EQUIP – New FDA Mandated Inspection Criteria

By Bonnie Rush, RT(R)(M)(QM)

Reprinted with permission of AuntMinnie.com

The FDA – under the Mammography Quality Standards Act (MQSA) – has taken a proactive stance to enhance the potential for maintaining and/or increasing cancer detection rates. A new inspection focus was announced at the September MQSA meeting by Dr. Helen Barr, director of the agency’s Division of Mammography Quality Standards. It consists of three questions about the QA/QC processes to support image quality and implement corrective action when needed. The new inspection criterion is titled Enhancing Quality Using the Inspection Program (EQUIP).

EQUIP begins January 2017 with an “educational” inspection to afford sites the opportunity to address implementation and/or verify if their program meets the mandates outlined below.

Question 1: Does the facility have procedures for corrective action when clinical images are of poor quality?

This question focuses on a QA program for clinical image review (CIR) and corrective action when images do not meet requirements. The inspector will validate there is a system in place. Although written policies and procedures are not required, any individual involved with the process must be able to verbally explain the system to the inspector. It stresses that the ultimate responsibility to determine viability of images lies with each involved interpreting physician (IP), with mandated ongoing feedback on image quality. Although it does not set a threshold or the mechanism to provide feedback and/or corrective action, it does require written documentation of the reason for any corrective action and ultimately supports that it was effective.

Question 2: Does the facility have procedures to ensure that clinical images continue to comply with the clinical image quality standards established by its accreditation body?

This question mandates clinical image quality procedures to comply with the accrediting body standards for CIR, which includes the accrediting body’s designated eight attributes: positioning, compression, exposure level, contrast, sharpness, noise, artifacts, and examination identification. Once again the FDA leaves the process to the facility to establish, but it must be documented and include a mechanism for regular review of a random sample of images by all involved technologists. It also requires that a sample of mammograms that were accepted for interpretation by each involved IP be reviewed at least annually, although the program encourages it be done more regularly. To detail compliance, the FDA suggests a summary report with a signed statement by the lead IP (LIP), CIR meeting records, memos of review results to RTs and IPs, and any other means the site wants to implement.

Question 3: Does the facility have a procedure for LIP oversight of QA/QC records and corrective actions?

This question pertains to QC process control and mandates that the LIP provide oversight of QA/QC records and any needed corrective actions. This oversight includes setting a review frequency which is suggested to be based on testing procedure timing. Although it is not mandated to be a written program, any corrective action is required to be documented when performed. As with question 1, the LIP must be able to detail the process. If the LIP is located off-site, the inspector will either interview them by phone the day of the inspection, or the site can provide a LIP attestation or an SOP signed by the LIP.

What is the motivation behind EQUIP? The primary reason for accreditation failures are clinical images, with positioning as the foremost reason, followed by lack of appropriate QC processes when imaging parameters are not adequate. But accreditation only occurs every three years and may lead to a lack of focus on quality of images during the interim years.

As a consultant I know this to be an issue. I get requests to appraise images for CIR attributes for accreditation submission; or a site is about to go through re-accreditation and realizes they have a need for a positioning update; or, more commonly, a site has failed accreditation and now needs remedial positioning training. Image quality should be evaluated daily to avoid these scenarios and to bring in a trainer as needed to keep skills updated.

The MQSA Insight article, EQUIP: Enhancing Quality Using the Inspection Program, reminds us that this is not a change to the original 21 CFR 900 requirements but will now take on a heightened focus as part of the yearly inspections to ensure that clinical images continue to comply with the accrediting body CIR standards.

Even if there is no actionable scenario in the year all of the new inspection questions require a process in place to ensure it is available should there be a failure to meet the EQUIP. No citations will be given in 2017. The citation given in year two for failure is a level 2 violation for the first such citation. The same citation in year three would require corrective action response at a Level 1 of 15 days rather than the 30 days for a Level 2 citation.

EQUIP is also in alignment with the new ACR 2016 Digital QC Manual in advancing the importance of a team approach to confirm imaging quality. Although it applies only to FFDM and CR mammography, there are two forms that can be a valuable resource for meeting EQUIP standards. The Radiologist Image Quality Feedback form would help to meet the CIR mandate. The Facility QC Review form can be used as-is for sites that change to the included tests. For those that have upgraded to 3D or that continue to utilize the manufacturer’s testing procedures, it can be used as a template to formulate a site-specific QC review form.

I encourage sites to address the adequacy of their program now. If there is a need for corrective action to update imaging quality – such as the all too common need for a positioning refresher – outside help is available. Let us acknowledge, before there is a failure, either through an inspection citation or through a false negative interpretation, that this is essential to ensure our screening program allows for a quality focus for every patient every day.