900.12(a)(2)(ii)(A)(B) and (C): Mammography requirements. All mammographic examinations shall be performed by radiologic technologists who meet the following mammography requirements: Have, prior to April 28, 1999 qualified as a 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;
(B) The performance of a minimum of 25 examinations under the direct supervision of an individual qualified under paragraph (a)(2) of this section; and
(C) At least 8 hours of training in each mammography modality to be used by the technologist in performing mammography exams.
Copies of certificates earned or other documentation from the training provider will suffice for initial mammography specific training. If documentation is not available, proper attestation will be acceptable for records dated up to October 1, 1994. FDA will continue to accept a limited form of attestation for CME/CEU received after October 1, 1994, in certain cases. (see Attestation - Acceptable Uses for Personnel Requirements)
Since training does not expire, expired certificates can be accepted as documentation. For example, if a technologist earned the ARRT(M) in the past but allowed it to expire, it still counts as 24 hours towards meeting the initial training requirement. The technologist can not, however, allow her ARRT(R) to expire if she is using it to meet 900.12(a)(2)(i). Maintenance of either a state license or the ARRT(R) is necessary to show that general qualifications are being maintained.
The term mammographic modality refers to a technology for radiography of the breast. 21 C.F.R. 900.2(z). Examples of long available mammographic modalities are screen-film mammography and xeromammography. An example of a relatively new mammographic modality is full field digital mammography (FFDM). Personnel whose training pertained solely to screen-film mammography would be required to obtain 8 hours of training in FFDM, if they are to begin providing services or interpretations using this modality after April 28, 1999. However, if those personnel gained their experience using investigational FFDM units (units that were used for research purposes before being approved by FDA for commercial distribution), they are considered to have met the 8 hour requirement. New mammographic modality training can be in many forms, including, but not limited to, professional training, special training courses, continuing medical education, and training provided by the manufacturer.
- Under what conditions may students or trainees work at facilities (perform mammographic examinations) to obtain knowledge and experience prior to meeting the appropriate initial qualifications?
- A radiologic technologist qualified under the interim regulations using the expired qualification route based on experience performing mammography. He/she stopped working as a technologist in August 1996, but now wishes to work again in mammography. The technologist never obtained the specific training in mammography required by October 1, 1996, under FDA's interim regulations. Under FDA's final regulations, is the technologist exempt from the new requirements for initial mammography training?
- If a technologist earned the ARRT(M) in the past but allowed it to expire, can she still count it as 24 hours towards meeting the initial training requirement?
- Under FDA's interim regulations, there were several courses that FDA had indicated would meet the specific training in mammography requirement. For new technologists, will FDA continue to accept these courses as adequate initial training under the final regulations?
- Under the interim regulations, FDA accepted certain specific State certificates in mammography as meeting the specific training in mammography requirement. For new technologists, will FDA continue to accept State certificates in mammography as adequate initial training under the final regulations?
- Can the ARRT advanced certificate in mammography be used to meet the initial training in mammography requirement?
- The American Society of Radiologic Technologists (ASRT) will provide to their members a computerized printout of the continuing education credits earned by ASRT-member technologists. Is this type of documentation acceptable for MQSA requirements?
- Is there a specific amount of training or number of mammograms of breast implant patients that the technologist must perform under direct supervision prior to performing these studies independently?
- Must the technologist complete the 40 hours of training prior to performing the 25 exams under direct supervision?
- What is an acceptable method for documenting the 40 contact hours of documented training specific to mammography?
- Under the interim regulations, physicians could not count interventional mammographic examinations toward the initial or continuing experience requirements. Has this same policy been extended to radiologic technologists under the final regulations?
- I have my ARRT (M) certificate. Will this certificate be sufficient documentation to show that I received training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques and imaging of patients with breast implants as specifically spelled out in 900.12(a)(2)(ii)(A)?
I am a technologist who wishes to become initially qualified as a radiologic technologist. I completed my 40 hours of initial mammography training in screen-film mammography and performed 25 mammograms under direct supervision but all the examinations were performed on a full field digital mammographic (FFDM) unit. Does this satisfy the regulatory requirement?
- I am a technologist who wishes to become initially qualified as a radiologic technologist. I completed 27.5 hours of initial mammography training in screen-film mammography and performed 25 mammograms under direct supervision. I wish to count the time spent performing these mammograms toward the 40 hour requirement. All of the examinations were performed on a full field digital mammographic unit. Is this acceptable and am I qualified to independently perform both screen-film and FFDM examinations?
Acceptable Documents for Radiologic Technologists Attestation for Training Credits Earned for the Initial Training Requirement after October 1, 1994 Credit Hours for the Advanced ARRT Certificate in Quality Management Direct Supervision of RTs and MPs (Definition) Radiologic Technologist License or Certification