900.12(a)(1)(ii)(A): All interpreting physicians shall maintain their qualifications by meeting the following requirement: Following the second anniversary date of the end of the calendar quarter in which the requirements of paragraph (a)(1)(i) of this section were completed, the interpreting physician shall have interpreted or multi-read at least 960 mammographic examinations during the 24 months immediately preceding the date of the facility’s annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in-between the two. The facility will choose one of these dates to determine the 24-month period.
The term “starting date” is used to describe the date on which an interpreting physician, radiographic technologist, or medical physicist has met all initial MQSA requirements and must begin to meet the continuing requirements for his or her specialty.
Any of the following options may be used to determine if the interpreting physician’s continuing experience requirement has been met:
Option 1: The inspector counts back 24 months from the date of the inspection. For example, if the inspection is conducted on November 10, 1999, the relevant time period would be determined by counting back 24 months from November 10, 1999 to November 10, 1997.
Option 2: The inspector counts back 24 months from the end of the previous full calendar quarter immediately preceding the inspection date. For the inspection date of November 10, 1999, the relevant time period would be determined by counting back from the end of the previous calendar quarter, i.e., September 30, 1999, to October 1, 1997.
Option 3: The inspector may also count 24 months from any date between the inspection date and the end of the previous full calendar quarter. This could be the case if the facility’s records are updated to such a date, i.e., between September 30, 1999, and November 10, 1999, in the above example.
FDA recommends that the facility try to consistently use the same dating option for all interpreting physicians and other personnel providing services to it. However, this is not required.
It is important for interpreting physicians who interpret at multiple facilities to update all facilities on the number of mammograms interpreted at other sites to ensure that their recorded experience is complete and accurate. Since the interpreting physician will not know more than a few days in advance when a facility for which he/she interprets will be inspected, updates should occur frequently (at least quarterly).
Physicians may document continuing experience by obtaining a letter, table, or printout from each facility, signed by a responsible facility official, stating that he/she has interpreted a given number of mammograms at the facility in a given time period. Alternatively, signed copies of facility logs could be provided.
- How is an individual’s starting date for beginning to meet the MQSA continuing requirements determined?
- A physician had over three months of training in mammography during residency, and has been reading and interpreting mammograms at a facility for several years. He or she has now passed the ABR certification exam. Will this change the starting date for the physician's continuing experience and continuing medical education?
- Does the starting date ever change, due to personnel taking time off after they qualify or if they re-qualify when they are found to be deficient for either continuing experience or continuing education?
- Under the regulations, if less than 24 months have passed since an interpreting physician’s starting date will he/she still be evaluated for continuing experience during an inspection?
- If a facility uses locum tenens interpreting physicians and the locum tenens is not working at the facility when it is inspected, must the facility have their continuing experience and continuing medical education updated quarterly or continuously, like the other (regular) interpreting physicians?
- If interpreting physicians do not start working directly in mammography after meeting the initial requirements, but decide to start working at a mammography facility later, what must they do to make sure they are in compliance with MQSA? What should facilities do before allowing new personnel, including locum tenens or those personnel who have left the facility but returned later, to provide mammography services?
- Under the interim regulations, physicians could not count interventional mammographic examinations toward the initial or continuing experience requirements. Does this continue under the final regulations?
- If an interpreting physician is the sole owner of a mammography facility (and therefore is considered the most responsible official of the facility), can the interpreting physician document his/her own continuing experience?