FDA EQUIP is an initiative to ensure mammography sites are continuously producing high quality images. MQSA inspectors are asking three questions:

1. Does the facility have procedures for corrective action when clinical images are of poor quality?
2. Does the facility have procedures to ensure that clinical images continue to comply with the clinical image quality standards established by the facility’s accreditation body?
3. Does the facility have a procedure for LIP oversight of QA/QC records and corrective actions?

Per the FDA, facilities are responsible for having adequate processes in place to meet the information gathering and review needs, but the FDA has not provided a process to follow.

To learn more about FDA EQUIP guidelines and requirements, review the links to the FDA EQUIP website below:

• EQUIP: Enhancing Quality Using the Inspection Program - FDA overview of EQUIP.
• EQUIP: Frequently Asked Questions - A must-read list to clarify commonly asked questions.

View the QC-Track FDA EQUIP Brochure

Image Quality Feedback
The QC-Track Credentials Feedback Log tracks feedback and corrective actions, and sends emails to the technologist when new feedback is entered.

Learn more: QC-Track Credentials Module

Image Quality Review
The QC-Track Events and Documents module sends email reminders when it's time to conduct an Image Review. Image review assessments and corrective action are then tracked in the QC-Track Credentials Image Review Log.

Learn more: QC-Track Events and Documents Module

LIP QA/QC Review and Sign-Off
QC-Track is a central hub for all mammography device QC data and documents. Additionally, electronic sign-off capabilities allow the LIP to conveniently review and sign-off at any time, from anywhere.

Learn more: QC-Track Mammography Module

Current clients may log into the Client Center to view step by step instructions on how to use QC-Track for EQUIP compliance:

1. EQUIP 1 - Feedback Log
2. EQUIP 2 - Review Log
3. EQUIP 3 - QA/QC Review and Sign-Off