A new MQSA regulatory program called Enhancing Quality Using the Inspection Process (EQUIP) became effective on January 1, 2017 to continue the promotion of clinical image quality. The program will be phased in over a 3 year period. This initial year is intended to be an educational year. During this year, inspectors will provide information about the program and alert the facility of the FDA participation expectations.  Year 2 will initiate the EQUIP inspection process. Failure of implementation of EQUIP will generate a level 2 citation and is subject to corrective action. In Year 3 and beyond, noncompliant facilities will receive a level 1 citation, clinical image review, corrective action, and a possible warning letter.

Many facilities are stepping up their emphasis on image quality as the most deficiencies and failure of clinical images is the results of poor positioning according to MQSA.  Everybody learned mammography positioning at the very beginning of mammo training, right? It seems over time, we forget a lot of what we knew, therefore, poor image quality. Refresher positioning training is a vital component of every corrective action plan.

MQSA documented in regulatory format the role and responsibilities of the Lead Interpreting Physician (LIP) for oversight of quality, the Interpreting Physicians’ (IPS) responsibility to follow facility corrective action procedures if asked to interpret poor quality images, and the facility’s responsibility to continuously comply with clinical image standards established by its accrediting agency.  It’s plainly spelled out but now we have a new regulatory program? What happened?

The FDA has been careful not to define how to meet the program requirements just as they did with the MQSA audit procedures. A facility must comply, but the choice of pathway is at the discretion of the facility.  The program must be described or documented to answer the three new questions in the inspection review.  These questions emphasize the importance of daily image quality review, regular facility wide quality reviews, and the personnel responsibilities for image quality that are currently defined in the regulations. The FDA purports that the program does not have to be written and the inspector has ability to decide if the oral rendition of the requirements is adequate. This may or may not reach reality in the field inspection process. More information can be found at the FDA website, www.fda.ov/radiation-emittingproducts.

By Peggy Hoosier, MEd, RT(R)(M)