DAR File No. 29911

Health, Epidemiology and Laboratory Services; HIV/AIDS, Tuberculosis Control/Refugee Health

R388-804

Special Measures for the Control of Tuberculosis

NOTICE OF PROPOSED RULE

DAR File No.: 29911
Filed: 05/02/2007, 10:17
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

The incorporated references in this rule have been updated by the bodies that established them, which necessitates an update to the incorporated materials. New testing methodology for identifying latent tuberculosis (TB) infection; a need to clearly define objectives related to the epidemiologic investigation; and new requirements for directly observed therapy (DOT) also necessitate an update to the rule.

Summary of the rule or change:

Updated incorporated materials provide the most recent TB control guidelines as set forth by the Centers for Disease Control and Prevention and the American Thoracic Society. The rule amendment recognizes any Federal Food and Drug Administration method for testing for latent TB infection. The amendment more clearly defines steps to be taken during the epidemiologic investigation and requires the administration of medications through use of directly observed therapy in all active TB cases.

State statutory or constitutional authorization for this rule:

Sections 26-6-4, 26-6-6, 26-6-7, 26-6-8, and 26-6-9; and Title 26, Chapter 6b

This rule or change incorporates by reference the following material:

Treatment of Tuberculosis, MMWR 2003; Controlling Tuberculosis in the United States: recommendations from the American Thoracic Society; CDC, and the Infectious Diseases Society of America, MMWR 2005; and Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection, MMWR 2000

Anticipated cost or savings to:

the state budget:

The use of an approved in vitro serological test will not impact the state budget as Federal Refugee Medical assistance funding is being used for its implementation and its use is voluntary. Once implemented, in vitro serologic testing should also yield cost savings in terms of medical staff time and the elimination of common false positive results. In vitro serological testing precludes the need for a second patient visit for test interpretation, repeat testing, and testing compliance. In a recent study (Lambert et al. Infect Control Hosp Epidemiol. 24:814-820, 2003) researchers found that the cost of implementing a skin testing program ranged from $41 to $362 per employee, with the skin test supplies representing less than 1.5% of the total cost of the program. Incorporating the updated references will not have a budgetary impact because they describe the standard of care which has been provided through local health department contracts for many years. The Department has required for many years, through contractual agreements with local health departments, that every person diagnosed with active TB disease receive DOT, which has been the international standard of care for many years. As such, there will be no additional funding provided by the state for this activity. The Department is required to submit information to the Centers for Disease Control and Prevention regarding contact investigations of persons with active TB disease. The amendment defines these steps more clearly and will not have a monetary impact because the activities represent the standard of care that has been funded through local health department contracts for many years. The addition of the term "isolation" will have no budgetary impact as quarantine was previously used incorrectly to describe the isolation process.

local governments:

Local health departments may choose to implement an in vitro serologic testing method but its use will be voluntary and no additional state funding will be made available if they choose to do so. If implemented, however, in vitro serologic testing should yield cost savings in terms of medical staff time and the elimination of common false positive results. In vitro serological testing precludes the need for a second patient visit for test interpretation, repeat testing, and testing compliance. In a recent study (Lambert et al. Infect Control Hosp Epidemiol. 24:814-820, 2003) researchers found that the cost of implementing a skin testing program ranged from $41 to $362 per employee, with the skin test supplies representing less than 1.5% of the total cost of the program. Incorporating the updated references will not have a budgetary impact because they describe the standard of care which has been provided through local health department contracts for many years. For many years, the local health departments have been required, by contractual agreement, to provide DOT to all individuals with active TB disease. Because local health departments are already required, by contract, to provide this service, there will be no increased cost associated with the change to the rule and no additional state or federal funding will be provided. For many years, the TB Control Program has provided funding to local health departments, by contractual agreement, to conduct a contact investigation of persons with active TB disease. The amendment will not impose increased costs because the local health departments are already receiving funding to provide these services. The addition of the term "isolation" will have no budgetary impact as quarantine was previously used incorrectly to describe the isolation process.

other persons:

The decision to use a particular testing method will, ultimately, be a voluntary decision each health care provider will have to make after considering cost/benefit and laboratory limitations. If implemented, however, in vitro serologic testing should yield cost savings in terms of medical staff time and the elimination of common false positive results. In vitro serological testing precludes the need for a second patient visit for test interpretation, repeat testing and testing compliance. In a recent study (Lambert et al. Infect Control Hosp Epidemiol. 24:814-820, 2003) researchers found that the cost of implementing a skin testing program ranged from $41 to $362 per employee, with the skin test supplies representing less than 1.5% of the total cost of the program. Incorporating the updated references will not have a budgetary impact because they describe the standard of care which has been provided through local health department contracts for many years. There will be no budgetary impact for DOT since it is currently conducted at the local health department level and funded at the State health department level. There will be no impact for contact investigation activities as it is currently conducted by the local health departments and not private health care providers. The addition of the term "isolation" will have no budgetary impact as quarantine was previously used incorrectly to describe the isolation process.

Compliance costs for affected persons:

There will be no compliance costs for the use of an in vitro serologic test since it is voluntary. There will be no compliance costs associated with DOT since it is conducted at the local health department level and funded through contractual agreement. There will be no compliance costs associated with contact investigation activities since the local health departments already receive funding to provide these services through contractual agreement. There will be not compliance costs for using the appropriate term "isolation" instead of the inappropriate term "quarantine".

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

Control of TB remains one of the core tasks of public health. This rule update is necessary to support those control efforts. The fiscal impact on businesses appears to be small and justified. David N. Sundwall, MD, Executive Director

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

Health
Epidemiology and Laboratory Services; 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:

Cristie Chesler at the above address, by phone at 801-538-9465, by FAX at 801-538-9913, or by Internet E-mail at cchesler@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:

07/02/2007

This rule may become effective on:

07/09/2007

Authorized by:

David N. Sundwall, Executive Director

R388. Health, Epidemiology and Laboratory Services; HIV/AIDS, Tuberculosis Control/Refugee Health.

R388-804. Special Measures for the Control of 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 document entitled "Case Definitions for Infectious Conditions Under Public Health Surveillance." The Department incorporates by reference the Centers for Disease Control and Prevention "Case Definitions for Infectious Conditions under Public Health Surveillance," MMWR;46(no. RR-10): 40-41, 1997.

([c]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, a negative chest radiograph and the absence of clinical signs and symptoms.

([d]e) Tuberculosis disease. A state of 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.

([e]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.

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

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

([h]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.

([i]j) Program. Utah Department of Health: Bureau of HIV/AIDS, Tuberculosis Control and Refugee Health: Tuberculosis Control/Refugee Health Program.

([j]k) Department. Utah Department of Health.

 

R388-804-4. Screening Priorities and Procedures.

(1) Private 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 [by skin test ]shall be completed using either the Mantoux tuberculin skin test method or an FDA approved in-vitro serologic test.

(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 yields results indicating tuberculosis exposure, the individual shall be referred for further medical evaluation.

 

R388-804-6. Treatment and Control.

(1) The Department incorporates by reference the ATS/CDC treatment standards as described in the segment entitled "[Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children," as published in the American Journal of Respiratory and Critical Care Medicine, Vol 149, pp. 1359-1374, 1994 and "Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection," American Journal of Respiratory and Critical Care Medicine, Vol. 161, pp. S221-S247, 2000]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 [shall be expected to]must adhere to the standards listed in this document.

(2) A health-care provider who treats an individual with tuberculosis disease shall use the 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 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.

(3) A health-care provider who treats an individual with tuberculosis disease shall provide for directly observed therapy for individuals diagnosed with active tuberculosis disease.[who do not adhere to self-administered therapy, have drug-resistant tuberculosis or have multi-drug resistant tuberculosis.]

(4) Individuals with infectious tuberculosis disease shall wear a mask approved by the local health department or the Program when outside the isolation area.

 

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 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.

 

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[are] available.

 

R388-804-9. Penalty for Violation.

(1) Any person who violates any provision of this rule may be assessed a civil money penalty not to exceed the sum of $5000 or be punished for violation of a class B misdemeanor for the first violation and for any subsequent similar violation within two years for violation of a class A misdemeanor as provided in Section 26-23-6.

 

KEY: tuberculosis, screening, communicable disease

Date of Enactment or Last Substantive Amendment: [February 2, 2001]2007

Notice of Continuation: August 20, 2002

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