6 Colo. Code Regs. § 1009-1 Regulation 4

Current through Register Vol. 47, No. 11, June 10, 2024
Regulation Regulation 4 - Treatment and Control of Tuberculosis

The emergence of multiple drug-resistant tuberculosis in this country and state dictates a coherent and consistent strategy in order to protect the public health from this grave threat. The underlying principles of disease control expressed in the following rules are as follows: use of the most rapid and modern diagnostic methods by laboratories, rapid reporting, full patient compliance with medical treatment, and prevention of spread of tuberculosis in healthcare settings. The tuberculosis statute (§ 25-4-501, et seq., C.R.S.) covers subject matters not included in these regulations.

A. All confirmed or suspected cases of active tuberculosis disease, regardless of whether confirmed by laboratory tests, shall be reported to the Department or county, district, or municipal public health agency within 1 working day by physicians, healthcare providers, hospitals, other similar private or public institutions, or any other person providing treatment to the confirmed or suspected case. The reports shall include the following information: the patient's name, date of birth, sex, race, ethnicity, phone number, physical address (including city and county), email address, preferred language, name and address of the reporting physician or agency; and such other information as is needed to locate the patient for follow-up. If reported by a physician, the physician shall also give the evidence upon which the diagnosis of tuberculosis was made, the part of the body affected, and the stage of disease.
B. Physicians, healthcare providers, and healthcare facilities shall report within 7 calendar days the following tuberculin skin test (TST) or Interferon-Gamma Release Assay (IGRA) result if it occurs in a healthcare worker, correctional facility worker, or detention facility worker; a positive TST (defined as = or > 5 mm induration) or positive IGRA test (based on manufacturer's interpretation criteria) if the worker has had prolonged or frequent face-to-face contact with an infectious tuberculosis case.
C. Laboratories shall report within 1 working day any result diagnostic of or highly correlated with active tuberculosis disease, including culture positive and nucleic acid amplification tests (NAAT) positives for Mycobacterium tuberculosis and sputum smears positive for acid fast bacilli, and shall report the results of tests for antimicrobial susceptibility performed on positive cultures for tuberculosis.
D. Results must be reported by the laboratory which performs the test, but an in-state laboratory which sends specimens to an out-of-state referral laboratory is also responsible for reporting the results.
E. When a laboratory performs a culture that is positive for Mycobacterium tuberculosis, the laboratory shall submit a sample of the isolate to the Department, Laboratory Services Division no later than one working day after the observation of positive findings.
F. The Department or county, district, or municipal public health agency is authorized to perform evaluations of the timeliness of laboratory diagnostic processes. The data collected in an evaluation may include the mean, median, and range for the following indices: the length of time from specimen collection to isolation; the length of time from isolation of an organism to identification of the organism as Mycobacterium tuberculosis; and the length of time from isolation until antimicrobial susceptibility test results are finalized. The Department or county, district, or municipal public health agency shall provide the laboratory and hospital the results of its evaluation, including comparison of the laboratory indices to norms for other similar laboratories.
G. The Board of Health determines that to prevent the emergence of multi drug-resistant tuberculosis (MDR-TB), it is necessary, appropriate and good medical practice for persons with active tuberculosis disease to receive directly observed therapy (DOT) for their disease. All healthcare providers and healthcare organizations are required to provide DOT for patients with active tuberculosis disease for the full course of therapy, unless a variance for a particular patient from this requirement is approved by the tuberculosis control program of the Department or Denver Public Health. DOT is not required for patients with extrapulmonary tuberculosis disease provided that the presence of pulmonary tuberculosis has been investigated and excluded. In applicable situations, a variance shall be granted in accordance with § 25-4-506(3), C.R.S.

Healthcare providers and healthcare organizations shall report to the Department or county, district, or municipal public health agency within 7 calendar days the name of any patient on DOT who has missed one dose. When requested by healthcare providers and healthcare organizations, the county, district, or municipal public health agency will ensure the provision of DOT to outpatients with active tuberculosis disease and this shall fulfill the requirement for the healthcare providers and healthcare organizations.

H. All healthcare providers within jails, prisons, and other incarceration facilities and hospitals and healthcare facilities providing inpatient treatment to persons with active tuberculosis disease shall notify the Department or county, district, or municipal public health agency of their intent to discharge a patient and involve the Department or county, district, or municipal public health agency in the discharge planning process prior to discharging the patient from the facility. The intention of the notification and involvement in discharge planning is to discuss the treatment plan for the patient and to assure adequate follow-up and coordination among healthcare providers and public health so that continuity of care and the DOT standard are met.
I. All licensed hospitals and nursing home facilities shall maintain a registry of the TST and/or IGRA test results of healthcare workers in their facility, including physicians and physician extenders who are not employees of the facility but provide care to or have face-to-face contact with patients in the facility. The facility shall maintain such TST and IGRA test results as confidential medical information. Pursuant to § 25-4-508, C.R.S., authorized personnel of the Department may inspect and have access to such register in the course of an investigation intended to identify sources and contacts of a case of active tuberculosis disease and to control tuberculosis.
J.
(1) With respect to tuberculosis treatment and control, the chief medical officer of a county, district, or municipal public health agency must be a physician licensed to practice medicine in the State of Colorado. The chief medical officer of a county, district, or municipal public health agency may design a program, consistent with good medical practice, of required screening for latent tuberculosis infection. The objective of the program must be to target persons who are at high risk of such infection based on recent local, state, national, or international epidemiologic data concerning the incidence of and risk factors for tuberculosis. The programs shall be limited to screening persons who are at increased risk of tuberculosis (TB) infection or TB disease or who participate in activities or who work in occupations and job categories that have a reasonably large proportion of persons at increased risk of tuberculosis. The programs should be designed so that the initial step in screening is the determination of whether a person has recognized risk factors for tuberculosis and if yes, then said person should undergo a TST or IGRA test and clinical evaluation to rule out TB disease. If free of signs and symptoms of tuberculosis disease, subsequent testing would be dependent on the results of the TST or IGRA test.
(2) If an individual has signs and symptoms compatible with tuberculosis in the infectious stages, the chief medical officer may require examination pursuant to § 25-4-506, C.R.S. The screening may be performed by an institution, organization, or agency acting at the direction of the county, district, or municipal public health agency. The results of the screening shall be given in writing to the person screened. Any person who is found to have latent tuberculosis infection without evidence of active disease shall be counseled and offered appropriate treatment by the agency performing the screening, but the person is not required to take such treatment.
(3) Locally required screening programs shall be evaluated and reviewed by the local board of health every three years.
(4) Nothing in this rule shall prohibit the Department or county, district, or municipal public health agencies from developing voluntary screening programs, from investigating and screening contacts of suspected or confirmed cases of tuberculosis in a contagious form, or from responding to potential outbreaks of tuberculosis in a community.

6 CCR 1009-1 Regulation 4

37 CR 18, September 25, 2014, effective 10/15/2014
38 CR 20, October 25, 2015, effective 11/14/2015
40 CR 08, April 25, 2017, effective 5/15/2017
41 CR 12, June 25, 2018, effective 7/15/2018
42 CR 10, May 25, 2019, effective 7/1/2019
44 CR 18, September 25, 2021, effective 10/15/2021
46 CR 06, March 25, 2023, effective 2/15/2023
46 CR 10, May 25, 2023, effective 6/14/2023