Active Physician
What does an active physician mean in the Mammography Audit?
An active physician is a doctor who currently performs mammogram interpretation at a facility and meets all criteria set by the FDA's MQSA regarding interpreting physicians.
What are the requirements for physicians to be considered an "Active Physician"?
The FDA's MQSA outlines the requirements for interpreting physicians as follows:
"(ii) Continuing experience and education. All interpreting physicians shall maintain their qualifications by meeting the following requirements:
(A) 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.
(B) Following the third 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 taught or completed at least 15 categories I continuing medical education units in mammography during the 36 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 36-month period. This training shall include at least six category I continuing medical education credits in each mammographic modality used by the interpreting physician in his or her practice; and
(C) Before an interpreting physician may independently interpret mammograms produced by a new mammographic modality, that is, a mammographic modality in which the physician has not previously been trained, the interpreting physician shall have at least 8 hours of training in the new mammographic modality.
(D) Units earned through teaching a specific course can be counted only once towards the 15 required by paragraph (a)(1)(ii)(B) of this section, even if the course is taught multiple times during the previous 36 months" (U.S. Food and Drug Administration, 2024).
What are the Continuing Experience and Education requirements for Active Interpreting Physicians?
The FDA's MSQA outlines the Continuing Experience and Education requirements for Interpreting Physicians as:
"(ii) Continuing experience and education. All interpreting physicians shall maintain their qualifications by meeting the following requirements:
(A) 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.
(B) Following the third 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 taught or completed at least 15 categories I continuing medical education units in mammography during the 36 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 36-month period. This training shall include at least six category I continuing medical education credits in each mammographic modality used by the interpreting physician in his or her practice; and
(C) Before an interpreting physician may independently interpret mammograms produced by a new mammographic modality, that is, a mammographic modality in which the physician has not previously been trained, the interpreting physician shall have at least 8 hours of training in the new mammographic modality.
(D) Units earned through teaching a specific course can be counted only once towards the 15 required by paragraph (a)(1)(ii)(B) of this section, even if the course is taught multiple times during the previous 36 months" (U.S. Food and Drug Administration, 2024).
What is a Continuing Experience Credit?
According to the FDA, a continuing experience credit (CEC), or continuing experience unit (CEU) qualifies as one contact hour of training.
Why does Mammologix conduct individual physician data and facility data analysis separately?
The FDA recommends that mammography data be analyzed separately for each active physician and overall facility analysis. This analysis helps determine if each physician meets performance benchmarks relating to mammography interpretation.
Who is the Audit Interpreting Physician, and what are their responsibilities?
The Audit Interpreting Physician reviews the medical audit data for a facility. These individuals record the date and results of the audit and communicate with other interpreting physicians about their individual results and the facility's overall results. If follow-up is required for the audit, the Audit Interpreting Physician is responsible for recording why the follow-up is being performed.
Who is the Lead Interpreting Physician, and what are their responsibilities?
The Lead Interpreting Physician leads the facility's quality assurance program. These individuals ensure that the facility meets all of the FDA's requirements regarding mammography quality assurance.
Sources:
U.S. Food And Drug Administration. (2017, Nov. 29). Mammography Quality Standards Act Regulations. FDA. https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mammography-quality-standards-act-regulations#s90011
U.S. Food and Drug Administration. (2024, April 23). MQSA 21 CFR Part 900 - Mammography. ECFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-I/part-900
U.S. Food & Drug Administration Policy Guidance Help System. (2017, Oct. 11). Why Is The Data Analyzed For The Aggregate And Then For Each Interpreting Physician? AccessData. https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/Why_is_the_data_analyzed_for_the_aggregate_and_then_for_each_interpreting_physician_.htm