January 1, 2019 marked the beginning of the third year of the Enhancing Quality Using the Inspection Program (EQUIP) initiative. As stated in a previous Insights Article and the EQUIP FAQs, the first year  of inspections (2017) conducted under the EQUIP initiative was an educational year during which no EQUIP-related violations were generated.  Level 2 violations were issued during the second year of inspections (2018) performed under the EQUIP initiative, and during inspection year three (2019) of the initiative, a violation of the same EQUIP question cited during the previous annual inspection will result in a Repeat Level 2 violation. As is the case with all repeat violations, facilities will be required to provide a written response to the FDA district office within 15 days of receiving the inspection report. Additionally, the Division of Mammography Quality Standards (DMQS) will refer facilities with Repeat Level 2 EQUIP violations to their accreditation bodies (ABs) for evaluation of two randomly selected mammograms performed by the facility. Please note that the ABs may charge a fee for this clinical image review.

Since the beginning of the EQUIP initiative, DMQS has, on a regular basis, performed analyses of inspections performed under the initiative. The most common violation continues to be related to the periodic clinical image quality review. Facilities must have a mechanism in place for regular reviews of image quality attributes of a sample of mammograms performed by each active radiologic technologist and a sample of mammograms accepted for interpretation by each active interpreting physician (IP). Additionally, there must be written documentation that such a review was performed since the previous inspection.

Inspectors have identified some of the following common issues related to the periodic clinical image quality review:

• Failing to include the IPs or lead IP in the review
• Using IP peer reviews that do not include a review of image quality
• Mistakenly believing that individual IPs reviewing images daily obviates the need for the periodic clinical image quality review
• Inadequately explaining the facility’s periodic clinical image quality review process to the inspector and/or failing to produce the required documentation of the periodic review at the time of inspection

Please keep in mind that facilities may be inspected within a 10-14 month window from the previous inspection date. If a facility performs its periodic clinical image quality review on an annual basis but the review has not taken place in the current inspection year because the annual inspection is being performed early, the facility will not be cited. Another example in which a facility would not be cited for failing to produce documentation of the clinical image quality review would be a newly certified facility that is being inspected for the first time prior to the facility being in operation for 12 months. However, in this case, the facility should be prepared to explain the mechanism it has in place for the review.

In conclusion, facilities are now being cited for repeat EQUIP violations. Facilities with Repeat Level 2 EQUIP violations will be contacted by their ABs about how to submit images for review. This image review will help the FDA, or a certifying state, determine if the failure to comply with the EQUIP initiative has adversely impacted image quality. In addition, facilities must also respond to their FDA District Offices about any repeat EQUIP citations. The goal of the EQUIP initiative is to help facilities improve or maintain the quality of their mammograms, as image quality is one of the most important factors in the accuracy of mammography results. Quality images are what patients need and deserve, so that breast cancer can be detected in its early, most treatable stages. And that is a goal we all share.

Many valuable resources regarding the EQUIP initiative are available on our website at https://www.fda.gov/mammography. MQSA inspectors are also a valuable resource on how to comply with EQUIP. Facilities can also contact the MQSA facility hotline at 1-800-838-7715 or by e-mail at [email protected]. DMQS will continue to update the MQSA Inspection News page with important information regarding the EQUIP initiative.