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  1. Mammography Quality Standards Act and Program

A Message from the Director, Division of Mammography Quality Standards (DMQS): EQUIP

A Message from the Director, Division of Mammography Quality Standards (DMQS): EQUIP

First, I want to thank everyone for the very positive feedback we have received about the series of articles on MQSA topics which we launched in 2015. We are glad that you have found them informative and relevant. You can send any suggestions for future topics to MQSAhotline@versatechinc.com.

As you know, on October 27, 2016, to coincide with the beginning of the 25th year since the passage of the Mammography Quality Standards Act (MQSA), DMQS launched the EQUIP initiative – Enhancing Quality Using the Inspection Program. As a high-quality image is a significant factor in the accuracy of mammography, we wanted to take the opportunity of using the annual inspection to emphasize the quality assurance regulations that have been in place since the MQSA Final Regulations were published. We have added three inspection questions to emphasize the importance of daily image quality review, regular facility-wide quality reviews, and the personnel responsibilities for image quality that are clearly spelled out in the Preamble and the Regulations. I hope many of you have had the opportunity to view my talk on EQUIP presented at the Sept. 15, 2016 National Mammography Quality Assurance Advisory Committee meeting. The video is available on our EQUIP page and it outlines why and how the EQUIP initiative came to be. On that same page you will find the link to our EQUIP Frequently Asked Questions – Facilities document, which we will revise and update around March of 2017, after we have had several months of experience with, and feedback from inspectors and facilities on, inspections containing the EQUIP questions. Feedback and suggestions for additional FAQs can be sent to the MQSA hotline link provided above.

Remember, the first year of inspections containing the EQUIP questions, beginning January 1, 2017, is an educational year. No facility will receive any citations related to the new EQUIP questions during this initial year. Your inspector will review the EQUIP questions with you so that you will know what to expect in subsequent inspections. Also remember that the EQUIP questions are simply designed to check that processes are in place for image quality feedback and review. Your facility is free to design processes that best fit your situation. There are many different ways to successfully provide feedback, review image quality, and satisfy the EQUIP inspection questions.

One part of EQUIP that seems to be causing a bit of confusion is the difference between the first question, “Does the facility have procedures for corrective action (CA) when clinical images are of poor quality?” and the second question, “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 (AB)?” In a sense, the daily review looks at each individual “tree,” while the regular review takes a step back and looks at the entire “forest”:

  • The first question is aimed at making sure your facility has a process in place for giving feedback on any poor-quality images presented for interpretation, and for documenting any corrective action taken, such as repeating the image. The goal of this daily review is to produce an individual mammogram that can be interpreted. Inspectors will be asking about your process; they will not be reviewing documentation of corrective action, so your method of documentation is strictly up to you.
  • The second question is designed not for daily feedback on individual mammograms, but instead for the facility as a whole to take the opportunity regularly (at least once a year) to review the quality of images performed by all of its technologists, as well as the quality of images accepted for interpretation by all of its interpreting physicians. Such an overview allows you to look for overall trends or issues at your facility regarding image quality, and to check that your facility is continuously complying with the image quality standards of your AB. The goal of this regular review is to identify any necessary improvements across the facility as a whole. The size of the samples of images you select to review and how you choose to conduct the quality review are entirely up to you. The inspector will only be looking for one of many possible forms of documentation (meeting minutes, a signed and dated statement or memo, etc.) that indicate that your facility has performed this type of review at least annually. Again, the details of how such a review is performed are up to you.

EQUIP is designed to spot image quality issues early so that they can be rapidly corrected, which is beneficial not only for patients, but also for facilities. The premise of EQUIP is that by continuously keeping mammography quality high, there will be less need for facilities to undergo Additional Mammography Reviews by ABs, that the need for mandatory Patient and Provider Notifications ordered by FDA will be reduced, and, most importantly, that women will receive high quality mammography from every facility every day. Please engage with your inspector during this educational year to learn how EQUIP can help your facility maintain image quality.

Helen J. Barr, MD