6 Colo. Code Regs. § 1009-1, reg. Regulation 4
Current through Register Vol. 47, No. 24, December 25, 2024
Regulation Regulation 4 - [Effective 1/14/2025] Treatment and Control of TuberculosisThe emergence of multi-drug-resistant tuberculosis in this country and state dictates a coherent and consistent strategy in order to protect public health. 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 one working day by physicians, healthcare providers, hospitals, private and public laboratories, 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 assigned at birth, race, ethnicity, phone number, physical address (including city and county), email address, preferred language, name and address, and phone number of the reporting physician or other healthcare provider 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 or why tuberculosis is being considered, the suspected or confirmed affected body, and whether it is confirmed or suspected tuberculosis disease. For the purposes of this reporting requirement, "suspected" is defined as anyone being considered for tuberculosis disease as part of the differential diagnosis, leading to the ordering and performing of any tuberculosis testing.B. Physicians, healthcare providers, and healthcare facilities shall report within four 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 one working day any result diagnostic of or highly correlated with active tuberculosis disease, including culture and nucleic acid amplification tests (NAAT) positive for Mycobacterium tuberculosis (MTB) or similar confirmatory testing, and sputum smears positive for acid-fast bacilli. Laboratories shall report the results of tests for antimicrobial susceptibility performed on positive cultures for tuberculosis.D. Results must be reported by the laboratory that 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, State Public Health Laboratory 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 standard medical practice for persons with active tuberculosis disease to receive directly observed therapy (DOT) throughout the treatment 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 tuberculosis clinic at the Public Health Institute at Denver Health. DOT is highly recommended as it remains standard practice, but is not required for patients with extrapulmonary tuberculosis disease, provided that the presence of pulmonary tuberculosis has been thoroughly investigated and excluded, including microscopy testing. 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 seven 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 all correctional and healthcare facilities providing inpatient testing or treatment to persons with suspected and confirmed active tuberculosis disease shall notify and include the Department or county, district, or municipal public health agency when they begin their discharge planning process and involve the Department or county, district, or municipal public health agency in the transition planning process prior to discharging the patient from the facility to ensure a safe and appropriate discharge plan is in place for the safety of the patient and the community. Public health will be involved in the discharge planning to ensure continuity of care, safe discharge for the patient and community, appropriate medication regimen, arrangement of home visits, and directly observed therapy.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 a 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 tuberculosisTB 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 tuberculosisTB disease if either test result is positive. 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 consistent with tuberculosis in the infectious stages, the state or local 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, reg. Regulation 4
37 CR 18, September 25, 2014, effective 10/15/201438 CR 20, October 25, 2015, effective 11/14/201540 CR 08, April 25, 2017, effective 5/15/201741 CR 12, June 25, 2018, effective 7/15/201842 CR 10, May 25, 2019, effective 7/1/201944 CR 18, September 25, 2021, effective 10/15/202146 CR 06, March 25, 2023, effective 2/15/202346 CR 10, May 25, 2023, effective 6/14/202347 CR 24, December 25, 2024, effective 1/14/2025