All interpreting physicians (including part-time and locum tenens staff) must meet MQSA requirements and must have initial and continuing qualification documentation available at the facility for any on-site visits. In addition, a qualification form for attestation of qualifications is required for initial, renewal and reinstatement applications. This qualification form is attached at the bottom of this article.
Board-Certified in Radiology
Not Board-Certified in Radiology
All of these:
All of these:
In addition, both of the below are initial requirements for all physicians interpreting mammograms:
Interpret 960 mammographic examinations over a 24-month period
15 Category I CME in mammography in a 36-month period (The FDA allows some flexibility in subject areas that may be counted toward the required mammography continuing education. (See the FDA’s Policy Guidance Health System for more information.)
For your convenience, the Interpreting Physician Requirements Form is attached below.
There is no regulation that requires a radiologist to be present during diagnostic mammography. However, the ACR Practice Guideline for the Performance of Screening and Diagnostic Mammography recommends that diagnostic mammograms be performed under direct supervision. Direct supervision is defined as the physician being present and immediately available to furnish assistance and direction throughout the performance of the procedure. Direct supervision may also be accomplished via telemammography as long as the interpreting physician is immediately available. The ACR guidelines are not requirements but are designed as an educational tool to assist practitioners in providing appropriate radiologic care for patients. They are not inflexible rules or requirements of practice and are not intended, nor should they be used, to establish a legal standard of care.
Documentation demonstrating MQSA qualifications should be available at the time of the facility’s MQSA inspection. The FDA recommends that MQSA inspectors give facilities 5 days to provide this documentation; however, inspectors are allowed to use their own discretion in providing this option. Several states have instructed their inspectors to cite facilities if the records are not available at the time of the inspection. Even if the inspector does give the facility time to get the records, the FDA still requires the inspector to give the facility a minor citation (Level 3) for failing to have the records on hand at the time of the inspection. MQSA inspectors must notify facilities at least 5 days in advance of the annual MQSA inspection. It is prudent to use this advance notice to make sure all documents are available in order to avoid the added costs and time spent trying to resolve this citation once it has been issued. If you do not meet the MQSA requirement for continuing education or continuing experience, you will need to reestablish your qualifications before resuming independent interpretation at this facility (note that if your qualifications and documentation were in order at other facilities that were inspected earlier the same year, you may continue to interpret at those facilities). The FDA website has guidance on “Reestablishing the Interpreting Physician Continuing Education Requirements” and/or “Reestablishing the Interpreting Physician Continuing Experience Requirement.”
The FDA has written the following useful guide to let facilities know how to get ready for an MQSA inspection: The Mammography Quality Standards Act Final Regulations: Preparing for MQSA Inspections; Final Guidance for Industry and FDA.
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