Standards for Diagnosis

Standard 1. All persons with otherwise unexplained productive cough lasting two–three
weeks or more should be evaluated for tuberculosis.

Standard 2. All patients (adults, adolescents, and children who are capable of producing
sputum) suspected of having pulmonary tuberculosis should have at
least two, and preferably three, sputum specimens obtained for microscopic
examination. When possible, at least one early morning specimen
should be obtained.

Standard 3. For all patients (adults, adolescents, and children) suspected of having
extrapulmonary tuberculosis, appropriate specimens from the suspected
sites of involvement should be obtained for microscopy and, where
facilities and resources are available, for culture and histopathological
examination.

Standard 4. All persons with chest radiographic fi ndings suggestive of tuberculosis
should have sputum specimens submitted for microbiological examination.

Standard 5. The diagnosis of sputum smear-negative pulmonary tuberculosis should
be based on the following criteria: at least three negative sputum smears
(including at least one early morning specimen); chest radiography fi ndings
consistent with tuberculosis; and lack of response to a trial of broadspectrum
antimicrobial agents. (NOTE: Because the fl uoroquinolones are
active against M. tuberculosis complex and, thus, may cause transient
improvement in persons with tuberculosis, they should be avoided.) For
such patients, if facilities for culture are available, sputum cultures should
be obtained. In persons with known or suspected HIV infection, the diagnostic
evaluation should be expedited.

Standard 6. The diagnosis of intrathoracic (i.e., pulmonary, pleural, and mediastinal or
hilar lymph node) tuberculosis in symptomatic children with negative sputum
smears should be based on the fi nding of chest radiographic abnormalities
consistent with tuberculosis and either a history of exposure to an
infectious case or evidence of tuberculosis infection (positive tuberculin
skin test or interferon gamma release assay). For such patients, if facilities
for culture are available, sputum specimens should be obtained (by expectoration,
gastric washings, or induced sputum) for culture.

Standard 7. Any practitioner treating a patient for tuberculosis is assuming an important
public health responsibility. To fulfi ll this responsibility the practitioner must
not only prescribe an appropriate regimen but, also, be capable of assessing
the adherence of the patient to the regimen and addressing poor
adherence when it occurs. By so doing, the provider will be able to ensure
adherence to the regimen until treatment is completed.

Standard 8. All patients (including those with HIV infection) who have not been treated
previously should receive an internationally accepted fi rst-line treatment
regimen using drugs of known bioavailability. The initial phase should consist
of two months of isoniazid, rifampicin, pyrazinamide, and ethambutol.
The preferred continuation phase consists of isoniazid and rifampicin given
for four months. Isoniazid and ethambutol given for six months is an alternative
continuation phase regimen that may be used when adherence
cannot be assessed, but it is associated with a higher rate of failure and
relapse, especially in patients with HIV infection.

The doses of antituberculosis drugs used should conform to international
recommendations. Fixed-dose combinations of two (isoniazid and rifampicin,
three (isoniazid, rifampicin, and pyrazinamide), and four (isoniazid,
rifampicin, pyrazinamide, and ethambutol) drugs are highly recommended,
especially when medication ingestion is not observed.

Standard 9. To foster and assess adherence, a patient-centered approach to administration
of drug treatment, based on the patient’s needs and mutual respect
between the patient and the provider, should be developed for all patients.
Supervision and support should be gender-sensitive and age-specifi c and
should draw on the full range of recommended interventions and available
support services, including patient counseling and education. A central
element of the patient-centered strategy is the use of measures to assess
and promote adherence to the treatment regimen and to address poor adherence
when it occurs. These measures should be tailored to the individual
patient’s circumstances and be mutually acceptable to the patient and
the provider. Such measures may include direct observation of medication
ingestion (directly observed therapy—DOT) by a treatment supporter who
is acceptable and accountable to the patient and to the health system.

Standard 10. All patients should be monitored for response to therapy, best judged in
patients with pulmonary tuberculosis by follow-up sputum microscopy (two
specimens) at least at the time of completion of the initial phase of treatment
(two months), at fi ve months, and at the end of treatment. Patients
who have positive smears during the fi fth month of treatment should be
considered as treatment failures and have therapy modifi ed appropriately.
(See Standards 14 and 15.) In patients with extrapulmonary tuberculosis
and in children, the response to treatment is best assessed clinically.

Follow-up radiographic examinations are usually unnecessary and may be
misleading.

Standard 11. A written record of all medications given, bacteriologic response, and
adverse reactions should be maintained for all patients.

Standard 12. In areas with a high prevalence of HIV infection in the general population
and where tuberculosis and HIV infection are likely to co-exist, HIV
counseling and testing is indicated for all tuberculosis patients as part of
their routine management. In areas with lower prevalence rates of HIV, HIV
counseling and testing is indicated for tuberculosis patients with symptoms
and/or signs of HIV-related conditions and in tuberculosis patients
having a history suggestive of high risk of HIV exposure.

Standard 13. All patients with tuberculosis and HIV infection should be evaluated to determine
if antiretroviral therapy is indicated during the course of treatment
for tuberculosis. Appropriate arrangements for access to antiretroviral
drugs should be made for patients who meet indications for treatment.
Given the complexity of co-administration of antituberculosis treatment
and antiretroviral therapy, consultation with a physician who is expert in
this area is recommended before initiation of concurrent treatment for tuberculosis
and HIV infection, regardless of which disease appeared fi rst.
However, initiation of treatment for tuberculosis should not be delayed.
Patients with tuberculosis and HIV infection should also receive cotrimoxazole
as prophylaxis for other infections.

Standard 14. An assessment of the likelihood of drug resistance, based on history of
prior treatment, exposure to a possible source case having drug-resistant
organisms, and the community prevalence of drug resistance, should be
obtained for all patients. Patients who fail treatment and chronic cases
should always be assessed for possible drug resistance. For patients in
whom drug resistance is considered to be likely, culture and drug susceptibility
testing for isoniazid, rifampicin, and ethambutol should be performed
promptly.

Standard 15. Patients with tuberculosis caused by drug-resistant (especially multipledrug
resistant [MDR]) organisms should be treated with specialized regimens
containing second-line antituberculosis drugs. At least four drugs
to which the organisms are known or presumed to be susceptible should
be used, and treatment should be given for at least 18 months. Patientcentered
measures are required to ensure adherence. Consultation with
a provider experienced in treatment of patients with MDR tuberculosis
should be obtained.

Standard 16. All providers of care for patients with tuberculosis should ensure that persons
(especially children under 5 years of age and persons with HIV infection)
who are in close contact with patients who have infectious tuberculosis
are evaluated and managed in line with international recommendations.
Children under 5 years of age and persons with HIV infection who have
been in contact with an infectious case should be evaluated for both latent
infection with M. tuberculosis and for active tuberculosis.

Standard 17. All providers must report both new and retreatment tuberculosis cases and
their treatment outcomes to local public health authorities, in conformance
with applicable legal requirements and policies.