ABSTRACT
Because tuberculosis is caused by an infectious organism that is spread from person to person through the air, public health measures are essential to control the disease. There are three priority strategies for tuberculosis prevention and control in the United States: (i) identifying and treating persons who have tuberculosis disease; (ii) finding persons exposed to infectious tuberculosis patients, evaluating them for Mycobacterium tuberculosis infection and disease, and providing subsequent treatment, if appropriate; and (iii) testing populations at high risk for latent tuberculosis infection (LTBI) and treating those persons who are infected to prevent progression to disease. These strategies for prevention and control of tuberculosis are discussed in a framework containing the following important topics: historical and epidemiological context of tuberculosis control, organization of public health tuberculosis control programs, legal basis for public health authority, conducting overall planning and development of policy, identifying persons who have clinically active tuberculosis, evaluation of immigrants, managing persons who have or who are suspected of having disease, medical consultation, interjurisdictional referrals, identifying and managing persons infected with Mycobacterium tuberculosis, providing laboratory and diagnostic services, collecting and analyzing data, and providing training and education. This chapter describes the role of the health department in the context of these components. This discussion is primarily applicable to tuberculosis prevention and control programs in the United States.
INTRODUCTION
Because tuberculosis is caused by an infectious organism that is spread from person to person through the air, public health measures are essential to control the disease. There are three priority strategies for tuberculosis prevention and control in the United States: (i) identifying and treating persons who have tuberculosis disease; (ii) finding persons exposed to infectious tuberculosis patients, evaluating them for Mycobacterium tuberculosis infection and disease, and providing subsequent treatment, if appropriate; and (iii) testing populations at high risk for latent tuberculosis infection (LTBI) and treating those persons who are infected to prevent progression to disease (1).
Although prevention and control of tuberculosis in the United States are primarily the responsibility of state and local tuberculosis control programs, rarely are these activities implemented solely by the health department. Patients with tuberculosis disease are usually diagnosed and often treated by private providers. Contacts of infectious cases may also be evaluated and treated by their private physicians or other community providers. Private providers, as well as non-health-department community or governmental entities, also test and treat individuals at high risk for LTBI. However, the health department is responsible for coordination and oversight of these activities to ensure that objectives related to tuberculosis prevention and control are achieved.
The Advisory Council for the Elimination of Tuberculosis identified seven core components of public health tuberculosis control programs (1):
Conducting overall planning and development of policy
Identifying persons who have clinically active tuberculosis
Managing persons who have or who are suspected of having disease
Identifying and managing persons infected with Mycobacterium tuberculosis
Providing laboratory and diagnostic services
Collecting and analyzing data
Providing training and education
This chapter describes the role of the health department in the context of these core components. This discussion is primarily applicable to tuberculosis prevention and control programs in the United States.
HISTORICAL AND EPIDEMIOLOGICAL CONTEXT OF TUBERCULOSIS CONTROL
Public health control measures for tuberculosis have evolved as knowledge regarding transmission developed and treatment options and infection control interventions became more effective. Before Koch discovered the tubercle bacillus, there were few public health measures to control tuberculosis, although morbidity and mortality data were collected by some jurisdictions. With the discovery of the tubercle bacillus and the advent of the sanatorium movement, the primary public health measure became the isolation of infectious persons in sanatoria. Admission to sanatoria was intended for treatment initially, but it soon became a control measure as well, with legally mandated hospitalization of some patients (2). However, the availability of beds never met the demand. In 1945, the United States had 450 tuberculosis hospitals with 79,000 beds, despite having many more reported incident cases. Effective chemotherapy first led to shorter durations of hospitalization and ultimately a sharp reduction in the need for hospitalization as outpatient treatment of tuberculosis became standard. In the 1960s and early 1970s, the previous lack of inpatient bed availability was reversed, resulting in the eventual closure of the tuberculosis hospitals. Hospitalization is now reserved for acute care, although forced confinement continues for a small number of recalcitrant patients (3–5).
Tuberculosis incidence and mortality began declining in the United States prior to the widespread use of sanatoria and well before the widespread introduction of effective chemotherapy (6). Systematic national surveillance for tuberculosis began in 1953, with a steady decline in reported incident cases from 84,304 in 1953 to 22,201 in 1985 (7). As cases of tuberculosis reached historical lows in the United States, the public health infrastructure for control also declined, as categorical federal funding ended and local funding was shifted to other priorities (8). Reported incident tuberculosis cases rose from 22,768 cases in 1986 to 26,673 cases in 1992 (7). This increase coincided with the onset of the human immunodeficiency virus (HIV) epidemic, with tuberculosis in HIV-infected persons contributing to the increase (8). Other factors associated with the increase in tuberculosis included nosocomial and institutional transmission of M. tuberculosis and increased cases occurring in foreign-born persons who emigrated from countries with high rates of tuberculosis (8). Following the resurgence of tuberculosis, federal, state, and local resources for tuberculosis prevention and control were substantially increased. These resources were directed to improve surveillance, increase the capacity of public health laboratories, and increase the number of tuberculosis patients treated with directly observed therapy (DOT) (8). As a result, the incidence of tuberculosis steadily declined from 1993 through 2014 (7). However, this progress appears to have leveled off recently, with 2014 experiencing only a 1.5% decrease in tuberculosis cases (the smallest decrease in a decade) and 2015 a small increase in cases (9).
The complexity of tuberculosis control and the challenges facing elimination of tuberculosis have, however, not diminished. In 2015, almost two-thirds of cases reported in the United States occurred in persons born in other countries (9). Therefore, the tuberculosis programs must provide interpreter services, be responsive to the cultural issues of their patients, and provide patient education to persons who may have different perceptions than health department staff and providers regarding tuberculosis disease and treatment. Along the U.S.-Mexico border, persons with tuberculosis travel back and forth, complicating treatment of their tuberculosis and the identification and follow-up of contacts (10). Coinfection with HIV occurs in 6% of patients reported with tuberculosis (7). This further complicates treatment options because of drug-drug interactions between highly active antiretroviral therapy and antituberculosis medications (11). Outbreaks in low-incidence areas often overwhelm local tuberculosis control program staff, resulting in increased transmission and morbidity from tuberculosis. Although rates of drug-resistant tuberculosis, particularly multidrug-resistant (MDR) tuberculosis, have declined since 1993, these cases continue to complicate treatment and prevention efforts (7). Currently, approximately 1% of tuberculosis cases are MDR, with greater than 80% of MDR cases occurring in foreign-born persons (7). All of these factors complicate efforts to control and eventually eliminate tuberculosis in the United States.
ORGANIZATION OF PUBLIC HEALTH TUBERCULOSIS PREVENTION AND CONTROL PROGRAMS
Tuberculosis prevention and control in the United States is the legal responsibility of the state and local governments (1, 12). Most tuberculosis prevention and control activities are conducted by local (city, district, or county) health departments, with oversight by state tuberculosis control programs; these activities include surveillance data and information collection and management, delivery of diagnostic and clinical services for tuberculosis patients and their contacts, contact investigation, planning and policy development, training and education, and monitoring and evaluation. The health department is responsible for ensuring that patients with suspected or confirmed tuberculosis disease have ready access to diagnostic and treatment services that meet national standards, and that persons with tuberculosis disease or LTBI complete treatment for their disease or infection. Medical care may be provided by private, community physicians who may or may not have an established relationship with the local tuberculosis control program. Indeed, hospital- or clinic-based health care practitioners, including those working in emergency departments, are usually the first source of medical care for persons with tuberculosis disease. These providers may also provide ongoing management of tuberculosis patients, as may HIV clinics, community clinics, correctional facilities, or nursing homes, but regardless of where a person receives medical care, the primary responsibility for ensuring the quality and completeness of all tuberculosis-related services rests with state and local public health agencies.
State tuberculosis control programs generally provide funding and technical support to local programs. Local and state programs also compile and report surveillance data; standardized collection of data and tracking of test results can improve care of patients with tuberculosis disease and infection. State programs may assist local programs with contact investigations or investigations of outbreaks. Some state programs also conduct operational and epidemiological research related to tuberculosis control either by themselves or in collaboration with an academic institution. Public health laboratories generally participate in state tuberculosis control programs, although large cities, counties, or other jurisdictions may also have public health laboratories. State tuberculosis programs are responsible for interactions with other state agencies and with other institutional entities that may have a role in tuberculosis control, such as correctional facilities, colleges or universities, and homeless shelters.
The Division of Tuberculosis Elimination (DTBE) in the National Center for HIV/AIDS, Viral Hepatitis, STD, and Tuberculosis Prevention at the U.S. Centers for Disease Control and Prevention (CDC) is primarily responsible for assisting with the federal public health aspects of tuberculosis control (12). This includes providing supplementary funding for state and local tuberculosis programs; providing technical assistance to programs; compiling, analyzing, and reporting surveillance data; providing national reference laboratory support; providing support in investigating outbreaks; and funding and conducting operational, epidemiological, clinical, and basic and applied laboratory studies relevant to programmatic tuberculosis control activities. The CDC provides supplementary funding through cooperative agreements to 67 project areas, including 50 states, 9 large cities, 5 U.S. territories, and 3 sovereign nations that formerly were U.S. trust territories. In 1992, during the tuberculosis resurgence in the United States, federal funding for tuberculosis prevention and control activities provided via the cooperative agreement mechanism increased substantially to address the rise in tuberculosis cases. Funding levels were based on the resurgence of tuberculosis and emergence of MDR tuberculosis in the late 1980s and early 1990s, with the greatest amount of additional funding going to those large cities hardest hit by the epidemic. Since then, some of the epidemiology of tuberculosis in the United States has evolved, but the overall funding amounts have remained relatively static and purchasing power has decreased due to inflation.
In 2005, the DTBE, in consultation with the National Tuberculosis Controllers Association (NTCA), developed a case-based formula to redistribute prevention and control funding based on epidemiological needs across tuberculosis programs in the country. This funding is distributed to the states via the Tuberculosis Elimination and Laboratory Cooperative Agreement (TB CoAg). The funding formula and its subsequent iterations have been based on tuberculosis surveillance data using variables for which there is universal and consistent reporting by all of the 67 funded jurisdictions in the National Tuberculosis Surveillance System. The formula also supports mycobacteriology work in 58 public health laboratories. Currently, the allocation of tuberculosis funding is based on an iteration of the funding formula that has both incidence (80%) and performance (20%) components. The formula consists of specific variables and corresponding weights (cases can carry weight of multiple variables).
Incidence variables applied to cases include the following:
Incident cases, 24%
U.S.-born minorities and foreign-born persons, 24%
Persons coinfected with HIV, 4%
Persons with MDR tuberculosis, 4%
Substance abusers, 4%
Persons experiencing homelessness within the past year, 4%
Immigrants and refugees with class B tuberculosis, 4% (In preimmigration evaluation, if the tuberculosis exam has positive findings other than infectious tuberculosis, a tuberculosis class B designation is given according to exam results as follows: class B1, the individual had an abnormal chest X ray [CXR] suggestive of tuberculosis, signs and symptoms of TB, or known HIV infection and negative sputum smears and cultures; class B2, the individual has a positive tuberculin skin test [TST] or interferon gamma release assay [IGRA] but did not have to provide sputum specimens and thus is diagnosed with LTBI [these are typically children]; and class B3, the individual is a recent contact of a person with infectious tuberculosis; an individual can have this designation along with another TB class designation.)
Persons with smear- or culture-positive pulmonary tuberculosis, 12%
Performance variables applied to cases include the following:
Culture positives on which drug susceptibility testing has been performed, 5%
Completion of treatment at <12 months among eligible patients, 15%
To provide appropriate technical assistance to programs, the CDC also provides funding to support Regional Training and Medical Consultation Centers (RTMCCs). These centers are regionally assigned to cover the nation and its territories; currently, there are five funded centers, including the Curry International Tuberculosis Center, affiliated with the University of California at San Francisco; the Heartland National Tuberculosis Center, affiliated with the University of Texas at Tyler; the Mayo Clinic Center for Tuberculosis; the Global Tuberculosis Institute at Rutgers, the State University of New Jersey; and the Southeastern National Tuberculosis Center at the University of Florida in Gainesville. These centers are responsible for the increasingly important activities of providing (i) training and technical assistance on various aspects of tuberculosis control for clinicians and state and local health department staff to build human resource capacity and (ii) medical consultations for treatment related to tuberculosis cases. Additionally, these centers develop tuberculosis educational materials and products.
Most CDC-funded epidemiological and clinical research is conducted through either the Tuberculosis Epidemiologic Studies Consortium (TBESC) or the Tuberculosis Trials Consortium (TBTC). The TBESC was established in 2001 and is currently comprised of 17 domestic sites. Each of these sites has established partnerships between an academic institution and a tuberculosis control program. The consortium jointly conducts programmatically relevant epidemiological, behavioral, economic, laboratory, and operations research on various aspects of tuberculosis control. The TBTC is primarily engaged in conducting clinical trials and diagnostics research with a network of clinical sites worldwide, including locations in the United States, Spain, Peru, Uganda, Kenya, South Africa, Vietnam, and Hong Kong; these sites conduct research to expand clinical and epidemiological knowledge of tuberculosis and to facilitate the diagnosis, clinical management, and prevention of tuberculosis infection and disease.
In addition to the CDC work of the DTBE, the CDC’s Division of Global Migration and Quarantine (DGMQ) in the National Center for Emerging and Zoonotic Infectious Diseases provides the U.S. Department of State with medical screening requirements (referred to as technical instructions [TI]) for all examining physicians, which outline in detail the scope of the medical examination for the screening for tuberculosis among persons overseas applying for U.S. immigration status, refugees, and nonimmigrants who are required to have an overseas medical examination (performed by panel physicians). In addition, civil surgeons, who are licensed physicians designated by the U.S. Citizenship and Immigration Services in the U.S. Department of Homeland Security to conduct required health screening examinations of foreign-born persons living in the United States who apply for permanent residency, must perform their medical examinations according to the procedures prescribed in the TI for civil surgeons. It is incumbent on civil surgeons to establish a working relationship with the tuberculosis control program of their respective local health department in order to report suspected and confirmed tuberculosis cases as mandated by law and perform required and recommended referrals.
LEGAL BASIS FOR PUBLIC HEALTH AUTHORITY
Federal and International Authority to Control Tuberculosis
Federal authority to control tuberculosis resides in multiple sources, including the U.S. Constitution, statutes, regulations, and Executive Orders. Congress may act only using powers enumerated in the Constitution (13). The U.S. Constitution, article I, section 8 (commonly referred to as the Commerce Clause), grants the federal government not only the power to tax and spend but also the power to regulate commerce “with foreign Nations, and among the several States, and with the Indian Tribes” (14). The U.S. Supreme Court has interpreted the Commerce Clause as empowering Congress to enact legislation intended to protect the public’s health. State and local health officials should understand that the exclusive authority to regulate interstate and foreign commerce is interpreted to implicitly provide federal legal power to control tuberculosis under limited circumstances.
The Commerce Clause is the legal foundation for section 361 of the Public Health Service Act (42 U.S. Code section 264), authorizing the Secretary of Health and Human Services to make and enforce regulations to prevent the entry and spread of communicable diseases from foreign countries into the United States and between states (15). The authority for implementing regulations to carry out these functions on a daily basis is delegated to the CDC; under the Public Health Service Act, federal isolation and quarantine are authorized by Executive Order of the President of the United States for a specifically enumerated list of communicable diseases. These diseases are currently defined by Executive Order 13295 (as amended by Executive Order 13375 on 1 April 2005 and Executive Order 13674 on 31 July 2014) and include cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute respiratory syndromes, and influenza caused by novel or reemergent influenza viruses that are causing or have the potential to cause a pandemic.
Under its regulatory authority to prevent the introduction and spread of communicable diseases, the CDC is currently authorized to detain, medically examine, and conditionally release persons arriving into the United States who are reasonably believed to have one of the communicable diseases listed in Executive Order 13295, as amended by Executive Order 13674 and Executive Order 13375, including infectious tuberculosis (16, 17). Further, the CDC has the authority to quarantine, isolate, or place under surveillance persons who have been exposed to or are infected with a quarantinable communicable disease and are arriving into the United States, moving between states, or may infect others who may subsequently move between states (16, 17). Under section 361 of the Public Health Services Act, the CDC may apprehend and examine only persons moving between states or who constitute a probable source of infection to persons moving between states and who are reasonably believed to be infected with a specified communicable disease in its qualifying stage, defined as the communicable stage of the disease or a noncommunicable stage if the disease would be likely to cause a public health emergency if transmitted to other individuals. If such persons are found to be infected, then the CDC may detain them as reasonably necessary.
On 19 January 2017, HHS published a Notice of the Publication of the Final Rule to update CDC’s regulatory authority to control communicable diseases. The revisions to 42 C.F.R. parts 70 (domestic) and 71 (foreign) are designed to aid the public health response to outbreaks of communicable diseases, such as Ebola, Middle East respiratory syndrome (MERS), repeated outbreaks of measles, as well as new or reemerging communicable diseases. Both the domestic and foreign portions of the Final Rule include new public health definitions; new regulatory language relating to noninvasive public health measures at U.S. ports and other U.S. locations; and administrative procedures applicable to individuals served with a federal public health order of isolation, quarantine, or conditional release (16, 17).
A related mechanism for preventing transmission of tuberculosis is the use of federal public health travel restrictions, including the public health Do Not Board (DNB) and Public Health Border Lookout record (PHLO), developed and managed by CDC in cooperation with the Department of Homeland Security and its component agencies: the Transportation Security Administration (TSA) and Customs and Border Protection (CBP). Once an individual is placed on the DNB list, airlines are instructed by TSA not to issue a boarding pass to the individual for any commercial domestic flight or for any commercial international flight arriving in or departing from the United States. A PHLO is issued to complement the DNB, alerting CBP officers when a person tries to enter the United States at any port of entry (seaport, airport, or land border), and is issued simultaneously with the DNB. International health officials and U.S. government agencies such as the Department of State, state and local health officials, and health care providers may submit a request to the CDC (via the CDC Emergency Operations Center, regional CDC Quarantine Station, or relevant state or local public health department) for use of federal public health travel restrictions. Upon receipt of such a request, CDC determines whether the person (i) is known or reasonably believed to be infectious or reasonably believed to have been exposed to a communicable disease and may become infectious with a communicable disease that would be a public health threat should the individual be permitted to board a commercial aircraft or travel in a manner that would expose the public and (ii) is not aware of his or her diagnosis, has been advised regarding the diagnosis and is noncompliant with public health requests or has shown potential for noncompliance, or is unable to be located; (iii) is at risk of traveling on a commercial flight or of traveling internationally by any means; or (iv) requires placement on the DNB list for effective response to outbreaks of communicable disease or to enforce a public health order (18).
If the CDC determines that an individual meets the above-referenced criteria, the TSA adds the person’s name to the DNB list and CBP issues a PHLO record. An individual is removed from federal public health travel restrictions either upon receipt by the CDC of the treating physician’s or public health authority’s statement (or other medical documentation) that the individual is no longer considered infectious or when the period in which the individual is at risk of becoming infectious lapses, without development of symptoms. Use of federal public health travel restrictions is intended to supplement existing disease control measures that may be implemented by international or domestic health authorities. With respect to tuberculosis, criteria have been developed to determine when a person with suspected or confirmed pulmonary tuberculosis is likely to be infectious, warranting restriction of travel if one or more of the other criteria for use of federal public health travel restrictions are met. The assessment of infectiousness includes clinical, radiographic, and microbiologic evaluation (e.g., sputum smear microscopy and culture results) and treatment adequacy (19). Individuals with suspected or confirmed MDR or extensively drug-resistant tuberculosis are subject to more stringent criteria, based on World Health Organization (WHO) guidelines for tuberculosis and air travel (20). These criteria include the requirement of negative culture results prior to removal of federal public health travel restrictions. The United States is also responsible for adhering to the requirements set forth in the revised International Health Regulations (IHR), promulgated by the WHO in 2005 and entered into force in 2007. The United States is one of 196 countries (including all WHO Member States) that are bound by the IHR, an international agreement related to prevention of and response to the international spread of disease. Under the IHR, the United States (and other parties to the agreement) must notify the WHO of (i) all events which may constitute a public health emergency of international concern within its territory and (ii) to the extent practicable, public health risks identified outside its territory that may cause international disease spread as manifested by exported or imported human cases, vectors which carry infection or contamination, or goods that are contaminated (21). {A public health emergency of international concern is defined as “an extraordinary event which is determined, as provided in [the IHR] (i) to constitute a public health risk to other States through the international spread of disease and (ii) to potentially require a coordinated international response.” Multiple factors determine when or if a person with tuberculosis would require notification under the IHR: (i) the potential for an international public health concern, (ii) the seriousness of the event’s public health impact, (iii) the unusual or unexpected nature of the event, (iv) whether there is a significant risk of international disease spread, and (v) whether there is a significant risk of international travel or trade restrictions.}
State Authority and Responsibility To Control Tuberculosis
Under the Tenth Amendment to the U.S. Constitution, “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people” (22). States thus retain primary authority over public health within their borders and can exercise “police power” to protect the public’s health; police power is defined as power exercised by the states to enact legislation and regulations to protect the public health, welfare, and morals and to promote the common good. This constitutional basis for authority was validated in Jacobson v. Massachusetts in 1905, in which the Supreme Court found that individual freedom may be subordinated for the benefit of the common welfare and is subject to police power (23). This power creates a responsibility in state and local public health officials to balance the protection of the public’s health with the preservation of individual liberty. State health departments are responsible for implementation to control the spread of infectious disease, including tuberculosis, and may also delegate police power to local governments. Additionally, in the 566 federally recognized Indian Nations, American Indian and Alaska Native tribal officials have police power authority to protect the health of their tribal members. Tribal health authorities may enforce restrictive measures to control tuberculosis within tribal lands, if their sovereignty laws contain such provisions.
The following laws serve to control the spread of tuberculosis: (i) statutes, which are laws enacted by state legislatures (localities similarly pass ordinances, but these laws must be consistent with state legal authorities; typically, the city council passes ordinances, but in many jurisdictions ordinances related to health or public health are passed by county boards of health or the equivalent); (ii) regulations, which are made by state agencies acting under the authority granted by statutes; they generally have the force of law and usually contain more detail than statutes; and (iii) case law, which consists of decisions by judges interpreting laws, with binding precedent created by appellate courts.
With considerable variation from state to state, statutory and regulatory provisions may address the following areas of tuberculosis control and prevention: case identification, management of tuberculosis cases, and other protections (24). Case identification laws include reporting laws and screening laws. Tuberculosis is a reportable disease in all 50 states and Washington, DC, but there is significant variation concerning required reporters, reporting time frame, and required content of reports (24). In some states, penalties are imposed for failure to report tuberculosis cases as required by law. Requirements can also include a duty to report nonadherent patients or other special circumstances (e.g., drug susceptibility test results or HIV status). Screening is usually required of populations at high risk of exposure to tuberculosis, such as health care workers and jail inmates, and may be a prerequisite for certain types of employment (e.g., grade school teachers and employees in day care facilities).
The majority of state tuberculosis control provisions concern aspects of tuberculosis case management, including, but not limited to, identification of tuberculosis cases (examination and contact investigations), provision of treatment (DOT and adherence to a treatment plan), treatment facilities, financing treatment, emergency detention, isolation (home isolation or isolation at a health or other appropriate facility), commitment, social distancing measures (exclusion from the workplace or school), and penalties for nonadherent patients. State and local health officials employ an incremental approach to implementing disease control measures, beginning with the least restrictive measure necessary to address the specific facts and circumstances of a case. Long-term commitment in a health or other appropriate facility is a significant restriction of individual liberty and due process is required, with periodic review of the court order imposing such confinement (constitutional provisions, including due process, are more fully discussed below). Finally, “other protections” accorded by statutes or regulations might address privacy and confidentiality, religious exemptions for tuberculosis treatment, specific due process procedures, and antidiscrimination provisions.
State tuberculosis control laws must conform to U.S. constitutional requirements. Relevant provisions may include the First, Fourth, and Eighth Amendments to the U.S. Constitution, which apply to the States through the authority of the Fourteenth Amendment. The First Amendment states that “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof” (25). If a law is neutral and of general applicability, an individual’s right to free exercise of religion is not violated. Despite this, many states provide religious exemptions for compulsory treatment for tuberculosis, in deference to interpretations of the First Amendment, state constitutional provisions, or other legal or policy considerations. The Fourth Amendment prohibits the government from conducting unreasonable searches and seizures. Courts evaluate the reasonableness of a search by weighing the intrusion into individual privacy against the government’s need for information. In the context of tuberculosis control, courts have held that a TST required by a government entity is considered a search under the Fourth Amendment (26). The Eighth Amendment prohibits the infliction of cruel and unusual punishment and may be raised, for example, by jail inmates contesting tuberculosis control measures, such as testing, isolation, or treatment.
The Fourteenth Amendment prohibits states from depriving any person of life, liberty, or property without due process of law, and due process has been a frequent subject of state court challenges to tuberculosis control measures. “Substantive due process” requires the government to have adequate justification for implementing laws or taking other official actions that impact an individual’s life, liberty, or property. The greater the liberty interest at stake, the more substantial the government justification must be. “Procedural due process” requires the government to use fair and reasonable procedures when contemplating action that will restrain a person’s liberty. Notice and an opportunity to be heard are among the most fundamental procedures that must be made available. State and local public health departments must work with their legal counsel to ensure that their actions comport with constitutional provisions and their jurisdiction’s legal authorities to prevent and control tuberculosis. Please see Table 1 for an analysis of court cases that illustrate these constitutional provisions.
TABLE 1.
Selected cases involving relevant constitutional provisions
| Case | Constitutional issue | Facts | Holding |
|---|---|---|---|
| Greene v. Edwards 263 S.E.2d 661 (WV, 1980) | 14th Amendment, procedural due process clause | Appellant was involuntarily committed to a West Virginia hospital for active tuberculosis. He received notice of the commitment hearing but was not informed of the right to counsel. An attorney was appointed for him during the hearing, but the trial court proceeded without allowing the patient and his attorney to consult privately. Appellant filed a writ of habeas corpus, challenging the constitutionality of the statute. | Court held that the W.V. Tuberculosis Control Act must afford the same protections granted to those involuntarily committed for mental illness, including (i) adequate written notice detailing the grounds and underlying facts on which commitment is sought; (ii) right to counsel; (iii) right to be present, to cross-examine, and to confront witnesses; (iv) standard of proof that is clear and cogent, and convincing evidence; and (v) right to a transcript of the proceeding for appeal purposes. |
| McCormick v. Stalder 105 F.3d 1059 (5th Cir. 1997) | 8th Amendment | Appellant tested positive for tuberculosis in prison and, in accordance with prison policy, was required to receive treatment for LTBI. If inmates are nonadherent, the policy provides that they can be isolated until the degree to which isolation is necessary is determined. Appellant claimed his 8th Amendment rights were violated because he submitted to medication to avoid isolation, he was not warned of side effects, and his consent to treatment was never obtained. | Court held that appellant’s 8th Amendment rights were not violated. Appellant failed to show that prison medical officials were “deliberately indifferent to his serious medical needs.” Note that this case concerns medical care and the rights of prisoners, involving a lower constitutional standard and minimal liberty interests compared to tuberculosis control efforts in the general population. |
| Newark v. J.S. 652 A.2d 265 (NJ, 1993) | 14th Amendment, substantive due process clause | J.S. was being treated for active tuberculosis in a city hospital when he sought to leave against medical advice. City authorities called an emergency commitment hearing, based on J.S.’s active tuberculosis status, homelessness, and history of nonadherence. The judge granted the emergency order, and the city then sought a final order for commitment while the patient was being treated for active tuberculosis. | The court weighed the city’s compelling interest of protecting its citizenry from disease against the fundamental liberty interest of being free from confinement. The court found that involuntary hospitalization was the least restrictive means to ensure prevention of the spread of tuberculosis in this case, because the patient was homeless and neither the patient nor his attorney proposed an alternate, less restrictive setting to be isolated from the public while receiving treatment for tuberculosis. |
| State v. Armstrong 239 P.2d 545 (WA, 1952) | 1st Amendment, free exercise clause | University of Washington board of regents promulgated a regulation requiring all students to submit to CXR examination prior to registration. The appellant requested an exemption from the examination, citing religious views. | Court held in favor of the board of regents, arguing that the regulation is preventive in nature—“Its primary concern is not for the possibly infected student, but is for those jeopardized by contact with such an individual.” Court weighed the public health interest of students and university employees against the 1st Amendment interest of individual student. “Infringement of appellant’s rights is a necessary consequence of a practical attempt to avoid the danger.” |
| Washington v. Cambra 165 F.3d 920 (CA, 1998) | 4th Amendment | A California state prison had a policy that required two tuberculosis tests for each prisoner—one when the prisoner is admitted to the facility and a second after 12 wks. Prison officials administered the second tuberculosis test against the will of the appellant. Appellant alleged that the prison officials violated his 4th Amendment rights against unreasonable search and seizure. | Summary judgment in favor of the prison officials affirmed. While the tuberculosis test is considered a 4th Amendment search, the prison’s tuberculosis testing policy was reasonably related to the legitimate goal of detecting and containing tuberculosis. |
It is also important to note that the responsibility to care for tuberculosis patients resides with the states, as does the authority to do so when necessary. Because states retain primary authority over public health within their borders, the CDC’s national tuberculosis program does not contain the infrastructure required for direct patient care and management. The Secretary of Health and Human Services, acting through the Director of the CDC, is authorized to make grants to states for preventive health service programs for the prevention, control, and elimination of tuberculosis; these funds are distributed via the TB CoAg (27). Because the purpose of TB CoAg funds is to assist efforts of state, local, and territorial tuberculosis programs to prevent, control, and eventually eliminate tuberculosis in the United States, the majority of funds authorized for the national tuberculosis program are distributed directly to the states for patient care; as a result, there is no availability for patient care provided from CDC.
CONDUCTING OVERALL PLANNING AND DEVELOPMENT OF POLICY
State and local tuberculosis control programs have the responsibility for developing tuberculosis control policies and procedures. A tuberculosis control plan should be developed in collaboration with community stakeholders and experts in medical and nonmedical tuberculosis management and should be based on an understanding of local epidemiological data, the capabilities and capacities of clinical and support services for patients, and knowledge of the fiscal resources available for tuberculosis control. All program staff should be provided ongoing tuberculosis education and training in the clinical and public health aspects of tuberculosis. Finally, it is critical to perform systematic monitoring and evaluation of tuberculosis program activities.
Planning for tuberculosis program activities begins by analyzing current epidemiological data, with close attention to recent trends. Morbidity trends (total cases and case rates) provide a general indication of future resource requirements. Not only do they provide insight into the amount of resources necessary for the management of tuberculosis patients but also they help to predict resources needed for contact investigation and tuberculin testing and LTBI treatment, since the numbers of contact investigations conducted and persons with LTBI tend to be proportional to tuberculosis morbidity.
The next level of analysis should focus on epidemiological trends, specifically the distribution of tuberculosis morbidity in the population served by the health department. Although general associations between tuberculosis and certain risk groups (e.g., persons living with HIV, persons experiencing homelessness, foreign-born persons, and racial and ethnic minorities) have been well documented, the relative importance of these risk groups varies based on location. Therefore, analysis of morbidity trends among these groups at the state and local levels is crucial to planning activities and interventions. This type of analysis also informs the tuberculosis program with respect to the needs for outreach to specific communities and hiring employees with suitable cultural and linguistic competencies.
Formal program evaluation is a critical process that contributes to both planning and accountability. In program evaluation, measurable indicators of program performance are created, and objectives are set for each indicator. This allows the program to determine if it is achieving its goals. The CDC has developed a framework for program evaluation of public health practices (28). The CDC framework is based on four principles: utility, i.e., ensuring that the user’s information needs are satisfied; feasibility, i.e., ensuring that the evaluation is viable and pragmatic; propriety, i.e., ensuring that the evaluation is ethical; and accuracy, i.e., ensuring that the evaluation produces findings that are considered correct. The framework includes six steps:
Engage stakeholders.
Describe the program.
Focus the evaluation design.
Gather credible evidence.
Justify conclusions.
Ensure use and share lessons learned.
Use of this methodology allows detailed examination of various aspects of a tuberculosis program. The program can determine which aspects are successful and which are in need of improvement. For those that need improvement, action steps can be designed and implemented to address shortcomings. Program evaluation should be a continual, iterative process.
In 2006, a team including representatives of state and local health departments, the NTCA, and the CDC used this framework to select 15 high-priority tuberculosis program objective categories and developed the National Tuberculosis Indicators Project (NTIP). The NTIP is a web-based system that enables the use of regularly reported tuberculosis surveillance data to measure program performance that reflect national priorities; it provides a standardized method for calculating indicators and tracking program progress across sites and over time, thus enabling the DTBE’s and programs’ abilities to assess the impact of tuberculosis control efforts locally as well as nationally. The NTIP utilizes data that are currently being reported to the DTBE via the Report of Verified Case of Tuberculosis, the Aggregate Reports for Tuberculosis Program Evaluation (ARPEs) on contacts, and the DGMQ’s Electronic Disease Notification (EDN) system for the follow-up evaluation of immigrants and refugees with class B tuberculosis. Tuberculosis programs do not have to do any additional work or collect any additional data to generate NTIP reports, and the use of these reports allows for comparisons of the progress of programs overtime and the progress of their performance relative to each other. There are eight national tuberculosis program objectives for 2020 categories, each with priority activities and target outcomes (Table 2). The year 2020 targets were established on the basis of performance from three different national surveillance systems: (i) targets for incidence rates and case management and laboratory reporting are derived from data for 2000 to 2013 from the National Tuberculosis Surveillance System, (ii) targets for contact investigation are derived from data for 2000 to 2011 from the ARPEs, and (iii) targets for immigrant and refugee health screening after U.S. arrival are derived from data for 2008 to 2012 from the EDN system. Targets are based on a statistical model that uses data to find trends from 2000 through the latest year with data available. State programs with low case numbers are excluded from the analysis. A regression model is used to predict the estimated 90th percentile in the year 2020, which serves as the target for 2020 for each objective. These values thus reflect the projected performance of the top 10% of tuberculosis programs in the United States in 2020. Officials at all 68 tuberculosis control programs (50 states, 10 large cities, and 8 U.S.-affiliated jurisdictions and territories) receiving federal tuberculosis cooperative agreement funds have online access to their own NTIP reports and the national summary (29).
TABLE 2.
National tuberculosis program objective categoriesa
| Goal/objective | Priority activity | Target |
|---|---|---|
| Reducing tuberculosis incidence | Tuberculosis incidence rate | 1.4 cases/100,000 persons |
| U.S.-born persons | 0.4 cases/100,000 persons | |
| Foreign-born persons | 11.1 cases/100,000 persons | |
| U.S.-born non-Hispanic blacks | 1.5 cases/100,000 persons | |
| Children younger than 5 yrs of age | 0.3 cases/100,000 persons | |
| Case management and treatment | Known HIV status | 98% (proportion of tuberculosis patients who have a positive or negative HIV test result reported) |
| Treatment initiation | 97% (proportion of tuberculosis patients with positive AFB sputum smear results who initiated treatment within 7 days of specimen collection) | |
| Recommended initial therapy | 97% (proportion of patients whose diagnosis is likely to be tuberculosis disease who are started on the recommended initial 4-drug regimen) | |
| Sputum culture result reported | 98% (proportion of patients ages 12 yrs or older with a pleural or respiratory site of disease who have a sputum culture result reported) | |
| Sputum culture conversion | 73% (proportion of patients with positive sputum culture results who have documented conversion to negative results within 60 days of treatment initiation) | |
| Completion of treatment | 95% (proportion of patients with newly diagnosed tuberculosis disease for whom 12 mo or less of treatment is indicated who complete treatment within 12 mo) | |
| Laboratory reporting | Turnaround time for culture | 78% (proportion of patients with cultures of respiratory specimens identified with MTBC that are reported by the laboratory within 25 days from the date the specimen was collected) |
| Turnaround time for NAA | 92% (proportion of patients with respiratory specimens positive for MTBC by NAA that are reported by the laboratory within 6 days from the date the specimen was collected) | |
| Drug susceptibility test results | 100% (proportion of patients with positive culture results who have initial drug susceptibility results reported) | |
| Universal genotyping | 100% (proportion of patients with a positive culture result who have an MTBC genotyping result reported) | |
| Contact investigation | Contact elicitation | 100% (proportion of patients with positive AFB sputum smear results who have contacts elicited) |
| Examination | 93% (proportion of contacts to sputum AFB smear-positive tuberculosis cases who are examined for infection and disease) | |
| Treatment initiation | 91% (proportion of contacts of sputum AFB smear-positive tuberculosis cases diagnosed with latent tuberculosis infection who start treatment) | |
| Treatment completion | 81% (proportion of contacts of sputum AFB smear-positive tuberculosis cases who have started treatment for latent tuberculosis infection who complete treatment) | |
| Evaluation of immigrants and refugees | Evaluation initiation | 84% (proportion of immigrants and refugees with abnormal CXRs read overseas as consistent with tuberculosis who initiate a medical examination within 30 days of notification) |
| Evaluation completion | 76% (proportion of immigrants and refugees with abnormal CXRs read overseas as consistent with tuberculosis who complete a medical examination within 90 days of notification) | |
| Treatment initiation | 93% (proportion of immigrants and refugees with abnormal CXRs read overseas as consistent with tuberculosis who are diagnosed with latent tuberculosis infection or have radiographic findings consistent with prior pulmonary tuberculosis on the basis of examination in the United States, for whom treatment was recommended who start treatment) | |
| Treatment completion | 83% (proportion of immigrants and refugees with abnormal CXRs read overseas as consistent with tuberculosis who are diagnosed with LTBI or have radiographic findings consistent with prior pulmonary tuberculosis on the basis of examination in the United States, and who have started on treatment and complete treatment) | |
| Data reporting | RVCT | 100% (completeness of each core RVCT data item reported to CDC, as described in the TB CoAg) |
| ARPE | 100% (completeness of each core ARPE data items reported to CDC, as described in the TB CoAg) | |
| EDN | 93% (completeness of each core EDN system data item reported to CDC, as described in the TB CoAg) | |
| Program evaluation | Evaluation activities | Increase program evaluation activities by monitoring program progress and tracking evaluation status of TB CoAg recipients. |
| Evaluation focal point | Increase the percentage of TB CoAg recipients who have an evaluation focal point. | |
| Human resource development | Development plan | Increase the percentage of TB CoAg recipients who submit a program-specific human resource development plan and a yearly update of progress, as outlined in the TB CoAg. |
| Training focal point | Increase the percentage of TB CoAg recipients who have a TB training focal point |
MTBC, M. tuberculosis complex; NAA, nucleic acid amplification; RVCT, report of verified cases of tuberculosis; ARPE, aggregate reports of program evaluation; EDN, electronic disease notification system.
In order to develop the capacity for conducting effective program evaluations at the state and local levels, the TB CoAg contains a requirement that each funded program have an individual on staff who is the designated program evaluation focal point. The purposes of program evaluation are to (i) increase programmatic accountability in implementing priority-based approaches depicted in the strategies from the logic model, (ii) identify and overcome bottlenecks supported by timely analysis and feedback, and (iii) continually improve program and clinical practices and performance. Program evaluation focal points are trained to identify opportunities to bridge the gaps between knowledge/learning and practices to improve program and clinical effectiveness. The Tuberculosis Program Evaluation Network is a network of these designated tuberculosis evaluation focal points in each tuberculosis control program. These focal points serve as the trainers and experts to help provide technical assistance and build program evaluation capacity within their state and local tuberculosis control programs. The goal of the Tuberculosis Program Evaluation Network is to build the capacity for tuberculosis program evaluation activities in state and local tuberculosis programs and increase the number of programs that are evaluating their program activities through the following means:
Engaging tuberculosis control professionals to monitor and evaluate tuberculosis control activities
Providing expertise and technical assistance for conducting tuberculosis program evaluation
Identifying and sharing effective program evaluation strategies
IDENTIFYING PERSONS WHO HAVE CLINICALLY ACTIVE TUBERCULOSIS
The first priority of tuberculosis prevention and control in the United States is identification and treatment of persons with active tuberculosis. Discovery of a previously undiagnosed case of tuberculosis should trigger several responses to interrupt transmission. These include placing the patient in respiratory isolation if contagious, starting the patient on appropriate tuberculosis treatment, and conducting a contact investigation. Health departments seek to be notified of patients with tuberculosis as early as possible and use active and passive methods of case finding to achieve this goal.
Active case finding occurs through contact and outbreak investigations and through screening of high-risk populations. The purpose of contact investigation is to find persons recently infected with tuberculosis. In a recent analysis of 84,998 persons examined as contacts of active tuberculosis cases from 2003 through 2012 in the United States, tuberculosis was diagnosed in 532 (0.6%) and LTBI in 15,411 (18.1%) (30).
When several tuberculosis cases are linked through traditional or molecular epidemiological methods, this may constitute an outbreak. A tuberculosis outbreak is generally defined as a situation where there are more TB cases than expected within a geographic area or population during a particular period and there is evidence of recent transmission of M. tuberculosis among those cases. Because an outbreak may reflect potential ongoing transmission, the use of more intensive methods may be necessary to ensure that all cases in the outbreak have been identified. These may include screening with CXRs and sputum sampling regardless of TST or IGRA results or symptoms. Because these tests incur considerable additional cost, their use in the initial phase of screening has usually been restricted to large outbreaks or those involving congregate settings or very high-risk populations (e.g., those in homeless shelters or prisons and HIV-infected persons) (31).
Although not in the outbreak setting, active case finding through screening of high-risk populations is another intervention that generally begins with targeted testing for LTBI. As with contact investigations, most persons found to be infected with tuberculosis have LTBI, but occasionally cases of active tuberculosis are also identified in screening high-risk populations (32). In congregate facilities with high rates of active disease, active case finding efforts using CXR screening programs have sometimes been successful in identifying early cases (33, 34).
Passive case finding constitutes the backbone of national surveillance, with the collection of the majority of epidemiological data that are used to describe tuberculosis trends at local, state, and national levels to guide efforts in prevention and control programs. Passive case finding consists of accepting reports of tuberculosis suspects and patients routinely reported from community medical providers and, consequently, tends to concern cases in which there is more advanced disease. In all U.S. states, reporting of tuberculosis patients is required by law (24); this practice plays an important role in guiding the allocation of services, including monitoring of respiratory isolation, case management, DOT, and contact investigation, all of which help to prevent further transmission.
EVALUATION OF IMMIGRANTS
In the United States, the percentage of tuberculosis cases in foreign-born persons has risen from 30% in 1993 to 66% in 2015. In 2015, the rate for the foreign-born population was approximately 13 times greater than for the U.S.-born population. More than half of the 6,335 foreign-born cases in 2015 were reported to occur in persons from five countries: Mexico (1,250), the Philippines (819), India (578), Vietnam (513), and China (424) (9). With the majority of tuberculosis cases in the United States occurring among individuals born outside the country, the link between immigration and overseas screening for tuberculosis has become increasingly important. The CDC has worked to reduce the incidence of tuberculosis in recent immigrants by strengthening the overseas medical examination for tuberculosis in people seeking an immigrant visa (35).
Each year, approximately 450,000 immigrants and 50,000 to 70,000 refugees enter the United States from overseas locations (35). Before entry into the United States, these applicants are required to undergo medical screening for any disease of public health significance, referred to as an inadmissible condition, which includes infectious tuberculosis. The CDC’s DGMQ has regulatory authority to define communicable diseases of public health significance and requirements of the scope of the medical examination. The DGMQ provides guidance through the TI to physicians who are responsible for conducting the medical exam (36).
Physicians who perform the required medical screening throughout the world are called panel physicians, and they have an agreement with the U.S. Department of State to serve in this capacity. Immigrants pay for the cost of their required screening, while the Bureau of Populations, Refugees, and Migration, Department of State, funds the screening of refugees.
The DGMQ provides technical oversight of the medical screening and designates teams who perform on-site visits using standardized evaluation tools. For tuberculosis, the DGMQ also identifies or helps develop tuberculosis laboratory and DOT facilities.
The DTBE provides subject matter expertise to the DGMQ for the tuberculosis portion of the required medical examination. This expertise has included consultation on various aspects of the screening algorithm used to detect tuberculosis and manage patients who are diagnosed with tuberculosis during the screening process. In turn, the DTBE has consulted with various groups for technical review of this work, including the Advisory Council for the Elimination of Tuberculosis and NTCA.
Tuberculosis has historically been screened for in U.S. immigration (37). An important TI for Tuberculosis (TB TI) was issued in 1991. These instructions required a CXR for applicants who were 15 years of age or older. Applicants with a CXR suggestive of tuberculosis had to provide three sputum specimens, which underwent microscopy for acid-fast bacilli (AFB). Applicants with at least one positive sputum smear were required to postpone travel to the United States and undergo treatment for tuberculosis disease until sputum smears were negative. Medical clearance was valid for 12 months for applicants with a CXR with no evidence of active tuberculosis disease and 6 months for applicants with an abnormal CXR suggestive of tuberculosis but with sputum smears negative for AFB (35).
The 1991 screening protocol was able to identify many people with infectious tuberculosis. However, the 2005 experience of resettling Hmong refugees from Wat Tham Krabok, Thailand, to the United States underscored the importance of modernizing the 1991 TB TI (38). The Hmong resettlement and a study among immigrants in Vietnam demonstrated the failure of the 1991 TB TI to detect smear-negative, culture-positive cases of tuberculosis disease (39). In the Hmong resettlement, a significant fraction of the undetected overseas cases were MDR tuberculosis (38). Additional studies have demonstrated the challenges of preventing importation of tuberculosis disease (40, 41). The U.S. tuberculosis community had recommended updating the 1991 TB TI, with consideration given to incorporating mycobacterial cultures and TST into the algorithm and developing classifications for applicants suspected of having LTBI (8, 42). The emergence of extensively drug-resistant tuberculosis further reinforced the importance of an overseas screening system for U.S. immigration applicants that can detect and adequately treat tuberculosis disease in the immigrant’s country of origin (43).
In 2007, the CDC published revised instructions (which were updated in 2009) for overseas medical screening of applicants for U.S. immigration to better detect and treat tuberculosis disease and improve risk stratification of applicants (36). While the instructions in effect since 1991 specified that applicants or refugees 15 years of age and older receive a CXR to identify active tuberculosis disease, further evaluation of tuberculosis suspects included only smear microscopy. In addition, the evaluation of children less than 15 years of age was limited to symptom review. The revised TI (Fig. 1) included several features to enhance tuberculosis case detection: (i) applicants 2 to 14 years of age living in countries with a WHO-estimated tuberculosis incidence rate of at least 20 cases per 100,000 population should have a TST or IGRA, and if the TST result is 5 mm or greater or the IGRA is positive, a CXR should be performed; (ii) sputum smears and culture for M. tuberculosis are required for applicants with a CXR suggestive of tuberculosis disease, with drug susceptibility testing required for positive isolates; and (iii) applicants with smear-positive or culture-positive tuberculosis must receive therapy according to the American Thoracic Society, CDC, and Infectious Diseases Society of America tuberculosis treatment guidelines delivered as DOT.
FIGURE 1.
Tuberculosis screening medical examination for applicants ≥2 years of age in countries with a WHO-estimated tuberculosis incidence rate of ≥20 cases per 100,000 population.
A recent evaluation of the immigrant and refugee screening program provided clear evidence that addition of culture for M. tuberculosis markedly improved detection of tuberculosis disease (44). The increase in detection of tuberculosis cases overseas coincided with a substantial decrease in tuberculosis cases among foreign-born persons in the United States within 1 year after their arrival, further indicative of the enhanced program’s success. One limitation of the immigrant screening program is its restriction to permanent immigrants and refugees (i.e., it does not include other visa holders, such as students and long-term workers). Furthermore, most tuberculosis cases in foreign-born individuals in the United States occur in persons who have been in the United States for 2 years or more (46). These cases are likely the result of reactivation of LTBI that was acquired outside of the United States. Addressing tuberculosis in this population will require expanded LTBI testing and treatment.
MANAGING PERSONS WHO HAVE OR ARE SUSPECTED OF HAVING DISEASE
After a patient with tuberculosis has been reported to the health department, it is the responsibility of the health department, in conjunction with the patient’s medical provider (if the provider is not the health department), to ensure that the patient completes an adequate treatment regimen (46). In this context, case management involves accessing and employing the medical and social resources needed to shepherd a patient through completion of treatment.
The first task of the case manager is to make certain that the patient has a medical provider who will assume responsibility for the patient’s tuberculosis treatment. The case manager should also oversee the administration of DOT, making it as convenient as possible for the patient while closely monitoring adherence. Monitoring for adverse effects and response to treatment (e.g., collection of follow-up sputum samples) should be performed, with any problems being promptly reported to the patient’s medical provider.
In addition to oversight of medical care, it is also important to assist the patient to overcome social barriers that may impede adherence to treatment (46, 47). Being ill with tuberculosis can impose significant financial hardship due to inability to work and due to costs of medical care that may not be covered by the health department (e.g., hospitalization). Patients may be eligible for medical and financial benefits such as Medicaid, Medicare, or disability insurance. The case manager should help the patient access social services to obtain these benefits and direct the patient to other governmental or nongovernmental community-based programs that can assist with housing, food, and transportation if needed (Table 3) (42, 46).
TABLE 3.
Possible components of a multifaceted, patient-centered treatment strategya
| Enablers: interventions to assist the patient in completing therapy | Incentives: interventions to motivate the patient, tailored to individual patient wishes and needs and, thus, meaningful to the patient |
|---|---|
| Transportation vouchers | Food stamps or snacks and meals |
| Convenient clinic hours and locations | Restaurant and grocery store coupons |
| Clinic personnel who speak the languages of the populations served | Assistance in finding or provision of housing |
| Reminder systems and follow-up of missed appointments | Clothing or other personal products |
| Social service assistance (referrals for substance abuse treatment and counseling, housing, and other services)Outreach workers (bilingual/bicultural as needed; can provide many services related to maintaining patient adherence, including provision of DOT, follow-up on missed appointments, monthly monitoring, transportation, sputum collection, social service assistance, and educational reinforcement) | BooksStipendsPatient contract |
| Integration of care for tuberculosis with care for other conditions |
Reproduced from the work of the American Thoracic Society, CDC, and Infectious Diseases Society of America (45).
Culture and language present other potential barriers to adherence. It is preferable that culturally and linguistically competent staff be used to provide medical care and education (42). If such individuals are not available, it is essential to have ready access to interpreters. In addition, all education materials should be appropriate for the culture, language, and reading level of the patient.
The final responsibility of the case manager is to review the treatment record before the case is closed to the health department. The case manager should ensure that an adequate number of doses of medication have been taken within the recommended duration and that the patient has had a good response to therapy indicative of cure. If these criteria have not been met, the case manager should confer with the tuberculosis controller and the patient’s medical provider to determine the appropriate course of action.
MEDICAL CONSULTATION
As tuberculosis cases have decreased in the United States, so have the number of medical providers with experience in treating tuberculosis patients (8). For this reason, the only local or statewide clinical expertise may reside within the public health department. Therefore, it is often necessary that health department physicians and nurses be available to provide medical consultation on diagnostic and treatment issues. Frequently, this service can be provided via telephone or e-mail. In some areas, medical providers can refer patients to a health department tuberculosis clinic for a more formal consultation. However, even health departments may no longer possess expertise in treating tuberculosis if they are in low-incidence areas. To address this need and increase access to expert medical consultation, the CDC has funded the RTMCCs to provide coverage throughout the United States and its territories. Currently, the five centers located in New Jersey, Florida, Minnesota, Texas, and California (Fig. 2) are each responsible for providing regional medical consultation services. These RTMCCs are staffed by nationally recognized tuberculosis experts, and consultations are free and available by telephone or e-mail. Overseas, the physicians screening U.S.-bound immigrants and refugees also have access to the RTMCC clinical consultation system when additional expertise is needed to manage immigrants or refugees with TB. The RTMCC medical consultants work closely with state and local tuberculosis programs in their region to ensure that critical public health activities related to tuberculosis patients are addressed. The recent use of immunomodulating medications and successes in transplant technology have given rise to additional populations at risk for and contracting tuberculosis, adding to the comorbidities that complicate management of tuberculosis cases, and have necessitated the availability of expert consultation in case management, often over extended periods. Newer tuberculosis diagnostics and the use of new or repurposed drugs with notable side effects have further complicated the care and treatment of tuberculosis patients in the United States. While the overall number of domestic tuberculosis cases has been decreasing, the complexity of the cases has been significant, necessitating consultation by the RTMCCs on an estimated 20% of the nation’s tuberculosis cases in recent years. In addition, each RTMCC offers regionally based core instructional courses for clinicians in case management and diagnostics, in clinical intensive updates in diagnosis, treatment, and prevention, and in performance of case cohort reviews.
FIGURE 2.
TB regional training and medical consultation centers (TB RTMCCs).
INTERJURISDICTIONAL RELATIONSHIPS
Tuberculosis prevention and control require patients to be treated until cured, but this goal may be complicated by lack of capacity or the inherent mobility of individuals. It is occasionally necessary for multiple jurisdictions to work together to ensure appropriate patient care and treatment completion.
Many states do not have appropriate facilities to treat patients with tuberculosis who need long-term inpatient treatment. For these states, consideration should be given to developing agreements with other states that have appropriate medical facilities and are willing to accept tuberculosis patients for care and treatment. While mutual aid agreements or memoranda of understanding have often been developed and used in the emergency preparedness context, such agreements may be effective for the voluntary or involuntary transfer of tuberculosis patients to out-of-state facilities. As an alternative to case-by-case decision making, states without appropriate medical facilities in which to treat patients who need long-term inpatient treatment (whether voluntary or involuntary) may want to consider entering into standing agreements with states possessing appropriate facilities. Legal counsel to state and local health departments should be consulted throughout the process of initiating, negotiating, executing, and implementing agreements.
Ensuring completion of treatment for all patients is critical in achieving and maintaining tuberculosis control. When patients move from one health department jurisdiction to another, making certain that they complete treatment becomes more difficult. According to one study, patients who move are five times more likely to default (48). This underscores the necessity of close cooperation and coordination between tuberculosis control programs when caring for mobile patients if optimal outcomes are to be attained.
To manage the complexities of treatment for tuberculosis patients who relocate while on therapy, the NTCA has developed a system for interjurisdictional referrals. A brief protocol can be downloaded from their website (http://www.tbcontrollers.org/). A form for transferring pertinent information about tuberculosis patients from the discharging health department to the receiving health department can also be found on the website. Information collected on the form includes identifying, demographic, clinical, laboratory, and treatment data. In addition, the form allows for exchange of information related to contact investigation and patients being treated for LTBI. When the discharging jurisdiction has reported the patient as a case to the CDC, it is also responsible for reporting the treatment outcome. Therefore, the receiving jurisdiction should provide follow-up information on transferred patients to the discharging jurisdiction. A form and instructions for providing interjurisdictional follow-up are also available on the NTCA website The NTCA system is primarily meant for interstate referrals. For intrastate referrals, it is best for local health departments to contact their state tuberculosis control program. Some states, such as California, have existing intrastate interjurisdictional referral systems that are similar to the one implemented by the NTCA.
Occasionally, tuberculosis programs may need to exchange information regarding tuberculosis patients with tuberculosis programs in other countries. The CureTB international referral program is a continuity-of-care program for tuberculosis patients and their contacts who move between the United States and other countries; this program is managed within the DGMQ at the CDC. CureTB supports continuity of care for individuals with active tuberculosis and their contacts by facilitating the exchange of information between health systems, educating patients about their illness, providing assistance in accessing follow-up care, and maintaining contact with the patient and health authorities until a final outcome is identified. Another issue is that of detainees in custody of Immigration and Customs Enforcement (ICE) of the U.S. Department of Homeland Security. A high percentage of detainees identified with active tuberculosis while in ICE custody are deported to their countries of origin before their treatment has been completed; these patients are at risk for interrupting or not completing treatment, developing drug-resistant tuberculosis, and transmitting tuberculosis disease to others, and they often reenter the United States after deportation (49). To facilitate treatment completion in this population, there are collaborative efforts between ICE, local and state health departments and health authorities in the United States, local public health authorities in foreign countries, U.S.-Mexico border health offices, binational health programs, foreign national tuberculosis programs, the Migrant Clinicians Network, and the CureTB program to arrange for tuberculosis treatment to continue in the patient’s home country after deportation. Medical “meet and greet” programs, where national tuberculosis program staff members of the receiving country meet the deportee at the airport or border crossing, are considered an option for detainees being deported to any country in which public health authorities can provide support (50). For assistance with patients moving to countries other than Mexico, it is recommended that health departments contact the CureTB program in the DGMQ at the CDC. The Global Tuberculosis Branch in the Division of Global HIV and Tuberculosis at CDC may also provide assistance.
IDENTIFYING AND MANAGING PERSONS INFECTED WITH M. TUBERCULOSIS
Investigation of Contacts of Infectious Tuberculosis Cases
Contact investigations are an essential function of tuberculosis control in the United States and have been identified as a priority strategy for prevention and control of tuberculosis (42). Among contacts of patients with pulmonary tuberculosis, approximately 1% will have tuberculosis disease and 15 to 25% will have LTBI (30). Up to 5% of contacts with newly acquired LTBI will develop tuberculosis within 2 years of infection (51). Contact investigations are therefore an effective method for active case finding and identifying persons with LTBI who are also at a high risk of developing tuberculosis disease. State and local public health agencies are responsible for ensuring that contact investigations are effectively conducted and that all exposed contacts are identified, evaluated for tuberculosis infection and disease, and appropriately treated. Consequently, 90% of contact investigations in the United States are performed by public health departments (8).
Targeted Testing and Treatment of LTBI
The number of persons in the United States with LTBI is currently estimated at 13 million (52). To continue progress toward the elimination of tuberculosis in the United States, public health programs must devise effective strategies to address the challenge of preventing tuberculosis in this population of infected persons. Guidelines on targeted testing and treatment of LTBI have been published (53, 54). These guidelines include recommendations for diagnosis and treatment of LTBI, as well as recommendations for identifying persons and groups to target for testing.
The health department has several potential roles in testing and treatment of persons with LTBI. Health departments may evaluate and treat persons who have been referred to the health department following diagnosis of LTBI by community providers. The health department may also test persons who are required to document that they are free from tuberculosis because of existing state and local regulations. This group may include food handlers, teachers, or students. Since these two activities are not necessarily targeted towards populations at risk for tuberculosis infection, their impact and effectiveness tend to be limited at best and counterproductive at worst in that resources may be diverted from higher-priority tuberculosis control and prevention activities.
Greater impact can be achieved by targeting populations at greater risk for LTBI and at greater risk for progression to tuberculosis if infected. The health department can do this by providing technical assistance and collaborating with persons, facilities, or agencies providing health care services to populations at risk or by implementing targeted testing and treatment programs in high-risk populations. Health departments must regularly evaluate the effectiveness and impact of their targeted testing activities to ensure that resources are appropriately allocated. Ineffective practices, such as testing low-risk populations, should be discontinued.
For decades, the TST was the only available tool for diagnosing LTBI. However, in 2001, the Food and Drug Administration (FDA) approved the first alternative test for the diagnosis of LTBI, an IGRA named QuantiFERON-TB (55). Since that time, QuantiFERON-TB has been modified (with the third generation, QuantiFERON-TB Gold In-Tube, currently in use) and a second, slightly different IGRA, T-SPOT.TB, has been approved by the FDA (56). All IGRAs are based on the same principle: that peripheral blood lymphocytes sensitized by M. tuberculosis infection will produce gamma interferon when subsequently exposed to M. tuberculosis antigens. Advantages of these tests include the need for only one patient visit (as opposed to two for TST), use of specific M. tuberculosis antigens that are not found in bacillus Calmette-Guérin (BCG) or most nontuberculous mycobacteria, and objective measurement of gamma interferon release (as opposed to the more subjective measurement of induration for TST). The CDC currently states that IGRAs can be used in any instance for which TST is used, with IGRAs being preferred for persons who have been BCG vaccinated or who are not likely to return for TST reading and TST being preferred for young children (56).
Similarly, for many years, treatment of LTBI has primarily been limited to a single drug, isoniazid. While isoniazid has been demonstrated to be highly efficacious in the prevention of progression to tuberculosis disease in persons with LTBI, the drug’s effectiveness is limited by the need for a prolonged course of treatment and hepatotoxicity. Completion rates for a 6- to 9-month course of isoniazid are 50 to 60% at best (57). Within the last two decades, better treatment regimens have also become available. Three months of once-weekly isoniazid and rifapentine (3HP) and four months of daily rifampin have been shown to have higher completion rates, with less hepatotoxicity than nine months of isoniazid (58, 59). A disadvantage of the 3HP regimen has been that the major efficacy study was done using DOT, and therefore, it was initially recommended to be used with DOT (54). Even with the added cost of DOT, the regimen is still cost-effective (60). However, preliminary data from a randomized clinical trial indicate that self-administered 3HP is safe, with completion rates still superior to those historically achieved with nine months of isoniazid (61).
PROVIDING LABORATORY AND DIAGNOSTIC SERVICES
Public health tuberculosis control programs are responsible for ensuring that suitable laboratory and diagnostic services are available for tuberculosis patients and individuals suspected of having tuberculosis. The most important component is the availability of accurate and rapid mycobacteriology laboratory services, since the laboratory is an essential part of the diagnosis, treatment, prevention, and control of tuberculosis (62). Core public health mycobacteriology services include fluorescent acid-fast microscopy, liquid culture, identification of M. tuberculosis complex isolates using rapid methods, and testing of M. tuberculosis complex isolates for susceptibility to first-line drugs used for treatment by rapid methods (63). Public health laboratories should also develop systems to facilitate specimen transport and ensure rapid reporting of results to tuberculosis control as well as the community health care providers and laboratories they serve. Public health laboratories that do not perform second-line drug susceptibility testing should have protocols in place for rapid referral of M. tuberculosis complex isolates to a reference laboratory as soon as rifampin resistance, or resistance to any two first-line drugs, is suspected. Since the diagnosis of tuberculosis in the United States involves a network of private and public laboratories with different levels of service, specimens from a single patient may be referred to several laboratories for more complex testing (64). Without excellent coordination and communication between public and private sector laboratories, diagnosis and treatment of tuberculosis patients may be delayed.
In addition to core services, public health laboratories should provide or ensure availability of nucleic acid amplification to detect M. tuberculosis complex directly in clinical specimens, when clinically indicated for patients for whom a diagnosis of tuberculosis is being considered but has not yet been established, and for whom the test result would alter case management or tuberculosis control activities (65, 66). It is necessary for public health laboratories to work with tuberculosis program partners to establish policies ensuring the appropriate utilization and interpretation of nucleic acid amplification tests (63). Since nucleic acid amplification testing does not replace the need for culture, these policies should ensure that all persons suspected of having tuberculosis have specimens collected for mycobacterial culture (65, 66). For nucleic acid amplification tests that detect resistance to rifampin but do not identify the specific genetic mutation present, public health laboratories should provide or ensure a mechanism for confirmation of rifampin resistance by DNA sequencing (66). Although IGRAs are currently not considered a core service of public health laboratories (63, 64), many public health laboratories perform these tests. Laboratories and tuberculosis control programs should collaborate to determine the need for IGRA in their jurisdiction (56).
The health department should also ensure that outpatient and inpatient facilities involved in the diagnosis and treatment of tuberculosis have access to chest radiology services, including interpretation. Prompt reporting of CXR findings is essential to providing care to tuberculosis patients and persons suspected to have tuberculosis. HIV counseling, testing, and referral must be readily available also. Finally, facilities providing tuberculosis treatments should provide adequate laboratory and diagnostic services to monitor patients for response to therapy and adverse reactions to treatment.
COLLECTING AND ANALYZING DATA
Public health programs cannot function effectively without rapid and accurate disease surveillance systems. The critical first step in maintaining effective surveillance is prompt tuberculosis case reporting. Vital elements in this process include reporting of positive test results from laboratories to the health department and reporting from physicians and nurse practitioners, clinics, hospitals, and other community health care providers. Health departments also engage in both passive and active case finding to facilitate case reporting. Active case finding includes routine communication with infection control practitioners in hospitals, correctional facilities, and other facilities that diagnose tuberculosis. The health department should create a tuberculosis registry and have the capacity for the electronic storage of records with updated information on all current and suspected tuberculosis cases. Data collection should include all information necessary to ensure the appropriate follow-up of tuberculosis patients and those suspected to have tuberculosis and for compiling local, state, and national surveillance reports. All clinically relevant information, including diagnostic laboratory results, drug susceptibility test results, and treatment regimens, should be included in the registry. Ideally, the health department should also collect and store data on contacts and persons tested for LTBI. Sufficient safeguards to ensure the quality of the data and to protect the confidentiality of the records should be instituted.
Tuberculosis control programs should analyze the data collected to monitor morbidity trends, determine the demographic characteristics of their patient population, monitor drug resistance rates, and determine the outcomes of treatment. Additional analyses should be done on the effectiveness and outcomes of contact investigations and LTBI targeted testing and treatment programs. These analyses should be used to assess program performance and progress toward achieving locally and nationally established program objectives. Planning for use of resources and implementation of interventions should be based on the results of the analysis of surveillance and program data. Annual reports of local tuberculosis morbidity rates and trends should be prepared and distributed to community providers and organizations, professional societies, and leaders.
An important component of data collection by the local health department is the prompt and complete reporting of tuberculosis cases to state tuberculosis control programs, with the states forwarding the reports to the CDC. These data are essential for state and national planning, assessment, and resource allocation. Since 2005, the DTBE has included program evaluation as a core requirement of its cooperative agreements with the 50 states, nine large cities, five territories, and three sovereign nations that formerly were U.S. territories. With the understanding of the resource limitations and constraints faced by tuberculosis programs, the NTIP was developed to facilitate the use of existing data to help programs prioritize activities and focus program evaluation efforts.
PROVIDING TRAINING AND EDUCATION
The primary training responsibility of state and local health departments is training the health department staff directly involved in tuberculosis prevention and control activities (42). Health department staff need ongoing training and education to remain current on treatment, patient management, and programmatic issues. As new guidelines for tuberculosis treatment, prevention, and control are published, staff need updates and related training. New staff members need intensive training to become adept at their job and gain general knowledge regarding tuberculosis transmission, infection, and disease, as well as develop proficiency in infection control procedures.
A secondary responsibility is education of the external community to ensure that community providers and clinicians have the knowledge and skills to appropriately diagnose and treat tuberculosis (42). Health care planners and policy makers should be educated on the continuing need to control and eliminate tuberculosis in their jurisdictions. Institutions such as hospitals, correctional facilities, nursing homes, and homeless shelters should be instructed on the need to maintain vigilance and adequate infection control practices to prevent the transmission of tuberculosis within their facilities. Tuberculosis control programs must work diligently with community groups, minority organizations, professional societies, and medical and nursing schools to meet the training and education needs of the community.
The TB Education and Training Network was formed in 2000 to bring tuberculosis professionals together to network, share resources, and build education and training skills (http://www.cdc.gov/tb/education/tbetn/). Membership includes representatives from tuberculosis programs, correctional facilities, hospitals, nursing homes, federal agencies, universities, the American Lung Association, RTMCCs, and other U.S. and international organizations interested in tuberculosis education and training issues.
Goals of this network include furthering tuberculosis education and training by the following:
Building, strengthening, and maintaining collaboration
Providing a mechanism for sharing resources to avoid duplication
Developing, improving, and maintaining access to resources
Providing updated information about tuberculosis courses and training initiatives
Assisting members in skill building
CONCLUSION
With the decline in tuberculosis incidence in the United States over the past two decades, programs must confront the decline in resources available for tuberculosis control and the decline in knowledge and skills among community providers and their own staff regarding the diagnosis, treatment, and control of tuberculosis. At the same time, outbreaks of tuberculosis resulting from delayed diagnosis of persons with infectious tuberculosis will continue to occur and can easily overwhelm the capacity of small public health programs to respond. New paradigms of public health response to tuberculosis, such as strengthening laboratory networks and regionalization of programs, will be necessary to meet the needs of low-incidence areas.
The most recent trends suggest that progress toward tuberculosis elimination is leveling off. The epidemiology of tuberculosis in the United States has changed substantially such that about two-thirds of cases occur in foreign-born persons. These factors will continue to challenge public health programs as they struggle to control tuberculosis in patient populations with diverse languages, cultures, and understandings of and beliefs about tuberculosis. Many programs have already adapted to this changing epidemiology of tuberculosis. Ultimately, control and elimination of tuberculosis in the United States will depend not only on the efforts of the state and local health departments and community providers but also on the success of international efforts.
In Ending Neglect: the Elimination of Tuberculosis in the United States, the Institute of Medicine recommended that the United States maintain control of tuberculosis through timely diagnosis and treatment of persons with tuberculosis disease; investigation, evaluation, and treatment of contacts of persons with infectious tuberculosis; and prevention of transmission through infection control while also advancing toward tuberculosis elimination largely through targeted testing and treatment of persons with LTBI (8). These fundamental challenges for tuberculosis public health programs will define their efforts and activities in the coming years.
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