Legislative Authority
Indiana Code Title 16, Article 38, Chapter 2
IC 16-38-2
Chapter 2. Cancer Registry
IC 16-38-2-1
Cancer registry; establishment
Sec. 1. (a) The state department shall establish a cancer registry for the purpose of:
(1) recording
(A) all cases of malignant disease; and
(B) other tumors and precancerous diseases required to be reported by:
(i) federal law or federal regulation; or
(ii) the National Program of Cancer Registries;
that are diagnosed or treated in Indiana; and
(2) compiling necessary and appropriate information concerning those cases, as determined by the state department;
in order to conduct epidemiologic surveys of cancer and to apply appropriate preventive and control measures.
(b) The department may contract for the collection and analysis of, and the research related to, the epidemiologic data compiled under this chapter.
As added by P.L.2-1993, SEC.21. Amended by P.L.93-2001, SEC.1; P.L.17-2004, SEC.2.
IC 16-38-2-2
Development of registry from existing data
Sec. 2. The state department shall, to the greatest extent possible, utilize information compiled by public or private cancer registries in the development of a statewide cancer registry under this chapter.
As added by P.L.2-1993, SEC.21.
IC 16-38-2-3
Reports
Sec. 3. (a) The following persons shall report to the cancer registry each confirmed case of cancer and other tumors and precancerous diseases required to be recorded under section 1 of this chapter:
(1) Physicians.
(2) Dentists.
(3) Hospitals.
(4) Medical laboratories.
(5) Ambulatory outpatient surgical centers.
(6) Health facilities.
(b) A person required to report information to the state cancer registry under this section may utilize, when available:
(1) information submitted to any other public or private cancer registry; or
(2) information required to be filed with federal, state, or local agencies;
when completing reports required by this chapter. However, the state department may require additional, definitive information.
As added by P.L.2-1993, SEC.21. Amended by P.L.17-2004, SEC.3.
IC 16-38-2-4
Confidentiality
Sec. 4. Except as provided in sections 5, 6, and 7 of this chapter, information obtained under this chapter by the state department concerning individual cancer patients is for the confidential use of the state department only.
As added by P.L.2-1993, SEC.21.
IC 16-38-2-5
Access to confidential information for
research purposes
Sec. 5. The state department shall grant any person involved in a legitimate research activity access to confidential information concerning individual cancer patients obtained by the state department
under this chapter if all of the following conditions are met:
(1) The person conducting the research provides written information about the following:
(A) The purpose of the research project.
(B) The nature of the data to be collected and how the researcher intends to analyze the data.
(C) The records the researcher desires to review.
(D) The safeguards the researcher will take to protect the identity of the patients whose records the researcher will be reviewing.
(2) The proposed safeguards are adequate to protect the identity of each patient whose records will be reviewed.
(3) An agreement is executed between the state department and the researcher that meets all of the following conditions:
(A) Specifies the terms of the researcher's use of the records.
(B) Prohibits the publication or release of the names of individual cancer patients or any facts tending to lead to the identification of individual cancer patients.
As added by P.L.2-1993, SEC.21.
IC 16-38-2-6
Additional information requests;
individual patients; consent
Sec. 6. Researchers may, with the approval of the state department, use the names of individual cancer patients when requesting additional information for research purposes or soliciting an individual patient's participation in a research project. However, if a researcher requests additional information for an individual cancer patient's participation in a research project, the researcher must first obtain the oral or written consent of the patient's attending physician. If the consent of the patient's attending physician is obtained, the researcher must then obtain the individual cancer patient's written consent by having the patient complete a release of confidential medical information form.
As added by P.L.2-1993, SEC.21.
IC 16-38-2-7
Release of confidential information
Sec. 7. The state department may release confidential information concerning individual cancer patients to the following:
(1) The cancer registry of another state if the following conditions are met:
(A) The other state has entered into a reciprocal agreement with the state department.
(B) The agreement provides that information that identifies a patient will not be released to any other person without the written consent of the patient.
(2) Physicians and local health officers for diagnostic and treatment purposes if the following conditions are met:
(A) The patient's attending physician gives oral or written consent to the release of the information.
(B) The patient gives written consent by completing a release of confidential medical information form.
As added by P.L.2-1993, SEC.21.
IC 16-38-2-8
Immunity from liability
Sec. 8. A person who reports information to the cancer registry system under this chapter is immune from any civil or criminal liability that might otherwise be imposed because of the release of what is otherwise confidential information.
As added by P.L.2-1993, SEC.21.
IC 16-38-2-9
Epidemiological information; release
Sec. 9. This chapter does not prevent the release to any interested person of epidemiological information that does not identify individual cancer patients.
As added by P.L.2-1993, SEC.21.
IC 16-38-2-10
Administrative rules
Sec. 10. The state department shall adopt rules under IC 4-22-2 necessary to carry out this chapter.
As added by P.L.2-1993, SEC.21.
IC 16-38-2-11
Annual report
Sec. 11. Not later than December 31 of each year, the department shall publish and make available to the public an annual report summarizing the information collected under this chapter during the previous calendar year.
As added by P.L.93-2001, SEC.2. Amended by P.L.17-2004, SEC.4.
Administrative Rule
Indiana Administrative Code Title 410, Article 21
ARTICLE 21. REPORTING
Rule 1. State Cancer Registry
410 IAC 21-1-1 Definitions
Authority: IC 16-38-2-10
Affected: IC 16-38-2
Sec. 1. As used in 410 IAC 21-1:
"Cancer registry" means a mechanism by which data relating to all cases of malignant disease that occur in Indiana residents is recorded and, necessary and appropriate information is compiled concerning those cases as determined by the board, in order to conduct epidemiologic surveys of cancer and to apply appropriate preventive and control measures.
"Confirmed case" means the best evidence available for determining the nature of malignant disease using the following methods and codes: 1 = positive histology; 2 = positive exfoliative histology in the absence of positive histology; (3 is vacant) 4 = positive microscopic confirmation not otherwise specified (NOS); (5 is vacant) 6 = direct visualization without microscopic confirmation; 7 = radiography without microscopic confirmation; 8 = clinical diagnosis (other than 6 or 7) including gross examination at autopsy; and 9 = unspecified whether or not microscopically confirmed, unknown. This is a priority series with code 1 taking precedence. Each number takes priority over all higher numbers (i.e., 1 over 4, and 5 over 9 etc.).
"Data set" means all clinical, pathological [sic.,] therapeutic and demographic information defined in 410 IAC 21-1-3 and 410 IAC 21-1-4.
"ICD-O" means International Classification of Diseases for Oncology, 1976, World Health Organization publication, Organisation Mondiale De La Sante, 1211, Geneva 27, Switzerland.
"Indiana resident" means an individual domiciled in the state of Indiana.
"Malignant disease" means confirmed cases of cancer enumerated in the ICD-O excluding superficial, squamous and basal cell carcinomas of the skin.
"Patient" means any individual who is ill, or undergoing diagnosis or treatment for disease by a dentist, medical laboratory, physician or hospital.
"Person" means an individual, association, partnership, corporation, or governmental entity.
"State board" means the Indiana state board of health. (Indiana State Department of Health; 410 IAC 21-1-1; filed Nov 7, 1986, 3:30 pm: 10 IR 420; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234)
410 IAC 21-1-2 General requirements
Authority: IC 16-38-2-10
Affected: IC 5-15-5.1-5; IC 16-38-2
Sec. 2. (a) All physicians, dentists, hospitals and medical laboratories shall report all confirmed cases of cancer occurring in Indiana residents who have been diagnosed or treated in Indiana, to the state board cancer registry.
(b) Any health care provider reporting to a public or private cancer registry on September 1, 1985 shall make available to the state cancer registry, all data as required under 410 IAC 21-1-3 (hospitals) or 410 IAC 21-1-4 (physicians, dentists and medical laboratories) upon the effective date of 410 IAC 21-1.
(c) The state board shall assure state cancer registry computer compatibility for any health care provider who on or before the effective date of 410 IAC 21-1 elects to transmit the required data by way of a computerized mechanism.
(d) Any health care provider who, after the effective date of 410 IAC 21-1, establishes a computerized mechanism for the purpose of transmitting abstracted data sets via computer link up, tape transfer, or direct interface, shall be responsible for assuring system compatibility with the state board cancer registry.
(e) Any health care provider who elects to transfer abstracted data sets to the state cancer registry in paper form, shall utilize an abstract form designed or approved by the state board pursuant to IC 5-15-5.1-5.
(f) All manually prepared data sets shall be mailed or delivered by the health care provider to the state cancer registry.
(g) All health care providers not reporting to a public or private cancer registry on September 1, 1985, shall begin submitting data on cases diagnosed on or after January 1, 1987 to the state cancer registry as set out in 410 IAC 21-1-3 (hospitals) or 410 IAC 21-1-4 (physicians, dentists and medical laboratories), no later than six (6) months following the date of such diagnosis.
(h) Reports of confirmed cases of malignant disease shall be submitted to the state cancer registry within six (6) months following a confirmed diagnosis. (Indiana State Department of Health; 410 IAC 21-1-2; filed Nov 7, 1986, 3:30 pm: 10 IR 420; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234)
410 IAC 21-1-3 Hospitals
Authority: IC 16-38-2-10
Affected: IC 16-38-2
Sec. 3. (a) All hospitals shall submit abstracted data sets to the state board cancer registry which shall include but not be limited to the following data items:
(1) site code
(2) accession number
(3) sequence number
(4) accession year
(5) social security number
(6) medical record number
(7) full name (including maiden name)
(8) home address, city, county [sic.,] state and zip code
(9) phone number
(10) date of birth
(11) sex
(12) race
(13) class of case
(14) admission date
(15) follow-up physician
(16) discharge date
(17) date of initial diagnosis
(18) topography code
(19) paired organ involvement
(20) histology code
(21) tumor grade
(22) diagnostic confirmation
(23) tumor size (largest dimension)
(24) number of positive nodes
(25) number of nodes examined
(26) sites of distant metastasis
(27) general summary stage
(28) TNM stage
(29) AJCC stage group
(30) TNM staging basis
(31) date and method of first course of treatment
(32) subsequent therapies/treatments (dates and methods)
(b) Available updated information regarding all elements enumerated in 410 IAC 21-1-3(a) shall be reported to the state board cancer registry each twelve (12) month period following the initial reporting of the disease. (Indiana State Department of Health; 410 IAC 21-1-3; filed Nov 7, 1986, 3:30 pm: 10 IR 421; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234)
410 IAC 21-1-4 Physicians, dentists and medical laboratories
Authority: IC 16-38-2-10
Affected: IC 16-38-2
Sec. 4. (a) Any physician [sic.,] dentist or medical laboratory who diagnoses a case of malignant disease when such case is not referred to a hospital for further diagnosis or treatment, shall submit required data sets to the state cancer registry. Such data sets shall include but not be limited to the following available data items:
(1) patient's full name (including maiden name)
(2) patient's address (including city, county [sic.,] state and zip code)
(3) social security number
(4) date of birth
(5) sex
(6) race
(7) date of diagnosis
(8) topography
(9) morphology
(10) diagnostic confirmation
(11) hospital referred to
(12) physician, dentist or laboratory license number
(13) physician [sic.,] dentist or laboratory name, address and phone number
(b) Physicians, dentists and medical laboratories whose offices are located within the confines of a hospital or, who are employed or contracted by a hospital and who diagnose or treat patients for malignant disease, shall not be required to report cases of malignant disease under 410 IAC 21-1-4. Such cases shall be reported in accordance with 410 IAC 21-1-3. (Indiana State Department of Health; 410 IAC 21-1-4; filed Nov 7, 1986, 3:30 pm: 10 IR 421; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234)
410 IAC 21-1-5 Security and confidentiality of data
Authority: IC 16-38-2-10
Affected: IC 5-14-3-10; IC 16-38-2
Sec. 5. (a) The state board shall assure confidentiality of patient record data when entering, retrieving, reviewing and utilizing such data.
(b) The state board shall take all precautions and security measures necessary in order to protect the cancer registry data from intrusion or misuse by unauthorized individuals, and to preserve the right to privacy of individual patients maintained on the registry.
(c) Pursuant to IC 5-14-3-10, any public employee or official, or any employee or officer of a contractor or subcontractor of a public agency who knowingly or intentionally discloses the identity of a patient maintained on the state cancer registry system to a person not authorized to receive such information, commits a Class A misdemeanor. Any public employee shall be disciplined in accordance with the personnel policies of the agency by which he is employed if he intentionally, knowingly, or recklessly discloses or fails to protect the identity of patients maintained on the state cancer registry system.
(d) A person who reports information to the cancer registry system in accordance with 410 IAC 21-1, is immune from any civil or criminal liability that might otherwise be imposed because of release of what is otherwise confidential information. (Indiana State Department of Health; 410 IAC 21-1-5; filed Nov 7, 1986, 3:30 pm: 10 IR 422; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234)
410 IAC 21-1-6 Cancer registry reports
Authority: IC 16-38-2-10
Affected: IC 16-38-2
Sec. 6. (a) The state board shall make available to all hospitals licensed under IC 16-10-1 [IC 16-10 was repealed by P.L.2-1993, SECTION 209, effective April 30, 1993.], a comprehensive annual report which outlines the trends of malignant disease in Indiana and focuses on specific elements of special study regarding the disease.
(b) Hospitals, physicians, dentists, laboratories and other persons may request and be provided with special reports from the state cancer registry, providing the data requested does not disclose the identity of a patient. (Indiana State Department of Health; 410 IAC 21-1-6; filed Nov 7, 1986, 3:30 pm: 10 IR 422; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234)
