Public Health and Border Security: HHS and DHS Should Further Strengthen Their Ability to Respond to TB Incidents
Published: 2008-10-14T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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. In  2007, more than 13,000 cases of TB disease were reported in the United  States. 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. 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. 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. 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.
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. 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.
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. 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.
subsections: section_title: Background
paragraphs: 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. 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.)
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.  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.
subsections: section_title: Coordination for TB Public Health Incidents
paragraphs: State and local health departments and federal agencies are to work  together to prevent the spread of TB in the United States.
subsections: section_title: State and Local Health Department Roles and Responsibilities
paragraphs: 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. 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.
section_title: HHS Roles and Responsibilities
paragraphs: 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. 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. 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.
section_title: DHS Roles and Responsibilities
paragraphs: 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. 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. 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. 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. 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.
section_title: HHS and DHS Memorandum of Understanding
paragraphs: 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.
section_title: The Two Spring 2007 TB Incidents
paragraphs: 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. (Fig. 2 provides more details about the incident involving  the U.S. citizen and officials’ actions.)  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.)
section_title: 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
paragraphs: 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.
subsections: section_title: HHS and DHS Lacked Comprehensive Procedures to Share Information and Coordinate Their Responses and Resources in the Two TB Incidents
paragraphs: 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. 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. 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.
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.
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 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. 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.
section_title: HHS and DHS Lacked Specific Procedures for Information Sharing within Each Department to Respond to the TB Incidents
paragraphs: 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.
section_title: CDC Lacked Procedures to Coordinate with State and Local Health Officials to Determine Use of Federal Isolation and Quarantine Authorities
paragraphs: 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. 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.
section_title: CBP Inspection Deficiencies Contributed to Delays in Locating the Individuals with TB
paragraphs: 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. 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.
section_title: 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
paragraphs: 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.
subsections: section_title: 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
paragraphs: 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. 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. 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. 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. 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. 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.  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.
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. Of these 72 requests, 21 were to add an individual  to the Do Not Board list. Table 2 shows the number of requests for  assistance CDC prepared for HHS to submit to DHS by type of request in  this period.
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. 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.
section_title: CDC Has Made Some Efforts to Inform State and Local Health Officials of New Procedures and Tools, but Has Not Completed All Actions
paragraphs: 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—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.
section_title: HHS and DHS Have Not Finalized Plans to Complete Coordination Actions between Federal Agencies
paragraphs: 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.
section_title: HHS and DHS Have Activities Under Way to Assess Their Ability to Respond to TB Incidents
paragraphs: 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.
subsections: section_title: CDC Officials Are Conducting Some Performance Monitoring of the New Procedures and Tools
paragraphs: 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.
section_title: HHS and DHS Officials Are Communicating Regularly in Order to Review Changes Made to Procedures and Tools
paragraphs: 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.
section_title: CDC Plans to Analyze Future After-Action Reports to Identify Improvements in Agency Response
paragraphs: 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.
section_title: HHS and DHS Officials Continue to Revise New Procedures and Tools Based on Subsequent TB Cases
paragraphs: 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. 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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.
As agreed with your offices, unless you publicly release its contents  earlier, we plan no further distribution of this report until 30 days after its  issuance date. At that time, we will send copies to the Secretary of Health  and Human Services and the Secretary of Homeland Security. Additional  copies will be sent to other interested congressional committees. In  addition, the report will be available at no charge on the GAO Web site at  http://www.gao.gov.
If you or your staff members have any questions about this report, please  contact Cynthia A. Bascetta at (202) 512-7114 or bascettac@gao.gov, or  Eileen R. Larence at (202) 512-6510 or larencee@gao.gov. Contact points  for our Offices of Congressional Relations and Public Affairs may be found  on the last page of this report. GAO staff who made contributions to this  report are listed in appendix IV.
section_title: Appendix I: CBP Traveler Inspection Procedures at Air and Land Ports of Entry
paragraphs: 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. 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.  (See fig. 5.)
subsections: section_title: Primary and Secondary Inspection Processes
paragraphs: 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.
section_title: Differences in Inspection Procedures at Air and Land Ports of Entry
paragraphs: 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.
subsections: section_title: Air Ports of Entry
paragraphs: 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. 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.
section_title: Land Ports of Entry
paragraphs: 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. 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. 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.
section_title: Public Health at Air and Land Ports of Entry
paragraphs: 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). 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.
section_title: Appendix II: Comments from the Department of Health and Human Services
section_title: Appendix III: Comments from the Department of Homeland Security
section_title: Appendix IV: GAO Contacts and Staff Acknowledgments
subsections: section_title: Acknowledgments
paragraphs: 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.
section_title: Related GAO Products
paragraphs: 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.