FDA's MQSA EQUIP Initiative for Mammography Facilities (posted 11/10/2016)

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Since the quality of mammograms is one of the most important determinants of the accuracy of mammography, the production of high quality clinical images by certified mammography facilities is one of the primary goals of the Mammography Quality Standards Act (MQSA). In fact, there are MQSA regulations which specifically address clinical image quality. Inspection questions related to these clinical image quality regulations have previously not been part of the annual inspection. As part of its Enhancing Quality Using the Inspection Process (EQUIP) initiative, FDA’s Division of Mammography Quality Standards (DMQS) developed inspection questions related to the image quality regulations and added them to the inspection program, thereby emphasizing the significance of continuous clinical image quality.

Attached is a document which combines all the current information and resources DMQS has posted on the MQSA Website for the EQUIP initiative to include the following:

  • MQSA Insights article - the 10/21/2016 article posted on the MQSA Insights Articles website, which gives an overview and objectives of the EQUIP initiative.
  • Facility EQUIP FAQ's - Anticipated Frequently Asked Questions designed specifically for facilities.
  • EQUIP Facility Leave- Behind Document - The MQSA inspectors will provide and discuss this document with facilities during the first year of the EQUIP implementation, which starts on 1/1/2017. This document provides facilities with information on the clinical image quality regulations, and the three new questions, and their sub-questions, that will be addressed during the annual MQSA inspections
  • EQUIP Quality Assurance/Quality Control Attestation by the Lead Interpreting Physician (LIP) - this attestation allows the LIP to attest that the facility has a procedure for LIP oversight of QA/QC records, including review of the frequency of performance of all required tests, and LIP review of corrective actions to determine that appropriate corrective actions were performed when needed.
  • Additionally, facilities may view an informational video about the EQUIP initiative here.

The bold underlined text in this document are hyperlinks for web addresses. You can simply click on them to access the website information. If you have been given a hardcopy of this document or you are having trouble accessing the hyperlinks, you can also go to www.fda.gov/mammography and click on "EQUIP Program Information" under the "What's New" section to view these documents.

Any questions regarding the EQUIP initiative may be answered by your MQSA inspector, or facilities may contact the MQSA Facility Hotline at 800-838-7715 or by e-mail at MQSAhotline@versatechinc.com.

Facility EQUIP Documents.pdf