900.12(a)(3)(iii)(B): Continuing experience. Following the second anniversary date of the end of the calendar quarter in which the requirements of paragraphs (a)(3)(i) and (a)(3)(ii) of this section were completed or of April 28, 1999, whichever is later, the medical physicist shall have surveyed at least two mammography facilities and a total of at least six mammography units 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 shall choose one of these dates to determine the 24-month period. No more than one survey of a specific facility within a 10-month period or a specific unit within a period of 60 days can be counted towards this requirement.
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 medical physicist’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 personnel providing services to it. However, this is not required.
It is important for medical physicists who perform surveys at multiple facilities to update all facilities on the number of surveys performed at other sites to ensure that their recorded experience is complete and accurate.
- 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 regulations, if less than 24 months have passed since a medical physicist’s starting date, will he/she still be evaluated for continuing experience during an inspection?
- Can a medical physicist who conducts surveys at only one facility count his or her annual surveys twice during a 24-month period? Can the same mammography unit be surveyed more than once per year to meet the six-unit requirement?
- If medical physicists 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?
- What are acceptable methods for documenting medical physicist initial and continuing experience?
- If two or more medical physicists perform an annual physics facility survey or unit survey can each count it towards meeting their continuing experience requirement?
- Can a mammography unit survey at a non-certified facility count toward the continuing experience requirement?
- Under the interim regulations, physicians could not count interventional mammographic examinations toward the initial or continuing experience requirements. Will this same policy be extended to medical physicists under the final regulations?
- If a medical physicist is the sole owner of a physics consulting business (and therefore is considered the most responsible official of that business), can the medical physicist document his/her own continuing experience?