Does your facility need help on applying for accreditation? In each issue of this newsletter, I'll present frequently asked questions (FAQs) of particular importance for medical physicists. You may also check out the ACR's accreditation web site portal for more FAQs, accreditation application information, and QC forms.
The following questions are for the new ACR Digital Mammography Quality Control Manual. Please feel free to contact us if you have questions about mammography accreditation.
Q. Will the ACR or FDA require that we follow the 2016 ACR Digital Mammography QC Manual to be ACR-accredited or MQSA-certified?
A. No. The FDA approved use of the 2016 ACR Digital Mammography QC through an alternative standard. This means that the 2016 manual may be use as an alternative to using your manufacturer's QC manual as currently required by the FDA regulations. Neither the FDA nor the ACR can require you to use the 2016 ACR Digital Mammography QC Manual under the current FDA regulations.
Q. If we choose to use the 2016 ACR Digital Mammography QC Manual, must we also perform the QC required by our equipment's manufacturer?
A. No. Because the FDA approved use of the 2016 ACR Digital Mammography QC through an alternative standard, if you choose to use the 2016 manual, you will no longer be required to perform any of the manufacturer's QC tests. Note that you must still perform any calibrations required by the manufacturer (e.g., Manufacturer Detector Calibration).
Q. Our facility would like to begin using the 2016 ACR Digital Mammography QC Manual and stop using our manufacturer's manual as soon as possible. Can we do so as soon as we receive our 2016 manual?
A. No, not yet. ACR publishes new QC procedures for its accreditation programs one year in advance of the time they go into effect. This provides time for facilities to become familiar with the new procedures (while using their existing procedures), time for the ACR to make software revisions to evaluate the new QC and phantom images and time for the FDA to integrate the new QC into their MQSA inspection procedures. The new manual should go into effect in July 2017. All accredited facilities will be directly notified once the new manual goes into effect and they may begin using it.
Q. After July 2017, may our facility begin using the 2016 ACR Digital Mammography QC Manual and stop using our manufacturer's manual?
A. Yes, but please note that before the facility QC technologist may start using the 2016 DMQC Manual on a unit, the medical physicist must first conduct an annual survey of the digital mammography unit and display devices using the 2016 manual and phantom. This is important to provide testing techniques and procedures for the QC technologist to use during routine QC. After this is done, the QC technologist may start performing routine QC using the 2016 manual.
Q. We really like some of the Management Forms in the Radiologic Technologist Section (e.g., ACR Technique and Procedure Summaries, Corrective Action Log, Facility Offsite Display Locations). May we use these forms even if we do not use the 2016 ACR Digital Mammography QC Manual and remain with our manufacturer's QC manual?
A. Yes. You may use the forms that do not involve testing even if you do not use the 2016 ACR Digital Mammography QC Manual.
Q. We really like some of new “tests” and forms that are in the Radiologic Technologist Section (e.g., Facility QC Review, System QC for Radiologist and Radiologist Image Quality Feedback). These tests are not currently part of our manufacturer's QC manual. May we use these tests and forms to complement our manufacturer's QC manual even if we do not use the 2016 ACR Digital Mammography QC Manual?
A. Yes. However, you may need to modify some of the forms to be applicable to your manufacturer's QC manual's tests.
Q. Will the ACR update the Digital Mammography QC Manual to include tests for tomosynthesis?
A. Yes. The ACR Subcommittee on Quality Assurance is currently working on an appendix for technologist and medical physicist tests of tomosynthesis features. Once completed, the appendix will be reviewed by tomosynthesis equipment manufacturers for applicability. The ACR draft must be reviewed and approved by the FDA before it becomes final. We hope the approved appendix will be available in 2017.
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