2018

Digital Mammography

QUALITY CONTROL MANUAL

Revised 2nd Edition — May 2020

Radiologist’s Section

Radiologic Technologist’s Section

Medical Physicist’s Section

 2018
Digital Mammography
QUALITY CONTROL MANUAL
2D and Digital Breast Tomosynthesis
Radiologist’s Section
Radiologic Technologist’s Section
Medical Physicist’s Section
American College of Radiology
Subcommittee on Quality Assurance in Mammography
of the
Committee on Mammography Accreditation

Eric A. Berns, PhD, FACR (chair)

Douglas E. Pfeiffer, MS, FACR Priscilla F. Butler, MS, FACR (ACR Staff Member)
Christine Adent, RT(R) Rhonda Baird, RT(R)
Jay A. Baker, MD, FACR Lora D. Barke, DO
Lawrence W. Bassett, MD, FACR Shelli Dixon, RT(R)
R. Edward Hendrick, PhD, FACR Debra L. Monticciolo, MD, FACR
Margarita L. Zuley, MD, FACR Lanna Zulkoski, RT(R)
John Sandrick, PhD (MITA, retired) Robert A. Uzenoff, BS (MITA)
Moustaffa Zerhouni (MITA) Marion Boston, RT(R) (ACR Staff Member)
Dustin A. Gress, MS (ACR Staff Member) Pamela L. Platt, BSRT(R) (ACR Staff Member)

Revised 2nd edition — May 2020

©Copyright 2018, American College of Radiology
 ACR 2018 Digital Mammography Quality Control Manual
User Terms and Conditions
ALL USERS
These terms and conditions shall apply to all users of the American College of Radiology’s 2018 Digital
Mammography QC Manual.

COPYRIGHT NOTICE/PERMISSION
Copyright© 2018 American College of Radiology. All rights reserved.

No part of this document may be reproduced or transmitted in any form or by any means, electronic or
mechanical, including photocopy, recording or any information storage or retrieval system, without the prior
written consent of the American College of Radiology.

The is a registered trademark and service mark of the American College of Radiology.

DISCLAIMER OF WARRANTIES AND LIMITATION OF LIABILITY

To the full extent permissible by applicable law, ACR disclaims all warranties, express or implied, including,
but not limited to, implied warranties of merchantability and fitness for a particular purpose. ACR does not
warrant that the ACR products, information, content, materials, products (including downloadable files) or
other products included on or otherwise made available to you through ACR, ACR’s servers or electronic
communications sent for ACR are free of viruses or other harmful components. ACR will not be liable for any
damages of any kind arising from the use of any ACR product, or from any information, content, materials,
products (including downloadable files) or other products included on or otherwise made available to you
through any ACR service, including, but not limited to direct, indirect, incidental, punitive, and consequential
damages, unless otherwise specified in writing.

Certain state laws do not allow limitations on implied warranties or the exclusion or limitation of certain
damages. If these laws apply to you, some or all of the above disclaimers, exclusions, or limitations may not apply
to you, and you might have additional rights.

DISCLAIMER ON FIGURES
The inclusion of photographs, illustrations or images of any manufacturer’s mammography or test equipment
(including mammography phantoms) in this manual does not imply endorsement of such mammography or
test equipment by the American College of Radiology. ACR includes these photographs, illustrations and images
only as educational aids to more clearly explain the steps that are needed to perform and evaluate the tests
outlined in the manual.

APPLICABLE LAW
By using any ACR product, you agree that the applicable federal law and the laws of the Commonwealth of
Virginia, without regard to principles of conflict of laws, will govern these Conditions of Use and any dispute of
any sort that might arise between you and ACR.
DISTRIBUTION
The Digital Mammography Quality Control Manual is provided free to all facilities accredited in the ACR
Mammography Accreditation Program and those applying for accreditation.

All others may purchase the manual from the ACR Education Catalog.

CITATION
Berns EA, Pfeiffer DE, Butler PF, et al. Digital Mammography Quality Control Manual. Reston, Va: American
College of Radiology; 2018.
 Contents

PREFACE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

RADIOLOGIST’S SECTION
I. Revisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
II. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
III. Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
IV. Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
V. QC Tests, Frequencies, and Timeframes for
Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
VI. Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
RADIOLOGIC TECHNOLOGIST’S SECTION
I. Revisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
II. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
III. Technologist Quality Control. . . . . . . . . . . . . . . . . . . . . . . . 39
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114
MEDICAL PHYSICIST’S SECTION
I. Revisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
II. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
III. Mammography Equipment Evaluation and
Annual Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .250
APPENDICES
I. Revisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255
II. CAR Digital Mammography Phantom
Scoring Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .256
III. Artifact Evaluation Guide . . . . . . . . . . . . . . . . . . . . . . . . . . 259

Digital Mammography Quality Control Manual v

 Preface

PREFACE, In February 2016, the FDA approved the ACR’s new Digital
Mammography Quality Control (QC) Manual and Digital
2 EDITION
ND
Mammography QC Phantom as an alternative standard for use in
routine QC of digital mammography equipment. This approval, as
an alternative standard, allowed mammography facilities, including
QC technologists and medical physicists, to use the new ACR
manual in lieu of manufacturers’ quality control manuals. However,
the approval specified that the new manual could not be used on
full-field digital mammography systems with advanced imaging
capabilities (e.g., tomosynthesis and contrast enhancement). In July
2018, the FDA approved the ACR’s QC procedures for digital breast
tomosynthesis (DBT) through an amendment to the 2016 alternative
standard. This updated 2018 Digital Mammography Quality Control
Manual integrates the new DBT QC procedures so that the entire
manual may be used for both full-field digital mammography and
DBT systems. [Author’s Note: Regarding digital mammography units
with contrast enhancement capability, the FDA has determined that
facilities may use this manual for QC of the 2D and DBT applications
of these units, and recommends that facilities follow manufacturer QC
procedures for contrast enhancement applications.]

I would again like to extend a sincere thank you to all who collaborated
on this 2nd Edition including the entire committee and ACR Staff. In
particular Doug Pfeiffer and Penny Butler dedicated countless hours to
bring this manual to fruition. Their efforts were invaluable.

Eric A. Berns, PhD, FACR

Chair, Subcommittee on Quality Assurance in Mammography of the

Committee on Mammography Accreditation

September 2018

vi Digital Mammography Quality Control Manual

 Preface

PREFACE, The American College of Radiology’s original ACR Committee on

Mammography Quality Assurance, chaired by Gerald Dodd, MD, first
1 EDITION
ST
published its Mammography Quality Control Manual in 1990 to provide
quality control procedures for screen-film mammography. Three more
versions were published, the latest in 1999 under the chairmanship of
R. Edward Hendrick, PhD. In 2000 the first full-field digital mammography
unit was approved by the US Food and Drug Administration (FDA) for
clinical use. Since then, the FDA has required that facilities perform quality
control for approved digital mammography systems according to their
respective manufacturer’s quality control manual.

In February 2016, the FDA approved the ACR’s new Digital Mammography
Quality Control (QC) Manual and Digital Mammography QC Phantom
as an alternative standard for use in routine QC of digital mammography
equipment. Currently, the FDA requires digital mammography facilities to
perform QC for approved imaging systems, according to their respective
manufacturers’ quality control manuals. 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).

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,
we have introduced a new phantom 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. 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 members of the ACR Subcommittee on Quality Assurance in

Mammography who participated in the publication of this manual
deserve our heartfelt thanks. This was truly a team effort. Our
radiologists consisting of Drs. Jay Baker, Lora Barke, Lawrence Bassett,

Digital Mammography Quality Control Manual vii

 Preface

Debra Monticciolo and Margarita Zuley provided physician guidance

that kept the manual grounded and relevant. Our technologist team
of Ms. Christine Adent and Ms. Shelly Dixon were voices of reason.
The ACR staff including Ms. Pamela Wilcox, Ms. Marion Boston and
Ms. Pamela Platt kept this project on track. A special thanks goes
to Doug Pfeiffer who spent countless hours contributing technical
expertise. Many thanks also go to our MITA committee members that
include John Sandrik, Robert Uzenoff, and in particular, Moustaffa
Zerhouni who was instrumental in the manufacture of the ACR
DM Phantom prototypes. We would also like to thank the following
outside reviewers who provided excellent, practical comments and
recommendations from the perspective of mammography technologists,
medical physicists and manufacturers: Rhonda Baird, Ken Coleman,
Merryl Fulmer, Joyce Goldsboro, Steve Jones, Anne Richards,
Albert Xthona, Brian Cote, Patrick Ploc and the members of the Medical
Imaging and Technology Alliance (MITA) Mammography Committee.
A very special thank you goes to Dr. R. Edward Hendrick who ultimately
provided the wisdom to navigate the project from beginning to end.

I would like to extend a personal thank you to Ms. Priscilla Butler who
kept the manual on track and did much of the work to bring this to fruition.
Her tireless work and perseverance are very much appreciated by me and
the entire committee. We could not have done this without her.

Eric A. Berns, PhD

Chair, Subcommittee on Quality Assurance in Mammography of the

Committee on Mammography Accreditation

July 2016

viii Digital Mammography Quality Control Manual

 2018
Digital Mammography

QUALITY CONTROL MANUAL

Radiologist’s Section
 Contents

I. REVISIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
II. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
III. DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
A. Quality Assurance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
B. Quality Assurance Committee. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
C. Quality Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
D. QA/QC Procedures Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
IV. RESPONSIBILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
A. Radiologist’s Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1. Lead Interpreting Physician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2. Interpreting Physician. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

B. Medical Physicist’s Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . 13

C. Radiologic Technologist’s Responsibilities. . . . . . . . . . . . . . . . . 14
V. QC TESTS, FREQUENCIES, AND TIMEFRAMES FOR
CORRECTIVE ACTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
VI. CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
REFERENCES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
A. Downloadable from the ACR Website
(www.acr.org). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
B. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

2 Digital Mammography Quality Control Manual

 I. Revisions

Revisions
Date Page(s) Section Description of Revisions

RADIOLOGIST’S SECTION
November 2nd edition with digital breast
2018 tomosynthesis QC

Digital Mammography Quality Control Manual Return to Table of Contents – 3

 II. Introduction

Introduction Regular mammographic screening significantly reduces mortality

from breast cancer. The effectiveness and success of screening and
diagnostic mammography, however, depends on consistent production
of high-quality mammographic images. It is widely known that
improving image quality in mammography can improve breast cancer
detection [1]. Achieving high image quality requires vigilant attention
to every step of quality control (QC). High standards must be maintained.

The American College of Radiology (ACR) established a voluntary

mammography accreditation program in 1987 to direct attention to the
need for reproducibly high-quality mammography [2, 3]. Calls for quality
assurance in mammography had come from breast imaging radiologists,
medical physicists, and other professional organizations and regulatory
groups. The ACR Subcommittee on Quality Assurance in Mammography,
under the Committee on Mammography Accreditation, establishes
practices and standards for QC in mammography. Since the original
publication of the screen-film manual in 1990, it has been updated
and revised several times to reflect improvements in mammographic
technology, improved QC procedures, and requirements of the Food and
Drug Administration’s (FDA) Final Rule for the Mammography Quality
Standards Act (MQSA) [4]. Pertinent FDA regulations are provided in
the boxes below. This version of the ACR Mammography QC Manual
provides guidance for image quality and QC of 2D and digital breast
tomosynthesis (DBT) full-field digital mammography (DM) systems
across all manufacturers.

Important: Although the FDA uses the term “interpreting physician”

throughout their regulations and guidance, since the overwhelming
majority of interpreting physicians are radiologists, the ACR Digital
Mammography Quality Control Manual uses the term “radiologists” to refer
to “interpreting physicians.”

The “Radiologist’s Section” details the mammography staff ’s

responsibilities in an ongoing mammography QC program.

• The lead mammography radiologist (lead interpreting physician)

has the responsibility for ensuring that all quality assurance
requirements are met. This is good practice and is mandated by
MQSA.
• Mammography radiologists (interpreting physicians) must
follow the facility procedures for corrective action when the
images they are asked to interpret are of poor quality.
• The medical physicist is responsible for overseeing all equipment-
related quality assurance practices.
• A primary quality control technologist must be identified by the
mammography facility to conduct all quality assurance activities
not assigned to the lead mammography radiologist or the medical
physicist.

4 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

The section on “Clinical Image Quality Evaluation” that was present

in the 1999 version of the screen-film quality control manual has been

RADIOLOGIST’S SECTION
removed from this manual. The ACR Mammography Quality Control
Manual for screen-film was the only ACR quality control manual
with a clinical image quality section; this change in the ACR Digital
Mammography Quality Control Manual makes it more consistent with
other ACR manuals and accreditation programs. The “Clinical Image
Quality Evaluation” section will be updated and made available on
the ACR website. Until a new document is provided, technologists and
radiologists can refer to the 1999 ACR Mammography Quality Control
Manual as well as training resources provided by the American Society
of Radiologic Technologists [5] for guidance on positioning and clinical
image quality.

Details of the mammography technologist’s and medical physicist’s

tests are given in the Radiologic Technologist’s Section and the Medical
Physicist’s Section, respectively.

The radiologist and mammography technologist must look at every

image with QC in mind. Deviations from high-quality performance
may occur quickly or gradually. Abrupt changes in quality may be
detected during routine clinical work. More gradual or subtle changes
require regular quality assurance testing for detection. The QC program
provides a framework within which even gradual or subtle problems can
be identified, isolated, and resolved before they significantly impact the
quality of patient images.

Digital Mammography Quality Control Manual Return to Table of Contents – 5

 III. Definitions

Definitions A. Quality Assurance

Quality assurance (QA) is a comprehensive concept that comprises all
management practices instituted by the lead mammography radiologist
to ensure that

• E
 very imaging procedure is necessary and appropriate to the clinical
problem at hand

• Th
 e images generated contain information critical to the solution of
that problem

• Th
 e recorded information is correctly interpreted and results made
available in a timely fashion to the patient and her physician

• Th
 e examination results in the lowest possible radiation exposure, cost,
and inconvenience to the patient consistent with imaging objectives

The QA program comprises many facets, including efficacy studies,

continuing education, QC, and preventive maintenance and calibration
of equipment.

A critical aspect of the QA program is the FDA-required ongoing

assessment of mammography interpretation quality through an annual
mammography medical outcomes audit [4]. All interpreting physicians
must participate in this process. Detailed guidance for conducting a
medical outcomes audit program is not addressed in this manual but can
be found in the Follow-up and Outcomes Monitoring Section [6] of the
2013 Breast Imaging Reporting and Data System Atlas [7].

900.12(f) Quality assurance—mammography medical outcomes audit. Each

facility shall establish and maintain a mammography medical outcomes audit
program to followup positive mammographic assessments and to correlate
pathology results with the interpreting physician’s findings. This program shall
be designed to ensure the reliability, clarity, and accuracy of the interpretation
of mammograms.
(1) General requirements. Each facility shall establish a system to collect and
review outcome data for all mammograms performed, including followup
on the disposition of all positive mammograms and correlation of pathology
results with the interpreting physician’s mammography report. Analysis of these
outcome data shall be made individually and collectively for all interpreting
physicians at the facility. In addition, any cases of breast cancer among women
imaged at the facility that subsequently become known to the facility shall
prompt the facility to initiate followup on surgical and/or pathology results
and review of the mammograms taken prior to the diagnosis of a malignancy.
(2) Frequency of audit analysis. The facility’s first audit analysis shall be initiated
no later than 12 months after the date the facility becomes certified, or 12
months after April 28, 1999, whichever date is the latest. This audit analysis
shall be completed within an additional 12 months to permit completion of
diagnostic procedures and data collection. Subsequent audit analyses will be
conducted at least once every 12 months.

6 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Definitions

(3) Audit interpreting physician. Each facility shall designate at least one

RADIOLOGIST’S SECTION
interpreting physician to review the medical outcomes audit data at least once
every 12 months. This individual shall record the dates of the audit period(s) and
shall be responsible for analyzing results based on this audit. This individual
shall also be responsible for documenting the results and for notifying other
interpreting physicians of their results and the facility aggregate results. If
followup actions are taken, the audit interpreting physician shall also be
responsible for documenting the nature of the followup.

B. Quality Assurance Committee

A Quality Assurance Committee (QAC) can be useful to provide oversight
of the QA program, setting the goals and direction, determining policies,
and assessing the effectiveness of QA activities.

A QAC should consist of the following:

• O
 ne or more radiologists, including the lead mammography
radiologist

• A medical physicist

• A facility manager

• A supervisory mammography technologist

• The quality control technologist

• O
 ther radiology department personnel involved in caring for
mammography patients (this may include a nurse, desk attendant,
medical secretary, or others)

The QAC also may include medical and paramedical staff from outside
the radiology department, such as a surgeon, referring physician, nurse
educator, nurse from a comprehensive breast clinic, etc. Anyone who
helps provide care to the patient seeking breast cancer screening or
diagnosis should be considered as a member of the QAC since his or her
efforts affect the quality of care and the satisfaction of the patient.

Routine evaluation and communication via the QAC are particularly

effective in larger mammography facilities. Some mammography facilities
may not need a formal QAC as long as communication among the staff is
routine and effective.

One of the major changes to the ACR Digital Mammography Quality

Control Manual is the addition of the Facility QC Review. The lead
mammography radiologist, along with the facility manager, must review

Digital Mammography Quality Control Manual Return to Table of Contents – 7

 III. Definitions

the QC test results at least quarterly, or more frequently if problems are

noted. (See Facility QC Review in the Radiologic Technologist’s Section
for more information.) This may become a responsibility of the QAC.

C. Quality Control
QC is an integral part of QA and consists of a series of distinct technical
procedures that ensure the production of a satisfactory product, i.e., high-
quality screening or diagnostic images. Four steps are involved:

• A
 cceptance testing to detect defects in equipment that is newly
installed or has undergone major repair

• Establishment of baseline performance of the equipment

• D
 etection and diagnosis of changes in equipment performance before
they become radiologically apparent

• V
 erification of equipment performance after service has been
performed

Specifics of the QC program for full-field digital mammography are

provided by the American College of Radiology in this manual.

Important: The QC program provides a frame of reference within which

even gradual or subtle problems can be identified, isolated, and resolved
before they significantly impact the quality of patient images.

D. QA/QC Procedures Manual

Working as a team, the mammography radiologist, QC technologist, and
medical physicist should develop and follow a mammography QA/QC
program that is available to all members of the staff. Proper documentation
of procedures and test results is an essential part of maintaining quality and
meeting FDA MQSA regulations. This information may be maintained as
hardcopy or electronically and must be available at the mammography
facility for review by the MQSA inspector and accreditation body.

The QC testing described in this ACR Quality Control Manual should be

a central part of the site’s QA/QC documentation. The facility’s QA/QC
program should contain

• Clearly assigned responsibilities for QA/QC testing

• Clearly developed procedures for QA/QC testing

8 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Definitions

• R
 ecords of the QC tests performed by the QC technologist and
medical physicist

RADIOLOGIST’S SECTION
• Records of any corrective action as a result of the QA/QC testing

• R
 ecords of routine and non-routine equipment service and
maintenance

• Records of QAC meetings

• A
 description of the orientation program for operators of
mammography equipment, including its duration and content

• Procedures for proper use and maintenance of equipment

• M
 ammographic techniques to be used, including pertinent
information on positioning, compression, appropriate image receptors,
imaging modes, and kVp-target-filter combinations if applicable

• P
 recautions to protect the operator of the equipment, the patient,
and individuals in surrounding areas from unnecessary radiation
exposure

• P
 olicies and employee responsibilities concerning personnel radiation
monitoring

• Procedures for cleaning and disinfection of mammography equipment

900.12(e) Quality assurance—equipment. (13) Infection control. Facilities shall

establish and comply with a system specifying procedures to be followed by the
facility for cleaning and disinfecting mammography equipment after contact
with blood or other potentially infectious materials. This system shall specify
the methods for documenting facility compliance with the infection control
procedures established and shall (i) comply with all applicable Federal, State,
and local regulations pertaining to infection control; and (ii) comply with the
manufacturer’s recommended procedures for the cleaning and disinfection
of the mammography equipment used in the facility; or (iii) if adequate
manufacturer’s recommendations are not available, comply with generally
accepted guidance on infection control, until such recommendations become
available.

Digital Mammography Quality Control Manual Return to Table of Contents – 9

 IV. Responsibilities

Responsibilities The radiologist, medical physicist, and QC technologist, working together

as a team, are the keys to providing optimum quality mammography
images, which will ultimately provide the best medical care possible to
the patient. Mammography team members are strongly encouraged to
review other sections of the ACR Digital Mammography QC Manual
that are not directed towards them. For example, the radiologist
should be familiar with Technologist’s Test Facility QC Review and the
Technologist’s Optional Tests System QC for Radiologist and Radiologist
Image Quality Feedback. The radiologic technologist should review the
Medical Physicist’s Test Evaluation of Site’s Technologist QC Program
and Evaluation of Display Device Technologist QC Program. The medical
physicist should be familiar with all of the radiologic technologist’s tests.

A. Radiologist’s Responsibilities
1. Lead Interpreting Physician

The FDA’s MQSA regulations [4] specify that a lead interpreting

physician (typically a radiologist) must be identified by the
mammography facility to have the general responsibilities of
ensuring that all MQSA-required activities are met. This individual
will most likely be the lead mammography radiologist. Radiologists
interpreting mammography must assume the primary responsibility
for the quality of mammography and for the implementation of an
effective QA program at their site. The staff ’s commitment to high
quality will often mirror that of the lead mammography radiologist.
The individuals performing QC tests need to know that the lead
radiologist understands the program and is interested in the results.
The radiologist needs to review the test results and trends periodically
and provide direction when problems are detected.

900.12(d) Quality assurance—general. (1) Responsible individuals. (i)

Lead interpreting physician. The facility shall identify a lead interpreting
physician who shall have the general responsibility of ensuring that the
quality assurance program meets all MQSA QA requirements. No other
individual shall be assigned or shall retain responsibility for quality
assurance tasks unless the lead interpreting physician has determined that
the individual’s qualifications for, and performance of, the assignment are
adequate.

The lead mammography radiologist’s (lead interpreting physician’s)

specific responsibilities in mammography QC are to

1. Ensure that technologists have adequate training and continuing

education in mammography.

2. Provide an orientation program for technologists based on a

carefully established procedures manual.

10 – Return to Table of Contents Digital Mammography Quality Control Manual

 IV. Responsibilities

3. Ensure that an effective QC program exists for all mammography

performed at the site. (The radiologist should provide motivation,

RADIOLOGIST’S SECTION
oversight, and direction to all aspects of the QC program. One
mechanism the radiologist can use to demonstrate commitment to
QC is routine use of the new Optional System QC for Radiologist
procedure and form in the Radiologic Technologist’s Section to
quickly evaluate the entire mammographic imaging chain from
the radiologist workstation.)

4. Select a single technologist to be the primary QC technologist to

perform the prescribed QC tests (in order to ensure consistency
in QC test performance) and to oversee tests that have been
delegated to other individuals. (It is not desirable, for example,
to rotate this assignment among a group of technologists.
Such a practice would introduce into the test results variability
extraneous to the items being tested. However, properly trained
backup QC technologists are essential to provide continuity when
the primary QC technologist is unavailable.)

900.12(d) Quality assurance—general. (1) Responsible individuals. (iv)

Quality control technologist. Responsibility for all individual tasks within
the quality assurance program not assigned to the lead interpreting
physician or the medical physicist shall be assigned to a quality control
technologist(s). The tasks are to be performed by the quality control
technologist or by other personnel qualified to perform the tasks. When
other personnel are utilized for these tasks, the quality control technologist
shall ensure that the tasks are completed in such a way as to meet the
requirements of paragraph (e) of this section.

5. Ensure that appropriate test equipment and materials are available

to perform the technologist’s QC tests.

6. Arrange staffing and scheduling so that adequate time is available

to carry out the QC tests and to record and interpret the results.
(Most tests take little time; however, the necessary time must be
incorporated into the daily schedule.)

7. Provide frequent and consistent positive and negative feedback to

technologists about clinical image quality and QC procedures.
(The new Optional Radiologist Image Quality Feedback
procedure and form in the Radiologic Technologist’s Section
was designed to assist radiologists with this responsibility.)

8. Select a medical physicist who will oversee the equipment-related

QC program and perform the medical physicist’s tests.

Digital Mammography Quality Control Manual Return to Table of Contents – 11

 IV. Responsibilities

9. Review the technologist’s test results at least quarterly or more

frequently if consistency has not yet been achieved. (See Facility
QC Review in the Radiologic Technologist’s Section.)

10. Review the medical physicist’s test results annually, or more

frequently when needed.

11. 
Oversee or designate a qualified individual to oversee the
radiation protection program for employees, patients, and other
individuals in the surrounding area.

12. 
Ensure that records concerning employee qualifications,
mammography technique and procedures, infection control
procedures, QC, safety, and protection are properly maintained
and updated in the mammography QA/QC procedures manual.

Important: The lead interpreting physician must review the

mammography facility’s QC at least quarterly.

The lead interpreting physician is ultimately responsible for image

quality produced under his or her direction and bears ultimate
responsibility for both proper QC testing and QA procedures in
mammography.

2. Interpreting Physician

Responsibilities of all mammography radiologists (interpreting

physicians) in mammography QC are to

1. Follow the facility procedures for corrective action when asked

to interpret images of poor quality. Radiologists should notice
and call the radiologic technologist’s attention to image quality
problems, including artifacts, whenever they occur.

2. Participate in the facility’s medical outcomes audit program.

3. Provide documentation of his or her current qualifications to

each mammography facility where they practice, according to
MQSA and local rules.

900.12(d) Quality assurance—general. (1) Responsible individuals.

(i) Interpreting physicians. All interpreting physicians interpreting
mammograms for the facility shall (A) follow the facility procedures
for corrective action when the images they are asked to interpret are of
poor quality, and (B) participate in the facility’s medical outcomes audit
program.

12 – Return to Table of Contents Digital Mammography Quality Control Manual

 IV. Responsibilities

B. Medical Physicist’s Responsibilities

RADIOLOGIST’S SECTION
The medical physicist’s responsibilities relate to equipment performance
and include

1. Image quality assessment

2. Patient dose evaluation

3. Operator safety concerns

Specific tests are listed in Table 1.

900.12(e) Quality assurance—equipment. (9) Surveys.

(iii) The medical physicist shall prepare a survey report that includes a summary
of this review and recommendations for necessary improvements.
(iv) The survey report shall be sent to the facility within 30 days of the date of
the survey.

The medical physicist must conduct appropriate tests after installation

of new equipment, reassembling existing equipment, replacement of
the x-ray tube, or other major service to the mammography unit. (See
Table 1.)

900.12(e) Quality assurance—equipment. (10) Mammography equipment

evaluations. Additional evaluations of mammography units or image
processors shall be conducted whenever a new unit or processor is installed,
a unit or processor is disassembled and reassembled at the same or a new
location, or major components of a mammography unit or processor
equipment are changed or repaired. All problems shall be corrected before
the new or changed equipment is put into service for examinations or film
processing. The mammography equipment evaluation shall be performed by a
medical physicist or by an individual under the direct supervision of a medical
physicist.

Facilities should purchase mammography units with features and

accessories appropriate to their practice and workflow needs.
Assuring the suitability of new equipment to a particular practice’s
needs can be facilitated by the thoughtful development and use of
purchase specifications. Purchase specifications describe to vendors
the type of equipment that is desired by the purchaser. The help of the
facility’s medical physicist is essential in developing effective purchase
specifications. The use of detailed purchase specifications with vendors
usually results in the vendors responding with detailed technical and
performance specifications for the purchaser’s use in the final selection
of equipment and as a basis for quantitative performance specifications
to be compared with measurements on the mammography equipment

Digital Mammography Quality Control Manual Return to Table of Contents – 13

 IV. Responsibilities

during acceptance testing. The purchase should be made contingent on

satisfactory performance during acceptance testing.

Acceptance testing is typically more rigorous than the QC program

detailed here and must be conducted by a qualified medical physicist.
This QC program is intended to document consistency of performance
after the unit has been accepted and put into service.

C. Radiologic Technologist’s Responsibilities

The radiologic technologist’s general responsibilities center on patient
care and image quality. More specifically, these include

1. Patient positioning

2. Compression

3. Image production

4. Image processing

5. Infection control

The specific QC procedures to be conducted by the QC technologist

are listed in Table 1. Radiologists should notice and call the radiologic
technologist’s attention to image quality problems, including artifacts,
whenever they occur.

900.12(d) Quality assurance—general. (1) Responsible individuals. (iv)

Quality control technologist. Responsibility for all individual tasks within the
quality assurance program not assigned to the lead interpreting physician or
the medical physicist shall be assigned to a quality control technologist(s).
The tasks are to be performed by the quality control technologist or by other
personnel qualified to perform the tasks. When other personnel are utilized
for these tasks, the quality control technologist shall ensure that the tasks are
completed in such a way as to meet the MQSA QA requirements.

14 – Return to Table of Contents Digital Mammography Quality Control Manual

 V. QC Tests, Frequencies, and Timeframes for Corrective Action

QC Tests, Frequencies, Before a facility QC technologist may start using the procedures in
the ACR Digital Mammography QC Manual for the first time on a
and Timeframes for

RADIOLOGIST’S SECTION
unit, the medical physicist must first conduct an annual survey of the
Corrective Action digital mammography unit and display devices using the manual and
the ACR Digital Mammography 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 ACR Digital Mammography QC Manual. For
current information and more details on transitioning to the ACR
Digital Mammography QC Manual, visit the Digital Mammography QC
Manual: Frequently Asked Questions on the ACR Digital Mammography
QC Manual Resources website.

Important: Before a facility may start using the procedures in the ACR
Digital Mammography QC Manual for the first time on a unit, the medical
physicist must first conduct an annual survey of the digital mammography
unit and display devices using the manual and the ACR Digital
Mammography Phantom.

The minimum frequencies for both the technologist and medical

physicist tests are listed in Table 1. The tests designated for DBT must
be conducted in addition to the applicable tests for the 2D full-field
digital mammography system. Applicable 2D tests must be performed
whether or not the system is used for 2D imaging since they test system
components which may impact DBT performance.

Important: All applicable 2D tests must be performed in additional to the

DBT tests for each system.

If the DBT system employs an “add-on” device, applicable 2D tests must

be repeated with the “add-on” device in place.

The technologist and medical physicist will use the same forms they use
for most of the digital mammography tests to record the data and results
of the DBT tests. The previous digital mammography forms have been
revised to allow for this. New forms have been added for DBT-unique
tests (e.g., DBT Volume Coverage).

If problems are occurring or if equipment is unstable, it may be necessary

to carry out some or all tests more frequently to identify problems before
they affect clinical image quality or patient safety. If the QC program
is just being initiated, it may be valuable to carry out QC tests more
frequently for the first few months. This will provide the QC technologist
with more experience in a shorter period of time and also will provide
better baseline data regarding the reliability of imaging equipment. The
necessity of performing tests designated as “Optional” or “If applicable” is
left to discretion of the QAC, especially the lead interpreting radiologist,

Digital Mammography Quality Control Manual Return to Table of Contents – 15

 V. QC Tests, Frequencies, and Timeframes for Corrective Action

QC technologist, and medical physicist team, who are most familiar

with the facility’s equipment and the quality needs of the mammography
practice.

In addition to performing the mammography QC tests at the minimum

frequencies indicated, tests also should be carried out for new equipment,
both when problems are suspected and after any service or preventive
maintenance. For example, the compression test should be carried out
both when a new x-ray system is installed and after any service adjustment
of compression force.

If any test fails, it is critical that the set up and techniques employed in the
test be checked and the test repeated to verify performance before initiating
corrective action. Upon confirmation of test failure, the MQSA Final Rule
requires that the source of the problem be identified and corrective action
be taken. In some cases, if test results fall outside of action limits, MQSA
requires that the source of the problem be identified and corrective action
taken before any further examinations are performed or any films are
processed using the component of the mammography system that failed
the test. Other test failures must be corrected within 30 days of the test
date (Table 1).

16 – Return to Table of Contents Digital Mammography Quality Control Manual

 V. QC Tests, Frequencies, and Timeframes for Corrective Action

Table 1. Digital Mammography (2D and DBT) Quality Control Tests

RADIOLOGIST’S SECTION
Test Minimum Frequency Corrective Action Timeframe
Technologist Tests
1. ACR DM Phantom Image Quality Weekly Before clinical use
2. C
 omputed Radiography Cassette Weekly Before clinical use
Erasure (if applicable)
3. Compression Thickness Indicator Monthly Within 30 days
4. Visual Checklist Monthly Critical items: before clinical use; less
critical items: within 30 days
5. Acquisition Workstation Monitor QC Monthly Within 30 days; before clinical use for
severe defects
6. Radiologist Workstation Monitor QC Monthly Within 30 days; before clinical use for
severe defects
7. Film Printer QC (if applicable) Monthly Before clinical use
8. Viewbox Cleanliness (if applicable) Monthly Before clinical use
9. Facility QC Review Quarterly Not applicable
10. Compression Force Semiannual Before clinical use
11. Manufacturer Calibrations (if applicable) Mfr. Recommendation Before clinical use
Optional - Repeat Analysis As Needed Within 30 days after analysis
Optional - System QC for Radiologist As Needed Within 30 days; before clinical use for
severe artifacts
Optional - Radiologist Image Quality Feedback As Needed Not applicable
Medical Physicist Tests
1. M
 ammography Equipment Evaluation (MEE) - MEE Before clinical use
MQSA Requirements
2. ACR DM Phantom Image Quality MEE and Annual Before clinical use
3. DBT Z Resolution MEE and Annual Within 30 days
4. Spatial Resolution MEE and Annual Within 30 days
5. DBT Volume Coverage MEE and Annual Before clinical use
6. Automatic Exposure Control System Performance MEE and Annual Within 30 days
7. Average Glandular Dose MEE and Annual Before clinical use
8. Unit Checklist MEE and Annual Critical items: before clinical use;
less critical items: within 30 days
9. Computed Radiography (if applicable) MEE and Annual Before clinical use
10. Acquisition Workstation Monitor QC MEE and Annual Within 30 days; before clinical
use for severe defects
11. Radiologist Workstation Monitor QC MEE and Annual Within 30 days; before clinical
use for severe defects
12. Film Printer QC (if applicable) MEE and Annual Before clinical use
13. Evaluation of Site’s Technologist QC Program Annual Within 30 days
14. E valuation of Display Device Technologist Annual Within 30 days
QC Program
15. Manufacturer Calibrations (if applicable) Mfr. Recommendation Before clinical use
16. Collimation Assessment MEE or Troubleshooting Within 30 days
Annual (DBT only)
MEE or Troubleshooting - Beam Quality MEE or Troubleshooting Before clinical use
(Half-Value Layer) Assessment
MEE or Troubleshooting - kVp Accuracy and MEE or Troubleshooting MEE: before clinical use;
Reproducibility troubleshooting: within 30 days
Troubleshooting - Ghost Image Evaluation Troubleshooting Before clinical use
Troubleshooting - Viewbox Luminance Troubleshooting Not applicable

Digital Mammography Quality Control Manual Return to Table of Contents – 17

 V. QC Tests, Frequencies, and Timeframes for Corrective Action

Important: Corrective action for any test performed for MEEs must be
made before clinical use.

Documentation of QC and corrective action is essential. Data forms are

provided in this manual and may be copied or downloaded from the
ACR Digital Mammography QC Manual Resources website for use in
performing and documenting the digital mammography QC program.
QC data forms may be stored as either hardcopy (for example, in a
notebook) or as a file on the computer. For some tests, it may be preferable
to use software provided by equipment manufacturers or third-party
vendors that can accumulate, trend, and print out QC data. However,
the QC technologist and medical physicist must verify that all required
information is available from such software before use. If QC records
are stored electronically, all records should be periodically backed up to
prevent loss.

Note: If QC records are stored electronically, all records should be

periodically backed up to prevent loss.

For detailed guidance on the FDA’s requirements for record retention, see
Quality Assurance Records and Retention of Personnel Records in the
FDA Policy Guidance Help System. All documentation must be made
available to MQSA inspectors during the annual inspection and the
facility’s accreditation body upon application and request.

900.12(d) Quality assurance—general. (2) Quality assurance records. The

lead interpreting physician, quality control technologist, and medical
physicist shall ensure that records concerning mammography technique and
procedures, quality control (including monitoring data, problems detected by
analysis of that data, corrective actions, and the effectiveness of the corrective
actions), safety, protection and employee qualifications to meet assigned
quality assurance tasks are properly maintained and updated. These quality
control records shall be kept for each test specified in paragraphs (e) and (f)
of this section until the next annual inspection has been completed and FDA
has determined that the facility is in compliance with the quality assurance
requirements or until the test has been performed two additional times at the
required frequency, whichever is longer.

Table 2 provides a complete list of all the digital mammography tests and
summarizes those tests that must be performed (as applicable) for the
modes that the facility uses clinically on its 2D and DBT systems.

18 – Return to Table of Contents Digital Mammography Quality Control Manual

 V. QC Tests, Frequencies, and Timeframes for Corrective Action

Table 2. Required Tests for Imaging Modes Used on 2D and DBT Systems

RADIOLOGIST’S SECTION
Imaging Modes to Test
System Used for Both 2D and System Used for DBT
DBT Acquisition Acquisition Only
2D w/Add-on
Test 2D DBT Device DBT DBT
Technologist Tests
1. ACR DM Phantom Image Quality *    & 2D*
2. C
 omputed Radiography Cassette Erasure *
(if applicable)
3. Compression Thickness Indicator * * *
4. Visual Checklist *   
5. Acquisition Workstation Monitor QC * *
6. Radiologist Workstation Monitor QC * *
7. Film Printer QC (if applicable) * *
8. Viewbox Cleanliness (if applicable) * *
9. Facility QC Review *   
10. Compression Force * * *
11. Manufacturer Calibrations (if applicable) *   
Medical Physicist Tests
1. Mammography Equipment Evaluation (MEE) * *
2. ACR DM Phantom Image Quality *    & 2D*
3. DBT Z Resolution  
4. Spatial Resolution *   
5. DBT Volume Coverage  
6. Automatic Exposure Control System Performance *   
7. Average Glandular Dose *   
8. Unit Checklist *   
9. Computed Radiography (if applicable) *
10. Acquisition Workstation Monitor QC * *
11. Radiologist Workstation Monitor QC * *
12. Film Printer QC (if applicable) * *
13. Evaluation of Site’s Technologist QC Program *   
14. Evaluation of Display Device Technologist QC Program * *
15. Manufacturer Calibrations (if applicable) *   
16. Collimation Assessment * *  
MEE or Troubleshooting - Beam Quality (Half-Value Layer * TF
*TF
[HVL]) Assessment
MEE or Troubleshooting - kVp Accuracy and Reproducibility *TF *TF
*Follow the procedures and frequency outlined for 2D QC
TF
HVL and kVp tests must include kVp, target, and filter combinations used for DBT

Digital Mammography Quality Control Manual Return to Table of Contents – 19

 V. QC Tests, Frequencies, and Timeframes for Corrective Action

As an example, if a facility has a system that performs 2D, 2D with an

add-on DBT device, and DBT, both the technologist and the medical
physicist must evaluate phantom images for the 2D, 2D with an
add-on DBT device, and DBT imaging modes. However, the Acquisition
Workstation Monitor QC and Radiologist Workstation Monitor QC tests
are only required to be evaluated using the 2D procedure and images.

If a system is not used for 2D mammography and is only used for DBT
imaging, the technologist and the medical physicist are required to
evaluate phantom images for the DBT and 2D imaging modes. For the
Acquisition Workstation and Radiologist Workstation QC Tests, the 2D
procedures should be used to evaluate the 2D image.

20 – Return to Table of Contents Digital Mammography Quality Control Manual

 VI. Conclusion

Conclusion The public expects our profession to provide accurately interpreted

mammograms of the highest quality. Only a strong, consistent

RADIOLOGIST’S SECTION
commitment to QA by all parties involved in performing mammography
will validate that trust.

Digital Mammography Quality Control Manual Return to Table of Contents – 21

 References

References A. Downloadable from the ACR Website

(www.acr.org)
- ACR Mammography Accreditation Program
- ACR Digital Mammography QC Manual Resources
- Destouet JM, Bassett LW, Yaffe MJ, Butler PF, Wilcox PA: The ACR’s
mammography accreditation program: ten years of experience since MQSA
JACR 2:7, 585-594, 2005.
- ACR Appropriateness® Criteria - Breast Imaging
- ACR BI-RADS® Atlas
- ACR Practice Parameter for the Performance of Screening and Diagnostic
Mammography
- ACR–AAPM–SIIM Practice Parameter for Determinants of Image Quality
in Digital Mammography

B. References
1. Taplin SH, Rutter CM, Finder C, Mandelson MT, Houn F, White E. Screening
mammography: clinical image quality and the risk of interval breast cancer.
AJR Am J Roentgenol. 2002;178:797-803.
2. McLelland R, Hendrick RE, Zinninger MD, Wilcox PA. The American
College of Radiology mammography accreditation program. AJR Am J
Roentgenol. 1991;157:473-479.
3. Destouet JM, Bassett LW, Yaffe MJ, Butler PF, Wilcox PA. The ACR’s
mammography accreditation program: ten years of experience since MQSA.
J Am Coll Radiol. 2005;2(7):585-594.
4. Department of Health and Human Services. FDA Mammography Quality
Standards, Final Rule. Fed Regist. 1997;62(208):55852-55994.
5. American Society of Radiologic Technologists. ASRT Continuing Education
Designed for Mammographers.
6. Sickles EA, D’Orsi CJ. ACR BI-RADS® Follow-up and Outcome Monitoring.
In: ACR BI-RADS® Atlas, Breast Imaging Reporting and Data System.
Reston, VA: American College of Radiology; 2013.
7. D’Orsi CJ, Sickles EA, Mendelson EB, et al. ACR BI-RADS® Atlas, Breast
Imaging Reporting and Data System. Reston, VA: American College of
Radiology; 2013.

22 – Return to Table of Contents Digital Mammography Quality Control Manual

 2018
Digital Mammography

QUALITY CONTROL MANUAL

Radiologic Technologist’s Section

 Contents

I. REVISIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
II. INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
A. MQSA and Quality Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
B. Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
C. Q
 C Tests, Frequencies, and Timeframes for
Corrective Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
III. Technologist Quality Control . . . . . . . . . . . . . . . . . . . . . . . . 39
A. Test Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
1. ACR Digital Mammography (DM) Phantom
Image Quality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
2. Computed Radiography (CR) Cassette Erasure
(if applicable). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
3. Compression Thickness Indicator . . . . . . . . . . . . . . . . . . . . 51
4. Visual Checklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
5. Acquisition Workstation (AW) Monitor QC. . . . . . . . . . . . 56
6. Radiologist Workstation (RW) Monitor QC. . . . . . . . . . . . 59
7. Film Printer QC (if applicable). . . . . . . . . . . . . . . . . . . . . . . . . 64
8. Viewbox Cleanliness (if applicable) . . . . . . . . . . . . . . . . . . . 67
9. Facility QC Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
10. Compression Force. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
11. Manufacturer Calibrations (if applicable) . . . . . . . . . . . . 74
Optional – Repeat Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Optional – System QC for Radiologist. . . . . . . . . . . . . . . . . . . 78
Optional – Radiologist Image Quality Feedback. . . . . . . . . 80
B. Quality Control Forms for 2D and DBT. . . . . . . . . . . . . . . . . . . . . 81
1. ACR Digital Mammography (DM) Phantom
Image Quality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
2. Computed Radiography (CR) Cassette
Erasure (if applicable). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
3. Compression Thickness Indicator . . . . . . . . . . . . . . . . . . . . 86
4. Visual Checklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

24 Digital Mammography Quality Control Manual

 Contents

5. Acquisition Workstation (AW) Monitor QC. . . . . . . . . . . . 88

6. Radiologist Workstation (RW) Monitor QC. . . . . . . . . . . . 89
7. Film Printer QC (if applicable). . . . . . . . . . . . . . . . . . . . . . . . . 90
8. Viewbox Cleanliness (if applicable) . . . . . . . . . . . . . . . . . . . 91
9. Facility QC Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
10. Compression Force. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
11. Manufacturer Calibrations (if applicable) . . . . . . . . . . . . 95
Optional – Repeat Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Optional – System QC for Radiologist. . . . . . . . . . . . . . . . . . . 99

TECHNOLOGIST’S SECTION
Optional – Radiologist Image Quality Feedback. . . . . . . . 100

RADIOLOGIC
C. Management Forms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
1. ACR Technique and Procedure Summaries . . . . . . . . . . 103
2. Corrective Action Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
3. Facility Offsite Display Locations. . . . . . . . . . . . . . . . . . . . 107
4. QC Summary Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
D. Mobile Mammography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
E. Infection Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
REFERENCES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
A. Downloadable from the ACR Website
(www.acr.org). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
B. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
C. Additional Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Digital Mammography Quality Control Manual 25

This page intentionally left blank.
 I. Revisions

Revisions Date Page(s) Section Description of Revisions

November 2nd edition with digital breast
2018 tomosynthesis QC
May 2020 29 Introduction Clarified FDA position
regarding QC for
contrast enhancement
mammography systems
May 2020 39-44 1. ACR Digital Clarified that phantom QC
Mammography (DM) needs to be performed using
Phantom Image clinical system settings
Quality
May 2020 74 11. Manufacturer Clarified Objectives
Calibrations

TECHNOLOGIST’S SECTION
RADIOLOGIC

Digital Mammography Quality Control Manual Return to Table of Contents – 27

 II. Introduction

INTRODUCTION A. MQSA and Quality Control

For the purposes of this manual, quality control (QC) is defined as the
routine performance and interpretation of equipment function tests and
of the corrective actions taken. The objective of QC is to detect, identify,
and correct equipment-related problems before they have a deleterious
effect on clinical images. Due to their day-to-day contact and familiarity
with their particular mammography equipment, radiologic technologists
are the front line of defense against potential imaging problems. The
purpose of this section of the manual is to provide effective and consistent
methods of detecting and identifying image quality problems. Together
with the radiologist, the medical physicist, and equipment service
personnel, radiologic technologists can eliminate these problems before
patient care is affected.

The 1999 American College of Radiology (ACR) Mammography Quality

Control Manual was developed specifically for screen-film mammography
to assist facility staff in complying with the Mammography Quality
Standards Act (MQSA) Final Rule, which went into effect on April 28,
1999 [1]. Since that time, screen-film has been almost entirely replaced
by digital mammography. Furthermore, a growing number of digital
mammography systems include digital breast tomosynthesis (DBT)
capability. The 1998 MQSA Final Rule specifies that “For systems with
image receptor modalities other than screen-film [i.e., digital or DBT], the
quality assurance program shall be substantially the same as the quality
assurance program recommended by the image receptor manufacturer,
except that the maximum allowable dose shall not exceed the maximum
allowable dose for screen-film systems.” See the MQSA Policy Guidance
Help System by the Food and Drug Administration (FDA) for more
information [2].

900.12(e) Quality assurance—equipment. (6) Quality control tests—other

modalities. For systems with image receptor modalities other than screen-film,
the quality assurance program shall be substantially the same as the quality
assurance program recommended by the image receptor manufacturer, except
that the maximum allowable dose shall not exceed the maximum allowable
dose for screen-film systems in paragraph (e)(5)(vi) of this section.

As of the publication date, five models and manufacturers of DBT

systems have been cleared by the Food and Drug Administration for
sale in the U.S. [3], each with its own QC manual. (Over 30 models and
manufacturers of digital mammography systems have been cleared.)
These manuals all have different manufacturer- and model-specific tests,
procedures, frequencies, and performance criteria. This variation is
necessary in most cases to accommodate the design differences inherent
to each device. Many of the tests, however, could be made more consistent
across platforms. The ACR Digital Mammography Quality Control
Manual has been designed to create a generic digital mammography QC

28 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

program by providing uniform test procedures, performance criteria,

and minimum test frequencies that can be used for all manufacturers
and models. 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 Manufacturer Calibrations test/procedure (if available) is
software-dependent and thus unique to each manufacturer.

Some digital mammography systems include contrast enhancement. The

FDA has approved the use of the new ACR Digital Mammography QC
Manual for digital mammography systems with contrast enhancement.
Facilities with contrast enhancement systems may follow this manual
for QC of the 2D and DBT applications of these units, but should follow
manufacturer QC procedures for contrast enhancement applications.

TECHNOLOGIST’S SECTION
Note: Facilities may use the new ACR Digital Mammography QC Manual

RADIOLOGIC
for digital mammography systems with contrast enhancement, but only
for the 2D and DBT applications. Facilities should follow manufacturer QC
procedures for contrast enhancement applications.

To legally allow facilities to use these new procedures instead of the

procedures required by their system’s QC manual, the ACR applied to
the FDA and was granted an amendment to the existing Alternative
Standard for Using the Quality Assurance Program Recommended by
the ACR Digital Mammography Quality Control Manual for Full-Field
Digital Mammography Systems, for Systems without Advanced Imaging.
The amended alternative standard specifies that facilities must use the
approved ACR Digital Mammography (DM) Phantom in concert with
all of the applicable manual’s procedures, performance criteria, and
minimum test frequencies for both 2D and DBT QC. This phantom has
been designed to cover most of the detector area and provide the same
attenuation as the small ACR mammography phantom used in the 1999
Mammography Quality Control Manual, which approximates a 4.2 cm
thick compressed breast consisting of 50% glandular and 50% adipose
tissue. If you have multiple phantoms, use the same phantom each time
on a given unit (Figure 1).

Digital Mammography Quality Control Manual Return to Table of Contents – 29

 II. Introduction

Figure 1. ACR DM Phantom. (Different manufacturers’ phantoms may appear slightly

different. Use of one manufacturer’s phantom photo does not imply ACR endorsement of
one phantom manufacturer over another.)

If a facility chooses to follow the ACR manual for its QC program, it

is no longer required to follow its manufacturer’s QC manual (for
2D or DBT). However, facilities should maintain their manufacturer’s
QC manual to refer to when performing ACR-required calibration or
troubleshooting tests.

Facilities may not use the new procedures with the small ACR
mammography phantom or use the newly developed ACR DM Phantom
with the old test procedures. The ACR DM Phantom was explicitly
designed as a tool for the ACR Digital Mammography Quality Control
Manual (for both 2D and DBT QC) and for the ACR Mammography
Accreditation Program to meet FDA MQSA phantom image quality and
dose requirements.

Note: The ACR Digital Mammography Phantom is required for the majority
of the QC tests in this manual. ACR-approved manufacturers of the
ACR Digital Mammography Phantom are listed on the ACR website. (For
more information, visit https://www.acraccreditation.org/Resources/
Digital-Mammography-QC-Manual-Resources.)

Although the ACR DM Phantom is the primary phantom used with

this manual, facilities should not discard any manufacturer-provided
phantoms since they may be needed for manufacturer-specified
calibrations or service personnel testing.

The digital mammography test procedures and forms were designed to

simplify the conduct, recording, and evaluation of digital mammography
QC for technologists. Commonly performed tests that seldom, if

30 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

ever, identified deficiencies were eliminated; low-yield tests had their

frequencies reduced. Forms were developed to aid technologists in
documenting their results.

One of the major and most important aspects of the manual is a quarterly,
documented review of the QC program performed by the lead interpreting
radiologist, the facility manager, and the QC technologist. (See Facility
QC Review) Although many high-quality facilities have such a review
in place already, experience from the ACR Mammography Accreditation
Program has demonstrated that lack of communication among the
radiologists, managers, technologists, and medical physicists is a frequent
underlying cause of poor-quality mammography. A structured review
process can be beneficial to all facilities. These reviews may be done in
person or via teleconference or video conference.

TECHNOLOGIST’S SECTION
In addition, several optional procedures and forms are provided to aid in
quality improvement. The System QC for Radiologist test is a structured

RADIOLOGIC
tool allowing the radiologist to work with the technologist in evaluating
the entire system performance at the radiologist workstation using a
standard clinical image selected by the radiologist. The Radiologist Image
Quality Feedback procedure and form enables the interpreting radiologist
to notify the technical staff when asked to interpret sub-optimal cases
(and also provides a way to commend the technical staff for exceptional
quality). Using this procedure also helps facilities comply with the MQSA
Final Rule that “All interpreting physicians interpreting mammograms
for the facility shall follow the facility procedures for corrective action
when the images they are asked to interpret are of poor quality.”

The manual also includes several management forms to help organize and
reference important information. The ACR Techniques and Summaries
form provides a location to record techniques used for routine QC testing.
The manual also provides a central location to record all corrective action
for the digital mammography systems in the Corrective Action Log.
(This makes it easier to document these important actions and have it
available for review by the management, the lead interpreting radiologist,
the medical physicist, and MQSA inspectors.) A Facility Offsite Display
Locations form creates a convenient list of all locations of radiologist
workstations and film printers (if applicable) to help with the management
of all offsite QC.

For each of the required technologist QC tests included in this manual,

the purpose and frequency of each test is clearly stated. The equipment
and materials required to carry out each test are listed, and a step-by-step
procedure is provided. Note that other methodologies for these tests may
be used, provided that they yield the same results as the methodologies
provided in this manual and have been reviewed and approved by the
facility’s medical physicist. Following each procedure is a discussion of
precautions and caveats. Performance criteria are provided along with
suggestions for the types of corrective actions that may be needed to
resolve problems.

Digital Mammography Quality Control Manual Return to Table of Contents – 31

 II. Introduction

Relevant MQSA regulations are provided to supplement responsibilities

and tests in this ACR Digital Mammography Quality Control Manual if
they apply.

B. Responsibilities
The MQSA Final Rule requires that the facility’s lead interpreting
physician (typically a radiologist) has the general responsibility of
ensuring that the quality assurance program meets all requirements.

In a facility where more than one technologist does mammography,

one technologist must be assigned the responsibilities of QC (the QC
technologist). Other qualified individuals may perform specific QC tests,
but they must be reviewed and evaluated by the primary QC technologist.
The primary QC technologist is responsible for ensuring that QC tasks
are done properly by standardizing test methodology, reviewing all data,
overseeing repeat testing before calling the medical physicist or service
personnel, and conferring with the radiologist and medical physicist.

900.12(d) Quality assurance—general. (1) Responsible individuals. (iv)

Quality control technologist. Responsibility for all individual tasks within the
quality assurance program not assigned to the lead interpreting physician or
the medical physicist shall be assigned to a quality control technologist(s).
The tasks are to be performed by the quality control technologist or by other
personnel qualified to perform the tasks. When other personnel are utilized
for these tasks, the quality control technologist shall ensure that the tasks are
completed in such a way as to meet the MQSA quality assurance requirements.

The medical physicist is required to conduct a mammography equipment

evaluation (MEE) of new equipment and after major repairs. This survey
must be done and all relevant tests must pass prior to use of digital
mammography equipment on patients. The medical physicist is also
required to perform an annual survey on each unit. (An occasional period
of up to 14 months between surveys is acceptable.) During this annual
survey, the medical physicist must at least review the technologist’s QC
test results and provide written recommendations if there are problems
or suggestions for improvement. The facility should provide this detailed
information to the equipment service engineer to facilitate repair. Review
of the technologist’s QC program by the radiologist and medical physicist
ensures that the QC program is carried out consistently and provides
oversight to make sure that changes in image quality are not inadvertently
overlooked.

Note: If the medical physicist determines that there is need for corrective
action, the facility should provide a copy of its medical physicist’s full report
to its equipment service engineer.

32 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

Mammography team members are strongly encouraged to review other

sections of the ACR Digital Mammography QC Manual that are not
directed towards them. For example, the radiologist should be familiar
with Technologist’s Test Facility QC Review and the Technologist’s
Optional Tests System QC for Radiologist and Radiologist Image
Quality Feedback. The radiologic technologist should review the Medical
Physicist’s Test Evaluation of Site’s Technologist QC Program and
Evaluation of Display Device Technologist QC Program. The medical
physicist should be familiar with all of the radiologic technologist’s tests.
The radiologist, medical physicist, and QC technologist, working together
as a team, are the keys to providing optimum quality mammography images,
which will ultimately provide the best medical care possible to the patient.

Note: Facility management, along with the QC technologist and medical

TECHNOLOGIST’S SECTION
physicist, should work together to ensure that all “display devices” are QC’d
and reviewed properly.

RADIOLOGIC
C. QC Tests, Frequencies, and Timeframes for
Corrective Action
Before a facility QC technologist may start using the procedures in
the ACR Digital Mammography QC Manual for the first time on a
unit, the medical physicist must first conduct an annual survey of the
digital mammography unit and display devices using the manual and
the ACR Digital Mammography 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 ACR Digital Mammography QC Manual. For
current information and more details on transitioning to the ACR
Digital Mammography QC Manual, visit the Digital Mammography QC
Manual: Frequently Asked Questions on the ACR Digital Mammography
QC Manual Resources website.

Important: Before a facility may start using the procedures in the ACR
Digital Mammography QC Manual for the first time on a unit, the medical
physicist must first conduct an annual survey of the digital mammography
unit and display devices using the manual and the ACR Digital Mammography
Phantom.

The minimum frequencies for both the technologist and medical

physicist tests are listed in Table 1. The tests designated for DBT must
be conducted in addition to the applicable tests for the 2D full-field
digital mammography system. Applicable 2D tests must be performed
whether or not the system is used for 2D imaging since they test system
components that may impact DBT performance.

Digital Mammography Quality Control Manual Return to Table of Contents – 33

 II. Introduction

Important: All applicable 2D tests must be performed in additional to the

DBT tests for each system.

If the DBT system employs an “add-on” device, applicable 2D tests must

be repeated with the “add-on” device in place.

The technologist and medical physicist will use the same forms they use
for most of the digital mammography tests to record the data and results
of the DBT tests. The previous digital mammography forms have been
revised to allow for this. New forms have been added for DBT-unique
tests (e.g., DBT Volume Coverage).

If problems are occurring or if equipment is unstable, it may be necessary

to carry out some or all tests more frequently to identify problems before
they affect clinical image quality or patient safety. If the QC program
is just being initiated, it may be valuable to carry out QC tests more
frequently for the first few months. This will provide the QC technologist
with more experience in a shorter period of time and also will provide
better baseline data regarding the reliability of imaging equipment. The
necessity of performing tests designated as “Optional” or “If applicable” is
left to discretion of the Quality Assurance Committee, especially the lead
interpreting radiologist, QC technologist, and medical physicist team,
who are most familiar with the facility’s equipment and the quality needs
of the mammography practice.

In addition to performing the mammography QC tests at the minimum

frequencies indicated, tests also should be carried out for new equipment,
both when problems are suspected and after any service or preventive
maintenance. For example, the compression test should be carried out
both when a new x-ray system is installed and after any service adjustment
of compression force.

If any test fails, it is critical that the set up and techniques employed in the
test be checked and the test repeated to verify performance before initiating
corrective action. Upon confirmation of test failure, the MQSA Final Rule
requires that the source of the problem be identified and corrective action
be taken. In some cases, if test results fall outside of action limits, MQSA
requires that the source of the problem be identified and corrective action
taken before any further examinations are performed or any films are
processed using the component of the mammography system that failed
the test. Other test failures must be corrected within 30 days of the test
date (Table 1).

34 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

Table 1. Digital Mammography (2D and DBT) Quality Control Tests

Test Minimum Frequency Corrective Action Timeframe
Technologist Tests
1. ACR DM Phantom Image Quality Weekly Before clinical use
2. Computed Radiography Cassette Weekly Before clinical use
Erasure (if applicable)
3. Compression Thickness Indicator Monthly Within 30 days
4. Visual Checklist Monthly Critical items: before clinical use;
less critical items: within 30 days
5. Acquisition Workstation Monitor QC Monthly Within 30 days; before clinical use for
severe defects
6. Radiologist Workstation Monitor QC Monthly Within 30 days; before clinical
use for severe defects
7. Film Printer QC (if applicable) Monthly Before clinical use
8. Viewbox Cleanliness (if applicable) Monthly Before clinical use

TECHNOLOGIST’S SECTION
9. Facility QC Review Quarterly Not applicable
10. Compression Force Semiannual Before clinical use
11. Manufacturer Calibrations (if applicable) Mfr. Recommendation Before clinical use

RADIOLOGIC
Optional - Repeat Analysis As Needed Within 30 days after analysis
Optional - System QC for Radiologist As Needed Within 30 days; before clinical
use for severe artifacts
Optional - Radiologist Image Quality Feedback As Needed Not applicable
Medical Physicist Tests
1. Mammography Equipment Evaluation (MEE) - MEE Before clinical use
MQSA Requirements
2. ACR DM Phantom Image Quality MEE and Annual Before clinical use
3. DBT Z Resolution MEE and Annual Within 30 days
4. Spatial Resolution MEE and Annual Within 30 days
5. DBT Volume Coverage MEE and Annual Before clinical use
6. Automatic Exposure Control System MEE and Annual Within 30 days
Performance
7. Average Glandular Dose MEE and Annual Before clinical use
8. Unit Checklist MEE and Annual Critical items: before clinical use;
less critical items: within 30 days
9. Computed Radiography (if applicable) MEE and Annual Before clinical use
10. Acquisition Workstation Monitor QC MEE and Annual Within 30 days; before clinical
use for severe defects
11 Radiologist Workstation Monitor QC MEE and Annual Within 30 days; before clinical
use for severe defects
12. Film Printer QC (if applicable) MEE and Annual Before clinical use
13. Evaluation of Site’s Technologist QC Program Annual Within 30 days
14. Evaluation of Display Device Technologist QC Annual Within 30 days
Program
15. Manufacturer Calibrations (if applicable) Mfr. Recommendation Before clinical use
16. Collimation Assessment MEE or Troubleshooting Within 30 days
Annual (DBT only)
MEE or Troubleshooting - Beam Quality MEE or Troubleshooting Before clinical use
(Half-Value Layer) Assessment
MEE or Troubleshooting - kVp Accuracy and MEE or Troubleshooting MEE: before clinical use;
Reproducibility troubleshooting: within 30 days
Troubleshooting - Ghost Image Evaluation Troubleshooting Before clinical use
Troubleshooting - Viewbox Luminance Troubleshooting Not applicable

Digital Mammography Quality Control Manual Return to Table of Contents – 35

 II. Introduction

Important: Corrective action for any test performed for MEEs must be made
before clinical use.

Documentation of QC and corrective action is essential. Data forms are

provided in this manual and may be copied or downloaded from the
ACR Digital Mammography QC Manual Resources website for use in
performing and documenting the digital mammography QC program.
QC data forms may be stored as either hardcopy (for example, in a
notebook) or as a file on the computer. For some tests, it may be preferable
to use software provided by equipment manufacturers or third-party
vendors that can accumulate, trend, and print out QC data. However,
the QC technologist and medical physicist must verify that all required
information is available from such software before use. If QC records
are stored electronically, all records should be periodically backed up to
prevent loss.

Note: If QC records are stored electronically, all records should be

periodically backed up to prevent loss.

For detailed guidance on the FDA’s requirements for record retention,

see Quality Assurance Records and Retention of Personnel Records in
the FDA’s MQSA Policy Guidance Help System. All documentation must
be made available to MQSA inspectors during the annual inspection and
the facility’s accreditation body upon application and request.

900.12(d) Quality assurance—general. (2) Quality assurance records. The

lead interpreting physician, quality control technologist, and medical
physicist shall ensure that records concerning mammography technique and
procedures, quality control (including monitoring data, problems detected by
analysis of that data, corrective actions, and the effectiveness of the corrective
actions), safety, protection and employee qualifications to meet assigned
quality assurance tasks are properly maintained and updated. These quality
control records shall be kept for each test specified in paragraphs (e) and (f)
of this section until the next annual inspection has been completed and FDA
has determined that the facility is in compliance with the quality assurance
requirements or until the test has been performed two additional times at the
required frequency, whichever is longer.

Table 2 provides a complete list of all the digital mammography tests and
summarizes those tests that must be performed (as applicable) for the
modes that the facility uses clinically on its 2D and DBT systems.

36 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

Table 2. Required Tests for Imaging Modes Used on 2D and DBT Systems
Imaging Modes to Test
System Used for Both 2D and System Used for DBT
DBT Acquisition Acquisition Only
2D w/Add-On
Test 2D DBT Device DBT DBT
Technologist Tests
1. ACR DM Phantom Image Quality *    & 2D*
2.  omputed Radiography Cassette Erasure
C *
(if applicable)
3. Compression Thickness Indicator * * *
4. Visual Checklist *   
5. Acquisition Workstation Monitor QC * *

TECHNOLOGIST’S SECTION
6. Radiologist Workstation Monitor QC * *
7. Film Printer QC (if applicable) * *
8. Viewbox Cleanliness (if applicable) * *

RADIOLOGIC
9. Facility QC Review *   
10. Compression Force * * *
11. Manufacturer Calibrations (if applicable) *   
Medical Physicist Tests
1. Mammography Equipment Evaluation (MEE) * *
2. ACR DM Phantom Image Quality *    & 2D*
3. DBT Z Resolution  
4. Spatial Resolution *   
5. DBT Volume Coverage  
6. Automatic Exposure Control System Performance *   
7. Average Glandular Dose *   
8. Unit Checklist *   
9. Computed Radiography (if applicable) *
10. Acquisition Workstation Monitor QC * *
11. Radiologist Workstation Monitor QC * *
12. Film Printer QC (if applicable) * *
13. Evaluation of Site’s Technologist QC Program *   
14. Evaluation of Display Device Technologist QC Program * *
15. Manufacturer Calibrations (if applicable) *   
16. Collimation Assessment * *  
MEE or Troubleshooting - Beam Quality (Half-Value Layer * TF
*TF
[HVL]) Assessment
MEE or Troubleshooting - kVp Accuracy and Reproducibility *TF *TF
*Follow the procedures and frequency outlined for 2D QC
TF
HVL and kVp tests must include kVp, target, and filter combinations used for DBT

Digital Mammography Quality Control Manual Return to Table of Contents – 37

 II. Introduction

As an example, if a facility has a system that performs 2D, 2D with an

add-on DBT device, and DBT, both the technologist and the medical
physicist must evaluate phantom images for the 2D, 2D with an
add-on DBT device, and DBT imaging modes. However, the Acquisition
Workstation Monitor QC and Radiologist Workstation Monitor QC tests
are only required to be evaluated using the 2D procedure and images.

If a system is not used for 2D mammography and is only used for DBT
imaging, the technologist and the medical physicist are required to
evaluate phantom images for the DBT and 2D imaging modes. For the
Acquisition Workstation and Radiologist Workstation QC Tests, the 2D
procedures should be used to evaluate the 2D image.

38 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

Technologist A. Test Procedures

Quality Control
1. ACR Digital Mammography (DM) Phantom Image Quality
OBJECTIVES To ensure that the image acquisition chain is consistently producing
adequate image quality and that artifacts are not clinically significant.

FREQUENCY Weekly, after relevant service, and upon installation of new equipment
(before clinical use).

TEST EQUIPMENT •  CR DM Phantom (required). This phantom has been designed to

A
cover the majority of the DM detector area and provide the same
attenuation as the small ACR mammography phantom used in the
1999 Mammography Quality Control Manual, which approximates a
4.2 cm thick compressed breast consisting of 50% glandular and 50%

TECHNOLOGIST’S SECTION
adipose tissue. If you have multiple phantoms, use the same phantom
each time on a given unit (Figure 1).

RADIOLOGIC
• ACR DM Phantom Image Quality form.

TEST PROCEDURE Important: Do not follow the phantom imaging instructions or technical
factors provided in the manufacturer’s QC manual. Be sure to follow the
instructions below. This technique must be the same as that used clinically
for a 4.2 cm thick compressed breast consisting of 50% glandular and 50%
adipose tissue, as defined by the FDA.

Important: If clinical images are acquired using a combination mode (i.e. 2D

plus DBT), then acquire the phantom using the clinical combination mode
and evaluate the combination image set (2D and DBT). If clinical 2D and DBT
images are acquired using separate acquisition modes, then acquire the 2D
and DBT phantom images independently using their respective clinical
modes.

900.2 Definitions. (uu) Standard breast means a 4.2 centimeter (cm) thick com­
pressed breast consisting of 50 percent glandular and 50 percent adipose tissue.

ACR DM Phantom Image Acquisition - 2D

1. Initiate an exam at the acquisition workstation as you would for a
patient.

2. Use a name and image designation system that allows tracking of QC

images. It is important to be able to match and identify the DM unit
to the printed image from that same unit. See example below:

a. Last Name: ACR DM Phantom

b. First Name: Room 1
c. Patient ID: “Date of Phantom Acquisition”
d. Date of Birth: “Date of Phantom Acquisition”

Digital Mammography Quality Control Manual Return to Table of Contents– 39

 III. Technologist Quality Control

3. Use the largest available image receptor size and corresponding

paddle for the ACR DM Phantom image acquisition. Ensure that
the type of paddle chosen (e.g., flex or fixed) is the one used for the
majority of clinical imaging.

Important: For computed radiography (CR), completely erase the CR

cassette prior to obtaining the phantom image.

4. Place the ACR DM phantom on the breast support surface as shown

in Figure 2. Be sure to position the phantom in the same location each
time you do the test to limit exposure variability. Check that

a. The pink wax insert is on the top side of the phantom and nearer
the chest wall
b. The phantom is centered left-to-right
c. The edge of the phantom is aligned with the chest wall edge of the
digital image receptor

Figure 2. ACR DM Phantom positioned for image acquisition on a 2D system.

5. Manually compress the paddle to approximately 5 decanewtons (daN)

or 12 pounds of compression force. It is important to use the same
compression force each time for this test. Note that at this compression
force, the compressed breast thickness indicator may not read 4.2 cm.

6. At the acquisition workstation, select the imaging mode from the
ACR Technique and Procedure Summaries form. This is the imaging
mode and technique that would be used for a clinical screening
exam acquisition of a 4.2 cm thick compressed breast consisting of
50% glandular and 50% adipose tissue. If a combination exposure
mode (i.e. 2D plus DBT) is most commonly used clinically, use the
combination mode for this test, record the data from the 2D and DBT

40 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

acquisitions, and use those images for analysis. If a 2D-only mode is

most commonly used clinically for screening, use the 2D-only mode
for this procedure step. (If the system uses selectable AEC sensor
positions, be sure to use the same position each time the phantom is
acquired.)

7. Record or verify the following demographic information at the top of

the form:

a. Facility
b. Mammography Accreditation Program (MAP) ID number
c. Room ID
d. X-ray unit manufacturer and model

TECHNOLOGIST’S SECTION
8. For each weekly image acquisition, verify and use the following
technique parameters in the ACR Technique and Procedure

RADIOLOGIC
Summaries form:

a. AEC mode
b. Paddle and image receptor size
c. Paddle type (regular or flex)
d. Compression force
e. AEC cell position (if applicable)
f. Target/filter (if applicable)
g. kVp (if applicable)
h. Density setting (if applicable)

Note: These parameters must be used for all subsequent phantom

exposures. Consistent exposure parameters will help in troubleshooting
problems.

9. Acquire an image of the phantom.

10. Record the following parameters that appear after the exposure on
the form:

a. Target/filter material (e.g., Mo/Mo, W/Ag, etc.)

b. kVp (e.g., 28)
c. mAs (e.g., 78.5)

ACR DM Phantom Image Acquisition - DBT

1. Initiate an exam at the acquisition workstation as you would for a
patient.

Digital Mammography Quality Control Manual Return to Table of Contents– 41

 III. Technologist Quality Control

2. Use a name and image designation system that allows tracking

of QC images. It is important to be able to match and identify the
mammography unit to the printed image from that same unit. See
example below:

a. Last Name: ACR DM Phantom

b. First Name: Room 1
c. Patient ID: “Date of Phantom Acquisition”
d. Date of Birth: “Date of Phantom Acquisition”
3. 
Use the largest available image receptor size and corresponding
paddle for the ACR DM Phantom image acquisition. Ensure that
the type of paddle chosen (e.g., flex or fixed) is the one used for the
majority of clinical imaging.

4. Place the ACR DM Phantom on the breast support surface as shown

in Figure 3. Be sure to position the phantom in the same location each
time you do the test to limit exposure variability. Check that

a. The pink wax insert is on the top side of the phantom and nearer
the chest wall
b. The phantom is centered left-to-right
c. The edge of the phantom is aligned with the chest wall edge of the
digital image receptor

Figure 3. ACR DM Phantom positioned for image acquisition on a DBT system.

42 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

5. Manually compress the paddle to approximately 5 daN or 12 pounds

of compression force. It is important to use the same compression
force each time for this test. Note that at this compression force, the
compressed breast thickness indicator may not read 4.2 cm.

6. At the acquisition workstation, select the DBT imaging mode and
technique that would be used for a clinical exam acquisition of a
4.2 cm thick compressed breast consisting of 50% glandular and 50%
adipose tissue. If a combination exposure mode (i.e. 2D plus DBT)
is most commonly used clinically, use the combination mode for this
test, record the data from the 2D and DBT acquisitions, and use those
images for analysis. If a DBT-only mode is most commonly used
clinically for screening, use the DBT-only mode for this procedure
step. (If the system uses selectable AEC sensor positions, be sure to
use the same position each time the phantom is acquired.)

TECHNOLOGIST’S SECTION
7. Record or verify the following demographic information at the top of

RADIOLOGIC
the form:

a. Facility
b. MAP ID number
c. Room ID
d. X-ray unit manufacturer and model
8. 
For each weekly image acquisition, verify and use the following
technique parameters in the ACR Technique and Procedure
Summaries form:

a. AEC mode
b. Paddle and image receptor size
c. Paddle type (regular or flex)
d. View or selected image
e. Compression force
f. AEC cell position (if applicable)
g. Target/filter (if applicable)
h. kVp (if applicable)
i. Density setting (if applicable)

Note: These parameters must be used for all subsequent phantom

exposures. Consistent exposure parameters will help in troubleshooting
problems.

Digital Mammography Quality Control Manual Return to Table of Contents– 43

 III. Technologist Quality Control

9. Acquire an image of the phantom.

10. Record the following parameters that appear after the exposure on
the form:

a. Target/filter material (e.g., Rh/Rh, W/Ag, etc.)

b. kVp (e.g., 32)
c. mAs (e.g., 78.5)
11. If the system uses an add-on device for DBT, repeat steps 3 through
11 in 2D mode with the DBT fixture in place.

DATA ANALYSIS AND ACR DM Phantom – 2D and DBT

INTERPRETATION
1. If possible, reduce the lighting in the acquisition room to be similar to
that in the radiologist’s reading room before image evaluation.

2. View the phantom image on the acquisition workstation display

monitor. If review is not possible on the acquisition workstation, then
review on a radiologist workstation.

Note: Digital mammography phantom images must be “for presentation”

(i.e., “processed,” not “for processing” or “raw”) for viewing and scoring
(if applicable).

For DBT images, scroll to the one slice in which the test objects are
3. 
best visualized. If “slices” are not available, then proceed to use the slab
in which the objects are best visualized. (See the ACR Technique and
Procedure Summaries form for guidance.) Record the best visualized
slice or slab.

4. Adjust the window width (WW) and window level (WL) settings to
optimize visualization of test objects (the test objects will be scored
in the next section). It is important not to use unreasonably narrow
WWs, which may enhance the appearance of artifacts. For guidance
on approximate values, refer to those used by your medical physicist
and recorded on the technologist’s ACR Technique and Procedure
Summaries form.

5. Using approximately the same WW and WL settings used to evaluate

the test objects, examine the entire phantom for both broad area
artifacts and detailed artifacts. (See Figure 4 for examples of properly
windowed ACR digital phantom images without artifacts.)

a. Broad area artifacts (e.g., non-uniformities, blotches, and

streaks) usually are best seen while observing the phantom
image as a whole and not in pieces (i.e., not magnified or at
full resolution).

44 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

b. Detailed artifacts (e.g., black or white pixels, clusters of pixels,

lines, or dust particles) usually are best seen while observing the
phantom image at full spatial resolution, where one pixel on the
display matches one pixel in the image, or with magnification,
using a zoom factor greater than 1.0.
6. See the Artifact Evaluation Guide in Appendix III for examples of
“good” or “artifact free” images and some common digital artifacts.

7. 
Record the absence or presence of artifacts on the form as a pass or
fail (P or F).

TECHNOLOGIST’S SECTION
RADIOLOGIC

Figure 4. Images of a properly windowed ACR DM Phantom with no artifacts.

A. 2D. B. DBT.

Digital Mammography Quality Control Manual Return to Table of Contents– 45

 III. Technologist Quality Control

8. To score the phantom image, adjust the WW and WL settings to

optimize visualization of test objects. You may need to slightly adjust
the WW and WL to obtain optimum visualization of each test object.
The zoom or magnification tool should also be used. Use a WW
and WL that permit the best visualization of fibers, speck groups,
and masses. Using the scoring methods described below, score the
number of fibers, speck groups, and masses seen in the phantom and
record on the form.

9. Do not deduct for artifacts. (Deducting for artifacts is no longer part
of the ACR DM Phantom scoring procedure.)

10. Scoring method (see Figure 5 and Table 3):

a. Count the number of visible objects from the largest object of

a given type (fiber, speck group, or mass) downward, until a
score of 0 or ½ is reached, then stop counting for that object
type. (This step is the same as used in the 1999 Mammography
Quality Control Manual [4].) For each test object type, the
minimum possible score is 0 objects and the maximum possible
score is 6 objects.

Figure 5. ACR DM Phantom wax insert map (test object sizes are not to scale).

b. Fibers
i. The fibers are manufactured to be 10 mm in length. If the
entire length of the fiber is not visible, measure it using the
display device’s electronic calipers.
ii. Count each fiber as 1 point if 8 mm or more of the fiber is
visible in the correct location and orientation.
iii. Count a fiber as ½ point if the fiber appears to be equal to or
greater than 5 mm and less than 8 mm in length and is in the
correct location and orientation.
iv. If a small gap in the fiber is visible, and it is less than the width
of the fiber, count the fiber as a full or half point depending
on the total visible length.

46 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

c. Speck groups
i. Count each speck group as 1 point if 4 to 6 specks are visible
in the proper locations in the group.
ii. Count a speck group as ½ point if 2 or 3 specks are visible in
the proper locations in the group.
d. Masses
i. Count each mass as 1 point if an object is visible in the correct
location and the mass appears to be generally circular against
the background (at least ¾ of the border is continuous and
generally round).
ii. Count a mass as ½ point if a mass-like object is visible in
the correct location but does not have a generally circular

TECHNOLOGIST’S SECTION
appearance (greater than ½ but less than ¾ of a circle).
e. Enter the final scoring result in each category (fibers, speck

RADIOLOGIC
groups, and masses) on the form.
11. If 2D add-on devices are used clinically with DBT, repeat the above
steps to score the resulting 2D image.

12. See the ACR Digital Mammography Phantom Scoring Guide in

Appendix II for examples on scoring.

Table 3. ACR DM Phantom Image Scoring Key

Test
Object Full Point Half Point
Fibers (6) • Full length visible (≥8 mm • At least half of length
long) visible (≥5 and <8 mm long)
• Correct location • Correct location
• Correct orientation • Correct orientation
• 1 break allowed (must be • 1 break allowed (must be
≤ width of fiber) ≤ width of fiber)
Speck • 4 to 6 specks visible • 2 to 3 specks visible
Groups (6) • Correct locations • Correct locations
Masses (6) • Density difference visible • Density difference visible
• Border is continuous and • Border is not continuous or
generally circular (≥ ¾ generally circular (≥ ½ and
border visible) < ¾ border visible)
• Correct location • Correct location

PRECAUTIONS AND If any of these quantities are outside of the action limits stated below, the test
CAVEATS should be repeated. Make sure the correct exposure mode has been used.

If one or two new computed radiography photostimulable phosphor

(PSP) plates are acquired between the medical physicist’s annual
surveys, the QC technologist must first check the plate before putting
it into clinical service. This must be done by following this ACR Digital
Mammography Phantom Image Quality procedure and sending the
completed form to the medical physicist for review.

Digital Mammography Quality Control Manual Return to Table of Contents– 47

 III. Technologist Quality Control

Note: If the facility replaces all of its PSP plates with new ones, the medical
physicist must perform a Mammography Equipment Evaluation consisting
of applicable tests.

PERFORMANCE CRITERIA ACR DM Phantom – 2D and DBT

AND CORRECTIVE ACTIONS
1. Artifacts must not be clinically significant. This aspect of the test fails
if artifacts are in a location that could impact clinical interpretation
and

a. Artifacts are as prominent as (or more prominent than) the

visible test objects in the phantom image, or
b. Artifacts obscure test objects in the phantom, or
c. Artifacts could affect clinical interpretation.
The cause of the artifact should be identified and isolated to
determine if it originates from the x-ray system, the detector, or the
monitor. If the artifact is confirmed to originate from the detector,
then a recalibration or flat-fielding of the detector may be needed.
Artifacts isolated to other components of the imaging chain should
be investigated.

After the artifact is resolved, repeat the phantom artifact test. If a

clinically significant artifact persists, contact your authorized service
representative. If the clinically significant artifact originated from the
x-ray/detector system, do not image patients until it is corrected. If
the clinically significant artifact originated from the monitor, do not
use the monitor until it is corrected.

2. The fiber score must be ≥2.0.

3. The speck group score must be ≥3.0.

4. The mass score must be ≥2.0.

TIMEFRAME FOR All failures of required items must be corrected before clinical use.
CORRECTIVE ACTION

48 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

2. Computed Radiography (CR) Cassette Erasure

(if applicable)
OBJECTIVES To ensure the cassette is free from signal information that could impact
image quality.

FREQUENCY Weekly.

Important: This test is only applicable to computed radiography systems.

TEST EQUIPMENT • All CR cassettes and CR readers.

TECHNOLOGIST’S SECTION
• Computed Radiography Cassette Erasure form.

RADIOLOGIC
TEST PROCEDURE 1. U
 sing the menu on the CR reader, select the option for CR cassette
erasure.

2. Place the CR cassette into the CR reader and initiate the erasure
process.

3. Repeat for all CR cassettes.

4. If a cassette fails the erasure test, repeat it.

5. If the CR cassette fails again, enter the date, cassette number, reason
for failure, and action taken under “Action Taken on Cassette” at the
bottom of the form.

6. Date and initial the form to indicate the test was completed.

7. If failing cassette(s) are put back into service at any time, document this
on the form along with the date and description of service performed.

PRECAUTIONS AND None

CAVEATS

PERFORMANCE CRITERIA 1. E
 ach cassette should successfully pass the CR cassette erasure
AND CORRECTIVE ACTIONS process.

2. If an error messages occurs, repeat the test on the cassette.

3. If an error message occurs again, pull the cassette from service and
investigate the error message.

Digital Mammography Quality Control Manual Return to Table of Contents– 49

 III. Technologist Quality Control

4. If the cassette cannot go through this procedure, or is rejected, the

cassette should be pulled from service until the problem is investigated
by a service engineer.

TIMEFRAME FOR Cassettes that do not successfully pass the erasure process must be taken
CORRECTIVE ACTION out of service immediately. After service or repair, the cassette should
undergo the erasure process before being put back in to service.

50 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

3. Compression Thickness Indicator

OBJECTIVES To ensure that the indicated compression thickness is within tolerance.

FREQUENCY Monthly, whenever inaccurate indicator performance is suspected, and

upon installation of new equipment (before clinical use).

TEST EQUIPMENT • An object to use as a compression thickness indicator phantom.

– This can be any commonly available object that is 10 cm long

by 10 cm wide (or less) and 4 to 6 cm in thickness. For example,
1 2-inch roll of medical tape or 2 1-inch rolls stacked on top of
each other would work.
– Do not use an object with sharp edges that would scratch the

TECHNOLOGIST’S SECTION
compression paddle or bucky.
– If tape is used, cover the sides of the roll (by using a thin plastic
bag or paper) to prevent adhesive from sticking to the equipment.

RADIOLOGIC
– Be sure to set aside the compression thickness indicator phantom
and label the object for use only for this test.
• A ruler with a mm/cm scale.

• Compression Thickness Indicator form.

TEST PROCEDURE 1. Record a description of the compression thickness indicator phantom

(e.g., “2 rolls of 1-inch tape”) on the form.

2. Measure the thickness of the phantom using the same units provided
on the indicator (cm or mm) and record this value on the form
(Figure 6).

Figure 6. Measuring the width of the compression thickness indicator phantom.

Digital Mammography Quality Control Manual Return to Table of Contents– 51

 III. Technologist Quality Control

3. In contact mode, place the phantom on the breast support so that it
is centered laterally and aligned flush with the chest wall edge of the
support (Figure 6).

4. Install the spot compression paddle (in contact mode).

a. If a spot compression paddle is not available, use the smallest,

non-flex compression paddle available.
b. Be sure to turn off the flex function of the paddle if possible.
5. Apply a compression force of approximately 10 to 15 pounds (4.4 to
6.7 decanewtons) to the phantom (Figure 7).

Figure 7. Position and compression of compression thickness indicator phantom using

spot compression paddle.

6. Record the indicated thickness on the form (in cm or mm).

7. Release the compression device.

DATA ANALYSIS AND 1. Subtract the actual, measured thickness of the phantom from the
INTERPRETATION indicated thickness.

2. Record the result on the form.

PRECAUTIONS AND Many systems use the indicated compression thickness to drive the
CAVEATS selection of initial kVp and filter under automatic exposure control.
Omitting such a test may have an impact on image quality and patient
dose, as suboptimal imaging techniques may be selected during imaging
if the compression thickness is not accurate.

52 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

If your compression thickness indicator phantom is lost or damaged,

obtain another object as identical to the previous object as possible.
Measure and record the thickness as before and start a new chart.

PERFORMANCE 1. The compression thickness indicator must be accurate to within

CRITERIA AND ±0.5 cm (±5 mm) of the actual thickness. For example, if the compression
CORRECTIVE ACTIONS thickness indicator phantom is 4.8 cm thick, the indicator may not show
that it is less than 4.3 cm thick nor greater than 5.3 cm thick.

2. If the test fails, recheck the measurement of the phantom with the
ruler and the setup of the equipment. Repeat the test.

3. If the test fails again, contact your authorized service representative.

TIMEFRAME FOR The source of the problem must be identified and corrective action taken

TECHNOLOGIST’S SECTION
CORRECTIVE ACTION within 30 days.

RADIOLOGIC

Digital Mammography Quality Control Manual Return to Table of Contents– 53

 III. Technologist Quality Control

4. Visual Checklist
OBJECTIVES To ensure that digital mammographic x-ray system indicator lights,
displays, mechanical locks and detents are working properly and that the
mechanical rigidity and stability of the equipment is optimum.

FREQUENCY Monthly, after relevant service, and upon installation of new equipment
(before clinical use).

TEST EQUIPMENT Visual Checklist form.

TEST PROCEDURE 1. Review all items listed on the visual checklist and indicate their status.
Be sure to rotate the C-arm the way you would for patient imaging.

2. If specific checks that are not on the form are recommended by your
medical physicist, add them to the checklist.

3. Date and initial the checklist where indicated.

DATA ANALYSIS AND None

INTERPRETATION
PRECAUTIONS AND When checking for cracks in paddles, face shields, and breast supports,
CAVEATS only indicate issues that impact patient safety and image quality. Tiny
cracks may not be a safety or image quality issue. If unsure of the potential
impact on image quality or safety, consult with the lead interpreting
radiologist or the medical physicist.

Some of the items on the visual checklist are operator convenience

features. Many of the items, however, are essential for patient safety and
high-quality diagnostic images. It may be necessary to add additional
items to the checklist that are specific to your particular equipment or
procedures. For example, various systems will have unique items that
should be checked. Consult with your medical physicist regarding the
manufacturer’s recommendations.

Items on the list that are not applicable to your system (e.g., “condition of
imaging plates and cassettes” if computed radiography [CR] is not used)
should be marked “not applicable” (NA).

PERFORMANCE CRITERIA The following tests listed in the Visual Checklist are critical, and failures
AND CORRECTIVE ACTIONS must be repaired or replaced before clinical use, as applicable:

• Cleaning solution must be available.

• All locks must work correctly.
• Paddles/face shields must not be cracked.
• The breast support must not be cracked.
•  e cassette holder for CR must hold and lock the cassette properly
Th
(small and large).

54 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

• The CR imaging plates and cassettes must be in acceptable condition.

Cassettes should be free of cracks and dents, latches should function
properly, and cassettes should run smoothly with the CR reader.
• The DBT assembly must move as designed through its range of
motion.
The following tests listed in the Visual Checklist are less critical, and
failures must be corrected within 30 days, as applicable:

• Magnification stands and paddles must be free from dust.

• The mammography room and countertops must be free from dust.
• Indicators must be working.
• The collimator light must be working.

TECHNOLOGIST’S SECTION
• Cables must be safely positioned.
• The C-arm motion must be smooth.

RADIOLOGIC
• The compression paddle motion must be smooth.
Items missing from the room should be replaced. Malfunctioning
equipment should be reported to the authorized service representative
for repair or replacement as soon as possible.

TIMEFRAME FOR Failures of critical tests must be corrected before clinical use; failures of
CORRECTIVE ACTION less critical tests must be corrected within 30 days.

Digital Mammography Quality Control Manual Return to Table of Contents– 55

 III. Technologist Quality Control

5. Acquisition Workstation (AW) Monitor QC

OBJECTIVES •  o ensure that AW monitors are clean and free from dust, fingerprints,
T
and other marks that may interfere with clinical information.

•  o ensure that monitors are calibrated correctly and the brightness

T
and contrast settings are appropriate.

•  o ensure that monitors meet manufacturer specifications via the

T
conduct of Monitor Manufacturer Automated Tests (if available).

Important: Monitor Manufacturer Automated Tests are required if such a

tests are available in the manufacturer’s documentation.

FREQUENCY Monthly, after relevant service, and upon installation of new equipment
(before clinical use).

TEST EQUIPMENT •  ry, soft, lint-free cloth or cleaning tissue recommended by your AW
D
manufacturer.

Note: Any other cleaning methods may lead to damage of the anti-reflective
screen coating. Please follow your AW manufacturer’s recommendations for
proper cleaning and cleaning material. If you don’t have them, ask the AW
manufacturer.

•  e American Association of Physicists in Medicine (AAPM) TG18-

Th
QC test pattern [5] is strongly preferred. If one is not available on
the monitor, ask the authorized service representative to install one.
If this is not possible, a SMPTE test pattern [6] or another pattern
that allows relevant measurements may be used (Figure 8). If it is not
possible to install a relevant test pattern on the monitor, this part of
the test is not applicable.

Figure 8. Test patterns: A. AAPM TG18-QC test pattern. B. SMPTE test pattern.

• Acquisition Workstation Monitor QC form.

56 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

TEST PROCEDURE Monitor Condition

1. Visually inspect the surface of the monitor for the presence of dust,
scratches, defects, fingerprints, shiny patches (from grease or gel),
and other foreign material (e.g., pen marks, etc.).

2. If dirt, fingerprints, or other foreign material is present, wipe the

monitor screen gently using a soft lint-free cloth dampened with
water, paying particular attention to the items listed above. Then wipe
with a dry, soft, lint-free cloth. A special-purpose screen cleaning
tissue or cloth recommended by the monitor manufacturer may also
be used.

3. After drying, recheck the monitor surface to be sure the items noted
in step 1 have been eliminated. If they were not, clean the monitor

TECHNOLOGIST’S SECTION
again.

4. Record significant findings on the form (see Performance Criteria

RADIOLOGIC
and Corrective Actions).

Test Pattern Image Quality (if available)

1. Reduce the lighting in the acquisition room to be similar to that in the
radiologist’s reading room before image evaluation.

2. Display the test pattern on the monitor. (If an appropriate test pattern
is not available on the AW, skip this test.)

3. Evaluate the test pattern for the following visible targets and record
pass or fail on the form (see the ACR Technique and Procedure
Summaries form for further guidance on monitor test pattern
evaluation):

a. Are the 0%-5% contrast boxes visible?

b. Are the 95%-100% contrast boxes visible?
c. Are the line-pair images at the center and four corners visible
and clearly distinguishable?

Monitor Manufacturer Automated Test (if available)

1. Open the monitor manufacturer automated test program.

2. Review the results and verify that all tests have passed.

3. Record an overall pass or fail on the form at the designated frequency.

DATA ANALYSIS AND None

INTERPRETATION

Digital Mammography Quality Control Manual Return to Table of Contents– 57

 III. Technologist Quality Control

PRECAUTIONS AND CAVEATS Ideally, monitor screens should be free of dust, fingerprints, and other
marks. Similarly, there should be no “shiny” patches or obvious non-
uniformities on the surface. As described below, significant blemishes
that interfere with the interpretation or QC of images must be corrected.

Most problems can be corrected by cleaning according to the manufacturer’s

instructions. However, if cleaning does not correct the problem, the
manufacturer should be contacted to evaluate and correct the problem.

Do not use cleaning products, abrasive materials, or alcohols that will

damage the anti-reflective coating on the screen.

Although this thorough check must be done and documented by the

technologist monthly, technologists should clean significant dirt from
their AW as it occurs if it is noted during daily use.

In most cases, Monitor Manufacturer Automated Tests and action

limits are available in manufacturer manuals or documents published
by the manufacturer. These tests are extremely valuable in maintaining
quality and are specific to each manufacturer. If a Monitor Manufacturer
Automated Test is available, the medical physicist should assist the facility
in verifying that the automated system is set up and functioning properly.

PERFORMANCE CRITERIA Monitor Condition

AND CORRECTIVE ACTIONS
Any large, significant blemish that interferes with the visualization or QC
of images is a failure. (If there are questions regarding the significance of
a monitor blemish, the lead interpreting radiologist should be consulted.)

Test Pattern Image Quality (if available)

1. The 0%-5% and 95%-100% contrast boxes must be visible.

2. The high-contrast line-pair patterns must be distinguishable at the

center and corners.

Monitor Manufacturer Automated Test (if available)

Monitors must pass all manufacturer tests.

TIMEFRAME FOR Monitor Condition

CORRECTIVE ACTION
All failures must be corrected before clinical use.

Test Pattern Image Quality (if available) and Monitor

Manufacturer Automated Test (if available)
All failures must be corrected within 30 days.

58 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

6. Radiologist Workstation (RW) Monitor QC

OBJECTIVES •  o ensure that radiologist workstation monitors are clean and free
T
from dust, fingerprints, and other marks that may interfere with
clinical information.

•  o ensure monitors are calibrated correctly and the brightness and

T
contrast settings are set correctly.

•  o ensure that the image acquisition chain is producing adequate

T
image quality and working consistently and that there are no obvious
artifacts.

•  o ensure that monitors meet manufacturer specifications via the

T
conduct of Monitor Manufacturer Automated Tests (if available).

TECHNOLOGIST’S SECTION
Important: Monitor Manufacturer Automated Tests are required if such

RADIOLOGIC
tests are available in the manufacturer’s documentation.

FREQUENCY Monthly, after relevant service, and upon installation of new workstations
(before clinical use).

TEST EQUIPMENT •  ry, soft, lint-free cloth or cleaning tissue recommended by your RW
D
manufacturer.

Note: : Any other cleaning methods may lead to damage of the anti-reflective
screen coating. Please follow your RW manufacturer’s recommendations for
instructions on proper cleaning and cleaning material. If you don’t have
them, ask the RW manufacturer.

• Acquired ACR Digital Mammography (DM) Phantom image.

•  e American Association of Physicists in Medicine (AAPM)

Th
TG18-QC test pattern is strongly preferred. If one is not available
on the monitor, ask the authorized service representative to install
one. If this is not possible, a SMPTE test pattern or another pattern
that allows relevant measurements may be used (Figure 8).

• Radiologist Workstation Monitor QC form.

TEST PROCEDURE Monitor Condition

1. Check the surface of the monitors for the presence of dust, scratches,
defects, fingerprints, shiny patches (from grease or gel), and other
foreign material (e.g., pen marks, etc.).

Digital Mammography Quality Control Manual Return to Table of Contents– 59

 III. Technologist Quality Control

2. If dirt, fingerprints, or other foreign material is present, wipe the

monitor screen gently using a soft lint-free cloth, dampened with
water, paying particular attention to the items noted above. Then wipe
with a dry, soft, lint-free cloth. A special-purpose screen cleaning
tissue or cloth recommended by the monitor manufacturer may also
be used.

3. After drying, recheck the monitor surface to be sure the items noted
in step 1 were eliminated. If they were not, clean the monitor again.

4. Record significant findings on the form (see Performance Criteria

and Corrective Actions).

ACR DM Phantom
1. Display a phantom image that was acquired on one of the digital
mammography units per instructions in Test #1 ACR Digital
Mammography Phantom Image Quality.

2. Evaluate for artifacts and score the phantom test objects as in Test #1
ACR Digital Mammography Phantom Image Quality.

Test Pattern Image Quality

1. Display the test pattern on the monitor.

2. Evaluate the test pattern for the following visible targets and record
pass or fail on the form (see the ACR Technique and Procedure
Summaries form for further guidance on monitor test pattern
evaluation):

a. Are the 0%-5% contrast boxes visible?

b. Are 95%-100% contrast boxes visible?
c. Are the line-pair images at the center and four corners visible
and clearly distinguishable?

Monitor Manufacturer Automated Test (if available)

1. Open monitor manufacturer automated test program.

2. Review the results and verify that all tests have passed.

3. Record an overall pass or fail on the form.

60 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

DATA ANALYSIS AND ACR DM Phantom

INTERPRETATION
1. Evaluate the phantom image for artifacts following the instructions
under Data Analysis and Interpretation in Test #1 ACR Digital
Mammography Phantom Image Quality.

2. Score the phantom image following the instructions under Data

Analysis and Interpretation in Test #1 ACR Digital Mammography
Phantom Image Quality.

3. Record results on the form.

PRECAUTIONS AND Ideally, monitor screens should be free of dust, fingerprints, and other
CAVEATS marks. Similarly, there should be no “shiny” patches or obvious non-
uniformities on the surface. As described below, significant blemishes

TECHNOLOGIST’S SECTION
that interfere with the interpretation or QC of images must be corrected.
If there are questions regarding the significance of a monitor blemish, the
lead interpreting radiologist should be consulted.

RADIOLOGIC
Most problems can be corrected by cleaning according to the
manufacturer’s instructions. However, if cleaning does not correct the
problem, the manufacturer should be contacted to evaluate and correct
the problem.

Abrasive materials or alcohols should not be used on monitor faces, since

the anti-glare surface on the display might be destroyed. Do not use
cleaning products, abrasive materials, or alcohols that will damage the
anti-reflective coating on the screen.

Although a thorough Monitor Condition check must be done and

documented by the technologist monthly, radiologists should clean
significant dirt from their RW as it occurs if it is noted during daily
use.

In most cases, Monitor Manufacturer Automated Tests and action limits

are available in manufacturer manuals or documents published by
the manufacturer. These tests are extremely valuable in maintaining
quality and are specific to each manufacturer. If a Monitor
Manufacturer Automated Test is available, the medical physicist
should assist the facility in verifying that the automated system is set
up and functioning properly.

PERFORMANCE CRITERIA Monitor Condition

AND CORRECTIVE ACTIONS
Any large, significant blemish that interferes with the interpretation
or QC of images is a failure. (If there are questions regarding the
significance of a monitor blemish, the lead interpreting radiologist
should be consulted.)

Digital Mammography Quality Control Manual Return to Table of Contents– 61

 III. Technologist Quality Control

ACR DM Phantom
1. Artifacts must not be clinically significant. This aspect of the test
fails if any artifacts are in a location that could impact clinical
interpretation and

a. They are as prominent as (or more prominent than) the visible

test objects in the phantom image, or
b. They obscure test objects in the phantom, or
c. They could affect clinical interpretation.
The cause of the artifact should be identified and isolated to
determine if it originates from the x-ray system, the detector, or
the RW monitor. If the artifact is confirmed to originate from the
detector, then a recalibration or flat-fielding of the detector may be
needed. Artifacts isolated to other components of the imaging chain
should be investigated.

After the artifact is resolved, repeat the phantom artifact test. If a

clinically significant artifact persists, contact your authorized service
representative. If the clinically significant artifact originated from the
x-ray/detector system, do not image patients until it is corrected. If
the clinically significant artifact originated from the RW monitor, do
not use the monitor to interpret patient images until it is corrected.

2. The fiber score must be ≥2.0.

3. The speck group score must be ≥3.0.

4. The mass score must be ≥2.0.

Test Pattern Image Quality

1. The 0%-5% and 95%-100% contrast boxes must be visible.

2. The high-contrast line-pair patterns must be distinguishable at the

center and corners.

Monitor Manufacturer Automated Test (if available)

Monitors must pass all manufacturer tests.

62 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

TIMEFRAME FOR Monitor Condition and ACR DM Phantom

CORRECTIVE ACTION
All failures must be corrected before clinical use.

Test Pattern Image Quality and Monitor Manufacturer

Automated Test (if available)
All failures must be corrected within 30 days.

TECHNOLOGIST’S SECTION
RADIOLOGIC

Digital Mammography Quality Control Manual Return to Table of Contents– 63

 III. Technologist Quality Control

7. Film Printer QC (if applicable)

OBJECTIVES To ensure adequate and consistent image quality on printed images
provided to referring physicians, patients, and other radiologists.

FREQUENCY •  onthly (if printer is used less than monthly, before clinical films are
M
printed).

• After relevant service (and before clinical use).

• Upon installation of new equipment (and before clinical use).

Note: Film printer QC is only required if they are used clinically for
mammography (i.e., for interpretation and to provide images to referring
physicians and patients). If such is the case, it is important that the facility
documents in its QC logs that that the film printer is not used clinically.

TEST EQUIPMENT • ACR Digital Mammography (DM) Phantom image (required).

• Densitometer.

• Film Printer QC form.

TEST PROCEDURE 1. Print the ACR DM Phantom image (acquired in Test #1 ACR Digital
Mammography Phantom Image Quality) without adjusting any
parameters (window width/window level, sizing, etc.) using the film
size used for the majority of clinical printing. (Refer to the ACR
Technique and Procedure Summaries form.) Print the digital images
without magnification or minification and as close to “true size” as
possible. The ACR recommends printing the phantom images so that
it is within 25% of the actual phantom size.

2. On the form, note the workstation used to print the image.

3. View the image.

DATA ANALYSIS AND ACR DM Phantom

INTERPRETATION
1. Evaluate the phantom image on the film for artifacts following the
instructions under Data Analysis and Interpretation in Test #1 ACR
Digital Mammography Phantom Image Quality.

2. Score the phantom image on the film following the instructions

under Data Analysis and Interpretation in Test #1 ACR Digital
Mammography Phantom Image Quality.

3. Record results on the form.

64 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

Background Optical Density

1. Measure the background optical density (OD) outside of the cavity
on the printed phantom image.

2. Record on the form.

Contrast
1. Record the background OD from above in the “Contrast” section of
the form.

2. Measure the OD inside the cavity and record on the form.

TECHNOLOGIST’S SECTION
3. Subtract the background OD from outside of the cavity from the OD
inside the cavity and record this on the form. This is the film contrast.

RADIOLOGIC
Contrast = Cavity OD–Background OD

Maximum Optical Density (Dmax)

1. Measure the OD near the outside edge of the film at a location where
the phantom image (including the detector area) is not located. If the
phantom image covers the entire film and there is insufficient room,
print a breast image and make this measurement in the non-breast
area.

2. See the ACR Technique and Procedure Summaries form for a detailed
schematic of where to measure the ODs.

PRECAUTIONS AND Many facilities never actually provide a final interpretation report
CAVEATS based on the hard copy images. However, even if a facility is using the
printer only to provide final interpretation-quality hardcopy images to
representatives, health-care providers, patients, or for retention purposes,
it still needs to perform all the required printer QC tests at appropriate
frequencies or prior to printing clinical images for patients and health-
care providers or for retention, whichever is less frequent. See the FDA
MQSA website for the most current requirements.

PERFORMANCE CRITERIA ACR DM Phantom

AND CORRECTIVE ACTIONS
1. Artifacts must not be clinically significant. This aspect of the test
fails if any artifacts are in a location that could impact clinical
interpretation and

a. They are as prominent as (or more prominent than) the visible

test objects in the phantom image, or

Digital Mammography Quality Control Manual Return to Table of Contents– 65

 III. Technologist Quality Control

b. They obscure test objects in the phantom, or

c. They could affect clinical interpretation.
If the artifact evaluation fails, check the softcopy images to determine
if the same artifact appears. If the same artifact appears on the
workstation, the problem should be addressed as described in the
workstation test. If the artifact does not appear on the workstation,
retest and seek service for the printer if the problem persists. Do not
print patient images until clinically significant artifacts are corrected.

2. The fiber score must be ≥2.0.

3. The speck group score must be ≥3.0.

4. The mass score must be ≥2.0.

Background Optical Density

Background OD must be ≥1.6. (Background optical densities between
1.7 and 2.2 are recommended; approximately 2.0 is optimal.)

Contrast
Contrast (cavity OD – background OD) must be ≥0.1.

Dmax
The Dmax must be ≥3.1 (≥3.5 is recommended).

TIMEFRAME FOR All failures of required items must be corrected before clinical use.
CORRECTIVE ACTION

66 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

8. Viewbox Cleanliness (if applicable)

OBJECTIVES To ensure that the viewboxes and viewing conditions are optimized and
maintained at an optimum level. If prior or outside clinical films are not
viewed on viewboxes, this test is not applicable.

FREQUENCY Monthly, after relevant service, and upon installation of new equipment
(before clinical use)

TEST EQUIPMENT • Cleaner recommended by viewbox manufacturer.

• Soft paper or cotton towels.

• Viewbox Cleanliness form.

TECHNOLOGIST’S SECTION
TEST PROCEDURE 1. Clean viewbox surfaces using cleaner recommended by viewbox
manufacturer and soft paper or cotton towels.

RADIOLOGIC
2. Ensure that all marks have been removed.

3. Visually inspect the viewboxes for uniformity of luminance.

4 Ensure that all viewbox masking equipment is functioning properly

and easily.

DATA ANALYSIS AND None.

INTERPRETATION

PRECAUTIONS AND High-quality viewboxes are still important in digital imaging because
CAVEATS comparison images may only be available on film. The accuracy of
the diagnosis and the efficiency of the radiologist are influenced by
the conditions under which the mammograms are viewed. Viewing
conditions may affect the diagnostic potential of even the best quality
mammograms. These conditions are determined by the luminance of the
viewboxes, the ambient room illumination or the amount of light falling
on the viewbox surface, and good masking of films on the viewbox.

Contrast is extremely important in the mammography image and is

degraded by extraneous light. Consequently, viewboxes should be
positioned to avoid light from windows, other viewboxes, and other
sources of bright light, either direct or reflected. General lighting in the
room should be at a low level and diffuse.

Viewboxes used in mammography should provide a relatively high

luminance level, generally higher than for viewing conventional
radiographs. Consequently, it is essential to mask the area around the
mammograms to exclude extraneous light that reduces image contrast
and limits the maximum densities that can be seen without “bright-
lighting” each film.

Digital Mammography Quality Control Manual Return to Table of Contents– 67

 III. Technologist Quality Control

If a separate viewbox is used by the QC technologist to check the density

of film images, this viewbox should be similar to the reading viewbox
in luminance and color of the light and should be used with ambient
lighting conditions similar to those in the room where the mammograms
are interpreted.

PERFORMANCE CRITERIA AND Any marks that are not easily removed with window cleaner must be
CORRECTIVE ACTIONS removed with a safe and appropriate cleaner. If viewboxes appear non-
uniform, all of the fluorescent lamps must be replaced as soon as possible.
If viewbox masks are difficult to use, appropriate service or modifications
should be requested.

TIMEFRAME FOR Failures must be corrected before clinical images are viewed on the
CORRECTIVE ACTION viewbox.

68 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

9. Facility QC Review
OBJECTIVES To ensure the lead interpreting radiologist and facility manager are aware
that all QC tests are performed at the required frequencies, that data
are collected appropriately, that results are adequately documented, that
corrective action is taken, and that no patient exams are conducted when
tests requiring correction before clinical use failed.

FREQUENCY Quarterly.

TEST EQUIPMENT • Facility QC forms and data.

• Facility QC Review form.

TEST PROCEDURE QC data/notebooks must be reviewed by both the lead interpreting

TECHNOLOGIST’S SECTION
radiologist and facility manager. These reviews may be done in person or
remotely (e.g., via teleconference or video conference).

RADIOLOGIC
1. Enter QC results from the most recent Medical Physicist’s ACR Digital
Mammography (DM) QC Test Summary form into the Facility QC
Review form prior to the meeting.

2. Enter QC results from the most recent week of technologist QC into

the form prior to the meeting.

3. Review the most recent quarter of QC data with both the lead
interpreting radiologist and facility manager.

4. Review each QC test and its results.

5. If any tests fail, note that corrective action was documented.

6. Discuss reasons for failure and documented corrective action.

7. Review the Medical Physicist’s ACR DM QC Test Summary and

report for each mammography unit.

8. Record performance of this quarterly review and annual review with

initials and date on the form.

DATA ANALYSIS AND None

INTERPRETATION

PRECAUTIONS AND The MQSA Final Rule specifies that the lead interpreting physician has
CAVEATS “the general responsibility of ensuring that the quality assurance program
meets all MQSA QA [quality assurance] requirements.” This responsibility
cannot be delegated to individuals such as the medical physicist or the
QC technologist. Routine and appropriate conduct of the Facility QC
Review demonstrates that this responsibility is being properly exercised.

Digital Mammography Quality Control Manual Return to Table of Contents– 69

 III. Technologist Quality Control

The lead interpreting radiologist, along with the facility manager, must
review the QC test results at least quarterly or more frequently if problems
are noted. It is particularly important for the lead interpreting radiologist
and the facility manager to note that all tests and necessary corrective
action are properly documented. Too often, investigations performed
by MQSA inspectors, MQSA certifying bodies, and mammography
accreditation bodies for non-compliance and quality issues demonstrate
that neither facility management nor lead interpreting radiologists were
aware that QC was not being performed at the required intervals or
documented at their facilities.

PERFORMANCE CRITERIA 1. If tests are not being done at an appropriate level or frequency, or if
AND CORRECTIVE ACTIONS corrective action for failures are not implemented and/or documented,
the facility needs to determine the reasons and allocate appropriate
training and/or time so the work is done properly.

2. If there are questions regarding the conduct of the test or data
interpretation, the medical physicist should be consulted for assistance
and additional training.

TIMEFRAME FOR Not applicable.

CORRECTIVE ACTION

70 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

10. Compression Force

OBJECTIVES To ensure that the mammography system can provide adequate compression
in both manual fine-adjustment and hands-free, initial power-drive modes,
that the equipment does not allow too much compression to be applied when
used in initial power-drive mode, and that adequate compression can be
maintained throughout image acquisition.

FREQUENCY Every 6 months (semiannual), whenever reduced, excessive, or unstable

compression is suspected, and upon installation of new equipment
(before clinical use).

TEST EQUIPMENT •  alibrated bathroom scale (The scale should be a flat, conventional,
C
analog type. Digital scales sample the data and may not respond properly
as additional pressure is applied slowly to the scale. Digital scales designed

TECHNOLOGIST’S SECTION
specifically to measure compression force may be used.)

• Several towels.

RADIOLOGIC
•  ther calibrated tools specifically designed to measure compression
O
force (such as digital gauges or compression force tools) may also be
used.

• Compression Force form.

TEST PROCEDURE 1. Place a towel on the breast support surface (to protect the image
receptor), then place the bathroom scale on the towel with the dial
or read-out positioned for easy reading. Locate the center of the scale
directly under the compression device (Figure 9).

2. Place one or more towels on top of the scale to prevent damage to the
compression paddle.

3. Check that the force available during manual fine-adjustment mode

meets minimum requirements.

a. Using the manual fine-adjustment mode, compress the scale

until a force of at least 25 pounds is noted.
b. Note if 25 pounds was achieved on the form.
c. Release the compression device.
4. Check that the maximum force available during initial power-drive
mode is within the required range of 25 to 45 pounds.

a. Using the hands-free, initial power-drive mode (e.g., foot pedal),

activate the compression device and allow it to operate until it
stops automatically. Do not tap the foot pedal (see Precautions
and Caveats for exceptions.)
b. Read and record the compression force on the form.

Digital Mammography Quality Control Manual Return to Table of Contents– 71

 III. Technologist Quality Control

5. Check that adequate force is maintained.

a. Hold compression for the length of time it usually takes to

either complete an average exposure or engage the manual fine-
adjustment control. Check that at least 25 pounds is maintained.
b. If the manual fine-adjustment control is engaged, then it must
maintain a compression force of at least 25 pounds for the length
of time it usually takes to complete an average exposure.
c. Note on the form if adequate force was maintained.
6. Release the compression device.

Figure 9. Setup for the compression force test. Note the towel covering the image
receptor under the scale and the towel on top of the scale to protect the paddle.

DATA ANALYSIS AND None

INTERPRETATION

PRECAUTIONS AND Adequate compression is essential for high-quality mammography.

CAVEATS Compression reduces the thickness of tissue that must be penetrated by
radiation, thereby reducing scattered radiation and increasing contrast,
while reducing radiation exposure to the breast. Compression improves
image sharpness by reducing the breast thickness, thereby minimizing
focal spot blurring of structures in the image, and by minimizing patient
motion. In addition, compression makes the thickness of the breast more
uniform, resulting in image signal values representing tissue-density
differences rather than thickness differences, making images easier to
interpret.

If the safety mechanism is not properly adjusted, it may be possible to

damage the compression device and associated components. If the
compression exceeds 200 newtons (20 decanewtons or 45 pounds) in the

72 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

initial power drive mode, immediately release the compression device

and ask a service engineer to make the appropriate adjustments.

The initial power drive on some mammography units (e.g., Siemens

Mammomat) is designed with a built-in sensor that terminates the
pressure applied to the paddle once the system’s software algorithm
determines that additional force will not achieve further thickness
reduction. This design is intended to maximize patient comfort while
achieving optimum compression. When such a device is pressed against a
hard surface (such as a bathroom scale), the sensor, recognizing that very
little or no compression has been achieved by the applied force up to that
point, terminates the pressure before the maximum force can be achieved.
When performing the compression test with such a device, the person
conducting the test (i.e., radiologic technologist or medical physicist)
may have to press the foot pedal more than once to accurately measure

TECHNOLOGIST’S SECTION
the maximum force. Failure to do so may lead the person conducting the
test to report an artificially low maximum compression force. This could

RADIOLOGIC
lead to an inappropriate failure of the initial power drive compression
device quality control test. See FDA Guidance.

If tools specifically designed to measure compression force are used, the

above procedures should be modified.

PERFORMANCE CRITERIA 1. A compression force of at least 25 pounds (111 newtons or 11.1

AND CORRECTIVE ACTIONS decanewtons) must be provided in both the initial power-drive and
manual fine-adjustment modes.

Note: This is the minimum compression force that is available to use on the
unit. It is not the minimum force that must be used to compress the patient.

2. For the initial power-drive mode, the maximum compression force

must be at least 25 pounds (111 newtons or 11.1 decanewtons) but no
more than 45 pounds (200 newtons or 20.0 decanewtons).

3. The initial power-drive mode must maintain a compression force of

at least 25 pounds (111 newtons or 11.1 decanewtons) for the length
of time it usually takes to engage the fine-adjustment control. The
fine-adjustment control must then maintain a compression force of at
least 25 pounds for the length of time it usually takes to complete an
average exposure.

TIMEFRAME FOR The source of the problem must be identified and corrective action taken
CORRECTIVE ACTION before any examinations are performed.

Digital Mammography Quality Control Manual Return to Table of Contents– 73

 III. Technologist Quality Control

11. Manufacturer Calibrations (if applicable)

OBJECTIVES To detect and automatically correct equipment problems, especially
related to digital detector performance. This may include compensating
for dead or over-responding pixels, structured or other noise, nonlinear
response, and other technical performance parameters.

FREQUENCY • Must be performed at the frequency specified by the manufacturer.

• Upon installation of new equipment (before clinical use).

Important: This test is applicable if the manufacturer’s documentation

includes routine detector calibration.

TEST EQUIPMENT • Manufacturer Calibrations form.

• Other forms per manufacturer’s recommendations.

TEST PROCEDURE 1. See manufacturer’s documentation for exact procedure steps. The
medical physicist should help the facility in locating and implementing
these procedures.

2. Enter the results on the form.

DATA ANALYSIS AND Follow manufacturer’s recommendations.

INTERPRETATION

PRECAUTIONS AND Most manufacturers provide specific instructions for system calibrations
CAVEATS (e.g., detector calibration). See the manufacturer’s documentation for
precautions and caveats.

PERFORMANCE CRITERIA The unit must meet the prescribed periodic calibrations.
AND CORRECTIVE ACTIONS

TIMEFRAME FOR Failures must be corrected before further clinical use.

CORRECTIVE ACTION

74 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

Optional – Repeat Analysis

OBJECTIVES To determine the number and cause of repeated mammograms. (Analysis
of these data will help identify ways to improve efficiency, as well as reduce
patient exposures.)

FREQUENCY As needed. (In order for the repeat rates to be meaningful, a patient
volume of at least 250 patients is needed, if possible. Some facilities may
choose to conduct routine repeat analyses. Forms are provided for both
monthly and quarterly checks.)

Note: Some equipment manufacturers provide an automated system to

collect, record, and analyze repeated clinical images. These systems may be
used instead of the procedure in this section as long as the system includes

TECHNOLOGIST’S SECTION
the following 2 key elements:
• Count of the total # of exposures made during the evaluation period
• % repeats during the same period: (# Repeat Exposures/Total #

RADIOLOGIC
Exposures) × 100%

TEST EQUIPMENT •  ll repeated mammograms (including data for repeated mammograms

A
that may have been placed in the patient’s medical record)

•  eans to count the total number of patient exposures made during

M
the test period

• Means for sorting images during analysis

• Optional - Repeat Analysis forms

TEST PROCEDURE 1. Count all repeated images for the length of time needed to examine at
least 250 patients (including those repeated images that were saved in
the patient’s medical record).

2. Also count the total number of patient exposures made during the
same time period.

3. Sort the repeated images into the categories listed in the Tally Sheet or
Daily Counting Sheet.

a. Images may be repeated for a wide variety of reasons. See

examples of images that should and should not be counted as
repeats in Table 4.
b. Good images (which appear to be acceptable mammograms
when retrospectively evaluated during the repeat analysis) may
have also been repeated.

Digital Mammography Quality Control Manual Return to Table of Contents– 75

 III. Technologist Quality Control

c. Wire or other localization images (e.g., I-125 radioactive seeds)

should not be included in the repeat analysis because they are
taken as part of the localization process.
d. Quality control images should not be included in the repeat
analysis.

Table 4. Reasons for Repeated Images

Patient-Related Repeats Technical Repeats Miscellaneous Repeats Do Not Count as Repeats

•P
 oor positioning • Exposure too low (excessive • Blank images • Wire localizations
noise)
•P
 atient motion • Good image (no • I-125 seed localizations
• Exposure too high (image apparent reason)
•P
 atient-caused artifacts saturation) • Additional views to image
• Other - miscellaneous the entire breast (e.g.,
• I ncorrect patient ID • Equipment-caused artifacts exaggerated lateral CCs
to obtain far post-lateral
• X-ray equipment failure tissue or multiple views for
patients with large breasts)
• Software failure
• Quality control
• Aborted automated
exposure control exposure

ANALYSIS AND 1. Determine the overall percentage of repeated exposures by dividing

INTERPRETATION the total number of repeated exposures by the total number of patient
exposures made during the analysis period, and multiply by 100%.

Total # Repeat Exposures

% Repeats = * 100
Total # Exposures

2. Determine the percentage of repeats in each “Reason for Repeat”

category by dividing the repeats in the category by the total number
of repeated exposures.
# Repeat Exposures in Category
% Repeats = * 100
Total # Repeat Exposures
PRECAUTIONS AND All images that are repeated (except for localization purposes) should be
CAVEATS included in the repeat analysis, not just those that the radiologist asked to
have repeated. Some facilities may keep repeated images in the patient’s
medical record along with good images. These repeated images must be
included in the repeat analysis.

Many facilities include all patients examined in their repeat analyses.

Collecting repeated images from a larger number of patients is encouraged
because it will yield more reliable data on causes for repeats. In order for
the repeat rates to be meaningful, a patient volume of at least 250 patients
is needed, if possible.

Repeated images from all mammography units should be collected. The

76 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

facility’s analysis and overall % repeats may be determined for the entire
facility or for each mammography unit at the facility. (Many facilities
choose to calculate both a facility-wide repeat rate and a repeat rate for
each unit in order to determine if equipment problems result in higher
repeat rates.) However, if a facility chooses to collect and analyze its repeat
data, it is important that the facility does this in a consistent manner so
that valid trends may be noted.

There is a real danger that technologists may alter their routine procedures
or criteria for accepting images if they know their repeated images will be
analyzed. This should be avoided.

PERFORMANCE CRITERIA The overall repeat rate ideally should be 2% or less, but a rate of 5% is
AND CORRECTIVE ACTIONS probably adequate if the radiologist and medical physicist agree that this
is a reasonable level. Too low or no repeat rate may also indicate that

TECHNOLOGIST’S SECTION
poor image quality is being tolerated. These rates should be based on a
volume of at least 250 patients to be meaningful. A “Reason for Repeat”

RADIOLOGIC
that is significantly higher than the others indicates an area for potential
improvement.

If the repeat rate exceeds the selected acceptance level of either 2% or 5%,
or if the repeat rate changes from the previously measured rate by more
than 2%, the change should be investigated and corrective action taken, if
necessary. For example, if the previous repeat rate was 1.8% and the new
repeat rate is 4.2%, then the follow-up described above is required.

Any corrective actions should be recorded on the Corrective Action

Log. In addition, the effectiveness of the corrective actions should be
assessed by performing another Repeat Analysis or carefully evaluating
the next quarterly Repeat Analysis after the corrective actions have been
implemented.

TIMEFRAME FOR The source of the problem should be identified and corrective action
CORRECTIVE ACTION taken within 30 days of the repeat analysis.

Digital Mammography Quality Control Manual Return to Table of Contents– 77

 III. Technologist Quality Control

Optional – System QC for Radiologist

OBJECTIVES To enable the radiologist to perform a quick and relevant evaluation of
the entire mammographic imaging chain that focuses primarily on the
detector and monitors. (This test is not intended to evaluate technologist
issues such as positioning and compression.)

FREQUENCY As needed.

TEST EQUIPMENT Optional – System QC for Radiologist form.

TEST PROCEDURE Part 1 – The Technologist

1. The technologist should complete step 1 on the form by first finding
an MLO image (acquired within the last two weeks) from each digital
mammography unit or computed radiography (CR) reader and then
entering the Room or CR ID to be evaluated.

2. Step 1 should be repeated on an additional form for each digital

mammography unit within a facility.

3. The technologist should deliver the form(s) to the radiologist for

completion.

4. 
Example: A radiologist can sit at one workstation and view the images
for all the digital mammography units or CR readers within a facility.
The radiologist does not need to evaluate every monitor at every
workstation.

Part 2 – The Radiologist

1. Complete steps 2 through 5 on the form.

2. Pull up the study listed in step 1 on the form.

3. Place the same MLO image from the same case and breast on each
monitor (or, for wide-screen monitors, on each side of the monitor, if
possible).

4. Evaluate the images for artifacts and check the appropriate boxes.

DATA ANALYSIS AND None

INTERPRETATION

PRECAUTIONS AND This test can be performed by the radiologist for all digital mammography
CAVEATS or CR units on the same workstation.

78 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

PERFORMANCE CRITERIA If any box is checked “Yes”, take appropriate corrective action.
AND CORRECTIVE ACTIONS

TIMEFRAME FOR 1. If an image quality problem or artifact impedes clinical interpretation,
CORRECTIVE ACTION seek service before using the workstation to interpret images.

2. If the artifact does not impede clinical interpretation, seek service
within 30 days.

TECHNOLOGIST’S SECTION
RADIOLOGIC

Digital Mammography Quality Control Manual Return to Table of Contents– 79

 III. Technologist Quality Control

Optional – Radiologist Image Quality Feedback

OBJECTIVES To ensure that radiologists provide feedback to the mammography
technologists on the quality of the examinations they interpret and the
need for additional images to complete the patient’s breast imaging
examination.

FREQUENCY As needed.

TEST EQUIPMENT Optional – Radiologist Image Quality Feedback form.

TEST PROCEDURE 1. The radiologist should check image quality assessment observations
as the cases are interpreted.

2. The radiologist should also give positive feedback if the image quality
is excellent.

3. Following the facility’s established internal protocol, the radiologist

should ensure that the mammography technologist receives all
pertinent feedback.

DATA ANALYSIS AND The facility management and staff should routinely evaluate this
INTERPRETATION information to examine possible areas for quality improvement.

PRECAUTIONS AND The MQSA Final Rule requires that “All interpreting physicians
CAVEATS interpreting mammograms for the facility shall follow the facility
procedures for corrective action when the images they are asked to
interpret are of poor quality.” Utilizing this procedure will help facilities
meet this requirement.

PERFORMANCE CRITERIA If the image-quality deficiency is severe, as judged by the interpreting

AND CORRECTIVE ACTIONS radiologist, the patient should be called back for additional imaging.
However, it is also useful for the radiologist to provide feedback for
image-quality issues that may not be so severe that the patient needs
to be recalled. It is also important to provide positive feedback to the
technologist for a job well done, for example, in cases where good image
quality is obtained on difficult-to-image patients.

TIMEFRAME FOR Not applicable

CORRECTIVE ACTION

80 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

B. Quality Control Forms for 2D and DBT

Routine and complete documentation of QC and corrective actions
is a critical part of quality mammography and is required by the
FDA mammography regulations. The QC forms in this section have
been developed to help you meet this goal and to comply with FDA
requirements. The QC form number corresponds to the test procedure
number provided in the previous section. Each form has been set up with
a brief summary of the test procedure, an area to record the test conditions
and techniques (to ensure that you do not change test conditions that
could cause variability in the results), and with reminders of action
limits and timeframes for corrective action. Be sure to consult the quality
control test procedure for the complete instructions if you have questions
about performing tests or analyzing data.

TECHNOLOGIST’S SECTION
For simplicity and uniformity, the DBT tests are intended to use the same
forms as the 2D tests. Document that the DBT tests were performed by
selecting the correct image “mode” on the form. (If you are using an

RADIOLOGIC
electronic version of the form, use the pull-down menu to select the
mode.) For example, on the ACR DM Phantom Image Quality form,
create a form for testing the 2D mode by entering “2D” in the heading
of the form. Then copy the form to create one to test the DBT mode and
enter “DBT” in the heading of the form. Note that for DBT you will need
to use a second or third page of the form for complete QC documentation.

The forms are also downloadable as Excel spreadsheets from the ACR
Digital Mammography QC Manual Resources website (go to Digital
Mammography Quality Control Test Forms). Although they have been
designed to help you record and analyze your QC results on a computer,
they may also be printed and completed manually.

1. ACR Digital Mammography (DM) Phantom Image Quality

2. C
 omputed Radiography (CR) Cassette Erasure
(if applicable)

3. Compression Thickness Indicator

4. Visual Checklist

5. Acquisition Workstation (AW) Monitor QC

6. Radiologist Workstation (RW) Monitor QC

7. Film Printer QC (if applicable)

8. Viewbox Cleanliness (if applicable)

9. Facility QC Review

Digital Mammography Quality Control Manual Return to Table of Contents– 81

 III. Technologist Quality Control

10. Compression Force

11. Manufacturer Calibrations (if applicable)

Optional – Repeat Analysis

Optional – System QC for Radiologist

Optional – Radiologist Image Quality Feedback

82 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

C. Management Forms

1. ACR Technique and Procedure Summaries

The ACR Technique and Procedure Summaries form provides a central
location to record technical parameters and setup instructions used for
imaging the ACR DM Phantom and evaluating the AAPM TG-18 QC
or SMPTE test patterns. These forms should be kept at the front of each
respective set of data for each test. These pages give instructions and keep
a log of previous and current techniques for subsequent tests.

2. Corrective Action Log

The Corrective Action Log provides a method for documenting any and all

TECHNOLOGIST’S SECTION
QC events needing corrective action that occur within a mammography
facility. This includes problems detected during the Radiologic
Technologist QC Tests, Medical Physicist Equipment Evaluation and

RADIOLOGIC
Annual Survey, and any other miscellaneous events that may arise.

3. Facility Offsite Display Locations

The Facility Offsite Display Locations form is provided to maintain a
current list of all locations or facilities providing final interpretations
of clinical images produced at your facility. This will aid your medical
physicist in ensuring that all offsite displays used for interpretation are
adequately tested.

The form should be reviewed annually and updated when there are any
changes in locations or facilities that provide interpretations.

4. QC Summary Checklists
To assist with the oversight of the QC program, mammography checklists
are provided to record the Weekly, Monthly, Quarterly, and Semi-Annual
Tests for both the mammography system and the display devices. These
checklists provide quick reminders of when QC tasks are due and also
provide records indicating that the tasks have been completed in a timely
manner. In addition, the ACR will request copies of these checklists
during the accreditation process to document that all required QC tests
were performed at the required frequencies.

All dates should be filled in prior to use of the checklist. Each time a
task is completed, the individual carrying out the task should initial
the appropriate area on the checklist. If a test is not performed because
a system is not in use (for example, one of the RW monitors is being
repaired, is not being clinically used, or is not available to test), the QC
technologist should put an “X” in the box and include a note of why the
test is not being performed.

Digital Mammography Quality Control Manual Return to Table of Contents– 101

 III. Technologist Quality Control

DIGITAL This checklist is for the digital mammography imaging unit located at the
MAMMOGRAPHY UNIT mammography facility.
QC SUMMARY CHECKLIST

FACILITY DISPLAY DEVICE This checklist is for the display devices (including the RW monitors, film
QC SUMMARY CHECKLIST printers, and viewboxes) that may or may not be at a different location
from the mammography imaging system.

102 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

D. Mobile Mammography
Mobile mammography systems are subject to all the QC requirements and
frequencies that apply to stationary mammography systems, including
DBT. In addition, the tests outlined in Table 5 must be performed after
each move of the mobile system at each examination location. For
example, if the mobile unit moves to 2 different locations within the same
day, all the applicable tests outlined below must be performed prior to
using the equipment at each location, so the tests would be performed
twice on that day.

Note: The tests outlined in Table 5 must be performed after each move of
the mobile system at each examination location.

TECHNOLOGIST’S SECTION
The evaluations should be made at the mobile unit’s site of operation
to verify that the mobile unit is performing adequately before any
patient examinations are conducted, before the mobile RW is used for

RADIOLOGIC
interpretation, or before the mobile film printer is used to generate
hardcopy of patient images. If the image quality is inadequate, then
immediate corrective action is required and the results of the corrective
action need to be verified via repeat testing before proceeding.

Table 5. Tests That Must Be Performed by the Technologist

After Each Mammography System Move to a New Location

QC Tests
• ACR DM Phantom Image Quality - after each move and prior to
examining patients
• Compression Thickness Indicator - after each move and prior to
examining patients
• Radiologist Workstation (RW) Monitor QC (for mobile RW only) - after
each move and prior to interpretation
• Film Printer QC (for mobile film printers only) - after each move and prior
to printing patient images

900.7 Mobile Units. The facility shall verify that mammography units used to
produce mammograms at more than one location meet the requirements
in paragraphs (e)(1) through (e)(6) of this section. [Quality assurance—
equipment requirements] In addition, at each examination location, before any
examinations are conducted, the facility shall verify satisfactory performance
of such units using a test method that establishes the adequacy of the image
quality produced by the unit.

Digital Mammography Quality Control Manual Return to Table of Contents– 111

 III. Technologist Quality Control

E. Infection Control
OBJECTIVE To prevent and control the spread of infection to employees, patients, and
visitors within the mammography facility.

GENERAL Mammography personnel must follow the facility’s established Infection

INFORMATION Control procedures. For additional guidance on infection control,
refer to OSHA’s Bloodborne Pathogens Standard (29 CFR 1910.1030),
any additional state and local regulations on this subject that may be
applicable to the facility, and the manufacturer’s procedures specific to
its equipment.

RESPONSIBILITIES •  e department manager/supervisor must ensure that the

Th
mammography facility has written procedures for cleaning and
disinfecting mammography equipment that has come in contact
with blood or other body fluids or potentially infectious materials.
If reference material is cited in the facility’s procedures, the facility
must have a copy of the referenced material. The procedures must
comply with applicable federal, state, and local regulations as well as
manufacturer’s recommendations.

•  e department manager/supervisor must also ensure that

Th
mammography personnel follow the infection control procedures.

FREQUENCY This procedure should be carried out between patients.

EQUIPMENT •  acility-approved disinfectant (the QC technologist should verify

F
with manufacturer that approved disinfectant will not damage
equipment)

• Disposable wipes

PROCEDURE STEPS 1. All surfaces in contact with the patient are to be wiped clean with a
facility-approved disinfectant at the end of each exam.

2. All linens are for single patient use. Following use, they are to be
deposited in appropriate bags for transport to laundry.

3. Any spills or drips on floors or equipment must be washed with a

facility-approved disinfectant.

4. If mammography equipment comes into contact with blood or

other potentially infectious agents, mammography personnel must
document that infection control procedures were performed on a log
or chart.

112 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Technologist Quality Control

900.13 Infection control. Facilities shall establish and comply with a system
specifying procedures to be followed by the facility for cleaning and disinfecting
mammography equipment after contact with blood or other potentially
infectious materials. This system shall specify the methods for documenting
facility compliance with the infection control procedures established and shall:
(i) Comply with all applicable Federal, State, and local regulations pertaining to
infection control; and
(ii) Comply with the manufacturer’s recommended procedures for the cleaning
and disinfection of the mammography equipment used in the facility; or
(iii) If adequate manufacturer’s recommendations are not available,
comply with generally accepted guidance on infection control, until such
recommendations become available.

TECHNOLOGIST’S SECTION
RADIOLOGIC

Digital Mammography Quality Control Manual Return to Table of Contents– 113

 VI. References

References A. Downloadable from the ACR Website

(www.acr.org)
– ACR Mammography Accreditation Program
– ACR Digital Mammography QC Manual Resources
– Destouet JM, Bassett LW, Yaffe MJ, Butler PF, Wilcox PA. The ACR’s
mammography accreditation program: ten years of experience since MQSA.
J Am Coll Radiol. 2005;2(7):585-594.
– ACR Appropriateness® Criteria - Breast Imaging
– ACR BI-RADS® Atlas
– ACR Practice Parameter for the Performance of Screening and Diagnostic
Mammography
– ACR–AAPM–SIIM Practice Parameter for Determinants of Image Quality
in Digital Mammography

B. References
1. Department of Health and Human Services. FDA Mammography Quality
Standards, Final Rule. Fed Reg., 1997;62(208):55852-55994.
2. U.S. Food and Drug Administration. Mammography Quality Standards Act
(MQSA) Policy Guidance Help System.
3. FDA Mammography Quality Standards Act and Program, Facility
Certification and Inspection (MQSA) - Digital Accreditation.
4. Hendrick RE, Bassett L, Botsco MA, et al. Mammography Quality Control
Manual. Reston, Va: American College of Radiology; 1999.
5. Samei E, Badano A, Chakraborty D, et al. Assessment of display performance
for medical imaging systems: executive summary of AAPM TG18 report.
Med Phys. 2005;32:1205-1225.
6. Gray JE. Use of the SMPTE test pattern in picture archiving and
communication systems. J Digit Imaging. 1992;5:54-58.

C. Additional Resources
– Berns EA, Hendrick RE, Cutter GR. Optimization of technique factors for a
silicon diode array full-field digital mammography system and comparison
to screen-film mammography with matched average glandular dose. Med
Phys. 2003;30:334-340.
– Bloomquist AK, Yaffe MJ, Pisano ED, et al. Quality control for digital
mammography in the ACRIN DMIST trial: part I. Med Phys 2006;33:719-736.
– Kruger RL, Schuler BA. A survey of clinical factors and patient dose in
mammography. Med Phys. 2001;28:1449-1454.
– Quality Control Manual Template for Manufacturers of Displays and
Workstations Devices Labeled for Final Interpretation in Full-Field Digital
Mammography. Rosslyn, Va: National Electrical Manufacturers Association;
XR 22-2006; 2006.
– Quality Control Manual Template for Manufacturers of Hardcopy Output
Devices Labeled for Final Interpretation in Full-Field Digital Mammography.
Rosslyn, Va: National Electrical Manufacturers Association; XR 23-2006; 2006.

114 – Return to Table of Contents Digital Mammography Quality Control Manual

 2018
Digital Mammography

QUALITY CONTROL MANUAL

Medical Physicist’s Section

Digital Mammography Quality Control Manual 115

 Contents

I. REVISIONS.......................................................................... 119
II. INTRODUCTION............................................................... 120
A. MQSA and Quality Control............................................................... 120
B. Responsibilities..................................................................................... 123
C. Q
 C Tests, Frequencies, and Timeframes for
Corrective Action................................................................................. 126
D. S urveys of Systems with Multiple Units and
Display Devices (Including Offsite Equipment)........................ 131
1. Mammography Equipment Evaluation (MEE) –
All New Digital Mammography Units and
Display Devices........................................................................... 132
2. Mammography Equipment Evaluation (MEE) –
New Digital Mammography Units
(with Existing Display Devices).............................................. 132
3. Mammography Equipment Evaluation (MEE) –
New Display Devices (with Existing Digital
Mammography Units)............................................................... 133
4. Annual Surveys............................................................................ 134
5. Major Component Service/Upgrade/Replacement/
Repair.............................................................................................. 135
E. Equipment Adjustments, Changes, or Repairs.......................... 137
III. MAMMOGRAPHY EQUIPMENT EVALUATION
AND ANNUAL SURVEY................................................... 139
A. Test Procedures.................................................................................... 139
1. Mammography Equipment Evaluation (MEE) –
MQSA Requirements for Equipment................................... 139
2. ACR Digital Mammography (DM) Phantom
Image Quality............................................................................... 143
3. DBT Z Resolution........................................................................ 157
4. Spatial Resolution....................................................................... 161
5. DBT Volume Coverage.............................................................. 164
6. Automatic Exposure Control System
Performance................................................................................. 167
7. Average Glandular Dose.......................................................... 171

116 Digital Mammography Quality Control Manual

 Contents

8. Unit Checklist............................................................................... 177

9. Computed Radiography (If Applicable)............................... 179
10. Acquisition Workstation (AW) Monitor QC....................... 182
11. Radiologist Workstation (RW) Monitor QC....................... 187
12. Film Printer QC (If Applicable)................................................. 193
13. Evaluation of Site’s Technologist QC Program................. 196
14. E valuation of Display Device Technologist
QC Program.................................................................................. 199
15. Manufacturer Calibrations (If Applicable).......................... 201
16. Collimation Assessment.......................................................... 202

MEE or Troubleshooting – Beam Quality
(Half-Value Layer) Assessment..................................................... 206

MEE or Troubleshooting – kVp Accuracy and
Reproducibility................................................................................... 210
Troubleshooting – Ghost Image Evaluation............................ 212
Troubleshooting – Viewbox Luminance................................... 215
B. Test Forms............................................................................................... 217
1. Mammography Equipment Evaluation and

PHYSICIST’S SECTION
MQSA Requirements................................................................. 220

MEDICAL
2. ACR DM Phantom Image Quality.......................................... 221
3. DBT Z Resolution........................................................................ 222
4. Spatial Resolution....................................................................... 223
5. DBT Volume Coverage.............................................................. 224
6. Automatic Exposure Control System Performance........ 225
7. Average Glandular Dose.......................................................... 227
8. Unit Checklist............................................................................... 228
9. Computed Radiography (If Applicable)............................... 229
10. Acquisition Workstation (AW) Monitor QC....................... 231
11. Radiologist Workstation (RW) Monitor QC....................... 232
12. Film Printer QC (If Applicable)................................................. 233

Digital Mammography Quality Control Manual 117

 Contents

13. Evaluation of Site’s Technologist QC Program................. 234

14. Evaluation of Display Device Technologist
QC Program.................................................................................. 235
15. Manufacturer Calibrations (If Applicable).......................... 236
16. Collimation Assessment.......................................................... 237
C. MEE or Troubleshooting Test Forms............................................. 238
1. MEE or Troubleshooting – Beam Quality
(Half-Value Layer) Assessment............................................... 239
2. MEE or Troubleshooting – kVp Accuracy and
Reproducibility............................................................................ 240
3. Troubleshooting – Ghost Image Evaluation..................... 241
4. Troubleshooting – Viewbox Luminance............................. 242
D. Summary Report Forms.................................................................... 243
1. Medical Physicist’s ACR DM QC Test Summary................ 244
2. Mammography Technique Chart.......................................... 246
3. Medical Physicist QC Letter for the Radiologist............... 247
E. Supplemental Forms.......................................................................... 249
1. Facility, Unit and Test Equipment Data............................... 250
REFERENCES......................................................................... 251
A. Downloadable from the ACR website (www.acr.org)............ 251
B. References.............................................................................................. 251
C. Additional Resources......................................................................... 252

118 Digital Mammography Quality Control Manual

 I. Revisions

Revisions Date Page(s) Section Description of Revisions

November 2nd edition with digital breast
2018 tomosynthesis QC
May 2020 121 Introduction Clarified FDA position
regarding QC for contrast
enhancement mammography
systems
May 2020 143-149 2. ACR Digital Clarified that phantom QC
Mammography needs to be performed using
(DM) Phantom clinical system settings, and
Image Quality that artifacts must be assessed
for all target-filter combinations
in clinical use
May 2020 163 4. Spatial Clarified 2D magnification
Resolution mode criteria
May 2020 167 6. Automatic Clarified Performance Criteria
Exposure
Control System
Performance
May 2020 201 15. Manufacturer Clarified Objectives
Calibration
May 2020 202-203 16. Collimation Clarified Frequency and Test
Assessment Procedure as they pertain to
2D vs. DBT and MEE vs. Annual
Survey vs. service events

PHYSICIST’S SECTION
MEDICAL

Digital Mammography Quality Control Manual Return to Table of Contents – 119

 II. Introduction

II. Introduction A. MQSA and Quality Control

For the purposes of this manual, quality control (QC) is defined as the
routine performance and interpretation of equipment function tests and
of the corrective actions taken. The objective of QC is to detect, identify,
and correct equipment-related problems before they have a deleterious
effect on clinical images. Together with the radiologist, the radiologic
technologist, and equipment service personnel, medical physicists can
help identify and eliminate these problems before patient care is affected.
The purpose of this section of the manual is to provide the medical
physicist with effective and consistent methodology for detecting and
identifying image quality problems.
The 1999 American College of Radiology (ACR) Mammography Quality
Control Manual was developed specifically for screen-film mammography
to assist facility staff in complying with the Mammography Quality
Standards Act (MQSA) Final Rule, which went into effect on April 28,
1999 [1]. Since that time, screen-film has been almost entirely replaced
by digital mammography. Furthermore, a growing number of digital
mammography systems include digital breast tomosynthesis (DBT)
capability. The 1998 MQSA Final Rule specifies that “For systems with
image receptor modalities other than screen-film [i.e., 2D or DBT], the
quality assurance program shall be substantially the same as the quality
assurance program recommended by the image receptor manufacturer,
except that the maximum allowable dose shall not exceed the maximum
allowable dose for screen-film systems.” See the MQSA Policy Guidance
Help System by the Food and Drug Administration (FDA) for more
information [2].

900.12(e) Quality assurance—equipment. (6) Quality control tests—other

modalities. For systems with image receptor modalities other than screen-film,
the quality assurance program shall be substantially the same as the quality
assurance program recommended by the image receptor manufacturer, except
that the maximum allowable dose shall not exceed the maximum allowable
dose for screen-film systems in paragraph (e)(5)(vi) of this section.

As of the publication date, five models and manufacturers of DBT

systems have been cleared by the FDA for sale in the U.S. [3], each with
its own QC manual. (Over 30 models and manufacturers of digital
mammography systems have been cleared.) These manuals all have
different manufacturer- and model-specific tests, procedures, frequencies,
and performance criteria [4]. This variation is necessary in most cases to
accommodate the design differences inherent to each device. Many of
the tests, however, could be made more consistent across platforms. The
ACR Digital Mammography Quality Control Manual has been designed
to create a generic digital mammography QC program by providing
uniform test procedures, performance criteria, and minimum test
frequencies that can be used for all manufacturers and models. 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

120 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

levels established by the manufacturer. For example, the Manufacturer

Calibrations test/procedure (if available) is software-dependent and thus
unique to each manufacturer.
Some digital mammography systems include contrast enhancement.
The FDA has approved the use of the new ACR Digital Mammography
QC Manual for digital mammography systems with contrast
enhancement. Facilities with contrast enhancement systems may
follow this manual for QC of the 2D and DBT applications of these
units, but should follow manufacturer QC procedures for contrast
enhancement applications.

Note: Facilities may use the new ACR Digital Mammography QC Manual
for digital mammography systems with contrast enhancement, but only
for the 2D and DBT applications. Facilities should follow manufacturer QC
procedures for contrast enhancement applications.

To legally allow facilities to use these new procedures instead of the

procedures required by their system’s QC manual, the ACR applied to the
FDA and was granted an amendment to the existing Alternative Standard
for Using the Quality Assurance Program Recommended by the ACR
Quality Control Manual for Full-Field Digital Mammography Systems, for
Systems without Advanced Imaging. The amended alternative standard
specifies that facilities must use the approved ACR Digital Mammography
(DM) Phantom in concert with all of the applicable manual’s procedures,
performance criteria, and minimum test frequencies for both 2D and
DBT QC. This phantom has been designed to cover most of the detector

PHYSICIST’S SECTION
area and provide the same attenuation as the small ACR mammography
phantom used in the 1999 Mammography Quality Control Manual, which
approximates a 4.2 cm thick compressed breast consisting of 50% glandular

MEDICAL
and 50% adipose tissue. If you have multiple phantoms, use the same
phantom each time on a given unit (Figure 1).

Figure 1. ACR DM Phantom. (Different manufacturer’s phantoms may appear slightly

different. Use of one manufacturer’s phantom photo does not imply ACR endorsement of
one phantom manufacturer over another.)

Digital Mammography Quality Control Manual Return to Table of Contents – 121

 II. Introduction

If a facility chooses to follow the ACR manual for its QC program, it

is no longer required to follow its manufacturer’s QC manual (for
2D or DBT). However, facilities should maintain their manufacturer’s
QC manual to refer to when performing ACR-required calibration or
troubleshooting tests.
Facilities may not use the new procedures with the small ACR
mammography phantom or use the newly developed ACR DM Phantom
with the old test procedures. The ACR DM Phantom was explicitly
designed as a tool for the ACR Digital Mammography Quality Control
Manual (for both 2D and DBT QC) and for the ACR Mammography
Accreditation Program to meet FDA MQSA phantom image quality and
dose requirements.

Note: The ACR Digital Mammography Phantom is required for the majority
of the QC tests in this manual. ACR-approved manufacturers of the
ACR Digital Mammography Phantom are listed on the ACR website.
(For more information, visit https://www.acraccreditation.org/Resources/
Digital-Mammography-QC-Manual-Resources.)

Although the ACR DM Phantom is the primary phantom used with

this manual, facilities should not discard any manufacturer-provided
phantoms since they may be needed for manufacturer-specified
calibrations or service personnel testing.
The new medical physics digital mammography test procedures and forms
were designed to simplify the conduct, documentation, and evaluation
of mammography equipment evaluations (MEEs) and annual surveys
for digital mammography. Commonly performed tests that seldom, if
ever, identified deficiencies have been eliminated, and low-yield tests
will now only be conducted during MEEs and not during routine annual
surveys. All tests are applicable to all manufacturers and models of digital
mammography equipment unless otherwise noted. Medical physicists are
encouraged to use the forms within this manual for data documentation
and their final reports, although they are not required. However, the
Medical Physicist’s ACR DM QC Test Summary form (or a copy with
identical tests recreated in the physicist’s software) must be submitted to
the ACR as part of the accreditation application.
For each of the required medical physicist tests included in this manual,
the purpose and frequency of each test is clearly stated. The equipment
and materials required to carry out each test are listed, and a step-by-step
procedure is provided. Note that other methodologies for these tests may be
used, provided that they yield the same results as the methodologies provided
in this manual. Following each procedure is a discussion of precautions and
caveats. Performance criteria are provided along with suggestions for the
types of corrective actions that may be needed to resolve problems.
Relevant MQSA regulations are provided to supplement responsibilities
and tests in this ACR Digital Mammography Quality Control Manual if
they apply.

122 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

B. Responsibilities
The MQSA Final Rule requires that the facility’s lead interpreting physician
(typically a radiologist) has the general responsibility of ensuring that the
quality assurance program meets all requirements.
In a facility where more than one technologist does mammography,
one technologist must be assigned the responsibilities of QC (the QC
technologist). Other qualified individuals may perform specific QC tests,
but they must be reviewed and evaluated by the primary QC technologist.
The primary QC technologist is responsible for ensuring that QC tasks
are done properly by standardizing test methodology, reviewing all data,
overseeing repeat testing before calling the medical physicist or service
personnel, and conferring with the radiologist and medical physicist.
Each facility must have the services of a medical physicist to survey
mammography equipment and oversee the equipment-related quality
assurance practices of the facility.

900.12(d) Quality assurance—general. (1) Responsible individuals. (iii) Medical

physicist.
Each facility shall have the services of a medical physicist available to survey
mammography equipment and oversee the equipment-related quality
assurance practices of the facility. At a minimum, the medical physicist(s) shall
be responsible for performing the surveys and mammography equipment
evaluations and providing the facility with the reports described in paragraphs
(e)(9) [Surveys] and (e)(10) [Mammography equipment evaluations] of this
section.

PHYSICIST’S SECTION
The medical physicist is required to conduct an MEE of new equipment

MEDICAL
and after major repairs. This survey must be done and all relevant tests
must be passed prior to use of digital mammography equipment on
patients.

Note: During the MEE, the medical physicist should complete the
Technologist’s ACR Technique and Procedure Summaries form (located in
the Technologist Section) to help the QC technologist use the appropriate
techniques during routine QC. This form should be reviewed and updated as
necessary during annual surveys.

Digital Mammography Quality Control Manual Return to Table of Contents – 123

 II. Introduction

900.12(e) Quality assurance—equipment. (10) Mammography equipment

evaluations. Additional evaluations of mammography units or image
processors shall be conducted whenever a new unit or processor is installed, a
unit or processor is disassembled and reassembled at the same or a new location,
or major components of a mammography unit or processor equipment are
changed or repaired. These evaluations shall be used to determine whether the
new or changed equipment meets the requirements of applicable standards in
paragraphs (b) and (e) of this section. All problems shall be corrected before
the new or changed equipment is put into service for examinations or film
processing. The mammography equipment evaluation shall be performed by a
medical physicist or by an individual under the direct supervision of a medical
physicist.

The medical physicist is also required to perform an annual survey on

each unit. (An occasional period of up to 14 months between surveys
is acceptable.) During this annual survey, the medical physicist must
also review the technologist’s QC test results and provide written
recommendations if there are problems or suggestions for improvement.
Review of the technologist’s QC program by the radiologist and medical
physicist ensures that the QC program is carried out consistently and
provides oversight to make sure that changes in image quality are not
inadvertently overlooked.

900.12(e) Quality assurance—equipment. (9) Surveys.

(i) At least once a year, each facility shall undergo a survey by a medical physicist
or by an individual under the direct supervision of a medical physicist. At a
minimum, this survey shall include the performance of tests to ensure that the
facility meets the quality assurance requirements of the annual tests described
in paragraphs (e)(5) and (e)(6) of this section and the weekly phantom image
quality test described in paragraph (e)(2) of this section.
(ii) The results of all tests conducted by the facility in accordance with
paragraphs (e)(1) through (e)(7) [quality control tests] of this section, as well as
written documentation of any corrective actions taken and their results, shall
be evaluated for adequacy by the medical physicist performing the survey.
(iii) The medical physicist shall prepare a survey report that includes a summary
of this review and recommendations for necessary improvements.

It is the responsibility of the medical physicist conducting these tests to

convey test results accurately to the facility in a written report, to make
recommendations to the facility for corrective actions according to
the test results, and to review the results with the radiologist and QC
technologist. The report must include a summary form outlining the pass
or fail results of each test along with documentation of the data obtained
during the test. The facility should provide this detailed information to the
equipment service engineer to facilitate repair. MQSA inspectors check
the medical physicist’s report to determine if the facility is in compliance
with MQSA regulations and if the medical physicist’s recommendations
have been considered by the facility.

124 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

Note: If there is need for corrective action, the medical physicist should
instruct the facility to provide a copy of its full report for the equipment
service engineer.

900.12(e) Quality assurance—equipment. (9) Surveys.

(iv) The survey report shall be sent to the facility within 30 days of the date of
the survey.
(v) The survey report shall be dated and signed by the medical physicist
performing or supervising the survey. If the survey was performed entirely or in
part by another individual under the direct supervision of the medical physicist,
that individual and the part of the survey that individual performed shall also
be identified in the survey report.

To assist the medical physicist in communicating test results and

recommendations, a Medical Physicist’s ACR DM QC Test Summary form
has been included in the Medical Physicist’s section of the QC manual.
A new report, the Medical Physicist QC Letter for the Radiologist, has
been added to help the medical physicist communicate essential, select
aspects of his or her report to the lead interpreting radiologist. A form is
provided for each test to guide the medical physicist in performing the
test, recording data, and evaluating the results. These test data forms are
flexible guides and can be modified by the medical physicist as necessary.
For many tests, a facility may not conduct mammography with that
equipment until a failure is corrected. Although the MQSA Final Rule

PHYSICIST’S SECTION
allows the medical physicist 30 days from the date of the survey to send
a report to the facility, a 30-day delay allows the facility no time to take
corrective actions. To help facilities comply with MQSA regulations, the

MEDICAL
medical physicist should immediately communicate any failures both
verbally and in writing.
Communication of test results and recommendations of corrective actions
are areas that can be improved in the practices of most medical physicists.
Corrective actions should not be limited to the repair of x-ray equipment
by qualified service personnel but should include recommendations that
will improve image quality, including recommendations concerning
detectors, technique factors, viewing conditions in the reading room, and
technologist QC. The medical physicist must, at a minimum, annually
review the results of technologist QC tests and make recommendations
regarding these tests, if needed. Furthermore, the medical physicist must
participate in annual reviews of the mammography QC program as a
whole to make sure that the program is meeting its objectives.
Mammography team members are strongly encouraged to review other
sections of the ACR Digital Mammography QC Manual that are not
directed towards them. For example, the radiologist should be familiar
with Technologist’s Test Facility QC Review and the Technologist’s
Optional Tests System QC for Radiologist and Radiologist Image
Quality Feedback. The radiologic technologist should review the Medical

Digital Mammography Quality Control Manual Return to Table of Contents – 125

 II. Introduction

Physicist’s Test Evaluation of Site’s Technologist QC Program and

Evaluation of Display Device Technologist QC Program. The medical
physicist should be familiar with all of the radiologic technologist’s tests.
The radiologist, medical physicist, QC technologist, and facility manager,
working together as a team, are the keys to providing optimum quality
mammography images, which will ultimately provide the best medical
care possible to the patient.

Note: Facility management, along with the QC technologist and medical

physicist, should work together to ensure that all “display devices” are QC’d
and reviewed properly.

C. QC Tests, Frequencies, and Timeframes

for Corrective Action
Before a facility QC technologist may start using the procedures in the
ACR Digital Mammography QC Manual for the first time on a unit,
the medical physicist must first conduct an annual survey of the digital
mammography unit and display devices using the manual and the ACR
DM 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
ACR Digital Mammography QC Manual. For current information and
more details on transitioning to the ACR Digital Mammography QC
Manual, visit the Digital Mammography QC Manual: Frequently Asked
Questions on the ACR Digital Mammography QC Manual Resources
website.

Important: Before a facility may start using the procedures in the ACR Digital
Mammography QC Manual for the first time on a unit, the medical physicist
must first conduct an annual survey of the digital mammography unit
and display devices using the manual and the ACR Digital Mammography
Phantom.

The minimum frequencies for both the technologist and medical

physicist tests are listed in Table 1. The tests designated for DBT must
be conducted in addition to the applicable tests for the 2D full-field
digital mammography system. Applicable 2D tests must be performed
whether or not the system is used for 2D imaging since they test system
components that may impact DBT performance.

Important: All applicable 2D tests must be performed in addition to the

DBT tests for each system.

If the DBT system employs an “add-on” device, applicable 2D tests must

be repeated with the “add-on” device in place.

126 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

The technologist and medical physicist will use the same forms they use
for most of the digital mammography tests to record the data and results
of the DBT tests. The previous digital mammography forms have been
revised to allow for this. New forms have been added for DBT-unique
tests (e.g., DBT Volume Coverage).
If problems are occurring or if equipment is unstable, it may be necessary
to carry out some or all tests more frequently to identify problems before
they affect clinical image quality or patient safety. If the QC program
is just being initiated, it may be valuable to carry out QC tests more
frequently for the first few months. This will provide the QC technologist
with more experience in a shorter period of time and also will provide
better baseline data regarding the reliability of imaging equipment. The
necessity of performing tests designated as “Optional” or “If applicable” is
left to discretion of the Quality Assurance Committee, especially the lead
interpreting radiologist, QC technologist, and medical physicist team,
who are most familiar with the facility’s equipment and the quality needs
of the mammography practice.
In addition to performing the mammography QC tests at the minimum
frequencies indicated, tests also should be carried out for new equipment,
both when problems are suspected and after any service or preventive
maintenance. For example, the compression test should be carried out
both when a new x-ray system is installed and after any service adjustment
of compression force.
If any test fails, it is critical that the setup and techniques employed in the
test be checked and the test repeated to verify performance before initiating
corrective action. Upon confirmation of test failure, the MQSA Final Rule
requires that the source of the problem be identified and corrective action

PHYSICIST’S SECTION
be taken. In some cases, if test results fall outside of action limits, MQSA
requires that the source of the problem be identified and corrective action

MEDICAL
taken before any further examinations are performed or any films are
processed using the component of the mammography system that failed
the test. Other test failures must be corrected within 30 days of the test
date (Table 1).

Digital Mammography Quality Control Manual Return to Table of Contents – 127

 II. Introduction

Table 1. Digital Mammography (2D and DBT) Quality Control Tests

Test Minimum Frequency Corrective Action Timeframe
Technologist Tests
1. ACR DM Phantom Image Quality Weekly Before clinical use
2. Computed Radiography Cassette Erasure (if applicable) Weekly Before clinical use
3. Compression Thickness Indicator Monthly Within 30 days
4. Visual Checklist Monthly Critical items: before clinical use;
less critical items: within 30 days
5. Acquisition Workstation Monitor QC Monthly Within 30 days; before clinical
use for severe defects
6. Radiologist Workstation Monitor QC Monthly Within 30 days; before clinical
use for severe defects
7. Film Printer QC (if applicable) Monthly Before clinical use
8. Viewbox Cleanliness (if applicable) Monthly Before clinical use
9. Facility QC Review Quarterly Not applicable
10. Compression Force Semiannual Before clinical use
11. Manufacturer Calibrations (if applicable) Mfr. Recommendation Before clinical use
Optional - Repeat Analysis As Needed Within 30 days after analysis
Optional - System QC for Radiologist As Needed Within 30 days; before clinical
use for severe artifacts
Optional - Radiologist Image Quality Feedback As Needed Not applicable
Medical Physicist Tests
1. Mammography Equipment Evaluation (MEE) - MQSA MEE Before clinical use
Requirements
2. ACR DM Phantom Image Quality MEE and Annual Before clinical use
3. DBT Z Resolution MEE and Annual Within 30 days
4. Spatial Resolution MEE and Annual Within 30 days
5. DBT Volume Coverage MEE and Annual Before clinical use
6. Automatic Exposure Control System Performance MEE and Annual Within 30 days
7. Average Glandular Dose MEE and Annual Before clinical use
8. Unit Checklist MEE and Annual Critical items: before clinical use;
less critical items: within 30 days
9. Computed Radiography (if applicable) MEE and Annual Before clinical use
10. Acquisition Workstation Monitor QC MEE and Annual Within 30 days; before clinical
use for severe defects
11. Radiologist Workstation Monitor QC MEE and Annual Within 30 days; before clinical
use for severe defects
12. Film Printer QC (if applicable) MEE and Annual Before clinical use
13. E valuation of Site’s Technologist QC Program Annual Within 30 days
14. E valuation of Display Device Technologist QC Program Annual Within 30 days
15. Manufacturer Calibrations (if applicable) Mfr. Recommendation Before clinical use
16. Collimation Assessment MEE or Troubleshooting Within 30 days
Annual (DBT only)
MEE or Troubleshooting - Beam Quality (Half-Value Layer) MEE or Troubleshooting Before clinical use
Assessment
MEE or Troubleshooting - kVp Accuracy and Reproducibility MEE or Troubleshooting MEE: before clinical use;
troubleshooting: within 30 days
Troubleshooting - Ghost Image Evaluation Troubleshooting Before clinical use
Troubleshooting - Viewbox Luminance Troubleshooting NA

128 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

Important: Corrective action for any test performed for MEEs must be made
before clinical use.

Documentation of QC and corrective action is essential. Data forms are

provided in this manual and may be copied or downloaded from the
ACR Digital Mammography QC Manual Resources website for use in
performing and documenting the digital mammography QC program.
QC data forms may be stored as either hardcopy (for example, in a
notebook) or as a file on the computer. For some tests, it may be preferable
to use software provided by equipment manufacturers or third-party
vendors that can accumulate, trend, and print out QC data. However,
the QC technologist and medical physicist must verify that all required
information is available from such software before use. If QC records
are stored electronically, all records should be periodically backed up to
prevent loss.

Note: If QC records are stored electronically, all records should be

periodically backed up to prevent loss.

For detailed guidance on the FDA’s requirements for record retention, see
Quality Assurance Records and Retention of Personnel Records in the
FDA’s MQSA Policy Guidance Help System. All documentation must be
made available to MQSA inspectors during the annual inspection and the
facility’s accreditation body upon application and request.

PHYSICIST’S SECTION
900.12(d) Quality assurance—general. (2) Quality assurance records. The lead
interpreting physician, quality control technologist, and medical physicist shall

MEDICAL
ensure that records concerning mammography technique and procedures,
quality control (including monitoring data, problems detected by analysis of
that data, corrective actions, and the effectiveness of the corrective actions),
safety, protection and employee qualifications to meet assigned quality
assurance tasks are properly maintained and updated. These quality control
records shall be kept for each test specified in paragraphs (e) and (f) of this
section until the next annual inspection has been completed and FDA has
determined that the facility is in compliance with the quality assurance
requirements or until the test has been performed two additional times at the
required frequency, whichever is longer.

Table 2 provides a complete list of all the digital mammography tests and
summarizes those tests that must be performed (as applicable) for the
modes that the facility uses clinically on its 2D and DBT systems.

Digital Mammography Quality Control Manual Return to Table of Contents – 129

 II. Introduction

Table 2. Required Tests for Imaging Modes Used on 2D and DBT Systems
Imaging Modes to Test
System Used for Both 2D and System Used for DBT
DBT Acquisition Acquisition Only
2D w/Add-On
Test 2D DBT Device DBT DBT
Technologist Tests
1. ACR DM Phantom Image Quality *    & 2D*
2. Computed Radiography Cassette *
Erasure (if applicable)
3. Compression Thickness Indicator * * *
4. Visual Checklist *   
5. Acquisition Workstation Monitor QC * *
6. Radiologist Workstation Monitor QC * *
7. Film Printer QC (if applicable) * *
8. Viewbox Cleanliness (if applicable) * *
9. Facility QC Review *   
10. Compression Force * * *
11. Manufacturer Calibrations (if applicable) *   
Medical Physicist Tests
1. Mammography Equipment Evaluation (MEE) * *
2. ACR DM Phantom Image Quality *    & 2D*
3. DBT Z Resolution  
4. Spatial Resolution *   
5. DBT Volume Coverage  
6. Automatic Exposure Control System Performance *   
7. Average Glandular Dose *   
8. Unit Checklist *   
9. Computed Radiography (if applicable) *
10. Acquisition Workstation Monitor QC * *
11. Radiologist Workstation Monitor QC * *
12. Film Printer QC (if applicable) * *
13. Evaluation of Site’s Technologist QC Program *   
14. Evaluation of Display Device Technologist QC * *
Program
15. Manufacturer Calibrations (if applicable) *   
16. Collimation Assessment * *  
MEE or Troubleshooting - Beam Quality *TF
*TF
(Half-Value Layer [HVL]) Assessment
MEE or Troubleshooting - kVp Accuracy and *TF *TF
Reproducibility
*Follow the procedures and frequency outlined for 2D QC
TF
HVL and kVp tests must include kVp, target, and filter combinations used for DBT

130 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

As an example, if a facility has a system that performs 2D, 2D with an

add-on DBT device, and DBT, both the technologist and the medical
physicist must evaluate phantom images for the 2D, 2D with an add-
on DBT device, and DBT imaging modes. However, the Acquisition
Workstation Monitor QC and Radiologist Workstation Monitor QC tests
are only required to be evaluated using the 2D procedure and images.
If a system is not used for 2D mammography and is only used for DBT
imaging, the technologist and the medical physicist are required to
evaluate phantom images for the DBT and 2D imaging modes. For the
Acquisition Workstation and Radiologist Workstation QC Tests, the 2D
procedures should be used to evaluate the 2D image.

Important: During MEEs of DBT systems, the medical physicist must

evaluate the kVp, target, and filter combinations used in DBT imaging.

D. Surveys of Systems with Multiple Units and

Display Devices (Including Offsite Equipment)
More and more mammography facilities are consolidating sites
containing a single mammography unit into facilities with multiple
units and radiologist workstations. Improved digital communications
technology also enables remote routine interpretation of breast images
by offsite radiologists. This introduces a new level of complexity for the
medical physicist when conducting and managing annual surveys and
mammography equipment evaluations (MEEs) of new equipment (and
after major repairs). The following scenarios provide guidance to the

PHYSICIST’S SECTION
medical physicist for the combination of testing that must be performed
for MEEs and annual surveys.

MEDICAL
For purposes of these examples, “display devices” refers to acquisition
workstations (AWs), radiologist workstations (RWs), or film printers (if
applicable). The solid and dashed arrows in the figures indicate that the
ACR DM Phantom image must be sent along this pathway and evaluated
(see the ACR DM Phantom Image Quality test) on the designated display
device. The gray shaded box indicates that all applicable testing from this
manual must be done for the devices included in the box.
MEEs and annual surveys of radiologist workstations must be conducted
on site by the medical physicist since the quality of the image displayed
on the monitor itself must be evaluated. This cannot be done remotely.
However, if the workstation is located at a great distance from the
mammography facility (e.g., another part of the country) the facility
may use the services of a medical physicist closer to the location of
the radiologist workstation. It is essential that MEE and annual survey
reports of offsite radiologist workstations be available at the facility where
the mammography unit is located in order to satisfy inspection and
accreditation requirements.
MEEs and annual surveys of film printers (if applicable) may be
conducted remotely by the medical physicist since the quality of the

Digital Mammography Quality Control Manual Return to Table of Contents – 131

 II. Introduction

image displayed may be evaluated on the resultant film that is shipped

to the medical physicist for review. Again, it is essential that MEE and
annual survey reports of offsite film printers be available at the facility
where the mammography unit is located in order to satisfy inspection
and accreditation requirements.

1. Mammography Equipment Evaluation – All New Digital

Mammography Units and Display Devices
In the scenario shown in Figure 2, all equipment (digital mammography
units, acquisition workstations, radiologist workstations, and film
printers) are replaced or newly installed at the facility. This may occur
at a new facility or an existing, previously accredited and certified
facility. The equipment may be new, previously owned, or relocated from
another facility under the same ownership. The phantom images used
for evaluation should have been acquired from any of the facility’s digital
mammography units within the past month.
The following combination of testing must be performed:

Figure 2. MEE – All New Digital Mammography Units and Display Devices.

2. Mammography Equipment Evaluation –

New Digital Mammography Units (with Existing
Display Devices)
In the scenario shown in Figure 3, only the digital mammography unit
1 (DM 1) is new (including the acquisition workstation). The display
devices (radiologist workstations and film printers) are pre-existing, as
is digital mammography unit 2 (DM 2). The new digital mammography
unit may be new, previously owned, or relocated from another facility
under the same ownership.

132 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

The following combination of testing must be performed:

Figure 3. MEE – New Digital Mammography Units (with Existing Display Devices).

3. Mammography Equipment Evaluation – New Display

Devices (with Existing Digital Mammography Units)
In the scenario in Figure 4, only display devices (an acquisition
workstation 2 (AW 2), radiologist workstations 1 and 4 (RW 1 and
RW 4), and film printer 2) are new. The digital mammography unit 2
(DM 2) is pre-existing. Digital mammography unit 1 (DM 1) and
acquisition workstation 1 (AW 1) are also pre-existing. The display devices

PHYSICIST’S SECTION
may be new, previously owned, or relocated from another facility under
the same ownership. The phantom images used for evaluation should
have been acquired from any of the facility’s digital mammography units

MEDICAL
within the past month.
The following combination of testing must be performed:

Figure 4. MEE – New Display Devices (with Existing Digital Mammography Units).

Digital Mammography Quality Control Manual Return to Table of Contents – 133

 II. Introduction

4. Annual Surveys
Medical physicists must conduct annual surveys on all digital mammography
units, acquisition workstations, radiologist workstations, and film printers
(if applicable). At some facilities, it is possible for the medical physicist to
do this at one time. However, many medical physicists choose to separate
the annual survey for the digital mammography units from that of the
display devices because the workstations or printers are located at different
physical locations from the digital mammography units or equipment repair
has shifted the timing of the survey(s). For this reason, the annual survey
scenarios in Figure 5 are presented separately for the digital mammography
units and the display devices. However, it is important to note that the
annual survey of the digital mammography units and the display devices
may be done at one time.
If the annual surveys for the display devices are done separately from
the digital mammography unit, a phantom image stored on the facility’s
picture archiving and communication system (PACS) may be used.
This image should have been acquired from any of the facility’s digital
mammography units within the past month.
The following combination of testing must be performed:

Figure 5 – Annual Surveys A. Digital Mammography Units. B. Display Devices.

134 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

5. Major Component Service/Upgrade/Replacement/Repair

The medical physicist must perform additional evaluations whenever
major components of the mammography equipment are changed or
repaired. The solid and dashed arrows in the figures indicate that the
ACR DM Phantom image must be sent along this pathway and evaluated.
The gray shaded box indicates that all applicable testing from this
manual must be done for the devices included in the shaded box. For
major component service, upgrade, replacement, or repair, the tests that
are applicable will depend on the component involved. For example, if
the collimator was repaired, the ACR DM Phantom Image Quality and
Collimation Assessment tests should be performed but the other tests
outlined in the QC manual may not be necessary.
In Figure 6, part A, a digital mammography unit (DM 1) has undergone
major service, while in part B, an acquisition workstation (AW 2), a
radiologist workstation (RW 1), and an offsite printer have undergone
major service.
The following combination of testing must be performed:

PHYSICIST’S SECTION
MEDICAL

Digital Mammography Quality Control Manual Return to Table of Contents – 135

 II. Introduction

Figure 6. Major Component Service/Upgrade/Replacement/Repair A. Digital

Mammography Unit 1. B. Display Devices (AW 2, RW 1, and Offsite Printer 2).

136 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. Introduction

E. Equipment Adjustments, Changes, or Repairs

At a minimum, the medical physicist must be on-site to perform or to
provide direct supervision for the performance of
• The annual survey
• Mammography equipment evaluations
Determining when a medical physicist must be on-site in connection
with adjustments, changes, or repair of equipment requires further
discussion. Adjustments, changes, or repairs of equipment can occur
as corrective actions for problems that caused the equipment to fail a
quality control test, as the result of an unexpected equipment failure, or
as a measure intended to prevent possible future inadequate equipment
performance. All adjustments, changes, or repairs must include some
form of verification testing to demonstrate that the affected equipment
meets the applicable standards. The FDA outlines 3 situations:
In the case of major adjustments, changes, or repairs, the
1. 
FDA regulations require the medical physicist to conduct an on-
site MEE.
2. The FDA also recommends that the medical physicist have a role
in some other changes or repairs through the provision of medical
physicist oversight where the facility consults with the medical
physicist to determine if an on-site visit is required or if other
personnel can verify that the standards are met.
3. The FDA recognizes that there are adjustments, changes, or repairs
for which verification (that the adjusted, changed, or repaired

PHYSICIST’S SECTION
equipment meets standards) can be performed by other qualified
personnel (e.g., radiologic technologist or service representative
with appropriate training/experience) without involving the medical

MEDICAL
physicist. However, the facility can consult its medical physicist in
these situations if it wishes.
Table 3 lists typical component adjustments, changes, or repairs that may
occur in a digital mammography system along with medical physicist
involvement (i.e., on-site, oversight, or optional) recommended by the
FDA and the ACR. Be sure to check the FDA’s MQSA Policy Guidance
Help System for current guidance on testing.

Digital Mammography Quality Control Manual Return to Table of Contents – 137

 II. Introduction

Table 3. Medical Physicist Involvement in Equipment Adjustments, Changes, or Repairs

Major Medical Physicist
Item Component Repair Involvement
Automatic Exposure AEC replacement Y On-site
Control (AEC) AEC recalibration that affects dose Y On-site
AEC sensor replacement Y On-site
AEC circuit board replacement Y On-site
Density control - internal adjustment* N Oversight
Thickness compensation - internal* adjustment N Oversight
Bucky Replacement AEC sensor also replaced Y On-site
AEC sensor not replaced N Oversight
DM detector also replaced Y On-site
DM detector not replaced N Oversight
Collimator Replacement Y On-site
Reassembly with blade replacement Y On-site
Adjustment N Oversight
Compression Device Pressure adjustment N Optional
Thickness scale accuracy adjustment but only if it N Oversight
affects AEC performance
Repair of auto decompression N Optional
Compression Paddle Paddle (new to facility) N Oversight
Deflection adjustment N Oversight
Adjustment due to extension beyond allowable N Oversight
limit, or visible on images
X-ray Unit Installation Y On-site
Reassembly Y On-site
X-ray tube replacement Y On-site
High voltage generator replacement Y On-site
Filter replacement Y On-site
Manufacturer’s software upgrade or Y On-site
modifications
DM detector replacement or repair Y On-site
kVp, mA, or time - internal* adjustments N Oversight
Display Devices New installation or replacement Y On-site
New video card or software upgrade Y On-site
Relocation N Oversight
Computed Radiography New installation or replacement of CR reader Y On-site
(CR) and Photostimulable Replacement of all PSP plates Y On-site
Phosphor (PSP) Plates
One or 2 new PSP plates N Oversight
*Internal adjustments refer to equipment adjustments that typically cannot be made by the operator.

138 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

Mammography A. Test Procedures

Equipment
Evaluation and 1. Mammography Equipment Evaluation (MEE) – MQSA
Requirements for Equipment
Annual Survey

OBJECTIVES To ensure that mammography equipment meets Section 900.12(b)

of FDA’s Final Rule for Mammography and complies with MEE-only
required tests.
FREQUENCY • As part of the MEE of new units, after relevant service, and after
component replacement.
• Because generators used in digital mammography are very stable, the
kVp Accuracy and Reproducibility tests that are based on the FDA
screen-film annual survey rule in Section 900.12(e)5(ii) need to be
done only for MEEs or if additional troubleshooting is needed to
diagnose a potential problem. Similarly, the Beam Quality (Half-
Value Layer) Assessment based on the FDA screen-film annual
survey rule in Section 900.12(e)5(iv) only needs to be done for
MEEs or if additional troubleshooting is needed to diagnose a
potential problem. See the procedures and forms in the MEE or
Troubleshooting Test section for instructions.

Note: For the kVp Accuracy and Reproducibility and Beam Quality (Half-
Value Layer) Assessment tests, see the procedures and forms in the MEE or
Troubleshooting Test section.

PHYSICIST’S SECTION
TEST EQUIPMENT General [Section 900.12(b)]

MEDICAL
Mammography Equipment Evaluation - MQSA Requirements checklist
(required)

TEST PROCEDURE General [Section 900.12(b)]

1. Evaluate each applicable item listed on the MQSA Requirements for
Mammography Equipment Checklist.
2. C
 heck whether each assessment meets FDA requirements.

DATA ANALYSIS AND General [Section 900.12(b)]

INTERPRETATION
None

PRECAUTIONS General [Section 900.12(b)]

AND CAVEATS
There are several digital mammography scenarios that may not be
applicable to FDA Rule Sec. 900.12 (b) (14) and (15), which outlines the

Digital Mammography Quality Control Manual Return to Table of Contents – 139

 III. Mammography Equipment Evaluation and Annual Survey

requirements for hotlighting or film masking devices. “Lighting” and

“Film masking” may be marked as “NA” if
1. No hardcopy interpretations are made
2. No hardcopy comparisons are made
3. 
For new units at existing facilities, these items were previously
evaluated and have not changed

X-ray Beam Limiting Device Illumination

[Section 900.12(b)5(ii)]
This test may not apply to systems without x-ray beam limiting devices
such as slot-scan systems.

Compression Paddle Deflection [Section 900.12(b)8(ii)(B)]

This test ensures that adequate compression is applied uniformly over the
breast for paddles that are designed to be flat and parallel to the breast
support.
Some paddles are designed not to be flat and parallel to the breast support
during compression. These paddles should not be evaluated using the
procedure described above but rather must meet the manufacturer’s
design specifications and maintenance requirements.

PERFORMANCE General [Section 900.12(b)]

CRITERIA AND
CORRECTIVE ACTIONS 1. Evaluate each applicable item listed on the MQSA Requirements for
Mammography Equipment checklist.
2. Check whether each assessment meets FDA requirements.

X-Ray Beam Limiting Device Illumination

[Section 900.12(b)5(ii)]
The light must provide an average illumination of not less than 160 lux
(15 ft-candles) at 100 cm or the maximum source-image receptor
distance, whichever is less.

Compression Paddle Deflection [Section 900.12(b)8(ii)(B)]

The compression paddle must be flat and parallel to the breast support
table and shall not deflect from parallel by more than 1.0 cm at any point
on the surface of the compression paddle when compression is applied.
(This does not apply to compression paddles not designed to be “flat and
parallel.”)
TIMEFRAME FOR All failures must be corrected before clinical use.
CORRECTIVE ACTION

140 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

APPLICABLE MQSA
REQUIREMENTS 900.12(b) Equipment.
(3) Motion of tube-image receptor assembly.
(i) The assembly shall be capable of being fixed in any position where it is
designed to operate. Once fixed in any such position, it shall not undergo
unintended motion.
(ii) The mechanism ensuring compliance with paragraph (b)(3)(i) of this section
shall not fail in the event of power interruption.
(4) Image receptor sizes.
(iii) Systems used for magnification procedures shall be capable of operation
with the grid removed from between the source and image receptor.
(5) Light fields. For any mammography system with a light beam that passes
through the X-ray beam-limiting device, the light shall provide an average
illumination of not less than 160 lux (15 foot-candles) at 100 cm or the
maximum source-image receptor distance (SID), whichever is less.
(6) Magnification.
(i) Systems used to perform non-interventional problem solving procedures shall
have radiographic magnification capability available for use by the operator.
(ii) Systems used for magnification procedures shall provide, at a minimum, at
least one magnification value within the range of 1.4 to 2.0.
(7) Focal spot selection.
(i) When more than one focal spot is provided, the system shall indicate, prior to
exposure, which focal spot is selected.
(ii) When more than one target material is provided, the system shall indicate,
prior to exposure, the preselected target material.
(iii) When the target material and/or focal spot is selected by a system algorithm
that is based on the exposure or on a test exposure, the system shall display,

PHYSICIST’S SECTION
after the exposure, the target material and/or focal spot actually used during
the exposure.

MEDICAL
(8) Compression. All mammography systems shall incorporate a compression
device.
(i) Application of compression. Effective October 28, 2002, each system shall
provide:
(A) An initial power-driven compression activated by hands-free controls
operable from both sides of the patient; and
(B) Fine adjustment compression controls operable from both sides of the
patient.
(ii) Compression paddle.
(A) Systems shall be equipped with different sized compression paddles
that match the sizes of all full-field image receptors provided for the system.
Compression paddles for special purposes, including those smaller than the
full size of the image receptor (for “spot compression”) may be provided. Such
compression paddles for special purposes are not subject to the requirements
of paragraphs (b)(8)(ii)(D) and (b)(8)(ii)(E) of this section.
(B) Except as provided in paragraph (b)(8)(ii)(C) of this section, the compression
paddle shall be flat and parallel to the breast support table and shall not
deflect from parallel by more than 1.0 cm at any point on the surface of the
compression paddle when compression is applied.

Digital Mammography Quality Control Manual Return to Table of Contents – 141

 III. Mammography Equipment Evaluation and Annual Survey

(C) Equipment intended by the manufacturer’s design to not be flat and parallel
to the breast support table during compression shall meet the manufacturer’s
design specifications and maintenance requirements.
(D) The chest wall edge of the compression paddle shall be straight and parallel
to the edge of the image receptor.
(E) The chest wall edge may be bent upward to allow for patient comfort but
shall not appear on the image.
(9) Technique factor selection and display.
(i) Manual selection of milliampere seconds (mAs) or at least one of its
component parts (milliampere (mA) and/or time) shall be available.
(ii) The technique factors (peak tube potential in kilovolt (kV) and either tube
current in mA and exposure time in seconds or the product of tube current and
exposure time in mAs) to be used during an exposure shall be indicated before
the exposure begins, except when automatic exposure controls (AEC) are used,
in which case the technique factors that are set prior to the exposure shall be
indicated.
(iii) Following AEC mode use, the system shall indicate the actual kilovoltage
peak (kVp) and mAs used during the exposure. The mAs may be displayed as
mA and time.
(14) Lighting. The facility shall make special lights for film illumination, i.e., hot-
lights, capable of producing light levels greater than that provided by the view
box, available to the interpreting physicians.
(15) Film masking devices. Facilities shall ensure that film masking devices that
can limit the illuminated area to a region equal to or smaller than the exposed
portion of the film are available to all interpreting physicians interpreting for
the facility.

142 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

2. ACR Digital Mammography (DM) Phantom Image Quality

OBJECTIVES To ensure that the image acquisition chain is consistently producing
adequate image quality, that artifacts are not clinically significant, and
that the signal-to-noise ratio and contrast-to-noise ratio are adequate.
FREQUENCY As part of the mammography equipment evaluation (MEE) of new units,
annually, and after relevant service.
TEST EQUIPMENT •  CR DM Phantom (required). This phantom has been designed to
A
cover the majority of the DM detector area and provide the same
attenuation as the small ACR mammography phantom used in the
1999 Mammography Quality Control Manual; it approximates a 4.2
cm thick compressed breast consisting of 50% glandular and 50%
adipose tissue. If you have multiple phantoms, use the same phantom
each time on a given unit (Figure 1).
• ACR DM Phantom Image Quality form.

Important: Do not follow the phantom imaging instructions or technical

factors provided in the manufacturer’s QC manual. Be sure to follow the
instructions below. This technique must be the same as that used clinically
for a 4.2 cm thick compressed breast consisting of 50% glandular and 50%
adipose tissue, as defined by the FDA.

Important: If clinical images are acquired using a combination mode (i.e. 2D

plus DBT), then acquire the phantom using the clinical combination mode
and evaluate the combination image set (2D and DBT). If clinical 2D and DBT
images are acquired using separate acquisition modes, then acquire the 2D
and DBT phantom images independently using their respective clinical modes.

PHYSICIST’S SECTION
900.2 Definitions. (uu) Standard breast means a 4.2 centimeter (cm) thick

MEDICAL
compressed breast consisting of 50 percent glandular and 50 percent adipose
tissue.

TEST PROCEDURE ACR DM Phantom Image Acquisition - 2D

1. Initiate an exam at the acquisition workstation as you would for a
patient.
2. Use a name and image designation system that allows tracking of QC
images. It is important to be able to match and identify the DM unit
to the printed image from that same unit. See example below:
a. Last Name: ACR DM Phantom
b. First Name: Room 1
c. Patient ID: “Date of Phantom Acquisition”
d. Date of Birth: “Date of Phantom Acquisition”
3. Use the largest available image receptor size and corresponding
paddle for the ACR DM Phantom image acquisition. Ensure that

Digital Mammography Quality Control Manual Return to Table of Contents – 143

 III. Mammography Equipment Evaluation and Annual Survey

the type of paddle chosen (e.g., flex or fixed) is the one used for the
majority of clinical imaging.

Important: For computed radiography (CR), completely erase the CR

cassette prior to obtaining the phantom image.

4. Place the ACR DM phantom on the breast support surface as shown

in Figure 7. Be sure to position the phantom in the same location
each time the test is performed to limit exposure variability. Check
that
a. The pink wax insert is on the top side of the phantom and nearer
the chest wall,
b. The phantom is centered left-to-right, and
c. The edge of the phantom is aligned with the chest-wall edge of
the digital image receptor.

Figure 7. ACR DM Phantom positioned for image acquisition on a 2D system.

5. 
Manually compress the paddle to approximately 5 decanewtons
(daN) or 12 pounds of compression force. It is important to use
the same compression force each time for this test. Note that at this
compression force, the compressed breast thickness indicator may
not read 4.2 cm.
6. At the acquisition workstation, select the imaging mode and technique
that would be used for a clinical screening exam acquisition of a 4.2
cm thick compressed breast consisting of 50% glandular and 50%
adipose tissue. If a combination exposure mode (i.e. 2D plus DBT)
is most commonly used clinically, use the combination mode for this
test, record the data from the 2D and DBT acquisitions, and use
those images for analysis. If a 2D-only mode is most commonly used
clinically for screening, use the 2D-only mode for this procedure
step. (If the system uses selectable AEC sensor positions, be sure to
use the same position each time the phantom is acquired.)

144 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

Note: This technique must match the technique used by the technologist
for his or her weekly QC. This technique should be listed in the ACR
Technique and Procedure Summaries form that the technologist maintains.

7. Record or verify the following demographic information at the top of

the form:
a. Facility
b. Mammography Accreditation Program (MAP) ID number
c. ACR DM phantom manufacturer and serial number
d. Room ID
e. X-ray unit manufacturer and model
f. Unit source-image receptor distance (SID) in centimeters (cm)
8. Record or verify and use the following technique parameters in the
“Phantom Setup” box at the top of the form. These parameters should
match the techniques found on the Technologist’s ACR Technique
and Procedure Summaries form, which should be located in the
phantom section of the technologist’s QC notebook.
a. AEC mode
b. Paddle and image receptor (IR) size
c. Paddle type (regular or flex)
d. View or selected image

PHYSICIST’S SECTION
e. Compression force

MEDICAL
f. AEC cell position (if applicable)
g. Target/filter (if applicable)
h. kVp (if applicable)
i. Density setting (if applicable)

Note: These parameters must be used for all subsequent phantom

exposures. Consistent exposure parameters will help in troubleshooting
problems.

9. Acquire an image of the phantom.

10. Record the following parameters that appear after the exposure on
the form:
a. Target/filter material (e.g., Mo/Mo, W/Ag, etc.)
b. kVp (e.g., 28)

Digital Mammography Quality Control Manual Return to Table of Contents – 145

 III. Mammography Equipment Evaluation and Annual Survey

c. mAs (e.g., 78.5)

d. The unit-indicated average glandular dose (AGD) in milligray
(mGy) for the phantom exposure, if available. (This will be
compared to the measured AGD in the Average Glandular Dose
test.)
11. Repeat for magnification mode and all target/filter combinations in
clinical use.

ACR DM Phantom Image Acquisition - DBT

1. Initiate an exam at the acquisition workstation as you would for a
patient.
2. Use a name and image designation system that allows tracking of QC
images. It is important to be able to match and identify the DM unit
to the printed image from that same unit. See example below:
a. Last Name: ACR DM Phantom
b. First Name: Room 1
c. Patient ID: “Date of Phantom Acquisition”
d. Date of Birth: “Date of Phantom Acquisition”
3. Use the largest available image receptor size and corresponding
paddle for the ACR DM Phantom image acquisition. Ensure that
the type of paddle chosen (e.g., flex or fixed) is the one used for the
majority of clinical imaging.
4. Place the DM phantom on the breast support surface as shown in
Figure 8. Be sure to position the phantom in the same location each
time the test is performed to limit exposure variability. Check that
a. The pink wax insert is on the top side of the phantom and nearer
the chest wall,
b. The phantom is centered left-to-right, and
c. The edge of the phantom is aligned with the chest-wall edge of
the digital image receptor.
5. Manually compress the paddle to 5 daN or 12 pounds of compression
force. It is important to use the same compression force each time for
this test. Note that at this compression force, the compressed breast
thickness indicator may not read 4.2 cm.
6. At the acquisition workstation, select the DBT imaging mode and
technique that would be used for a clinical exam acquisition of a 4.2
cm thick compressed breast consisting of 50% glandular and 50%
adipose tissue. If a combination exposure mode (i.e. 2D plus DBT)
is most commonly used clinically, use the combination mode for this
test, record the data from the 2D and DBT acquisitions, and use
those images for analysis. If a DBT-only mode is most commonly

146 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

Figure 8. ACR DM Phantom positioned for image acquisition on a DBT system.

used clinically for screening, use the DBT-only mode for this
procedure step. (If the system uses selectable AEC sensor positions,
be sure to use the same position each time the phantom is acquired.)

Note: This technique must match the technique used by the technologist
for his or her weekly QC. This technique should be listed in the ACR Technique

PHYSICIST’S SECTION
and Procedure Summaries form that the technologist maintains.

MEDICAL
7. Record or verify the following demographic information at the top of
the form:
a. Facility
b. MAP ID number
c. ACR DM phantom manufacturer and serial number
d. Room ID
e. X-ray unit manufacturer and model
f. Unit SID in cm
8. 
Record or verify and use the following technique parameters in the
“Phantom Setup” box at the top of the form. These parameters should
match the techniques found on the Technologist’s ACR Technique
and Procedure Summaries form, which should be located in the
phantom section of the technologist’s QC notebook.
a. AEC mode
b. Paddle and IR size

Digital Mammography Quality Control Manual Return to Table of Contents – 147

 III. Mammography Equipment Evaluation and Annual Survey

c. Paddle type (regular or flex)

d. View or selected image
e. Compression force
f. AEC cell position (if applicable)
g. Target/filter (if applicable)
h. kVp (if applicable)
i. Density setting (if applicable)

Note: These parameters must be used for all subsequent phantom

exposures. Consistent exposure parameters will help in troubleshooting
problems.

9. 
Acquire an image of the phantom.
10. Record the following parameters that appear after the exposure on
the form:
a. Target/filter material (e.g., Rh/Rh, W/Ag, etc.)
b. kVp (e.g., 32)
c. mAs (e.g., 78.5)
d. The unit-indicated AGD in mGy for the phantom exposure, if
available (This will be compared to the measured AGD in the
Average Glandular Dose test.)
11. 
If the system uses an add-on device for DBT, repeat steps 3-11 in 2D
mode with the DBT fixture in place.

DATA ANALYSIS AND ACR DM Phantom – 2D and DBT

INTERPRETATION
1. If possible, reduce the lighting in the acquisition room to be similar
to that in the radiologist’s reading room before image evaluation.
2. 
View the phantom image on the acquisition workstation (AW)
display monitor. If review is not possible on the AW, then review on
a radiologist workstation.

Note: Digital mammography phantom images must be “for presentation”

(i.e., “processed,” not “for processing” or “raw”) for viewing and scoring (if
applicable).

148 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

For DBT images, scroll to the one slice in which the test objects are
3. 
best visualized. If “slices” are not available, then proceed to use the
slab in which the objects are best visualized.
4. Adjust the window width (WW) and window level (WL) settings to
optimize visualization of test objects (the test objects will be scored
in the next section). It is important not to use unreasonably narrow
WWs that may enhance the appearance of artifacts.
5. Record the approximate WW and WL settings (and best visualized
slice or slab # for DBT scoring) on the Technologist’s ACR Technique
and Procedure Summaries form.
6. 
Using approximately the same WW and WL settings used to
evaluate the test objects, examine the entire phantom for both broad
area artifacts and detailed artifacts. (See Figure 9 for examples of a
properly windowed ACR digital phantom images without artifacts.)
a. Broad area artifacts (e.g., non-uniformities, blotches, and streaks)
usually are best seen while observing the phantom image as a
whole and not in pieces (i.e., not magnified or at full resolution).
b. Detailed artifacts (e.g., black or white pixels, clusters of pixels,
lines, or dust particles) usually are best seen while observing the
phantom image at full spatial resolution, where one pixel on the
display matches one pixel in the image, or with magnification,
using a zoom factor greater than 1.0.
7. See the Artifact Evaluation Guide in Appendix III for examples of
“good” or “artifact free” images and some common digital artifacts.
8. For phantom images from each mode and target/filter combination,

PHYSICIST’S SECTION
record the absence or presence of artifacts on the form as a Pass or
Fail (P or F).

MEDICAL
9. To score the phantom image, adjust the WW and WL settings to
optimize visualization of test objects. You may need to slightly adjust
the WW and WL to obtain optimum visualization of each test object.
The zoom or magnification tool should also be used. Use a WW
and WL that permit the best visualization of fibers, speck groups,
and masses. Using the scoring methods described below, score the
number of fibers, speck groups, and masses seen in the phantom and
record the scores on the form. (See Figure 10.)
10. Do not deduct for artifacts. (Deducting for artifacts is no longer part
of the ACR DM Phantom scoring procedure.)
11. Scoring method (see Figure 11 and Table 4):
a. Count the number of visible objects, from the largest object of a
given type (fiber, speck group, or mass) downward, until a score
of 0 or ½ is reached, then stop counting for that object type.
(This step is the same as used in the 1999 Mammography Quality
Control Manual [5].) For each test object type, the minimum
possible score is 0 objects and the maximum possible score is
6 objects.

Digital Mammography Quality Control Manual Return to Table of Contents – 149

 III. Mammography Equipment Evaluation and Annual Survey

Figure 9. Images of a properly windowed ACR DM Phantom with no artifacts.

A. 2D. B. DBT.

b. Fibers
i. The fibers are manufactured to be 10 mm in length. If the
entire length of the fiber is not visible, measure it using the
display device’s electronic calipers.
ii. Count each fiber as 1 point if 8 mm or more of the fiber is
visible in the correct location and orientation.
iii. Count a fiber as ½ point if the fiber appears to be equal to or
greater than 5 mm and less than 8 mm in length and is in the
correct location and orientation.

150 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

Figure 10. DBT image of a magnified and properly windowed ACR DM Phantom.

PHYSICIST’S SECTION
MEDICAL
Figure 11. ACR DM Phantom wax insert map (test object sizes are not to scale).

Table 4. ACR DM Phantom Image Scoring Key

Test
Object Full Point Half Point
Fibers (6) • Full length visible (≥8 mm • At least half of length
long) visible (≥5 and <8 mm long)
• Correct location • Correct location
• Correct orientation • Correct orientation
• 1 break allowed (must be ≤ • 1 break allowed (must be ≤
width of fiber) width of fiber)
Speck • 4 to 6 specks visible • 2 to 3 specks visible
Groups (6) • Correct locations • Correct locations
Masses (6) • Density difference visible • Density difference visible
• Border is continuous and • Border is not continuous or
generally circular (≥ ¾ generally circular (≥ ½ and
border visible) < ¾ border visible)
• Correct location • Correct location

Digital Mammography Quality Control Manual Return to Table of Contents – 151

 III. Mammography Equipment Evaluation and Annual Survey

iv. If a small gap in the fiber is visible, and it is less than the width
of the fiber, count the fiber as a full or half point depending on
the total visible length.
c. Speck groups
i. Count each speck group as 1 point if 4 to 6 specks are visible
in the proper locations in the group.
ii. Count a speck group as ½ point if 2 or 3 specks are visible in
the proper locations in the group.
d. Masses
i. Count each mass as 1 point if an object is visible in the correct
location and the mass appears to be generally circular against
the background (at least ¾ of the border is continuous and
generally round).
ii. Count a mass as ½ point if a mass-like object is visible in
the correct location but does not have a generally circular
appearance (greater than ½ but less than ¾ of a circle).
12. Enter the final scoring result in each category (fibers, speck groups,
and masses) on the form.
13. If the system uses a separate breast support system for DBT, repeat
steps 1-12 for the 2D mode image acquired with the DBT breast
support system in place.
14. If 2D add-on devices are used clinically, repeat the above steps to
score the resulting 2D image.
15. See the ACR DM Phantom Scoring Guide in Appendix II for
examples on scoring.

Signal-to-Noise Ratio (SNR) and Contrast-to-Noise Ratio

(CNR) – 2D Only

Note: Some systems do not permit CNR measurements. Other systems

permit CNR measurements, but care must be taken to ensure that
measurements are being made on the appropriate image type (“raw” or
“for-processing,” rather than “processed”).

1. If the manufacturer provides a DC offset, record this value on the

form.
2. Record the last MEE’s CNR on the form if available. (This does not
apply to MEEs.)
3. Calculate the lower limit for the current CNR as 85% of the last
MEE’s CNR, and record.
4. Verify that the appropriate image for region of interest (ROI) analysis
is being used. This can be done by verifying that the signal value

152 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

measured in the CNR cavity of the ACR DM Phantom is higher than

the signal value measured in the background area of the ACR DM
Phantom, using steps 5-7 below. This verifies that a thinner region of
the phantom has higher signal at the detector.
5. With the image displayed so that the CNR cavity is clearly visible,
place a circular or rectangular ROI of approximately 1 cm diameter
over and entirely contained within the 2 cm diameter CNR cavity.
Record the mean signal value (or mean analog to digital units) as
Mean Cavity Signal on the form. This number will be used to calculate
the CNR. (See Figure 12.)
6. In a similarly sized ROI as used above, but adjacent to and outside
the CNR cavity, measure the Mean Background (Bkgd) Signal and
record it on the form.
7. Using the same background ROI outside the CNR cavity as above, enter
the standard deviation (Std Dev) of background signal on the form.
8. Calculate the SNR as:

(Mean Bkgd Signal – DC offset)

SNR =
Std Dev of Bkgd

(Omit the DC offset if this does not apply for the DM unit being
tested.)
9. Record the SNR on the form.
10. Calculate the CNR as:

PHYSICIST’S SECTION
(Mean Cavity Signal – Mean Bkgd Signal)
CNR =
Std Dev of Bkgd

MEDICAL
11. Record the CNR on the form.

Figure 12. Image of ROI placement on ACR DM Phantom.

Digital Mammography Quality Control Manual Return to Table of Contents – 153

 III. Mammography Equipment Evaluation and Annual Survey

Distance Measurement – 2D and DBT

1. 
Using a measurement tool within the manufacturer software,
measure the distance across the wax insert in the anode-cathode (A-
C) direction. For DBT, this measurement should be made in the test
object slice (or slab). (See Figure 13.)
2. Record the measurement on the form.
PRECAUTIONS AND The phantom image must be scored and all criteria pass on the AW for this
CAVEATS test. Scoring the phantom image on the radiologist workstation may be
helpful to determine the source of a failure as seen on the AW. However,
if a failing AW-evaluated phantom image quality test passes on the

Figure 13. Images of distance measurement on ACR DM Phantom. A. 2D. B. DBT.

154 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

radiologist workstation, the phantom image quality test remains a failure.

If any of these quantities is outside of the action limits stated below, the
test should be repeated. Make sure the correct exposure mode has been
used.
The ROI placed over the 2 cm diameter CNR cavity should not touch or
extend beyond the edges of the area. The ROI placed outside the CNR
cavity should be to the left or right of the area to avoid any possible
influence of heel effect on signal.
CNR results from the last MEE may not be available for many reasons
such as a change in medical physicist, loss of QC records greater than
three years, etc. If CNR results from the last MEE are not available, use
the CNR results from the oldest relevant annual survey as a baseline to
compare the current results. Be sure to note this in the annual survey
report.
Changes in detectors, software changes, and recalibration may significantly
impact CNR. In these situations, medical physicist testing after these
changes should be considered an MEE, so the CNR should not be compared
against values from the last MEE. The type of change that prompted the
MEE should be documented in the medical physicist’s report.

PERFORMANCE CRITERIA ACR DM Phantom – 2D and DBT

AND CORRECTIVE ACTIONS
1. Artifacts must not be clinically significant. This aspect of the test
fails if any artifacts are in a location that could impact clinical
interpretation and

PHYSICIST’S SECTION
a. Artifacts are as prominent as (or more prominent than) the
visible test objects in the phantom image, or

MEDICAL
b. Artifacts obscure test objects in the phantom, or
c. Artifacts could affect clinical interpretation.
The cause of the artifact should be identified and isolated to
determine if it originates from the x-ray system, the detector,
or the monitor. If the artifact is confirmed to originate from the
detector, a recalibration or flat-fielding of the detector may be
needed. Artifacts isolated to other components of the imaging
chain should be investigated.
After the artifact is resolved, repeat the phantom artifact test. If
a clinically significant artifact persists, contact your authorized
service representative. If the clinically significant artifact
originated from the x-ray/detector system, do not image patients
until it is corrected. If the clinically significant artifact originated
from the monitor, do not use the monitor until it is corrected.
2. The fiber score must be ≥2.0.
3. The speck group score must be ≥3.0.
4. The mass score must be ≥2.0.

Digital Mammography Quality Control Manual Return to Table of Contents – 155

 III. Mammography Equipment Evaluation and Annual Survey

SNR and CNR – 2D Only

1. The SNR must be ≥40.0.
2. The CNR must be ≥2.0.
3. The CNR must be ≥85% of the last MEE’s CNR. (This component of
the test does not apply to MEEs.)

Note: During annual surveys, the CNR is compared to the value measured
during the most recent MEE. The deviation of the CNR from this original
value is used to monitor changes in the imaging chain over time. A deviation
more than -15% from the value measured at the time of the last MEE would
result in a failure. Corrective actions would be required prior to clinical use.
During a MEE, the value measured would be used for future comparisons.

Distance Measurement – 2D and DBT

The distance measured across the wax insert parallel to the A-C axis must
be 70.0 mm ±14.0 mm.

General
1. If any of these quantities are not within action limits, the test should
be repeated, making sure the correct AEC mode has been used. If
phantom scores are below the stated minimum score, the facility
should contact its authorized service representative.
2. Record and date any comments and required corrective action in the
Technologist’s Corrective Action Log form.
TIMEFRAME FOR All failures of required items must be corrected before clinical use.
CORRECTIVE ACTION

156 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

3. DBT Z Resolution
OBJECTIVES To ensure that blurring in the z-direction is not excessive.
FREQUENCY As part of the mammography equipment evaluation (MEE) of new units,
annually, and after relevant service.
TEST EQUIPMENT • DBT image from ACR Digital Mammography (DM) Phantom Image
Quality test.
• DBT Z Resolution form.
TEST PROCEDURE 1. If annual testing, record the baseline full width at half maximum
(FWHM) value from the MEE (or the oldest annual survey if the
MEE is not available). Otherwise, perform the following steps to
create a baseline Z-resolution value.
2. Using the phantom image acquired from the ACR DM Phantom Image
Quality test (Figure 14), obtain signal data over the specks as follows:

PHYSICIST’S SECTION
MEDICAL
Figure 14. ACR DM Phantom Image.

Note: Use the reconstructed DBT slices (for presentation) for Z-resolution
measurements.

a. Scroll to the slice (slab) where the center speck in the largest
speck group is most in focus and brightest. This is slice 0.
b. Zoom in on the largest speck group on the ACR DM Phantom
image (Figure 15).
c. Place a region of interest (ROI) over the center speck (Figure 16).
d. Record the maximum signal value on the form at the Slice
Location 0.
3. 
Repeat step 2 for the other 5 specks in the group.
4. 
Determine mean background signal as follows:
a. Place an ROI over the background adjacent to the center speck
(Figure 17).

Digital Mammography Quality Control Manual Return to Table of Contents – 157

 III. Mammography Equipment Evaluation and Annual Survey

Figure 15. Zoom in on largest speck group.

Figure 16. ROI placement over center speck in largest speck group.

Figure 17. ROI placement over the background.

b. Record the mean background signal value on the form at the Slice
Location 0.
5. Repeat steps 2-4 for the following slices and record the signal values
on the form at the appropriate slice locations:
a. 2 slices below slice 0 (−2)

158 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

b. 1 slice below slice 0 (−1)

c. 1 slice above slice 0 (+1)
d. 2 slices above slice 0 (+2)
6. See Figures 18 through 20 for illustrations of DBT slice identification
and ROI placements.
7. Average the maximum signal values of the six specks on each slice to
get the Average Max Speck Signal over the six specks.
8. If Δ Z-Res Diff, as calculated below, is greater than or equal to
0.5 for slice −2 or slice +2, repeat steps 4-9 for slice −3 and/or slice
+3, as needed, as indicated in the next section.

Figure 18. Illustration of the blurring of the largest speck through the five DBT slices.

PHYSICIST’S SECTION
MEDICAL
Figure 19. Images of the 5 different slice locations for Z-resolution signal
measurements.

Figure 20. Images of the 5 different slice locations for Z-resolution measurements
with ROI placement locations.

DATA ANALYSIS AND 1. For each DBT slice (−2, −1, 0, +1, +2), subtract the Mean Background
INTERPRETATION Signal from the Average Maximum Speck Signal, yielding
Z-Resolution Signal Difference (Z-Res Diff):
Z-Res Diff = Average Max Speck Signal – Mean Background Signal

Digital Mammography Quality Control Manual Return to Table of Contents – 159

 III. Mammography Equipment Evaluation and Annual Survey

2. For DBT slices −2, −1, +1, and +2, calculate the Δ Z-Res Diff, the
fraction of Z-Res Diff of that slice relative to DBT slice 0:
Δ Z-Res Diffi = Z-Res Diffi / Z-Res Diff0
3. If Δ Z-Res Diff2 is greater than or equal to 0.5, calculate Δ Z-Res
Diff3.
4. If Δ Z-Res Diff-2 is greater than or equal to 0.5, calculate Δ Z-Res
Diff-3.
5. 
From the DBT Z Resolution form, determine the FWHM.

Note: FWHM is the distance between points on the curve at which the
function reaches half its maximum value. In this test, the curve represents
ratios of signal in each slice compared to Slice 0, so the maximum is 1.0
and half maximum is 0.5. The x-axis represents distance in the depth (z)
direction. Therefore, FWHM is in units of mm and is the distance that the
speck is spread in the z-direction. For a more complete description of the
graphical plot measurement, see the American College of Radiology Digital
Mammography QC Manual: Frequently Asked Questions.

PRECAUTIONS AND It may be helpful to review the DBT Z-Resolution form, which illustrates
CAVEATS the Δ Z-Res Diffi calculation.

PERFORMANCE MEEs
CRITERIA AND
CORRECTIVE ACTIONS The initial (MEE) Z-Resolution measurement becomes the baseline value
for future Z-Resolution measurements. There is no action limit for the
initial Z-Resolution measurement.

Annual Surveys
The FWHM value of the current image set must be within ±30% of the
baseline value. If the Performance Criteria are not met, a qualified service
engineer must be contacted to correct the problem.
TIMEFRAME FOR Failures must be corrected within 30 days.
CORRECTIVE ACTION

160 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

4. Spatial Resolution
OBJECTIVES To measure the limiting spatial resolution as an indicator of detector
performance.
FREQUENCY As part of the mammography equipment evaluation of new units,
annually, and after relevant service.
TEST EQUIPMENT • ACR Digital Mammography (DM) Phantom.
• Line pair (lp) pattern with frequencies up to 10 lp/mm.
• Spatial Resolution form.
TEST PROCEDURE – 2D 1. Create a test patient.
AND DBT
2. Turn off all image processing to acquire a “for processing” (e.g.,
“raw”) image.
3. Install a compression paddle.
4. Place the ACR DM Phantom on the breast support with the wax
insert facing up and away from the chest-wall edge (rotated 180°
from the normal orientation of the phantom).
5. Place the line pair pattern on the phantom at a 45° angle (see Figure 21).
6. Lightly compress the line pair pattern to ensure that it remains secure
during the exposure.
7. Make one exposure using a manual technique as close to the ACR
DM Phantom technique as possible.
8. Repeat steps 3-7 for any other targets used clinically.

PHYSICIST’S SECTION
9. Install the magnification stand and paddle and enter the unit’s most
frequently used clinical magnification mode. Repeat steps 3-7 for

MEDICAL
clinically used targets.
10. Repeat steps 3-8 in the DBT imaging mode.
11. If the system uses an add-on device for DBT, repeat steps 3-8 in 2D
mode with the DBT fixture in place.

Digital Mammography Quality Control Manual Return to Table of Contents – 161

 III. Mammography Equipment Evaluation and Annual Survey

A B

C
Figure 21. A. Bar pattern placement for the Spatial Resolution test on a 2D system.
The bar pattern is at a 45° angle to the chest-wall edge. B. Magnification setup. C. DBT
setup.

DATA ANALYSIS AND 1. At the acquisition station, view each image using full resolution and
INTERPRETATION the greatest zoom available. (See Figures 22 and 23.)
2. Record the highest frequency for which at least half the length of the
lines can be continuously resolved in each image. (See Figure 23.)
3. Ensure that the polarity of the lines does not reverse. If reversal
occurs, the limiting resolution has been surpassed.

Figure 22. Image of bar pattern properly visualized for the Spatial Resolution Test.

162 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

Figure 23. Bar pattern magnified for analysis. In this pattern, 4.0 lp/mm are
distinguishable.

4. If the system uses an add-on device for DBT, repeat steps 1-3 for the
2D image acquired with the DBT fixture in place.
PRECAUTIONS AND It is recognized that limiting spatial resolution is an imperfect substitute
CAVEATS for a detailed determination of modulation transfer function. However,
limiting spatial resolution is more easily measured in the field and serves
as an acceptable analog for purposes of detector performance consistency.

PHYSICIST’S SECTION
PERFORMANCE 1. Spatial resolution of the 2D image(s) must be ≥4.0 lp/mm.
CRITERIA AND

MEDICAL
CORRECTIVE ACTIONS 2. Spatial resolution of the 2D magnification mode image(s) must be
≥6.0 lp/mm.
3. Spatial resolution of the DBT image(s) must be ≥2.0 lp/mm.
4. If limiting spatial resolution does not meet these criteria, service
must be scheduled.
TIMEFRAME FOR Failures must be corrected within 30 days.
CORRECTIVE ACTION

Digital Mammography Quality Control Manual Return to Table of Contents – 163

 III. Mammography Equipment Evaluation and Annual Survey

5. DBT Volume Coverage

OBJECTIVES A visual test to assure that the entire breast volume is imaged during the
DBT acquisition.
FREQUENCY As part of the mammography equipment evaluation of new units,
annually, and after relevant service.
TEST EQUIPMENT • ACR Digital Mammography (DM) Phantom.
• Two 0.1-mm thick sheets of aluminum.
• DBT Volume Coverage form.
TEST PROCEDURE 1. Initiate an exam at the acquisition workstation as you would for a
patient.
2. Use a name and image designation system that allows tracking of
QC images. It is important to be able to match and identify the
mammography unit to the printed image from that same unit. See
example below:
a. Last Name: ACR Volume Coverage
b. First Name: Room 1
c. Patient ID: “Date of Phantom Acquisition”
d. Date of Birth: “Date of Phantom Acquisition”
3. 
Enter DBT mode.
4. Use the largest available image receptor size and corresponding
paddle for the ACR DM Phantom image acquisition. Ensure that
the type of paddle chosen (e.g., flex or fixed) is the one used for the
majority of clinical imaging.
5. Place the DM phantom on the breast support surface as shown in
Figure 24. Be sure to position the phantom in the same location each
time the test is performed to limit exposure variability. Check that
a. The pink wax insert is facing up and away from the chest-wall
edge (rotated 180° from the normal orientation of the phantom),
b. The phantom is centered left-to-right, and
c. The edge of the phantom is aligned with the chest wall edge of the
digital image receptor.
6. Place 0.1 mm aluminum sheets on top of and below the DM phantom
as shown in Figure 24.
7. Manually compress the paddle to 5 decanewtons or 12 pounds of
compression force. It is important to use the same compression
force each time for this test. Note that at this compression force, the
compressed breast thickness indicator may not read 4.2 cm.
8. Make one exposure in the DBT mode using a manual technique as
close to the ACR DM Phantom DBT technique as possible.

164 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

PHYSICIST’S SECTION
MEDICAL
B
Figure 24. A. ACR DM Phantom with 0.1 mm aluminum sheets positioned for image
acquisition. B. Zoomed photograph of DBT Volume Coverage setup.

DATA ANALYSIS AND At the acquisition workstation, scroll through the image set using
INTERPRETATION the thinnest slices available. Determine if both the top and bottom
aluminum sheets are well defined and in focus in their respective planes.
(See Figure 25.)

Digital Mammography Quality Control Manual Return to Table of Contents – 165

 III. Mammography Equipment Evaluation and Annual Survey

A B

Figure 25. A. Image of ACR DM Phantom with aluminum sheets in focus at bottom
of phantom. B. Image of ACR DM Phantom with aluminum sheets in focus at top of
phantom.

PRECAUTIONS AND If the system fails the test, verify that the aluminum sheets are properly
CAVEATS positioned and repeat the test.
PERFORMANCE Each aluminum sheet must be well defined within one slice, or the system
CRITERIA AND is not imaging the entire breast volume.
CORRECTIVE ACTIONS

TIMEFRAME FOR Failures must be corrected before clinical use.

CORRECTIVE ACTION

166 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

6. Automatic Exposure Control System Performance

OBJECTIVES To assess the performance of the automatic exposure control (AEC)
function and to verify consistency in detector signal-to-noise level for a
range of breast thickness.
FREQUENCY As part of the mammography equipment evaluation (MEE) of new units,
annually, and after relevant service.
TEST EQUIPMENT • Compression paddles.
•  our or more tissue-equivalent attenuators (e.g., acrylic, BR-12,
F
BR-50) providing approximate thicknesses of 2, 4, 6, and 8 cm and
of sufficient area to resemble an average-sized compressed breast and
cover the AEC area.
• Magnification stand, if used clinically for 2D imaging.
• Automatic Exposure Control System Performance form.
TEST PROCEDURE 1. Create a test patient on the acquisition workstation.
2. Install the small size paddle, if available. Otherwise, install the large
size paddle.
3. Center 2.0 cm of tissue-equivalent attenuator on the image receptor
and position it so the chest-wall edge of the attenuator is aligned with
the chest-wall edge of the image receptor. (See Figure 26.)
4. Lower the compression paddle to 2 cm compression thickness (or
5 decanewtons per 12 lbs of compression force).
5. 
If applicable, set the density control function (or exposure

PHYSICIST’S SECTION
compensation step) to 0.
6. If applicable, set the AEC sensor to the center of the phantom.

MEDICAL
7. Select the large focal spot.
8. Acquire an image using the AEC mode used clinically.
9. Make an exposure.

A B

Figure 26. Position of attenuator for Automatic Exposure Control System Performance
test in contact mode. A. 2D. B. DBT.

Digital Mammography Quality Control Manual Return to Table of Contents – 167

 III. Mammography Equipment Evaluation and Annual Survey

10. Record the relevant technique information (AEC Mode, Density

Setting or Exposure Compensation, target, filter, kVp, mAs, and
indicated average glandular dose) on the form.
11. Repeat steps 3-10 for the 4, 6, and 8 cm phantoms.
12. Set up the equipment with the magnification stand as shown in
Figure 27 and repeat steps 3-10 for the 4 cm phantom.
13. Repeat steps 3-11 in DBT mode.
14. If the system uses an add-on device for DBT, repeat steps 3-11 in 2D
mode with the DBT fixture in place.

Figure 27. Position of attenuator for Automatic Exposure Control System Performance
test in magnification mode.

DATA ANALYSIS AND 1. If the manufacturer provides a DC offset, record this value on the
INTERPRETATION form.
2. Record the signal-to-noise ratio (SNR) results from the last MEE on
the form. (This does not apply to MEEs.)
3. 
Calculate the lower limit and the upper limit for each mode/
attenuator SNR as ±15% of the last MEE’s SNR, and record.
4. Use only “for processing” (e.g., “raw”) images for analysis.
5. For DBT, find the center slice or slab in the image set and use the
thinnest available slice.
6. On the radiologist workstation, use a circular or rectangular region
of interest (ROI; approximately 3 cm from chest wall and centered
left to right) to measure the mean signal value (or mean analog to
digital units) in the middle of the phantom. (See Figure 28.)
7. Record the mean signal value as Mean Bkgd Signal on the form;
record the standard deviation as Std Dev of Bkgd.

168 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

A B

Figure 28. Position of ROI to measure pixel value (approximately 3 cm from chest wall
and centered left to right). A. 2D. B. DBT.

8. Calculate the SNR as

(Mean Bkgd Signal – DC offset)

SNR =
Std Dev of Bkgd
(Omit the DC offset if this does not apply for the DM unit being
tested.)

Note: If the acquisition workstation does not have ROI capability, the
medical physicist should use one of the following alternatives to complete
the test:

PHYSICIST’S SECTION
• Make the ROI measurement on the radiologist workstation.
• Using image analysis software, make the ROI measurement on an external

MEDICAL
computer system.
• If neither of the above alternatives are available, use the manufacturer’s
AEC evaluation procedure, equipment, and form.

PRECAUTIONS AND Manufacturer operating manuals and/or guidance documents should be

CAVEATS checked to see if there are DC offset values that should be used for the
calculation of the SNR.
It is important to note that tissue-equivalent attenuators (e.g., acrylic,
BR-12, BR-50) do not have exactly same attenuation characteristics as
breast tissue. These materials may be more accurately correlated to breast
tissue by using data available in published articles such as the one by
Dance [6].
SNR results from the last MEE may not be available for many reasons
such as a change in medical physicist, loss of QC records greater than
three years, etc. If SNR results from the last MEE are not available, use
the SNR results from the oldest relevant annual survey as a baseline to
compare the current results. Be sure to note this in the annual survey
report.

Digital Mammography Quality Control Manual Return to Table of Contents – 169

 III. Mammography Equipment Evaluation and Annual Survey

It is recognized that SNR is not strictly defined for DBT images. However,
these calculated values should remain consistent year-to-year if the AEC
is performing consistently.
Note that if components in the imaging chain are replaced (i.e., detector,
x-ray tube, etc.) SNR may not meet the annual survey performance
criteria of ±15% of the last MEE’s SNR. If this is the case, the reason
should be noted, a new baseline should be established, and the test should
be passed.

PERFORMANCE CRITERIA AND MEE and Annual Surveys

CORRECTIVE ACTIONS
The SNR must be ≥40.0 for the 4.0 cm phantom in 2D contact mode.

Annual Surveys
The SNR must be within ±15% of the last MEE’s SNR for each thickness
and mode tested. (This component of the test does not apply to MEEs.)

General
1. If any of these quantities are not within action limits, the test should
be repeated. If the results remain below the performance criteria, the
facility should contact its authorized service representative.
2. Record and date any comments and required corrective action in the
Technologist’s Corrective Action Log form.
TIMEFRAME FOR Failures must be corrected within 30 days; for MEEs, before clinical use.
CORRECTIVE ACTION

170 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

7. Average Glandular Dose

OBJECTIVES To measure the entrance exposure for an average patient (approximately
a 4.2 cm thick compressed breast consisting of 50% glandular and 50%
adipose tissue), calculate the associated average glandular dose and
ensure that the unit-indicated average glandular dose (if available) is
reasonably accurate.
FREQUENCY As part of the mammography equipment evaluation (MEE) of new units,
annually, and after relevant service.
TEST EQUIPMENT • I onization chamber and electrometer or other appropriate dosimetry
device calibrated at mammographic x-ray beam energies.
•  n integrated, solid-state instrument (one that automatically
A
measures kVp, half-value layer [HVL], and dose) is also acceptable.
(The instrument must be calibrated for the target/filter combination
in use or be adjusted with an appropriate correction factor. See
Precautions and Caveats.)
• Average Glandular Dose form.

TEST PROCEDURE Breast Entrance Exposure and Average Glandular

Dose – 2D and DBT

Note: This procedure uses the technique factors that result from the ACR
Digital Mammography (DM) Phantom Image Quality test. This technique
must be the same as that used clinically for a 4.2-cm thick compressed
breast consisting of 50% glandular and 50% adipose tissue, as defined
by the FDA. Exposure measurements made at a corresponding manual

PHYSICIST’S SECTION
technique in 2D mode (or fixed mode) can be used to calculate average
glandular dose for DBT images.

MEDICAL
1. Place a lead sheet or other protective device on the image receptor.
This is intended to protect the detector from repeated exposures.
2. Position the center of the dosimeter at a height of 4.2 cm above the
breast support and just under the paddle. Center the dosimeter
approximately 4 cm in from the chest-wall edge of the image receptor.
Make sure that the entire dosimeter is exposed (see Figure 29).
3. Secure the dosimeter in position, and do not change its position
during the following measurements.

Note: Mammographic imaging systems have a significant x-ray intensity

gradient along the anode-cathode direction due to the anode heel effect.
Maintaining a constant dosimeter position during measurements is critical.
When measurements are to be compared with others made previously, it
is also critical that the original measurement position be re-established as
closely as possible.

4. Position the compression device in the x-ray beam, just in contact

with the dosimeter (as shown in Figure 29).

Digital Mammography Quality Control Manual Return to Table of Contents – 171

 III. Mammography Equipment Evaluation and Annual Survey

A B

Figure 29. Exposure setup. Compression device positioned so that it is just in contact
with the dosimeter. A. Side view diagram. B. Top view diagram. C. Photo.

5. Set the target material, filtration, and kVp at the values at which the
ACR DM Phantom image was acquired in the 2D mode, and record
the settings on the form. Also, record the HVL (previously measured
during the MEE) for those same parameters on the form. Finally,
record on the form the automatic exposure control (AEC) mode and
mAs at which the ACR DM Phantom image was acquired in the 2D
mode.
6. Manually set mAs as close as possible to that obtained under the
AEC exposure of the ACR DM Phantom and record the value on the
form.
7. Make a manual exposure and record the measured exposure on the
form.
8. 
Repeat step 7 until three exposures have been recorded.
9. If available, record the unit-indicated average glandular dose from
the ACR DM Phantom Image Quality test form.
10. Set the target material, filtration, and kVp at the values at which the
ACR DM Phantom image was acquired in the DBT mode, and record
the settings on the form. Also, record the HVL (previously measured
during the MEE) for those same parameters on the form. Finally,
record on the form the AEC mode and mAs at which the ACR DM
Phantom image was acquired in the DBT mode. Repeat steps 6-9 for
the DBT mode.

172 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

Note: If the phantom image was acquired in a combination mode, only use
the technical factors associated with the DBT portion of the exposure for the
DBT average glandular dose assessment.

DATA ANALYSIS AND 1. 

If necessary, correct the average exposure with the dosimeter’s
INTERPRETATION appropriate energy correction factor.
2. 
Determine the mR/mAs at the skin entrance.
3. Calculate the total AEC exposure at the skin entrance by multiplying
the mR/mAs by the mAs obtained during the AEC exposure of the
ACR DM Phantom.

Note: Use the acrylic g-factor * c-factor * 8.76 mGy/R values when
determining the average glandular dose from the ACR DM Phantom
techniques for a 4.2-cm thick compressed breast consisting of 50% glandular
and 50% adipose tissue. Both acrylic and BR-12 values are provided for
breast thicknesses of 2 to 8 cm if the medical physicist wishes to determine
average glandular doses for a broader range of breast thicknesses.

4. 
Compute the average glandular dose using the following equation:
AGD = Kgcs
AGD = Average Glandular Dose (mGy)
K = Entrance Exposure (mR)

PHYSICIST’S SECTION
g = g-factor for breast simulated with acrylic or BR-12

MEDICAL
c = c-factor for breasts simulated with acrylic or BR-12
s = s-factor for clinically used spectra
a. K is the exposure in the absence of backscatter at the entrance
surface of the breast. (The amount of backscatter in the described
setup is small enough to be ignored while maintaining adequate
accuracy for this test.)
b. The factor g corresponds to a glandularity of 50% and is derived
from values calculated from Dance [6].
c. The factor c corrects for any difference in breast composition
from 50% glandularity. (See Table 5 and Table 6; additional
phantom thicknesses are provided if the medical physicist would
like to determine dose for other breast thicknesses.)
d. The factor s corrects for differences due to the choice of x-ray
spectrum (see Table 7) [6, 7, 8, 9].

Digital Mammography Quality Control Manual Return to Table of Contents – 173

 III. Mammography Equipment Evaluation and Annual Survey

Table 5. g-factor * c-factor * 8.76 mGy/R for Acrylic

g-factor * c-factor * 8.76 mGy/R for Acrylic
Breast HVL (mm Al)
Thickness (cm) 0.3 0.35 0.4 0.45 0.5 0.55 0.6
2 2.944 3.301 3.639 3.945 4.226 4.490 4.720
4 1.672 1.897 2.114 2.348 2.589 2.820 3.071
4.2 1.609 1.828 2.037 2.261 2.499 2.736 2.972
6 1.164 1.320 1.471 1.639 1.781 2.015 2.220
8 0.847 0.967 1.087 1.195 1.315 1.483 1.647

Table 6. g-factor * c-factor * 8.76 mGy/R for 50% Glandularity BR-12

g-factor * c-factor * 8.76 mGy/R for BR-12
Breast HVL (mm Al)
Thickness (cm) 0.3 0.35 0.4 0.45 0.5 0.55 0.6
2 3.4164 3.7931 4.1435 4.4588 4.7567 5.0195 5.1421
4 1.8133 2.0586 2.2864 2.5316 2.7857 3.0310 3.2762
4.2 1.7292 1.9640 2.1847 2.4230 2.6700 2.9083 3.1536
6 1.1826 1.3490 1.5067 1.6819 1.8746 2.0674 2.2864
8 0.8585 0.9811 1.1038 1.2264 1.3490 1.5330 1.7082

Table 7. s-factors for Acrylic and BR-12 [6, 7, 8, 9]

s-factors for Acrylic and BR-12
Target/Filter s-factor
Mo/Mo 1.000
Mo/Rh 1.017
Rh/Rh 1.061
Rh/Al 1.044
Rh/Ag 1.087
W/Rh 1.042
W/Al (0.5 mm) 1.134
W/Al (0.7 mm) 1.082
W/Ag 1.042

PRECAUTIONS AND Current and accurate calibration of dosimeters is essential and required
CAVEATS under the FDA MQSA Final Rule [1]. See the FDA’s MQSA Policy Guidance
Help System [2] frequently asked questions on air kerma calibration. It is
well known that the energy response for ionization chamber-based air
kerma measuring instruments is typically flat in the 20-40 kVp range.
For solid-state air kerma measuring instruments, however, the energy
response is not flat, and because of this, the air kerma readings from these
instruments may need to be adjusted by an appropriate correction factor.
The correction may already be handled internally by the instrument, or

174 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

you may need to contact the instrument manufacturer for the correction
factor [10].
The medical physicist should ensure that the HVL has been determined
for the target/filter and kVp combination used for DBT imaging during
the MEE.
If the facility has changed its target/filter and kVp combination for an
average patient (and the corresponding HVL was not determined during
the MEE), or if the medical physicist suspects that the HVL may have
significantly changed since the MEE, the medical physicist should re-
evaluate the HVL for use in the current Average Glandular Dose test.
The previously published 1999 ACR Mammography Quality Control
Manual [5] used a method adapted from Barnes and Wu to calculate
average glandular dose. This method was limited to four target/filter
combinations, a limited range of kVp and HVL settings, one breast
thickness (4.2 cm), and one tissue glandularity value (50% adipose-50%
glandular). This manual is using a different method published by
Dance [6], which utilizes a single formula (D = Kgcs), where D is the
average glandular dose, K is the entrance exposure at the upper surface
of the breast without backscatter, g is the entrance exposure to mean
glandular dose conversion factor, c corrects for differences in breast
composition from 50% glandularity, and s corrects for differences in x-ray
spectra. This method accommodates most target/filter combinations
used in modern systems, nearly all clinically relevant breast thicknesses,
a wider range of beam qualities, and a wider range of breast glandularity.
There is a minor difference between the two methodologies: an average
of 1.0% difference in AGD values using the Barnes and Wu method [5]

PHYSICIST’S SECTION
compared to the Dance method [6] for a cross-section of target/filter
combinations and kVps used in the 1999 manual.

MEDICAL
PERFORMANCE CRITERIA 1. The average glandular dose for a single cranio-caudal view of the
AND CORRECTIVE ACTIONS ACR DM Phantom in either 2D or DBT mode must not exceed 3.0
mGy. (Dose from a mode that combines a 2D view with a DBT view,
such as “Combo” mode, is not subject to the 3.0 mGy performance
criteria. Each view within the mode should be compared separately
against the performance criteria.)
If the calculated value exceeds these levels, action must be taken to
2. 
evaluate and eliminate the cause of excessive dose.
3. If the unit-indicated average glandular dose is available, it should be
within ±25% of the calculated average glandular dose.
TIMEFRAME FOR • Doses exceeding 3 mGy must be corrected before clinical use.
CORRECTIVE ACTION
•  ailures of the unit-indicated average glandular dose must be
F
corrected within 30 days; for MEEs, before clinical use.

Digital Mammography Quality Control Manual Return to Table of Contents – 175

 III. Mammography Equipment Evaluation and Annual Survey

APPLICABLE MQSA
REQUIREMENTS 900.12(e)(6) Quality control tests—other modalities.
For systems with image receptor modalities other than screen-film, the quality
assurance program shall be substantially the same as the quality assurance
program recommended by the image receptor manufacturer, except that the
maximum allowable dose shall not exceed the maximum allowable dose for
screen-film systems in paragraph (e)(5)(vi) of this section.
900.12(e)(5)(vi) Dosimetry.
The average glandular dose delivered during a single cranio-caudal view
of an FDA-accepted phantom simulating a standard breast shall not exceed
3.0 milligray (mGy) (0.3 rad) per exposure. The dose shall be determined with
technique factors and conditions used clinically for a standard breast.

176 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

8. Unit Checklist
OBJECTIVES To ensure that all locks, detents, angulation indicators, and mechanical
support devices for the x-ray tube and breast support assembly are
operating properly and that the DICOM image file headers are correctly
populated.
FREQUENCY As part of the mammography equipment evaluation (MEE) of new units,
annually, and after relevant service.
TEST EQUIPMENT Unit Checklist form.

TEST PROCEDURE 1. 
Verify that the freestanding dedicated mammography unit is
mechanically stable under normal operating conditions (*critical test).
2. Verify that all moving parts move smoothly, without undue friction;
that cushions or bumpers limit the range of available motions; and
that no obstructions hinder the full range of motions within these
limits.
3. Set and test each lock and detent independently to ensure that
mechanical motion is prevented when the lock or detent is set
(*critical test).
4. Verify that the detector or image receptor holder assembly is free
from wobble or vibration during normal operation (*critical test).
5. If cassette-based, verify that the image receptor slides smoothly into
the proper position in the image receptor holder assembly.
6. If cassette-based, verify that the cassette is held securely for any
orientation of the image receptor holder assembly (*critical test).

PHYSICIST’S SECTION
7. Verify that in normal operation the patient and operator are not
exposed to sharp or rough edges or other hazards including electrical

MEDICAL
hazards (*critical test).
8. Verify that the compression paddles are all intact with no cracks or
sharp edges (*critical test).
9. Verify that the mammography area is clean and free from significant
dust and debris that may cause artifacts.
10. Verify that the operator is protected by adequate radiation shielding
during exposure (*critical test).
11. Verify that all indicators work properly.
12. Verify that automatic decompression can be overridden to maintain
compression (for procedures such as needle localizations) and
its status displayed continuously (if automatic decompression is
available) (*critical test).
13. Verify that compression can be manually released in the event
of a power or automatic release failure by turning power off to
the equipment. This can be verified by placing a phantom under
compression and using manual controls to release the compression
(*critical test).

Digital Mammography Quality Control Manual Return to Table of Contents – 177

 III. Mammography Equipment Evaluation and Annual Survey

14. Verify that the audible exposure indicator is at an appropriate

volume level.
15. Verify that the DBT assembly moves as designed through its range
of motion (*critical test).
16. Verify that current and accurate technique charts are posted,
confirmed by consulting with the mammography technologist
if possible.
17. 
Add other unit-specific checks as necessary.
18. 
Record the pass or fail of each inspection item on the form.
DATA ANALYSIS AND Not applicable
INTERPRETATION

PRECAUTIONS AND None

CAVEATS

PERFORMANCE CRITERIA Critical items that are hazardous, inoperative, or operate improperly must
AND CORRECTIVE ACTIONS be repaired by appropriate service personnel or replaced.
TIMEFRAME FOR Failures of critical tests (*) must be corrected before clinical use;
CORRECTIVE ACTION less critical tests must be corrected within 30 days; for MEEs, before
clinical use.

APPLICABLE MQSA
REQUIREMENTS 900.12(e)(5)(xi) Decompression.
If the system is equipped with a provision for automatic decompression after
completion of an exposure or interruption of power to the system, the system
shall be tested to confirm that it provides:
(A) An override capability to allow maintenance of compression;
(B) A continuous display of the override status; and
(C) A manual emergency compression release that can be activated in the event
of power or automatic release failure.

178 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

9. Computed Radiography (if applicable)

OBJECTIVES To meet the additional QC needs of computed radiography (CR) system
photostimulable phosphor (PSP) imaging plates.
FREQUENCY As part of the mammography equipment evaluation (MEE) of new units,
annually, and after relevant service or acquisition of new PSP plates. (If a
new PSP plate is acquired, this test may be performed by the QC techno­
logist with oversight by the medical physicist; see Precautions and Caveats.)

Important: This test is only applicable to computed radiography systems.

TEST EQUIPMENT • ACR Digital Mammography (DM) Phantom.

• Computed Radiography form.

TEST PROCEDURE Plate-to-Plate Uniformity

1. Erase all CR cassettes.
2. Create a patient ID as outlined in the ACR DM Phantom Image
Quality test to acquire images or use manufacturer software to
acquire images.
3. Place the ACR DM Phantom on the breast support, and lower the
compression paddle to achieve a force of 5 daN.
4. Using AEC, expose the plate using a technique as close as possible
to the ACR DM Phantom technique acquired in the ACR Digital
Mammography Phantom Image Quality test.

PHYSICIST’S SECTION
5. Record the mAs on the form.

MEDICAL
6. Process the acquired CR image using no image processing if possible.
7. 
At a workstation, place a region of interest having an area of
approximately 5 cm2 in the center of each image. Record the
measured mean signal values and standard deviation on the form.
Calculate the signal-to-noise ratio (SNR) for each image using the
procedure described in the ACR Digital Mammography Phantom
Image Quality test.
8. Repeat steps 1-7 for all plates at the facility (i.e., large and small).

Plate-Specific Artifact Analysis

1. View the images acquired as described above on a workstation, with
the window width and window level set to optimize the viewing of
the test objects.
2. Record all clinically significant artifacts on the form.

CR Reader Scanner Performance

1. Place a cassette on top of the breast support plate.

Digital Mammography Quality Control Manual Return to Table of Contents – 179

 III. Mammography Equipment Evaluation and Annual Survey

2. Place a pair of thin steel rulers or another thin metal object on top of
the cassette in a T shape. (See Figure 30.)
3. Make a manual exposure at a technique close to 25 kVp and 4 mAs.
4. Process the cassette.

Note: The CR Reader Scanner Performance procedure only needs to

be performed on one cassette for each reader. (It does not need to be
conducted for each plate.)

Figure 30. CR reader scanner performance.

DATA ANALYSIS AND None

INTERPRETATION

PRECAUTIONS AND Most plate manufacturers recommend a delay of 15 minutes prior to

CAVEATS processing plates. However, the main requirement is that the same time
delay between exposure and processing (±1 minute) be used for all plates.
Time can be saved by sequentially exposing the cassettes and waiting
approximately 2 minutes between each exposure. Then, sequentially
process the plates in the same order so that each subsequent plate enters
the reader approximately 2 minutes after the prior plate.
If one or two new PSP plates are acquired between the medical physicist’s
annual surveys, the QC technologist must first check the plate before
putting it into clinical service. This must be done by following the
Technologist’s ACR Digital Mammography Phantom Image Quality
procedure and sending the completed form to the medical physicist for
review.

180 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

Note: If the facility replaces all of its PSP plates with new ones, the medical
physicist must perform an MEE consisting of applicable tests.

PERFORMANCE Plate-to-Plate Uniformity

CRITERIA AND
CORRECTIVE ACTIONS 1. The mAs of any plate exposure must not differ by more than ±10%
from the mean mAs of all plates of the same size.
2. If the mAs of a plate differs by more than ±10% from the mean, the
plate must be removed from service and replaced.
3. The SNR of any plate must not differ by more than ±15% from the
mean SNR of all plates of the same size.
4. If the SNR of a plate is more than ±15% from the mean, the plate
must be removed from service and replaced.

Plate-Specific Artifact Analysis

1. 
Artifacts should be below a level at which they could obscure
important structures or pathology and must not mimic important
structures or pathology. Setting the window level and width to have
good visualization of test objects in the ACR DM Phantom provides
reasonable settings to assess artifacts.
2. The cause of objectionable artifacts must be further investigated.
3. If only a subset of plates demonstrate artifacts, clean the plates and
retest. If the artifacts persist, the plates should be removed from
service and replaced. If the artifact appears on all images, the cause

PHYSICIST’S SECTION
is likely in the x-ray unit or in the CR reader. The source should be
isolated and appropriate service called.

MEDICAL
CR Reader Scanner Performance
It is recommended that the edges of the steel ruler in both directions be
crisp and linear. There should be no jagged or non-linear edges visible at
the ruler’s edge.
TIMEFRAME FOR Failures of required items must be corrected before clinical use.
CORRECTIVE ACTION

Digital Mammography Quality Control Manual Return to Table of Contents – 181

 III. Mammography Equipment Evaluation and Annual Survey

10. Acquisition Workstation (AW) Monitor QC

OBJECTIVES •  o ensure that AW monitors are clean and free from dust, fingerprints,
T
and other marks that may interfere with clinical information.
•  o ensure that monitors are calibrated correctly and brightness and
T
contrast settings are set correctly.
•  o ensure that monitors meet manufacturer specifications via the
T
conduct of Monitor Manufacturer Automated Tests (if available).

Important: Monitor Manufacturer Automated Tests are required if such

tests are available in the manufacturer’s documentation.

FREQUENCY As part of the mammography equipment evaluation of new equipment,

annually, and after relevant service.

TEST EQUIPMENT •  e American Association of Physicists in Medicine (AAPM)

Th
TG18-QC test pattern [11] is strongly preferred. If one is not
available on the monitor, ask the authorized service representative
to install one. If this is not possible, a SMPTE test pattern [12] or
another pattern that allows relevant measurements may be used. See
Figure 31. If it is not possible to install a relevant test pattern on the
monitor, this part of the test is not applicable.
•  APM TG18 LN8-01 and LN8-18 test patterns for the luminance
A
check, or other patterns that allow for measurement of Lmin and Lmax
(if available). See Figure 32.
•  APM TG18 UNL80 test pattern for luminance uniformity, or
A
other patterns that allow for measurement of luminance uniformity
(if available). See Figure 33.
• Luminance meter
• Acquisition Workstation Monitor QC form

A B

Figure 31. Test patterns: A. AAPM TG18-QC test pattern. B. SMPTE test pattern.

182 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

A B

Figure 32. Test patterns: A. AAPM TG18 LN8-01 test pattern. B. AAPM TG18 LN8-18 test
pattern.

PHYSICIST’S SECTION
MEDICAL
Figure 33. AAPM TG18 UNL80 test pattern.

TEST PROCEDURE Monitor Condition

1. Visually inspect the surface of the monitor for the presence of dust,
scratches, defects, fingerprints, shiny patches (from grease or gel),
and other foreign material (e.g., pen marks, etc.).
2. Record significant findings on the form (see Performance Criteria
and Corrective Actions).

Test Pattern Image Quality (if available)

1. Reduce the lighting in the acquisition room to be similar to that in
the radiologist’s reading room before image evaluation.
2. Display the test pattern on the monitor. (If an appropriate test pattern
is not available on the AW, skip this test.)

Digital Mammography Quality Control Manual Return to Table of Contents – 183

 III. Mammography Equipment Evaluation and Annual Survey

3. Evaluate the test pattern for the following visible targets and record
pass or fail on the form:
a. Is the test pattern centered appropriately?
b. Are the 0%-5% contrast boxes visible?
c. Are the 95%-100% contrast boxes visible?
d. Are the alphanumerics sharp and legible?
e. Are the line-pair images at the center and four corners visible
and clearly distinguishable?
f. Are the grayscale ramps smooth and continuous?

Luminance Check (if available)

1. Using the TG18 LN8-01 and LN8-18 test patterns, measure Lmin and Lmax
with a luminance meter in the center of each box. (See Figure 32.)
2. Record these values on the form.
3. If possible, obtain the manufacturer specifications for Lmin and Lmax
and enter them on the form.

Luminance Uniformity (if available)

1. Using the TG18 UNL80 test pattern, measure the luminance at each
of the four corners of the monitor and at the center of monitor. (See
Figure 33.)
2. Record these values on the form.

DICOM Grayscale Display Function (GSDF) Evaluation

(if available)
1. If possible, use the monitor manufacturer’s built-in software to verify
that the result of the DICOM GSDF grayscale test meets the monitor
manufacturer’s performance criteria.
2. The medical physicist may perform this test manually if he or she
believes an independent verification is needed or if the manufacturer
does not provide built-in software.

Monitor Manufacturer Automated Test (if available)

1. Open the monitor manufacturer automated test program.
2. For initial setup, review the monitor manufacturer’s frequencies,
action limits, and other test parameters to verify if appropriate for
mammography.
3. Review the results and verify that all tests have passed.
4. Record an overall pass or fail on the form.

184 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

DATA ANALYSIS AND Luminance Uniformity (if available)

INTERPRETATION
Calculate the percent difference of the luminance values measured in the
image display area using the following equation:
200 * (Lmax – Lmin)
% difference =
(Lmax + Lmin)
where Lmax and Lmin are the maximum and minimum measured luminance
values, respectively.
PRECAUTIONS AND Ideally, monitor screens should be free of dust, fingerprints, and other
CAVEATS marks. Similarly, there should be no “shiny” patches or obvious non-
uniformities on the surface. As described below, significant blemishes
that interfere with the interpretation or QC of images must be corrected.
Most problems can be corrected by cleaning according to the manufacturer’s
instructions. However, if cleaning does not correct the problem, the
manufacturer should be contacted to evaluate and correct the problem.
In most cases, Monitor Manufacturer Automated Tests and action
limits are available in manufacturer manuals or documents published
by the manufacturer. These tests are extremely valuable in maintaining
quality and are specific to each manufacturer. If a Monitor Manufacturer
Automated Test is available, the medical physicist should assist the facility
in verifying that the automated system is set up and functioning properly.

PERFORMANCE CRITERIA Monitor Condition

AND CORRECTIVE ACTIONS
Any large, significant blemish that interferes with the visualization or QC
of images is a failure. (If there are questions regarding the significance of

PHYSICIST’S SECTION
a monitor blemish, the lead interpreting radiologist should be consulted.)

Test Pattern Image Quality (if available)

MEDICAL
1. The test pattern must be centered appropriately.
2. The 0%-5% and 95%-100% contrast boxes must be visible.
3. The alphanumerics must be sharp and legible.
4. The high-contrast line-pair patterns must be distinguishable at the
center and corners.
5. The grayscale ramps must be smooth and continuous.

Luminance Check (if available)

Lmin must be within ±30% of the value specified by the manufacturer,
if available. Lmax must be within ±10% of the value specified by the
manufacturer, if available. If no specified values are available, luminance
values must be Lmin ≤1.5 cd/m2 and Lmax ≥150 cd/m2.

Luminance Uniformity (if available)

The calculated % difference for an individual monitor must be ≤30%.

Digital Mammography Quality Control Manual Return to Table of Contents – 185

 III. Mammography Equipment Evaluation and Annual Survey

DICOM GSDF Evaluation (if available)

The measured contrast response values must not deviate from the targeted
contrast response by more than ±10%.

Monitor Manufacturer Automated Test (if available)

Monitors must pass all manufacturer tests.

TIMEFRAME FOR Monitor Condition

CORRECTIVE ACTION
All failures must be corrected before clinical use.

Test Pattern Image Quality, Luminance Check, Luminance

Uniformity, DICOM GSDF, and Monitor Manufacturer
Automated Test (if available)
All failures must be corrected within 30 days.

186 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

11. Radiologist Workstation (RW) Monitor QC

OBJECTIVES • To ensure that RW monitors are clean and free from dust, fingerprints,
and other marks that may interfere with clinical information.
•  o ensure monitors are calibrated correctly and the brightness and
T
contrast settings are set correctly.
•  o ensure that the image acquisition chain is producing adequate
T
image quality and working consistently and that there are no obvious
artifacts.
•  o ensure that monitors meet manufacturer specifications via the
T
conduct of Monitor Manufacturer Automated Tests (if available).

Important: Monitor Manufacturer Automated Tests are required if such

tests are available in the manufacturer’s documentation.

FREQUENCY As part of the mammography equipment evaluation of new equipment,

annually, and after relevant service.
TEST EQUIPMENT • Acquired ACR Digital Mammography (DM) Phantom image.
•  e American Association of Physicists in Medicine (AAPM) TG18-QC
Th
test pattern is strongly preferred. If one is not available on the monitor,
ask the authorized service representative to install one. If this is not
possible, a SMPTE test pattern or another pattern that allows relevant
measurements may be used. (See Figure 31.)
•  APM TG18 LN8-01 and LN8-18 test patterns for the luminance
A

PHYSICIST’S SECTION
check, or other patterns that allow for measurement of Lmin and Lmax.
(See Figure 32.)

MEDICAL
•  APM TG18 UNL80 test pattern for luminance uniformity, or
A
other patterns that allow for measurement of luminance uniformity.
(See Figure 33.)
• Luminance meter.
• Radiologist Workstation Monitor QC form.

TEST PROCEDURE Ambient Light

Evaluate the reading room environment where the RW resides for
appropriate ambient light levels for mammography interpretation.

Monitor Condition
1. Visually inspect the surface of the monitor for the presence of dust,
scratches, defects, fingerprints, shiny patches (from grease or gel),
and other foreign material (e.g., pen marks, etc.).
2. Record significant findings on the form (see Performance Criteria
and Corrective Actions).

Digital Mammography Quality Control Manual Return to Table of Contents – 187

 III. Mammography Equipment Evaluation and Annual Survey

ACR DM Phantom
1. 
Display a phantom image that was acquired on one of the
digital mammography units per instructions in the ACR Digital
Mammography Phantom Image Quality test.
2. Evaluate for artifacts and score the phantom test objects as in the
ACR Digital Mammography Phantom Image Quality test.

Distance Measurement
1. 
Using a measurement tool within the manufacturer software,
measure the distance across the wax insert as shown in Figure 34.
2. Record results on the form.

Figure 34. Distance measurement on ACR DM Phantom.

Test Pattern Image Quality

1. Display the test pattern on the monitor.
2. Evaluate the test pattern for the following visible targets and record
pass or fail on the form:
a. Is the test pattern centered appropriately?
b. Are the 0%-5% contrast boxes visible?
c. Are the 95%-100% contrast boxes visible?
d. Are the alphanumerics sharp and legible?
e. Are the line-pair images at the center and four corners visible
and clearly distinguishable?
f. Are the grayscale ramps smooth and continuous?

188 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

Luminance Check
1. 
Using the TG18 LN8-01 and LN8-18 test patterns (or other
appropriate phantom as indicated above), measure Lmin and Lmax with
a luminance meter in the center of each box. (See Figure 32.)
2. Record these values on the form.
3. If possible, obtain the manufacturer specifications for Lmin and Lmax
and enter them on the form.

Luminance Uniformity
1. Using the TG18 UNL80 test pattern, measure the luminance at
each of the four corners of the monitor and at the center of monitor.
(See Figure 33.)
2. Record these values on the form.

DICOM Grayscale Standard Display Function (GSDF)

Evaluation (if available)
1. If possible, use the monitor manufacturer’s built-in software to verify
that the result of the DICOM GSDF grayscale test meets the monitor
manufacturer’s performance criteria.
2. The medical physicist may perform this test manually if he or she
believes an independent verification is needed or if the manufacturer
does not provide built-in software.

Monitor Manufacturer Automated Test (if available)

PHYSICIST’S SECTION
1. Open monitor manufacturer automated test program.

MEDICAL
2. For initial setup, review the monitor manufacturer’s frequencies,
action limits, and other test parameters to verify if appropriate for
mammography.
3. Review the results and verify that all tests have passed.
4. Record an overall pass or fail on the form.

DATA ANALYSIS AND ACR DM Phantom

INTERPRETATION
1. Evaluate the phantom image for artifacts following the instructions
under Data Analysis and Interpretation in the ACR Digital
Mammography Phantom Image Quality test.
2. Score the phantom image following the instructions under Data
Analysis and Interpretation in the ACR Digital Mammography
Phantom Image Quality test.
3. Record results on the form.

Digital Mammography Quality Control Manual Return to Table of Contents – 189

 III. Mammography Equipment Evaluation and Annual Survey

Luminance Uniformity
1. Calculate the percent difference of the luminance values measured in
the image display area using the following equation:
200 * (Lmax – Lmin)
% difference =
(Lmax + Lmin)
where Lmax and Lmin are the maximum and minimum measured
luminance values respectively.
2. Compare the center luminance measurements on both monitors.
The % difference should be ≤20%.
PRECAUTIONS AND Ideally, monitor screens should be free of dust, fingerprints, and other
CAVEATS marks. Similarly, there should be no “shiny” patches or obvious non-
uniformities on the surface. As described below, significant blemishes
that interfere with the interpretation or QC of images must be corrected.
Most problems can be corrected by cleaning according to the
manufacturer’s instructions. However, if cleaning does not correct the
problem, the manufacturer should be contacted to evaluate and correct
the problem.
In most cases, Monitor Manufacturer Automated Tests and action
limits are available in manufacturer manuals or documents published
by the manufacturer. These tests are extremely valuable in maintaining
quality and are specific to each manufacturer. If a Monitor Manufacturer
Automated Test is available, the medical physicist should assist the facility
in verifying that the automated system is set up and functioning properly.

PERFORMANCE CRITERIA Ambient Light

AND CORRECTIVE ACTIONS
This recommended test is a subjective evaluation by the medical physicist
using his or her professional judgment to determine if the reading
environment is appropriate for interpreting mammograms. The ACR-
AAPM-SIIM Practice Parameter for Determinants of Image Quality in
Digital Mammography recommends 20-45 lux as appropriate ambient
light illuminance in digital mammography reading rooms. (Note: there
are varying data on optimal light levels for reading environments.)

Monitor Condition
Any large, significant blemish that interferes with the interpretation or QC
of images is a failure. (If there are questions regarding the significance of a
monitor blemish, the lead interpreting radiologist should be consulted.)

ACR DM Phantom
1. Artifacts must not be clinically significant. This aspect of the test
fails if any artifacts are in a location that could impact clinical
interpretation and
a. They are as prominent as (or more prominent than) the visible
test objects in the phantom image, or

190 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

b. They obscure test objects in the phantom, or

c. They could affect clinical interpretation.
The cause of the artifact should be identified and isolated to
determine if it originates from the x-ray system, the detector, or
the RW monitor. If the artifact is confirmed to originate from the
detector, a recalibration or flat-fielding of the detector may be needed.
Artifacts isolated to other components of the imaging chain should
be investigated.
After the artifact is resolved, repeat the phantom artifact test. If a
clinically significant artifact persists, contact your authorized service
representative. If the clinically significant artifact originated from the
x-ray/detector system, do not image patients until it is corrected. If
the clinically significant artifact originated from the RW monitor, do
not use the monitor to interpret patient images until it is corrected.
2. The fiber score must be ≥2.0.
3. The speck group score must be ≥3.0.
4. The mass score must be ≥2.0.

Distance Measurement
The distance measured across the wax insert parallel to the anode-cathode
axis must be 70.0 mm ±14.0 mm.

Test Pattern Image Quality

PHYSICIST’S SECTION
1. The test pattern must be centered appropriately.
2. The 0%-5% and 95%-100% contrast boxes must be visible.

MEDICAL
3. The alphanumerics must be sharp and legible.
4. The high-contrast line-pair patterns must be distinguishable at the
center and corners.
5. The grayscale ramps must be smooth and continuous.

Luminance Check
Lmin must be within ±30% of the values specified by the manufacturer,
if available. Lmax must be within ±10% of the values specified by the
manufacturer, if available. If no specified values are available, luminance
values must be Lmin ≤1.5 cd/m2 and Lmax ≥420 cd/m2.

Luminance Uniformity
The calculated % difference for an individual monitor must be ≤30%.
The calculated % difference between a pair of monitors for the center
luminance value must be ≤20%.

Digital Mammography Quality Control Manual Return to Table of Contents – 191

 III. Mammography Equipment Evaluation and Annual Survey

DICOM GSDF Evaluation (if available)

The measured contrast response values must not deviate from the targeted
contrast response by more than ±10%.

Monitor Manufacturer Automated Test (if available)

Monitors must pass all manufacturer tests.

TIMEFRAME FOR Monitor Condition, ACR DM Phantom and Distance

CORRECTIVE ACTION Measurement
All failures must be corrected before clinical use.

Test Pattern Image Quality, Luminance Check, Luminance

Uniformity, DICOM GSDF Evaluation, and Monitor
Manufacturer Automated Test (if available)
All failures must be corrected within 30 days.

192 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

12. Film Printer QC (if applicable)

OBJECTIVES To ensure adequate and consistent image quality of printed images
provided to referring physicians, patients, and other radiologists.
FREQUENCY As part of the mammography equipment evaluation of new units,
annually, and after relevant service.

Note: Testing film printers during equipment evaluations and annual

surveys is only required if they are used clinically for mammography (i.e., for
interpretation and to provide images to referring physicians and patients). If
such is the case, it is important that the facility document in its QC logs that
that the film printer is not used clinically.

TEST EQUIPMENT • ACR Digital Mammography (DM) Phantom image (required).

• Densitometer.
• Ruler.
• Film Printer QC form.
TEST PROCEDURE 1. Print the ACR DM Phantom image (acquired in the ACR Digital
Mammography Phantom Image Quality test) without adjusting any
parameters (window width/window level, sizing, etc.) using the film
size used for the majority of clinical printing. Print the digital images
without magnification or minification and as close to “true size” as
possible. The ACR recommends printing the phantom image so that
it is within 25% of the actual phantom size.

PHYSICIST’S SECTION
2. On the form, note the workstation used to print the image.

MEDICAL
3. Optional – print images on other size film.
4. View the image.

DATA ANALYSIS AND ACR DM Phantom Scoring

INTERPRETATION
1. Evaluate the phantom image on film for artifacts following the
instructions under Data Analysis and Interpretation in the ACR
Digital Mammography Phantom Image Quality test.
2. Score the phantom image(s) on film following the instructions under
Data Analysis and Interpretation in the ACR Digital Mammography
Phantom Image Quality test.
3. Record results on the form.

Background Optical Density

1. Measure the background optical density (OD) outside of the cavity
on the printed phantom image.
2. Record on the form.

Digital Mammography Quality Control Manual Return to Table of Contents – 193

 III. Mammography Equipment Evaluation and Annual Survey

Contrast
1. Record the background OD from above in the “Contrast” section of
the form.
2. Measure the OD inside the cavity and record the measurement on
the form.
3. Subtract the background OD from outside of the cavity from the OD
inside the cavity and record it on the form. This is the film contrast.
Contrast = Cavity OD – Background OD

Maximum Optical Density (Dmax)

1. Measure the OD near the outside edge of the film at a location where
the phantom image (including the detector area) is not located. If the
phantom image covers the entire film and there is insufficient room,
print a breast image and make this measurement in the non-breast
area.
2. See the Technologist’s ACR Technique and Procedure Summaries
form in the Technologist Section for a detailed schematic of where to
measure the ODs.

Distance Measurement
1. With a ruler, measure the distance across the wax insert in the anode-
cathode (A-C) direction and record on the form. (See Figure 35.)

Figure 35. Image of distance measurement on ACR DM Phantom.

194 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

PRECAUTIONS AND None

CAVEATS

PERFORMANCE CRITERIA ACR DM Phantom

AND CORRECTIVE ACTIONS
1. Artifacts must not be clinically significant. This aspect of the test
fails if any artifacts are in a location that could impact clinical
interpretation and
a. They are as prominent as (or more prominent than) the visible
test objects in the phantom image, or
b. They obscure test objects in the phantom, or
c. They could affect clinical interpretation.
If the artifact evaluation fails, check the softcopy images to
determine if the same artifact appears. If the same artifact
appears on the workstation, the problem should be addressed as
described in the workstation test. If the artifact does not appear
on the workstation, retest and seek service for the printer if the
problem persists. Do not print patient images until clinically
significant artifacts are corrected.
2. The fiber score must be ≥2.0.
3. The speck group score must be ≥3.0.
4. The mass score must be ≥2.0.

Background Optical Density

PHYSICIST’S SECTION
Background optical density must be ≥1.6. (Background optical densities
between 1.7 and 2.2 are recommended; approximately 2.0 is optimal.)

MEDICAL
Contrast
Contrast (cavity OD – background OD) must be ≥0.1.

Dmax
The Dmax must be ≥3.1 (≥3.5 is recommended).

Distance Measurement
The distance measured across the wax insert parallel to the A-C axis must
be 70.0 mm ±14.0 mm.
TIMEFRAME FOR All failures of required items must be corrected before clinical use.
CORRECTIVE ACTION

Digital Mammography Quality Control Manual Return to Table of Contents – 195

 III. Mammography Equipment Evaluation and Annual Survey

13. Evaluation of Site’s Technologist QC Program

OBJECTIVES •  o ensure that technologist QC is being performed correctly, to
T
compare the QC technologist’s and the medical physicist’s ACR
Digital Mammography (DM) Phantom scores, and to identify areas
where image quality and QC testing can be improved.
• 
To enable the medical physicist to provide an external assessment of
quality and possibly compare image quality and QC practices with
those of other mammography sites.
• 
To present an opportunity for the medical physicist to provide or
recommend further education to the QC technologist, if deficiencies
are noted.
FREQUENCY Annually.
TEST EQUIPMENT 1. Technologist QC forms since the last medical physicist’s survey.
2. Evaluation of Site’s Technologist QC Program form.

TEST PROCEDURE General Procedures

1. Evaluate if each technologist’s QC test
a. Is being performed correctly and at the appropriate frequency
and that QC data appear to be correct
b. Is analyzed correctly, that calculations are performed according
to the Technologist Section procedures, and that results are
compared to the procedures’ action limits
c. 
Results in needed corrective actions being performed and
documented
2. On the form, record any deficiencies such as missing data, incorrect
scoring or calculations, missing corrective action documentation,
and any other observed problems.
3. Provide comments and findings as necessary. If the QC technologist
is doing a good job on the routine QC, it is helpful to provide this
positive feedback, as well as feedback on items that need improvement.

ACR DM Phantom Image Quality

1. Record the medical physicist and QC technologist ACR DM Phantom
scores in their respective boxes.
2. If there are significant differences, discuss them with the QC
technologist.
DATA ANALYSIS AND 1. 
Although all noted deficiencies should be recorded on the form,
INTERPRETATION only significant deficiencies should lead to a “Fail” assessment for
the Overall Technologist QC Program. For the program to receive an
overall PASS,
a. There must be no significant missing data,

196 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

b. The tests must be analyzed without gross errors, and

c. Appropriate corrective action for failures must be taken and
documented.
2. The following FDA Level 2 non-compliance items can be used
as guidance to determine whether the Overall Technologist QC
Program fails:
a. 
Not conducting a phantom image test for 2-3 weeks in a
consecutive 12-week working period,
b. Failure to conduct a phantom image test at clinical settings, and
c. Not taking timely corrective action for failed items.
3. The medical physicist should use his or her judgment to determine
what constitutes a significant deficiency. The following are examples:
a. Two weeks of the weekly ACR DM Phantom Image Quality
testing were missing in the entire year (one in April, another in
November). Although the medical physicist should note this on
the form, the overall evaluation for the site’s technologist QC
program should be PASS.
b. The 2 most recent consecutive weeks of the weekly ACR DM
Phantom Image Quality testing were missing in the evaluated year
(with no explanation or corrective action in the QC records). The
overall evaluation for the site’s technologist QC program should
be FAIL, and the medical physicist should point out that this may
be a trend in need of correction.
c. All weekly QC tests were missing 4 weeks in a row, but in the

PHYSICIST’S SECTION
QC records the facility manager and lead interpreting radiologist
noted that they are aware of this occurrence, why it occurred,

MEDICAL
and that corrective action was taken so it would not occur again.
The site’s technologist QC program would PASS since corrective
action was taken to prevent future occurrences. The medical
physicist should make a note of the circumstances and corrective
action on the form. For example, “the QC technologist was on
temporary disability; since that time a backup QC technologist
was trained to assume QC responsibilities in case of future
unexpected absences.”
d. The QC technologist was routinely subtracting for artifacts when
scoring the ACR DM Phantom. Although the medical physicist
should note this on the form, the overall evaluation for the site’s
technologist QC program should PASS. (However, if the medical
physicist notes during the following year’s annual survey that
the same QC technologist continues to subtract for artifacts, the
overall evaluation for the site’s technologist QC program should
FAIL.)
4. Be sure to note on the Evaluation of Site’s Technologist QC
Program form if the QC technologist is performing his or her QC
responsibilities well.

Digital Mammography Quality Control Manual Return to Table of Contents – 197

 III. Mammography Equipment Evaluation and Annual Survey

PRECAUTIONS AND The medical physicist should conduct this review so that he or she
CAVEATS is confident that all required tests have been correctly completed at
the required intervals and appropriate corrective action was taken if
necessary. For example, when reviewing the tests of a QC technologist
or facility that is new to the medical physicist, he or she should review
all the tests and corrective action for the previous year. Similarly, if the
equipment is new to the facility, a thorough review of QC should be done.
If the medical physicist establishes confidence that QC is being conducted
as required, he or she may only need to review samples of the QC during
future surveys. If the samples reveal missing data, irregular results, or
missing corrective action, a complete review should be conducted.
This important evaluation helps the facility prepare for its annual MQSA
inspection by identifying missing tests or inadequate documentation. If
tests are found missing, however, it is imperative that the QC technologist
does not perform and back-date any tests to compensate for the omissions.
The medical physicist should advise the facility to make a note that they are
aware of the missing tests and document efforts to prevent occurrence in
the future. See the FDA’s topic on Radiologic Technologists: Falsification
of Documentation for information on QC records.
Medical physicists should provide the QC technologist with one-on-one
training or recommend sources of appropriate training if deficiencies in
the conduct of the tests are noted. Although it is the medical physicist’s
responsibility to perform this review annually and to bring any
deficiencies to the attention of the facility and lead interpreting physician,
it is the responsibility of the facility and lead interpreting physician to see
that measures are taken to ensure that all required tests are performed as
specified by the medical physicist and at the required frequencies.
PERFORMANCE CRITERIA 1. The Site’s Technologist QC Program must receive an overall PASS
AND CORRECTIVE ACTIONS evaluation.
2. If significant deficiencies are found, they must be documented in the
form, and action should be taken to correct the problems. Depending
on the nature of the deficiency, correction may entail actions such as
obtaining appropriate test equipment or providing additional training
or coursework for the QC technologist, or facility management could
decide to provide sufficient time for the QC technologist to perform the
required duties. QC technologists should be assisted by both the medical
physicist and facility management to resolve any identified issues.
TIMEFRAME FOR Failures must be corrected within 30 days.
CORRECTIVE ACTION

APPLICABLE MQSA
REQUIREMENTS 900.12(e) Quality assurance—equipment. (9) Surveys. (ii) The results of all tests
conducted by the facility in accordance with paragraphs (e)(1) through (e)(7)
[mostly technologist quality control tests] of this section, as well as written
documentation of any corrective actions taken and their results, shall be
evaluated for adequacy by the medical physicist performing the survey.

198 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

14. Evaluation of Display Device Technologist QC Program

OBJECTIVES • To ensure that technologist QC tests for radiologist workstation
(RW) monitors, film printers (if applicable), and viewboxes are being
performed correctly at both local and offsite locations.
•  o identify areas where image quality and QC testing can be
T
improved.
FREQUENCY Annually.

TEST EQUIPMENT • Technologist QC forms.

• Evaluation of Display Device Technologist QC Program form.
TEST PROCEDURE 1. Evaluate whether all technologist’s QC tests for the RW monitors,
film printers, and viewboxes are being performed correctly, that
QC data appear to be correct, and that analysis and calculations
are performed according to the Radiologic Technologist’s Section
procedures and action limits.
2. Review the Corrective Action Log to ensure it is being used
appropriately, documentation of corrective action appears to be
written correctly, and all items have been corrected.
3. On the form, record any deficiencies such as missing data, incorrect
scoring or calculations, missing corrective action documentation,
and any other observed problems.
4. Provide comments and findings at the bottom of the form.

Note: This evaluation may be done by the primary site’s medical physicist

PHYSICIST’S SECTION
or the medical physicist providing services for the offsite equipment. In any
case, the evaluation must be performed and documented at least annually

MEDICAL
for each display device.

DATA ANALYSIS AND Not applicable

INTERPRETATION

PRECAUTIONS AND See the Evaluation of Site’s Technologist QC Program test.

CAVEATS
This evaluation may be performed by either the primary site’s medical
physicist performing the facility’s annual survey or, if the display devices
are at an offsite location, by another medical physicist local to the site. If
another medical physicist evaluates the QC, he or she must provide annual
documentation to the primary mammography site (e.g., a completed
Evaluation of Display Device Technologist QC Program form).
PERFORMANCE CRITERIA 1. All Technologist Quality Control Tests for the RW monitors and film
AND CORRECTIVE ACTIONS printers must be performed correctly with correct documentation.
If deficiencies are found by the medical physicist and documented
in the form, action must be taken to correct the problems.
Technologists should be assisted by both the medical physicist and
facility management to resolve these issues.

Digital Mammography Quality Control Manual Return to Table of Contents – 199

 III. Mammography Equipment Evaluation and Annual Survey

2. Additionally, this test is meant to serve as an external assessment

of quality and a comparison of image quality and QC practices
with those of other mammography sites. This review provides an
opportunity for valuable feedback to the site on methods of quality
improvement.
TIMEFRAME FOR Failures must be corrected within 30 days.
CORRECTIVE ACTION

APPLICABLE MQSA
REQUIREMENTS 900.12(e) Quality assurance—equipment. (9) Surveys. (ii) The results of all tests
conducted by the facility in accordance with paragraphs (e)(1) through (e)(7)
[mostly technologist’s quality control tests] of this section, as well as written
documentation of any corrective actions taken and their results, shall be
evaluated for adequacy by the medical physicist performing the survey.

200 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

15. Manufacturer Calibrations (if applicable)

OBJECTIVES To detect and automatically correct equipment problems, especially
related to digital detector performance. This may include compensating
for dead or over-responding pixels, structured or other noise, nonlinear
response, and other technical performance parameters.

FREQUENCY As part of the mammography equipment evaluation of new units,

annually, and after relevant service.

Important: This test is applicable if the manufacturer’s documentation

includes routine calibration

TEST EQUIPMENT • Manufacturer Calibrations form.

• Other forms per manufacturer’s recommendations.
TEST PROCEDURE 1. 
See manufacturer’s documentation for exact procedure steps.
The medical physicist should help the facility in locating and
implementing these procedures.
2. 
Enter the results or verification of completion on the form.
DATA ANALYSIS AND Follow manufacturer’s recommendations.
INTERPRETATION

PRECAUTIONS AND Most manufacturers provide specific instructions for system calibrations
CAVEATS (e.g., detector calibration). See the manufacturer’s documentation for
precautions and caveats.

PHYSICIST’S SECTION
PERFORMANCE CRITERIA Manufacturers’ recommendations should be followed.
AND CORRECTIVE ACTIONS

MEDICAL
TIMEFRAME FOR Manufacturers’ recommendations should be followed.
CORRECTIVE ACTION

Digital Mammography Quality Control Manual Return to Table of Contents – 201

 III. Mammography Equipment Evaluation and Annual Survey

16. Collimation Assessment

OBJECTIVES • To ensure that the x-ray field aligns with the light field.
• 
To ensure that the collimator allows for full coverage of the image
receptor by the x-ray field but does not allow significant radiation
beyond its edges.
• 
To ensure that the chest-wall edge of the compression paddle aligns
acceptably with the chest-wall edge of the image receptor.
FREQUENCY For 2D: as part of the mammography equipment evaluation
• 
(MEE) of new units, after relevant service, and after component
replacement (Because digital mammography units are very stable,
the Collimation Assessment test, which is based on the FDA screen-
film annual survey rule in Section 900.12(e)5(vii), only needs to be
done for MEEs or if additional troubleshooting is needed to diagnose
a potential problem.)
•  or DBT: as part of the MEE of new units, annually, and after
F
relevant service.
TEST EQUIPMENT • Five coins, four of one size (e.g., pennies), one of a larger size (e.g., a
nickel). Other flat, radiopaque objects may be used in place of coins.
• 
A collimation test tool—the detector used to record the collimation
test images (e.g., film, computed radiography [CR] plates, electronic
instruments, etc.)—is left to the discretion of the medical physicist.
Several alternatives are possible:
– film-screen cassettes
– diagnostic x-ray CR cassettes
– mammography CR cassettes
– self-developing film
– electronic radiation “rulers”
As each of these requires substantially different setup and exposure
conditions than the others, only general directions are provided
below. Specific implementation must be adapted to the particular
detector used.
• Collimation Assessment form.
TEST PROCEDURE 1. Create a test patient.
2. 
Remove the compression paddle.
3. 
Select the largest field of view (FOV).
4. If testing a DBT system, set up the unit to make an exposure in the
2D mode.

Note: The Collimation test for DBT units is performed in 2D mode, not DBT
mode.

202 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

5. If the detector is CR, place an appropriately sized cassette in the

normal orientation in the image receptor holder.
6. Place the external radiation detector on top of the breast support. If
the detector does not cross each edge of the radiation field, use either
multiple detectors or multiple exposures to capture all four borders
of the x-ray field.
7. Align the edge of one of the four smaller coins with each edge of the
light field, with the center of the coin positioned within the light field.
8. Tape the larger coin to the underside of the compression paddle and
within the paddle so that the outer edge of the coin is aligned with
the inner chest-wall edge of the paddle. Be sure to position this coin
so that it does not interfere with the smaller coin indicating the chest-
wall edge light field border.
9. 
Replace the paddle and position it 4–6 cm from the breast support.
10. Make an exposure appropriate to achieve a useable image on both the
unit’s detector and the external detector.
11. 
For MEE of new unit, or after relevant service or component
replacement, repeat steps 2-10 for all available anode tracks.
12. 
For MEE of new unit, or after relevant service or component
replacement, repeat steps 2-10 for the small FOV. If the unit shifts
the small FOV across the detector for left and right breast laterality,
all three positions (left, center, and right) must be evaluated.
DATA ANALYSIS AND 1. From the external detector(s), determine the distance between the
INTERPRETATION light field and the radiation field. For step 3 below, record the sign

PHYSICIST’S SECTION
of the deviation: if the radiation field extends beyond the edge of the
light field, record the value as positive; if the radiation field does not
extend fully to the edge of the light field, record the value as negative.

MEDICAL
2. From the image in the acquisition workstation, determine the
difference between each light field edge and the border of the visible
image, maintaining the sign: if the coin is fully visible, the difference
will be positive; if the coin is only partially visible, the difference will
be negative.
3. For each edge, sum the values determined in steps 1 and 2 of this
section; this is the deviation between the radiation field and the
visible image.
4. For the larger coin, measure the distance between the diameter of
the coin in the image on the acquisition workstation and the dimension
of the coin perpendicular to the chest-wall edge as the distance
from the paddle edge to the image receptor edge, maintaining the sign.
(See Figure 36.)
a. If the coin is not fully visible, record the value as positive.
b. If the coin is fully visible, record the value as negative.

Digital Mammography Quality Control Manual Return to Table of Contents – 203

 III. Mammography Equipment Evaluation and Annual Survey

Figure 36. Chest-wall side collimation assessment with larger coin.

PRECAUTIONS AND It may be necessary to correct for magnification effects in the images. As
CAVEATS necessary corrections will depend on the exact methodology used and
the system being tested, only this general warning can be provided.

Note: If a large exposure is required for the external detector (such as self-
developing film), care must be taken to protect the unit’s detector. Either
use an appropriate attenuator between the external detector and unit’s
detector or make one exposure to capture the coins on the image, then
place adequate lead over the unit’s detector to complete the light field/
radiation field measurement with the external detector. A 3 mm (1/8”)
aluminum plate, large enough to cover the entire detector, also may be laid
directly on the breast support surface.

PERFORMANCE CRITERIA AND 1. If a light localizer is used, congruence of the light field with the
CORRECTIVE ACTIONS radiation field should be such that the total misalignment (sum
of misalignments on opposite sides) is within 2% of source-image
receptor distance (SID) as required by 21 CFR §1020.31(f)(3) [13].
The x-ray field should not extend beyond any of the four sides
of the image receptor by more than +2% of the SID. At the chest
wall side, the radiation field must extend to the edge of the image
to minimize excluding breast tissue adjacent to the chest wall.
Ideally, the entire image receptor should be exposed. However,
since most manufacturers have designed their collimators to meet
the FDA manufacturer’s requirement for general x-ray equipment,
which specifies that the x-ray field not exceed the size of the image
receptor, a tolerance of −2% of the SID on the right and left sides is
acceptable. (For example, an image with a 1.1-cm “white gap” on its
left side would be acceptable on a unit with a SID of 60 cm). A greater
tolerance of −4% of SID is acceptable at the anterior side of the film
to allow for appropriate image marking.

204 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

2. The chest-wall edge of the compression paddle should be aligned

just beyond the chest-wall edge of the image receptor such that
the chest-wall edge of the compression paddle does not appear in the
digital mammography image. In addition, the chest-wall edge of the
compression paddle should not extend beyond the chest-wall edge of
the image receptor by more than 1% of the SID. Proper alignment of
the edge of the compression paddle with the chest-wall edge of the
image receptor holder assembly is necessary for proper positioning
and compression of the breast. If the edge of the compression paddle
extends too far beyond the image receptor edge, the patient’s chest is
pushed away from the image receptor and some breast tissue will be
excluded from the image. This situation is unacceptable and is not
permitted. If the edge of the compression paddle does not extend
far enough, the breast tissue will not be properly pulled away from
the chest wall and compressed for visualization in the image, and a
shadow of the vertical edge of the compression paddle may be visible
in the image, possibly obscuring clinical information.
3. If the Suggested Performance Criteria are exceeded, a qualified
service engineer should be contacted to correct the problem as soon
as possible.
TIMEFRAME FOR • All failures must be corrected within 30 days.
CORRECTIVE ACTION
• For MEEs, failures must be corrected before clinical use.

PHYSICIST’S SECTION
MEDICAL

Digital Mammography Quality Control Manual Return to Table of Contents – 205

 III. Mammography Equipment Evaluation and Annual Survey

MEE or Troubleshooting – Beam Quality (Half-Value Layer)

Assessment
OBJECTIVES To ensure that the half-value layer (HVL) of the x-ray beam is adequate
to minimize patient breast dose but not so excessive that contrast is lost
in the resultant image.
FREQUENCY As part of the mammography equipment evaluation (MEE) of new units,
if technique factors impacting beam quality are changed for a 4.2-cm
thick compressed breast consisting of 50% glandular and 50% adipose
tissue (and, thus, the ACR Digital Mammography [DM] Phantom) and
after relevant service.

Note: If the facility changes technique factors (that impact beam quality and
dose) for a 4.2-cm thick compressed breast consisting of 50% glandular and
50% adipose tissue, and the HVL was not previously determined for those
factors, the medical physicist should measure the HVL for the appropriate
factors during the annual survey. Also, if there is any concern regarding a
significant dose change, the HVL should be re-evaluated.

TEST EQUIPMENT • I onization chamber and electrometer or other appropriate dosimetry

device calibrated at mammographic x-ray beam energies.
• 0 .1-mm thick sheets of high-purity aluminum (99.9% pure) or 99%
pure aluminum (type 1100 aluminum alloy) of length and width
sufficient to cover the dosimeter fully. (The stated thickness should
be accurate to within ±0.005 mm.)

Note: The use of type 1100 aluminum alloy for HVL measurement can give
(depending on specific samples) HVL values up to 7.5% lower than those
measured using high-purity aluminum. If type 1100 aluminum is used,
results should be corrected to agree with those obtained using high-purity
aluminum.

•  n integrated, solid-state instrument (one that automatically

A
measures kVp, HVL, and dose) is also acceptable. See Precautions
and Caveats.
• Beam Quality (Half-Value Layer) Assessment form.

TEST PROCEDURE 1. Raise the breast compression paddle as close as possible to the x-ray
tube.
2. Cover the detector with a protective device (e.g., a lead sheet or lead
apron).
3. Place the dosimeter 4.2 cm above the image receptor holder assembly,
centered left to right and 4 cm in from the chest-wall edge of the
image receptor. The dosimeter should be fully within the x-ray field.
(See Figure 37.)

206 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

A B

Figure 37. HVL setup. Compression device positioned so that it is as close to the x-ray
tube as possible. A. Side view diagram. B. Top view diagram. C. Photo.

4. Select the target/filter and kVp used for the ACR DM Phantom

PHYSICIST’S SECTION
acquisition, and record the information on the data form.
5. Set the unit to manual mAs, with a time setting long enough to

MEDICAL
provide an exposure sufficiently close to the ACR DM Phantom
technique.
6. Use the collimator, if possible, to collimate the x-ray beam so that the
dosimeter is just fully exposed (to minimize backscatter).
7. Make an exposure without aluminum sheets between the x-ray tube
and the dosimeter.
8. Only 2 additional exposures are necessary to complete the test. Select
two thicknesses that will most likely result in exposures just above
and just below one-half the original exposure reading (taken without
any added aluminum sheets between the x-ray tube and dosimeter).
a. 
Add sufficient aluminum (e.g., 0.3 mm) between the x-ray
tube and the dosimeter by placing the aluminum on top of the
compression paddle. Use the light field (if available) to verify
that the x-ray path to the dosimeter is fully blocked by the
aluminum sheet(s). Make an exposure and record the dosimeter
reading. This reading should be greater than one-half the original
exposure reading.

Digital Mammography Quality Control Manual Return to Table of Contents – 207

 III. Mammography Equipment Evaluation and Annual Survey

b. Repeat with an additional 0.1-mm sheet of aluminum between

the x-ray tube and dosimeter, and record the dosimeter reading.
This last reading should be less than one-half the original
exposure reading.
9. Repeat steps 4-8 for other kVp/target/filter settings ranging from the
lowest to the highest used clinically. Be sure to check at least 1 HVL
for each target/filter combination.
DATA ANALYSIS AND To calculate the HVL by logarithmic interpolation, use the following
INTERPRETATION notation and procedure. Denote the direct exposure reading, without
any added aluminum, as E0. Divide this value in half and find the two
exposure readings and added aluminum thicknesses that bracket the E0/2
exposure. Let Ea be the exposure reading that is just greater than one-
half of E0, and let ta be the corresponding aluminum thickness. Let Eb
be the exposure reading that is just less than one-half of E0, and let tb the
corresponding aluminum thickness. Ea will be greater than Eb, while ta
will be less than tb. With this notation, the HVL may be computed using
the formula

tb ln[ 2Ea ] – ta ln[ 2Eb ]

E0 E0
HVL =
Ea
ln[ ]
Eb
where the HVL will be given in the same units as ta and tb (i.e., millimeters
of aluminum).
PRECAUTIONS AND During MEEs the medical physicist must determine HVLs for all target/
CAVEATS filter combinations and a range of clinically used kVps. If, after the
MEE, the facility uses a new clinical kVp, it may not be necessary for the
medical physicist to perform another HVL measurement. If the new kVp
is bracketed by kVps used for previous HVL measurements, the medical
physicist may interpolate a new HVL to use in average glandular dose
assessments for the new kVp.
If an integrated, solid-state instrument (one that automatically measures
kVp, HVL, and dose) is used, the above procedures would not apply. The
HVL may be entered into the results area of the form.
Using solid-state detectors for determining half-value layers may
provide accuracy challenges if they are not calibrated for the target/
filter combination in use. The FDA has provided guidance for medical
physicists on this topic. See the FDA’s MQSA Policy Guidance Help
System topic on non-invasive solid state instruments.

208 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

PERFORMANCE At a given kVp setting in the mammographic kilovoltage range (below

CRITERIA AND 50 kVp), the HVL determined with the compression paddle in place
CORRECTIVE ACTIONS must be equal to or greater than the values in the table from the FDA
regulations below.

The HVL shall meet the specifications of FDA’s Performance Standards for
Ionizing Radiation Emitting Products (Part 1020.30) for the minimum HVL.
These values, extrapolated to the mammographic range, are shown in the
table below. Values not shown may be determined by linear interpolation or
extrapolation.

X-ray Tube Voltage (kilovolt peak) and Minimum HVL

Measured Minimum HVL
Designed Operating Operating (millimeters of
Range (kV) Voltage (kV) aluminum)
Below 50 20 0.20
25 0.25
30 0.30

TIMEFRAME FOR All failures must be corrected before clinical use.

CORRECTIVE ACTION

PHYSICIST’S SECTION
MEDICAL

Digital Mammography Quality Control Manual Return to Table of Contents – 209

 III. Mammography Equipment Evaluation and Annual Survey

MEE or Troubleshooting – kVp Accuracy and Reproducibility

OBJECTIVES To ensure that the kVp is accurate (within ±5% of the indicated kVp) and
that the kVp is reproducible, having a coefficient of variation equal to or
less than 0.02.

FREQUENCY As part of the mammography equipment evaluation (MEE) of new

units, after relevant service, and after component replacement. (Because
generators used in digital mammography are very stable, the kVp Accuracy
and Reproducibility test, which is based on the FDA screen-film annual
survey rule in Section 900.12(e)5(ii), only needs to be done for MEEs or
if additional troubleshooting is needed to diagnose a potential problem.)

TEST EQUIPMENT • k Vp meter capable of determining kVp to an accuracy of ±1.5 kVp

and a precision of 0.5 kVp within the mammographic kVp range.
• Lead sheet or other attenuator to protect the image receptor.
•  n integrated, solid-state instrument (one that automatically
A
measures kVp, half-value layer [HVL], and dose) is also acceptable.
(See Precautions and Caveats.)
• kVp Accuracy and Reproducibility form.

TEST PROCEDURE 1. In manual timing mode, select the most commonly used clinical kVp
setting (within the specified accuracy range of the meter) and record
on the data form. Also record nominal focal spot size, exposure time,
and mA (or mAs) setting.
2. Set up the test device following the manufacturer’s instructions.
3. Make three exposures in the same manual mode settings, and record
the measured kVp values.
4. Repeat the procedure at the lowest clinically used kVp that can be
measured by the kVp test device and the highest available clinically
used kVp, but make only one exposure at each setting. (Reproducibility
needs to be checked only at the most commonly used clinical kVp
unless variability is suspected at other settings.)
DATA ANALYSIS AND 1. 
To determine kVp accuracy, average the readings for each kVp setting
INTERPRETATION tested and compare this average value with the value of the preset
nominal kVp.
2. To determine kVp reproducibility, compute the standard deviation
of the kVp values for each kVp setting and calculate the coefficient of
variation of kVp (standard deviation divided by the mean).

PRECAUTIONS AND If an integrated, solid-state instrument (one that automatically measures

CAVEATS kVp, HVL, and dose) is used, the above procedures may not apply. Be sure
that the meter is calibrated for the target/filter combination as well as the
kVp range in use. Using solid-state detectors for assessing kVp may provide
challenges if they are not calibrated for the target/filter combination in
use. The FDA has provided guidance for medical physicists on this topic.
See the FDA’s MQSA Policy Guidance Help System topic on non-invasive
kVp meters.

210 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

PERFORMANCE CRITERIA 1. If the average measured kVp differs by more than ±5% (e.g., ±1.5 kVp
AND CORRECTIVE ACTIONS at 30 kVp) from the nominal kVp setting, the unit should be checked
by appropriate service personnel.
2. If the coefficient of variation exceeds 0.02 for any kVp setting, the
unit should be checked by appropriate service personnel.
TIMEFRAME FOR • When the test is performed for an MEE, all failures must be corrected
CORRECTIVE ACTION before clinical use.
•  hen the test is performed for troubleshooting, all failures must be
W
corrected within 30 days.

PHYSICIST’S SECTION
MEDICAL

Digital Mammography Quality Control Manual Return to Table of Contents – 211

 III. Mammography Equipment Evaluation and Annual Survey

Troubleshooting – Ghost Image Evaluation

OBJECTIVES To evaluate the extent to which previous exposures impact later exposures
on the detector. (This may be manifested in two ways. The earlier
exposures may cause a change in the sensitivity of the detector, leading
to under- or over-response to a later exposure, which is called “ghosting.”
Also, residual signal (shadows) of prior images may be retained. This is
also known as “lag.” For simplicity, both phenomena will be referred to in
this document as “ghosting.”)
TEST EQUIPMENT • ACR Digital Mammography (DM) Phantom.
• 0 .1-mm thick aluminum, approximately 10 cm × 10 cm (aluminum
used for half-value layer attenuation works well).
• Timer (watch, stopwatch, etc.).
• Ghost Image Evaluation form.
TEST PROCEDURE 1. Create a test patient.
2. Turn off all image processing, if possible.
3. Install the largest compression paddle.
4. Place the ACR DM Phantom on the right half of the breast support
plate with the edge placed at the middle of the image receptor,
running from chest wall to the anterior edge such that it extends
approximately 2.5 cm beyond the left-to-right center line of the
breast image. If the system has automatic exposure control (AEC)
sensors, they must be fully covered by the phantom. (See Figure 38.)
5. If possible, select an AEC detector location approximately 5 cm from
the chest wall.
6. Lower the paddle and compress to 5 decanewtons.
7. Acquire an image using the technique used for imaging the ACR DM
Phantom.

Figure 38. Phantom placed offset on the detector.

212 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

8. Immediately start timing.

9. Move the uniform attenuator so that it covers the entire breast
imaging area. Place the aluminum in the center of the imaging field,
on top of the uniform attenuator, and aligned with the chest-wall
edge of the paddle, ensuring that it extends at least 2 cm beyond the
previous edge of the acrylic attenuator. (See Figure 39.)

Figure 39. Phantom placed on the image receptor with the aluminum sheet placed
correctly.

10. One minute after the first image was acquired, or within as short

PHYSICIST’S SECTION
a time as the system will allow if longer than 1 minute, acquire a
second image using the same techniques as the first image.

MEDICAL
11. Use a circular or rectangular region of interest tool (area ~1 cm2) to
measure the mean signal value in the following 3 regions in the raw
version of the second image acquired (see Figure 40):
a. The mean signal (S1) value over the uniform attenuator on the
side where the attenuator was present in the first image
b. The mean signal (S2) value over the uniform attenuator plus the
aluminum square on the side where the attenuator was present in
the first image
c. The mean signal (S3) value over the uniform attenuator plus the
aluminum square on the side where no uniform attenuator was
present in the first image

Digital Mammography Quality Control Manual Return to Table of Contents – 213

 III. Mammography Equipment Evaluation and Annual Survey

Figure 40. Signal measurement locations.

DATA ANALYSIS AND Calculate the Ghosting Index using the formula:
INTERPRETATION S –S
Ghosting Index = 3 2
S1 – S2

PRECAUTIONS AND None

CAVEATS

PERFORMANCE If the ghosting index is more than ±0.3, repeat the test. If the ghosting
CRITERIA AND index still exceeds ±0.3, service personnel should be contacted.
CORRECTIVE ACTIONS

TIMEFRAME FOR Failures must be corrected before clinical use.

CORRECTIVE ACTION

214 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

Troubleshooting – Viewbox Luminance

OBJECTIVES To ensure that the luminance of viewboxes used for interpretation of
mammograms meets or exceeds minimum levels.
TEST EQUIPMENT • Luminance meter.
• Viewbox Luminance form.

TEST PROCEDURE
Note: The measurement procedures described below follow, as closely as
possible, those recommended by the National Association of Photographic
Manufacturers (NAPM). Additional measurements are described in the
NAPM standard that the medical physicist may wish to include, e.g.,
luminance uniformity.

1. 
Reproduce the typical ambient lighting conditions for the reading
room, including overhead and task lighting, that is used when
mammograms are interpreted.
2. 
For each viewbox used for mammographic interpretation, turn
on the lights in the viewbox at least 30 minutes before making the
following measurements.
3. Place the luminance meter with its detector parallel to and facing the
viewbox surface.
4. 
Make the measurement and record the result as the viewbox
luminance.
5. Visually inspect each viewbox for uniformity of luminance and

PHYSICIST’S SECTION
for uniformity of color of the lighting. Note nonuniformities. Also
evaluate viewboxes for proper function of masking devices and the
presence of dirt or marks.

MEDICAL
6. Repeat the tests for all viewboxes used for interpreting mammograms
on film.
DATA ANALYSIS AND Compare the measured luminance to the action limit and determine pass
INTERPRETATION or fail.

PRECAUTIONS AND Many photometric units of measurement exist but are seldom used. For
CAVEATS simplicity we will consider only the SI photometric unit of luminance, the
candela per square meter.
Luminance is the amount of light either scattered or emitted by a surface,
measured in cd/m2 (formerly “nit”). Other units often used for luminance
are foot-lamberts. To convert foot-lamberts to cd/m2, multiply the
numerical value by 10.764/π (3.426).

Viewbox Reading Conditions

Ambient room lighting and masking of film to exclude bright areas
of the viewbox from being seen by the radiologist are very important.
In particular, any unmasked area of the viewbox or bright ambient
light results in loss of low-contrast perceptibility, which is of primary

Digital Mammography Quality Control Manual Return to Table of Contents – 215

 III. Mammography Equipment Evaluation and Annual Survey

importance in mammography interpretation. This decreased perceived

image contrast is a result of light scattered and reflected from the surface
of the film being viewed as well as light scattered in the eye (veiling glare).
PERFORMANCE Viewboxes used for interpreting mammograms and clinical image quality
CRITERIA AND review by the technologist should be capable of producing a luminance
CORRECTIVE ACTIONS of at least 3,000 candela per square meter (cd/m2). The illumination levels
should be 45 lux, or preferably less. All viewboxes used for mammographic
interpretation must be masked to the exposed area of the film.
It is essential to mask the area around mammograms to exclude
extraneous light, which reduces low-contrast perceptibility and also
limits the maximum densities that can be seen without “bright-lighting”
each image. Viewboxes should be positioned to avoid light from
windows, other viewboxes, and other sources of bright light, either direct
or reflected. Visually check the viewboxes to ensure that all bulbs are
producing light of the same color and luminance level.
If the luminance level of the viewbox is less than 3,000 cd/m2, or if
the luminance or the color of light of the individual lamps appears
significantly different from others in the same viewbox, all bulbs in the
viewbox should be replaced at the same time.

216 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

B. Test Forms
Routine and complete documentation of QC and corrective actions are
a critical part of quality mammography and are required by the FDA
mammography regulations. The QC forms in this section have been
developed to help meet this goal and to comply with FDA requirements.
The QC form number corresponds to the test procedure number provided
in the previous section. Each form has been set up with a brief summary
of the test procedure, an area to record the test conditions and techniques
(to ensure that test conditions that could cause variability in the results
are not changed), and reminders of action limits and timeframes for
corrective action. Be sure to consult the quality control test procedure for
the complete instructions if there are questions about performing tests or
analyzing data.
For simplicity and uniformity, the DBT tests are intended to use the same
forms as the 2D tests. Document that the DBT tests were performed by
selecting the correct image “mode” on the form. (If you are using an
electronic version of the form, use the pull-down menu to select the
mode.) Note that for some DBT tests you will need to use a second or
third page of the form for complete QC documentation.
The forms are also downloadable as Excel spreadsheets from the ACR
Digital Mammography QC Manual Resources website (go to Digital
Mammography Quality Control Test Forms). Although they have been
designed to help you record and analyze your QC results on a computer,
they may also be printed and completed manually.

1. Mammography Equipment Evaluation and MQSA

PHYSICIST’S SECTION
Requirements

MEDICAL
2. 
ACR DM Phantom Image Quality

3. 
DBT Z Resolution

4. 
Spatial Resolution

5. 
DBT Volume Coverage

6. 
Automatic Exposure Control System Performance

7. 
Average Glandular Dose

8. 
Unit Checklist

9. 
Computed Radiography (if applicable)

Digital Mammography Quality Control Manual Return to Table of Contents – 217

 III. Mammography Equipment Evaluation and Annual Survey

10. 
Acquisition Workstation (AW) Monitor QC

11. 
Radiologist Workstation (RW) Monitor QC

12. 
Film Printer QC (if applicable)

13. 
Evaluation of Site’s Technologist QC Program

14. 
Evaluation of Display Device Technologist QC

15. 
Manufacturer Calibrations (if applicable)

16. 
Collimation Assessment

218 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

C. MEE or Troubleshooting Test Forms

1. MEE or Troubleshooting – Beam Quality

(Half-Value Layer) Assessment

2. 
MEE or Troubleshooting – kVp Accuracy and
Reproducibility

3. 
Troubleshooting – Ghost Image Evaluation

4. 
Troubleshooting – Viewbox Luminance

238 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Mammography Equipment Evaluation and Annual Survey

D. Summary Report Forms

1. 
Medical Physicist’s ACR DM QC Test Summary

2. 
Mammography Technique Chart

3. 
Medical Physicist QC Letter for the Radiologist

PHYSICIST’S SECTION
MEDICAL

Digital Mammography Quality Control Manual Return to Table of Contents – 243

 Medical Physicist's ACR DM QC Test Summary (cont)
Facility Name 0 MAP ID-Unit# (00000-00) 00000 - 00
Mfr & Model Room ID 0
Survey Date January 0, 1900

Corrective Action Summary*

*Note: This is only a summary page, the Corrective Action Log Form may contain further details.

Utilize Corrective
Action Log Form

Initials
Required/ Date
Recommended Time Frame Description Completed

Medical Physicist's Section 4z. MP FORMS_2019-09-30.xlsx

 III. Mammography Equipment Evaluation and Annual Survey

E. Supplemental Forms

1. 
Facility, Unit, and Test Equipment Data

PHYSICIST’S SECTION
MEDICAL

Digital Mammography Quality Control Manual Return to Table of Contents – 249

 References

References A. Downloadable from the ACR Website

(www.acr.org)
– ACR Mammography Accreditation Program
– ACR Digital Mammography QC Manual Resources
– Destouet JM, Bassett LW, Yaffe MJ, Butler PF, Wilcox PA. The ACR’s
mammography accreditation program: ten years of experience since MQSA.
J Am Coll Radiol. 2015;2(7):585-594.
– ACR Appropriateness®Criteria - Breast Imaging
– ACR BI-RADS®Atlas
– ACR Practice Parameter for the Performance of Screening and Diagnostic
Mammography
– ACR–AAPM–SIIM Practice Parameter for Determinants of Image Quality
in Digital Mammography

B. References
1. Department of Health and Human Services. FDA Mammography Quality
Standards, Final Rule. Fed Reg. 1997;62(208):55852-55994.
2. U.S. Food and Drug Administration. Mammography Quality Standards Act
(MQSA) Policy Guidance Help System.
3. 
FDA Mammography Quality Standards Act and Program, Facility
Certification and Inspection (MQSA) - Digital Accreditation.
4. Williams MB, Goodale PJ, Butler PF. The current status of full-field digital
mammography quality control. J Am Coll Radiol. 2004;1:936-951.

PHYSICIST’S SECTION
5. Hendrick RE, Bassett L, Botsco MA, et al. Mammography Quality Control
Manual. Reston, Va: American College of Radiology; 1999.
6. 
Dance DR, Skinner CL, Young KC, Beckett JR, Kotre CJ. Additional

MEDICAL
factors for the estimation of mean glandular breast dose using the UK
mammography dosimetry protocol. Phys Med Biol. 2000;45:3225-3240.
7. Dance DR, Young KC, van Engen RE. Further factors for the estimation
of mean glandular dose using the United Kingdom, European and IAEA
breast dosimetry protocols. Phys Med Biol. 2009;54(14):4361-4372.
8. Dance DR, Young KC, van Engen RE. Estimation of mean glandular dose
for breast tomosynthesis: factors for use with the UK, European and IAEA
breast dosimetry protocols. Phys Med Biol. 2011;56:453-471.
9. van Engen RE, Bosmans H, Bouwman RW, et al. Protocol for the Quality
Control of the Physical and Technical Aspects of Digital Breast Tomosynthesis
Systems, Version 1.01. Nijmegen, The Netherlands: European Reference
Organisation for Quality Assured Breast Screening and Diagnostic Services
(EUREF); June 2016.
10. 
Brateman LF, Heintz PH. Solid-state dosimeters: a new approach for
mammography measurements. Med Phys. 2015;42:542-557.
11. Samei E, Badano A, Chakraborty D, et al. Assessment of display performance
for medical imaging systems: executive summary of AAPM TG18 report.
Med Phys. 2005;32:1205-1225.

Digital Mammography Quality Control Manual Return to Table of Contents – 251

 References

12. 
Gray JE. Use of the SMPTE test pattern in picture archiving and
communication systems. J Digit Imaging. 1992;5:54-58.
13. Electronic products; performance standard for diagnostic x-ray systems and
their major components. Fed Regist. 2005;70:33997-34042.

C. Additional Resources
– Berns EA, Hendrick RE, Cutter GR. Optimization of technique factors for a
silicon diode array full-field digital mammography system and comparison
to screen-film mammography with matched average glandular dose. Med
Phys. 2003;30:334-340.
– Bloomquist AK, Yaffe MJ, Pisano ED, et al. Quality control for digital
mammography in the ACRIN DMIST trial: part I. Med Phys. 2006;33:719-
736.
– Kruger RL, Schuler BA. A survey of clinical factors and patient dose in
mammography. Med Phys. 2001;28:1449-1454.
– Pollard BJ, Samei E, Chawla AS, et al. The influence of increased ambient
lighting on mass detection in mammograms. Acad Radiol. 2009;16:299-304.
– Quality Control Manual Template for Manufacturers of Displays and
Workstations Devices Labeled for Final Interpretation in Full-Field Digital
Mammography. Rosslyn, Va: National Electrical Manufacturers Association;
XR 22-2006; 2006.
– Quality Control Manual Template for Manufacturers of Hardcopy Output
Devices Labeled for Final Interpretation in Full-Field Digital Mammography.
Rosslyn, Va: National Electrical Manufacturers Association; XR 23-2006;
2006.

252 – Return to Table of Contents Digital Mammography Quality Control Manual

 2018
Digital Mammography

QUALITY CONTROL MANUAL

Appendices
 Contents

I. REVISIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255
II. A
 CR DIGITAL MAMMOGRAPHY (DM) PHANTOM
SCORING GUIDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256
A. Phantom. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256
B. Scoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
III. ARTIFACT EVALUATION GUIDE. . . . . . . . . . . . . . . . . . . . . 259
A. Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
B. Examples of Clinically Significant Artifacts. . . . . . . . . . . . . . . . 260
C. E xamples of Minor, Clinically Insignificant
Artifacts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262

254 Digital Mammography Quality Control Manual

 I. Revisions

Revisions Date Page(s) Section Description of Revisions

November 2nd edition with digital
2018 breast tomosynthesis QC

APPENDICES

Digital Mammography Quality Control Manual Return to Table of Contents – 255

 II. ACR Digital Mammography (DM) Phantom Scoring Guide

ACR Digital A. Phantom

Mammography (DM)
Phantom Scoring Guide

Figure 1. ACR DM Phantom diagram, showing locations of contrast-to-noise ratio

(CNR) cavity and test objects for scoring.

Figure 2. ACR DM Phantom wax insert map (test object sizes are not to scale).

256 – Return to Table of Contents Digital Mammography Quality Control Manual

 II. ACR Digital Mammography (DM) Phantom Scoring Guide

Table 1. ACR DM Phantom Test Object Sizes

Fibers Speck Groups Masses
(diameter) (glass sphere diameter) (thickness)
1 0.89 mm 0.33 mm 1.00 mm
2 0.75 mm 0.28 mm 0.75 mm
3 0.61 mm 0.23 mm 0.50 mm
4 0.54 mm 0.20 mm 0.38 mm
5 0.40 mm 0.17 mm 0.25 mm
6 0.30 mm 0.14 mm 0.20 mm

APPENDICES

Digital Mammography Quality Control Manual Return to Table of Contents – 257

 II. ACR Digital Mammography (DM) Phantom Scoring Guide

B. Scoring
1. For digital breast tomosynthesis images, scroll to the slice or slab in
which the test objects are best visualized.

2. 
Adjust window width and window level to optimize visualization of
each set of test objects.

3. Count total number of fibers, speck groups, and masses.

4. Do not subtract for artifacts.

Table 2. ACR DM Phantom Image Scoring Key

Test Object Full Point Half Point
Fibers (6) • Full length visible (≥8 mm long) • At least half of length visible
(≥5 and <8 mm long)
• Correct location
• Correct location
• Correct orientation
• Correct orientation
• 1 break allowed (must be
≤ width of fiber) • 1 break allowed (must be
≤ width of fiber)
Speck • 4-6 specks visible • 2-3 specks visible
Groups (6) • Correct locations • Correct locations
Massas (6) • Density difference visible • Density difference visible
• Border is continuous and • Border is not continuous or
generally circular (≥ ¾ border generally circular (≥ ½ and
visible) < ¾ border visible)
• Correct location • Correct location

5. Example below: Score - 3.5 fibers, 4.0 specks, 4.5 masses

Figure 3. ACR DM Phantom wax insert scoring example.

258 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Artifact Evaluation Guide

Artifact A. Procedure
Evaluation Guide 1. Zoom image to full resolution and pan.

2. 
Using approximately the same window width and window level
settings used to evaluate the test objects, examine the entire phantom
for both broad area artifacts and detailed artifacts. Entire field of view
should be free of artifacts that may impede clinical interpretation.

3. 
Artifact evaluations are assigned a “Fail” if artifacts are present that
impede clinical interpretation.

4. 
Artifact evaluation passes if the image is free of artifacts (see Figure 4) or
artifacts are clinically insignificant.

Figure 4. ACR DM Phantom with no artifacts.

APPENDICES

Digital Mammography Quality Control Manual Return to Table of Contents – 259

 III. Artifact Evaluation Guide

B. Examples of Clinically Significant Artifacts

1. Gridlines.

Figure 5. Unacceptable appearance of gridlines on small ACR mammography phantom

image.

2. Ghosting.

Figure 6. Flat-field image illustrating unacceptable ghosting.

260 – Return to Table of Contents Digital Mammography Quality Control Manual

 III. Artifact Evaluation Guide

3. Collimator cut-off.

Figure 7. White line along chest-wall edge of image due to collimator misalignment.

4. Blotchiness (digital breast tomosynthesis [DBT]).

APPENDICES

Figure 8. Example of DBT image of ACR Digital Mammography Phantom positioned

at the optimal slice location for optimal test object visualization. Artifacts appear as
blotchy density differences in different locations across the phantom These artifacts
should not pass the artifact evaluation.

Digital Mammography Quality Control Manual Return to Table of Contents – 261

 III. Artifact Evaluation Guide

C. Examples of Minor, Clinically Insignificant

Artifacts
1. Blotchiness.

Figure 9. Clinically insignificant blotchiness on small ACR mammography phantom

image due to filter.

262 – Return to Table of Contents Digital Mammography Quality Control Manual