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Persons using assistive technology might not be able to fully access information in this file. For assistance, please send e-mail to: [email protected]. Type 508 Accommodation and the title of the report in the subject line of e-mail. Essential Components of a Tuberculosis Prevention and Control Program Recommendations of the Advisory Council for the Elimination of TuberculosisAdvisory Council for the Elimination of Tuberculosis January 1995 CHAIRMAN Charles M. Nolan, M.D. Director, Tuberculosis Control Seattle-King County Department of Public Health Seattle, WA ACTING EXECUTIVE SECRETARY Samuel W. Dooley, Jr., M.D. Acting Associate Director for Science National Center for Prevention Services Centers for Disease Control and Prevention Atlanta, GA MEMBERS Paul T. Davidson, M.D. Los Angeles County Department of Health Services Los Angeles, CA Miguel A. Escobedo, M.D. El Paso City/County Health District El Paso, TX Sue C. Etkind, R.N., M.S. * Massachusetts Department of Public Health Jamaica Plain, MA Charles P. Felton, M.D. Harlem Hospital Center New York, NY Kathleen F. Gensheimer, M.D. Maine Department of Human Services Augusta, ME Jeffrey Glassroth, M.D. Northwestern University Medical School Chicago, IL Kathleen S. Moser, M.D. San Diego County Department of Health Services San Diego, CA Gisela F. Schecter, M.D., M.P.H. * San Francisco Tuberculosis Control Program San Francisco, CA Jeffrey R. Starke, M.D. Baylor College of Medicine Houston, TX Lillian J. Tom-Orme, Ph.D. Utah Department of Health Salt Lake City, UT Betti Jo Warren, M.D. King-Drew Medical Center Los Angeles, CA EX OFFICIO MEMBERS G. Stephen Bowen, M.D. Health Resources and Services Administration Rockville, MD Michael J. Brennan, Ph.D. Food and Drug Administration Bethesda, MD Georgia S. Buggs Office of Minority Health Public Health Service Rockville, MD Warren Hewitt, Jr. Substance Abuse and Mental Health Services Administration Rockville, MD J. Terrell Hoffeld, D.D.S. Agency for Health Care Policy and Research Rockville, MD Gary A. Roselle, M.D. Department of Veterans Affairs Cincinnati, OH Zeda Rosenberg, Sc.D. National Institutes of Health Bethesda, MD Bruce Tempest, M.D. Indian Health Service Gallup, NM Basil P. Vareldzis, M.D. Agency for International Development Washington, DC LIAISON REPRESENTATIVES John B. Bass, Jr., M.D. American Thoracic Society University of South Alabama Mobile, AL Nancy Dunlap, M.D. American College of Chest Physicians University of Alabama at Birmingham Birmingham, AL Wafaa El-Sadr, M.D., M.P.H. Infectious Disease Society of America Harlem Hospital Center New York, NY Alice McIntosh American Lung Association New York, NY Norbert P. Rapoza, Ph.D. American Medical Association Chicago, IL Michael L. Tapper, M.D. Society for Hospital Epidemiology of America Lenox Hill Hospital New York, NY COMMITTEE REPRESENTATIVES Advisory Committee on the Prevention of HIV Infection Walter F. Schlech, M.D. Victoria General Hospital Halifax, Nova Scotia, Canada Hospital Infection Control Practices Advisory Committee Susan Forlenza, M.D. Nassau County Medical Center East Meadows, NY
The following CDC staff member prepared this report: Patricia M. Simone, M.D. Division of Tuberculosis Elimination National Center for Prevention Services in collaboration with the Advisory Council for the Elimination of Tuberculosis Summary Tuberculosis (TB) rates declined steadily for decades in the United States, but several complex social and medical factors caused TB morbidity to increase 14% from 1985 through 1993. The recent increases in TB morbidity have placed additional demands on state and local TB control programs, which already had been substantially weakened by inadequate staffing and funding support. TB programs throughout the nation must be revitalized if they are to provide core TB control activities that enable effective responses to this public health challenge. This report describes a model for TB control programs and the essential components of a successful TB control program, including three priority strategies for TB prevention and control: a) identifying and treating persons who have active TB, b) finding and screening persons who have had contact with TB patients to determine whether they are infected with Mycobacterium tuberculosis or have active TB and providing appropriate treatment, and c) screening populations at high risk for TB infection and the development of TB disease to detect infected persons and providing therapy to prevent progression to active TB. State and local health departments have primary responsibility for preventing and controlling TB. To meet this challenge successfully, TB control programs should be able to administer activities that include the following core components:
this report to provide a national standard by which policymakers, TB control program managers, and others evaluating TB programs can assess individual TB control programs. The report may also help local programs to obtain and maintain adequate resources for TB control activities. In addition to defining the essential components of a TB control program, this report emphasizes the importance of a) prioritizing TB control activities; b) coordinating care with other health-care providers, facilities, and community organizations; c) using alternative approaches to TB control (e.g., the expanded use of directly observed therapy); d) targeting screening and prevention programs to high-risk populations; and e) following current recommendations for the treatment of TB. TB control program managers should make every effort to incorporate each of these components into their program activities. TB programs may perform these activities directly, or programs may coordinate with other providers to ensure the implementation of these activities. Failure to meet these core standards can decrease a TB program's effectiveness in controlling this reemergent public health risk. INTRODUCTION The incidence of tuberculosis (TB) was declining in the United States until recently, and in 1989, goals were set to eliminate the disease by the year 2010 (1). However, instead of continuing to decline, TB morbidity increased 14% from 1985 through 1993 (2). This recent trend has been attributed to several factors, including the human immunodeficiency virus (HIV) epidemic, the occurrence of TB in foreign-born persons from countries that have a high prevalence of TB, and the transmission of Mycobacterium tuberculosis in congregate settings (e.g., health-care facilities, correctional facilities, drug-treatment centers, and homeless shelters). The increase in TB and the complexity of factors associated with this increase have placed additional demands on public health TB control programs, yet many of these programs lack adequate support for services necessary for TB control. In particular, funding for TB control programs has been reduced markedly because of the increased competition for public health funds; the decrease in government services at federal, state, and local levels; and the decline in TB cases reported before 1985 (3). The public health-care infrastructure must be rebuilt to meet the challenge of the recent resurgence of TB cases (4). In the United States, state and local health departments have legal responsibility for the prevention and control of TB in communities. Three strategies are fundamental to the prevention and control of TB. The first priority is identifying and treating persons who have active TB; this priority entails identifying persons who have TB, ensuring that they complete appropriate therapy, and, in exceptional circumstances, using confinement measures. The second priority is finding and screening persons who have been in contact with TB patients to determine whether they have TB infection or disease and providing them with appropriate treatment. The third priority is screening high-risk populations to detect persons who are infected with M. tuberculosis and who could benefit from therapy to prevent the infection from progressing to TB disease. To implement these three strategies, public health TB control programs should coordinate with health-care providers from several community organizations to ensure the provision of direct services for TB patients. Health departments are responsible for providing centralized, coordinated systems for many activities extending beyond individual patient care (e.g., identifying TB cases; ensuring that patients complete therapy; performing contact investigations; screening high-risk groups; and collecting, analyzing, and publishing epidemiologic and surveillance data). PURPOSE The Advisory Council for the Elimination of Tuberculosis (ACET) has prepared this report to provide a national standard ** for the assessment of individual TB control programs by TB control program managers, policymakers, and other persons evaluating TB programs. This report also may be used to assist local programs in obtaining and maintaining adequate resources for TB control activities. In addition to defining the essential components of a TB control program, these recommendations emphasize the importance of prioritizing TB control activities; coordinating care with other health-care providers, facilities, and community organizations; and using alternative approaches to TB control (e.g., the expanded use of directly observed therapy, targeted screening and prevention programs to high-risk populations, and adoption of current recommendations for the treatment of TB) (5-7). Although the size and structure of TB control programs vary according to each community's specific needs, TB control program managers should attempt to incorporate each of these core components into program activities. OVERALL PLANNING AND POLICY To achieve effective TB control and progress toward TB elimination, TB control programs should develop an overall TB control strategy, including written policies and procedures, and should be able to provide guidance and oversight to local facilities and practitioners involved in TB control activities. TB control programs should ensure that appropriate laws and adequate staff and funding are available to support TB control activities. These programs also should form networks and coalitions with community groups to assist with implementing TB control activities. An Overall TB Control Strategy and Written Policies and Procedures TB control programs should develop an overall TB control strategy in collaboration with local health-care providers, professional societies, and voluntary organizations. To determine specific needs, the program should use local TB morbidity data and standard indicators of program performance (e.g., the rate of completion of therapy). The plan should be developed by the state or local ACET in conjunction with community TB coalition representatives. The TB control strategy should outline program priorities and objectives reflecting the specific needs of the community and the roles of the various agencies, organizations, and providers. TB control programs should also have written policies and procedures that clearly define the standard of practice for TB treatment and prevention in the community (1,5-18). periodically and revised as needed. Advising Local Institutions and Practitioners TB control programs should provide consultation and oversight for the TB control activities of local facilities and practitioners (and local health departments where appropriate) to ensure that these efforts reflect current standards of care and public health practice. The consultation may be provided by either health department staff or local or regional medical experts who have agreed to act as consultants for the health department. Consultants should be available to advise local practitioners about patient management problems (e.g., monitoring treatment adherence); at least one consultant should be experienced in treating patients having drug-resistant TB. Information on the latest laboratory techniques and technology, guidance about appropriate laboratory methods for local facilities and laboratories, and assistance in conducting contact or outbreak investigations should be available from TB control programs or their consultants. TB programs should seek opportunities to inform persons or facilities about activities and technologies that can improve TB services. Appropriate Laws and Regulations to Support TB Control Activities TB control programs periodically should review applicable laws, regulations, and policies to ensure their consistency with currently recommended medical and public health practices (8). States and municipalities should create laws, regulations, and policies that provide support and a legal basis for the following TB control activities:
settings (e.g., correctional facilities) to apply recommended measures for infection control. Adequate and Appropriate Staff to Conduct TB Control Activities TB control programs should have adequate and appropriate staff to ensure the fulfillment of TB control activities outlined in this report. The number and type of staff for these programs may vary, depending on the local TB morbidity and the specific needs of the community. Staff are necessary for program planning, program funding, record-keeping, education, and coordination of health department activities with other TB control activities in the community. All TB control programs should have a designated program manager. These programs should have access to, or have on staff, epidemiologists qualified to conduct data-based evaluation and surveillance activities. Community outreach workers are needed to deliver directly observed TB therapy, thereby ensuring continuity and completion of treatment. Outreach workers may also be involved in other activities (e.g., educating patients, observing preventive therapy, conducting contact investigations, arranging or providing transportation, assisting patients with social services, serving as interpreters, and assisting clinicians with clinical services). These outreach workers may be nurses or lay persons specifically trained for these activities. The TB program should ensure that outreach workers have adequate clinical and administrative supervision. Depending on clinic needs, clinic staff may be composed of various combinations of nurses, physicians, physician assistants, and other workers. In many areas, clinics have nurse managers responsible for providing most of the education, treatment, clinical monitoring, prevention services, and supervisory needs of the clinic. A physician who is qualified and trained in the diagnosis, management, and clinical monitoring of TB should be available on staff or employed on a contract basis. Clinic staff should have characteristics appropriate to the community's cultural and language needs. Adequate Funding to Conduct TB Control Activities TB control programs should seek funding for TB control activities from federal, state, local, and private sources. They should work with local organizations (e.g., state and local medical societies, lung associations, and TB coalition members) to educate policymakers about the local TB problem and local program priorities, needs, and objectives. Networks with Community Groups Optimal TB prevention and control activities require a multidisciplinary approach. Thus, TB control programs in communities having a high prevalence of TB should form networks and coalitions with local groups (e.g., cultural and ethnic organizations, community clinics, places of worship, professional societies, lung associations, and medical and nursing schools). In collaborating with these community groups, the TB control program should a) ensure that community leaders, health-care providers, and policymakers are knowledgeable about TB; b) help educate the public about TB; and c) provide guidance and assistance for local screening and prevention services. Coalitions with community groups help TB control programs reach high-risk groups more effectively and provide culturally appropriate services. TB control programs should educate and advise community groups to ensure the quality and appropriateness of TB control activities in accordance with the community's needs. The National Coalition to Eliminate Tuberculosis exemplifies a national coalition involved in educating health-care providers and the public about TB. MANAGING PERSONS WHO HAVE DISEASE OR WHO ARE SUSPECTED OF HAVING DISEASE TB control programs should ensure that the services needed to evaluate, treat, and monitor TB patients are readily available in each community. In many areas, these services may be provided directly by the state TB control program. In other areas, local TB control programs or health-care professionals, with supervision and consultation from the state TB control program, provide treatment services to patients. Although some patients may undergo most of their evaluation and treatment in settings other than the health department, the major responsibility for monitoring and ensuring the quality of all TB-related activities in the community should be undertaken by the health department as part of its duties to protect the public health. The public health goals of TB patient management are to initiate treatment promptly and ensure the completion of effective therapy to cure illness, reduce transmission, and prevent the development of drug-resistant TB. Clinical Services Developing a Treatment Plan A specific health department employee (case manager) should be assigned primary responsibility and held accountable for ensuring that each patient is educated about TB and its treatment, that therapy is continuous, and that contacts are examined. Some specific responsibilities also may be assigned to other persons (e.g., clinical supervisors {nurses, physicians, or physician assistants}, outreach workers, health educators, and social workers). As soon as TB is diagnosed or suspected, treatment should be started, and the TB case should be reported to the health department. Within 3 working days after the case is reported, a health department worker should visit the patient in the hospital or home to initiate patient education, identify contacts, make appropriate referrals for medical evaluation, and detect possible problems related to adherence to therapy. In cooperation with the other medical, nursing, and outreach staff providing care to the patient, the case manager should develop an initial treatment and monitoring plan based on the initial visit, the medical and nursing assessment, and other available information (Table_1). The initial treatment plan should be developed within 1 week of diagnosis (i.e., within 1 week of initiation of therapy for a person suspected to have TB or within 1 week of identification of a person having a positive culture). This treatment plan should be reviewed regularly and modified as needed when additional relevant information becomes available (e.g., susceptibility-test results) or when the care of the patient is transferred from one provider to another. The treatment plan should include the specifics of the medical regimen, a monitoring plan for toxicity and for clinical and bacteriologic response, and an assessment of the patient's social, behavioral, and additional medical needs that may affect continuity or completion of therapy (19). The health department employee responsible for monitoring treatment adherence should identify and implement methods that promote adherence and that are appropriate to the patient's needs and desires. A treatment plan should be designed for efficiency and economy of services and convenience to the patient. When developing and implementing a treatment plan, TB control programs should work closely with health-care providers from local hospitals, drug-treatment centers, HIV clinics, correctional facilities, health maintenance organizations, private physicians' offices, and other facilities where TB patients receive medical care. TB control programs should fulfill their mandated responsibilities and also respect the relationship between patient and primary health-care provider. Clinic Services Clinic services provided by TB control programs should be accessible and acceptable to the members of the community served by the clinic. Clinic hours should be convenient and preferably should include some evening hours for persons who work or attend school during the day. The clinic should be easily accessible by public transportation, or transportation should be provided. Intervals between the time of referral and the time of appointment and waiting times in the clinic should be kept to a minimum. In busy TB clinics or multipurpose clinics, priority should be given to persons having TB or suspected of having TB and to persons receiving TB medications. Clinic services, including diagnostic evaluation, medications, and transportation, should be provided without consideration of the patient's ability to pay. The clinic should have staff members who speak the same language and have similar cultural and socioeconomic backgrounds as the community served by the clinic, or the clinic should employ persons trained to work in cross-cultural settings. Promoting Adherence Methods for promoting adherence to therapy should be tailored to the patient's needs, life-style, social support system, and beliefs about health. An assessment of these factors should be included in the development of a treatment plan (19,20). Patients should be educated about the causes and effects of TB, the dosing and possible adverse reactions of their medication, and the importance of taking their medication according to the treatment plan. To facilitate adherence, the plan should use short-course treatment regimens and, for patients whose therapy is not directly observed, fixed-dose combination tablets. Providing transportation to the clinic also is important for promoting adherence. A welcoming and respectful atmosphere within the clinic setting is fundamental to maintaining adherence. Consideration should be given to treating all patients with directly observed therapy (DOT) (6,7). With DOT, a health-care provider or other responsible person observes the patient swallowing each dose of anti-TB medication. DOT may be administered with daily or intermittent regimens and may be given to patients in an office or clinic setting or by an outreach worker in the patient's home, place of employment, school, or other mutually agreed-upon place. In some instances, DOT may be administered by the staff of correctional facilities or drug-treatment programs, home health-care workers, staff of maternal and child health facilities, or a responsible community or family member. Incentives and enablers should be available to enhance adherence to therapy. These incentives range from simple approaches (e.g., offering a cup of coffee or food discount coupons and talking with a patient while he or she is waiting in the clinic) to complex approaches (e.g., obtaining food and housing for a homeless patient). Health-care professionals, including private practitioners, who become aware of a TB patient who has demonstrated an inability or unwillingness to adhere to a prescribed treatment regimen should consult the health department. The TB control program should assist in evaluating the patient for the causes of nonadherence to therapy and provide assistance (e.g., outreach-worker services) to enable the patient to complete the recommended therapy. If the patient still fails to adhere to treatment, the health department should take appropriate action based on local laws and regulations. This action could entail seeking court-ordered DOT or detention for those patients who are unwilling or unable to complete their treatment and who are infectious or who are at risk for becoming infectious or developing drug-resistant TB. Additional services may be necessary to facilitate continuity and completion of therapy. Social workers, translators, and referral sources for drug-treatment services should be available in the clinic or easily accessible to the patients. Referral System for Other Medical Problems A system should be in place to facilitate referral of TB patients for evaluation and treatment of other medical problems, including those conditions (e.g., HIV infection, underlying malignancy, diabetes mellitus, and substance abuse) that may affect the course or outcome of TB treatment. Consultants should see referred patients in a timely fashion, and the assessment and recommendations of the consultant should be made available promptly to the referring health-care provider. If patients receive care in more than one setting, treatment should be coordinated with the other health-care providers to ensure continuity and completion of therapy, minimize drug interactions, and avoid duplication of efforts. The TB program should take primary responsibility for ensuring TB treatment and monitoring for adherence. Clinical Consultative Services Expert medical consultation should be available for management of all TB patients, including those who have drug-resistant TB. These consultative services should be available to the TB control program and health-care providers in the community. The consultation may be provided by a staff member of the TB control program or by a local or regional consultant collaborating with the health department. Inpatient Care Regardless of the patient's ability to pay, appropriate accommodations should be available for any TB patient requiring inpatient hospital care for TB or other conditions. The facility should have effective infection control measures in place to prevent transmission of TB infection in the hospital (12). Medical staff knowledgeable about the management of TB patients should be available to assist in the care of the patient while hospitalized. In addition, appropriate medications should be available in the facility so that the patient can continue therapy in the hospital. Appropriate diagnostic services (e.g., radiology and mycobacteriology) should be available to monitor the patient for adverse reactions, the progress of treatment, and other medical conditions. The local TB program and the facility should develop and implement protocols to ensure rapid reporting of known or suspected TB cases to the local health department. Confinement Capability To ensure that patients receive treatment until they are cured, TB control programs should have adequate legal authority and appropriate facilities available to isolate and treat patients who have infectious TB. When all less restrictive measures have failed, TB control programs also should have the authority to detain patients unwilling or unable to complete their treatment. This authority also should apply to nonadherent patients who are no longer infectious, but who are at risk for again becoming infectious or for the development of drug-resistant TB. Infection Control TB control programs should serve the medical community as sources of information and consultation regarding appropriate infection control practices (12). During interactions with the medical community, TB control programs should emphasize the need to maintain a high level of suspicion for TB in evaluating patients who have TB symptoms and also the importance of early diagnosis and isolation and prompt initiation of therapy. The programs should give expert advice or provide referrals to experts for information about appropriate infection control measures for different settings (e.g., hospitals, clinics, nursing homes, correctional facilities, homeless shelters, and drug-treatment centers). TB control programs should provide guidance to local facilities and the community to ensure the availability of an appropriate number of TB isolation rooms to meet community needs. Because local needs may change, the adequacy of the number of isolation rooms should be reassessed each year as part of the evaluation of the TB control program. TB control programs should educate the staff of facilities providing care for TB patients about the need for routine periodic evaluation of infection control practices and may also assist in the evaluation process. Assistance may include providing current recommendations and regulations to the facility, providing names of experts in infection control, or providing access to personnel involved in programmatic evaluations. Coordinating Care with Other Health-Care Providers and Facilities TB patients often receive care in multiple settings, including HIV clinics, drug-treatment centers, correctional facilities, hospitals, nursing homes, or primary care clinics. When patients move among these various settings, continuity and completion of therapy may be compromised unless a system for the coordination of care exists. Discharge planning for hospitalized patients should begin as soon as TB is diagnosed (i.e., at the time of initiation of therapy in a suspected case or identification of a positive culture in a confirmed case). A representative from the TB control program should visit the patient in the hospital to identify contacts, collect information for the initial treatment plan, and ensure that no obstacles to the patient's follow-up care exist (see Managing Persons Who Have Disease or Who Are Suspected of Having Disease). To provide and coordinate continuous TB treatment and to facilitate transfers of care, TB control programs should communicate regularly with providers and facilities involved in TB patient care, including hospitals, infection-control practitioners, private practitioners, community clinics, correctional facilities, homeless shelters, and drug-treatment centers. TB control programs should consider using a computerized system for coordinating the care of TB patients. IDENTIFYING PERSONS WHO HAVE CLINICALLY ACTIVE TB Diagnostic Methods Clinics providing services for TB patients should have access to the basic methods necessary for the diagnosis of TB, including tuberculin skin testing, chest radiography, sputum induction, and mycobacteriology services for smears, cultures, and drug-susceptibility testing (see Laboratory and Diagnostic Services). TB control programs should provide guidance to facilities about appropriate diagnostic methods for different circumstances. Sputum smear examinations and cultures for mycobacteria should be performed on persons suspected of having active pulmonary or laryngeal TB. Tuberculin testing is the standard method for screening asymptomatic populations for infection with M. tuberculosis. However, screening initially for disease rather than infection may be more appropriate in some circumstances (e.g., when tuberculin skin-test results may be unreliable, when application and reading of the test may be impractical, or when the consequences of an undiagnosed case may be severe). For example, because elderly persons living in long-term care facilities are at high risk for the development of TB and may be anergic, all patients admitted to these facilities should have an initial screening chest radiograph. Chest radiography also may be the preferable screening method for persons incarcerated in jails or residing in other settings where TB is common and where diagnostic delays may result in large numbers of persons being exposed to TB. Case Finding Most persons who have TB are diagnosed when they seek medical care for symptoms caused by TB or other medical conditions. Therefore, for early identification of TB cases, health-care providers in the community must have an awareness of TB. Conducting contact investigations is another important way to find TB cases and may yield approximately 700 cases per 100,000 persons evaluated (CDC Program Management Reports 1990-1992, unpublished data). Health departments should seek cases of TB through active surveillance of mycobacteriology laboratories. Routine screening with chest radiographs to identify persons who have disease is justifiable in certain situations, particularly when the prevalence of TB is extremely high (e.g., among homeless populations or certain immigrant or refugee populations from areas that have a high prevalence of TB) or when the consequences of an undiagnosed case of TB are severe (e.g., in residential facilities for HIV-infected persons, correctional facilities, homeless shelters {21,22}, or nursing homes). Using local epidemiologic data, TB programs should identify these high-risk groups and settings and determine whether screening is indicated. Contact Investigation Staff of TB control programs should begin a contact investigation as soon as they are notified of a suspected or confirmed case of TB. TB control programs should educate health-care providers in the community about the need for prompt reporting of suspected cases. Contact investigations are important for identifying persons who have TB infection and who are at high risk for the development of active disease. Contact investigations are also important for detecting cases of active TB (5). The priority, speed, and extent of a contact investigation should be influenced by the likelihood of transmission (based on the characteristics of the source patient, environment, and contacts) and the possible consequences of infection (especially for HIV-infected contacts or contacts who are young children). IDENTIFYING AND MANAGING PERSONS INFECTED WITH M. TUBERCULOSIS TB Skin Testing of High-Risk Groups TB control programs should assess the prevalence and incidence of TB and the sociodemographic characteristics of TB patients and infected persons in each community. On the basis of these data, TB control programs should design tuberculin screening programs to reach the community's high-risk groups (13,16). Regular evaluation of the usefulness of these screening programs is extremely important because, in general, screening should not be given preference over higher priority activities (e.g., treatment of TB patients and contact investigation). The practice of screening low-risk groups should be discontinued. TB control programs should identify and establish working relationships with persons, facilities, and agencies providing health-care services to high-risk populations and should assist them in developing and implementing screening programs appropriate for various situations. Decisions to initiate programs to skin test high-risk groups should be based on the ability of the TB control program and these community groups to provide adequate preventive therapy services. For appropriate implementation of screening programs, the TB control program and local facilities should be able to perform tuberculin skin tests, read and interpret the tests, evaluate those persons who have positive results, initiate preventive therapy when appropriate, monitor patients for adverse reactions, and ensure that patients complete preventive therapy. The plan for evaluation and treatment of patients should be developed before testing begins. Health-care providers serving high-risk groups should receive assistance from TB control programs in planning and providing these services, including training staff and evaluating screening programs to determine their effectiveness. Members of high-risk groups should be educated about the problem of TB in their community and should be involved in the implementation of screening and prevention programs. LABORATORY AND DIAGNOSTIC SERVICES Chest Radiograph and Interpretation Outpatient and inpatient facilities offering TB treatment should have ready access to a sufficient quantity of radiology equipment and enough trained radiology technicians so that chest radiographs can be obtained each day during clinic hours for all patients needing them. Furthermore, the chest radiograph should be interpreted by a qualified person, and the report of the chest radiograph findings should be available within 24 hours. Mycobacteriology Laboratory To ensure that results of acid-fast examinations of specimens are available promptly (ideally, within 24 hours of specimen collection), TB control programs should have access to adequate mycobacteriology laboratory services. Reports of isolation and identification of M. tuberculosis should be available within 10-14 days, and reports of drug-susceptibility tests should be available within 15-30 days of specimen collection. The TB control program should work closely with the laboratory to ensure rapid delivery of specimens to the laboratory and prompt laboratory reporting of acid-fast bacilli smears, culture results, and results of drug-susceptibility tests to the clinician and health department. The laboratory should use rapid laboratory methods, including fluorescent acid-fast staining procedures, inoculation of a liquid medium as primary culture, nucleic acid probes to identify M. tuberculosis, and, using radiometric (e.g., BACTEC (R)) or similar systems, testing of M. tuberculosis isolates for susceptibility to the first-line drugs (23). These mycobacteriology laboratory services also should be available to TB control programs for monitoring bacteriologic response to therapy. Diagnostic Services to Assess Drug Toxicity The outpatient and inpatient facilities where TB treatment is offered should provide, or have access to, diagnostic services for monitoring patients for potential adverse reactions to anti-TB medications. At least monthly during therapy, patients receiving anti-TB medications should be evaluated by a health-care professional (e.g., nurse, physician, or physician assistant) and questioned about possible adverse reactions. The facilities offering TB treatment should be able to perform visual acuity and color vision evaluations on site. Blood tests for liver enzymes, blood urea nitrogen, creatinine, uric acid, complete blood count, and platelets may be performed at an outside laboratory; however, phlebotomy services should be available on site. Audiometry should be available on site or at another accessible location. In geographic areas that have a high prevalence of drug-resistant TB, testing of serum levels for anti-TB medications, especially cycloserine, should be available through a reference laboratory. HIV Testing and Counseling All persons who have confirmed or suspected TB should be offered HIV counseling and antibody testing. If TB clinics are unable to perform on-site counseling and testing, they should coordinate with HIV-testing programs to make these services available. In geographic areas that have a high prevalence of HIV-infected persons, TB prevention and control staff should be trained and qualified to provide routine HIV counseling and antibody testing. DATA COLLECTION AND ANALYSIS Case Reporting TB control programs should ensure and facilitate TB case reporting from various community sources (e.g., physicians, laboratories, hospitals, and pharmacies) and routinely monitor the completeness of reporting and the duration of time between diagnosis and reporting. TB control programs also should communicate regularly with infection-control practitioners in hospitals and other facilities that frequently diagnose TB. Case reporting is essential to the compilation of national, state, and local morbidity reports and to program planning and evaluation, and prompt reporting is necessary for effective contact tracing. TB Registry To carry out mandatory community public health responsibilities, health department TB control programs should maintain a computerized record system (case registry) with up-to-date information on all current clinically active and suspected TB cases in the community. To ensure follow-up of all TB patients and those persons suspected of having TB, registry information (e.g., smear, culture, and susceptibility results; clinical status; chest radiograph results; and doses of medications being administered) should be obtained and updated on a continuing basis. A specific health department staff member should review detailed registry information for TB cases at least monthly to identify patients who have potential problems with adherence or response to therapy (e.g., patients who have persistently positive sputum or who are taking medications to which their TB organisms are resistant) and to ensure follow-up (e.g., initiating field follow-up visits or arranging medical consultation with providers). TB control programs also should maintain records on the examination and treatment status of the contacts of infectious TB patients and other groups of high-risk infected persons (e.g., persons coinfected with M. tuberculosis and HIV). Protection of Confidentiality TB control programs should devise policies to ensure the data security and confidentiality of TB records. Strategies should be in place to protect all TB reports, records, and files containing patient names or other identifying information. Local policies regarding the security and confidentiality of such information, including HIV test results, must adhere to all laws applicable in state and local jurisdictions (8,24). TB control programs should collaborate with HIV programs to develop and implement such policies. Drug Resistance Surveillance TB control programs should ensure that drug-susceptibility tests are performed on all initial isolates of M. tuberculosis and that the results are reported promptly to the primary care provider and the local health department. TB control programs should monitor local drug resistance rates to assess the effectiveness of local TB control efforts and to determine the appropriateness of the currently recommended initial TB treatment regimen for the area. Data Analysis and Program Evaluation To determine morbidity rates, trends, and demographic characteristics of the TB patient population in the area, TB control programs should analyze the data collected each year. Local health departments should rapidly report cases, including the necessary demographic information, to state health departments, and states should regularly forward the reports to CDC. Timely and complete reporting is essential for local, state, and national public health planning and assessment. TB control programs should assess program performance by determining the rates for completion of therapy, contact identification, and initiation and completion of preventive therapy. At least annually, TB control program staff should assess progress toward achievement of program objectives. To facilitate the monitoring of TB morbidity and program performance, programs should implement computerized systems for data collection and analysis. Program evaluation reports should be shared with the appropriate public, private, and community groups. TB control programs should periodically review screening activities to assess their effectiveness in identifying infected persons and in ensuring that these persons are completing courses of preventive therapy when appropriate. If reviews demonstrate that few or no new cases are being identified by particular screening activities, these activities should be discontinued. Programs also should conduct periodic reviews of selected records systems (e.g., laboratory reports, pharmacy reports, AIDS registries, and death certificates) to validate the surveillance system and to detect any failure to report cases. TB control programs should analyze each new TB case and each death caused by TB to determine whether the case or death could have been prevented. Based on such a review, new policies should be developed and implemented to reduce the number of preventable cases and deaths. In collaboration with community-based organizations and professional societies, health departments should prepare annual reports based on these assessments. These reports should document the extent and nature of the TB problem in the area, assess the adequacy of prevention and control measures, and provide recommendations for program improvements. Some TB programs may determine that an outside review by experts from the state health department, CDC, local lung associations, or other TB experts may be helpful to determine methods for improving program performance and community TB control and for providing support for major changes (e.g., significant restructuring or acquisition of new resources). TRAINING AND EDUCATION Staff Training TB control programs should provide appropriate training and evaluation for all program staff at time of employment and at regular intervals so that staff can maintain an accurate, up-to-date level of knowledge about TB, public health practice, management and evaluation skills, and other related topics. Education for Health-Care Providers and Members of the Community TB control programs should provide leadership in TB education in the community. To determine needs for training and education, TB control programs should monitor the level of knowledge about TB among health-care providers, policymakers, and other community members who provide services to TB patients (e.g., the staff of social services departments, correctional services departments, mental health offices, and legal service offices). TB control programs should work closely with medical and nursing schools, schools of public health, community-based organizations, professional societies, minority advocacy groups, and others to meet the training and education needs of the community. References
** The word "standard" is being used to indicate a prototype
established by
authority, custom, or general consent.
TABLE 1. Elements of a treatment plan for TB patients
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I. Assignment of responsibility
A. Case manager (i.e., person assigned primary responsibility)
B. Clinical supervisor (e.g., nurse, physician, physician assistant)
C. Other caregivers (e.g., outreach worker, nurse, physician, physician assis-
tant)
D. Person responsible for completing the contact investigation
II. Medical evaluation
A. Tests for initial evaluation (e.g., tuberculin skin test, chest radiograph,
smear, culture, susceptibility tests, HIV test), including results of each test
and date completed
B. Important medical history (e.g., previous treatment, other risk factors for
drug resistance, known drug intolerances, and other medical problems)
C. Potential adverse reactions
1. Appropriate baseline laboratory tests to monitor toxicity (e.g., liver en-
zymes, visual acuity, color vision, complete blood count, audiogram,
BUN, and creatinine), including results of each test and date com-
pleted
2. Potential drug interactions
D. Obstacles to adherence
III. TB treatment
A. Medications, including dosage, frequency, route, date started, and date
to be completed for each medication
B. Administration
1. Method (directly observed or self-administered)
2. Site(s) for directly observed therapy
IV. Monitoring
A. Tests for response to therapy (e.g., chest radiograph, smear, and culture),
including planned frequency of tests and results
B. Tests for toxicity, including planned frequency of tests and results
V. Adherence plan
A. Proposed interventions for obstacles to adherence
B. Plan for monitoring adherence
C. Incentives and enablers
VII. TB education
A. Person assigned for culturally appropriate education
B. Steps of education process and date to be completed
VIII. Social services
A. Needs identified
B. Referrals, including date initiated and results
IX. Follow-up plan
A. Parts of treatment plan to be carried out at TB clinic
B. Parts of treatment plan to be carried out at other sites and person(s) con-
ducting activities
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