Public Health and Border Security
HHS and DHS Should Further Strengthen Their Ability to Respond to TB Incidents Gao ID: GAO-09-58 October 14, 2008In spring 2007, the Department of Health and Human Services (HHS), the Department of Homeland Security (DHS), and state and local health officials worked together to interdict two individuals with drug-resistant infectious tuberculosis (TB) from crossing U.S. borders and direct them to treatment. Concerns arose that HHS's and DHS's responses to the incidents were delayed and ineffective. GAO was asked to examine (1) the factors that affected HHS's and DHS's responses to the incidents, (2) the extent to which HHS and DHS made changes to response procedures as a result of the incidents, and (3) HHS's and DHS's efforts to assess the effectiveness of changes made as a result of the incidents. GAO reviewed agency documents and interviewed officials about the procedures in place at the time of the incidents and changes made since.
Various factors--a lack of comprehensive procedures for information sharing and coordination and border inspection shortfalls--hindered the federal response to the two TB incidents. GAO's past work and federal internal control standards call for collaborative communication and coordination across agencies; communication flowing down, across, and up agencies to help managers carry out their internal control responsibilities; and effective leadership, capabilities, and accountability to ensure effective preparedness and response to hazardous situations. HHS and DHS finalized a memorandum of understanding in October 2005 intended to promote communication and coordination in response to public health incidents, but they had not fully developed operational procedures to share information and coordinate their efforts. Thus, HHS and DHS lost time locating or identifying the individuals to interdict them at the U.S. border. Also, HHS lacked procedures to coordinate with state and local health officials to determine when to use federal isolation and quarantine authorities, which further contributed to the delay in the federal response to one of the incidents. Finally, DHS had deficiencies in its process for inspecting individuals at the border, which caused delays in locating the individuals with TB. HHS and DHS have subsequently implemented procedures and tools intended to address deficiencies identified by the incidents, consistent with GAO's past work and internal control standards, but the departments could take additional steps to enhance their ability to respond to future TB incidents. Since the 2007 incidents, HHS and DHS have developed formal procedures for HHS to request DHS's assistance, and DHS has (1) developed a watch list for airlines to identify individuals with TB and other infectious diseases who are to be stopped from traveling and (2) revised its border inspection process to include a requirement that individuals with TB identified by HHS be subject to further inspection. DHS has also enhanced its process for creating public health alerts based on some variations of biographic information (e.g., name, date of birth, or travel document information), but has not explored the benefits of creating these alerts based on other variations, which impeded DHS's ability to interdict one of the individuals at the border. In addition, HHS has not yet completed efforts to provide information on changes in procedures to state and local health officials, who typically originate requests for assistance, to help mitigate delays in accessing federal assistance. HHS and DHS identified additional actions that need to be taken to further strengthen their response, but have not developed plans for completing them. HHS and DHS have activities under way to assess the effectiveness of the new procedures and tools, including performance monitoring and cross-agency meetings to discuss and revise the new procedures and tools based on actual experiences. HHS and DHS have coordinated on more than 70 requests for assistance since the 2007 incidents through February 2008; officials said they view each incident as a test of the efficacy of their responses.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-09-58, Public Health and Border Security: HHS and DHS Should Further Strengthen Their Ability to Respond to TB Incidents
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
October 2008:
Public Health and Border Security:
HHS and DHS Should Further Strengthen Their Ability to Respond to TB
Incidents:
Tuberculosis Public Health Incidents:
GAO-09-58:
GAO Highlights:
Highlights of GAO-09-58, a report to congressional requesters.
Why GAO Did This Study:
In spring 2007, the Department of Health and Human Services (HHS), the
Department of Homeland Security (DHS), and state and local health
officials worked together to interdict two individuals with drug-
resistant infectious tuberculosis (TB) from crossing U.S. borders and
direct them to treatment. Concerns arose that HHS‘s and DHS‘s responses
to the incidents were delayed and ineffective. GAO was asked to examine
(1) the factors that affected HHS‘s and DHS‘s responses to the
incidents, (2) the extent to which HHS and DHS made changes to response
procedures as a result of the incidents, and (3) HHS‘s and DHS‘s
efforts to assess the effectiveness of changes made as a result of the
incidents. GAO reviewed agency documents and interviewed officials
about the procedures in place at the time of the incidents and changes
made since.
What GAO Found:
Various factors”a lack of comprehensive procedures for information
sharing and coordination and border inspection shortfalls”hindered the
federal response to the two TB incidents. GAO‘s past work and federal
internal control standards call for collaborative communication and
coordination across agencies; communication flowing down, across, and
up agencies to help managers carry out their internal control
responsibilities; and effective leadership, capabilities, and
accountability to ensure effective preparedness and response to
hazardous situations. HHS and DHS finalized a memorandum of
understanding in October 2005 intended to promote communication and
coordination in response to public health incidents, but they had not
fully developed operational procedures to share information and
coordinate their efforts. Thus, HHS and DHS lost time locating or
identifying the individuals to interdict them at the U.S. border. Also,
HHS lacked procedures to coordinate with state and local health
officials to determine when to use federal isolation and quarantine
authorities, which further contributed to the delay in the federal
response to one of the incidents. Finally, DHS had deficiencies in its
process for inspecting individuals at the border, which caused delays
in locating the individuals with TB.
HHS and DHS have subsequently implemented procedures and tools intended
to address deficiencies identified by the incidents, consistent with
GAO‘s past work and internal control standards, but the departments
could take additional steps to enhance their ability to respond to
future TB incidents. Since the 2007 incidents, HHS and DHS have
developed formal procedures for HHS to request DHS‘s assistance, and
DHS has (1) developed a watch list for airlines to identify individuals
with TB and other infectious diseases who are to be stopped from
traveling and (2) revised its border inspection process to include a
requirement that individuals with TB identified by HHS be subject to
further inspection. DHS has also enhanced its process for creating
public health alerts based on some variations of biographic information
(e.g., name, date of birth, or travel document information), but has
not explored the benefits of creating these alerts based on other
variations, which impeded DHS‘s ability to interdict one of the
individuals at the border. In addition, HHS has not yet completed
efforts to provide information on changes in procedures to state and
local health officials, who typically originate requests for
assistance, to help mitigate delays in accessing federal assistance.
HHS and DHS identified additional actions that need to be taken to
further strengthen their response, but have not developed plans for
completing them.
HHS and DHS have activities under way to assess the effectiveness of
the new procedures and tools, including performance monitoring and
cross-agency meetings to discuss and revise the new procedures and
tools based on actual experiences. HHS and DHS have coordinated on more
than 70 requests for assistance since the 2007 incidents through
February 2008; officials said they view each incident as a test of the
efficacy of their responses.
What GAO Recommends:
GAO recommends that DHS explore the feasibility of enhancing its
capability to create public health alerts based on other variations of
biographic information, and that HHS and DHS work together to continue
to inform state and local health officials about new tools and
procedures and develop plans for completing actions to ensure
coordination among agencies.
HHS and DHS generally concurred with GAO‘s recommendations and are
taking actions to respond to them.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-09-58]. For more
information, contact Cynthia A. Bascetta at (202) 512-7114 or
bascettac@gao.gov or Eileen R. Larence at (202) 512-6510 or
larencee@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
HHS's and DHS's Lack of Comprehensive Procedures for Information
Sharing and Coordination and CBP Inspection Deficiencies Hindered the
Response to the TB Incidents:
HHS and DHS Implemented Procedures and Tools to Address Response
Deficiencies, but Could Take Further Steps to Complete Actions
Identified as a Result of the 2007 TB Incidents:
HHS and DHS Have Activities Under Way to Assess Their Ability to
Respond to TB Incidents:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: CBP Traveler Inspection Procedures at Air and Land Ports of
Entry:
Appendix II: Comments from the Department of Health and Human Services:
Appendix III: Comments from the Department of Homeland Security:
Appendix IV: GAO Contacts and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Step-by-Step Procedures for HHS to Request Assistance from
DHS:
Table 2: HHS Requests for Assistance regarding Individuals with TB
Disease Submitted to DHS from May 2007 through February 2008:
Figures:
Figure 1: Characteristics of TB:
Figure 2: Description of TB Incident Involving the U.S. Citizen,
January through May 2007:
Figure 3: Description of TB Incident Involving Mexican Citizen, April
through May 2007:
Figure 4: Information Flow for HHS Requests for DHS Assistance:
Figure 5: Border Crossings at Ports of Entry in Fiscal Year 2005:
Abbreviations:
CBP: U.S. Customs and Border Protection:
CDC: Centers for Disease Control and Prevention:
DEOC: Director's Emergency Operations Center:
DGMQ: Division of Global Migration and Quarantine:
DHS: Department of Homeland Security:
FMFIA: Federal Managers' Financial Integrity Act of 1982:
HHS: Department of Health and Human Services:
HIPAA: Health Insurance Portability and Accountability Act of 1996:
NOC: National Operations Center:
OHA: Office of Health Affairs:
SARS: severe acute respiratory syndrome:
SOC: Secretary's Operations Center:
TB: tuberculosis:
TECS: Treasury Enforcement Communications System:
TSA: Transportation Security Administration:
WHTI: Western Hemisphere Travel Initiative:
United States Government Accountability Office:
Washington, DC 20548:
October 14, 2008:
The Honorable Joseph I. Lieberman:
Chairman:
The Honorable Susan M. Collins:
Ranking Member:
Committee on Homeland Security and Governmental Affairs:
United States Senate:
The Honorable Charles E. Grassley:
Ranking Member:
Committee on Finance:
United States Senate:
The Honorable Hillary Rodham Clinton:
United States Senate:
This report is a publicly available version of our report regarding
Department of Health and Human Services (HHS) and Department of
Homeland Security (DHS) attempts to interdict two individuals with drug-
resistant tuberculosis (TB) disease at the border so that they could
direct them to treatment. Our original report was designated law
enforcement sensitive because, according to DHS, it contained specific
information of a sensitive nature.
An estimated 2 billion people--one-third of the world's population--are
infected with Mycobacterium (M.) tuberculosis, the bacterium that
causes TB, approximately 9 million of whom have transmissible TB
disease.[Footnote 1] In 2007, more than 13,000 cases of TB disease were
reported in the United States.[Footnote 2] Without proper treatment, TB
can be fatal. Moreover, health officials are concerned that the number
of individuals who have TB that is resistant to many of the most
effective medications is increasing worldwide and these individuals
have fewer options for effective treatment. While the total number of
individuals with drug-resistant TB in the United States is relatively
small (116 cases of multiple-drug-resistant TB were reported in 2006,
the most recent year for which such data are available), these cases
require significant human and financial resources to provide care and
treatment. An individual case of drug-resistant TB can cost an average
of $500,000 for in-patient hospital services alone. Because drug-
resistant TB can develop when a patient is nonadherent--unwilling or
unable to follow a treatment regimen--state and local health
departments and federal agencies have a responsibility to work together
to help ensure adherence as part of their effort to prevent the spread
of TB in the United States.
In general, physicians and local health departments have the primary
responsibility for managing day-to-day care and treatment of
individuals with TB. State and local health departments are responsible
for reporting cases of TB to HHS. In addition to monitoring the
occurrence of disease in the United States, HHS has overall federal
responsibility for preventing the introduction of communicable
diseases, such as TB, from foreign countries.[Footnote 3] In so doing,
HHS is to work with DHS, which is responsible for reducing the threat
of terrorism and natural crises, including bioterrorism. By statute,
U.S. customs officers are to assist in the enforcement of quarantine
rules and regulations.[Footnote 4] In October 2005, HHS and DHS signed
a memorandum of understanding intended to create a broad agreement for
the departments to share information and work together during public
health incidents.
In the spring of 2007, HHS requested DHS's assistance in attempting to
interdict at the border two individuals with drug-resistant TB disease
so that they could direct them to treatment. According to HHS
documents, in May 2007, one of these individuals, a U.S. citizen,
traveled abroad against advice from physicians. When state and local
health officials were unable to find this person and serve him with a
written order not to travel, they requested help from HHS. While he was
traveling abroad, HHS located him and attempted to direct him to
treatment. HHS then contacted DHS for assistance. However, while HHS
and DHS were determining a course of action to attempt to prevent him
from traveling further by airplane, he once again traveled.
Furthermore, as the departments were working to intercept him at the
U.S. border, he was able to reenter the country because a U.S. Customs
and Border Protection (CBP) officer, in violation of CBP policy,
ignored a computerized alert in CBP's border screening and inspection
system to detain him. In a separate incident, a Mexican citizen with
drug-resistant TB who had a prior history of nonadherence to treatment
crossed the U.S.-Mexico border approximately 20 times during April and
May 2007. HHS and DHS worked together to try to prevent him from
crossing the border, but attempts to identify him in DHS databases
failed on several occasions. According to HHS officials, both
individuals were eventually located and received treatment, and none of
the people who might have been in contact with these individuals were
reported to have contracted TB.
Both TB incidents required a coordinated federal response--mainly from
HHS's Centers for Disease Control and Prevention (CDC) and DHS's
Transportation Security Administration (TSA) and CBP--in order to
locate the individuals and conduct activities to protect their health
and the health of the public. However, HHS was unable to deter the
travel of these individuals and DHS was initially unable to interdict
them at the border. You raised questions concerning HHS's and DHS's
responses to the TB incidents. Because of these questions, we examined:
(1) What factors affected HHS's and DHS's responses to the two TB
incidents? (2) To what extent have HHS and DHS made changes to response
procedures as a result of the TB incidents? (3) What are HHS and DHS
doing to assess the effectiveness of any operational changes they have
made in response to the TB incidents?
To determine what factors affected HHS's and DHS's responses to the two
TB incidents, we reviewed the policies and procedures each had in place
at the time of the incidents for conducting a coordinated response to a
public health incident, as well as laws and regulations. We interviewed
headquarters officials at HHS, CDC, DHS, CBP, and TSA about their
responses. In addition, we visited a land port of entry that was
involved in one of the incidents--the Bridge of the Americas in El
Paso, Texas--and an air port of entry--Dulles International Airport
outside of Washington, D.C.--to obtain additional information about the
procedures in place at the time of the incidents.[Footnote 5] We
examined whether the existing procedures for information sharing
between HHS and DHS provided for timely response to the incidents--that
is, whether officials were sufficiently knowledgeable of their roles to
respond to the incidents immediately. In so doing, we compared their
responses to the incidents with prior GAO reports on practices to
enhance and sustain agency collaboration and our Standards for Internal
Control in the Federal Government for guidelines on internal controls-
-components of an organization's management that provide reasonable
assurance that certain objectives, including effectiveness and
efficiency of operations, are being achieved.[Footnote 6]
To identify changes made to response procedures as a result of the TB
incidents, we reviewed new and revised policy documents and interviewed
HHS and DHS officials as to whether and how their procedures were
changed and whether new ones were created. We observed the use of new
agency procedures and interviewed HHS and DHS officials at the Bridge
of the Americas and Dulles International Airport. To identify the
extent to which these changes addressed limitations identified by the
incidents, we reviewed agency documents, including HHS's and CDC's
after-action reports on the TB incident involving the U.S.
citizen.[Footnote 7] These after-action reports identified deficiencies
in their response to the TB incidents and made recommendations to
improve their response in future incidents. We also reviewed HHS's and
CDC's plans and policies for tracking the steps they are taking to
address the recommendations identified in the after- action reports. At
the time we conducted our review, DHS and the White House Homeland
Security Council were preparing after-action reports on the U.S.
citizen incident, and DHS and HSC officials separately briefed us on
the content of their after-action reports, including the
vulnerabilities exposed by the incidents and corrective actions taken.
We also analyzed the implementation of new and existing public health
tools for homeland security developed as part of new HHS and DHS
procedures.[Footnote 8]
To determine what HHS and DHS are doing to assess the effectiveness of
any operational changes they have made in response to the TB incidents,
we reviewed documents, including the departments' plans to develop a
compilation report of all after-action reports completed annually, to
identify trends in agency response needs and to make further revisions
to procedures as needed. We also interviewed HHS, CDC, and DHS
officials about their plans to monitor the performance of any new
procedures and tools.
We are not generalizing our findings to other infectious diseases or
broader public health incident response because of the unique nature of
the course of events that unfolded during the two TB incidents and
because the diagnosis, pathology, and treatment of TB disease differ
from those of other diseases. We also did not examine any international
factors that might have affected the response to the incidents, nor did
we examine the potential effect of any changes made by the departments
on international health organizations or coordination for international
public health incident response.[Footnote 9] We conducted this
performance audit from October 2007 through October 2008 in accordance
with generally accepted government auditing standards. Those standards
require that we plan and perform the audit to obtain sufficient,
appropriate evidence to provide a reasonable basis for our findings and
conclusions based on our audit objectives. We believe that the evidence
obtained provides a reasonable basis for our findings and conclusions
based on our audit objectives.
Results in Brief:
Various factors--a lack of comprehensive procedures for information
sharing and coordination as well as border inspection shortfalls--
hindered the federal response to the two TB incidents. Our Standards
for Internal Control in the Federal Government calls for agencies to
implement practices that enhance and sustain collaboration, including
frequent communication among and within the agencies. In addition, our
previous work also calls for agencies to demonstrate leadership,
capability, and accountability for preparing for, responding to, and
recovering from emergencies and hazardous situations, and establish
compatible policies and procedures for operating across agency
boundaries.[Footnote 10] At the time the two TB incidents occurred, HHS
and DHS had in place an October 2005 memorandum of understanding
creating a broad agreement to communicate and coordinate during public
health emergencies. However, the memorandum did not outline how the
departments would share information and coordinate their efforts in
responding to events such as the two TB incidents. In addition, HHS had
general procedures for sharing information about incidents of
infectious diseases among senior managers at HHS and DHS through the
agencies' operations centers. However, these procedures did not address
the types of assistance available from DHS, particularly CBP and TSA,
and how to request it. HHS and DHS also lacked procedures for sharing
information and coordinating with senior officials within each
respective department to involve them in decision making, which
resulted in senior officials not being able to ensure that resources
were available to take appropriate action. Also, CDC had not developed
procedures for informing state and local health officials about the
process for coordinating with CDC to determine whether federal
isolation and quarantine authorities should be used to deter the travel
of an individual with TB. Absent procedures for coordinating with CDC,
state and local health officials responding to the incident involving
the U.S. citizen were uncertain how to request federal assistance,
causing the initial delay in the federal response. Finally, CBP had
deficiencies in its traveler inspection process, which led to further
delays in locating the individuals and deterring their travel.
Specifically, the CBP officer at the port of entry who scanned the U.S.
citizen's travel documents into the Treasury Enforcement Communications
System (TECS)--CBP's computerized border screening and inspection
system--ignored the electronic alert and instructions to refer the
individual for further inspection. Instead, the officer allowed the
individual to enter the United States without this inspection, in
violation of CBP procedures. In the other incident, CBP was unable to
locate the Mexican citizen because the information he provided on his
medical records was incomplete and did not match the information
available in TECS from his visa application.[Footnote 11] Furthermore,
TECS did not automatically query possible variations of certain
biographic information (e.g., name, date of birth, and travel document
information) that might have helped CBP locate the individual.
HHS and DHS have implemented various procedures and tools intended to
address deficiencies identified by the 2007 TB incidents, but could
take additional steps to enhance their ability to respond to future TB
incidents. HHS and DHS have initiated actions consistent with our past
work on agency coordination for, preparation for, and response to
hazardous situations and federal internal control standards to enhance
information sharing and coordination.[Footnote 12] Specifically,
following the incidents and in conjunction with the 2005 memorandum of
understanding, HHS and DHS established procedures to channel
information across and within the organizations to ensure that agency
officials at all levels were informed about potential TB incidents so
that managers in the field and at headquarters could coordinate their
decisions about responding and allocate resources accordingly. Under
the new request for assistance procedures, HHS officials at field
offices are to notify headquarters officials when they become aware of
potential TB incidents, whereupon HHS officials are to request DHS's
assistance to help interdict the individuals with TB at the border.
Additionally, HHS and DHS have begun to use public health screening and
border inspection tools. For example, when HHS requests DHS assistance,
the names of the individuals HHS identifies as public health threats
are placed on a new TSA "Do Not Board" list--designed in response to
concerns about TB traveler incidents--whereby airlines are notified
that they should not allow the individuals on any commercial flights to
or from the United States. In addition, individuals with TB whom HHS
officials are trying to locate are identified on "public health
alerts," which are to be entered into TECS and conveyed to each CBP
officer inspecting travelers at ports of entry. If an officer
encounters an individual identified in a public health alert, the
officer is to send the individual for further inspection and possible
isolation. CBP has also modified TECS to prevent officers from
overriding alerts, thereby preventing a recurrence of the events in
2007 when an officer allowed the U.S. citizen to enter the country even
though CBP had instructed port officials to stop the individual.
Despite these changes, DHS and HHS may be missing various opportunities
to further enhance their ability to respond, as follows:
* First, DHS may be able to further strengthen its TECS search
capabilities. At the time of the incidents, CBP was not able to
identify the Mexican citizen and deter him from crossing the border
because TECS searches did not query on various combinations of the
available identifying biographic information. In response to the
incidents, DHS enhanced its process for creating public health records
to provide for queries on variations of some, but not all, available
biographic information. CBP has not examined whether the benefits of
conducting these additional searches on other types of biographic
information offset the costs of increased time needed to process
individuals through ports of entry. According to CBP, a slight increase
in the time needed to conduct inspections, especially at land ports of
entry, can result in substantial traveler delays and traffic
congestion. More specifically, according to CBP, increasing TECS search
capabilities has the potential to generate an increase in the number of
false matches received. This could increase the amount of time needed
by officers to review false matches and, according to CBP, further
increase wait times at the border. Nonetheless, without exploring the
benefits and costs of conducting searches on other combinations of
biographic information, DHS may be missing an opportunity to increase
its ability to detect persons with known cases of infectious TB and
interdict them upon entry to the United States.
* Second, although HHS has developed the internal processes to inform
HHS managers and DHS about potential incidents involving individuals
with TB who intend to travel, HHS has not yet completed actions to
systematically inform state and local health officials who work with
individuals with TB about the new procedures and tools. Educating state
and local health officials could help prevent delays in accessing
federal assistance and ensure that new procedures and tools informing
them how to access this assistance are used appropriately. Such
education is especially important since state and local health
officials are usually the first to become aware of TB cases.
* Third, HHS and DHS have identified additional actions that need to be
taken to further strengthen the departments' responses to incidents
involving individuals with TB who intend to travel. For example,
according to DHS officials, HHS and DHS need to further examine issues
related to distribution of personal and medical information of
individuals with communicable diseases who pose potential public health
threats. However, as of September 2008, HHS and DHS had not finalized
plans for completing actions that would promote cross-coordination
among federal departments and their agencies, though officials said
that they planned to meet to further address the additional actions
that need to be taken. Without clear plans with associated time frames
for completing these actions, the agencies may not be able to further
strengthen their ability to respond to and prevent the cross-border
travel of individuals with known cases of infectious TB.
HHS and DHS have several activities under way to assess implementation
of the new procedures and tools. Federal internal control standards
call for agencies to assess the quality of performance over time so
that deficiencies can be identified and addressed.[Footnote 13] HHS's
and DHS's activities include monitoring the performance of the new
request for assistance procedures and tools, holding cross-agency
meetings to discuss how information sharing and coordination could be
further improved, and creating an annual report, based on after-action
reports conducted after some incidents, intended to analyze trends and
identify potential improvements. In addition, HHS and DHS are
evaluating the new procedures and tools based on TB incidents as they
arise. According to HHS and DHS officials, they view the more than 70
requests for assistance that HHS made of DHS from May 2007 through
February 2008 as "natural exercises" of the request for assistance
procedures.
To ensure continuing improvements in HHS's and DHS's new procedures and
tools developed in response to the 2007 TB incidents and to improve
awareness of these changes, we are making the following three
recommendations.
We recommend that the Secretary of DHS direct CBP to determine whether
the benefits exceed the costs of enhancing TECS capabilities when
creating public health alerts to include other variations of biographic
information that could further enhance its ability to locate
individuals who are subject to public health alerts and, if so, to
implement this enhancement. We also recommend that the Secretary of HHS
and the Secretary of DHS work together to:
* continue to inform and educate state and local health officials about
the new procedures and tools and:
* develop plans with time frames for completing additional actions that
require cross-agency coordination to respond to future TB incidents.
In commenting on a draft of this report, HHS and DHS generally
concurred with our recommendations.
Background:
M. tuberculosis, the bacterium that causes TB, is spread from person to
person, usually through coughing, sneezing, or speaking. TB disease
occurs when the bacteria actively multiply in the lungs or other sites
in the body.[Footnote 14] If left untreated, a person with TB disease
can spread the bacteria to an average of 10 to 15 people each year.
Also, without proper treatment, TB can be fatal. Because the bacteria
that cause TB are naturally slow-growing, final confirmed diagnosis of
TB disease, including a determination of drug resistance, can take from
6 to 16 weeks, according to CDC. This lengthy process, along with other
factors, makes diagnosis of TB difficult. (Fig. 1 provides information
about the characteristics of TB.)
Figure 1: Characteristics of TB:
This figure is a combination of text and illustrations showing the
characteristics of TB.
[See PDF for image]
Source: GAO analysis of CDC information.
[End of figure]
TB disease is treated with a combination of TB medications that must be
taken regularly. Individuals who have TB bacteria that are not
resistant to drugs can be treated with 6 to 9 months of the most
effective medications. Those with TB bacteria that are resistant to at
least two of the most effective medications (multiple-drug-resistant
TB) require treatment for 18 to 24 months with other TB medications
that are much less effective, usually have more negative side effects,
and are more expensive.[Footnote 15] Nonadherence to the drug regimen
can lead to the development of drug-resistant TB, which can be
transmitted from a person with active disease to an uninfected person
in the same way that non-drug-resistant TB is transmitted. If a person
infected with a drug-resistant strain of TB develops TB disease, his or
her strain will be drug resistant as well.
Because adherence to treatment regimens is essential to prevent TB
bacteria from becoming resistant to available medications, individuals
diagnosed with TB disease in the United States are typically treated
via directly observed therapy. In such therapy, patients take their
medications in the presence of a health care provider, from several
times a week to every day. Individuals enrolled in directly observed
therapy are more likely to complete their treatment regimens.
Coordination for TB Public Health Incidents:
State and local health departments and federal agencies are to work
together to prevent the spread of TB in the United States.
State and Local Health Department Roles and Responsibilities:
In addition to day-to-day care and treatment for patients with TB
disease, state and local health departments have the primary
responsibility for TB control efforts. Each state health department has
a state TB controller who oversees TB prevention and control programs
in the local health departments, where in most cases their workers
provide care and treatment for TB patients, including directly observed
therapy. State and local health departments are to work closely with
staff at CDC to alert them to problems as they arise and, if necessary,
request CDC assistance with nonadherent individuals with TB.
Individuals with or exposed to certain diseases, including TB disease,
are also subject to state and federal isolation and quarantine
authorities.[Footnote 16] State and local jurisdictions have the
primary legal authority to issue isolation and quarantine orders, and
consequently do not regularly involve the federal government when
attempting to locate individuals who are or may become nonadherent to
their drug regimens. Isolation and quarantine laws vary across states;
officials in some states must obtain a court order or establish that a
patient is not adhering to medical advice or treatment prior to
issuance of an isolation order. Furthermore, states may vary in their
enforcement of such orders. However, according to state and federal
health officials, the majority of TB patients adhere to treatment
recommendations, including remaining in isolation units in hospitals or
in isolation at home until they are no longer infectious.
HHS Roles and Responsibilities:
HHS has largely delegated to CDC the task of preventing the
introduction, transmission, and spread of communicable diseases, such
as infectious TB, from foreign countries into the United States,
including the ability to apprehend, detain, isolate, or conditionally
release a person entering the United States believed to be infected
with certain communicable diseases. CDC's overall mission is to protect
the health of all Americans through health promotion, disease
prevention, and preparedness. CDC's centers, divisions, and offices
also develop and disseminate guidance to state and local health
departments on federal recommendations and procedures for disease
control and prevention. CDC also provides resources and funding and
collaborates with U.S. and Mexican health agencies for TB care and
treatment for U.S. or Mexican citizens who cross the U.S.-Mexico border
frequently.
Within CDC, the Division of Tuberculosis Elimination is responsible for
directing TB prevention and control programs in the United States,
formulating national TB policies and guidelines, and helping to control
TB worldwide. The Division of Tuberculosis Elimination also provides
programmatic consultation, technical assistance, outbreak response
assistance, and laboratory support to state and local health
departments, and provides technical assistance to TB programs in other
countries by collaborating with international partners.[Footnote 17]
CDC's Division of Global Migration and Quarantine (DGMQ) is responsible
for working to reduce illness and death from infectious diseases, such
as TB, among immigrants, refugees, international travelers, and other
mobile populations that cross international borders, as well as for
preventing the introduction of infectious diseases into the United
States and promoting the health of people living along the U.S.
borders. To facilitate this work, DGMQ operates CDC's 20 quarantine
stations at U.S. ports of entry.[Footnote 18] Quarantine station
officials are responsible for assessing whether ill persons can enter
the country and determining what measures should be taken to prevent
the spread of infectious diseases into the United States. Most of the
quarantine stations are located in airports and work closely with state
and local health departments and CBP officers at nearby or collocated
ports of entry. DGMQ trains CBP officers on how to identify and respond
to travelers, animals, and cargo that may pose an infectious disease
threat.
CDC's Coordinating Office for Terrorism Preparedness and Emergency
Response works under the Assistant Secretary for Preparedness and
Response in HHS and is responsible for directing and coordinating CDC's
response to public health threats. This office operates the Director's
Emergency Operations Center (DEOC), which collects information about
potential public health threats 24 hours a day, 7 days a week, and is
the central location for CDC's public health response activities for
specific incidents. The DEOC is responsible for sharing information
with, and if necessary, requesting additional resources from HHS
through its Secretary's Operations Center (SOC) during a response to a
public health incident. The SOC, managed by HHS's Office of the
Assistant Secretary for Preparedness and Response, is the focal point
for synthesis of critical public health and medical information on
behalf of the U.S. government. Both the SOC and the DEOC are intended
to provide a formal, central point of management and oversight at their
respective agencies to enable senior agency officials and subject-
matter experts to take advantage of agency resources and capabilities
in responding to an incident.
DHS Roles and Responsibilities:
DHS is responsible for coordinating with federal, state, local, and
private entities to secure the nation, prevent terrorist attacks within
the United States, and provide emergency management and planning, among
other activities. According to statute, DHS is to aid HHS in the
enforcement of federal quarantine rules and regulations.[Footnote 19]
The Office of Health Affairs (OHA), which began operations in April
2007, serves as DHS's principal agent for medical and health matters.
It is responsible for managing DHS's biodefense programs, ensuring the
nation's health preparedness in the event of terrorism or natural
disasters, and protecting the health of DHS's workforce. Also, TSA,
CBP, and the Office of Operations Coordination operate within DHS.
TSA is responsible for ensuring the security of the national
transportation network while ensuring the free movement of people and
commerce. TSA has responsibility for safeguarding all modes of
transportation, including strengthening the security of airport
perimeters and restricted airport areas; screening passengers against
terrorist watch lists, such as the No Fly list; and inspecting
passengers, baggage, and cargo at over 400 commercial airports
nationwide.[Footnote 20] TSA is tasked with preventing a public health
threat on commercial air carriers through its broad authority to
protect the transportation system against any threat that could
endanger individuals during travel. TSA's Freedom Center is the primary
coordination point for the federal, state, and local agencies dealing
with transportation security on a daily basis.
A key part of CBP's mission is to prevent the entry of terrorists into
the United States. CBP screens people, conveyances, and goods entering
the United States, while facilitating the flow of legitimate trade and
travel into and out of the United States. CBP's mission also includes
carrying out traditional border-related responsibilities, including
narcotics interdiction, enforcing immigration and customs laws,
protecting the nation's food supply and agriculture industry from pests
and diseases, and enforcing trade laws. All travelers requesting to
enter the United States, including U.S. citizens, are subject to
examination. Individuals may be referred for enhanced inspection for a
variety of reasons, such as criminal records, inclusion on a national
registry for sex offenders, or prior immigration or customs violations,
or may be randomly selected. As appropriate, CBP also conducts searches
of people, merchandise, and conveyances entering or exiting the United
States, to ensure that merchandise may be lawfully imported or exported
and duties collected.
CBP officers are responsible for conducting inspections to permit
admissible individuals to enter the country. In general, U.S. citizens
who demonstrate their citizenship are to be admitted, although those
citizens believed to be infected with or exposed to TB or other
communicable diseases specified by Executive Order may be subject to
isolation or quarantine immediately upon admission.[Footnote 21]
Noncitizens seeking entry must establish that they are admissible under
U.S. immigration law; those determined to have a communicable disease
of public health significance are inadmissible, unless granted a
waiver.[Footnote 22] During the inspection process, CBP officers are to
use TECS--CBP's computerized border screening and inspection system--in
addition to other databases to assess admissibility and purpose for
entering the country and to corroborate information. Individuals may be
admitted or denied entry and returned to the country of origin. In
addition, individuals may be detained temporarily pending an
admissibility determination, detained for purposes of prosecuting a
violation of U.S. law, or turned over to another law enforcement
entity. (App. I provides more detailed information about the CBP
inspection process.) In addition to electronic alerts available in
databases, CBP officers also rely on be-on-the-lookout notices--which
are similar to wanted posters, disseminated by CBP's Office of Field
Operations and hung at ports of entry--to identify individuals who pose
potential threats attempting to enter the United States. The
Commissioner's Situation Room--CBP's 24-hour, 7-day-a-week center for
facilitating communication between CBP headquarters and the field
offices--serves as the entry point for reporting of incidents from
field offices. CBP also assists CDC quarantine station officials with
the distribution of health risk information for the traveling public,
such as notices that alert travelers to possible exposure to
communicable diseases abroad and offer guidance on how to protect
themselves.
The DHS Office of Operations Coordination is responsible for monitoring
the nation's security on a daily basis and coordinating activities
within DHS and with external entities, such as governors' offices and
law enforcement partners. Within the Office of Operations Coordination,
the National Operations Center (NOC) serves as the focal point for
these coordination efforts by collecting information about potential
homeland security threats 24 hours a day, 7 days a week. The NOC serves
as the primary hub for federal emergency and public health preparedness
and response by combining and sharing information, communications, and
operations coordination pertaining to the prevention of terrorist
attacks and domestic emergency management with other federal, state,
local, tribal, and nongovernmental emergency operations centers,
including TSA's Freedom Center and CBP's Commissioner's Situation Room.
HHS and DHS Memorandum of Understanding:
In October 2005, HHS and DHS signed a memorandum of understanding that
was intended to provide a basis for federal cooperation to enhance the
nation's preparedness to prevent the introduction, transmission, and
spread of quarantinable and serious communicable diseases, such as TB,
from foreign countries into the United States. According to CBP
officials, the memorandum was developed following the 2003 outbreak of
severe acute respiratory syndrome (SARS) in order to prepare the
departments for circumstances that would need a coordinated response.
CDC is the designated agency with responsibility for HHS activities
supported by the memorandum. CBP, Coast Guard, and Immigration and
Customs Enforcement are the designated DHS agencies with responsibility
for assisting CDC in the enforcement of isolation and quarantine
authorities.
The Two Spring 2007 TB Incidents:
Two TB incidents occurred in spring 2007. One involved a U.S. citizen
who traveled by commercial airline internationally and subsequently
reentered the United States at the Canadian border at the Champlain,
New York, land port of entry. The other involved a Mexican citizen who
crossed the U.S.-Mexico border multiple times at the El Paso, Texas,
land port of entry. In both incidents, according to HHS, the
individuals with TB did not follow the medical advice of federal,
state, and local public health officials and instead continued to
travel.
In the incident involving the U.S. citizen, state and local health
officials reported that once they determined that the U.S. citizen
posed a public health threat, they orally recommended to him that he
not travel and reviewed options to restrict his international travel.
State and local health officials reported that from May 11 to May 13,
they attempted to hand deliver a letter to the individual that
emphasized the seriousness of drug-resistant TB and the potential
threat he posed to others, and included a recommendation that he
postpone his travel. However, according to CDC officials, state and
local health officials reported that they were unable to deliver the
letter because, unbeknownst to them, the individual had left the United
States 2 days earlier than he had previously planned, despite advice
not to travel. When federal public health officials became involved in
the response, they contacted the individual overseas and made efforts
to advise him about seeking treatment and how to return to the United
States. Once CDC notified CBP of the incident, CBP entered an alert in
TECS that provided instructions to detain the individual if he was
encountered at any port of entry. However, HHS reported that the
individual continued with his travel plans against medical advice. For
example, when a CDC quarantine officer located the individual abroad
and attempted to direct him to treatment in Europe, the individual
changed his travel plans again, left his hotel, and did not contact CDC
until he returned to the United States. Upon his return, according to
HHS, CDC was able to contact him via cell phone and he agreed to
undergo treatment for drug-resistant TB.[Footnote 23] (Fig. 2 provides
more details about the incident involving the U.S. citizen and
officials' actions.)
Figure 2: Description of TB Incident Involving the U.S. Citizen,
January through May 2007:
This figure is a chart showing the description of a TB incident
involving the U.S. citizen, January through May 2007.
[See PDF for image]
Source: GAO analysis of HHS, DHS, and state/local health department
information.
[End of figure]
In the incident involving the Mexican citizen, the individual's
physician in Mexico notified U.S. state and local health officials on
April 16 that the individual was routinely crossing the U.S.-Mexico
border. Those officials immediately contacted CDC officials, who also
notified CBP and requested that it issue a be-on-the-lookout notice and
enter a TECS alert to deter the individual from traveling. However,
according to both agencies, federal officials were unable to locate
information about him in available databases. Despite multiple searches
by CBP, he was checked at the border approximately 20 times during
April and May 2007, and was able to cross into the United States.
According to officials from both agencies, the Mexican citizen did not
turn over his visa when his physician initially requested it, which
would have allowed CDC and CBP officials to locate information about
him. On May 31, approximately a month after state and local health
officials first notified federal officials of the incident, the Mexican
citizen gave his visa to his physician. (Fig. 3 provides more details
about the incident involving the Mexican citizen and officials'
actions.)
Figure 3: Description of TB Incident Involving Mexican Citizen, April
through May 2007:
This figure is a chart showing the description of a TB incident
involving a Mexican citizen, April through May 2007.
[See PDF for image]
Source: GAO analysis of HHS and DHS information.
Note: We followed up in February 2008, at which time the patient
remained in treatment according to CDC officials, and had not made any
subsequent attempts to cross the border according to CBP officials.
[End of figure]
HHS's and DHS's Lack of Comprehensive Procedures for Information
Sharing and Coordination and CBP Inspection Deficiencies Hindered the
Response to the TB Incidents:
Various factors--a lack of comprehensive procedures for information
sharing and coordination as well as border inspection shortfalls--
hindered the federal response to the two TB incidents. HHS and DHS
lacked formal procedures for sharing information with each other. They
had established a memorandum of understanding in October 2005 creating
a broad agreement to communicate and coordinate during public health
emergencies. However, the departments were unable to carry out the
intent of the memorandum because they had not developed specific
operational procedures to share information and coordinate their
efforts to respond to events such as the two TB incidents. In addition,
HHS had general procedures for sharing information about incidents of
infectious diseases among senior managers at HHS and DHS through the
agencies' operations centers. However, HHS and CDC did not have
procedures that outlined what assistance was available to them from
DHS, particularly from CBP and TSA, and how to request it. The two
departments also lacked internal procedures outlining how to share
information and coordinate with senior officials within each department
about the TB incidents to involve them in decision making, which
resulted in senior officials not being able to ensure that resources
were available to take appropriate action. In addition, CDC had not
developed procedures to inform state and local health officials about
the process for coordinating with CDC to determine whether federal
isolation and quarantine authorities should be used to deter the travel
of an individual with TB, causing the initial delay in the federal
response. Furthermore, CBP had deficiencies in its traveler inspection
process, which led to further delays in locating the individuals and
deterring their travel.
HHS and DHS Lacked Comprehensive Procedures to Share Information and
Coordinate Their Responses and Resources in the Two TB Incidents:
Despite the memorandum of understanding between HHS and DHS in place at
the time of the incidents, the departments lacked comprehensive
procedures needed to share information with each other and coordinate
resources to deter cross-border travel of nonadherent individuals with
infectious disease, such as TB. Our previous work has identified
practices to enhance and sustain agency collaboration, including
frequent communication among the agencies and the establishment of
compatible policies, procedures, and other means of operating across
agency boundaries.[Footnote 24] Additionally, Standards for Internal
Control in the Federal Government calls for (1) management to ensure
that there are adequate means of communicating with, and obtaining
information from, external stakeholders that may have a significant
impact on the agency achieving its goals and (2) effective
communication flowing down, across, and up the organization to enable
managers to carry out their internal control responsibilities.[Footnote
25] Finally, our work on emergency management outlines three basic
elements that constitute effective preparedness and response to
hazardous situations, including the spread of infectious diseases. The
three basic elements are (1) leadership, where clear roles and
responsibilities are effectively communicated and understood in order
to facilitate rapid and effective decision making; (2) capabilities,
for which plans are integrated and key players define what needs to be
done, where, by whom, and how well; and (3) accountability, where
officials work to ensure that resources are used appropriately for
valid purposes, including developing operational plans that are tested
and taking corrective action as needed.[Footnote 26]
Although the memorandum of understanding outlined a broad agreement to
promote information sharing in the event of a public health incident,
it did not provide specific operational procedures for the departments
and their component agencies to share information with each other to
respond to events such as the two TB incidents. In addition, HHS had
general procedures for senior managers to share information about
infectious diseases with senior DHS officials through their operations
centers. However, we learned through discussions with DHS officials and
from the HHS and CDC after-action reports that during the incident
involving the U.S. citizen, HHS and CDC did not have procedures
outlining what assistance was available from DHS, particularly from CBP
and TSA, and how to request it. Some of the DHS capabilities that were
unclear to HHS and CDC decision makers included:
* CBP's search capabilities for locating individuals and their travel
itineraries, their travel histories, or both in order to stop cross-
border travel;
* the availability of TECS and be-on-the-lookout notices through CBP,
which could have assisted officers in identifying the individuals so
that they could locate them at any U.S. port of entry; and:
* TSA's ability to prevent the individuals from flying into and out of
the United States.[Footnote 27]
Because CDC was unsure whether or how DHS could offer assistance for
public health purposes, CDC did not request assistance from CBP until 4
days after state health department officials notified CDC of the
incident.
HHS and DHS also lacked procedures for sharing individual health
information between the departments for public health incident
response, including how broadly to share it, which delayed the federal
response to the incidents. CDC and DHS officials we interviewed said
that CDC was initially slow to provide this identifying information to
TSA officials while the agencies were determining a course of action
and whether TSA's No Fly list could be used to prevent the U.S.
citizen's air travel, thus hindering their ability to locate and deter
the individual from traveling. Public health and law enforcement
authorities generally have different approaches to sharing such
information, as reflected in their missions and responsibilities.
According to CDC officials, in an effort to limit disclosure of
individuals' private medical information, agency staff generally
refrain from sharing identifying information with each other, even when
discussing a potential incident, preferring to refer to people and
places as "the patient" or "hospital A." On the other hand, CBP and
TSA, as a law enforcement and security agency, respectively, need
accurate and complete identifying information to locate and detain
individuals. In the incident involving the U.S. citizen, CDC officials
took several hours to provide the person's name and health information
after initially contacting DHS for assistance because they were unsure
how the information was going to be used and protected. CDC's hesitancy
delayed CBP's dissemination of a be-on-the-lookout notice and placement
of an alert in TECS. CDC officials indicated that generalized concerns
over the applicability of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) and Privacy Act restrictions on the
sharing of individual information[Footnote 28] contributed to a delay
in their sharing this information with DHS. However, as CDC has
concluded, in this instance both laws appear to permit the disclosure
to DHS, without patient authorization, of individually identifiable
health information acquired for the purpose of controlling the spread
of disease.[Footnote 29] According to CDC, there was a concern that the
lack of procedures for sharing identifying and health information
between agencies resulted in this information being disseminated over
law enforcement channels more broadly than may have been necessary
under the circumstances. In addition, concerns were raised that
password protection for the information disseminated may have been
insufficient.
HHS and DHS Lacked Specific Procedures for Information Sharing within
Each Department to Respond to the TB Incidents:
Along with a lack of comprehensive procedures for information sharing
with each other, HHS and DHS lacked specific procedures for
communicating across their respective component agencies about public
health incidents, which contributed to uncertainty about whether and
when CDC, TSA, or CBP should notify senior officials at HHS or DHS
about potential incidents. According to Standards for Internal Control
in the Federal Government, effective communication should occur in a
broad sense with information flowing down, across, and up
organizations. Lacking specific procedures, HHS and CDC officials used
a "standard of reasonableness" that involves professional discretion as
a basis for determining whether the individual posed a potential public
health threat and when to notify senior officials. CDC officials told
us that using this standard involves some subjective judgment.
According to CDC, its quarantine station officials initially believed
that the two TB incidents could be resolved locally without notifying
senior officials, which led to delays in the federal response in both
incidents. For example, in the U.S. citizen incident, senior officials
at HHS and CDC were not notified by CDC quarantine station officials at
the field office level about the incident early enough to ensure timely
use of federal isolation and quarantine authorities to deter his
travel. In addition, CBP and TSA lacked written procedures for internal
communication regarding how to handle public health incidents and when
to notify DHS senior officials about the efforts of officials in the
field to respond to requests from CDC quarantine station officials.
During this incident, CBP officials at the air port of entry became
involved on May 22, but they did not notify DHS senior officials until
May 24. In the incident involving the Mexican citizen, CBP officials at
the land port of entry did not notify DHS senior officials until 14
days (April 16 to April 30) after CDC requested CBP assistance.
CDC Lacked Procedures to Coordinate with State and Local Health
Officials to Determine Use of Federal Isolation and Quarantine
Authorities:
CDC had not developed procedures to inform state and local health
officials about the process for coordinating with CDC to determine
whether federal isolation and quarantine authorities should be used to
deter the travel of an individual with TB, causing the initial delay in
the federal response. Although some information on federal isolation
and quarantine authorities was available on CDC's Web site, guidance on
the process by which state and local health officials were to obtain
federal assistance had not been developed.[Footnote 30] As a result,
state and local health officials responding to the incident involving
the U.S. citizen were uncertain how to request federal assistance and,
prior to doing so, attempted but failed to contact the individual to
deter him from traveling, ultimately contributing to the delay in the
federal response. Eight days (May 10 to May 18) elapsed from when a
state health department official discussed options for restricting the
U.S. citizen's international travel with a CDC quarantine station
official, without confirming that a specific individual intended to
travel, to when the state requested formal assistance from CDC.
Officials from an association representing state and local health
officials and CDC officials stated that many state and local health
officials are not aware of federal isolation and quarantine authorities
and how they are to be implemented and enforced. CDC is preparing
further guidance to clarify the implementation and enforcement of these
authorities.
CBP Inspection Deficiencies Contributed to Delays in Locating the
Individuals with TB:
Deficiencies in CBP's traveler inspection operations further
contributed to the delay in federal efforts to locate the two
individuals with TB and direct them to treatment. When responding to
HHS's request for assistance to deter the U.S. citizen from traveling,
CBP issued a TECS alert to determine when the U.S. citizen planned to
return to the United States. When he crossed the border at a land port
of entry after having flown into Canada, the CBP officer queried the
individual's travel documents in TECS to check against law enforcement
systems for outstanding warrants, or criminal or administrative
violations, and to assist with determining admissibility into the
United States. However, the officer ignored the electronic alert and
instructions to refer the individual for further inspection, in
violation of CBP procedures. Instead, the CBP officer cleared the TECS
alert and allowed the individual to enter the country without the
required further inspection. When responding to the incident involving
the Mexican citizen, CDC and CBP officials did not know that they had
received incomplete or inaccurate biographic information or both. As a
result, at the time of the incidents, a TECS database search would not
prompt a "match" if incomplete or inaccurate biographic information was
used for a query. According to CBP officials, incomplete and inaccurate
information delayed the identification of the individual by over 1
month and allowed him to travel into the United States approximately 20
times after CDC first notified CBP to look for and deter him.
According to CBP officials, they realized within a day of initiating
the TECS searches that the identifying information was incomplete
because the searches did not produce a travel history, which typically
shows an individual's travel in and out of the United States. Also, the
searches of visa databases, which could have provided more information
about his identity, did not produce any information on the individual,
who was said to be a frequent traveler.[Footnote 31] Once CBP officers
realized that the Mexican citizen's identifying information was
incomplete, they contacted CDC the next day to confirm the identifying
information and told CDC officials that they suspected that the
information was incomplete. According to agency officials, 4 days after
CDC first notified CBP about the Mexican citizen, CDC notified CBP that
some of the biographic information from the Mexican citizen's medical
records was inaccurate. Using corrected information, CBP immediately
revised the TECS alert and the local be-on-the-lookout notice; however,
when a new TECS search still did not produce information, CBP contacted
CDC. Although CDC had made attempts, it did not obtain accurate and
complete biographic information. On May 31, about 6 weeks after CDC
first contacted CBP officials, the Mexican citizen gave his border-
crossing card, a type of visa, to his physician. CDC was then able to
provide CBP with the complete and accurate biographic information, and
DHS took possession of his card, thus preventing further crossing. With
the accurate information from the Mexican citizen's documents, DHS
officials located his travel history in TECS on May 31, determined that
he had crossed the southern border 21 times from April 16 through May
31, and entered an accurate alert in TECS.
HHS and DHS Implemented Procedures and Tools to Address Response
Deficiencies, but Could Take Further Steps to Complete Actions
Identified as a Result of the 2007 TB Incidents:
HHS and DHS have implemented various procedures and tools intended to
address deficiencies identified by the 2007 TB incidents. However, CBP
has not implemented TECS modifications that might further help officers
identify individuals who have been diagnosed with TB at ports of entry.
In addition, CDC has not yet to completed efforts to inform state and
local health officials about the existence of the new procedures and
tools or how to successfully use them in order to facilitate requesting
federal assistance and ensure that new procedures and tools are used
appropriately. Finally, HHS and DHS have identified additional actions
that need to be taken to further strengthen the departments' ability to
respond to incidents involving individuals with TB who intend to
travel. However, as of September 2008, HHS and DHS had not finalized
plans for completing these actions.
HHS and DHS Implemented New Procedures and Tools Intended to Address
Information Sharing, Coordination, and Public Health Screening and
Border Inspection Deficiencies Identified by the TB Incidents:
HHS and DHS officials--including officials from CDC, CBP, and TSA--met
in June 2007 to develop new procedures and tools to determine how DHS
might be able to help HHS respond to public health incidents, develop a
framework for coordinating with each other during responses to public
health incidents, and ensure the appropriate level of agency
involvement and use of agency resources. To help promote enhanced
information sharing across and within both departments, HHS and DHS
developed new procedures for HHS to request assistance from DHS. These
new procedures are consistent with practices identified in our past
work for enhancing and sustaining agency collaboration and for
establishing leadership, capabilities, and accountability for
preparedness and response.[Footnote 32] They are also consistent with
Standards for Internal Control in the Federal Government, which calls
for management to ensure that there are adequate means of communicating
internally and with external stakeholders.[Footnote 33] Under the new
procedures, HHS officials at field offices, such as quarantine stations
and ports of entry, are to notify headquarters officials when a TB or
other public health incident develops, whereupon these officials are to
make requests to DHS headquarters to task TSA and CBP officials at
ports of entry with taking action to interdict individuals with TB and
other infectious diseases at the borders. HHS prepares written requests
for assistance that include the information DHS needs to respond, such
as the individual's name, date of birth, and action to be taken if the
individual is encountered.[Footnote 34] DHS and HHS have also included
safeguards designed to ensure the privacy of the individual in the
request for assistance process. The request for assistance form is
received only by appropriate HHS and DHS officials responsible for
responding to and completing requests, and officials from both
departments send the written requests via e-mail, as password-protected
documents. CDC and DHS officials said that the new procedures for
information sharing are also intended to allow the agencies to take
advantage of existing procedures, resources, and capabilities while
maintaining the close professional relationships between CDC and CBP
officers at ports of entry.
DHS, particularly TSA and CBP, has also worked with HHS, particularly
CDC, to implement new tools intended to deter the cross-border travel
of individuals with infectious TB. Specifically, TSA modified an
existing tool--the No Fly list--to create a Do Not Board list for
infectious air travelers who are nonadherent with treatment and intend
to travel. The Do Not Board list is a roster of individuals whom CDC
requests be denied boarding onto a commercial airline flight into, out
of, or within the United States because they pose a potential public
health threat to passengers, air carriers, or the transportation
system. CDC's criteria for placement of an individual on the Do Not
Board list include public health officials' belief that (1) the
individual has an a communicable disease that would constitute a public
health threat if he or she were allowed to travel by airplane; (2) the
individual is unaware of, or will become nonadherent to, public health
recommendations regarding treatment or other instructions; and (3) the
individual intends to travel by airplane. According to CDC officials,
the agency requests removal of an individual from the list when state
or local health officials confirm that the individual has undergone
sufficient treatment to be determined noninfectious. HHS officials said
that the list is reviewed at least monthly. TSA maintains the Do Not
Board list, which is separate from other watch lists for air carriers,
such as the No Fly list used to prevent known terrorists from boarding
airplanes, but functions in a similar manner. TSA sends the Do Not
Board list to domestic and foreign air carriers on a daily basis as an
addendum to the No Fly list.[Footnote 35] U.S. air carriers are to
screen all passengers against the Do Not Board list (regardless of the
flight's origination or destination). International carriers are to
screen passengers who are arriving in or departing from the United
States but not passengers traveling outside the United States.
HHS and DHS officials said they believe that the request for assistance
process and the Do Not Board list could be used to address travelers
with other infectious diseases, though CDC officials said the most
likely use would be for travelers with infectious TB.[Footnote 36]
Although the Do Not Board list was created in response to the incident
involving the U.S. citizen, officials said that individuals with
infectious diseases other than TB, such as measles, SARS, or a strain
of influenza with pandemic potential, could be placed on the Do Not
Board list if they met the criteria. Generally, CDC expects that it
could use the new procedures and tools in instances where health
officials have identified infectious individuals who have a substantial
risk to expose others and there is a strong belief by health officials
that an infected individual intends to travel. However, according to
CDC officials, the use of the Do Not Board list to prevent travel by
individuals with other infectious diseases would be less likely because
they would become ill more quickly and feel too unwell to travel, be
more visibly ill, and recover more quickly than individuals with TB. In
addition, CDC officials said that the Do Not Board list requires
careful review of individual cases. In the event of a large disease
outbreak, CDC's ability to look at individual cases to place them on
the Do Not Board list would be limited, officials said.
CBP also created and implemented a new TECS public health alert (1 week
after the U.S. citizen reentered the country) to help ensure that DHS
is able to assist CDC in locating individuals with infectious diseases,
including TB, who are attempting to enter the United States. According
to CBP officials, prior to the TB incidents, TECS public health alerts
were indistinguishable from other types of alerts and information on
how to manage an individual with infectious disease, including TB, was
not prominently displayed in the alert. Now, when CDC requests CBP
assistance for individuals who intend to travel against medical advice,
if the individual's license, passport, visa, or other identifying
document or biographical information is scanned or manually entered
into TECS, the new TECS public health alert is displayed prominently on
the CBP officer's computer screen, with specific instructions for the
officer to isolate the individual and contact CDC immediately. As with
the Do Not Board list, federal officials must know an individual has an
infectious disease, including TB, to place a public health alert in
TECS. Furthermore, according to CBP officials, if the identifying
information provided to physicians or recorded in health records does
not match the information entered in visa databases, visas and other
travel documents generated from these databases will not produce a
match when queried and CBP officers will not know to detain the
individual, as in the case involving the Mexican citizen. Furthermore,
if an individual's information (passport or visa) is not scanned or
manually entered into TECS when he or she enters the United States,
officers will not discover the public health alert and will not detain
the individual.
CBP also took other actions to strengthen TECS computer screening
mechanisms and search capabilities for public health alerts. These
changes were intended to ensure that CBP officers at ports of entry
adhere to agency protocols and instructions for all TECS alerts, either
public health or otherwise. At the time of the incident involving the
U.S. citizen, the CBP officer who admitted the individual into the
country was able to bypass the requirement to refer individuals for
further inspection because there was no supervisory review. According
to CBP officials, to prevent this, CBP upgraded TECS computer
programming so that all TECS public health alert matches are
automatically sent to terminals where referrals receive supervisory
review intended to ensure that individuals receive the required
additional inspection and referral to CDC. With this change, officers
are no longer able to override the public health alert in TECS without
first diverting the individual for further screening. The public health
alert can only be overridden in TECS once the individual has cleared
the more detailed inspection (called secondary inspection).
In addition, CBP enhanced computer search capabilities for TECS public
health alerts. According to CBP officials, in the incident involving
the Mexican citizen, the officer who entered the TECS alert did not use
varying combinations of the biographic information during his search
because he believed that the information CDC provided was accurate.
According to CBP officials, as of May 2008, when a public health alert
is entered into TECS, the system is now programmed to create multiple
public health alerts on variations of specific types of the biographic
information entered. However, CBP officials told us that the TECS
programming changes do not create variations on other combinations of
an individual's available biographic information. A CBP official told
us that CBP could further modify TECS to create public health alerts
using different combinations of other available biographic information,
but CBP had not explored the feasibility of making this change and had
not examined whether the benefits of conducting these additional
searches on other types of biographic information offset the cost of a
possible increase in the time needed to process individuals through
busy ports of entry. According to CBP, a slight increase in the time
needed to conduct inspections, especially at land ports of entry, can
result in substantial traveler delays and traffic congestion.
Nonetheless, without exploring whether the costs of conducting searches
on these other combinations of biographic information exceed the
benefits, DHS may be missing an opportunity to enhance its ability to
detect persons with known cases of infectious disease and deter them
from entering the United States.
These changes to TECS notwithstanding, CBP's ability to identify
individuals who are the subject of public health alerts--and ultimately
deter their cross-border travel--largely depends on CBP officers'
compliance with prescribed inspection procedures. In November 2007, we
reported on weaknesses in inspection procedures at U.S. ports of
entry.[Footnote 37] We said that CBP had taken action to address
weaknesses in 2006 inspection procedures, such as not verifying the
citizenship and admissibility of each traveler, that contributed to
failed inspections. However, our follow-up work conducted months after
CBP's actions showed that weaknesses still existed. In July 2007, CBP
issued detailed procedures for conducting inspections, including
requiring field office managers to assess compliance with these
procedures. However, CBP had not established an internal control to
ensure that field office managers share their assessments with CBP
headquarters to help ensure that the new procedures are consistently
implemented across all ports of entry and reduce the risk of failed
traveler inspections. We recommended that CBP implement internal
controls to help ensure that field office directors communicate to
agency management the results of their monitoring and assessment
efforts so that agencywide results can be analyzed and necessary
actions taken to ensure that new traveler inspection procedures are
carried out in a consistent way across all ports of entry. CBP agreed
with our recommendation and stated that it has begun to take action to
address it. A CBP official told us that CBP intends to finalize the
results of field office assessments in October 2008.
Figure 4 shows the flow of requests for assistance from HHS to DHS,
together with the steps each agency takes to prepare, submit, and
complete these requests. Step-by-step procedures for each agency are
explained in table 1.
Figure 4: Information Flow for HHS Requests for DHS Assistance:
This figure is a flowchart showing the information flow for HHS
requests for DHS assistance.
[See PDF for image]
Source: GAO (data); Art Explosion (graphics).
[End of figure]
Table 1: Step-by-Step Procedures for HHS to Request Assistance from
DHS:
Step 1: Step 2;
State or local health officials contact the closest CDC quarantine
station and provide information about a particular case.: Quarantine
officer convenes conference call to local TB controller, state health
official, and officials from CDC's Division of Tuberculosis Elimination
and GMQ to review the request and information about the case and to
discuss appropriate available assistance.[A] The quarantine officer
then routes the information to senior DGMQ officials at CDC
headquarters.
Step 1: Step 3;
State or local health officials contact the closest CDC quarantine
station and provide information about a particular case.: DGMQ
officials determine what type of assistance to request from TSA/ CBP[B]
and prepare a written request with information necessary to complete
requested action to submit to the DEOC. Written requests for assistance
typically include information about the individual (name, date of
birth, passport information), type of illness, history of nonadherence
to treatment or history of travel, and instructions for TSA or CBP
officials who may encounter the individual. Request forms also include
contact information for CDC officials who can provide TSA or CBP with
additional information about or assistance with the case. DGMQ confirms
action taken with health department and encourages health officials to
contact the individual to inform him or her of the (1) placement on the
Do Not Board list, (2) entering of his or her name in TECS as a public
health alert, and (3) importance of adhering to TB treatment regimen.
Step 1: Step 4;
State or local health officials contact the closest CDC quarantine
station and provide information about a particular case.: DEOC
officials submit written request for assistance to the HHS SOC for
review.
Step 1: Step 5;
State or local health officials contact the closest CDC quarantine
station and provide information about a particular case.: HHS SOC
officials review the request to determine if the agency can provide
additional resources or assist CDC with the case and submit the request
to the DHS NOC.
Step 1: Step 6;
State or local health officials contact the closest CDC quarantine
station and provide information about a particular case.: OHA medical
officer on duty in the NOC reviews the request for assistance. OHA
contacts DGMQ directly with any questions.[C].
Step 1: Step 7;
State or local health officials contact the closest CDC quarantine
station and provide information about a particular case.: Depending on
the type of assistance requested, TSA, CBP, or both take the requested
action. TSA confirms request with OHA, manually adds individual's name
to the Do Not Board list, and sends it to airlines as with the No Fly
list. In instances in which several hours will pass before the list is
forwarded to the airlines, TSA will send messages to the airlines
noting the addition of a single name to the Do Not Board list. CBP
enters a TECS public health alert and searches passenger name records
to attempt to locate the individual.[D] CBP also prepares a be- on-the-
lookout notice for posting at ports of entry.
Source: GAO analysis of HHS and DHS information.
[A] Not all requests for assistance result in the placement of
individuals on the Do Not Board list or in TECS. CDC sometimes advises
the local health department to work with individuals to consider other
options for treatment. CDC also encourages health officials to begin
the process to issue a state isolation order if necessary. On the other
hand, CDC officials also stated that in some instances in which
physicians or local health officials did not feel strongly that an
individual with TB met the criteria for placement on the list, CDC
disagreed and requested assistance from DHS.
[B] In order to help ensure that individuals with TB undergo a complete
course of treatment, CDC also works with DHS to extend an individual's
authorized stay in cases in which, for example, an individual's visa
will expire soon or to change travel dates for airline tickets.
[C] OHA officials stated that in cases in which they had to follow up
with CDC regarding a request, it was usually to verify with CDC reasons
for requesting placement of an individual on the Do Not Board list but
not requesting a TECS public health alert for that individual, or vice
versa. OHA officials stated that they defer to CDC's determination for
assistance.
[D] According to CBP officials, in cases in which an individual with TB
is highly infectious, CBP is able to search passenger name records
multiple times in an hour.
[End of table]
The departments and their component agencies were able to test how the
new procedures worked in practice because information provided by HHS
for the period May 2007 to February 2008 showed that HHS coordinated
with DHS to request assistance for 72 actions to place individuals on,
or remove them from, the Do Not Board list, or to place or remove
public health alerts in TECS.[Footnote 38] Of these 72 requests, 21
were to add an individual to the Do Not Board list.[Footnote 39] Table
2 shows the number of requests for assistance CDC prepared for HHS to
submit to DHS by type of request in this period.[Footnote 40]
Table 2: HHS Requests for Assistance regarding Individuals with TB
Disease Submitted to DHS from May 2007 through February 2008:
HHS types of requests for assistance: Request to enter a public health
alert in TECS;
Number of requests: 10.
HHS types of requests for assistance: Request to remove a public health
alert from TECS;
Number of requests: 25.
HHS types of requests for assistance: Request to add a name to Do Not
Board list;
Number of requests: 21.
HHS types of requests for assistance: Request to remove a name from Do
Not Board list;
Number of requests: 16.
HHS types of requests for assistance: Total requests for individuals
with TB disease;
Number of requests: 72.
Source: GAO analysis of information provided by CDC.
[End of table]
All requests were for individuals with TB disease who fit the criteria
jointly established by CDC and DHS. In reviewing these requests for
assistance, we found that actions were typically completed within 24
hours of the time CDC initiated the request.[Footnote 41] According to
DHS officials, all requests were considered high priority and were
addressed. We also determined that CDC's requested assistance complied
with its criteria and included CDC contact information and detailed
instructions, such as how CBP officers should protect themselves and
others if they encounter the individual.
CDC Has Made Some Efforts to Inform State and Local Health Officials of
New Procedures and Tools, but Has Not Completed All Actions:
Although CDC has made some efforts to educate health officials,
according to CDC officials the agency has not yet completed all actions
to provide information to health officials who work with individuals
with TB about the new procedures and tools, or about the criteria for
adding individuals to or removing them from the Do Not Board list or
TECS. For example, CDC has presented information on the Do Not Board
list at various conferences and association meetings, such as the June
2008 meeting of the state epidemiologists association and the November
2007 meeting of its advisory council for TB elimination. Additionally,
CDC has used the Morbidity and Mortality Weekly Report[Footnote 42]--a
publication CDC makes available on its Web site at no charge--to
provide state and local officials with information about the criteria
for placement on or removal from the Do Not Board list or TECS. The
article describing the criteria was published in a September 2008
issue. However, other CDC actions to inform state and local officials
have yet to be completed. CDC plans to publish a companion product to
the Morbidity and Mortality Weekly Report article, which would consist
of a letter notifying officials of the publication and a guidance
document describing the new tools and procedures that would be sent via
e-mail to state and local health officials. According to CDC officials,
the companion product will also be posted on CDC's Web site, and CDC
will host Web-based seminars for state and local TB programs.
According to health officials, HHS requests for DHS assistance to deter
individuals with TB from traveling originate primarily with state and
local health officials, such as TB controllers, state and local health
department staff, and public and private physicians, who typically have
primary contact with individuals with TB and are more likely to be
aware that an individual might be planning to travel. Knowledge of the
new procedures and tools among these officials could prevent delays in
accessing federal assistance, as occurred with the U.S. citizen.
According to CDC officials, some health officials should already be
familiar with the new procedures because a number of them helped CDC
develop the criteria to determine whether an individual with TB should
be removed from the Do Not Board list or TECS. Furthermore, CDC
officials said they believe that state and local health department
officials should be aware of the changes because of CDC's close
relationships with their professional associations. These associations
have a role in promoting national policy and serving as liaisons
between local, state, and territorial and federal health departments.
However, an official with one such association said that staff
independently discovered the new procedures and tools, while staff from
another association told us that they were not aware of them.
Additionally, information about the new procedures and tools may be
especially important for those states with lower relative numbers of TB
cases, which may have less experience in accessing federal assistance.
Moreover, providing information about the criteria for new procedures
and tools can help ensure that state and local health officials can use
them appropriately. For example, in one case, an individual with TB who
had been added to the Do Not Board list presented a letter from county
health officials to airline staff stating that he no longer posed a
health risk to other travelers. Because county health officials did not
follow the correct procedure to notify CDC and request the individual's
removal from the Do Not Board list, he was not allowed to board his
flight.[Footnote 43]
HHS and DHS Have Not Finalized Plans to Complete Coordination Actions
between Federal Agencies:
As of September 2008, the two departments had not finalized plans for
completing additional actions they identified that are intended to
further strengthen their ability to respond to incidents involving
individuals with TB who intend to travel. HHS and DHS officials told us
that this was because their proposals for the additional work were
undergoing internal department review, required implementation over
time, or required further coordination with other departments and their
component agencies. It is unclear how much additional work is needed
because the departments did not have detailed plans and time frames for
completing these actions. Without these plans and time frames, HHS and
DHS will not have fulfilled the actions they identified as necessary to
strengthen their ability to respond to and prevent the cross-border
travel of individuals with infectious TB. HHS and DHS officials said
that they planned to meet in the fall of 2008 to further address the
additional actions that need to be taken.
Examples of some incomplete actions that require cross-agency
coordination include the following:
* HHS, in conjunction with CDC and DHS, plans to develop a training
module for its personnel to increase awareness of existing agency
capabilities, available resources, procedures for requesting
assistance, and communication protocols, according to the department's
after-action report on the U.S. citizen incident. HHS officials said
that while the agency may have specific procedures in place, they may
be applied inconsistently if officials in field offices are unaware of
them. However, these officials did not specify how they would
coordinate with CDC and DHS to finalize plans to develop or conduct the
training.
* CDC recommended that DGMQ, which operates the quarantine stations at
ports of entry, provide training and materials on infection control for
communicable diseases to CBP officers stationed at the ports of entry.
Specifically, DGMQ planned to give CBP officers small cards with
information on the use of personal protective equipment and procedures
for isolating individuals with suspected or confirmed infectious
diseases at ports of entry, to accompany officers' personnel badges.
However, according to DGMQ officials, CDC's progress on this
recommendation was delayed because of several factors, including the
need to negotiate with the CBP officers' union, which DGMQ did not
foresee. DGMQ officials told us that they had coordinated with the CBP
officers' union, but they did not have a specific date for when they
planned to issue the cards, which are still under agency review.
* CDC is collaborating with the Department of State and other agencies,
that are developing policies and procedures for using federal resources
to assist in transporting citizens and legal residents involved in a
public health incident abroad back to the United States. In the
incident involving the U.S. citizen, CDC did not use its plane to fly
the individual from Europe to the United States because the agency did
not want to expose the crew and any other passengers to TB. According
to CDC, while the agency worked to develop alternate suggestions for
travel or medical care for the U.S. citizen overseas, he once again
traveled against medical advice. CDC officials we spoke with said that
the agency was in the process of equipping the CDC plane with
appropriate medical equipment to transport individuals with infectious
respiratory diseases. However, officials said that activities related
to the transport of U.S. citizens back into the country require
continued coordination with the Department of State, which has primary
responsibility for assisting U.S. citizens abroad, and the Department
of Defense, which has appropriate medical equipment available.
* According to DHS officials, HHS and DHS need to further examine
issues related to ensuring that the distribution of personal and
medical information of individuals with communicable diseases who pose
potential public health threats is limited to protect privacy, while at
the same time conducting the necessary public health and law
enforcement activities to deter their travel and direct them to
treatment. Officials from both departments told us that they are
concerned that a perceived lack of procedures for safeguarding personal
information could provide a disincentive for an individual both to
disclose his or her illness and to seek treatment. DHS has recommended
convening subject-matter experts in patients' rights and the rights of
the public to be protected from potential exposure to infectious
diseases to determine appropriate procedures for law enforcement
officers who assist HHS in locating nonadherent individuals. DHS
officials said that the chief privacy officers for HHS and DHS have
begun to work together to address this issue.
HHS and DHS Have Activities Under Way to Assess Their Ability to
Respond to TB Incidents:
According to CDC officials, both departments have activities under way
to assess the effectiveness of the new procedures and tools.
Specifically, they plan to conduct performance monitoring of the new
request for assistance procedures and tools, discuss how information
sharing and coordination could be further improved, and develop an
annual report based on after-action reports that analyzes trends and
identifies potential improvements in agency response. In addition, both
departments are evaluating the new procedures and tools based on TB
incidents as they arise.
CDC Officials Are Conducting Some Performance Monitoring of the New
Procedures and Tools:
According to CDC officials, the agency is conducting some performance
monitoring of the new procedures and tools, such as tracking the number
of individuals who are being placed on and removed from the Do Not
Board list and the time lapse between when HHS submits a request for
assistance to DHS and when DHS completes the request. CDC officials
review this information during monthly staff meetings to identify areas
for improvement. In addition, CDC officials said that the request for
assistance procedures would be included as part of a measure that will
be monitored by its Division of Emergency Operations. This division
regularly monitors about 60 protocols for operations at any one time to
find ways to improve the performance of the protocols. CDC officials
also stated that they plan to implement CDC's secure data network to
transmit written requests for assistance between the departments, as
opposed to the current method of e-mailing requests as password-
protected documents, to improve security and decrease processing time.
HHS and DHS Officials Are Communicating Regularly in Order to Review
Changes Made to Procedures and Tools:
According to HHS and DHS officials, they communicate on a monthly and
weekly basis to discuss changes made to procedures and tools as a
result of the 2007 TB incidents and their continued applicability to
responding to TB cases, as well as issues related to information
sharing for responding to such cases. For example, these officials
reported that in addition to the initial June 2007 meeting, they hold
in-person monthly meetings to help officials refine the new procedures
and tools as necessary to better address potential limitations in
future incident response. For example, during these meetings, officials
discuss what information DHS needs to complete an HHS request for
assistance to ensure that the appropriate action is taken. Officials
said that they also use these meetings as an opportunity to discuss the
differences in the approaches CDC, TSA, and CBP officials have toward
public health incidents, such as the agencies' practices for sharing
identifying information. Officials from HHS, CDC, and DHS's OHA also
reported that they communicate by phone and e-mail several times a week
to discuss the status of current requests for assistance and other
public health issues that may require DHS assistance. According to CDC
and DHS officials, this informal and frequent contact encourages
information sharing across the departments and their component
agencies, allowing them to better understand and effectively address
issues.
CDC Plans to Analyze Future After-Action Reports to Identify
Improvements in Agency Response:
CDC officials said that they plan to develop an annual compilation
report analyzing all after-action reports, including those for TB, that
were completed in the previous year. Analysis of these reports, which
is to generally include summaries of the events and observations for
improvement, allow CDC officials to identify trends, review progress
over time, and determine recommendations for broad agency improvement
for future public health response. CDC plans to issue the first annual
compilation report for those after-action reports completed in 2008,
but has not set a target date for issuance. As of September 2008, CDC
officials told us that the first compilation report would not include
the incident involving the U.S. citizen, and would only include those
incidents occurring after August 2008.
HHS and DHS Officials Continue to Revise New Procedures and Tools Based
on Subsequent TB Cases:
According to HHS and DHS officials, they are using the departments'
responses to subsequent TB cases as opportunities to revise the new
procedures and tools and develop skills to help enhance their response
to future TB incidents. Internal control standards for the federal
government call for agencies to assess the quality of performance over
time so that deficiencies can be identified and addressed.[Footnote 44]
CDC and DHS officials said that they view each use of the request for
assistance procedures and tools as a "natural exercise" that provides
an opportunity to identify areas for improvement and refine the
procedures and tools as necessary. For example, according to DHS
officials, CDC officials responded to DHS feedback by increasing the
level of detail about the medical condition of the individual included
on requests submitted to DHS while simultaneously increasing the
privacy protections of the identifying information provided on the
forms. Also, after subsequent incidents, CDC officials determined that
it was necessary to specify which agency officials should participate
in the conference calls that include CDC, state, and local officials to
determine whether an individual with an infectious disease, such as TB,
who intended to travel justified a need to request assistance from DHS.
According to HHS officials, the agency's coordination with DHS for more
than 70 requests for assistance since the 2007 TB incidents also has
helped agency officials become familiar with their roles in the
information-sharing process that is outlined in the new procedures.
Conclusions:
The new procedures and tools that HHS and DHS established in the wake
of the spring 2007 incidents involving the two individuals with drug-
resistant TB have improved federal interagency information sharing and
coordination for responding to TB incidents and could lay the
foundation for continuing improvement in responding to future TB
incidents. In addition, as a result of the collaboration between HHS
and DHS in making these changes, each department now has a clearer view
of how the other's mission and approach to public health incidents
differs from its own, which could further enhance their ability to
collaborate in responding not only to similar TB incidents but also to
other future public health threats.
Despite DHS's progress in enhancing TECS so that CBP officials can
better identify individuals via electronic public health alerts, this
enhancement is applicable only for some types of biographic
information, but not others. Not exploring the costs and benefits of
further modifying TECS to create public health alerts based on
variations of additional types of biographic information may result in
missed opportunities to locate persons subject to public health alerts
and deter them from entering the United States.
Additionally, HHS and DHS have more opportunities to improve their
information-sharing efforts in responding to future TB incidents. For
example, unless state and local health officials are informed and
educated about the new tools and procedures, delays in accessing
federal assistance, like those encountered during the two TB incidents,
could persist. Specifically, without wide dissemination of the
procedures for placing individuals with TB on, or removing them from,
the Do Not Board list, or for placing or removing a public health alert
in TECS, state and local health officials may not be aware of the
federal assistance at their disposal for use in locating individuals
with TB who are nonadherent with treatment and may intend to travel
against medical advice. Additionally, state and local health officials
who have limited knowledge of these changes and no previous experience
in working with federal officials at the field office level may
encounter difficulties in using the new procedures and tools.
Furthermore, HHS and DHS have identified additional actions that they
need to take to further strengthen their ability to respond to
incidents involving individuals with TB who intend to travel, including
some actions that require cross-agency coordination for completion.
However, the departments have not developed an action plan for ensuring
that these multiagency efforts are accomplished. Absent a clear plan
with associated time frames for completing cross-agency actions, the
departments may not be accountable for taking the corrective actions
and ensuring that all identified deficiencies are mitigated.
Recommendations for Executive Action:
To ensure continuing improvements in HHS's and DHS's new procedures and
tools developed in response to the 2007 TB incidents and to improve
awareness of these changes, we are making the following three
recommendations.
We recommend that the Secretary of DHS direct CBP to determine whether
the benefits exceed the costs of enhancing TECS capabilities when
creating public health alerts to include variations on other types of
biographic information that could further enhance its ability to locate
individuals who are subject to public health alerts and, if so, to
implement this enhancement. We also recommend that the Secretary of HHS
and the Secretary of DHS work together to:
* continue to inform and educate state and local health officials about
the new procedures and tools and:
* develop plans with time frames for completing additional actions that
require cross-agency coordination to respond to future TB incidents.
Agency Comments and Our Evaluation:
We requested comments on a draft of this report from HHS and DHS. Both
departments provided written comments in letters dated September 24,
2008, and September 30, 2008, respectively, which are summarized below
and reprinted in appendixes II and III.
HHS and DHS generally agreed with our recommendations. With regard to
our first recommendation on enhancing TECS capabilities to include
variations on other types of biographic information, DHS said that CBP
has completed a cost-benefit analysis and determined that this
enhancement would increase to an unmanageable level the number of
possible alerts requiring further research by CBP officers and increase
delays at ports of entry. However, in response to our recommendation,
CBP is drafting a policy and new procedures that when implemented will
require that officers (1) review an individual's biographic information
when entering public health alerts to determine whether variations on
this information could produce an accurate public health alert and, if
so, (2) create a new public health alert based on the variation of this
biographic information. CBP believes that this approach will enhance
capabilities without causing delays, although we believe that it will
be important to monitor implementation to ensure that the approach
provides the intended results.
With regard to our second recommendation, HHS and DHS stated that they
were working together on efforts that, once completed, will help to
ensure that state and local health officials are better informed about
the new procedures and tools. Finally, HHS and DHS stated that they
were working to address our third recommendation to develop plans with
time frames for completing the remaining actions that require cross-
agency coordination, but did not address whether they were developing
plans with time frames for completing the other remaining additional
actions. We believe that absent these plans, there is no guarantee the
departments will complete these actions that are important for ensuring
full cross-agency coordination in response to future TB and other
public health incidents.
In commenting on a draft of this report, HHS stated that it disagreed
with our assessment of "the lack of agency coordination." However, we
found that following the incidents HHS and DHS had identified
coordination deficiencies in their responses, which they deemed serious
enough to require the development of new procedures and tools. DHS also
raised two issues regarding our findings related to CBP. First, DHS
noted that CBP field locations often receive and handle requests from
CDC regarding individuals with communicable diseases and that CBP
officials at the time handled the incident involving the Mexican
citizen at the local level according to existing protocols. Second, CBP
wished to clarify that although procedures have been "fine-tuned" since
the incident occurred, CBP believes that the procedures in place at the
time of the incidents were comprehensive. We maintain that the fact
that CBP created new standard operating procedures for communicating
with HHS and for restricting international travel of persons with such
public health concerns is evidence that the protocols and procedures in
place at the time were not comprehensive or effective.
HHS and DHS also provided technical comments. We have amended our
report to incorporate these clarifications where appropriate.
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If you or your staff members have any questions about this report,
please contact Cynthia A. Bascetta at (202) 512-7114 or
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report. GAO staff who made contributions to this report are listed in
appendix IV.
Signed by:
Cynthia A. Bascetta:
Director, Health Care:
Signed by:
Eileen R. Larence:
Director, Homeland Security and Justice:
[End of section]
Appendix I: CBP Traveler Inspection Procedures at Air and Land Ports of
Entry:
U.S. Customs and Border Protection (CBP), a component agency of the
Department of Homeland Security (DHS), is the agency in charge of
inspecting individuals seeking to enter the United States at air, land,
and sea ports of entry.[Footnote 45] Each day, over 1 million
individuals, both non-U.S. citizens and U.S. citizens, seek entry into
the United States. In addition to determining whether these individuals
are eligible to enter the country, CBP officers perform a wide range of
law enforcement duties, such as screening cargo for weapons or illegal
goods, preventing narcotics and agricultural pests from entering the
country, and identifying and arresting persons with criminal warrants.
Nearly 75 percent of all border crossings are at land ports of entry,
and nearly 95 percent are at air or land ports.[Footnote 46] (See fig.
5.)
Figure 5: Border Crossings at Ports of Entry in Fiscal Year 2005:
This figure is a pie chart showing the percentages of border crossings
at ports of entry in fiscal year 2005.
Land: 317,765,246: 74%;
Air: 86,123,406: 20%;
Sea: 26,228,248: 6%.
[See PDF for image]
Note: Fiscal year 2005 is the most recent year for which data on
travelers entering the United States are available by mode of entry.
[End of figure]
Primary and Secondary Inspection Processes:
According to CBP officials, the inspection of individuals arriving at
air and land ports of entry is described as a layered process designed
to ensure management, control, and security of U.S. borders while
facilitating the flow of millions of legitimate individuals and goods
into the United States. Officers are trained in customs and immigration
law, law enforcement techniques, and agricultural requirements and must
be able to carefully observe individuals, while using available tools,
equipment, and support, in order to make sound decisions on whether to
admit, detain, or deny entry to a traveler. CBP policies and procedures
for inspecting individuals at all ports of entry require officers to
determine the nationality of individuals and their admissibility, that
is, whether they are eligible to enter the country. Because most
individuals attempting to enter the country through ports of entry have
a legal basis for doing so, a streamlined screening procedure referred
to as primary inspection is used to process those individuals who can
readily be identified as admissible.
Persons whose admissibility cannot be readily determined may be
subjected to a more detailed review called secondary inspection. This
involves a closer inspection of travel documents and possessions,
additional questioning by CBP officers, and cross-references through
multiple law enforcement databases, including the Treasury Enforcement
Communications System (TECS), to verify the traveler's identity,
background, and purpose for entering the country, and to detect any
violations or risks to the public. In secondary inspection, an officer
makes the final determination to admit the traveler, deny admission, or
take other actions (such as releasing the traveler to another law
enforcement entity for prosecution) based upon the results of the
inspection. When possible, CBP officers also rely on canine and
antiterrorism task force teams to conduct discretionary inspections of
travelers throughout the inspection process.
Differences in Inspection Procedures at Air and Land Ports of Entry:
Although the procedures for inspecting individuals are generally the
same at air and land ports of entry, there are differences that are due
to variations in the ports' operational environments.
Air Ports of Entry:
The procedures for inspecting individuals at air ports of entry differ
from those at land ports of entry because commercial airlines are
required to electronically transmit passenger manifest information to
CBP through the Advanced Passenger Information System prior to the
departure of international flights either from the United States or
from other countries that are bound for the United States. This advance
manifest information allows CBP time to conduct prescreening by
querying a variety of law enforcement databases, including TECS and
other types of alerts, to detect lookout records and warnings for
various violations before individuals enter the country. Upon arrival
in the United States at an air port of entry, however, individuals
undergo the same general process in primary and secondary inspection as
they do at land ports of entry. During primary inspection, individuals
arriving by air must present documentation of citizenship and
admissibility, such as a U.S. passport, permanent resident card, or
foreign passport containing a visa issued by the Department of
State.[Footnote 47] CBP officers must take physical possession of
identification and match the photo with the individual, request
declaration of residence, obtain an oral declaration concerning length
of stay, ascertain purpose or intent of travel, and obtain a binding
written customs declaration. However, unlike procedures at land ports
of entry, CBP officers perform TECS queries during primary inspection
on all individuals to identify potential matches to lookouts and
warnings that were detected through the prescreening process. When an
officer determines through primary inspection that additional
questioning or inspection is required, individuals are referred to
secondary inspection along with individuals who are matched to a TECS
alert or warning as detected through the prescreening process.
Land Ports of Entry:
CBP officers face a greater challenge to identify and screen
individuals at land ports of entry, in part because of the lack of
advance traveler information and the high volume of travelers who can
arrive by vehicle or on foot at virtually any time. Given these
challenges, CBP officers rely heavily on observation and interview
skills to be able to quickly detect suspicious activity or potential
violations that may render a person inadmissible. During primary
inspection, CBP officers are directed to conduct inspections on all
travelers. As part of that inspection process, CBP officers are to
perform TECS queries on as many travelers as feasible.[Footnote 48] All
vehicles are queried in TECS using license plate readers installed in
primary inspection vehicle lanes. For pedestrian lanes, the traveler's
name can be machine read from the travel document or manually keyed
into TECS by the CBP officer. For vehicles, CBP officers frequently
inspect multiple travelers entering in a single vehicle, and TECS
queries are generally conducted on the individuals and the vehicle
data. In addition, CBP officers visually examine the vehicle and
inspect car passengers, verify license plate information, and monitor
for the presence of radioactive material, among other tasks.[Footnote
49] For vehicles, CBP officers frequently inspect multiple travelers
entering in a single vehicle, and the TECS queries are generally
conducted on the individuals and on the vehicle. If necessary, CBP
officers are to refer the travelers and their vehicle for secondary
inspection.
Public Health at Air and Land Ports of Entry:
In addition to screening millions of travelers during primary and
secondary inspection, CBP officers are responsible for observing all
travelers for obvious signs and symptoms of quarantinable and
communicable diseases, such as (1) fever, which could be detected by a
flushed complexion, shivering, or profuse sweating; (2) jaundice
(unusual yellowing of skin and eyes); (3) respiratory problems, such as
severe cough or difficulty breathing; (4) bleeding from the eyes, nose,
gums, or ears or from wounds; and (5) unexplained weakness or
paralysis. However, CBP officials emphasized that CBP officers are not
medically trained or qualified to physically examine or diagnose
illness among arriving travelers.
There are three general scenarios in which CBP officers encounter ill
persons who are in need of medical attention or who may pose a public
health threat:
* In the most common scenario, CBP officers encounter an individual who
discloses that he/she needs medical attention for various health
reasons.
* CBP officers suspect an individual may need medical attention or may
pose a public health risk to others (e.g., individual exhibits obvious
signs and symptoms of illness, such as fever, weakness, or both, as
observed by officers).
* CBP officers encounter an individual who is an exact match to a
public health alert in TECS and may pose a public health risk to
others.
In all three scenarios, CBP protocols require officials, at a minimum,
to isolate the person while notifying officials at CDC and, depending
on the circumstance, to contact the designated local public health
authorities (e.g., hospitals and emergency medical personnel).[Footnote
50] Each port of entry is supplied with personal protective equipment,
including masks and gloves, and inspecting officers must use this
equipment in dealing with travelers suspected of having communicable or
quarantinable illnesses, as well as while handling the individuals'
documents and belongings. CBP officers are responsible for coordinating
with CDC to provide assistance in identifying arriving individuals from
areas with known communicable disease outbreaks.
[End of section]
Appendix II: Comments from the Department of Health and Human Services:
The report number referenced in these comments changed to GAO-09-58.
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
September 24, 2008:
Cynthia Bascetta:
Director, Health Care:
Government Accountability Office:
441 G. Street NW:
Washington, DC 20548:
Dear Ms. Bascetta:
Enclosed are the Department's comments on the U.S. Government
Accountability Office's (GAO) draft report entitled: "Public Health And
Border Security: HHS and DHS Should Further Strengthen Their Ability to
Respond to TB Incidents" (GAO-08-I 076N1).
The Department appreciates the opportunity to review and comment on
this report before its publication.
Sincerely,
Signed by:
Jennifer R. Luong:
for:
Vincent J. Ventimiglia, Jr.:
Assistant Secretary for Legislation:
Attachment:
General Comments Of The Department Of Health And Human Services (HHS)
On The Government Accountability Office's (GAO) Draft Report Entitled:
HHS AND DHS Should Further Strengthen Their Ability To Respond To TB
Incidents (GAO-08-1076NI):
The Centers for Disease Control and Prevention (CDC) wishes to thank
the GAO for the opportunity to review and comment on this Draft Report.
CDC concurs with the GAO's recommendations and respectfully submits the
following general comments.
With regards to privacy issues – specifically pages 10, 24, 25, 41: CDC
has published a system of records notice ("SORN") setting forth the
agency's routine uses for how it may distribute individually
identifiable information relating to quarantine activities pursuant to
the Privacy Act. A copy of this system notice will be sent to center
policy along with these comments.
With regards to CDC's communication with partners – specifically in the
opening of the document and found on pages: Highlights section/opening
page, 7, 10, 11, 22, 26, 27, 29, 38, 39, and 40, 45, and 46: CDC has
made extensive efforts to provide information to its partners and
stakeholders. This has included presentations at the following:
* Council of State and Territorial Epidemiologists
* National Public Health Preparedness Summit
* National TB Controller Association
* Advisory Committee for the Elimination of TB
* Los Angeles County Public Health Conference
* 58th Annual TB/RD Institute - Tuberculosis: Shrinking World, Growing
Problem
* National Tuberculosis Controllers Workshop in Atlanta
* Annual FBI/CDC Joint Criminal and Epidemiological Investigations
Workshop (Denver, CO)
* Advisory Council for the Elimination of Tuberculosis
* World Tuberculosis Day Conference Held by Miami-Dade County Health
Department
* California Tuberculosis Controllers' Conference
* Southwest Tuberculosis Controllers Meeting.
CDC has also walked through the criteria and procedure with the
numerous state health departments involved in requesting DHS assistance
since June 2007.
As stated above, CDC concurs with GAO's recommendations surrounding the
collaboration, communication and implementation planning with DHS in
informing state and local health officials about the new procedures and
tools. We also concur with GAO's recommendation regarding planning for
future incidents that require cross-agency coordination. However, we
disagree with GAO's assessment of the lack of agency coordination; in
the attached Technical Comments, we provide examples of this
collaboration – many specifically related to the May 2007 incident
referenced in the Report.
[End of section]
Appendix III: Comments from the Department of Homeland Security:
The report number referenced in these comments changed to GAO-09-58.
U.S. Department of Homeland Security:
Washington, DC 20528:
Homeland Security:
September 30, 2008:
Ms. Cynthia Bascetta:
Director, Health Care:
Ms. Eileen R. Larence:
Director, Homeland Security and Justice:
U.S. Government Accountability Office:
441 G St., NW:
Washington, DC 20548:
Dear Ms. Bascetta & Ms. Larence:
The U.S. Department of Homeland Security (DHS) appreciates the
opportunity to review and comment on the Government Accountability
Office's (GAO) draft report GAO-08-1076NI titled Public Health And
Border Security: HHS and DHS Should Further Strengthen Their Ability to
Respond to TB Incidents (290670).
The GAO report examined two public health incidents that took place in
the spring of 2007; one involving a U.S. citizen and a second incident
involving a Mexican citizen. Regarding the incident involving the U.S.
citizen, U.S. Customs and Border Protection (CBP) had a single point of
failure in this case. The GAO recognized that the situation has been
corrected and has resulted in structural and technological improvements
to border security due to immediate and decisive action by CBP
leadership. CBP reiterates its commitment to proactively utilize the
lessons learned from this incident to strengthen homeland defenses and
response to infected travelers.
With regard to the incident involving the Mexican citizen, the report
states that "CBP officials at the land port of entry did not notify DHS
senior officials until 14 days after CDC (Centers for Disease Control
and Prevention) requested CBP assistance." CBP ports of entry and field
locations often receive requests from local CDC counterparts regarding
individuals with communicable diseases. Some of the CDC stations are co-
located with CBP at ports of entry. CBP was handling this incident on
the local level according to existing protocols. CBP placed nationwide
alerts in its databases for the name, as provided by the CDC, but it
did not result in any matches. Upon learning of the individual's true
identity, CBP updated the original nationwide alert with accurate
identification information. CBP has no record of the individual
crossing through a port of entry into the United States after the
Mexican citizen's true identity was established.
The report also states that DHS lacked comprehensive procedures for
information sharing and coordination and had border inspection
shortfalls which hindered the federal response to the two TB incidents.
We would like to clarify that although procedures have been fine-tuned
as a result of the two incidents, they were comprehensive. Moving
forward and incorporating lessons learned, we have developed standard
operating procedures that support both the DHS and U.S. Department of
Health and Human Services (HHS) operational protocols. Our procedures
describe the communication pathways between HHS and DHS for requesting
public health assistance, and procedures to restrict international
travel of a person, or persons, suspected or diagnosed with a
quarantinable disease or a communicable disease of public health
significance.
DHS generally concurs with the report's three recommendations to
enhance the federal response to future TB incidents. Following are our
recommendation-specific comments; technical comments were provided
under separate cover.
GAO Recommendation 1: We recommend that the Secretary of DHS direct CBP
to determine whether the benefits exceed the costs of enhancing TECS
capabilities when creating public health alerts to include variations
on other types of biographic information which could further enhance
their ability to locate individuals who are subject to public health
alerts and, if so, to implement this enhancement.
DHS Response: Concur. Upon evaluation of the benefits and costs of
enhancing TECS search capabilities, CBP concluded that further
variation on the biographic information would not only result in
increased delays, but substantially increase the number of possible
matches. The possible matches would be so numerous that officers would
not be able to direct their attention to the most critical closest
matches.
In an effort to satisfy the intent of this recommendation, CBP is
drafting a new policy and procedures for officers creating subjects of
special interest (e.g. Public Health). These new procedures would
include a review of the biographic information to determine if
variations to the information are possible. This solution offers a
controlled and expandable approach to extending the biographic search
for measurement against operational impacts.
GAO Recommendation 2: The Secretary of HHS and the Secretary of DHS
work together to inform and educate state and local health officials
about the new procedures and tools.
DHS Response: Concur. This effort is already underway through routine
CDC outreach to state and local health officials, but also, formally,
via a Morbidity and Mortality Weekly Report article and commentary that
was released September 18, 2008. CDC was the primary author, but DHS
collaborated. DHS and CDC have an ongoing working relationship with
state, local, and tribal authorities to continually improve mutual
understanding of each other's role.
GAO Recommendation 3: Secretary of HHS and Secretary of DHS work
together to develop plans with timeframes for completing additional
actions that require cross-agency coordination to respond to future TB
incidents.
DHS Response: Concur, The jointly developed Standard Operating
Procedures (SOPs) for this effort which were formalized and presented
to the appropriate oversight committees in Congress were placed in
operation late last summer and have an excellent history of enabling
close, formal cooperation on TB incidents. In addition, as GAO is
aware, DHS has an ongoing program of periodic meetings to assess the
efficiency of the system and to modify it as needed. The next formal
interagency meeting, involving not only HHS and DHS, but the U.S.
Department of State, U.S. Department of Justice and U.S. Department of
Defense will occur the week of September 29, 2008.
We thank you for the opportunity to review and provide comments on this
draft report and look forward to working with you on future homeland
security issues.
Sincerely,
Signed by:
Jerald E. Levine:
Director:
Departmental GAO/OIG:
Liaison Office:
[End of section]
Appendix IV: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Cynthia A. Bascetta, (202) 512-7114 or bascettac@gao.gov:
Eileen R. Larence, (202) 512-6510 or larencee@gao.gov:
Acknowledgments:
In addition to the contacts named above, Karen Doran, Assistant
Director; John Mortin, Assistant Director; George Bogart; Frances Cook;
Katherine Davis; Shana Deitch; Jennifer DeYoung; Raymond Griffith;
Catherine Kim; Maren McAvoy; Carolina Morgan; Roseanne Price; Janay
Sam; Jessica Smith; and Ellen Wolfe made significant contributions to
this report.
[End of section]
Related GAO Products:
Border Security: Despite Progress, Weaknesses in Traveler Inspections
Exist at Our Nation's Ports of Entry. GAO-08-329T. Washington, D.C.:
January 3, 2008.
Global Health: U.S. Agencies Support Programs to Build Overseas
Capacity for Infectious Disease Surveillance. GAO-07-1186. Washington,
D.C.: September 28, 2007.
Border Security: Security Vulnerabilities at Unmanned and Unmonitored
U.S. Border Locations. GAO-07-884T. Washington, D.C.: September 27,
2007.
Influenza Pandemic: Further Efforts Are Needed to Ensure Clearer
Federal Leadership Roles and an Effective National Strategy. GAO-07-
781. Washington, D.C.: August 14, 2007.
Global Health: Global Fund to Fight AIDS, TB and Malaria Has Improved
Its Documentation of Funding Decisions but Needs Standardized Oversight
Expectations and Assessments. GAO-07-627. Washington, D.C.: May 7,
2007.
Border Security: Continued Weaknesses in Screening Entrants into the
United States. GAO-06-976T. Washington, D.C.: August 2, 2006.
Emergency Preparedness: Some Issues and Challenges Associated with
Major Emergency Incidents. GAO-06-467T. Washington, D.C.: February 23,
2006.
Results-Oriented Government: Practices That Can Help Enhance and
Sustain Collaboration among Federal Agencies. GAO-06-15. Washington,
D.C.: October 21, 2005.
Emerging Infectious Diseases: Review of State and Federal Disease
Surveillance Efforts. GAO-04-877. Washington, D.C.: September 30, 2004.
Global Health: Challenges in Improving Infectious Disease Surveillance
Systems. GAO-01-722. Washington, D.C.: August 31, 2001.
Public Health: Trends in Tuberculosis in the United States. GAO-01-82.
Washington, D.C.: October 31, 2000.
Managing for Results: Barriers to Interagency Coordination. GAO/GGD-00-
106. Washington, D.C.: March 29, 2000.
Standards for Internal Control in the Federal Government. GAO/AIMD-00-
21.3.1. Washington, D.C.: November 1999.
[End of section]
Footnotes:
[1] Individuals who have been exposed to TB and have a positive TB test
but who do not have TB bacteria growth in their lungs or other sites in
the body are said to have latent TB infection and cannot transmit TB to
other people.
[2] The annual number of TB cases in the United States is declining;
however, the rate of decline has slowed from 7.3 percent from 1993
through 2000 to 3.8 percent from 2000 through 2007. See Centers for
Disease Control and Prevention, "Trends in Tuberculosis - U.S., 2007,"
Morbidity and Mortality Weekly Report, vol. 57, no. 11 (2008).
[3] See 42 U.S.C. § 264.
[4] 42 U.S.C. § 268(b).
[5] Ports of entry are government-designated locations where CBP
screens persons, goods, and conveyances. There are 327 air, land, and
sea ports of entry in the United States.
[6] See GAO, Standards for Internal Control in the Federal Government,
GAO/AIMD-00-21.3.1 (Washington, D.C.: November 1999). We used the
criteria in these standards, issued pursuant to the requirements of the
Federal Managers' Financial Integrity Act of 1982 (FMFIA), to provide
the overall framework for establishing and maintaining internal control
in the federal government, Pub. L. No. 97-255, 96 Stat. 814. Also
pursuant to FMFIA, the Office of Management and Budget issued Circular
No. A-123, revised December 21, 2004, to provide the specific
requirements for assessing the reporting on internal controls. Internal
control standards and the definition of internal control in Circular A-
123 are based on the aforementioned GAO standards. See also Related GAO
Products at the end of this report.
[7] CDC does not plan to issue its after-action report on the U.S.
citizen incident in a final format. An after-action report generally
includes a summary of the event and observations for improvement.
Neither HHS nor DHS completed after-action reports for the incident
involving the Mexican citizen with TB. CDC officials said that an after-
action report was not required because the response did not require the
use of Director's Emergency Operations Center (DEOC) resources or
capabilities. CDC officials said that they typically prepare after-
action reports only for incidents that require DEOC capabilities,
according to CDC policy.
[8] To determine how the new procedures worked in practice, we analyzed
information provided by HHS that showed the number of requests for
assistance that HHS made to DHS from May 2007 through February 2008,
the type of action requested, the extent to which the request
communicated the risk of the disease, and how long it took DHS to
implement the requested action.
[9] At the time of the incidents, the revised International Health
Regulations had been ratified but was not yet in effect. The
International Health Regulations, which went into effect later that
same year, is a legally binding agreement among countries that agree to
the regulations and the World Health Organization that provides a
framework for the coordination of the management of public health
emergencies of international concern. CDC notified the World Health
Organization of the TB incident involving the U.S. citizen under the
auspices of the International Health Regulations; however, the World
Health Organization was not involved in HHS's or DHS's attempts to
locate the U.S. citizen.
[10] See GAO, Results-Oriented Government: Practices That Can Help
Enhance and Sustain Collaboration among Federal Agencies, GAO-06-15
(Washington, D.C.: Oct. 21, 2005); Catastrophic Disasters: Enhanced
Leadership, Capabilities, and Accountability Controls Will Improve the
Effectiveness of the Nation's Preparedness, Response, and Recovery
System, GAO-06-618 (Washington, D.C.: Sept. 6, 2006); and GAO/ AIMD-00-
21.3.1.
[11] A visa is a travel document for people seeking to travel to the
United States for a specific purpose, including to immigrate, study,
visit, or conduct business; the document allows a person to travel to a
U.S. port of entry and ask for permission to enter the country. The
State Department processes visa applications, issues visas, and
maintains information about individuals who have visas in various visa
databases.
[12] GAO-06-15, GAO-06-618, and GAO/AIMD-00-21.3.1.
[13] GAO/AIMD-00-21.3.1.
[14] Five to 10 percent of people with latent TB infection will develop
active TB disease sometime in their lives. Only individuals with active
TB disease can transmit TB to other people.
[15] With proper treatment, more than 95 percent of individuals with
non-drug-resistant TB can be cured, whereas from 30 percent to 80
percent of individuals with drug-resistant TB can be cured, depending
on the level of drug resistance.
[16] Isolation and quarantine are public health measures intended to
stop the spread of communicable disease. Isolation refers to the
separation of people who are sick with an infectious illness from those
who are not infected. Quarantine refers to the separation of persons
who are not currently sick but have been exposed to an infectious agent
and may become sick, spread illness to others, or both. Both isolation
and quarantine restrict the movement of those who are infected. In most
cases, isolation is voluntary. HHS's isolation and quarantine
authorities are limited to a list of quarantinable communicable
diseases specified by Executive Order of the President, which, in
addition to infectious TB, currently includes cholera, diphtheria,
plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute
respiratory syndrome, and influenza caused by novel or reemergent
viruses that are causing or have the potential to cause a pandemic. See
42 U.S.C. § 264(b); Exec. Order No. 13295, 68 Fed. Reg. 17255 (Apr. 4,
2003), as amended by Exec. Order No. 13375, 70 Fed. Reg. 17299 (Apr. 1,
2005).
[17] CDC works closely with the World Health Organization, whose Stop
TB Strategy aims to reduce the global burden of TB by 2015. During
international public health incidents, the World Health Organization
also coordinates rapid outbreak response and manages and disseminates
relevant information to its global partners.
[18] Each quarantine station has jurisdiction over one to five states,
which includes the ports of entry located in those states. The
exceptions are the three quarantine stations a piece in California and
Texas, each of which has jurisdiction over ports of entry in part of
the state, in addition to jurisdiction over ports of entry in one or
more additional states. DGMQ quarantine station officials work closely
with and train DHS, CBP, and other partners at ports of entry.
[19] 42 U.S.C. § 268(b).
[20] The No Fly list contains the names of individuals with known or
suspected links to terrorism and is a subset of the consolidated
terrorist watch list that is maintained by the Federal Bureau of
Investigation's Terrorist Screening Center. While the Terrorist
Screening Center maintains the No Fly list, TSA is responsible for the
administration of the list as well as for disseminating it to airlines
once daily.
[21] See 42 U.S.C. § 264; 42 C.F.R. § 71.32(a); and Exec. Order No.
13295, 68 Fed. Reg. 17255 (Apr. 4, 2003), as amended by Exec. Order No.
13375, 70 Fed. Reg. 17299 (Apr. 1, 2005).
[22] DHS has the authority to grant waivers of inadmissibility if
certain criteria are met.
[23] Once the individual reentered the United States, CDC issued a
provisional federal isolation order--the first since 1963. Upon his
return to the United States, CDC arranged his travel under this
isolation order.
[24] GAO-06-15.
[25] GAO/AIMD-00-21.3.1.
[26] GAO-06-618.
[27] Although TSA had policies and procedures in place for nominating
individuals with suspected ties to terrorism to the No Fly list, it did
not have a comparable way to prevent someone from flying because of
public health concerns.
[28] HIPAA, Pub. L. No. 104-191, subtitle F of title II, 110 Stat.
1936, 2021-2034 (pertinent part codified as amended at 42 U.S.C. §§
1320d to d-8) (restrictions apply only to health plans, health care
clearinghouses, and, in certain instances, health care providers).
Privacy Act of 1974, Pub. L. No. 93-579, § 3, 88 Stat. 1896, 1897
(codified as amended at 5 U.S.C. § 552a) (restrictions apply to
agencies).
[29] See 45 C.F.R. § 164.512(b) (2007), and 5 U.S.C. § 552a(b).
[30] According to CDC, while state and local public health authorities
may require formal hearings to compel patient isolation or restrict
patient movement, federal authorities to temporarily isolate or
quarantine a patient can be applied quickly, without a formal hearing.
[31] The State Department issues a type of visa, the border-crossing
card, to Mexican citizens for travel to the United States. Mexican
citizens can apply for a border-crossing card at U.S. consulates
throughout Mexico. Once the State Department approves their
applications, Mexican citizens are able to use the cards to apply for
entry to the country without additional documentation, provided they
are seeking admission by land or sea as temporary visitors for business
or pleasure from a contiguous territory.
[32] See GAO-06-15 and GAO-06-618.
[33] See GAO/AIMD-00-21.3.1.
[34] According to CDC officials, the procedures for HHS to request
assistance from DHS also provide a formal, streamlined mechanism for
CDC to request information from CBP and air carriers to conduct contact
tracing. To assist in this effort, CBP compiles passenger records and
provides the information directly to the DEOC, rather than routing it
back through the NOC and the SOC, to protect individuals' privacy. CBP
then notifies the NOC that the information was provided to the DEOC to
complete the request. Upon request from DHS, airlines also directly
provide CDC with information collected from passenger manifests and the
departure/arrival forms airline passengers complete when flying
internationally.
[35] According to CDC, foreign ministries of health or the World Health
Organization can request that individuals be placed on the Do Not Board
list and would request that assistance through CDC.
[36] In the year since the new procedures and tools have been developed
and implemented, CDC has not had to request DHS assistance or use the
tools to deter travel in any cases other than for individuals with TB.
[37] See GAO, Border Security: Despite Progress, Weaknesses in Traveler
Inspections Exist at Our Nation's Ports of Entry, GAO-08-219
(Washington, D.C.: Nov. 5, 2007).
[38] For the purposes of our review, totals were derived from request
forms prepared by CDC for HHS to submit to DHS. The total number of
requests for assistance represents the total number of written request
forms CDC prepared for HHS to submit electronically to DHS, not the
total number of individuals with TB or other infectious diseases
planning travel. Some forms included requests for more than one type of
assistance, such as a request to place an individual on the Do Not
Board list and a request to place a public health alert in TECS for the
same individual. CDC officials explained that any discrepancies in the
number of requests--for example, more requests to remove a public
health alert from TECS than the number of requests to place a public
health alert in TECS--may be because public health alerts were entered
into TECS at a port of entry prior to the implementation of the
procedures that centralized the process for requesting assistance and
were therefore not submitted on a written request form.
[39] In addition, for the period May 2007 to February 2008, HHS
requested passenger locater information from CBP in 56 instances so
that CDC could conduct contact tracing investigations to identify and
contact individuals who may have been exposed to TB on board an
airplane, bringing the total number of requests to 128. These 56
requests were for passenger manifests on flights where individuals may
have been exposed to measles, mumps, rubella, and TB.
[40] In September 2008, HHS officials provided updated numbers for
requests for assistance made during the period from June 2007 through
May 2008. During that time frame, officials said that HHS requested
assistance for 103 actions to place individuals with TB disease on, or
remove them from, the Do Not Board list or to place or remove public
health alerts in TECS.
[41] We did not examine how quickly CBP provided CDC with passenger
locator information. CDC is currently updating regulations to expand
reporting requirements for ill passengers on board flights and ships
arriving from foreign countries. 70 Fed. Reg. 71,892, 71,928 (Nov. 30,
2005) (to be codified at 42 C.F.R. pts. 70 and 71). The proposed
regulations would require airlines and ocean liners to maintain
passenger and crew lists with detailed contact information and submit
these lists electronically to CDC within 12 hours of a request. 70 Fed.
Reg. at 71,940 (to be codified at 42 C.F.R. § 71.10).
[42] The Morbidity and Mortality Weekly Report is a primary vehicle for
informing state and local public health officials about new federal
guidance.
[43] According to CDC officials, the county health department faxed its
request to a quarantine station rather than to a specific contact at
CDC headquarters. CDC officials told us that the individual left the
airport before airline officials or CBP could direct him to CDC.
[44] GAO/AIMD-00-21.3.1.
[45] A port of entry is a government-designated location where CBP
inspects persons, goods, and conveyances arriving by air, land, or sea
to determine whether they may be lawfully admitted into the country.
[46] There are a total of 327 air, land, and sea ports of entry in the
United States.
[47] In accordance with section 7209 of the Intelligence Reform and
Terrorism Prevention Act of 2004, as amended (Pub. L. No. 108-458, §
7209, 118 Stat. 3638, 3823), DHS implemented new document requirements
at air ports of entry on January 23, 2007, for U.S. citizens and
nonimmigrant citizens of Canada, Bermuda, and Mexico entering the
United States from within the Western Hemisphere. They generally have
been required to present a valid passport since January 23, 2007, but
were not previously required to do so. DHS refers to these new
requirements as the Western Hemisphere Travel Initiative (WHTI). DHS is
required by law to implement WHTI document requirements at land ports
of entry no earlier than June 1, 2009.
[48] CBP officials stated that the number of TECS queries conducted
during primary inspection depends upon various factors at land ports of
entry, including the volume of travelers seeking entry. However, CBP
officers are required to perform name queries on all travelers who
appear to be inadmissible to the United States, or who are suspected of
violating U.S. laws. If this cannot be accomplished during the primary
inspection, it is required that such travelers be referred for further
processing.
[49] Field officers are required to carry personal radiation detectors
while on duty. Personal radiation detectors are devices that allow
officers to monitor for the presence of radioactive material while
inspecting vehicles.
[50] If the incident occurs at a port of entry collocated with a
quarantine station, CBP officials are instructed to notify the CDC
official at the quarantine station on-site.
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