Why MQSA Regulations Matter in Mammography
All mammography facilities must be certified according to the Mammography Quality Standards Act (MQSA) in order to legally operate.
MQSA guidelines are in place to:
- Improve the quality of care delivered across all mammography facilities
- Reduce the errors in clinical imaging mammography
- Ensure all technologists and interpreting physicians are well-trained and practicing high standards for mammography delivery
- Ensure mammography facilities have the proper procedures in place to consistently deliver high-quality patient care, evaluate radiologist performance, and effectively handle complaints.
Who do the MQSA Regulations Apply to?
MQSA regulations apply to all mammography facilities that take, process, or interpret mammograms. The impact on the radiologic technologists performing the mammograms, the physicians interpreting the images, the QA technologists monitoring quality standards for the facility, and the medical physicists surveying the equipment within the facility. The content below provides information on mammography facility procedures and quality assurance as they relate to MQSA Regulations. This content is not exhaustive, and it is recommended to review the official MQSA regulations page for a full understanding of the scope of the regulations.
Section (d) &(e) in MQSA Regulations Subpart B, Sec. 900.12
Each facility must assign the following roles to oversee quality assurance across the facility:
- Lead interpreting physician
- Interpreting physicians
- Medical physicist
- Quality control technologist
Facilities must also maintain comprehensive records regarding mammography techniques and procedures, quality control, safety, protection, and employee certification.
Quality assurance audit process:
Addressed in Section (f) in MQSA Regulations Subpart B, Sec. 900.12
Facilities are responsible for the establishment and maintenance of a mammography audit program to ensure reliability, clarity, and accuracy of the interpretation of mammograms.
- Each facility must establish a system to collect and review outcome data for all mammograms performed, both individually and collectively for radiologists.
- Medical outcomes audit data is to be reviewed by a designated interpreting physician (IP) at least once every 12 months.
- It is the responsibility of the IP to determine whether the images are of poor quality and provide constructive feedback.
FDA MQSA EQUIP
As of 2017, the FDA MQSA Enhancing Quality Using the Inspection Program (EQUIP) was established to emphasize high-quality clinical imaging in mammography. This program identified three main inspection priorities:
- Assessing facility procedures to ensure clinical images comply with accreditation body standards for quality and regular image quality reviews are conducted by technologists and interpreting physicians.
- Assessing the facility’s corrective procedures when image quality is poor, including a process for continual feedback to imaging personnel for performance improvements.
- Assessing procedures for ensuring LIP oversight of QA/QX recordkeeping, including assessing whether appropriate corrective actions have been taken when necessary.