Menu of Suggested Provisions For State Tuberculosis Prevention and Control Laws
A. Mandated Reporting
Descriptive Note: Workshop participants (See Introduction, page 3) recommended a timeframe of 24 hours to report suspected or confirmed cases of TB. The general requirement below that “anyone having knowledge” of a disease shall report to authorities is intended to supplement laws requiring specific persons or entities to report TB. Two alternate provisions are included requiring healthcare providers to report; the provision on administrators is intended to encompass a wide range of persons or entities that states would generally require to report TB. The provision on federal or tribal entities is an excerpt from an existing Arizona regulatory provision, but no legal citation is included because it has been summarized. The provision has reportedly been effective in fostering a working relationship between local health departments in the state and federal entities and tribes. The clause “to the extent permitted by law” may alleviate concerns regarding enforceability and federalism.
Timeframe for Reporting
- Any reporter of a suspected or confirmed case of tuberculosis shall report to the designated department or official within twenty-four (24) hours.
- Anyone having knowledge or reason to believe that any person has a communicable disease shall report the facts to the local health officer or to the department. Wis. Stat. § 252.05 (2009).
Listing of Specific Persons or Entities Required to Report
- Any healthcare provider (defined as any doctor of medicine, of osteopathy, or of dental science, or a registered nurse, social worker, doctor of chiropractic, or psychologist licensed under [state licensure code], or an intern, or a resident, fellow, or medical officer licensed under [state licensure code], or a hospital, clinic or nursing home and its agents and employees, or a public hospital and its agents and employees) laboratory, board of health or administrator of a city, state or private institution or hospital who has knowledge of a case of confirmed tuberculosis or clinically suspected tuberculosis, shall notify the [TB Program] in the Department within 24 hours…Upon receipt of such notice, the [TB Program] shall notify the local board of health in the community where the case resides within 24 hours. 105 Mass. Code Regs. 300.180 (2010).
- Physicians, pharmacists, nurses, hospital administrators, medical examiners, morticians, laboratory administrators and others who provide health care services to persons with tuberculosis or suspected tuberculosis shall report suspected and confirmed cases of tuberculosis to the department within twenty-four (24) hours.
- Any person who is in charge of a clinical laboratory in which a laboratory examination of any specimen derived from the human body yields microscopical, cultural, immunological, serological, or other evidence of disease or illness as the Department may specify, shall promptly notify the official local health department or the state health department of such findings. Each notification shall give the date and result of the test performed, the name and the date of birth of the person from whom the specimen was obtained, and the name and address of the physician for whom such examination or test was performed.
- The laboratory director must report to the state or local health department the identification of, or laboratory findings suggestive of, the presence of the microbiologic organisms, diseases, or conditions listed in these rules.
- Every administrator [defined as the person having control or supervision over a health care facility, correctional facility, school, youth camp, child care center, preschool, or institution of higher education] shall report any person who is ill or infected with any disease listed in [reportable disease regulation] within the required timeframe, and shall make a report as set forth in [regulation specifying the method of reporting and content of reports]. Administrators may delegate these reporting requirements to a member of the staff, but this delegation does not relieve the health care provider or administrator of the ultimate reporting responsibility.
Federal or Tribal Entities:
- To the extent permitted by law, a federal or tribal entity shall comply with the reporting requirements in this Article. Examples:
- If the federal or tribal entity is participating in the diagnosis or treatment of an individual, the federal or tribal entity shall comply with the reporting requirements for a health care provider;
- If the federal or tribal entity is operating a facility that provides health care services, the federal or tribal entity shall comply with the reporting requirements for an administrator of a health care institution;
- For the purposes of this Section, “federal or tribal entity” means a person operating within this state, whether on federal or tribal land or otherwise, under the authority of an agency or other administrative subdivision of the federal government or a tribal nation and who is (for example):
- Licensed as a doctor of allopathic, naturopathic, osteopathic, or homeopathic medicine under the laws of this or another state;
- Operating a facility that provides health care services.
Other persons or entities:
- Infection surveillance staff
- Public health officials
- Administrators of congregate settings
- Emergency medical service personnel, law enforcement officers, firefighters
- Persons in charge of food establishments.
Local – State Reporting
- Each local board of health shall report to the Department the occurrence or suspected occurrence of any disease reported to the board of health, pursuant to [regulation describing diseases reportable to local boards of health]. When available, the case’s name, date of birth, age, sex, address and disease must be included for each report. The report shall be in a form or manner deemed acceptable by the Department. Each case shall be reported, immediately, but no later than 24 hours after receipt by the local board of health. 105 Mass. Code Regs. 300.110 (2010).
Descriptive Note: If states choose to adopt detailed provisions on information/data to be reported, consideration should be given to whether the provisions should be in statute or regulation (usually, promulgation of regulations would be the appropriate vehicle due to agency expertise and because regulations generally may be amended or updated more expeditiously than statutes). The first bullet below is an example of a regulation that requires reporters to complete and submit all information on the jurisdiction’s form rather than listing in the statute all of the detailed information that is required to be reported. States adopting this sort of provision may choose to incorporate the form by reference. The second bullet is an example of a more detailed provision; no citation is listed because it is a combination of two existing state regulatory provisions. The third bullet is an excerpt from a California statutory provision and was specifically included in this section because it has reportedly been effective in incentivizing health facilities in the state to report individuals with suspected or confirmed TB. Few states have laws requiring reporting of latent tuberculosis infection (LTBI), but two alternate provisions are included for states considering adoption of such provisions. Where resources permit, adoption of LTBI reporting laws may facilitate surveillance and enable TB programs to identify patients who should be started on preventive treatment. Finally, four examples of laboratory reporting provisions are included, ranging from general to detailed (the third bullet relates to genotyping). No citations are included because language was changed or deleted at the recommendation of the APHL TB Steering Committee (e.g., deletion of language not relevant to TB).
- All individuals or entities reporting suspected or confirmed cases of tuberculosis shall complete and submit reports required by this rule using forms and formats approved for use by the department. A reporter using a reporting system or systems, to the extent approved by the department, is deemed to comply with the reporting requirements of this rule until such use is no longer considered active by the department.
- A report shall be submitted to the department within twenty-four (24) hours of a diagnosis of tuberculosis or upon suspicion that a person has tuberculosis. This report shall contain the following information concerning the patient diagnosed with tuberculosis or suspected of having tuberculosis:
- Patient’s name, address and county and whether the patient is homeless;
- Telephone number;
- Sex and date of birth;
- Race and ethnic origin;
- Country of origin and the month and year the patient arrived in the United States;
- Site of the disease;
- Chest X-ray date and its results;
- Specimen source, smear, nucleic acid amplification, culture and drug susceptibility test results;
- Tuberculin skin test history;
- HIV status;
- Whether the patient is a resident of a correctional facility;
- Whether the patient is a resident of a long-term care facility;
- Alcohol or drug use history;
- Initial drug regimen;
- Drug toxicity and monitoring records, and a listing of other patient medications to evaluate the potential for drug-drug interactions;
- Signature of the person submitting the report; and
- Date the report is submitted.
Updates of patients’ progress or lack of progress shall be submitted to the department including, but not limited to, the latest microbiology results of cultures, any development of drug resistance, the most recent chest X-ray results, clinical symptoms and treatment. The health care provider shall report any screening of contacts, with the names and addresses and results of the screening tests of the contacts, to the local health department. Also, the health care provider shall report to the local health department the names of persons who were contacts to cases and did not return for follow-up.
- A health facility, local detention facility, or state correctional institution shall not discharge or release 1) a person known to have active tuberculosis disease, or 2) a person who the medical staff of the health facility or of the penal institution has reasonable grounds to believe has active tuberculosis disease, unless: …notification and a written treatment plan pursuant to [statutory provision requiring disease notification report to local health officer, including an individual treatment plan] has been received by the local health officer. When prior notification would jeopardize the person’s health, the public safety, or the safety and security of the penal institution, the notification and treatment plan shall be submitted within 24 hours of discharge, release, or transfer. Cal. [Health & Safety] Code § 121361 (Deering 2009).
Latent Tuberculosis Infection (LTBI):
- Latent Tuberculosis Infection shall be reported to the local health authority or the Department of Health within three (3) calendar days of first knowledge or suspicion. Mo. Code Regs. tit. 19, § 20-20.020 (2009).
- Any health care provider, board of health or administrator of a city, state or private institution or hospital who has knowledge of a case of latent tuberculosis infection (LTBI), as diagnosed by a tuberculin skin test performed with purified protein derivative (PPD) antigen by the Mantoux method, or by any other diagnostic test approved for this purpose by the federal Food and Drug Administration, that results in a reaction that represents a positive test according to the most recently published guidelines of the U.S. Centers for Disease Control and Prevention, shall notify the [TB Program] in the Department in a written or electronic format as designated by the Department, with information regarding the name and address of the individual, date of birth, gender, size of the positive skin test or alternative test result, treatment initiated and, as requested by the Department, information about risk of exposure to tuberculosis. 105 Mass. Code Regs. 300.180 (2010).
- Any laboratory that receives a specimen for tuberculosis testing shall report all positive results obtained by any appropriate procedure, including a procedure performed by an out-of-state laboratory, to the local health officer and to the department.
- Laboratories are required to report the following to the department:
- Results of smears that are positive for acid-fast bacilli.
- Results of cultures positive for any member of the M. tuberculosis complex (i.e., M. tuberculosis, M. bovis, M. africanum) or any other mycobacteria.
- Results of rapid methodologies, including nucleic acid amplification, which are indicative of M. tuberculosis complex.
- Special reporting requirements for Tuberculosis:
- Test results must also be submitted by laboratories to the state TB program [address and phone number may be added here].
- The genotype must be reported. If genotyping is not available, the isolate must be submitted to the state public health laboratory [address and phone number may be added here]. The Department will provide the mailing materials and pay mailing costs.
- The director of a clinical laboratory conducting an examination of a specimen submitted for analysis shall report to the Department, within 24 hours of obtaining results, all positive or reactive laboratory findings which indicate the presumptive or confirmed presence of M. tuberculosis complex, and also any laboratory findings which are otherwise required to be reported pursuant to this section or this Article; provided that findings indicating the presumptive or confirmed presence of M. tuberculosis complex, as well as outbreaks or suspected outbreaks, shall also be reported to the Department immediately. A clinical laboratory which refers a specimen to another laboratory for examination shall provide to the testing laboratory all of the information the testing laboratory will need to fully comply with the reporting requirements set forth in this Code.
- Reports shall contain all of the information and data elements required by the reporting forms or electronic reporting format approved by the Department, including but not limited to: 1) the full name, date of birth and address of the person from whom the specimen was taken; the race, ethnicity and gender of such person, if known; the date the specimen was collected; and the type of specimen; 2) the medical record number, if known, identification number or code assigned to the person, if any, and other personal identifiers as may be required by the Department; 3) the name, address and telephone number of the physician or other authorized health care practitioner who submitted the specimen, the health care facility, if any, that submitted the specimen, and the clinical laboratory that referred the specimen, if any; 4) the name and address of the clinical laboratory which performed the test; 5) the date the test or tests results were first available, 6) the name(s) of test or tests performed; 7) the positive or reactive results; 8) the drug susceptibility test results for Mycobacterium tuberculosis complex. This requirement includes traditional broth, agar and newer automated methods of drug susceptibility testing, as well as molecular-based methods that assay for molecular determinants of drug resistance.
- Reports shall also include all laboratory findings which indicate presumptive presence of tuberculosis, the results of smears found positive for acid-fast bacilli (AFB), all results including negatives and species identification on samples which had positive smears, and all drug susceptibility testing results. Such reports shall specify the laboratory methodology used and shall state whether the specimen was susceptible or resistant to each anti-tuberculosis drug at each concentration tested.
- Reports required pursuant to this article shall be made in a manner and form prescribed by the department.
Descriptive Note: Failing to report suspected or confirmed TB cases can potentially result in detrimental health outcomes for the individual with TB and ongoing transmission. Some states impose a penalty for persons or entities failing to report as required by law. This section includes examples of several different types of legal penalties: licensure-related penalties, fines, and misdemeanor offenses. The first bullet is a provision that relates to California’s Citation and Fine Program, which has reportedly been effective in improving the level of communicable disease reporting by physicians in the state.
- Citations and Fines.
- For purposes of this article, “board official” shall mean the chief, deputy chief or supervising investigator II of the enforcement program of the board or the chief of licensing of the board.
- A board official is authorized to determine when and against whom a citation will be issued and to issue citations containing orders of abatement and fines for violations by a licensed physician or surgeon of the statutes referred to in [regulatory provision listing citable offenses].
- [NOTE: The regulatory provision listing citable offenses includes a violation of the state Business and Professions Code, statutory provision on Unprofessional Conduct, for violations of the provisions relating to: the duty to report persons with any infectious, contagious, or communicable disease to the local health officer; failure to report persons with active TB; the duty to examine or refer for examination household contacts of persons with active TB; and reporting requirements involving reportable diseases and conditions to local health officers. Source: Cal. Code Regs. tit. 16, § 1364.11 (2009)].
- A citation shall be issued whenever any fine is levied or any order of abatement is issued. Each citation shall be in writing and shall describe with particularity the nature and facts of the violation, including a reference to the statute or regulations alleged to have been violated. The citation shall be served upon the individual personally or by certified mail. Cal. Code Regs. tit. 16, § 1364.10 (2009).
- An individual who repeatedly fails to file any mandatory report specified in this chapter is subject to a report being made to the licensing board governing the professional activities of the individual. The department shall notify the individual each time that the department determines that the individual has failed to file a required report. The department shall inform the individual in the notification that the individual may provide information to the department to explain or dispute the failure to report. Iowa Code § 139A.25 (2009).
- Any individual or entity, knowing of the existence of a reportable disease, who fails promptly to report the same in accordance with this section, shall be deemed guilty of a Class V misdemeanor for each offense.
Descriptive Note: States may consider adopting provisions requiring healthcare providers to inform public health officials when their patients with TB are nonadherent in order for public health officials to coordinate and implement any necessary public health action. Nonadherence may include leaving the hospital against medical advice, cessation of treatment, or failure to adhere to a treatment plan or other measures to prevent transmission of TB.
- When a tuberculosis patient leaves the hospital against medical advice, the administrator shall, within 24 hours thereafter, notify both the local health officer of the county responsible for the tuberculosis patient’s hospital care and the local health officer of the jurisdiction to which the tuberculosis patient is believed to have gone. Mich. Admin. Code r. 325.178 (2009).
- Each health care provider who treats a person for active tuberculosis disease, each person in charge of a health facility, or each person in charge of a clinic providing outpatient treatment for active tuberculosis disease shall promptly report to the local health officer at the times that the health officer requires, but no less frequently than when there are reasonable grounds to believe that a person has active tuberculosis disease, and when a person ceases treatment for tuberculosis disease. Situations in which the provider may conclude that the patient has ceased treatment include times when the patient fails to keep an appointment, relocates without transferring care, or discontinues care. Cal [Health & Safety] Code § 121362 (Deering 2009).
- The physician or his or her designee shall immediately report to the local health officer when a person with tuberculosis disease does any of the following:
- Terminates treatment against medical advice.
- Fails to comply with the medical treatment plan.
- Fails to comply with measures to prevent transmission.
- Leaves the hospital against the advice of a physician. Wis. Admin. Code [DHS] § 145.10 (2009).
Descriptive Note: States may consider having systems in place that maximize the reporting of new TB cases, minimize the reporting of duplicate suspected and confirmed TB cases, and protect the confidentiality of reports. Below are examples of provisions addressing TB registries, appropriate uses and disclosure of information contained in reports (including scientific and research use), and immunity of reporters. No citation is included for the last provision in this section because “in good faith” was added to the existing language of the state’s law.
- Each local health department shall maintain a register of all diagnosed or suspected cases of tuberculosis. In addition, each local health department shall also maintain a register of individuals to whom that health department is providing preventive therapy. Quarterly status reports on suspected and diagnosed cases shall be furnished to the department of health tuberculosis control program. Wash. Admin. Code § 246-170-031 (2009).
- The [department] shall keep a register of each individual who has tuberculosis. The [department] shall have exclusive control of the register, and may not disclose information in the register about any individual to any person who is not authorized by law to have the information. Md. Code Ann., Health-Gen. § 18-322 (LexisNexis 2009).
- Reports required; confidentiality; limitations on use; immunity
- In order to further the protection of public health, such reports and notifications may be disclosed by the department, the official local health department, and the person making such reports or notifications to the Centers for Disease Control and Prevention of the Public Health Service of the United States Department of Health and Human Services or its successor in such a manner as to ensure that the identity of any individual cannot be ascertained. To further protect the public health, the department, the official local health department, and the person making the report or notification may disclose to the official state and local health departments of other states, territories, and the District of Columbia such reports and notifications, including sufficient identification and information so as to ensure that such investigations as deemed necessary are made.
- The appropriate board, health department, agency, or official may: 1) Publish analyses of such reports and information for scientific and public health purposes in such a manner as to ensure that the identity of any individual concerned cannot be ascertained; 2) discuss the report or notification with the attending physician; and 3) make such investigation as deemed necessary. Neb. Rev. Stat. Ann. § 71-503.01 (LexisNexis 2009).
- Any information, data, and reports with respect to a case of tuberculosis that are furnished to, or procured by, a county or district tuberculosis control unit or the department of health shall be confidential and used only for statistical, scientific, and medical research for the purpose of controlling tuberculosis in this state. No physician, hospital, or other entity furnishing information, data, or reports pursuant to this chapter shall by reason of such furnishing be deemed to have violated any confidential relationship, be held to answer for willful betrayal of a professional confidence, or be held liable in damages to any person. Ohio Rev. Code Ann. § 339.81 (LexisNexis 2009).
- Any medical practitioner, any official health department, the department, or any other person making such [tuberculosis] reports or notifications in good faith shall be immune from suit for slander or libel or breach of privileged communication based on any statements contained in such reports and notifications.