WSR 01-04-086

PERMANENT RULES

DEPARTMENT OF HEALTH


[ Filed February 7, 2001, 10:53 a.m. ]

Date of Adoption: January 12, 2001.

Purpose: The rules revision was undertaken to update the list of reportable cancers and data elements to current standards of practice, to define reporting responsibilities and to clarify access and use of cancer registry data for public health purposes.

Citation of Existing Rules Affected by this Order: Repealing chapter 246-430 WAC.

Statutory Authority for Adoption: RCW 70.54.270.

Other Authority: RCW 43.20.050, 43.70.130.

Adopted under notice filed as WSR 00-24-131 on December 6, 2000.

Changes Other than Editing from Proposed to Adopted Version: WAC 246-102-010 (1)(d) was deleted due to changes in the national standard for cancer case reporting effective for cases diagnosed January 1, 2001, and later.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 1, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 7, Amended 0, Repealed 7.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 8, Amended 0, Repealed 7. Effective Date of Rule: Thirty-one days after filing.

February 6, 2001

Mary C. Selecky

Secretary

OTS-4535.2

Chapter 246-102 WAC

CANCER REGISTRY


NEW SECTION
WAC 246-102-001   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 residents of Washington. This chapter establishes the criteria and procedures for identifying and reporting cancer cases and defines the standards for access and release of cancer information.

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NEW SECTION
WAC 246-102-010   Definitions.   For the purposes of RCW 70.54.230, 70.54.240, 70.54.250, 70.54.260, 70.54.270, and this chapter, the following words and phrases shall have the following meaning unless the context clearly indicates otherwise:

(1) "Cancer case" means:

(a) Any malignant neoplasm with the exception of basal and squamous cell carcinoma of the skin;

(b) All brain tumors;

(c) Basal and squamous cell carcinoma of the external genital organ sites (vulva, labia, clitoris, prepuce, penis, scrotum);

(d) Cancer in situ, except carcinoma in situ of the uterine cervix; or

(e) 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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NEW SECTION
WAC 246-102-020   Who must report.   By statute (RCW 70.54.240), the responsibility for identifying and reporting cases of cancer rests with health care facilities, independent clinical laboratories, and other principal health care providers. The department may, at its discretion, delegate some or all of these responsibilities to contractors or other designees. A list of the contractors and designees responsible for identifying and reporting cases of cancer diagnosed at specific sites in Washington is available for review at the department.

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NEW SECTION
WAC 246-102-030   Cancer case identification.   (1) Contractors or designees shall identify reportable cancer cases diagnosed and treated at cancer diagnosis and treatment facilities.

(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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NEW SECTION
WAC 246-102-040   Data collection requirements.   (1) Contractors or designees shall complete cancer abstracts for patients identified through cancer diagnosis and treatment facilities.

(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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NEW SECTION
WAC 246-102-050   Form, frequency, and format for reporting.   (1) Contractors or designees shall:

(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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NEW SECTION
WAC 246-102-060   Data quality assurance.   (1) Contractors or designees shall:

(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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NEW SECTION
WAC 246-102-070   Access and release of information.   (1) Cancer registry information shall be used only for statistical, scientific, medical research and public health purposes. Contractors and designees must comply with chapter 70.02 RCW regarding the disclosure of patient health care information.

(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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Washington State Code Reviser's Office