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 the types of cancer and other tumorous and precancerous diseases to be reported to the department and which includes:

(1) Any primary in situ or invasive malignant neoplasm (with the exception of basal cell and squamous cell carcinoma of the skin and carcinoma in situ of the cervix); and

(2) Benign and borderline intracranial and central nervous system neoplasms.

(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) "Person providing diagnostic or treatment services to patients with cancer" means a person who diagnoses a patient as having cancer or provides treatment services (with the exception of end of life care) to patients for a cancer diagnosis in a health care facility including, but not limited to, an ambulatory surgical treatment center, a freestanding cancer treatment center, a radiation therapy center, a chemotherapy treatment center, a nursing home, an oncology or dermatology clinic, a laboratory, or any other facility which provides diagnostic or treatment services to patients with cancer.

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

(I) "Protected health information" has the same meaning as in section 3701.17 of the Revised Code.

Effective: 10/19/2015
Five Year Review (FYR) Dates: 08/04/2015 and 10/15/2020
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) Each physician, dentist, hospital, or person providing diagnostic or treatment services to patients with cancer shall report each case of cancer to the department in a manner approved by the director. Reports shall be made for all patients diagnosed or treated in Ohio, regardless of the patient's state of residence. 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 of residence at diagnosis;

(8) State of residence at diagnosis;

(9) Zip code of residence at diagnosis;

(10) Date of birth;

(11) Sex;

(12) Race;

(13) Hispanic origin;

(14) Age in years at diagnosis;

(15) Date of diagnosis;

(16) Date of first contact for this patient for this cancer at this facility;

(17) Type of reporting source;

(18) Primary site;

(19) Laterality;

(20) Sequence number;

(21) Histology;

(22) Grade;

(23) Diagnostic confirmation;

(24) First course of treatment;

(25) Date treatment began;

(26) Class of case;

(27) Tobacco use;

(28) Date of last contact (or death);

(29) Managing physician's name;

(30) Stage at diagnosis;

(31) Primary site supporting text;

(32) Histology supporting text;

(33) Stage at diagnosis supporting text; and

(34) First course of treatment supporting text.

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.

(B) Each and every physician, dentist, hospital, and other person who diagnose patients as having cancer will report the patient's cancer within six months of the date of diagnosis. Facilities or persons providing treatment services to patients for a cancer diagnosis will report the patient's cancer within six months of the date of first contact with the patient.

(C) All physicians, dentists, hospitals or other persons who diagnose patients as having cancer or provide treatment services to patients for a cancer diagnosis 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.

Replaces: 3701-4-02

Effective: 10/19/2015
Five Year Review (FYR) Dates: 10/15/2020
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 cancer which are furnished to, or procured by, the department shall be confidential and shall be used only for public health surveillance and research for the purposes of reducing the morbidity or mortality of cancer.

(B) A person involved with a research project may be given access to confidential information if all the following conditions are met and if the research project is approved by the department's institutional review board:

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

(2) 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;

(3) 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 and/or destruction 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. The agreement will prohibit the publication or release of protected health information.

(C) Notwithstanding paragraphs (A) and (B) of this rule, a researcher may, with the approval of the department's institutional review board, contact individual cancer patients to request additional information for research purposes or to solicit a patient's participation in a research project. The researcher shall first notify the patient's managing physician of the intent to contact the patient. Unless the patient's managing physician informs the researcher within a reasonable time that the patient should not be contacted, the researcher may contact the patient. The researcher shall obtain the patient's verbal or written consent prior to requesting additional information or including the patient in a research project.

(D) Notwithstanding paragraphs (A) and (B) of this rule the department may release confidential information concerning individual cancer patients who are not Ohio residents to the cancer registry of the patient's state of residence at diagnosis.

(E) Nothing in this rule prevents the release to any person of summary, statistical, or aggregate information that does not identify individual cancer patients.

Replaces: 3701-4-03

Effective: 10/19/2015
Five Year Review (FYR) Dates: 10/15/2020
Promulgated Under: 119.03
Statutory Authority: 3701.262
Rule Amplifies: 3701.263
Prior Effective Dates: 5/20/1993