900.12(a)(1)(iv)(A)(1)(2) and (3): Interpreting physicians who fail to meet the continuing experience requirements of paragraph (a)(1)(ii)(A) of this section shall:
(1) Interpret or multi-read at least 240 mammographic examinations under the direct supervision of an interpreting physician, or
(2) Interpret or multi-read a sufficient number of mammographic examinations, under the direct supervision of an interpreting physician, to bring the physician’s total up to 960 examinations for the prior 24 months, whichever is less.
(3) The interpretations required under paragraph (a)(1)(iv)(A)(1) or (a)(1)(iv)(A)(2) of this section shall be done within the 6 months immediately prior to resuming independent interpretation.
When an interpreting physician (IP) fails to meet the continuing experience requirement of reading 960 mammograms in the “previous 24 months,” the regulation requires that he or she not read mammograms independently until he or she re-qualifies. The IP can re-qualify by reading, within a 6-month period under direct supervision, either 240 mammograms or the balance needed to bring the total to 960. FDA considers the “previous 24 months” to begin from the facility inspection date, or the date of the most recent calendar quarter preceding the inspection, or any date in between.
Requalification does not affect or change the date on which such individuals met their initial qualification requirements, therefore, the starting dates on which such individuals must begin to meet their continuing requirements remains the same.
When reading prospectively under direct supervision, at a minimum, the qualified interpreting physician must be identified on the report.
Documentation: It will generally be sufficient if the interpreting physician’s file contains a letter, table, or printout from each facility at which he or she interprets mammography examinations, signed by the person performing the direct supervision or a responsible facility official. The document should state who provided the direct supervision and that the interpreting physician interpreted or multi-read a given number of examinations at that facility in a given time period. It is assumed that these numbers are based upon more extensive records, such as facility logs, that can be reviewed if there are any questions. The facility logs themselves can then be used as documentation. Provision of summary letters, tables, or printouts will speed up the inspection and rarely will the more detailed records be requested.
Requalification only allows the interpreting physician to read independently again, it does not waive meeting the requirement of 960 mammographic examinations in 24 months.
Upon requalification, the interpreting physician will be exempt from an adverse finding for the continuing experience requirement for a period of 6 months after the requalification date. This policy will give the interpreting physician the time needed to practice in order to meet the continuing experience requirement by the end of the 6 months exemption period.
Following are two scenarios which illustrate how the regulation may be met:
1: An interpreting physician has read 288 of the 960 mammographic examinations over the past 24-month period. By reading 240 mammographic examinations under direct supervision within six months or less, he/she can reestablish his/her qualifications under the continuing experience requirement and may then again read and interpret mammographic examinations independently.
2: An interpreting physician has read 912 of the 960 mammographic examinations required over the past 24-month period. By reading mammographic examinations from 48 patients under direct supervision within six months or less, he/she can reestablish his/her qualifications under the continued experience requirement and may then again read and interpret mammographic examinations independently.
- A physician only read 80 mammographic examinations independently in the 24 months prior to the facility's inspection. If the physician reads 240 examinations within six months under the direct supervision of a qualified interpreting physician to requalify, can he or she resume reading mammography film independently? Is there anything else the physician needs to be concerned about with respect to his or her continuing experience?
- Under the interim regulations, FDA had a continuing experience policy stating that once interpreting physicians requalified to work independently, they were exempt from an adverse finding for this requirement for a period of six months after the requalification date. Will this policy continue and will it be expanded under the final regulations to include radiologic technologists?
- Can those examinations interpreted under direct supervision during the requalification process count toward meeting the continuing experience requirement at future inspections(s)?
Personnel undergoing requalification should not be considered trainees. Therefore, their names and associated information should be collected and recorded in the inspection record. The inspector should indicate the person’s requalifying status in the remarks section. When queried regarding requalifying personnel’s continuing experience, the inspector should enter an “X”.
Both the qualified supervising physician and the requalifying physician can sign the report as long as it is clear the qualified supervising physician is supervising the requalifying physician.