September 23, 2016

FDA Launches EQUIP Mammography Quality Initiative

The Food and Drug Administration has unveiled Enhancing Quality through the Inspection Process (EQUIP), a new clinical image quality initiative to address changes in the type of compliance issues seen at mammography facilities subject to the Mammography Quality Standards Act (MQSA) program.

The FDA announced EQUIP at the Sept. 15 meeting of the National Mammography Quality Assurance Advisory Committee (NMQAAC). EQUIP is intended to address the MQSA requirements for Lead Interpreting Physician (LIP) oversight of quality, the Interpreting Physicians’ (IPs) responsibility to follow facility corrective action procedures if asked to interpret poor quality images, and a facility’s responsibility to continuously comply with the clinical image quality standards established by its accrediting body.

To implement EQUIP, the FDA will add the following questions to the quality assurance components of its facility inspections to assess compliance with image quality requirements:

Does the facility have procedures for corrective action (CA) when clinical images are of poor quality? (Yes / No)
  1. Do the procedures include a mechanism for providing ongoing IP feedback on image quality to RT’s or other designated facility personnel? (Yes / No)
  2. Do the procedures include a mechanism for documenting any needed corrective actions and documenting the effectiveness of any corrective actions taken? (Yes / No)
Does the facility have procedures to ensure that clinical images continue to comply with the clinical image quality standards established by its accreditation body? (Yes / No)
  1. Do the procedures include a mechanism for regular reviews of image quality attributes of a sample of mammograms performed by each active RT and a sample of mammograms accepted for interpretation by each active IP? (Yes / No)
  2. Is there documentation of such review since the last inspection? (Yes / No) [Note: Documentation could include: a summary report; signed statement by the LIP that a review was performed; clinical image review records; memos to RTs and IPs, etc.]
Does the facility have a procedure for LIP oversight of QA/QC records and corrective actions? (Yes / No) [Note: LIP provides answers verbally, provides answers in an attestation, or an SOP signed by the LIP is presented at inspection.]
  1. Does the procedure include LIP oversight of QA/QC records including review of the frequency of performance of all required tests? (Yes / No) [Note: This includes tests performed by the QC technologist, medical physicist and any other designated personnel.]
  2. Does the procedure include LIP review to determine whether appropriate corrective actions were performed when needed? (Yes / No)
The FDA is planning a November/December “go-live” date but will not immediately cite facilities that have not implemented EQUIP. Instead, the program will be phased in over three years. The initial year is intended to provide facilities with information about EQUIP and alert them of the FDA’s expectations related to the program. In year two, facilities failing to implement EQUIP will received a level 2 citation and will be subject to corrective action. In year three and beyond, noncompliant facilities will receive a Level 1 citation and will have to undergo clinical image review by their Accrediting Body, corrective action, and a possible warning letter.

During testimony before the NMQAAC, Debra Monticciolo, MD, FACR, the American College of Radiology (ACR) Breast Imaging Commission Chair, raised concerns as to whether EQUIP would, indeed, result in improved image quality. She emphasized the importance of FDA inspector training to ensure consistency in how the program is implemented and encouraged the FDA to adopt a mechanism for facilities to provide feedback to the FDA if they believe the new survey standard is not being appropriately applied.

The NMQAAC meeting also featured updates on issues ranging from recently approved Alternative Standards, including the ACR’s Digital Mammography QC Manual, an analysis of compliance cases/inspection citations, proposed breast density reporting requirements, enhanced inspector training and future challenges for MQSA. The FDA reported that rulemaking now underway is expected to address breast density notification requirements.