900.12(a)(1)(i)(C): The interpreting physician shall have a minimum of 60 hours of documented medical education in mammography, which shall include: Instruction in the interpretation of mammograms and education in basic breast anatomy, pathology, physiology, technical aspects of mammography, and quality assurance and quality control in mammography. All 60 of these hours shall be category I and at least 15 of the category I hours shall have been acquired within 3 years immediately prior to the date that the physician qualifies as an interpreting physician. Hours spent in residency specifically devoted to mammography will be considered as equivalent to category I continuing medical education credits and will be accepted if documented in writing by the appropriate representative of the training institution.
900.12(a)(2)(ii)(A): Mammography requirements. All mammographic examinations shall be performed by radiologic technologist under paragraph (a)(2) of this section of FDA’s interim regulations of December 21, 1993, or completed at least 40 contact hours of documented training specific to mammography under the supervision of a qualified instructor. The hours of documented training shall include, but not necessarily be limited to: (A) Training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques, imaging of patients with breast implants.
900.12(a)(3)(i)(B)(2): Have 20 contact hours of documented specialized training in conducting surveys of mammography facilities.
FDA will continue to accept a limited form of attestation in certain cases where the following conditions exist:
(1) The documentation for a training event lacks specific reference that the training was in topics directly related to the regulated areas in mammography. This includes any training directly related to achieving quality mammography (e.g., anatomy of the breast, positioning, interpretation of mammographic examinations, quality assurance procedures). Training in an area not covered by the regulations shall not be accepted as meeting the requirements for initial training (e.g., stereotactic techniques, breast ultrasound, needle localization).
(2) It is possible for conference attendees to earn training credits in different subject areas at that training event (e.g., angiography, pediatric radiography, orthopedic radiography, and mammography).
In order to attest when these conditions apply, the interpreting physician, radiologic technologist, and medical physicist will need to provide:
(1) A letter, certificate or other documentation from the training provider identifying the total number of credits actually earned at the conference, and
(2) Documentation (for example, conference agendas) showing the total number of hours of training offered at the conference which were in topics directly related to the regulated areas in mammography.
Facility personnel can then attest to the mammography training credits earned at the training event. However, the training credits attested to may not exceed the total number of credits identified in items 1 or 2 above.
When the certificate identifies only the total number of training credits earned at the conference and it is not clear that all of the training hours were in topics directly related to the regulated areas in mammography, the inspector will need to review the conference agenda to calculate the total training credits which can be applied to the MQSA initial training requirement. The inspector must compare the number of attested hours to the total number of agenda hours that are applicable toward the initial training requirement. This ensures the attested hours do not exceed the number of applicable agenda hours.
FDA’s “Attestation Regarding Requirements of the Mammography Quality Standards Act” form (ATTESTATION FORM), or a form with similar elements or equivalent, shall be used for this purpose.
- Under the interim regulations, personnel were allowed to attest to training, education, or experience that was earned before October 1, 1994. Under FDA’s final regulations, will this still be allowed? What about attestation for training or experience earned between October 1, 1994 and April 28, 1999?
- Are there any exceptions for attestation for education or training earned after October 1, 1994?
Attestation Form: Attestation Regarding Requirements of the Mammography Quality Standards Act Interpreting Physician Continuing Education Interpreting Physician Initial Training 60 hours of CME Medical Physicist Continuing Education Medical Physicist Initial Training Radiologic Technologist Continuing Education Radiologic Technologist Mammography Specific Training