Menu of Suggested Provisions For State Tuberculosis Prevention and Control Laws

C. Laboratory Testing

Descriptive Note: Most of the provisions in this section are excerpts from existing laboratory reporting regulations but may be characterized as laboratory testing laws. The first bullet below is an example of a provision that may be utilized, where resources permit, in states desiring to require specimens to be sent to the department’s public health laboratory for confirmation. The second bullet is an example of a provision that might be more appropriate for high incidence states or states with fewer resources that want isolates sent to the department’s public health laboratory, but do not want to require it to confirm identification or drug susceptibilities for all cases. The second bullet may also be utilized for genotyping purposes. The fourth bullet requiring rapid testing along with culture facilitates earlier detection of TB, positively impacting patient care. The APHL TB Steering Committee drafted the provision on nucleic acid amplification testing, which is designed to encourage use of such testing.

• A physician who diagnoses a case of tuberculosis must ensure that a specimen from the individual is sent to the department’s public health laboratory, if the individual has pulmonary, laryngeal, or pleural tuberculosis and he/she is able to produce a sputum sample with or without induction. Whenever a clinical laboratory finds a specimen tests positive for M. tuberculosis complex or acid-fast bacilli, the laboratory must forward the specimen to the department’s public health laboratory for confirmation of the results and drug susceptibility testing.
• A laboratory that initially receives any clinical specimen which yields Mycobacterium tuberculosis complex, or yields a preliminary result indicative of Mycobacterium tuberculosis complex, is responsible for ensuring that the following are submitted:
  • 1) All preliminary results and any interpretation of those results to the appropriate local health department.
  • 2) The first Mycobacterium tuberculosis complex isolate, or subculture thereof, from the patient being tested for tuberculosis, to the department.
  • 3) Any Mycobacterium tuberculosis complex isolate, or subculture thereof, from a follow-up specimen, collected 90 days or more after the collection of the first Mycobacterium tuberculosis complex positive specimen. Mich. Admin. Code r. 325.179 (2009).
• In order to ensure susceptibility testing, laboratories shall submit a representative and viable sample of the initial culture positive for any member of the M. tuberculosis complex to the state laboratory or other laboratory designated by the board to receive such specimen.
• Any laboratory that performs primary culture for mycobacteria shall also perform bacterial identification for Mycobacterium tuberculosis complex using an approved rapid testing procedure specified by the department by rule or have access to rapid M. tuberculosis complex identification directly from the positive primary culture via a reference or public health laboratory. The results of the identification test shall be available within 24-72 hours of detection of the positive culture.
  • Laboratories that provide mycobacteriology services shall provide nucleic acid amplification testing (NAA) or equivalent testing upon request for the purpose of early detection of M. tuberculosis complex in clinical specimens. Laboratories that are unable to provide this service shall have a regular and efficient arrangement with a reference laboratory for prompt NAA testing. When a physician requests NAA testing for detection of M. tuberculosis complex in a patient specimen, results shall be available within 72 hours (whether testing is performed in-house or referred to a reference laboratory).
  • Any laboratory that identifies Mycobacterium tuberculosis complex shall ensure that antimicrobial drug susceptibility tests are performed on the initial isolate. The laboratory shall report the results of these tests to the local health officer and the department.
  • Any laboratory that performs primary culture for mycobacteria shall perform mycobacterial identification using an approved rapid testing procedure specified in the “Assessing Your Laboratory” document by the Association of Public Health Laboratories, unless specified otherwise by the TB controller.