MQSA Regulatory Accommodation for Changes to the ABR Certification Examination Process: FDA Guidance

MQSA Regulatory Accommodation for Changes to the ABR Certification Examination Process: FDA Guidance

Medical residents who are preparing to graduate this June and who wish to be classified as an interpreting physician according to the MQSA need to be aware of requirements changes that went into effect last year.  The ABR made changes to their certification process which led the FDA to come out with guidelines to accommodate those ABR changes.  This confusing process, and attendant requirements, are explained below.

MQSA Requirements for Interpreting Physicians

In 1992 the Mammography Quality Standards Act (MQSA) became law to ensure that all women would have access to mammography for early detection of breast cancer.  The MQSA outlines the standards under which medical physicians and technologists must operate to ensure quality mammograms.  One of the requirements defines the experience and continuing education required of interpreting physicians and requires significant number of exams for the prior two years before interpreting.

ABR Requirements for Certification 

In mid 2014, the American Board of Radiology (ABR) announced changes to the certification exam process that requires residents to demonstrate diagnostic radiology proficiency across all areas through completing a comprehensive exam and 36 months of residency training.  The effect with this new certification process is that graduates can’t become board certified during their medical residency, and wouldn’t be qualified to perform exams to meet the MQSA standards.

FDA Accommodation

After being notified of this change by the ABR, the federal Food and Drug Administration (FDA) announced a plan to consider an amendment to the language in the MQSA that defines the initial qualification requirements for interpreting physicians.  The FDA has provided guidelines as regulatory accommodation to the ABR changes.  This will help ensure that graduating medical residents can still meet the MQSA qualifications for interpreting physicians, and will enable them to begin interpretation of mammograms.

The guidance from the FDA has been provided to MQSA inspectors and includes the following conditions for newly graduated medical residents:

• Under direct supervision, residents must have interpreted 240 mammographic examinations during any six month period over the two most recent years of the medical residency.  This accommodation allows for the 240 exams to have occurred any time during the two year residency, as long as the exams fall within six months of each other.  This is a looser requirement than previously issued which required the six months to be the last six months in the residency program.  
• A resident must have completed at least three months of formal training that includes mammogram interpretation and other topics related to mammography.  The other topics must include education in radiation effects, radiation protection, and radiation physics specific to mammography.
• Residents must complete a minimum of 60 category 1 hours of medical education in mammography.  These must be documented hours and they must include mammogram interpretation; basic breast anatomy, pathology, and physiology; technical aspects of mammography; and quality assurance and quality control in mammography.  A minimum of 15 of the category 1 hours must have been obtained during the three years directly before the date that the physician qualified as an interpreting physician.

The ABR’s new certification applies to graduates on or after June 2014.  With this, the MQSA will issue a new residency letter template to be posted on their website and shared with the ABR for distribution to medical residency programs. All other pre-existing residency letter templates will still be allowed for their subsequent time periods and their specific qualification requirements for interpreting physicians.

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