Chapter 3701-4 Ohio Cancer Incidence Surveillance System

3701-4-01 Definitions.

As used in rules 3701-4-01 to 3701-4-03 of the Administrative Code:

(A) "Cancer" means any primary malignant neoplasm with the exception of basal and squamous carcinoma of the skin and carcinoma in situ of the cervix.

(B) "Dentist" means a person who is licensed under section 4715.12 or 4715.15 of the Revised Code to practice dentistry.

(C) "Department" means the department of health.

(D) "Director" means the director of health.

(E) "Hospital" has the same meaning as in section 3727.01 of the Revised Code.

(F) "Ohio cancer incidence surveillance system" means a population based cancer registry maintained at the department pursuant to section 3701.261 of the Revised Code to monitor the incidence of various types of malignant diseases in Ohio, make appropriate epidemiologic studies to determine any causal relations of such disease with occupational, nutritional, environmental, or infectious conditions, and alleviate or eliminate any such conditions

(G) "Physician" means a person who holds a valid certificate issued under Chapter 4731. of the Revised Code.

R.C. 119.032 review dates: 08/23/2010 and 08/15/2015
Promulgated Under: 119.03
Statutory Authority: 3701.262
Rule Amplifies: 3701.262
Prior Effective Dates: 5/20/1993

3701-4-02 Responsibility for reporting.

(A) There is hereby created the Ohio cancer incidence surveillance system. In the development and administration of the Ohio cancer surveillance system the department may use information compiled by public or private cancer registries and may contract for the collection and analysis of, and the research related to, the information recorded under this section.

(B) Each physician, dentist, hospital, or person providing diagnostic or treatment services to patients with cancer shall report each case of cancer to the department on forms provided by the department or on computer tape or diskette. The report shall contain information regarding the patient which includes but is not limited to the following:

(1) Last name of patient;

(2) First name of patient:

(3) Middle initial of patient;

(4) Social security number of patient (if available);

(5) County of residence at diagnosis;

(6) City of residence at diagnosis;

(7) Street address at diagnosis;

(8) State of residence at diagnosis;

(9) Zip code at diagnosis;

(10) Birth date;

(11) Sex;

(12) Race;

(13) Hispanic origin;

(14) Age in years at diagnosis;

(15) Date of diagnosis;

(16) Date of first contact for this cancer office, (outpatient or inpatient);

(17) Source of information;

(18) Anatomical site of this cancer;

(19) Laterality of diagnosis;

(20) Sequence;

(21) Histology;

(22) Grade;

(23) O.C.I.S.S. source reporting code number:-

(24) American joint committee on cancer edition number;

(25) Diagnostic confirmation;

(26) First course of treatment;

(27) Date treatment began;

(28) Class of case;

(29) Occupation and industry;

(30) Tobacco use;

(31) Date of death;

(32) Underlying cause of death;

(33) Physician's name;

(34) Stage at diagnosis per american joint committee on cancer;

(35) Stage at diagnosis per surveillance, epidemiology, and end results;

(36) Primary site text - from medical reports;

(37) Histology text - from medical reports;

(38) Staging text - from medical reports; and

(39) Treatment text - from medical reports.

Any person required to report pursuant to this paragraph may elect to report to the department through an existing cancer registry if the registry submits the information in accordance with the requirements of this rule.

(C) Each and every physician, dentist, hospital, and other person providing diagnostic services to patients with cancer will report the diagnosis within six months of the date of diagnosis. Facilities or persons providing treatment services to patients with cancer will report the case within six months of the date of first contact with the case patient.

(D) All physicians, dentists, hospitals or persons providing diagnostic or treatment services to patients with cancer shall grant to the department or its authorized representative access to all records that identify cases of cancer or establish characteristics of cancer, the treatment of cancer, or the medical status of any identified cancer patient.

(E) Furnishing information, including records, reports, statements, notes, memoranda, or other information, to the department of health either voluntarily or as required by this rule, or to a person or governmental entity designated as a medical research project by the department does not subject a physician, dentist, hospital, or person providing diagnostic or treatment services to patients with cancer to liability in an action for damages, or other relief for furnishing the information.

(F) This rule does not affect the authority of any person or facility providing diagnostic or treatment services to patients with cancer to maintain facility-based tumor registries, in addition to complying with the reporting requirements of this rule.

R.C. 119.032 review dates: 08/23/2010 and 08/15/2015
Promulgated Under: 119.03
Statutory Authority: 3701.262
Rule Amplifies: 3701.262
Prior Effective Dates: 5/20/1993, 6/27/98

3701-4-03 Confidentiality; research.

(A) Any information, data, and reports with respect to a case of malignant disease which are furnished to, or procured by, any cancer registry in this state or the department of health shall be confidential and shall be used only for statistical, scientific, and medical research for the purposes of reducing the morbidity or mortality of malignant disease. No physician, dentist, person, or hospital furnishing such information, data, or report to any such cancer registry or the department of health, with respect to a case of malignant disease treated or examined by such physician, dentist, or person, or confined in such hospital, shall by reason of such furnishing be deemed to have violated any confidential relationship, or be held liable in damages to any person, or be held to answer for willful betrayal of a professional confidence within the meaning and intent of section 4731.22 of the Revised Code.

(B) Information concerning individual cancer patients obtained by the department for the Ohio cancer incidence surveillance system is for the confidential use of the department. However, a person involved with a medical research project may be given access to confidential information if the medical research project meets the standards established in paragraph (C) of this rule and if all the following conditions are met:

(1) The person conducting the research provides written information about the purpose of the research project, the nature of the data to be collected and how the researcher intends to analyze it, the records the researcher seeks to review, and the safeguards the researcher will take to protect the identity of patients whose records the researcher will be reviewing;

(2) The person conducting the research submits verification of his credentials and of the credentials of other individuals involved in conducting the research;

(3) In the view of the director of health, the proposed safeguards are adequate to protect the identity of each patient whose records will be reviewed. Safeguards for the protection of the identity of patients shall include, but are not limited to, provisions to limit access to identifying data to only those individuals who during the course of the project need access to such information for research purposes and provisions for the maintenance of the confidentiality of identifying information after the termination of the project;

(4) An agreement is executed between the department and the researcher that specifies the terms of the researcher's use of the records and 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.

(C) Based on the written information submitted to the director pursuant to paragraph (B) of this rule, the director shall determine that access to confidential information concerning individual cancer patients shall be made available to a person involved in a medical research project if the medical research project meets the following standards:

(1) The medical research project has clearly defined goals that pertain to cancer prevention and control;

(2) For case control studies, the research design used in the medical research project will involve a sufficiently large sample size that any meaningful difference between cases and controls will be statistically significant. For other studies, the research project will provide enough cases for meaningful analysis of the data for identification of potential risk factors and intervention strategies for cancer prevention and control; and

(3) The medical research project will be conducted at a university, hospital, or other medical research institution by competent researchers who have the ability to analyze and interpret data.

(D) Notwithstanding paragraphs (A) and (B) of this rule, a researcher may, with the approval of the department, use the names of individual cancer patients when requesting additional information for research purposes or soliciting a patient's participation in a research project. If a researcher requests additional information or a cancer patient's participation in a research project, the researcher shall 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 shall obtain the patient's written consent by having the patient complete a release of confidential information form.

(E) Notwithstanding paragraphs (A) and (B) of this rule, the department may release confidential information concerning individual cancer patients to physicians for diagnostic and treatment purposes if the patient's attending physician gives oral or written consent to the release of the information and the patient gives written consent by completing a release of confidential information form.

(F) Notwithstanding paragraph (A) and (B) of this rule the department may release confidential information concerning individual cancer patients to the cancer registry of another state, if the other state has entered into a reciprocal agreement with the department and the agreement provides that the state will comply with this section and that information identifying a patient will not be released to any person without the written consent of the patient.

(G) Nothing in this rule prevents the release to any person of epidemiological information that does not identify individual cancer patients.

R.C. 119.032 review dates: 08/23/2010 and 08/15/2015
Promulgated Under: 119.03
Statutory Authority: 3701.262
Rule Amplifies: 3701.263
Prior Effective Dates: 5/20/1993