Maybe last year you heard something from your MQSA inspector about EQUIP: Enhancing Quality Using the Inspection Program and quickly tuned out because he or she mentioned that while they were telling you about this requirement now, they would not be holding you to it until 2018. Well, here we are, 2018!!
And we at MPC want to know if you are EQUIPped and if you fully understand what this means to your mammography department. The MQSA regulations require 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)). Furthermore, 21 CFR 900.12(d)(1)(ii)(A)) requires a facility to follow the facility procedures for corrective action when the images they are asked to interpret are of poor quality and for the lead interpreting physician to ensure records concerning quality control are properly maintained and updated…..WOW that is a lot of regulatory speak! What DOES this all mean? Essentially these requirements have been “on the books” for a very long time, we just haven’t given them very much attention up until now because we had other things to worry about. In the past, the imaging chain was the weak link; either the processor or the limitations of the machine were impairing optimal image outcome. With the digital (and now 3D) world this is no longer the case. The weak link is either in the physician’s interpretation or the technologist’s ability to position properly and now the FDA is taking note. So we round back to the introductory statement of this blog, is your mammography department EQUIPped? Do you have the necessary policies in place to show you are meeting all of the requirements in 21 CFR 900.12? Do you have a solid QC program to ensure your physicians and technologists are doing everything possible to maintain the best mammography image quality possible for interpretation? If your answer is no, don’t fret, your friendly MPC mammography physicist is well equipped and can provide you with all of the necessary documentation to meet all of the requirements in EQUIP. You only need to reach out to your physicist to obtain this information, but don’t wait 2018 is already well under way!