The MQSA (Mammography Quality Standards Act and Program), monitored by the FDA, has been in regulation for 25 years with the primary purpose of monitoring clinical imaging quality at mammography facilities.
Once a year, an inspector visits an accredited breast imaging center to ensure they are compliant with the MQSA standards regarding equipment and dose. Since this regulation went into effect, technology has changed significantly allowing for better image quality and therefore is rarely an issue.
Accountability for Positioning and Compression
The opportunity for improvement is in positioning and compression, both of which rely on humans and are prone to variation and errors.
Recognizing an opportunity for improvement, the MQSA recently introduced a new initiative modeled after the Medical Outcomes Audit. The new program, called EQUIP (Enhancing Quality Using the Inspection Program), went into effect on January 1st, 2017. The goal of EQUIP is to prepare facilities to address image quality on a continual basis and include the lead interpreting physician and/or interpreting physician as the person ultimately responsible for the image quality.
It is important to note that the change will not require images to be reviewed at inspections, but instead look at the facility’s processes set in place to ensure image quality is continually being inspected.
EQUIP Now Part of MQSA Annual Inspection
Regulations on quality assurance will be added to the inspector’s checklist and citations will be given for inadequate or missing image quality processes in place. Questions during inspection will now be asked to support the new regulations on Quality Assurance, Clinical Image Quality, and Quality Control.
- 900.12 (d)(1)(ii)(A) All interpreting physicians shall follow the facility procedures for corrective action when the images they are asked to interpret are of poor quality.
- 900.12(d)(2) Quality assurance records. The lead interpreting physician ... shall ensure that records concerning mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions, and the effectiveness of the corrective actions), safety, protection and employee qualifications to meet assigned quality assurance tasks are properly maintained and updated.
- 900.12(i) Clinical image quality. Clinical images produced by any certified facility must continue to comply with the standards for clinical image quality established by that facility's accreditation body.
Timeline for Improvement
2017 will be a grace period with no citations issued upon inspection. Instead MQSA inspectors will use their annual visit to review the requirements for EQUIP with staff. Citations will start in 2018.
The reason for the EQUIP initiative is to place significance on the importance of clinical image quality which determines the accuracy of the mammogram and should result in fewer AMRs (Additional Mammography Reviews) failing due to poor image quality.
A Focus on Better Postioning
Although the new regulation is a positive movement towards better imaging, it will demand a focus on better positioning. Each Technologist’s images will be reviewed and if the images fail, corrective action must be set in place by the lead interpreting physician.
Receptor plate covers, such as Bella Blankets® protective coverlets, can assist mammography technologists with positioning and tissue acquisition by preventing breasts from slipping out under compression or sticking to the receptor plate. In one study, "The Impact of Thin Protective Coverlets on Positioning and Tissue Acquisition in Breast Imaging," there was increased tissue acquisition in 77% of the patients from previous year mammograms where no receptor plate cover had been used.
Where to Learn More
About EQUIP: The FDA has posted Frequently Asked Questions for Facilities on their website and plan to update them after approximately 3‐6 months of inspector experience and facility feedback.