Additional Mammography Review and Patient Notification

Section 370 Section 370.140  Additional Mammography Review and Patient Notification a)         If the Agency believes that mammography quality at a facility has been compromised and may present a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by the Agency, for review by the accreditation body.  This additional mammography review will help the Agency to determine whether the facility is in compliance with this Part and, if not, whether there is a need to notify affected patients, their physicians or the public that the reliability, clarity and accuracy of interpretation of mammograms has been compromised. b)         If the Agency determines that the quality of mammography performed by a facility, whether or not certified under Section 370.50 of this Part, was so inconsistent with the quality standards established in this Part as to present a significant risk to individual or public health, the Agency may require the facility to notify patients who received mammograms at the facility, and their referring physicians, of the deficiencies presenting the risk, the potential harm resulting, appropriate remedial measures and other relevant information as the Agency may require.