PROPOSED RULES
Original Notice.
Preproposal statement of inquiry was filed as WSR 99-20-056.
Title of Rule: Chapter 246-102 WAC, Cancer registry.
Purpose: The purpose of cancer case reporting is to monitor the incidence of cancer in the state. Information collected through the cancer registry system is used by medical, research and public health professionals to understand, control and reduce occurrences of cancer in Washington residents. This chapter establishes the criteria and procedures for identifying and reporting cancer cases and defines the standards for access and release of cancer information.
Other Identifying Information: This proposal is supported by the Washington State Cancer Registry Advisory Council, which includes representatives of local health jurisdictions, physician specialties, hospitals, cancer registries and patient advocacy groups.
Statutory Authority for Adoption: RCW 70.54.270.
Statute Being Implemented: RCW 70.54.230 - 70.54.270.
Summary: The proposal amends existing cancer registry rules to modify the list of reportable cancer types to reflect the cancers that are currently reported; modify the list of reportable data items to eliminate unusable elements and update terms; encourage the use of new technology to obtain cancer information; clarify the reporting responsibilities of contractors, health care facilities and health care providers; and clarify access to and disclosure of confidential information for public health information.
Reasons Supporting Proposal: This proposal is the result of Executive Order 97-02 findings.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Valerie Spadt, Cancer Registry Program Manager, New Market Campus, Mailstop 47835, (360) 236-2624.
Name of Proponent: Washington State Department of Health, governmental.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: The cancer registry rules are intended to improve the state's ability to understand, control and reduce the occurrence of cancer. The cancer registry enables the department and its partners to (a) assess morbidity associated with specific types of cancer; (b) determine the mortality and case-fatality rates for specific types of cancer; (c) identify and investigate cancer clusters; and (d) assess the utilization and effectiveness of primary and/or secondary measures for preventing specific types of cancer.
Proposal Changes the Following Existing Rules: The proposal modifies the existing cancer registry rules to: Modify the list of reportable cancer types to accurately reflect the cancers that are currently reported; update the list of reportable data items to eliminate unusable elements and update terms; encourage the use of new technology available for obtaining cancer information; clarify the reporting responsibilities of contractors, health care facilities and health care providers; and clarify access to and disclosure of confidential information for public health purposes.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed revisions to the cancer reporting rules do not impose costs on the small business categories affected by this regulation, therefore a small business economic impact statement is not required.
RCW 34.05.328 does not apply to this rule adoption. This rule is not legislatively significant. The proposed changes to the cancer registry rules primarily improve clarity and efficiency. The underlying policy of the rule and the requirements remain intact.
Hearing Location: Labor and Industries Building, Room S-117, 7273 Linderson Way S.W., Tumwater, WA 98501, on January 9, 2001, at 1:00 p.m.
Assistance for Persons with Disabilities: Contact Kelley Hix at (360) 236-3676, by January 2, 2001, TDD (800) 833-6388 or (360) 586-2714.
Submit Written Comments to: Valerie Spadt, Mailstop 47835, Olympia, Washington 98504-7835, fax (360) 586-2714, by January 9, 2001.
Date of Intended Adoption: January 12, 2001.
December 6, 2000
Mary C. Selecky
Secretary
OTS-4535.1
CANCER REGISTRY
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(1) "Cancer case" means:
(a) Any malignant neoplasm with the exception of basal and squamous cell carcinoma of the skin;
(b) Basal and squamous cell carcinoma of the external genital organ sites (vulva, labia, clitoris, prepuce, penis, scrotum);
(c) All brain tumors;
(d) Ovarian tumor of borderline or low malignant potential;
(e) Cancer in situ, except carcinoma in situ of the uterine cervix; or
(f) Other diagnoses necessary to meet the reporting requirements of the Center for Disease Control's National Program of Cancer Registries, the National Cancer Institute's Surveillance Epidemiology and End Results Program, the Commission on Cancer, and the North American Association of Central Cancer Registries (a copy is available for review at the department).
(2) "Cancer diagnosis or treatment facilities" means hospitals, surgical centers, outpatient radiation therapy centers, doctors' offices, independent clinical laboratories and any other facilities where cancer cases are diagnosed or treated.
(3) "Confidential information" means any information which could lead to the identification of cancer patients, cancer diagnosis or treatment facilities, independent clinical laboratories, or attending health care providers.
(4) "Contractors" means agencies designated by contract with the department of health to perform activities related to identification, collection, and processing of cancer data.
(5) "Department" means the Washington state department of health.
(6) "Designees" means hospital-based cancer registries and other persons or entities designated by the department to perform data collection activities.
(7) "Hospital-based cancer registry" means a cancer registry which is maintained by a hospital or other health care facility.
(8) "In situ" means tumors described as "in situ" by the pathologist reading the diagnostic report(s).
(9) "Institutional review board" means any board, committee, or other group formally designated by an institution, or authorized under federal or state law, to review, approve the initiation of, or conduct periodic review of research programs to assure the protection of the rights and welfare of human research subjects as defined in RCW 70.02.010.
(10) "Patient" means a case, suspected case or contact.
(11) "Principal health care provider" means the attending health care provider recognized as primarily responsible for diagnosis and treatment of a patient, or in the absence of such, the health care provider initiating diagnostic testing or treatment for the patient.
(12) "Reportable cancer case" means any cancer case diagnosed in a Washington state resident after the effective date of these rules.
(13) "Resident" means an individual residing in Washington state at the time of cancer diagnosis.
(14) "Stage of disease" means a cancer classification system encompassing attributes of a tumor as determined and described by:
(a) Summary Staging Guide, Surveillance Epidemiology and End Results (SEER), Program, April 1977; except when superseded by more up-to-date measures (a copy is available for review at the department); and
(b) Manual for Staging of Cancer, 5th Edition, American Joint Committee on Cancer, (AJCC), 1998, except when superseded by more up-to-date measures (a copy is available for review at the department).
(15) "State cancer registry" means the statewide cancer data base maintained by the department of health.
(16) "State cancer registry contract" means the legal agreement by which contractors are authorized to obtain information on reportable cancer cases. It also means the document specifying the contractors' obligations to the state cancer registry with respect to how and when information is collected, processed, and provided and how quality assurance standards are met.
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(2) Cancer diagnosis or treatment facilities shall:
(a) Organize case finding documents by procedure or service date to permit identification of cancer cases; and
(b) Submit or make available, case finding documents including the following if maintained:
(i) Disease and operation indices for cancer cases;
(ii) Pathology and cytology reports;
(iii) New patient radiation logs;
(iv) New patient chemotherapy logs; and
(v) Other alternative case finding documents that are necessary to identify or verify reportable cancer cases;
(c) Cancer diagnosis or treatment facilities shall submit case finding documents by paper form, computer disk, or electronic file or make batched hard copy documents available for on-site review, within forty-five days of the date of service.
(3) On request, principal health care providers shall identify to contractors, designees, or the department reportable cancer cases diagnosed at facilities other than hospitals, surgical centers, and outpatient radiation therapy centers (as specified under WAC 246-102-030 and 246-102-040) unless the patient was hospitalized for additional cancer diagnosis or treatment services within one month of diagnosis.
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(2) Cancer diagnosis or treatment facilities shall provide contractors or their designees with access to pathology and cytology reports and all medical records pertaining to identified cancer cases.
(3) On request by the contractor, designee or the department, principal health care providers or their staff shall be responsible for completing cancer abstracts for patients diagnosed at facilities other than hospitals, surgical centers, and outpatient radiation therapy centers, unless the patient was hospitalized for additional cancer diagnosis or treatment services within one month of diagnosis.
(4) The following information items shall be included in cancer abstracts, providing the information is available from the patient's medical records:
(a) Patient information:
(i) Name;
(ii) Address at time of diagnosis;
(iii) Sex;
(iv) Race;
(v) Hispanic origin;
(vi) Birthdate;
(vii) Age at time of diagnosis;
(viii) Social Security number;
(ix) State or country of birth;
(x) Usual occupation;
(b) Diagnostic information:
(i) Date first seen for this cancer;
(ii) Primary site or sites;
(iii) Histologic type or types, behavior and grade;
(iv) Date of each diagnosis;
(v) Method or methods of diagnostic confirmation;
(vi) Stage of disease at diagnosis using:
(A) Summary stage; and
(B) AJCC system if maintained by the cancer diagnostic or treatment facility;
(vii) Sequence;
(viii) Laterality;
(c) First course of treatment information:
(i) Date of initial treatment;
(ii) All treatment modalities given as part of first course of therapy;
(d) Other information:
(i) Name and address of cancer diagnosis or treatment facility providing information;
(ii) Medical record number;
(iii) Name and address of principal health care provider; and
(iv) Other items necessary to meet the reporting requirements of the Center for Disease Control's National Program of Cancer Registries, the National Cancer Institute's Surveillance Epidemiology and End Results Program, the Commission on Cancer, and the North American Association of Central Cancer Registries (a copy is available at the department).
(5) The department may require submission of additional information from contractors or designees as needed to assess data reliability and validity.
(6) Contractors shall prepare detailed data collection protocols for inclusion in the state cancer registry contract.
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(a) Prepare electronic data files containing information from cancer abstracts in a format specified by the department; and
(b) Provide electronic files to the state cancer registry at intervals specified by written agreement with the department.
(2) On request by the contractor, designee or the department, principal health care providers shall complete and submit cancer abstracts to contractors, designees, or the department under WAC 246-102-020 and 246-102-030 within sixty days following a patient's cancer diagnosis date if the patient was not hospitalized for a cancer-related diagnosis or treatment within one month of diagnosis.
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(a) Assess the completeness and accuracy of case identification and data collection through computerized edit programs and on-site audits, or make available information and documentation for this purpose; and
(b) Maintain a system for retrieval of completed cancer abstracts for a period up to ten years.
(2) Cancer diagnosis or treatment facilities shall:
(a) Make available to the contractor, designee or the department, all case finding source documents and medical records for data quality assurance activities.
(b) Maintain a system for retrieval of case finding source documents and medical records for a period up to ten years.
(3) The department may require contractors or designees to make available all findings from data quality assurance activities for review and verification.
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(2) The department may release confidential registry information for research purposes after the research project has been reviewed and approved by an institutional review board and a confidentiality agreement is negotiated (a copy of the institutional review board procedures and application are available from the department).
(3) The department may release confidential registry information for projects to assess threats to public health or improve public health practice after the project has been reviewed and approved by the department and a data-sharing agreement is negotiated (a copy of the procedures for data-sharing agreements is available from the department).
(4) Cancer diagnosis or treatment facilities may require contractors or designees to sign an agreement of confidentiality regarding access and release of cancer data and prepare, administer, and maintain confidentiality oaths as needed.
(5) Cancer diagnosis or treatment facilities shall adhere to recommendations in RCW 70.54.260 regarding content of confidentiality agreement if confidentiality agreements are used.
(6) Cancer diagnosis and treatment centers shall make available to cancer patients printed information which describes the purpose of the state cancer registry, the statutory requirements which apply to health care facilities, independent clinical laboratories, and other principal health care providers to identify and report cases of cancer to the state cancer registry, and to protect the confidential information that is reported, the public health and research uses of information in the state cancer registry, the circumstances under which cancer registry information is disclosed for these purposes and the relevant RCW and WAC pertaining to the state cancer registry.
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OTS-4536.1
REPEALER
The following chapter of the Washington Administrative Code is repealed:
| WAC 246-430-001 | Purpose. |
| WAC 246-430-010 | Definitions. |
| WAC 246-430-020 | Cancer case identification. |
| WAC 246-430-030 | Data collection requirements. |
| WAC 246-430-040 | Form, frequency, and format for reporting. |
| WAC 246-430-050 | Data quality assurance. |
| WAC 246-430-060 | Access and release of information. |