900.12(a)(2)(iv)(A): Continuing experience requirements. Following the second anniversary date of the end of the calendar quarter in which the requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were completed or of April 28, 1999, whichever is later, the radiologic technologist shall have performed a minimum of 200 mammography examinations during the 24 months immediately preceding the date of the facility’s annual 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 radiologic technologist’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, 2001, the relevant time period would be determined by counting back 24 months from November 10, 2001 to November 10, 1999.
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, 2001, the relevant time period would be determined by counting back from the end of the previous calendar quarter, i.e., September 30, 2001 to October 1, 1999.
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, 2001 and November 10, 2001, in the above example.
FDA recommends that the facility try to consistently use the same dating option for all radiologic technologists providing services to it. However, this is not required.
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. The document should state that the technologist has 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.
FDA recommends that these numbers be provided and updated on at least a quarterly basis. Facilities that plan to use the date of inspection as the end of the 24 months may wish to update them more frequently, perhaps monthly, to minimize the effort needed at the last minute in preparing for an inspection.
- How is an individual’s starting date for beginning to meet the MQSA continuing requirements determined?
- Does the starting date ever change due to personnel taking time off after they qualify or if they requalify when they are found to be deficient for either continuing experience or continuing education?
- Under the final regulations, if less than 24 months have passed since a radiologic technologist’s starting date, will he/she still be evaluated for continuing experience during an inspection?
- If radiologic technologists 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?
- A technologist works in a small facility with a limited number of patients and several mammography technologists, so meeting the 200 examination requirement over a 24-month period will be difficult. If he or she assists another technologist while performing an examination, can both technologists count the exams they perform together?
- What are acceptable forms of documentation for demonstrating that the technologist's continuing experience requirement has been met?
- Can simulated examinations (person not irradiated) count toward the initial, or continuing, or requalification experience requirement?
- 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 am qualified to perform screen-film mammograms independently but also performed some FFDM mammograms while under direct supervision. Can I count those FFDM mammograms toward my continuing experience requirement?
- What is an acceptable method for documenting the 40 contact hours of documented training specific to mammography?
- I am the physicist in question 10. Once I’ve completed my initial requirements, can I independently perform both screen-film and FFDM surveys?