The ability to find breast cancer in its early, most treatable stages depends heavily on the quality of the mammograms being interpreted. With an enhanced focus on image quality, the FDA launched the Enhancing Quality Using the Inspection Program (EQUIP) initiative on January 1, 2017. As part of the EQUIP initiative, FDA's Division of Mammography Quality Standards (DMQS) developed inspection questions based on the Mammography Quality Standards Act's (MQSA) clinical image quality regulations, as well as questions to emphasize the responsibilities of the Lead Interpreting Physician in the clinical image quality process. DMQS developed and posted a number of informational articles, articles, documents, and videos to the MQSA Inspection News page to help facilities navigate EQUIP. Furthermore, FDA built an educational year into the program, during which facilities were inspected against the new EQUIP questions, but no citations were issued for unsuccessful responses to those inspection questions.
That educational year recently ended on March 2, 2018, and DMQS released an update to the MQSA inspection software which activated the citations related to the EQUIP inspection questions. For inspections performed after March 2, 2018, deficiencies related to the EQUIP inspection questions will result in Level 2 citations, which require facilities to perform and submit documentation of corrective action to FDA within thirty days of the inspection.
On August 25, 2017, we posted an Insights article outlining what we observed during the first six months of EQUIP inspections during the educational year. We are now updating those results to include the entire first year of EQUIP inspections. Between January 1, 2017 and December 31, 2017, there were 8,486 annual MQSA inspections performed under the EQUIP initiative and overall, 43% of those inspections had one or more EQUIP deficiencies. The chart below shows a breakdown of how many deficient inspections were recorded for each EQUIP sub-question. The highest number of deficient inspections were for sub-questions 2(a) and 2(b), which cover the periodic clinical image quality review. This is similar to the results we saw at 6 months into the initiative.
|EQUIP Question||Number of Deficient Inspections||Percent of Total Inspections|
|Question 1(a) - There is no system in place that includes a mechanism for providing ongoing IP feedback on image quality||990||12%|
|Question 1(b) - There is no system in place that includes a mechanism for documenting any needed corrective action and the effectiveness of any corrective action taken||1,971||23%|
|Question 2(a) - There is no mechanism in place for regular reviews of image quality attributes of a sample of mammograms performed by each active RT and a sample of mammograms accepted for interpretation by each active IP||2,776||33%|
|Question 2(b) - There is no documentation of review since the last inspection||2,588||30%|
|Question 3(a) - There is no system in place for LIP oversight, including review of the frequency of performance of all required tests||1,579||19%|
|Question 3(b) - There is no system in place for LIP review to determine whether appropriate corrective actions were performed when needed||1,891||22%|
This tells us that while many facilities have mechanisms in place to provide ongoing image quality feedback from interpreting physicians to technologists, about a third of facilities are missing the opportunity to take a periodic facility-wide look at clinical image quality and the quality of actual mammograms performed or interpreted by facility personnel. Facilities are free to design this periodic overview of quality to best suit their needs, and while we encourage this review to take place more frequently, the minimum frequency is once since the last inspection.
Remember that level 2 citations are now being issued for EQUIP questions. During the third year of EQUIP in 2019, any repeat EQUIP violations will trigger your accreditation body to perform a clinical image review of mammograms performed by your facility.
Your inspector is a valuable resource on how to comply with EQUIP. Again, there are also many valuable resources on our website at https://www.fda.gov/mammography. You can also contact our MQSA facility hotline at 1-800-838-7715 or by e-mail at MQSAhotline@versatechinc.com.
DMQS will continue to update the MQSA Inspection News page for important information regarding the EQUIP initiative, which uses the inspection process to emphasize the importance of image quality, one of the most important determinants of the accuracy of mammography.