Section 216-RICR-40-20-4.8 - Mammography4.8.1ApplicabilityThe provisions of this section are in addition to, and not in substitution for, other applicable provisions of this Subchapter.
4.8.2Certification RequirementsA. Only X-ray systems in compliance with the requirements of the Mammography Quality Standards Reauthorization Act of 1998, Pub. Law 105-248, and 21 C.F.R. 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, Pub. Law 105-248, and 21 C.F.R. 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, Pub. Law 105-248, and 21 C.F.R. Part 900.4.8.3Retention of Mammography X-raysPursuant to R.I. Gen. Laws § 23-4.9-1, each mammographic imaging facility that takes a mammography X-ray of any individual within Rhode Island shall keep and maintain that mammography X-ray pursuant to the Mammography Quality Standards Reauthorization Act of 1998, Pub. Law 105-248, and 21 C.F.R. Part 900.
216 R.I. Code R. 216-RICR-40-20-4.8
Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/28/2023