Virginia Regulatory Town Hall

Proposed Text

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Action:
Repeal Cancer Registry sections, Establish New Regulatory ...
Stage: Proposed
 
12VAC5-90-150 Authority.  (Repealed.)

Part VIII
Cancer Reporting

Article 9 (§ 32.1-70 et seq.) of Title 32.1 of the Code of Virginia authorizes the establishment of a statewide cancer registry.

12VAC5-90-160 Reportable cancers and tumors.  (Repealed.)

Clinically or pathologically diagnosed cancers, as defined in 12VAC5-90-10, and benign brain and central nervous system tumors shall be reported to the Virginia Cancer Registry in the department. Carcinoma in situ of the cervix is not reportable.

12VAC5-90-170 Those required to report.  (Repealed.)

Any person in charge of a medical care facility, clinic, or independent pathology laboratory which diagnoses or treats cancer patients is required to report. Physicians are required to report cases of cancer in those instances when it has been determined that a medical care facility, clinic, or instate pathology laboratory has not reported. Any person making such report shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.

12VAC5-90-180 Report contents and procedures.  (Repealed.)

Each report shall include the patient's name, address (including county or independent city of residence), age, date of birth, sex, date of diagnosis, date of admission or first contact, primary site of cancer, histology (including type, behavior, and grade), basis of diagnosis, social security number, race, ethnicity, marital status, usual occupation, usual industry, sequence number, laterality, stage, treatment, recurrence information (when applicable), name of reporting facility, vital status, cause of death (when applicable), date of last contact, history of tobacco and alcohol use, and history of service in Vietnam and exposure to dioxin-containing compounds, when applicable.

Reporting shall be by electronic means where possible. Output file formats shall conform to the most recent version of the North American Association of Central Cancer Registries' standard data file layout. Facilities without electronic reporting means and physicians shall submit the required information on the Virginia Cancer Registry Reporting Form. A copy of the pathology report(s) should accompany each completed reporting form, when available. Medical care facilities and clinics reporting via the reporting form should also submit a copy of the admission form and discharge summary.

Reports shall be made within six months of the diagnosis of cancer and submitted to the Virginia Cancer Registry on a monthly basis. Cancer programs conducting annual follow-up on patients shall submit follow-up data monthly in an electronic format approved by the Virginia Cancer Registry.

12VAC5-101-10 Definitions

"Cancer" means all carcinomas, sarcomas, melanomas, leukemias, and lymphomas excluding localized basal and squamous cell carcinomas of the skin, except for lesions of the mucous membranes.

"Clinic" means any facility, freestanding or associated with a hospital that provides preventive, diagnostic, therapeutic, rehabilitative, or palliative care or services to outpatients.

 "Independent pathology laboratory" means a nonhospital or a hospital laboratory performing surgical pathology, including fine needle aspiration biopsy and bone marrow specimen examination services, which reports the results of such tests directly to physician offices, without reporting to a hospital or accessioning the information into a hospital tumor registry.

 "Medical care facility" means any hospital licensed in the Commonwealth or any hospital operated by, or contracted to operate by, an entity of the United States government or the Commonwealth of Virginia.

"Physician" means any person licensed to practice medicine or osteopathy by the Virginia Board of Medicine.

12VAC5-101-20 Authority

Article 9 (§ 32.1-70 et seq.) of Title 32.1 of the Code of Virginia authorizes the establishment of a statewide cancer registry.

12VAC5-101-30 Reportable Cancers and Tumors

Clinically or pathologically diagnosed cancers, as defined in 12VAC5-101-10, and benign brain and central nervous system tumors shall be reported to the Virginia Cancer Registry. Carcinoma in situ of the cervix is not reportable.

12VAC5-101-40 Required Reporters

Any person in charge of a medical care facility, clinic, or independent pathology laboratory which diagnoses or treats cancer patients is required to report. Physicians are required to report cases of cancer. Any person making such report shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.  

12VAC5-101-50 Report Contents and Procedures

A. Each report shall include the patient's:

1. Name;

2. Address (including county or independent city of residence);

3. Age;

4. Date of birth;

5. Sex;

6. Date of diagnosis;

7. Date of admission or first contact;

8. Primary site of cancer;

9. Histology (including type, behavior, and grade);

10. Basis of diagnosis;

11. Social security number;

12. Race;

13. Ethnicity;

14. Marital status;

15. Usual occupation;

16. Usual industry;

17. Sequence number;

18. Laterality;

19. Stage;

20. Treatment;

21. Name of reporting facility;

22. Vital status;

23. Cause of death (when applicable);

24. Date of last contact;

25. History of tobacco and alcohol use; and

26. History of service in Vietnam and exposure to dioxin containing compounds.

Should any of the elements within this subpart be missing, the report shall be rejected.

B. Reporting shall be by electronic means. Output file formats shall conform to the most recent version of the North American Association of Central Cancer Registries' standard data file layout.

C. In the event that a required reporter as defined within 12VAC5-101-40 is not capable of making electronic reports, the required reporter shall submit the information detailed within 12VAC5-101-50 (A) on the Virginia Cancer Registry Reporting Form. The department shall abstract these cases.

D. Reports shall be made within six months of the diagnosis of cancer and submitted to the Virginia Cancer Registry on a monthly basis.

E. If a required reporter as defined within 12VAC5-101-40 fails to report in a format prescribed within 12VAC5-101-50 (B) or (C), authorized department personnel may enter the consenting facility, access the information and report it in the appropriate format.