In February 2016,
the FDA approved the ACR’s new Digital Mammography Quality Control (QC) Manual (see Figure 1) and Digital Mammography QC Phantom (see Figure 2) as an alternative standard for use in routine QC of digital mammography equipment.
This approval,
as an alternative standard,
allows mammography facilities,
including QC technologists and medical physicists,
to use the new ACR manual in lieu of manufacturers’ quality control manuals.
The FDA alternative standard specifies that the new manual may be used only for full-field digital mammography systems without advanced imaging capabilities (e.g.,
tomosynthesis and contrast enhancement).
This new manual has been designed to create a universal digital mammography QC program by providing uniform test procedures,
performance criteria,
and minimum test frequencies that can be used for all manufacturers and models.
(See Table 1.) Due to the unique manufacturer-specific design of certain equipment features,
a few tests and criteria in the manual refer to the instructions and performance levels established by the manufacturer.
For example,
the detector calibration test (if available) is software-dependent and thus unique to each manufacturer.
Deference to the manufacturer tests and criteria has been clearly indicated throughout the manual.
The manual consists of 3 sections: Radiologist’s Section,
Radiologic Technologist’s Section,
and Medical Physicist’s Section.
The latter two sections contain detailed instructions and procedures for quality control tests without being too rigid,
allowing for differences between digital manufacturers.
Action limits are given for each test.
The objective of this manual is to ensure high quality digital mammograms while keeping radiation doses low.
New to this release are tests,
and ways to run a QC program,
that have resulted from the evolution of modern digital mammography.
Today,
facilities have grown to include networks that have multiple digital manufacturers,
different monitor manufacturers,
different PACS systems,
and,
most significantly,
multiple locations.
Every QC test in the manual has been adapted for digital mammography.
Additionally,
a new phantom has been introduced that resembles the previous ACR accreditation mammography phantom but has changed in size to optimize for artifact evaluation while maintaining the ability to measure dose according to FDA requirements and similar test object scoring (see Figure 3).
The move from film display to softcopy display has presented a new challenge for quality control and documentation.
The concept of a quality control team with the radiologist included in a formal quality control review test is new to this manual.
The new manual was a collaborative effort among medical physicists,
radiologists,
mammography technologists and industry.
Written by the ACR’s Subcommittee on Mammography Quality Assurance (Eric Berns,
PhD [chair],
Jay Baker,
MD,
Lora Barke,
DO,
Lawrence Bassett,
MD,
R.
Edward Hendrick,
PhD,
Debra Monticciolo,
MD,
Doug Pfeiffer,
MS,
Margarita Zuley,
MD,
Christine Adent,
RT(R),
Shelli Dixon,
RT(R),
John Sandrick,
PhD [MITA],
Robert Uzenoff,
BS [MITA],
Moustaffa Zerhouni [MITA],
Priscilla Butler,
MS,
[ACR Staff],
Marion Boston,
RT(R) [ACR Staff Member] and Pamela Platt,
BSRT(R) [ACR Staff]),
the manual provides user-friendly instructions to perform and document QC across all manufacturers and types of digital mammography equipment.
The 2016 ACR Digital Mammography Quality Control Manual is now available in electronic format.
A link was sent to all mammography facilities accredited by the ACR to download the new manual at no charge.
Medical physicists associated with these facilities may also obtain the link from their facilities to download the new manual at no charge.
Individuals not associated with ACR-accredited facilities may purchase the manual from the ACR catalog at http://www.acr.org/Education/Education-Catalog.
To support the use of the new manual,
the ACR has developed the new ACR Digital Mammography QC Manual Resources webpage (see Figure 4).
Free webinars are provided to aid technologists and medical physicists in using the new QC manual and phantom and the ACR’s Digital Mammography Quality Control Manual Frequently Asked Questions are frequently updated.
In addition,
Excel QC forms are available for personalization and download.
The ACR’s Subcommittee on Mammography Quality Assurance will be adding an appendix with digital breast tomosynthesis QC tests in 2017.