The 2018 ACR® Digital Mammography Quality Control Manual can help you implement a modern and streamlined quality control (QC) program for digital mammography practices and imaging equipment — including detailed responsibilities of the radiologist, technologist and medical physicist.
A Paradigm Shift for QC
In 2016, the U.S. Food and Drug Administration (FDA) approved the ACR alternative standard request to allow mammography facilities to use the ACR Digital Mammography Quality Control Manual and Digital Mammography QC Phantom in routine QC of digital equipment. In 2018, the FDA approved the Digital Breast Tomosynthesis (DBT) supplement, which has been integrated into the 2018 edition of the manual.
Approval of this alternative standard and DBT supplement enables mammography QC technologists and medical physicists to use the new manual in lieu of manufacturers’ quality control manuals.
The FDA specifies that the new manual may be used only for full-field digital mammography systems and systems with DBT (not for contrast enhancement systems). Effective Nov. 19, 2018, facilities can choose to use the new ACR Digital Mammography QC Manual for all applicable digital mammography units and discontinue using the manufacturer’s QC manual.
Because the new manual makes QC testing simpler and faster, many facilities are opting to purchase new phantoms and make the shift to the new quality control approach. Since new phantoms can be expensive, it makes sense to be well prepared for the transition.
Four Tips to Help You Get Ready
- Access the 2018 ACR Digital Mammography Quality Control Manual
The 2018 ACR Digital Mammography Quality Control Manual includes QC procedures that cover both 2D mammography and DBT, allowing a single, unified QC program for all facilities regardless of unit type or manufacturer. ACR members can download a free copy of the ACR Digital Mammography Quality Control Manual from the Medical Physics Resources page (login required). Nonmembers can purchase the manual . Accredited facilities received a complimentary download link when the manual was released; please contact DMQC@acr.org if you need assistance.
The new manual contains sections for the radiologist, radiologic technologist and medical physicist. The technologist and medical physicist sections contain detailed instructions and procedures for QC tests. This edition also has material relevant to DBT QC, including FDA-approved QC procedures.
Be sure each group within your team has time to familiarize themselves with the new manual and the changes required for accreditation — well in advance of the time you plan to deploy the new phantom and begin using it for QC and testing.
- Allow Plenty of Time to Train Physicists and Technologists
While the new manual makes QC faster and easier, there are significant differences between it and using manufacturers’ QC manuals. For that reason, it is imperative to ensure that your physicists and technologists have training on how to use the manual.
The ACR Subcommittee on Quality Assurance in Mammography developed a two-part series of webinars on how to use the 2018 ACR Digital Mammography Quality Control Manual with 2D and DBT for technologists and medical physicists. Visit the ACR Digital Mammography QC Manual Webinars section of the ACR Digital Mammography QC Manual Resources web page to view webinar recordings and slides.
- Develop a Transition Plan for QC Testing
Before your facility’s QC technologist can start using the new manual on a unit, the medical physicist must first conduct an annual survey of the digital mammography unit for 2D and DBT and display devices using the new manual and phantom.
It is important for the medical physicist to review the new QC testing techniques and procedures with the QC technologist prior to implementing routine QC. After this is done, the QC technologist can start performing routine QC using the manual.
- Use the New Manual and Phantom for ACR Accreditation
On Nov. 19, 2018, the ACR implemented the 2018 ACR Digital Mammography Quality Control Manual within the accreditation process. Facilities that choose to use the 2018 ACR Digital Mammography Quality Control Manual can submit phantom images obtained with the ACR Digital Mammography Phantom and QC results using the new manual for accreditation of 2D and DBT systems. It is not necessary to notify the ACR prior to switching to the new manual or submitting for accreditation.