900.12(a)(2)(iv)(B) Requalification. Radiologic technologists who fail to meet the continuing experience requirements of paragraph (a)(2)(iv)(A) of this section shall perform a minimum of 25 mammography examinations under the direct supervision of a qualified radiologic technologist, before resuming the performance of unsupervised mammography examinations.
When a radiologic technologist (RT) fails to meet the continuing experience requirement of performing 200 mammograms in the “previous 24 months,” the RT must not perform mammograms independently until the RT re-qualifies. The RT can re-qualify by performing 25 mammograms under direct supervision. 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.
When a facility is inspected within the 6-month period following the date the RT re-qualified, FDA does NOT intend to cite the facility if the RT has not performed a total of 200 mammograms in the previous 24 months. We consider this the 6-month exemption period. If the facility is inspected any time after the 6-month exemption period has expired (even 1 day after) and the RT has not performed a total of 200 mammograms in the previous 24 months, FDA DOES intend to cite the facility. In summary, as long as the RT has performed at least 200 mammograms by the facility's next inspection, the RT is compliant with MQSA regulations.
Example #1:An RT has been performing mammography for more than two years and is hired by a new facility on 9/3/2007. The RT has performed only 100 mammograms since 9/1/2005. The RT performs 25 mammograms under direct supervision by 9/25/2007. The facility is inspected on 1/15/2008. At the time of the inspection, this RT has performed 150 mammograms, which includes the 25 under supervision, since 9/1/2005. Should the facility be cited?
No, because the RT’s continuing experience requirement falls under the 6-month exemption period, which expires on 3/24/2008.
Example #2:This same facility is inspected on 4/15/2008 and the RT has performed 175 mammograms, which includes the 25 under supervision, since 4/1/2006. Should the facility be cited?
Yes, because the 6-month exemption period after requalification has passed and the RT has not performed the required 200 mammograms.
Example #3:This same facility is inspected on 4/15/2008 and the RT has performed 200 mammograms, which includes the 25 under direct supervision, since 4/1/2006, but the RT had performed only 175 mammograms by 3/31/08 (a date after the 6-month exemption period). Should the facility be cited?
No, because the RT has performed the required 200 mammograms by the date of the inspection.
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 meet their continuing requirements remains the same.
Requalification only allows the radiological technologist to perform mammograms independently again, it does not waive meeting the requirement of 200 mammographic examinations in 24 months. Upon requalification, the radiological technologist 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 radiological technologist the time needed to practice in order to meet the continuing experience requirement by the end of the 6 months exemption period.
Documentation: It will generally be sufficient if the technologist’s file contains a letter, table, or printout from each facility at which he or she performs mammography examinations, signed by a responsible facility official or the person performing the direct supervision. The document should state who provided the direct supervision and that the technologist performed 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.
- A radiologic technologist only performed 80 mammographic examinations independently in the 24 months prior to the facility's inspection. If the radiologic technologist performs 25 examinations within six months under the direct supervision of a qualified radiologic technologist, can he or she resume performing mammographic examinations independently? Is there anything else the technologist 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 simulated examinations (person not irradiated) count toward the initial, or continuing, or requalification experience requirement?