MQSA Inspection Preparation
Is your Annual Inspection quickly approaching? We’re here to help.
We ensure you comply with quality regulations by:
Our powerful breast imaging workflow and operations consulting program can serve as the perfect must-have for any breast imaging facility in need of guidance. We are here to help you reach your workflow and organizational goals.
Do you need to train a new lead tech on Inspection Preparation?
What are the expectations for the MQSA EQUIP program?
You will need to show that you have a program in place for the evaluation of clinical images (separate from your QC documentation). Standards for the evaluation of image quality will be those that are currently used by your facility’s accreditation body, which is in most cases the American College of Radiology (ACR). This will include the 8 factors evaluated by the ACR: Positioning, Contrast, Exposure Level, Compression, Sharpness, Noise, Artifacts, and Exam ID. Together, radiologists and technologists are required to review images, provide feedback, and state corrective actions. These steps must be clearly documented. Citations will be given for those facilities who are not in compliance with FDA MQSA regulations.
While all of this may seem ominous and daunting, these regulations reflect the mutual goal of all those involved in breast imaging: to provide the best in patient care by producing the best images possible! As such, we are here to help you achieve this goal.
What are the goals of the MQSA EQUIP?
The promotion of clinical image quality is a primary goal of the Mammography Quality Standards Act (MQSA). In fact, there is a requirement in the MQSA regulations that “clinical images produced by any certified facility must continue to comply with the standards for clinical image quality established by that facility’s accreditation body” (21 CFR 900.12(i)). When performing clinical image reviews, FDA‐approved accreditation bodies (AB) must include in the review the eight image quality attributes listed at 21 CFR 900.4(c)(2) .
Would you like to start implementing changes today at your own pace?
Mammography Educators created the Image Quality & Positioning Problem-Solving for Breast Imagers: Meeting EQUIP Standards manual to address specific imaging standards outlined by the FDA’s EQUIP guidelines.
We discuss eight categories that affect image quality in detail in this work. The book includes reasonable expectations for meeting those standards and positioning problem solving with corrective actions. Radiologists and technologists alike will benefit from this program and raise the standards for mammographic image quality at their facility. This EQUIP manual acts as a necessary sequel to our mammography positioning guidebook. The manual features forwards by eminent Breast Imaging Radiologists: Drs. Daniel Kopans and Michael Linver.