Chapter 3701-15 Tuberculosis
As used in this chapter:
(A) "Active tuberculosis" means the same as set out in section 339.71 of the Revised Code.
(B) "Approved course of therapy" means the same as set out in section 339.73 of the Revised Code.
(C) "Case management" means a strategy used to ensure that patients complete tuberculosis treatment. The three elements of case management are: assignment of responsibility, systematic regular review, and plans to address barriers to adherence.
(D) "Directly observed therapy" means that a health care worker or other trained individual observes the tuberculosis patient ingesting each dose of the prescribed medications.
(E) "Latent tuberculosis infection" or "LTBI" means a positive reaction to the tuberculin skin test or BAMT, negative bacteriologic studies (if done), and no clinical, bacteriologic, or radiographic evidence of active tuberculosis.
(F) "Mantoux tuberculin skin test" means injecting 0.1 ml of 5-TU PPD intradermally into the volar or dorsal surface of the forearm.
(G) "Suspected tuberculosis" means a person with or without a positive Mantoux tuberculin skin test or BAMT who meets any of the following criteria:
(1) Has a specimen that is positive for acid-fact bacilli on smear.
(2) Has been prescribed two or more anti-tuberculosis medications for the treatment of active tuberculosis.
(3) Has a radiologic finding consistent with active tuberculosis.
(4) Has clinical symptoms or findings consistent with active tuberculosis.
(H) "Targeted tuberculin testing" means a strategic component of tuberculosis control that identifies persons at high risk for developing tuberculosis who would benefit by treatment of latent tuberculosis infection.
(I) "Blood assay for m. tuberculosis" or "BAMT" means any whole-blood assay for m. tuberculosis infection based on the release of gamma interferon (IFN-y) from antigen-specific T cells previously sensitized with mycobacterial antigens.
R.C. 119.032 review dates: 08/15/2013 and 08/15/2018
Promulgated Under: 119.03
Statutory Authority: 3701.146
Rule Amplifies: 339.71, 339.73, 3701.14
Prior Effective Dates: 1/1/1974, 7/23/98, 10/24/03, 1/1/09
An acceptable tuberculosis program, designated pursuant to division (A) of section 339.72 of the Revised Code, is a program that includes at least the components set forth in this rule.
(A) Provides hospitalization for patients with active or suspected tuberculosis for whom an acceptable ambulatory treatment plan cannot be devised.
(B) An outpatient program ensuring the following services:
(1) Maintenance of a tuberculosis case registry with up-to-date information on all current clinically active and suspected tuberculosis cases within the area served using the designated Ohio department of health reporting system. Maintenance of records on the examination and treatment status of the contacts to infectious tuberculosis patients and other groups of high-risk infected persons.
(2) Laboratory and diagnostic services as follows:
(a) Access to radiology equipment and trained radiology technicians.
(b) Access to mycobacteriology laboratory services that meet the following criteria:
(i) Results of acid-fast examinations of specimens are available within twenty-four hours of the date the specimen is received at the lab.
(ii) Reports of isolation and identification of M. tuberculosis should be available within fourteen to twenty-one days of the date the specimen is received at the laboratory.
(iii) Reports of drug-susceptibility tests for first-line drugs should be available within fifteen to thirty-five days of specimen collection of the date the specimen is received at the laboratory.
(C) A case management system to monitor and ensure adherence to treatment, which includes an assignment of responsibility, systematic review of the case, and plans to address barriers to adherence.
(D) Prevention and control activities that include the following three priority strategies:
(1) Identifying and treating all persons who have tuberculosis disease. This means finding cases of tuberculosis and ensuring that patients complete appropriate therapy.
(2) Finding and evaluating persons who have been in contact with tuberculosis patients to determine whether they have latent tuberculosis infection or active tuberculosis disease, and treating them appropriately.
(3) As resources permit, screening high-risk groups for latent tuberculosis infection to identify candidates for treatment of latent tuberculosis infection and to ensure the completion of treatment.
(a) Targeted tuberculin testing shall be conducted only among groups at high risk and discouraged in those at low risk.
(b) Infected persons who are considered to be at high risk for developing active tuberculosis shall be offered treatment for latent tuberculosis infection, irrespective of age, unless medically contraindicated.
(E) Policies and procedures as follows:
(1) The tuberculosis control unit shall outline program priorities and objectives reflecting the specific needs of the community.
(2) The tuberculosis control unit shall have written policies and procedures that clearly define the standard of practice for tuberculosis treatment and prevention in the community.
(3) The tuberculosis control unit shall provide consultation and oversight for the tuberculosis control activities of local health care facilities and practitioners to ensure that their efforts reflect the current standards of care and public health practice.
(A) Except as set out in this rule, for purposes of section 3701.14 of the Revised Code, the Ohio department of health adopts, by reference, the following tuberculosis standards:
(1) The recommendations of the United States centers for disease control and prevention as set out in "Core Curriculum on Tuberculosis: What Every Clinician Should Know."
(a) Copies of the "Core Curriculum" may be obtained at "www.cdc.gov/tb/webcourses/corecurr/index.htm".
(2) The recommendations of the United States centers for disease control and prevention, the American thoracic society, and infectious diseases society of America as set out in "Treatment of Tuberculosis," "American Journal of Respiratory and Critical Care Medicine, 2003; 167."
(3) The recommendations of the United States centers for disease control and prevention as set out in "Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection," "Morbidity and Mortality Weekly Report: Recommendations and Reports, Vol. 49, No. RR-6, June 9, 2000."
(4) The recommendations of the United States centers for disease control and prevention as set out in "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Setting, 2005," "Morbidity and Mortality Weekly Report: December 30, 2005/54(RR17); 1-141."
(B) Except as set out in paragraph (A) of this rule, the standards for performing tuberculosis screenings shall be as follows:
(1) Decisions related to tuberculosis screening activities shall be based on local epidemiologic data identifying groups at risk of tuberculosis infection.
(2) Health care agencies or other facilities shall consult with the local tuberculosis control unit before starting a tuberculosis screening program to ensure that adequate provisions are made for the evaluation and treatment of persons whose tuberculin skin tests or BAMT are positive.
(C) Except as set out in paragraph (A) of this rule, the standard for performing examinations of individuals who have been exposed to tuberculosis and individuals who are suspected of having tuberculosis shall be as follows:
(1) The standard examination method for identifying persons with latent tuberculosis infection is the Mantoux tuberculin skin test or BAMT.
(2) The standard examination method for identifying persons with active tuberculosis includes:
(a) A medical history;
(b) A physical examination;
(c) A Mantoux tuberculin skin test, or BAMT;
(d) A chest radiograph;
(e) Specimens collected for bacteriologic or histologic examination.
(D) Except as set out in paragraph (A) of this rule, the standard for providing treatment for individuals with tuberculosis shall be as follows:
(1) A specific treatment and monitoring plan shall be developed in collaboration with the local tuberculosis control unit within one week of the presumptive diagnosis.
(2) The plan shall include a description of an approved course of therapy, the methods of assessing and ensuring adherence to the anti-tuberculosis regimen, and the methods of monitoring for adverse reactions.
(E) Except as set out in paragraph (A) of this rule, the standard for methods of preventing individuals with tuberculosis from infecting other individuals shall be as follows:
(1) Local tuberculosis control units shall ensure that a complete and timely contact investigation is done for tuberculosis cases reported in the area served by the unit.
(2) Local tuberculosis control units shall ensure that the services needed to evaluate, treat, and monitor tuberculosis patients are made available in each community, without regard to the patients' ability to pay for such services as specified in section 339.73 of the Revised Code.
(F) Except as set out in paragraph (A) of this rule, the standard for laboratories performing clinical tuberculosis testing shall be as follows:
(1) Laboratories shall hold a Clinical Laboratory Improvement Act (CLIA) certificate of compliance or accreditation with a specialty in microbiology and a subspecialty in mycobacteriology.
(2) Laboratories which do not meet the criteria specified in this paragraph will be considered unacceptable for the purpose of performing testing for tuberculosis.
(3) Facilities which use out-of-state laboratories shall be held accountable for ensuring that the testing for tuberculosis meets the criteria as set out in this rule and in paragraph (A) of rule 3701-15-02 of the Administrative Code.
R.C. 119.032 review dates: 09/15/2008 and 01/01/2014
Promulgated Under: 119.03
Statutory Authority: 3701.146
Rule Amplifies: 339.71, 339.72, 3701.14
Prior Effective Dates: 10/24/2003
Rescinded eff 9-01-08