DAR File No. 41334

Health, Disease Control and Prevention; HIV/AIDS, Tuberculosis Control/Refugee Health

Rule R388-804

Special Measures for the Control of Tuberculosis

Notice of Proposed Rule

(Amendment)

DAR File No.: 41334
Filed: 03/01/2017 10:29:31 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this amendment is to clarify facility and patient responsibilities as expected by public health; update references; and update diagnostic criteria to be consistent with the recommendations from the Center for Disease Control (CDC).

Summary of the rule or change:

The rule change: 1) clarifies the need for an inpatient facility to consult with and obtain approval for discharge of an active tuberculosis (TB) case; and 2) clarifies patient responsibilities in order to comply with public health and potential for involuntary isolation as a result of noncompliance.

Statutory or constitutional authorization for this rule:

• Section 26-6-4
• Section 26-6-7
• Section 26-6-9
• Section 26-6-6
• Title 26, Chapter 6b
• Section 26-6-8

This rule or change incorporates by reference the following material:

• Updates Clinical Practice Guidelines: Clinical Infectious Diseases (2016) doi, published by Centers for Disease Control and Prevention, 12/08/2016
• Updates Infectious Diseases Society of America. Official ATS/CDC/IDSA Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis. Clinical Infectious Diseases (2016) , published by Centers for Disese Control and Prevention, 08/10/2016

Anticipated cost or savings to:

the state budget:

This amendment has no anticipated costs to the budget as the amendment does not impact changes in program administration or TB screening requirements.

local governments:

This amendment has no anticipated cost to local government. Local health departments receive contractual funds from the TB Program to provide assistance and screening.

small businesses:

This amendment has no anticipated cost to small businesses as they have no interaction with the TB Program.

persons other than small businesses, businesses, or local governmental entities:

This amendment has no anticipated cost to business, individuals, local governments, and persons that are not small businesses. Local health departments are contracted to provide TB services to identified individuals. The amendment provides additional clarification that addresses behavior that is already protocol but does not require actions that require monetary outlay.

Compliance costs for affected persons:

This amendment does not anticipate any cost to any affected persons since there are no specific expected changes in practice that would require additional facility expenditures. The proposed changes simply clarify what has always been expected of facilities and individuals. Any individual identified by the TB Program as being symptomatic for active TB or having a potential exposure to TB may be required to be tested and all costs will be covered by the TB Program.

Comments by the department head on the fiscal impact the rule may have on businesses:

The proposed amendment clarifies the need for inpatient facilities to consult with local health departments before discharge of a patient diagnosed with tuberculosis. It also requires such patients to comply with the treatment plan established by the provider and public health or be subject to involuntary isolation pursuant to the Utah Communicable Disease and Control Act. There is no fiscal impact on business because the amendment clarifies requirements already included in protocol.

Joseph Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Disease Control and Prevention; HIV/AIDS, Tuberculosis Control/Refugee Health
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Amelia Self at the above address, by phone at 801-538-6221, by FAX at 801-538-9913, or by Internet E-mail at aself@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

05/01/2017

This rule may become effective on:

05/08/2017

Authorized by:

Joseph Miner, Executive Director

R388. Health, Disease Control and Prevention; HIV/AIDS, Tuberculosis Control/Refugee Health.

R388-804. Special Measures for the Control of Tuberculosis.

R388-804-1. Authority and Purpose.

(1) This rule establishes standards for the control and prevention of tuberculosis as required by Section 26-6-4, Section 26-6-6, Section 26-6-7, Section 26-6-8, and Section 26-6-9 of the Utah Communicable Disease Control Act and Title 26, Chapter 6b, Communicable Diseases-Treatment, Isolation and Quarantine Procedures.

(2) The purpose of this rule is to focus the efforts of tuberculosis control on disease elimination. The standards outlined in this rule constitute the minimum expectations in the care and treatment of individuals diagnosed with, suspected to have, or exposed to tuberculosis.

 

R388-804-2. Definitions.

(1) The definitions described in Section 26-6b apply to this rule, and in addition:

(a) Tuberculosis. A disease caused by Mycobacterium tuberculosis complex, i.e., Mycobacterium tuberculosis, Mycobacterium bovis, or Mycobacterium africanum.

(b) Acid-fast bacilli (AFB). Denotes bacteria that are not decolorized by acid-alcohol after having been stained with dyes such as basic fuschsin; e.g., the mycobacteria and nocardiae.

(c) Case of tuberculosis. An episode of tuberculosis disease meeting the clinical or laboratory criteria for tuberculosis as defined in the National Notifiable Diseases Surveillance System (NNDSS). The Department incorporates by reference the Tuberculosis 2009 Case Definition, CSTE (Council of State and Territorial Epidemiologists) Position Statement, 09-ID-65.

(d) Tuberculosis infection. The presence of M. tuberculosis in the body but the absence of clinical or radiographic evidence of active disease as documented by a significant tuberculin skin test, or Interferon Gamma Release Assay (IGRA), e.g. Quantiferon or T-SPOT, a negative chest radiograph and the absence of clinical signs and symptoms.

(e) Tuberculosis disease. A state of active[infectious or communicable] tuberculosis, pulmonary or extra-pulmonary, as determined by a chest radiograph, the bacteriologic examination of body tissues or secretions, other diagnostic procedures or physician diagnosis.

(f) Directly observed therapy. A method of treatment in which health-care providers or other designated individuals physically observe the individual ingesting anti-tuberculosis medications.

(g)Drug resistant tuberculosis. Tuberculosis bacteria which is resistant to one or more anti-tuberculosis drug.

(h) Multi-drug resistant tuberculosis. Tuberculosis bacteria which is resistant to at least isoniazid and rifampin.

(i) Suspect case. An individual who is suspected to have tuberculosis disease, e.g., a known contact to an active tuberculosis case or a person with signs and symptoms consistent with tuberculosis.

(j) Program. Utah Department of Health: Bureau of Epidemiology; Prevention, Treatment, and Care Program.[Bureau of HIV/AIDS, Tuberculosis Control and Refugee Health: Tuberculosis Control/Refugee Health Program.]

(k) Department. Utah Department of Health.

 

R388-804-3. Required Reporting.

(1) Tuberculosis is a reportable disease. Individuals shall immediately notify the Department by telephone of all suspect and confirmed cases of pulmonary and extra-pulmonary tuberculosis as required by R386-702-2, R386-702-3.

(2) The report may also be made to the local health department, who shall notify the Department of all suspect and confirmed cases within 72 hours of report.

 

R388-804-4. Screening Priorities and Procedures.

(1) Private providers[physicians] and local health departments shall screen individuals considered to be at high risk for tuberculosis disease and infection before screening is conducted in the general population. Priorities shall be established based on those at greatest risk for disease and in consideration of the resources available.

(2) Individuals considered at high risk for tuberculosis include the following:

(a) Close contacts of those with infectious tuberculosis;

(b) Persons infected with human immunodeficiency virus;

(c) Individuals who inject illicit drugs;

(d) Inmates of adult and youth correctional facilities;

(e) Residents of nursing homes, mental institutions, other long term residential facilities and homeless shelters;

(f) Recently arrived foreign-born individuals, within five years, from countries that have a high tuberculosis incidence or prevalence;

(g) Low income or traditionally under-served groups with poor access to health care, e.g., migrant farm workers and homeless persons;

(h) Individuals who are substance abusers and members of traditionally under-served groups;

(i) Individuals with certain medical conditions that may predispose them to tuberculosis infection and disease, e.g., diabetes, cancer, silicosis, and immune-suppressive disorders;

(j) Individuals who have traveled for extended periods of time in countries that have a high tuberculosis incidence or prevalence;

(k) Other groups may be identified by order of the Department, as needed to protect public health.

(3) Employers who are required to follow Occupational Safety and Health Administration guidelines for the prevention of tuberculosis transmission disease shall develop and implement an employee screening program.

(4) Tuberculosis screening shall be completed using either the Mantoux tuberculin skin test method or an FDA approved in-vitro serologic test, e.g. IGRA.

(a) Screening for tuberculosis with chest radiographs or sputum smears to identify individuals with tuberculosis disease is acceptable in places where the risk of transmission is high and the time required to give the skin test makes the method impractical.

(b) If the skin test or serologic test yields results indicating tuberculosis exposure, the individual shall be referred for further medical evaluation.

 

R388-804-5. Diagnostic Criteria.

In diagnosing tuberculosis, health care providers shall be expected to adhere to the standards listed in this document.

(1) The Department incorporates by reference the [American Thoracic Society ](IDSA/ATS/CDC) diagnostic and classification standards as described in the segment entitled "Clinical Practice Guidelines:[Diagnostic Standards and Classification] Diagnosis of Tuberculosis in Adults and Children," Clinical Infectious Diseases (2016) doi: 10.1093/cid/ciw694 First published online: December 8, 2016.[published in the American Journal of Respiratory and Critical Care Medicine, Vol 161, pp. 1376-1395, 2000.]

(2) The Department incorporates by reference the CDC diagnostic and classification standards for use of Nucleic Acid Amplification test in the document entitled "Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis," MMWR; 58 (01); 7-10, 2010.

(3) The Department incorporates by reference the CDC diagnostic and classification standards for use of Interferon Gamma Release Assays as described in the document entitled, "Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection, United States, 2010" MMWR; 59 (no. RR-5); 1-25, 2010.

[In diagnosing tuberculosis, health care providers shall be expected to adhere to the standards listed in this document.]

 

R388-804-6. Treatment and Control.

(1) The Department incorporates by reference the IDSA/ATS/CDC treatment standards as described in the segment entitled "Infectious Diseases Society of America. Official ATS/CDC/IDSA Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis ". Clinical Infectious Diseases (2016) doi: 10.1093/cid/ciw376, August 10, 2016, "Centers for Disease Control and Prevention. Treatment of Tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of America. " MMWR 2003; 52 (No. RR-11), Centers for Disease Control and Prevention. Controlling Tuberculosis in the United States: Recommendations from the American Thoracic Society; CDC, and the Infectious Diseases Society of America. MMWR 2005; 54 (No. RR-12)" and "Centers for Disease Control and Prevention. Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection. MMWR 2000; 49 (No. RR-6)."[ In treating tuberculosis, health care providers must adhere to the standards listed in this document.]

(2) A health-care provider who treats an individual with tuberculosis disease shall use the IDSA/ATS/CDC treatment standards as a reference for the development of a comprehensive treatment and follow-up plan for each individual. The plan shall be developed in cooperation with the individual and approved by the local health department or the Program. Health-care providers shall routinely document an individual's[individuals'] adherence to prescribed therapy for tuberculosis infection and disease. If isolation is indicated, the plan for isolation shall be approved by the local health department or the Program. Discharge from an inpatient facility shall not occur without the knowledge of, and in agreement with the local health department and/or the Program.

(3) A health-care provider who treats an individual with suspect or active tuberculosis disease shall provide for directly observed therapy[for individuals diagnosed with active tuberculosis disease].

(4) Individuals with infectious tuberculosis disease shall comply with the treatment plan as set forth by the provider and public health, including but not limited to isolation if necessary, wear ing a mask approved by the local health department or the Program when outside the isolation area , abiding by a plan of directly observed therapy, providing laboratory samples, and attending all scheduled provider visits.

(5) Any individual who will not comply with public health shall be subject to involuntary isolation as establish in the Utah Communicable Disease Control Act.

 

R388-804-7. Epidemiologic Investigations.

(1) The local health department shall conduct a contact investigation immediately upon report of an AFB smear positive suspected or confirmed case of laryngeal, respiratory, or pleural tuberculosis disease.

(2) The contact investigation shall include interviewing, counseling, educating, examining and obtaining comprehensive information about those who have been in contact with individuals who have infectious tuberculosis.

(a) The investigation shall begin within three days of notification of an AFB smear positive suspected or confirmed case and the initial evaluation shall be completed within fourteen days of notification.

(b) Investigations of contacts to persons with active TB disease shall include the evaluation of contacts and the treatment of infected contacts.

(c) The local health department shall submit demographic data to the Department at 30 days and at 120 days after initiation of the contact investigation, and following the completion of prophylactic treatment.

 

R388-804-8. Payment for Isolation and Quarantine.

(1) Individuals who are isolated or quarantined at the expense of the Department shall provide the Department with information to determine if any other payment source for the costs associated with isolation or quarantine is available.

 

R388-804-9. Penalty for Violation.

(1) Any person who violates any provision of this rule may be assessed a civil money penalty as provided in Section 26-23-6.

 

KEY: tuberculosis, screening, communicable diseases

Date of Enactment or Last Substantive Amendment: [September 23, 2015]2017

Notice of Continuation: September 30, 2016

Authorizing, and Implemented or Interpreted Law: 26-6-4; 26-6-6; 26-6-7; 26-6-8; 26-6-9; 26-6b