The FDA is stepping up its focus on quality assurance in breast imaging by adding three questions to annual inspections, starting in 2017. Radiology administrators should be aware of these changes, but they don’t have to feel blind-sided by them—the FDA won’t issue citations for violations until 2018.
The Mammography Quality Standards Act (MQSA) was enacted in 1992 in response to widespread issues in breast cancer screening, such as poor quality, inadequate equipment and a lack of accreditation. The results were encouraging—quality improved in much of the country without leading to the closures that can accompany tightening regulations.
However, requirements for quality assurance of image quality have generally gone unverified by inspectors, prompting the FDA to establish the Enhancing Quality Using the Inspection Program (EQUIP) Initiative. Announced in September at the National Mammography Quality Assurance Advisory Committee (NMQAAC), EQUIP addresses the MQSA requirements for corrective action in the face of sub-standard images and the role of the Lead Interpreting Physician (LIP) in the quality assurance process.
During the initial year of implementation facilities will not be cited for violations of these requirements, but lapses in the second year of EQUIP will result in Level 2 citations—requiring a written response to the FDA district office within 30 days.
1. Does the facility have procedures for corrective action (CA) when clinical images are of poor quality?
a. Do the procedures provide a mechanism for ongoing interpreting physician feedback on image quality to radiologic technologists or other designated facility personnel?
b. Do the procedures require documenting any corrective actions taken and documenting the effectiveness of any corrective actions taken?
Facilities are not required to create a written procedure, but the facilities must explain the procedure to the inspector. Whether the system is written or verbal, it must include mechanisms for interpreting physician (IP) feedback and documenting any corrective actions. Individual facilities have a great amount of agency when it comes to designing the CA documentation, with no requirements on time frame or specific actions.
2. Does the facility have procedures to ensure that clinical images continue to comply with the clinical image quality standards established by the facility’s accreditation body?
a. Do the procedures include a mechanism for regular reviews of image quality attributes of a sample of mammograms performed by each active radiologic technologists and a sample of mammograms accepted for interpretation by each active IP?
b. Is there documentation of such review since the last inspection?
By default, the reviews must happen annually to satisfy the requirements of the question. However, the FDA encourages more frequent review of reporting mechanisms, either monthly or quarterly. Unlike the mechanism for interpreting physician feedback, this process must have written documentation. Acceptable submission include a summary report, signed statement by a lead interpreting physician, clinical image review meeting records, etc.
3. Does the facility have a procedure for LIP oversight of quality assurance/quality control (QA/QC) records and corrective actions?
a. Does the procedure include requirements for LIP oversight of QA/QC records, including review of the frequency of performance of all required tests?
b. Does the procedure include requirements for LIP review to determine whether appropriate corrective actions were performed when needed?
This oversight procedure does not have to be in person—the FDA will accept contact via phone, an important factor for teleradiology as the lead interpreting physician may not be onsite. Again, there is no required frequency, but the responsibility for the reviews rests on the shoulders of the LIP, putting the onus on him/her to ensure that QA review happens at the necessary frequency.