September 1, 2017 — The Division of Mammography Quality Standards (DMQS) of the U.S. Food and Drug Administration (FDA) released new data from an analysis of inspections performed under the Enhancing Quality Using the Inspection Program (EQUIP) initiative. All data was collected from Jan. 1, 2017, through June 30, 2017.
Announced by the FDA in October 2016, the EQUIP program was created to ensure mammography facilities are adhering to the highest standards when assessing the quality of their mammograms. The program added three questions to the regular inspection process and eliminated two.
During this first year of inspections that include the EQUIP questions, facilities will not receive citations related to the new EQUIP questions. However, inspectors are responsible for recording facility responses to the EQUIP questions and any deficiencies are noted on the post-inspection report. These are then discussed during the inspection close-out session so that facilities are aware of what would have been cited if citations were in effect. This provides facilities with the opportunity to address these deficiencies prior to inspection citations being issued, beginning with inspections performed on or after Jan. 1, 2018.
As of June 30, 2017, there have been 4,166 annual MQSA inspections performed under the EQUIP initiative. Overall, 44 percent 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 was related to sub-questions 2(a) and 2(b), which cover the periodic image quality review.
| EQUIP Question | No. 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 | 542 | 13% |
| 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 | 1,045 | 25% |
| 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 | 1,421 | 34% |
| Question 2(b) - There is no documentation of review since the last inspection | 1,263 | 30% |
| Question 3(a) - There is no system in place for LIP oversight, including review of the frequency of performance of all required tests | 803 | 19% |
| Question 3(b) - There is no system in place for LIP review to determine whether appropriate corrective actions were performed when needed | 937 | 22% |
The DMQS said it had anticipated that Question 2 might be the most difficult for facilities to meet, mainly due to the fact that while many facilities engage in daily feedback, not all of them take the opportunity to do an assessment of image quality for the facility as a whole, including all technologists and interpreting physicians in that assessment. This type of assessment allows the facility an overall look at the quality of the breast images it produces, as well as a look at the less-often-assessed quality of images that its interpreting physicians are accepting for interpretation. Image quality is a responsibility that should be shared by both technologists and interpreting physicians. Supplementing the daily feedback process with this type of assessment can potentially lead to systemic remedies that improve a facility’s image quality, according to the DMQS. Although the division encourages facilities to do this assessment more frequently, it must be done and documented at least once a year.
The agency note that the EQUIP questions are designed to check that processes are in place for this image quality review, not specific review details. Facilities are free to design processes that best fit their individual situations and practices. This flexibility allows for many different ways to successfully meet Question 2, as well as the other EQUIP questions, and thereby satisfy the EQUIP inspection questions.
DMQS encourages providers to please take time to engage with their inspector during this educational year to learn how EQUIP can help the facility maintain image quality. Beginning with inspections performed on or after Jan. 1, 2018, Level 2 citations will be issued to facilities who have not successfully implemented the processes covered by the EQUIP inspection questions.
For more information: www.fda.gov
April 18, 2024 
