Section 1651. Mammography requirements

A. Only x-ray systems, pursuant to the Mammography Quality Standards Reauthorization Act of 1998 (Pub.L. 105-248) and 21 CFR Part 900, shall be used for screening and diagnostic mammography.

B. A facility performing mammography shall have a valid certificate issued by the U.S. Department of Health and Human Services, pursuant to the Mammography Quality Standards Reauthorization Act of 1998 and 21 CFR Part 900.

C. A facility performing mammography shall ensure that the additional mammography activities of processing the x-ray film, interpreting the image, and maintaining viewing conditions, wherever performed, meet all quality standards pursuant to the Mammography Quality Standards Reauthorization Act of 1998 and 21 CFR Part 900.

D. The operator of the mammography machine shall be certified by the American Registry of Radiologic Technologists (ARRT) and shall have had specialized training in mammography meeting the requirements set forth by the U.S. Food and Drug Administration under the Mammography Quality Standards Reauthorization Act of 1998.

E. When film developing is not available or the patient chooses not to wait, the patient shall be notified within two business days if another mammogram is necessary. This requirement does not imply or require that a diagnostic opinion be made at the time of the mammogram. The interpreting physician may require that the mammogram be retaken if, in the opinion of the physician, the study is of inadequate quality.

F. Agency inspectors may conduct unannounced inspections during normal business hours.

Historical Notes

Derived from Volume 31, Issue 24, eff. August 27, 2015.

Statutory Authority

§ 32.1-229 of the Code of Virginia.