also, unless the
agencies' inventory requirements lists are up-to-date and reflect
their own identified needs, the agencies cannot guarantee that
they have the supplies on hand to fulfill their mission.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-01-463
ACCNO: A00706
TITLE: Combating Terrorism: Accountability Over Medical Supplies
Needs Further Improvement
DATE: 03/30/2001
SUBJECT: Accountability
Biological warfare
Chemical warfare
Emergency preparedness
Interagency relations
Internal controls
Inventory control
Medical supplies
Terrorism
CDC National Pharmaceutical Stockpile
Program
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GAO-01-463
Report to the Chairman of the Subcommittee on National Security, Veterans
Affairs and International Relations, Committee on Government
Reform, House of Representatives
March 2001 COMBATING TERRORISM
Accountability Over Medical Supplies Needs Further Improvement
GAO- 01- 463
Letter 3 Appendixes Appendix I: Objective, Scope, and Methodology 30
Appendix II: Comments From the Department of Health and Human Services 32
Appendix III: Comments From the Department of Veterans Affairs 38 Appendix
IV: Comments From the Department of Defense 42 Appendix V: GAO Contact and
Staff Acknowledgments 44
Glossary 46 Related GAO Products
48 (as of November 30, 2000)
Figures Figure 1: U. S. Chemical and Biological Medical Supplies Used to
Combat Terrorism 8
Figure 2: CDC Operations 14
Lett er
March 30, 2001 The Honorable Christopher Shays Chairman Subcommittee on
National Security, Veterans Affairs and International Relations Committee on
Government Reform House of Representatives
Dear Mr. Chairman: This report responds to your request that we follow up on
the status of the corrective actions taken by the responsible agencies to
address the internal control weaknesses and recommendations previously
reported in October 1999 1 that could affect the United States? ability to
effectively respond to
chemical or biological terrorist incidents. This ability is dependent, among
other things, on the plans, methods, and procedures used to ensure that the
medical supplies designated for this purpose are current, accounted for, and
ready for use. The President?s fiscal year 2001 budget proposed spending
about $11.3 billion to combat terrorism. Among the resources the federal
government is devoting to combating chemical and biological terrorism is
funding to develop and maintain a national stockpile 2 of
pharmaceutical and medical supplies that can be used to treat civilian and
military victims of chemical and biological terrorist acts.
1 Combating Terrorism: Chemical and Biological Medical Supplies Are Poorly
Managed (GAO/ HEHS/ AIMD- 00- 36, October 29, 1999). 2 Marine Corps Chemical
Biological Incident Response Force (CBIRF) officials refer to the medical
supplies they maintain as a working stock. To simplify our presentation, we
refer to CBIRF?s medical supplies as a stockpile.
In response to your request, our objective was to follow up on actions taken
to address our recommendations that the Department of Health and Human
Services? (HHS) Office of Emergency Preparedness (OEP) and Centers for
Disease Control and Prevention (CDC), 3 the Department of Veterans Affairs
(VA), 4 and U. S. Marine Corps Chemical Biological Incident Response Force
(CBIRF) establish sufficient systems of internal control over chemical and
biological pharmaceutical and medical supplies by (1) conducting risk
assessments, (2) arranging for periodic, independent inventories of the
stockpiles, (3) implementing a tracking system that retains complete
documentation for all supplies ordered, received, and
destroyed, and (4) rotating stock properly. Results in Brief OEP, VA, CDC,
and CBIRF have made significant progress toward implementing the
recommendations made in our October 1999 report to address identified
internal control weaknesses. Management at each of the responsible agencies
has given priority to and placed emphasis on strengthening internal controls
over the stockpiles. As a result, corrective actions have reduced inventory
discrepancy rates and improved accountability. At the same time, we found
that in all the areas associated with our prior recommendations, additional
steps can be taken to ensure
that pharmaceutical and medical supplies that can be used to treat victims
of chemical and biological terrorist incidents are current, accounted for,
and readily available for use.
3 At the time of our prior review, CDC was in the initial start- up phase of
its National Pharmaceutical Stockpile Program; therefore, we did not assess
its internal controls. However, we made recommendations to CDC, along with
the other responsible agencies, to consider in implementing its program. 4
Under a memorandum of agreement with OEP, VA is responsible for the
purchase, storage, quality control, maintenance, exercise, and contingent
deployment of pharmaceutical and medical supplies. Also, VA is a purchasing
and contracting agent for CDC?s National Pharmaceutical Stockpile Program.
VA does not maintain its own stockpile for use in the event of a terrorist
incident.
Although OEP, VA, CDC, and CBIRF conducted risk assessments since our last
report, we found instances where the risk assessments were not sufficiently
comprehensive or where actions identified to mitigate risks had not yet been
implemented. For example, CDC?s risk assessment did not adequately address
risks specific to the development phase of the National Pharmaceutical
Stockpile Program (NPSP), in which CDC is partnering 5 with various
contractors and subcontractors to manage and store its medical supplies.
Although it placed supplies at five of its six locations, at the end of our
fieldwork CDC had not finalized agreements with its partners covering key
responsibilities. Without such agreements in place,
there is an increased risk that mission critical activities may not be
carried out.
In other instances, actions taken to mitigate risks were not yet fully
implemented. For example, while CDC?s risk assessment identified theft as a
risk, and its handbook specified erecting a fence as a deterrent, stockpiles
were placed at four locations prior to erecting the fences. In another case,
OEP had identified the sensitivity of the medical supplies to extreme
temperatures as a risk that could affect drug stability and potency and had
subsequently installed temperature monitoring devices. However, during one
of our site visits we noted that the monitor registered nine degrees higher
than the maximum temperature recommended by the
manufacturers. In April 2001, OEP plans to replace affected stock and
relocate the stockpile, which constitutes over 20 percent of OEP?s total
stock. In the interim, the affected items may not be effective, should an
incident occur. 5 Partnering, in the context of this report, is the
association of two or more entities in a business relationship.
Each of the responsible agencies has conducted various periodic inventory
counts and, as a result, discrepancies between inventory records and
physical inventories have significantly decreased. However, OEP has not yet
provided to VA, nor has VA developed written guidance stipulating the
frequency of inventory counts or acceptable discrepancy rates. In addition,
we found instances where certain medical supplies on hand at CBIRF fell
short of those specified in the Commanding Officer?s (CO?s) medical
allowance list, which provides an interim baseline for medical supplies
needed. CBIRF does not plan to order additional supplies to conform to this
list, because the Marine Corps System Command (MARCORSYSCOM) has provided a
specific authorized medical allowance list (AMAL), 6 which supercedes the
CO?s list. MARCORSYSCOM is in the process of programming funding and
developing the fielding plan for CBIRF to follow
in adjusting its stock levels to conform to the AMAL. Further, OEP does not
have an updated inventory requirements list to reflect recent changes in the
composition of its stockpile. Unless OEP updates its inventory requirements
list and conducts periodic inventories in the future, OEP will not be able
to determine whether it has the necessary supplies to meet its
mission or identify patterns of shortages, overages, or other discrepancies
and take timely action. Although inventory discrepancy rates have
significantly improved since our prior report, the current inventory
tracking systems used by OEP, VA, CDC,
and CBIRF lack certain fundamental information as previously reported. For
example, the agencies? systems still do not record and track all activity
throughout the life cycle of each product stocked. The agencies are taking
steps to replace their current systems with ones that are capable of
tracking pharmaceutical and medical supplies from the time an order is
placed until the item is consumed or otherwise disposed of. At the
completion of our fieldwork, CDC was reviewing vendor proposals for a new
system. OEP expects to rely on the results of CDC?s review and use the same
system as that selected by CDC. The Marine Corps has developed a new
inventory system, ATLAS II+, that it expects to implement at CBIRF by June
2001.
6 Authorized Medical Allowance List (AMAL) sets the minimum level of medical
supplies to be kept on hand to meet mission needs.
In determining whether OEP, VA, CDC, and CBIRF are properly rotating
pharmaceutical and medical supplies in a timely manner, we inspected the
agencies? inventories and records and found no expired items in OEP?s and
CDC?s stockpiles. This was a marked improvement for OEP, since we had found
expired items in its active inventory in our prior review. For CBIRF, we
identified 161 expired items on hand during our October 2000 inventory
count, but this represented less than 1 percent of its inventory. However,
these expired items included controlled substances such as morphine
sulfate, acetaminophen and codeine phosphate, and midazolam 7 that had
expired but not been replaced. Neglecting to remove and replace expired
items especially controlled substances promptly, increases the risk of an
inadequate supply of effective items being on hand and available for
deployment with CBIRF should a terrorist incident occur.
We are making 13 new recommendations to the responsible agencies to (1)
minimize the risks associated with partnering with private companies and
other entities, (2) improve accountability over pharmaceutical and medical
supplies, and (3) ensure the effectiveness of supplies on hand.
We obtained written comments on a draft of this report from HHS, VA, and the
Department of Defense (DOD). The agencies concurred with the overall
conclusion of the report and 12 of 13 recommendations. HHS did
not agree with our recommendation that CDC install fencing prior to placing
inventories at storage locations. Subsequently, we modified our
recommendation as follows: ?To the extent practical, install proper fencing
prior to placing inventories at storage locations.? In addition, we
clarified the potential impact of certain other issues based on agency
comments. Also, in their comments, the agencies described several actions
that they are taking to strengthen management controls in response to our
recommendations. Background The United States has established a national
policy for combating chemical and biological terrorism and managing the
consequences of terrorist attacks. In the event of a domestic chemical or
biological terrorist incident,
local and state governments would be the first to respond in assisting
civilian victims. If the consequences of such an incident overwhelmed state
and local capabilities, federal assistance could be given to support their 7
See glossary for a definition of pharmaceuticals and medical supplies.
efforts. Critical to that assistance are the chemical and biological medical
supplies maintained by OEP, VA, CDC, and CBIRF. A description of the support
these agencies could provide is described below and depicted in figure 1.
Figure 1: U. S. Chemical and Biological Medical Supplies Used to Combat
Terrorism Source: GAO analysis based on our review of HHS?s and CDC?s
operating plans and CBIRF documents.
If a national emergency has been declared, the Federal Emergency Management
Agency (FEMA) is responsible for managing the support provided by other
federal agencies and coordinating response activities with state and local
authorities. FEMA coordinates the federal response through the Federal
Response Plan and the Terrorism Incident Annex, which establishes a general
concept of operations for the federal response to a terrorist incident.
FEMA, through the Federal Response Plan, has designated HHS as the lead
agency to coordinate medical assistance in the
event of a federally declared natural or man- made disaster, including
chemical or biological terrorist incidents. Within HHS, OEP is responsible
for implementing and coordinating this medical assistance and has, among
other efforts, established four National Medical Response Teams (NMRTs) in
different regions of the country and staffed the teams with specially
trained doctors, nurses, other health care providers, and emergency
personnel whose mission is to decontaminate and/ or treat victims of a
terrorist attack. Under a memorandum of agreement between VA and OEP, VA
maintains a medical stockpile containing antidotes, antibiotics, and
medical supplies for responding to chemical terrorist attacks at locations
near each team. OEP also maintains one smaller stockpile that contains only
antidotes for chemical incidents. This stockpile can be loaned to local
governments or predeployed for special events, such as the Olympic Games.
For the past 26 years, among other duties, CDC has maintained the nation?s
stockpile of the smallpox vaccine. In fiscal year 1999, the Congress
appropriated $51 million to CDC to establish and implement the NPSP. 8 CDC
received an additional $52 million of stockpile funds in each of the
following 2 fiscal years. The program is responsible for establishing a
pharmaceutical and medical stockpile to counter the potential threats to
civilian populations of injury or disease due to chemical or biological
terrorism. Within this charge, the program?s primary focus is on biological
terrorist attacks. Since November 1999, CDC has been building the National
Pharmaceutical Stockpile (NPS), which is comprised of two types of
inventories. The first is a rapid response inventory of pharmaceutical and
medical supplies that can be positioned at any location in the nation
within 12 hours of a federal decision to deploy assets, referred to as
12hour push packages by CDC. The second is a larger stock of supplies that
can be deployed within 24 to 36 hours of notification, and can be tailored
to
address a particular type of incident and augment the rapid response
inventory, referred to as vendor managed inventories. 9 In the event of an
incident, its stock is shipped in bulk and is accompanied by CDC technical
advisors who assist and advise state and local officials in organizing the
bulk stock medications into individual doses and implement plans to
distribute and dispense the medication. VA acts as a purchasing agent for
NPSP medical materiel, providing CDC access to VA?s purchasing experience
and the ability to purchase medical supplies at significant discounts.
CBIRF, created in April 1996 by the Commandant of the Marine Corps, is an
incident response force and maintains a working stock of medical material to
provide emergency medical care and stabilization of injured CBIRF personnel
and a limited number of other casualties. CBIRF is also trained and equipped
to provide for the detection and identification of chemical agents as well
as for casualty extraction and decontamination. Thus, it should be noted
that the purpose of the medical supplies managed by
CBIRF is fundamentally different from that of OEP?s and CDC?s programs in
that CBIRF stocks chemical antidotes and medical supplies in only those
amounts sufficient to treat team members and a limited number of civilian
8 Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999
(P. L. 105277). 9 Vendor managed inventories are carried on the
manufacturers? inventory records as either ?government owned? or ?government
reserved? and may be rotated with the vendor?s normal operating stock in
order to assure freshness.
victims. Accordingly, its stock of antidotes and medical supplies is much
smaller than that of OEP and CDC.
Scope and To determine the status of corrective actions taken to address our
prior Methodology
recommendations, we interviewed responsible agency officials, reviewed
agency documentation, and observed agency operations and facilities at the
OEP, VA, CDC, and CBIRF sites that currently store medical supplies. We also
performed a 100- percent count of the CBIRF medical supplies with CBIRF
assistance and observed and participated in counts of OEP and CDC
medical supplies with OEP, VA, and CDC officials. The scope of our work
spanned from the point that OEP, CDC, and CBIRF identified medical supplies
to be included in their inventories to the point that the medical supplies
would be released from the storage sites in response to a terrorist
incident. Our review did not include an analysis of (1) how these stockpiles
fit into national counterterrorism plans, (2) the concept of operations for
the use of these stockpiles, or (3) whether these stockpiles contain the
appropriate medications. We also did not review management controls over
medical supplies after the point that they would be deployed for a terrorist
incident. These issues are the subject of several recently published GAO
studies. 10 We conducted our review from August 2000 through December 2000
in accordance with generally accepted government auditing standards. See
appendix I for a full description of our objective, scope and methodology.
Agencies Performed In October 1999, we reported that neither OEP, VA, nor
CBIRF had Risk Assessments but
determined the risks that face their stockpiles, assessed the likelihood of
each risk?s occurrence, and established plans to detect or mitigate the
risks. Did Not Recognize or
Since then these agencies have completed risk assessments that identify
Mitigate All Relevant
risks and actions to mitigate those risks. CBIRF not only completed a risk
Risks
assessment, including a physical security analysis, but it also implemented
controls to mitigate risks identified in its assessment. However, for CDC
and OEP we found instances where the risk assessments were not sufficiently
comprehensive or where actions identified to mitigate risks had 10 Combating
Terrorism: Observations on Biological Terrorism and Public Health
Initiatives (GAO/ T- NSIAD- 99- 112, March 16, 1999), Combating Terrorism:
Need for Comprehensive Threat and Risk Assessments of Chemical and
Biological Attacks (GAO/ NSIAD- 99- 163, September 7, 1999), and Combating
Terrorism: Linking Threats to Strategies and Resources (GAO/ T- NSIAD- 00-
218, July 26, 2000).
not been fully implemented. For example, CDC and OEP are partnering with
various federal and commercial entities for the storage, management, and
transporting of their pharmaceutical and medical supplies. As of the
completion of our fieldwork, neither agency had considered all of the risks
posed by delegating key responsibilities to other entities, nor had they
taken all the necessary steps to mitigate those risks.
The federal government?s standards for internal control 11 state that
internal control should provide for an assessment of the risks the agency
faces from both external and internal sources. According to these standards,
agencies should conduct risk assessments to (1) identify all potential
internal and external risks, (2) rank the risks by assessing their
likelihood and their effect on achieving mission objectives, and (3) act to
mitigate those risks. Until each agency develops and fully implements
comprehensive risk assessments and plans for mitigating those risks, each
will have limited
assurance that mission critical activities will be carried out as
contemplated. Risk Assessments Did Not CDC completed a risk/ benefit
assessment in February 2000 that identified Recognize All Risks
and analyzed the significance of the hazards and risks facing the NPS as a
Inherent in Partnering With basis for establishing actions needed to
mitigate those risks. However, CDC Other Entities
did not consider risks that might threaten its mission as a result of
partnering with other entities, especially during the start- up phase of the
program, which began in January 1999 and is still ongoing. In November 1999,
CDC partnered with VA to serve as a purchasing and contracting agent for the
NPSP. The partnership allowed CDC to take advantage of VA?s contracting
experience and purchasing power by having VA purchase supplies at
significant discounts, thereby achieving significant cost savings that could
benefit other areas of the program. VA received
initial funds from CDC and began purchasing materiel for the rapid response
inventory in November 1999.
Once items were purchased, VA configured the supplies to establish eight
rapid response inventories, also referred to as ?push packages.? At the end
of our fieldwork, CDC had placed six of its rapid response inventories at
five of six permanent sites managed by a wholesale distributor or other 11
Internal Control: Standards for Internal Control in the Federal Government
(GAO/ AIMD00-
21.3. 1, November 1999).
external parties, as illustrated in figure 2, prior to obtaining signed
agreements with its proposed partners for the storage, management, and
transporting of stock in the event of an incident. CDC placed three of the
inventories with a wholesale distributor, which CDC anticipates will also
manage the supplies stored at these facilities. Three of the inventories
were placed at two privately owned warehouses. CDC anticipates the wholesale
distributor will manage the stockpiles located at these warehouses. The
remaining two inventories have not been placed at permanent sites, but CDC
expects to place one at a private warehouse, which will be managed
by the wholesale distributor, and the other at a federal facility, which
will be managed by CDC with assistance from a part- time employee at the
site.
Figure 2: CDC Operations
Source: GAO analysis based on the review of CDC?s NPSP Operating Plan.
In November 2000, CDC developed and issued standard operating procedures in
the form of a handbook to the managers of the wholesale distributor, which
is responsible for storing and managing CDC?s supplies stored at its
facilities and managing those stored at the private warehouses. CDC also
issued its handbook to the managers at the private warehouses. There is not,
however, a written agreement between CDC, VA, and the wholesale distributor
that covers all the wholesale distributor?s responsibilities. While the
handbook provides guidance for storing and
managing CDC?s supplies, without written agreements between CDC and its
partners covering key responsibilities, there is a greater risk that those
procedures will not be carried out. In addition, the handbook does not fully
address policies, procedures, and control activities that apply to the
private warehouses that are responsible for storing, but not managing, the
supplies. For example, the handbook does not provide guidelines to the
private warehouses for granting access to the stockpiles for rotation and
management of the stock by the
wholesale distributor or part- time employee at the federal facility.
Likewise, the handbook does not provide an interim plan that addresses
access and security controls or rotation of expiring stock by others.
Without adequate procedures in place to guide control activities, management
cannot be assured that responsibilities are clearly communicated to
warehouse personnel entrusted with NPS materiel,
raising the risk that unauthorized access to the supplies will be gained or
that stock will not be timely and consistently rotated. In addition, while
CDC officials told us that they plan to use private air cargo and land
transport companies to transport the stockpiles in the event of a terrorist
incident, as of the completion of our fieldwork, there were no standard
operating procedures or signed agreements to cover these arrangements.
OEP completed its risk assessment in December 2000. However, it did not
recognize all the risks associated with delegating responsibility for the
storage and management of its stockpiles to VA. Between April and December
2000, OEP and VA jointly drafted both national and local operating plans 12
in accordance with their memorandum of agreement. 12 The OEP/ VA national
plan addresses the responsibilities, concept of operations and procedures
for the procurement, storage, management and deployment of OEP?s stockpiles.
The local plans address key responsibilities of VA personnel as it relates
to each storage site,
for example the amount of space and level of security to be provided and
procedures to be followed for the controlled release of supplies when
federal assistance is requested in response to a chemical or biological
terrorist incident.
However, these plans had not been finalized or approved by OEP as of the end
of our fieldwork. Although the draft local operating plans were provided to
the VA locations storing the stockpiles, security personnel at two of the
locations were unable to provide us with a copy of the draft plan or
associated training materials. In addition, they could not demonstrate that
the plan had been communicated to them and was readily available to use in a
test or an actual terrorist incident.
Actions Identified by CDC For OEP and CDC, we also noted instances where
risks had been and OEP to Mitigate Risks appropriately identified, but plans
for mitigating these risks were not fully Were Not Fully
implemented. For example, CDC?s risk assessment identified physical
Implemented security as a risk, and its handbook specified a number of
actions to mitigate the risks including the use of alarms, video devices,
and chain link
fences of at least 10 feet with lock- secured gates around the NPS
inventory. However, the stockpiles were placed at four locations prior to
erecting fences to segregate the CDC stock from that of the wholesale
distributor or others sharing adjacent warehouse space. Placing the
stockpiles at storage facilities prior to erecting fencing exposes the
supplies to unauthorized access. For up to 3- 1/ 2 months, the supplies were
not segregated by fencing at four of the facilities and management was
unable to limit or control access to the supplies, as prescribed in CDC?s
standard operating procedures.
OEP also prepared a risk assessment that identified the risks to its
program, determined the probability of occurrence, and established plans for
mitigating the risks. However, some plans were not fully implemented by the
end of our fieldwork. For example, one of the risks identified in the
assessment was the sensitivity of the medical supplies to extreme
temperatures that could damage the drug or medical item. According to OEP?s
risk assessment, should this occur, the items affected were to be
replaced. Since our prior study, OEP installed temperature monitoring
devices at each of the locations to monitor temperature minimums and
maximums during the period between site visits. We noted during our site
visit to its central location that the temperature monitoring device at the
facility registered 95 degrees Fahrenheit, and that manufacturers of some
pharmaceuticals stored in this facility warrant their products only if the
items are stored at temperatures not over 86 degrees. While the facility is
heated in the winter, it lacks air conditioning. This facility houses over
20 percent of OEP?s stock of pharmaceutical and medical supplies, most of
which is not refrigerated. Pharmaceuticals subjected to the extreme
temperatures included diazepam, atropine, and ciprofloxacin. There was no
way of knowing how often or for how long the temperature exceeded the
maximum over the summer at this location because these devices cannot
measure the frequency or duration in which appropriate
temperatures for storage of pharmaceuticals were exceeded. Such information
would be necessary to determine whether the subjected pharmaceutical and
medical supplies are at risk of deterioration due to exposure to extreme
temperatures.
Subjecting pharmaceuticals to excessive temperatures can affect the
stability and utility of the items. According to VA?s Handbook, items
exposed to extreme temperatures are to be inspected by qualified VA
personnel, local health officials, or if necessary, the Food and Drug
Administration (FDA). The handbook states that stock confirmed unfit for use
should be dropped from inventory records and physically disposed of as soon
as possible. However, in this case such procedures were not followed.
Rather, OEP officials told us that they planned to relocate the
stockpile to an environmentally controlled facility in April 2001, and
replace the affected goods at that time. In the meantime, these items may
not be effective in the event of a terrorist incident.
In the course of our review, we also found weaknesses in OEP?s physical
security over controlled substances at its central location. During our
November site visit, we noted that the OEP storage cages at this location
did not comply with Drug Enforcement Administration (DEA) regulations for
the storage of controlled substances. The storage cage within the warehouse
facility used to store OEP medical supplies, including controlled
substances, was not equipped with an alarm system which upon unauthorized
entry would transmit a signal to VA security or the local police agency, as
required by DEA regulations. 13 OEP officials told us that they do not plan
to add an alarm system at this location because of their plans to move these
supplies to the new facility in April 2001. They stated
that the new facility will comply with DEA regulations. In the meantime,
inadequate physical safeguards raise the risk that the controlled substances
could be stolen and the theft not promptly detected.
13 21 CFR 1301. 72 (b)( 4)( v), (2000).
Inventory Accuracy We previously reported large discrepancies between data
recorded in
Improved but CBIRF?s and OEP?s inventory systems and physical counts of
their
inventories. In addition, during our prior review, we noted that while OEP
Additional Actions Are
had identified and prepared a list of the minimum pharmaceuticals and Needed
medical supplies needed to carry out its mission (requirements list), CBIRF
had not. In our current review, we noted that while discrepancies still
existed, the accuracy of both CBIRF and OEP inventory records had improved
significantly. However, OEP lacked certain detailed written inventory
procedures necessary to help ensure overall reliability of inventory
records. We also found in our current review that CBIRF had
developed a requirements list; however, it did not have on hand all items
included in the list. Also, OEP had not updated its requirements list for
significant increases to its stockpile. These issues need to be addressed in
order to ensure the readiness of the inventory in the event of a chemical or
biological incident. Since our October 1999 report, CDC has developed an
inventory requirements list and is using the list as a basis for making
inventory purchases to establish the NPS. It has also begun performing
periodic inventory counts, and as of the end of our fieldwork, no unresolved
discrepancies between medical supplies on hand and system data had been
identified.
Periodic Inventories Since our inventory counts of CBIRF?s medical supplies
in 1999, the
Reduced Discrepancy Rates discrepancy rate has declined from 26 percent to
approximately 10 percent. While this is a significant improvement, we found
during our most recent
counts that the inventory system still had inaccurate or incomplete data. We
found discrepancies in quantities, expiration dates, and lot numbers.
Approximately 6.7 percent of the discrepancies we found were quantity
discrepancies and approximately 3. 3 percent were discrepancies in the lot
numbers or expiration dates. It is important to note, however, that no
discrepancies were found between the records for controlled substances and
data from the physical inventory of controlled substances. CBIRF had no
official explanation for the noted variances and identified human error as
the likely cause.
In response to our prior report, VA began performing quarterly inventory
counts on behalf of OEP in April 2000. As a result, the inventory
discrepancy rate declined from approximately 11 percent, as previously
reported, to less than 1 percent in November 2000. In addition to current
inventory items on hand for immediate deployment in response to an incident,
VA was also holding certain expired controlled substances for OEP, pending
approval by FDA to extend the shelf life of these items. As of
December 2000, VA was holding 17,897 expired items for OEP for this purpose.
When we counted these expired items and compared the results to VA?s
inventory records, we found that approximately 5 percent of the expired
items were not listed in the system. DEA regulations require that a complete
and accurate record of all controlled substances on hand shall be maintained
in written form. 14 VA officials told us that they attribute the higher
discrepancy rate for these expired items to less frequent inventory
counts and a lack of periodic reconciliation of system data to what is on
hand.
While OEP?s overall discrepancy rate has significantly improved, it has not
provided, nor has VA established, written guidance stipulating acceptable
discrepancy rates or the frequency of inventory counts. Sustained progress
is dependent upon setting goals against which performance can be
measured and conducting periodic inventories. Without these, OEP will not be
able to measure improvement or determine the reliability of inventory
records. Since CDC is in the process of establishing the NPS, it just
recently began performing quarterly cyclical inventory counts, as well as
quality assurance reviews. From September through November 2000, we observed
and participated in CDC?s quarterly inventory counts at three sites. To
date, no unresolved discrepancies have been identified between the
quantities of supplies recorded in the inventory system and the physical
counts.
Inventory Requirement We previously reported that OEP had a list of
pharmaceutical and medical Levels Were Not Always supplies and quantities
required to meet its mission. In fiscal year 1999,
Provided or Followed OEP authorized the purchase of about $1. 6 million in
chemical antidotes to
increase the total number of victims that could be treated in a chemical
incident from 8,000 to 20, 000. At the end of our fieldwork, OEP had not yet
updated and issued an official inventory requirements list to reflect recent
14 21 CFR 1304. 11, (2000).
increases in its stockpile. As a result, OEP cannot be assured that it has
the right composition and quantity of medical supplies readily available,
and VA has no official baseline for maintaining the requisite materiel on
hand to support OEP?s mission.
In our October 1999 report we also noted that CBIRF did not have an approved
list of what items should be in its inventory. In May 2000, CBIRF
established a CO?s Medical Allowance List. The allowance list, updated in
December 2000, provided an interim baseline for the medical supplies that
CBIRF officials determined were needed to meet the agency?s mission until
the MARCORSYSCOM issued a CBIRF specific AMAL. Subsequently,
CBIRF officials told us that MARCORSYSCOM had approved the AMAL, but it had
not yet provided the funding nor developed the fielding plan for adjusting
the stock to conform to the AMAL as of the end of our fieldwork. When we did
our inventory count in October 2000, we noted that CBIRF did
not have on hand all of the medical supplies included in its May 2000 CO
list. For example, the CO list called for 406 intravenous sets but only 163
were on hand. Also, the CO list called for stocking 394 oropharyngeal
airways, but only 166 were on hand. CBIRF officials told us that they do not
plan to order additional supplies until MARCORSYSCOM provides funding and
develops a fielding plan for CBIRF to follow in adjusting its inventory
of medical supplies, because they want to avoid potentially overstocking
supplies. As such, the CO stated that once the MARCORSYSCOM programs funds
and develops the fielding plan, CBIRF will adjust its physical stock to
conform to the AMAL.
We found that CDC had developed internal guidelines for the composition and
stock levels of medical supplies purchased to establish the NPS,
particularly the rapid response inventory. CDC developed its initial
inventories pursuant to guidance contained in the 1999 HHS Operating Plan
for Bioterrorism Initiative, with input from the NPSP Working Group, which
consisted of external experts in emergency response/ medicine, public
health, pharmacy and logistics management. CDC later established a medical
review panel of internal subject- matter experts in infectious disease,
emergency response/ medicine, public health, medical management and
toxicology, to review, validate and make
recommendations regarding the NPS composition and stock levels on an as
needed basis. We concluded that CDC followed its internal guidelines for
establishing the composition and stock levels of its medical supplies and is
using its requirements list to guide its purchase of supplies for the NPS.
As of the end of our fieldwork, CDC had filled approximately 47 percent of
its rapid response inventory requirement, based on the requirements list.
However, the requirements for the vendor- managed inventory had not been
filled, since CDC had just begun negotiations and contracting with vendors
for this inventory. Current Tracking
We previously reported that the responsible agencies? inventory systems
Systems Do Not did not adequately track inventory items and recommended that
they implement tracking systems that retain complete documentation for all
Record Inventory
supplies that have been ordered, received, and destroyed. The current
Activity Over the Life
inventory systems used by OEP, VA, CDC, and CBIRF still lack certain Cycle
of the Supplies
fundamental information, which impedes their ability to comprehensively
track their pharmaceutical and medical supplies. Maintaining accountability
over inventories requires that the agencies be able to record and track all
activity associated with each product stocked throughout its life cycle.
Such information is needed to monitor activity affecting the stockpiles and
make timely decisions about adjusting the composition and stock levels of
the inventory as well as ordering replacements for expiring supplies. Each
agency is in the process of replacing its current system with one that is
expected to be able to track
medical supplies from the time an order is placed until the item is consumed
or otherwise disposed of. Until these upgrades are complete, information
relating to order, receipt, removal, destruction, and cost of supplies is
not readily available to the responsible agencies. CDC has defined its
requirements for inventory software and recently completed a review of
vendor proposals. CDC?s goal is to have the new system in place by April
2001. CDC?s requirements include the capability to track inventory
throughout each item?s life cycle. Since automated information about the NPS
will be kept on a variety of independent computer systems, CDC recognizes
the need for its system to interface with those of its partners, and to
continually track the overall status, activity, and cost of supplies.
Because OEP?s and CDC?s system needs are similar, OEP expects to rely on the
results of CDC?s review of system capabilities and vendor proposals and use
the same system as that selected by CDC.
The Marine Corps has developed a new inventory management system, the ATLAS
II +, that it expects to implement at CBIRF by June 2001. In response to our
October 1999 report, CBIRF implemented an interim
inventory system in September 2000, which is capable of tracking inventory
quantities, expiration dates and lot numbers, pending transition to the new
system. In addition to these capabilities, CBIRF expects its new system to
be able to report whether items are on order, whether items ordered have
been received, and whether items are pending shelf- life extension or
waiting to be destroyed.
Rotation Policies and We previously reported that the responsible agencies?
inventories included Practices at CBIRF and
items that had expired but not been replaced and recommended that they
properly rotate supplies. For example, we found that OEP had 2,000 amyl CDC
Need nitrite inhalants on hand which had expired 8 months prior to our 1999
Improvement visit. In response to our report, we found that all responsible
agencies have
developed policies and procedures related to rotating stock in their
inventories. However, in some cases, planned approaches were not completely
implemented.
Proper rotation entails replacing pharmaceuticals and medical supplies that
have expired or are close to their expiration dates with current stock.
Agency policies require expired items to be segregated and destroyed,
redistributed, or put into the shelf- life extension program discussed
earlier. If expired items are not appropriately removed and replaced, there
is an increased risk of ineffective items being deployed, an adequate supply
of effective items being unavailable, or contemplated cost savings not being
realized. During our October 2000 counts at CBIRF, we found that 161 expired
pharmaceutical and medical supplies, including 146 controlled substances,
were on hand. Among the expired controlled substances that had not been
replaced were morphine sulfate, acetaminophen and codeine phosphate, and
midazolam. The senior member of the CBIRF controlled substances inventory
board told us that, prior to our October 2000 count, he had
informed the CO that the inventory contained expired controlled substances
and requested the CO?s approval to destroy the items. He subsequently
informed us that CBIRF had destroyed the expired controlled substances on
December 20, 2000. However, as of January 2001, CBIRF had not replaced the
expired items with current stock in sufficient quantities to meet the
minimum stock levels determined by the CO?s medical allowance list.
According to CBIRF officials, a decision on whether to replace these expired
items is pending and will be made once the MARCORSYSCOM
provides program funds and the fielding plan for the CBIRF specific AMAL.
Although CDC?s inventory was too new for any of its items to have expired,
it had not finalized agreements with a private sector partner to implement a
stock rotation method designed to rotate soon- to- expire pharmaceuticals
into the commercial marketplace and replace them with fresh stock.
In December 1999, CDC developed a unique concept for medical materiel
management, termed ?rotation- in- place.? CDC found that given the demand in
the commercial market place for certain pharmaceutical items held by the
program, NPS materiel could be more economically maintained by partnering
with a pharmaceutical wholesale company. Under the partnership arrangement,
the wholesaler could sell certain pharmaceuticals to hospitals and other
customers before the items reached their expiration dates and replace these
items with fresh stock. Thus, it would be unnecessary to hold the CDC stock
until expiration, dispose of it,
and replace the disposed items at full cost. This approach would result in
significant cost savings that could be funneled back into the program. We
were told by CDC officials that the wholesale company requires the items
be returned for redistribution not less than 6 months prior to the
expiration date to allow it to redistribute the supplies to its other
customers with a 6- month minimum shelf life remaining on the items. CDC
adopted a 12 month ?trigger? date to ensure that items will be flagged and
rotated in time to meet the wholesale company?s 6 month requirement.
CDC is continuing to negotiate with the wholesaler to rotate the items. If
an agreement is not finalized so that supplies can be redistributed by June
2001, CDC could lose the opportunity for cost savings for approximately $4.
3 million of CDC?s inventory, which will expire by December 2001. Without
finalized agreements in place, the expiring medical materiel may
have to be replaced at full cost and the expired items destroyed. Conclusion
Since our last report, the responsible agencies have significantly improved
accountability over the medical supplies designated to treat victims of
chemical or biological terrorism. However, ensuring that supplies are
current, accounted for and readily available for use is dependent in large
part on successful collaboration with other entities. Until CDC and OEP
formalize certain ad hoc arrangements with other entities covering the
storage, management, stock rotation and transporting of supplies, they will
face the risk that, should a chemical or biological incident occur, the
appropriate supplies will not be available when needed. Also, unless the
agencies? inventory requirements lists are up- to- date and reflective of
their own identified needs, the agencies are limited in assuring that they
have the
supplies needed to fulfill their mission.
Recommendations for To minimize risks associated with partnering with
private- sector
Executive Action companies and other entities in managing the National
Pharmaceutical Stockpile, we recommend that the Secretary of Health and
Human Services require the Director of the Centers for Disease Control and
Prevention to
execute written agreements as soon as possible with all CDC?s partners
covering the storage, management, stock rotation and transporting of medical
supplies designated for treatment of biological or chemical terrorism
victims; issue written guidance on security to private warehouses that
store stockpiles, on such issues as granting access to the wholesale
distributor for stock rotation; and to the extent practical, install
proper fencing prior to placing inventories at storage locations.
To improve accountability over medical supplies in its inventory, we
recommend that the Secretary of Health and Human Services require the
Director of the Office of Emergency Preparedness to finalize, approve, and
issue an inventory requirements list; improve physical security at its
central location to comply with DEA
regulations, or move the supplies as soon as possible to a location that
meets these requirements; issue a written policy on the frequency of
inventory counts and
acceptable discrepancy rates; finalize and implement approved national and
local operating plans addressing VA?s responsibilities for the procurement,
storage,
management, and deployment of OEP?s stockpiles; and train VA personnel and
conduct periodic quality control reviews to
ensure that national and local operating plans are followed. To ensure the
effectiveness of medical supplies in its inventory, we recommend that the
Secretary of Health and Human Services require the Director of the Office of
Emergency Preparedness to
immediately contact FDA or the pharmaceutical and medical supply
manufacturers of items stored at its central location to determine the
impact of items exposed to extreme temperatures; replace those items
deemed no longer usable; and either add environmental controls to the
current location or move the
supplies as soon as possible to a climate controlled space.
To ensure that medical supplies on hand reflect those identified as being
needed to respond to a chemical or biological terrorism incident, we
recommend that the Marine Corps Systems Command program funding and complete
the fielding plan for the CBIRF specific authorized medical allowance list
and that the Commandant of the Marine Corps require the
Commanding Officer of the Chemical Biological Incident Response Force to
adjust its stock levels to conform with the authorized medical allowance
list and remove expired items from its stock and replace them with current
pharmaceutical and medical supplies. Agency Comments We obtained written
comments on a draft of this report from the
Departments of Health and Human Services, Veterans Affairs, and Defense. The
agencies concurred with the overall conclusion of the report and 12 of 13
recommendations. However, in several instances where they concurred with the
recommendations, they took exception to the related risk that we noted. The
individual agencies? responses related to the 13 recommendations are
summarized below, and are reprinted in their
entirety in appendixes II through IV. HHS concurred with our recommendation
that CDC finalize written agreements with its partners covering the storage,
management, stock rotation and transporting of medical supplies. In its
response, HHS stated that CDC has accelerated the establishment of final
contractual agreements and standard operating procedures for each of its
NPSP partners and, since
the end of our fieldwork, has finalized some of those agreements. However,
HHS did not agree that mission critical activities could be compromised by
not having written agreements in place. HHS explained that it proceeded with
the placement of the 12- hour push packages prior to executing final
agreements in order to make the NPSP response available as soon as it was
technically feasible. The NPSP is relying on existing contractual agreements
between VA and its commercial partners while it finalizes agreements with
these same partners. While these existing agreements are designed to address
VA?s hospital supply needs, they do not address key
responsibilities, requirements, and control activities specific to the NPSP.
We recognize the need to position the stockpiles for rapid deployment as
soon as possible. However, we continue to believe that without final written
agreements specifying key responsibilities of all parties, mission
critical activities may not be carried out as contemplated.
HHS also concurred with our recommendation that CDC issue written guidance
on security to private warehouses that store stockpiles, covering such
issues as granting access to the wholesale distributor for stock rotation.
HHS noted that it is in the process of updating its existing standard
operating procedures to include information regarding controlled access to
the NPSP inventory, key responsibilities for stock rotation, and guidelines
for rotation of stock. However, HHS did not agree that the lack of such
guidance increased the risk of unauthorized entry or failure to rotate
inventory in a consistent and timely manner, because the private warehouses
have their own security procedures in place. While we did not find any
evidence that the integrity of the stockpiles had been
compromised, or that stock rotations did not occur in a timely manner, we
believe that written guidance is essential to reducing the risk of
misunderstandings between CDC and its partners regarding security and
rotation requirements. The actions HHS described that CDC is currently
taking should address the risks noted in our report by ensuring that
security and other procedures specific to the NPSP are carried out. HHS did
not concur with our recommendation that CDC install fencing prior to placing
inventories at storage locations, because it believes that there was no risk
of theft during the initial months of the 12- hour push package placements.
CDC stated that it did not intend for the installation of fencing to be a
theft deterrent, but rather to serve as means of segregating
CDC supplies from assets belonging to others sharing adjacent storage space.
The NPSP standard operating procedures highlight the importance of
protecting and securing the pharmaceutical supplies by requiring that access
to the assets be limited by chain link fencing and lock- secured gates.
Further, the operating procedures state that the storage facility must (1)
specify the employees who can access the area, (2) have a system for
identifying employees with access to the assets, (3) have a process in place
to ensure that only those specified employees gain access to the area, and
(4) enforce its rules of access with rigor. While we agree that the storage
facilities have their own security procedures in place, we continue to
believe that fencing provides the added benefit of limiting access to only
authorized individuals. However, we agree that theft is not the primary
risk, and we have modified our recommendation as follows, ?To the extent
practical, install proper fencing prior to placing inventories at storage
locations.?
HHS agreed with all six of our recommendations regarding improving
accountability over OEP?s medical supplies and ensuring their effectiveness.
In its response, HHS described several actions it had taken to
address our recommendations as follows. OEP approved an updated inventory
requirements list on February 27, 2001. Further, national and local
operating plans were approved and are being transmitted to VA. Also, OEP has
taken steps to provide training to VA personnel and has conducted periodic
quality control reviews. OEP has assessed the pharmaceuticals at
the central location and, based on its findings, will continue to store them
at this site until the supplies are moved to a new location in April. At
that time, all temperature sensitive items will be replaced. In addition,
OEP has directed VA to conduct a physical inventory of supplies stored at
each
location annually. While we did not provide OEP with a suggested tolerable
inventory discrepancy rate, as noted in its response, we commend OEP for
establishing a zero tolerable error rate for controlled substances and a 3-
to 5- percent error rate for other items. Although we did not address
recommendations to VA in this report, the
department provided comments detailing actions that it is taking in support
of the NPSP and the management of OEP?s inventory of medical supplies used
to combat terrorism. VA acknowledges OEP?s new inventory
requirements list and will adjust the inventories to comply with that list
in June 2001. Also, VA will augment OEP?s final operating plans with
sitespecific plans and will assist OEP in scheduling staff to receive
related training.
DOD generally concurred with both of our recommendations to adjust its stock
levels to conform to the CBIRF specific authorized medical allowance list
and to remove expired items from stock and replace them with current
pharmaceutical and medical supplies. The Marine Corps is in the process of
programming funding and ordering supplies to augment CBIRF?s existing
inventory of medical supplies to conform to the AMAL. Further, CBIRF will
segregate expired materiel from serviceable stock and will dispose of
expired materiel not included in the DOD/ FDA shelf- life extension program.
DOD also emphasized the fundamental differences between the purpose of its
medical supplies and those of CDC and OEP. In
response, we added further clarification to the background section of our
report.
As we agreed with your office, unless you publicly announce the contents of
this report earlier, we will not distribute it until 30 days after its date.
At that time, we will send copies to the Honorable Dennis J. Kucinich,
Ranking Minority Member of your Subcommittee; Senator Fred Thompson,
Chairman, and Senator Joseph I. Lieberman, Ranking Member, Senate
Governmental Affairs Committee; Representative Dan Burton, Chairman, and
Representative Henry A. Waxman, Ranking Minority Member, House Governmental
Reform Committee; the Honorable Donald H. Rumsfeld, Secretary of Defense;
the Honorable Tommy Thompson, Secretary of Health and Human Services; the
Honorable Anthony J. Principi, Secretary of Veterans Affairs; the Honorable
Mitchell E. Daniels, Jr., Director of the
Office of Management and Budget; and other interested parties. We will also
make copies available to others upon request. Please contact me at (202)
512- 9508 or Alana Stanfield, Assistant Director, at (202) 512- 3197 or by
e- mail at calboml@ gao. gov or stanfielda@ gao. gov if you have any
questions. Other major contributors to this report are listed in appendix V.
Sincerely yours,
Linda M. Calbom Director, Financial Management and Assurance
Appendi Appendi xes x I
Objective, Scope, and Methodology Our objective was to determine the status
of the corrective actions that OEP, VA, CDC, and CBIRF had taken to address
our prior recommendations for improving management controls over medical
supplies designated to treat victims of chemical and biological terrorism.
To determine whether these agencies had conducted risk assessments and
organized program activities to mitigate risks, we obtained and reviewed
each agency?s risk assessment to determine its congruency with mission
objectives as well as any actual or planned control activities to mitigate
identified risks. To determine whether the agencies had arranged for
periodic inventories,
we (1) held discussions with agency officials to understand their inventory
methodologies, (2) reviewed policies, procedures, and actions implemented to
perform periodic independent inventories, (3) examined evidence that
agencies had performed periodic inventories, and (4) assessed agencies?
follow- up actions for adequacy.
To assess the accuracy and currency of recorded medical supply data, we
performed a 100- percent count of the CBIRF medical supplies with CBIRF
assistance and observed and participated in counts of the CDC and OEP
medical supplies with CDC, OEP, and VA officials. We then compared the count
results to inventory system data to identify discrepancies in recorded
quantities, expiration dates, and lot numbers. We calculated the discrepancy
rate by dividing the number of discrepancies we found by the total number of
recorded on- hand medical supply items.
Where available, we also compared on- hand pharmaceutical and medical
supplies to management?s inventory requirements lists to determine whether
agencies had the recommended and approved type and quantity of supplies on-
hand to effectively carry out their missions.
To determine whether agencies had implemented inventory tracking systems
that retained complete documentation over the life cycle of the medical
supplies, we interviewed agency officials to understand their current
inventory tracking systems? capability to record, monitor, and account for
on- hand medical supplies, and observed the systems? output data. We also
gained an understanding of the current inventory- tracking
systems? general controls and assessed them for adequacy. To determine
whether agencies had acted to properly replace expired or about to expire
items with current stock (rotate supplies), we
(1) interviewed agency officials, (2) reviewed policies and procedures for
rotating supplies, (3) assessed agencies? inventory tracking systems?
capability to track medical supplies through their life cycle, (4) observed
rotations at OEP sites, and (5) analyzed inventory reports to determine
whether expired items had been timely rotated or scheduled for rotation. We
also reviewed management controls for expired controlled substances that are
being held in storage at VA, pending FDA approval of OEP?s shelf life
extension program, including performing a 100- percent count of controlled
substances on hand and reconciliation with system data.
To determine the additional actions OEP, VA, CDC, and CBIRF need to take to
enhance their management controls, we gained an understanding of current
management controls via inquiries, observations, and inspections
and compared them to the criteria in our Standards for Internal Control in
the Federal Government (GAO/ AIMD- 00- 21.3. 1, November 1999) and Internal
Control Management and Evaluation Tool (GAO/ AIMD Exposure Draft, October
2000). We also considered criteria in the Office of Management and Budget
Circular A- 123, Management Accountability and
Control, revised June 21, 1995; 31 U. S. C. 3512 (the Federal Managers?
Financial Integrity Act of 1982); and the Federal Financial Management
Systems Requirements of the Joint Financial Management Improvement Program.
As part of our work, we also reviewed certain presidential directives and
the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, as amended, to determine U. S. policy on chemical and
biological terrorism.
The scope of our review did not include an analysis of (1) how these
stockpiles fit into national counterterrorism plans, (2) the concept of
operations for the use of these stockpiles, or (3) whether these stockpiles
contain the appropriate medications. We did not examine the stockpiles and
inventories held by U. S. military forces and managed by the Defense
Logistics Agency for military purposes. We also excluded from our review
controls over stockpiles that are maintained by Metropolitan Response System
Teams in several U. S. cities for chemical and biological terrorist
incidents. We did not review controls over the inventory of smallpox
vaccine, since no weaknesses were identified in our prior report. We
conducted our review from August 2000 through December 2000 in accordance
with generally accepted government auditing standards.
Comments From the Department of Health Appendi x II and Human Services
Comments From the Department of Veterans
Appendi x II I Affairs
Appendi x V I Comments From the Department of Defense
Appendi x V
GAO Contact and Staff Acknowledgments GAO Contact Linda M. Calbom, (202)
512- 9508 Acknowledgments In addition to the contact named above Louise
Beck, Cary Chappell, David
Grindstaff, Bronwyn Hughes, Charles Norfleet, Alana Stanfield, McCoy
Williams, and Maria Zacharias made key contributions to this report.
Glossary Acetaminophen and
An over the counter pain reliever and fever reducer combined with a Codeine
Phosphate
narcotic analgesic used to treat moderate to severe pain. 1 Amyl nitrite An
inhalation drug that is used as an antidote for cyanide poisoning. It is
also a common recreational stimulant known as a popper. Atropine A cardiac
drug that is also used to reverse the effects of organophosphate poisoning.
Ciprofloxacin A drug, also known as Cipro, that is used to treat infections,
including anthrax. Controlled Substance A substance that has a high
potential for abuse, as classified by the
Controlled Substances Act, title II of the Comprehensive Drug Abuse
Prevention and Control Act of 1970.
Diazepam A drug that is used to treat the symptoms of anxiety, convulsions,
and muscle spasms. Its brand name is Valium.
Midazolam A drug used to produce sleepiness or drowsiness and to relieve
anxiety before surgery or certain procedures. It is also used to produce
loss of consciousness before and during surgery. Morphine Sulfate A drug in
the class of narcotic analgesics used to treat moderate to severe
pain. 1 The pharmaceuticals listed here may have alternative uses in a
chemical or biological incident. We have described their primary purpose.
Oropharyngeal Airway A device that is inserted into an unobstructed pharynx
through the mouth to provide an airway.
Related GAO Products (as of November 30, 2000)
Combating Terrorism: Federal Response Teams Provide Varied Capabilities;
Opportunities Remain to Improve Coordination (GAO- 01- 14, November 30,
2000). West Nile Virus Outbreak: Lessons for Public Health Preparedness
(GAO/ HEHS- 00- 180, September 11, 2000). Combating Terrorism: Linking
Threats to Strategies and Resources (GAO/ TNSIAD- 00- 218, July 26, 2000).
Combating Terrorism: Comments on Bill H. R. 4210 to Manage Selected
Counterterrorist Programs (GAO/ T- NSIAD- 00- 172, May 4, 2000).
Combating Terrorism: How Five Foreign Countries Are Organized to Combat
Terrorism (GAO/ NSIAD- 00- 85, April 7, 2000).
Combating Terrorism: Issues in Managing Counterterrorist Programs (GAO/ T-
NSIAD- 00- 145, April 6, 2000). Combating Terrorism: Chemical and Biological
Medical Supplies Are Poorly Managed (GAO/ T- HEHS/ AIMD- 00- 59, March 8,
2000).
Combating Terrorism: Chemical and Biological Medical Supplies are Poorly
Managed (GAO/ HEHS/ AIMD- 00- 36, October 29, 1999). Combating Terrorism:
Observations on the Threat of Chemical and Biological Terrorism (GAO/ T-
NSIAD- 00- 50, October 20, 1999). Combating Terrorism: Need for
Comprehensive Threat and Risk Assessments of Chemical and Biological Attack
(GAO/ NSIAD- 99- 163, September 7, 1999).
Combating Terrorism: Observations on Growth in Federal Programs (GAO/ T-
NSIAD- 99- 181, June 9, 1999). Combating Terrorism: Use of National Guard
Response Teams Is Unclear (GAO/ NSIAD- 99- 110, May 21, 1999). Combating
Terrorism: Issues to Be Resolved to Improve Counterterrorist Operations
(GAO/ NSIAD- 99- 135, May 13, 1999).
Combating Terrorism: Observations on Biological Terrorism and Public Health
Initiatives (GAO/ T- NSIAD- 99- 112, March 16, 1999).
Combating Terrorism: Observations on Federal Spending to Combat Terr or i sm
(GAO/ T- NSIAD/ GGD- 99- 107, March 11, 1999). Combating Terrorism:
Opportunities to Improve Domestic Preparedness Program Focus and Efficiency
(GAO/ NSIAD- 99- 3, November 12, 1998). Combating Terrorism: Observations on
Crosscutting Issues (GAO/ T- NSIAD98- 164, April 23, 1998).
Combating Terrorism: Threat and Risk Assessments Can Help Prioritize and
Target Program Investments (GAO/ NSIAD- 98- 74, April 9, 1998).
Combating Terrorism: Spending on Governmentwide Programs Requires Better
Management and Coordination (GAO/ NSIAD- 98- 39, December 1, 1997).
Combating Terrorism: Federal Agencies? Efforts to Implement National Policy
and Strategy (GAO/ NSIAD- 97- 254, September 26, 1997).
(916371) Lett er
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Appendix I
Appendix I Objective, Scope, and Methodology
Page 31 GAO- 01- 463 Combating Terrorism
Page 32 GAO- 01- 463 Combating Terrorism
Appendix II
Appendix II Comments From the Department of Health and Human Services
Page 33 GAO- 01- 463 Combating Terrorism
Appendix II Comments From the Department of Health and Human Services
Page 34 GAO- 01- 463 Combating Terrorism
Appendix II Comments From the Department of Health and Human Services
Page 35 GAO- 01- 463 Combating Terrorism
Appendix II Comments From the Department of Health and Human Services
Page 36 GAO- 01- 463 Combating Terrorism
Appendix II Comments From the Department of Health and Human Services
Page 37 GAO- 01- 463 Combating Terrorism
Page 38 GAO- 01- 463 Combating Terrorism
Appendix III
Appendix III Comments From the Department of Veterans Affairs
Page 39 GAO- 01- 463 Combating Terrorism
Appendix III Comments From the Department of Veterans Affairs
Page 40 GAO- 01- 463 Combating Terrorism
Appendix III Comments From the Department of Veterans Affairs
Page 41 GAO- 01- 463 Combating Terrorism
Page 42 GAO- 01- 463 Combating Terrorism
Appendix IV
Appendix IV Comments From the Department of Defense
Page 43 GAO- 01- 463 Combating Terrorism
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Appendix V
Appendix V GAO Contact and Staff Acknowledgments
Page 45 GAO- 01- 463 Combating Terrorism
Page 46 GAO- 01- 463 Combating Terrorism
Glossary Page 47 GAO- 01- 463 Combating Terrorism
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Related GAO Products (as of November 30, 2000) Page 49 GAO- 01- 463
Combating Terrorism
United States General Accounting Office Washington, D. C. 20548- 0001
Official Business Penalty for Private Use $300
Address Correction Requested Presorted Standard
Postage & Fees Paid GAO Permit No. GI00
*** End of document ***
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