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.

According to the FDA, facilities may record their QC data on a computer, rather than using handwritten charts or tables. In these cases, the facility may maintain either the electronic data or a hardcopy printout of the data. To learn more, read the FDA Statement on Electronic Records .

The following conditions must be met for electronic records:

1. Quality control data must be easily accessible for review by the inspector during MQSA inspections
2. The facility must be able to print a hardcopy from the digitized records
3. The digitized data must be maintained for the time frame required by the regulation

QC-Track reports are easy to generate and easy for inspectors to read. They can be saved as PDFs in advance of the inspection for quick access, and can also be printed. QC-Track has been successfully used in thousands of MQSA inspections.

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