(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." 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 Drug-Susceptible Tuberculosis," " Clinical Infectious Diseases," 2016; 63(7):e147-95.
(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," as modified by " Recommendations for Use of an Isoniazid-Rifapentine Regimen with Direct Observation to Treat Latent Mycobacterium Tuberculosis Infection," "Morbidity and Mortality Weekly Report": December 9, 2011 / 60(48); 1650-1653.
(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 test or blood assay for Mycobacterium tuberculosis (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.
Five Year Review (FYR) Dates: 1/5/2018 and 01/03/2023
Promulgated Under: 119.03
Statutory Authority: 3701.146
Rule Amplifies: 339.71, 339.72, 3701.14
Prior Effective Dates: 10/24/2003, 01/01/2009, 11/01/2013