NEMA Standards Publication XR 22-2006

“Quality Control Manual” Template for Manufacturers of Displays and

Workstations Labeled for Final Interpretation
in Full-field Digital Mammography

Published by:

National Electrical Manufacturers Association

1300 North 17th Street, Suite 1752
Rosslyn, Virginia 22209

www.nema.org

© Copyright 2006 by the National Electrical Manufacturers Association. All rights including translation into
other languages, reserved under the Universal Copyright Convention, the Berne Convention for the
Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions.
 NOTICE AND DISCLAIMER

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CONTENTS
Page
Foreword to the Device Manufacturer ..................................................................................................... iii
Foreword ...................................................................................................................................................... 1
Section 1 OVERVIEW OF THE QUALITY CONTROL MANUAL ............................................................... 2
1.1 Scope......................................................................................................................................... 2
1.2 Regulatory Considerations ........................................................................................................ 2
1.3 Structure of the Document......................................................................................................... 2
1.4 Alternative Standard on Use of Test Results ............................................................................ 2
Section 2 QC TESTS FOR THE RADIOLOGIC TECHNOLOGIST ............................................................ 4
2.1 Introduction ................................................................................................................................ 4
2.2 QC Intervals............................................................................................................................... 4
2.3 Display Screen Cleanliness....................................................................................................... 4
2.3.1 Frequency .....................................................................................................................4
2.3.2 Objective .......................................................................................................................4
2.3.3 Equipment Required .....................................................................................................4
2.3.4 Procedure......................................................................................................................4
2.3.5 Action Limit....................................................................................................................5
2.3.6 Use of Test Results.......................................................................................................5
2.4 Viewing Conditions Check for the Display................................................................................. 5
2.4.1 Frequency .....................................................................................................................5
2.4.2 Objective .......................................................................................................................5
2.4.3 Equipment Required .....................................................................................................5
2.4.4 Procedure......................................................................................................................5
2.4.5 Action Limit....................................................................................................................5
2.4.6 Use of Test Results.......................................................................................................5
2.5 Image Quality Check ................................................................................................................. 5
2.5.1 Frequency .....................................................................................................................5
2.5.2 Objective .......................................................................................................................6
2.5.3 Equipment Required .....................................................................................................6
2.5.4 Procedure......................................................................................................................6
2.5.5 Action Limit....................................................................................................................6
2.5.6 Use of Test Results.......................................................................................................7
2.6 Radiologic Technologist QC Test Results Record Forms......................................................... 7
2.6.1 Chart 1 – Daily Tests.....................................................................................................7
2.6.2 Chart 2 – Image Quality Check .....................................................................................7
Section 3 QC TESTS FOR THE MEDICAL PHYSICIST............................................................................. 8
3.1 Introduction ................................................................................................................................ 8
3.2 Viewing Conditions Check and Setting ..................................................................................... 8
3.2.1 Frequency .....................................................................................................................8
3.2.2 Objective .......................................................................................................................8
3.2.3 Equipment Required .....................................................................................................8
3.2.4 Procedure......................................................................................................................8
3.2.5 Action Limit....................................................................................................................9
3.2.6 Use of Test Results.......................................................................................................9
3.3 Display Luminance and Gray-Scale Calibration Check ............................................................ 9
3.3.1 Frequency .....................................................................................................................9
3.3.2 Objective .......................................................................................................................9
3.3.3 Equipment Required .....................................................................................................9
3.3.4 Procedure....................................................................................................................10
3.3.5 Action Limits ................................................................................................................10
3.3.6 Use of Test Results.....................................................................................................10
3.4 Image Quality Check ............................................................................................................... 10

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3.4.1 Frequency ...................................................................................................................10

3.4.2 Objective .....................................................................................................................10
3.4.3 Equipment Required ...................................................................................................10
3.4.4 Procedure....................................................................................................................10
3.4.5 Action Limits ................................................................................................................10
3.4.6 Use of Test Results.....................................................................................................10
3.5 Phantom Image Quality Test ................................................................................................... 11
3.5.1 Frequency ...................................................................................................................11
3.5.2 Objective .....................................................................................................................11
3.5.3 Equipment Required ...................................................................................................11
3.5.4 Procedure....................................................................................................................11
3.5.5 Action Limit..................................................................................................................11
3.5.6 Use of Test Results.....................................................................................................11
3.6 Medical Physicist QC Test Results Record Forms.................................................................. 12
3.6.1 Chart 3 – Site and System Summary..........................................................................12
3.6.2 Chart 4 – Viewing Conditions Check and Setting .......................................................13
3.6.3 Chart 5 – Display Luminance and Gray-Scale Calibration Check ..............................14
3.6.4 Chart 6 – Image Quality Check ...................................................................................14
3.6.5 Chart 7 – Phantom Image Quality Test.......................................................................15
Section 4 GUIDANCE ................................................................................................................................ 16
4.1 Display Screen Cleanliness..................................................................................................... 16
4.2 Viewing Conditions Check for the Display............................................................................... 16
4.3 Image Quality Check ............................................................................................................... 16
4.4 Viewing Conditions Check and Setting ................................................................................... 16
4.5 Display Luminance and Gray-Scale Calibration Check .......................................................... 17
4.6 Phantom Image Quality Test ................................................................................................... 17
4.7 Mammography Equipment Evaluations................................................................................... 17

© Copyright 2006 by the National Electrical Manufacturers Association.

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(This foreword is to be removed from the manufacturer’s final QC manual.)

Foreword to the Device Manufacturer

When full-field digital mammography (FFDM) systems were first introduced, all components (e.g., image
receptor, acquisition workstation, diagnostic workstation, hardcopy output device) were provided or
qualified for use by the image receptor manufacturer (IRM). The IRM also provided a comprehensive
quality control (QC) plan to enable mammography facilities to meet their responsibilities under the Quality
Mammography Standards of the Mammography Quality Standards Act (MQSA). Subsequently the U.S.
Food and Drug Administration (FDA) approved manufacturers other than the IRMs to market hardcopy
and softcopy displays for FFDM images. This has made system QC more difficult since, under MQSA
regulations, the facility is required to follow a quality assurance program substantially the same as the
one recommended by the IRM. However, the QC plan of the IRM might not adequately address the
needs of components developed by other manufacturers.

This increasing heterogeneity of FFDM systems has created a desire to delegate the responsibility for
developing QC procedures for the individual system components to the manufacturers of those
components. However, it is also desirable, especially for the end-user, to retain some consistency in the
QC documentation that accompanies new FFDM components. The Mammography Group of the NEMA
X-ray Imaging Section has developed a template that provides both a consistent presentation format and
a minimum set of QC tests that should be included as part of the quality assurance plan of a display or
workstation labeled for final interpretation in an FFDM system.

Within this document, “display” refers to an electronic image presentation device with minimal image
processing capability. “Workstation” refers to an electronic device capable of sophisticated image
processing as well as image storage and retrieval. A workstation is expected to incorporate at least one
and most likely more than one display. The tests in this template primarily address the QC of the display
either as an independently operating device or as a component of a workstation.

Display and workstation manufacturers who follow this template when developing their quality assurance
programs and include at least the tests listed, will have incorporated the essential aspects of quality
assurance that the image receptor manufacturers have included in their recommended quality assurance
programs. This will ease the burden of the mammography facility to establish and maintain a quality
assurance program for the display or workstation substantially the same as the one recommended by the
IRM. The sections following this foreword to the device manufacturer constitute the content of the QC
template.

Each QC test includes a testing frequency, a set of procedure steps, action limits that define acceptable
outcomes for the test, and instructions on the use of the test results. Examples of each of these elements
are included in the template. In some cases, test conditions and action limits that have been found to be
appropriate and reasonable have been included in the QC tests.

However, it is recognized that it might not be practical or possible on all displays or workstations to
implement verbatim the tests as set forth in these examples. The content of this template may be
incorporated in whole or in part as deemed appropriate by the manufacturer of the display or workstation.
However, it is recommended that the manufacturer include in the QC plan a test for each concept
presented in this template. The manufacturer may alter the details of the tests to accommodate the
characteristics of a specific display or workstation or particular regulatory requirements.

Within the template are instructions and comments to the manufacturer using the template. These
instructions and comments are italicized and enclosed in brackets, e.g., [Manufacturer to …]. The

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manufacturer of the display or workstation must insert the necessary information. In the context of this
document, the “manufacturer” is the entity seeking clearance from FDA to market the device. For
example, in the case of a workstation produced by one manufacturer but incorporating displays produced
by a second, the producer of the workstation would be considered the manufacturer referred to in the
template. However, if the display manufacturer also sells displays that can be incorporated into an
imaging network independent of a workstation, the display manufacturer would be the one to provide the
material for the template.

The manufacturer may also include additional tests beyond those specified in the template. Each such
test must include the elements and follow the form of the tests included in the template. The content of
the procedure must be written in regulatory language using auxiliary verbs such as “shall” or “must” or the
imperative mood. It may not include references to other documents or commercial products. Such
references as well as recommendations regarding test procedures may be included in a Guidance
section of the QC plan. An example of Guidance is included as the final section of the template. The
manufacturer should review the content of this Guidance section and provide material of a similar nature
appropriate to the manufacturer’s product.

Test patterns suitable for performing some of the tests in the template have been prepared by Task
Group #18 (TG 18) of the American Association of Physicists in Medicine and by the Society of Motion
Picture and Television Engineers (SMPTE). The TG 18 report and test patterns are available as “AAPM
Online Report #3: Assessment of Display Performance for Medical Imaging Systems” and Supplemental
Files, Imaging Informatics Subcommittee Task Group #18. These documents are available at
• http://www.aapm.org/pubs/reports
• http://www.aapm.org/pubs/reports/public/OR_03_Supplemental/

The SMPTE pattern is available as “SMPTE Recommended Practice RP 133-1991 - Specifications for
Medical Diagnostic Imaging Test Pattern for Television Monitors and Hard-Copy Recording Cameras” and
is available at
• http://www.smpte.org/smpte_store/standards/
and at
• http://brighamrad.harvard.edu/research/topics/vispercep/tutorial.html
It is recommended to include any required test patterns with the equipment for ease of use by the
operator and to ensure that the correct pattern is used for each test.

© Copyright 2006 by the National Electrical Manufacturers Association.

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Foreword

Quality Control (QC) is important in any imaging system, but it is especially important in mammography.
MQSA1 regulations mandate that “each facility shall establish and maintain a quality assurance program
to ensure the safety, reliability, clarity, and accuracy of mammography services performed at the facility”
(21 CFR 900.12(d)). The steady movement from screen/film mammography to full-field digital
mammography (FFDM) makes system quality control more difficult because FFDM systems are
becoming increasingly heterogeneous. No longer are all of the system components (e.g., image receptor,
acquisition workstation, diagnostic workstation, displays, hardcopy output device) provided or qualified for
use by the image receptor manufacturer.

As a result, there is an increasing need for QC at the component level. This manual provides QC
procedures for the [Manufacturer to enter commercial name of device], a [Manufacturer to specify display
or workstation] that receives images from an FFDM system, and presents them for final interpretation.
The procedures in this manual represent a minimum set of QC tests that should be included as part of the
quality assurance plan of a display or workstation used for final interpretation in an FFDM system.

1
The United States Mammography Quality Standards Act, as amended by the Mammography Quality
Standards Reauthorization Acts of 1998 and 2004 (MQSRA).

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Section 1
OVERVIEW OF THE QUALITY CONTROL MANUAL

1.1 SCOPE
This document defines the minimum set of Quality Control (QC) tests to be applied to the [Manufacturer
to enter commercial name], a [Manufacturer to specify display or workstation] labeled for final
interpretation of images acquired using a full-field digital mammography (FFDM) image acquisition
system. This document is intended to constitute an element of the Quality Assurance Plan (QAP) of the
mammographic facility.

Except for the Phantom Image Quality Test, Sec. 3.5, these tests are intended to monitor the
performance of the [Manufacturer to specify display or workstation] as a component of the full-field digital
mammography system and not the performance of the system as a whole. Hence, a characteristic such
as compatibility of the component with the communication protocols used in an imaging network is not an
element of these tests.

These tests are intended to monitor the consistency over time of the device’s performance. While they
may be included as elements of acceptance testing, they are not intended to represent the entirety of an
acceptance test.

1.2 REGULATORY CONSIDERATIONS

Facilities subject to the provisions of the Mammography Quality Standards Act (MQSA) that use image
receptors other than screen/film must follow a quality assurance program substantially the same as the
one recommended by the image receptor manufacturer [21 CFR 900.12(e)(6)]. It remains the
responsibility of the facility to determine whether or not this QC plan is substantially the same as the one
recommended by the image receptor manufacturer for the FFDM system in use at that facility.

1.3 STRUCTURE OF THE DOCUMENT

This QC Manual consists of three main sections:
a. QC Tests for the Radiologic Technologist (Section 2).
b. QC Tests for the Medical Physicist (Section 3).
c. Guidance (Section 4).

1.4 ALTERNATIVE STANDARD ON USE OF TEST RESULTS

[It is recommended that the manufacturer of the mammographic display or workstation apply to the FDA
for an Alternative Requirement to 21 CFR 900.12(e)(8)(ii)(A) to separate the actions to be taken for the
display from the actions for acquisition systems and to deal with the actions to be taken by an operator
upon the failure of a test in the QC plan of the display or workstation. Wording for such an Alternative
Requirement is suggested below.]

The actions to be taken in regard to the QC plan for the mammography [Manufacturer to specify
display or workstation] are as follows:

21 CFR 900.12(e)(8): Use of test results.

For the image display system

(ii) If the test results for the image display system of the FDA-approved, full-field digital mammography
(FFDM) equipment fall outside of the action limits, the source of the problem shall be identified and
corrective actions shall be taken:

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(A) Before any further mammographic images are reviewed using the component of the image display
system that failed any of the following tests:
(1) Display Screen Cleanliness
(2) Viewing Conditions Check for the Display
(3) Viewing Conditions Check and Setting
(4) Image Quality Check
(5) Phantom Image Quality Test

(B) Within 30 days of the test date for the following test:
(1) Display Luminance and Gray-Scale Calibration Check

© Copyright 2006 by the National Electrical Manufacturers Association.

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Section 2
QC TESTS FOR THE RADIOLOGIC TECHNOLOGIST

2.1 INTRODUCTION
QC tests are simple checks which ensure that the [Manufacturer to specify display or workstation] is
operating to its design standards. They are intended to detect any changes in settings which might
compromise image quality, as well as any deterioration in equipment performance over time.

QC tests for the [Manufacturer to specify display or workstation] are described in the following sections:
• Section 2.3 Display Screen Cleanliness.
• Section 2.4 Viewing Conditions Check for the Display.
• Section 2.5 Image Quality Check.

Section 2.6 provides charts for use in recording the results of the various checks. It is recommended that
you use the chart pages in this manual to make copies for recording the results.

2.2 QC INTERVALS
The QC tests described in this section must be performed at least as frequently as specified in the test
descriptions and as summarized in Table 2-1.

Table 2-1
INTERVALS FOR PERFORMING QC TESTS

Procedure Minimum Frequency Section

Daily or when interpretations
Display Screen Cleanliness 2.3
are planned
Daily or when interpretations
Viewing Conditions Check for the Display 2.4
are planned
Image Quality Check Weekly 2.5

Refer to Section 4, Guidance, for additional information regarding application of the QC Tests.

2.3 DISPLAY SCREEN CLEANLINESS

2.3.1 Frequency
Daily or on days when clinical image reviews or interpretations are planned.

2.3.2 Objective
To ensure good image review conditions by keeping the display screens free of dust, finger prints, and
other marks.

2.3.3 Equipment Required

[Manufacturer to identify appropriate cleaning materials and provide cautionary guidance as necessary.]

2.3.4 Procedure
1. Check the screen to verify that it is free from dust, finger prints, and other marks.

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2. If dust, finger prints, or other marks are observed to be present, clean the display screens using a
cloth or cleaning tissue to remove dust, finger prints, and other marks.
3. Record completion of the procedure on Chart 1.

2.3.5 Action Limit

The screen must be free from dust, finger prints, and other marks.

2.3.6 Use of Test Results

If these results are not obtained, the source of the problem must be identified, and corrective action
taken, before any further mammographic images are reviewed or interpreted using the display that failed.
See Section 4.1.

2.4 VIEWING CONDITIONS CHECK FOR THE DISPLAY

2.4.1 Frequency
Daily or on days when image reviews or interpretations are planned.

2.4.2 Objective
To ensure optimal viewing conditions.

2.4.3 Equipment Required

None.

2.4.4 Procedure
1. Review the data form “Viewing Conditions Check and Setting” posted in the reading room during the
most recent Medical Physicist’s evaluation. On this data form you will find the reading room
conditions established as optimal during this evaluation.
2. Compare the reading room configuration to the one specified in the data form.
3. If differences exist between the configuration specified and the actual one, adjust the room
configuration to match the configuration specified in the data form. For example, if desk lights were
specified to be turned off, turn them off, or, if curtains were specified to be closed, close them. For
additional information on maintaining the appropriate illuminance level, see Section 4.2.
4. Record completion of the check on Chart 1.

NOTE—On the “Viewing Conditions Check and Setting” data form posted by the Medical Physicist you will find the value of the
ambient illuminance. This is a record of the most recent measurement and provides a comparison value for the next Medical
Physicist survey. The Radiologic Technologist is not required to measure the ambient illuminance as part of the Viewing Conditions
Check.

2.4.5 Action Limit

The viewing conditions must agree with those established during the most recent evaluation by a Medical
Physicist.

2.4.6 Use of Test Results

If the reading room configuration has changed, the source of the problem must be identified, and
corrective action taken, before any further mammographic images are reviewed or interpreted using the
display. See Section 4.2.

2.5 IMAGE QUALITY CHECK

2.5.1 Frequency
Weekly.

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2.5.2 Objective
To ensure that the display is calibrated for the reading of mammographic images.

2.5.3 Equipment Required

None.

2.5.4 Procedure
(It is recommended that the manufacturer base this test on comprehensive test patterns such as those
developed by the SMPTE and by TG-18 of the American Association of Physicists in Medicine. These
comprehensive patterns may be supplemented by other patterns specified by the equipment
manufacturer in order to test for all of the characteristics identified below. The manufacturer shall provide
a Procedure and Action Limits appropriate for the test patterns specified. Subsequent reference in this
section to “pattern” in the singular does not imply a constraint to use only a single test pattern to
accomplish the specified tests.)

1. View the test pattern on all displays used for final interpretation of mammograms.

NOTE—It is intended that the test pattern be viewed without modification of its size or gray scale. The pattern is displayed with
each pixel of the pattern represented by one pixel of the display. For the test to remain valid, magnification or zoom features of the
display must not be used when evaluating the appearance of the features described below. Additionally, the intensity levels used in
the pattern are intended to enable evaluation of the gray scale calibration of the display. Adjustment of contrast, brightness, window
width, window level, or other gray scale modifications must not be applied.

2. View the display from the position that would be used by a single viewer seated directly in front of the
display. The observer must be at least 50 cm from the display screen.
3. Examine each image on each display carefully for the following features.
a. Verify that there are no new artifacts or non-uniformities.
b. Verify that a continuous gray-scale ramp appears continuous and free from contrast reversal.
That is, along the length of the ramp, the brightness must not include dark-light-dark or light-dark-
light transitions.
c. Verify that borders and lines of the pattern are visible and straight and that the pattern appears to
be centered in the active area of the display.
d. Verify that the 0%-5% contrast pattern is visible.
e. Verify that the 95%-100% contrast pattern is visible.
f. Verify that each gray-level step of a discontinuous gray-scale ramp can be distinguished from the
adjacent steps.
g. Verify that the alphanumeric characters that appear on the pattern are sharp and in focus.
h. Verify that the high contrast line-pair images at the center and corners of the pattern are
distinguishable.
4. Record the results on Chart 2.

2.5.5 Action Limit

If any of the following conditions are not met, the display fails the test. Take action as specified in
2.5.6.
a. There must be no artifacts or non-uniformities that mimic or obscure clinical information.
b. There must be no discontinuities or contrast reversals in the continuous gray-scale ramps.
c. Borders and lines of the pattern must be visible and straight and the pattern must appear to be
centered in the active area of the display.
d. The 0%-5% contrast shall be visible.
e. The 95%-100% contrast shall be visible.
f. Each gray-level step shall be distinguishable from the adjacent ones.
g. The alphanumeric characters shall appear sharply focused.
h. The high-contrast line-pair patterns must be distinguishable at the center and the corners of the
display screen for both the horizontal and vertical orientations of the line-pair patterns.

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2.5.6 Use of Test Results

If the system fails the test, the source of the problem must be identified and corrective action taken,
before any further mammographic images are reviewed or interpreted using the display. See Section 4.3.

2.6 RADIOLOGIC TECHNOLOGIST QC TEST RESULTS RECORD FORMS

2.6.1 Chart 1 – Daily Tests
Facility: ___________________________________ Room: ___________________________________

Year Month
Date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Initials

Display
cleanliness
Viewing
conditions
Year Month
Date 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Initials

Display
cleanliness
Viewing
conditions

2.6.2 Chart 2 – Image Quality Check

Facility: ___________________________________ Room: ___________________________________

Date

Initials
Left Right
Display
(Pass/Fail) (Pass/Fail)
Artifacts, non-uniformities

Gray-scale continuity

Borders, lines, centering

0%-5% contrast

95%-100% contrast

Gray steps

Alphanumerics

Line-pair images (center)

Line-pair images (corners)

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Section 3
QC TESTS FOR THE MEDICAL PHYSICIST

3.1 INTRODUCTION
The QC tests listed in this section must be performed by the Medical Physicist to ensure that the
[Manufacturer to enter commercial name] [Manufacturer to specify display or workstation] provides a high
level of mammographic image quality. These tests also form the basis of the mammography equipment
evaluations (MEEs) that must be performed following the installation of a [Manufacturer to enter
commercial name] [Manufacturer to specify display or workstation], the repair or replacement of a major
component of the system, the relocation of the display to a new viewing environment, or substantial
change of the illumination of an existing viewing environment. Additional information regarding changes
of viewing conditions is included in Section 4.2. Additional information regarding the tests to be done for
MEEs can be found in Section 4.7.

NOTE—When performed as part of an MEE, all required tests must pass before the device may be used to interpret clinical images.

In addition to MEE testing, the QC tests described in this section must be performed at least as frequently
as specified in the test descriptions and as summarized in Table 3-1. These tests are described in
Sections 3.2, 3.3, 3.4, and 3.5. Charts for recording the results of the QC tests or MEEs are provided in
Section 3.6.

Table 3-1
INTERVALS FOR PERFORMING QC TESTS

Procedure Minimum Frequency Sec.

Viewing Conditions Check and Setting Annually 3.2
Display Luminance and Gray-Scale Calibration Check Annually 3.3
Image Quality Check Annually 3.4
At installation of a display or
Phantom Image Quality Test workstation and during specified 3.5
Mammography Equipment Evaluations

3.2 VIEWING CONDITIONS CHECK AND SETTING

3.2.1 Frequency
Annually

3.2.2 Objective
To ensure optimal viewing conditions.

3.2.3 Equipment Required

Illuminance photometer with a minimum resolution not exceeding 1 lux.

3.2.4 Procedure
1. Place the displays in optimal positions in the room. See Section 4.4.

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2. Reduce any lighting coming from sources such as viewboxes, or overhead, or task lighting to the
minimum, to reproduce typical ambient lighting conditions that would be set for reading digital images
on the display.
3. Check that the ambient lighting set at Step 2 is stable (no flickering effect due to any of the lighting
sources that are turned on).
4. Make each display as dark as possible. For example, minimize the application windows or display a
black, flat field.
5. Obtain the illuminance reading at each display. Position the photometer with its sensitive area facing
away from the surface of the display and located at the center of the display and on the display
surface.

NOTE—The medical physicist must take care not to block any light that could be detected by the photometer.

6. Read the illuminance value and verify that it does not exceed the value specified in the Action Limit.
7. If the value is greater than the specified limit, adjust the room ambient light and/or the room
configuration in such a way that the illuminance does not exceed that limit.
8. Record a description of the room configuration established as optimal in the data form as detailed in
Steps 9 through 11.
9. Fill out a check-list of the condition of major elements in the reading room (for example, display
positions, room lights, desk lights, curtains).
10. Record the illuminance on the data form.
11. Draw a room layout on the data form sufficiently accurate to enable the Radiologic Technologist to
reproduce the illumination conditions as they were at the time the illuminance level was set.
12. Post the form in the reading room, so that it will be readily available for the Radiologic Technologist’s
daily “Viewing Conditions Check.”
13. Restore each display to its normal condition, i.e., undo any measures taken in Step 4 to darken the
display.

3.2.5 Action Limit

[The manufacturer must either provide an action limit or define a procedure by which the physicist can
establish an action limit appropriate for the ambient conditions and the display. For CRT-based displays,
FDA has requested that all image receptor manufacturers set an upper limit for the ambient illuminance of
20 lux.]

3.2.6 Use of Test Results

If the system fails the test, the source of the problem must be identified and corrective action taken,
before any further mammographic images are reviewed or interpreted using the display. See Section 4.4.

3.3 DISPLAY LUMINANCE AND GRAY-SCALE CALIBRATION CHECK

3.3.1 Frequency
Annually

3.3.2 Objective
To ensure that each display is calibrated for the reading of mammographic images.

3.3.3 Equipment Required

Luminance photometer [If a photometer is not provided with the display or one with particular
characteristics is needed to perform the test, the manufacturer must provide the necessary specifications
for the photometer. To ensure the required accuracy of the photometer, the manufacturer must specify
the nature of any calibration that is necessary. This could include, for example, calibration by a
calibration laboratory or a procedure whereby the photometer readings are intercompared with a
photometer known to be in calibration. The manufacturer must also identify what, if any, calibration

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documentation the user must include in the QC record. This could include, for example, the date of the
last calibration or intercomparison.]

3.3.4 Procedure
[This test is intended to check the consistency of the black and white levels and the gray-scale display
function. Additional tests, e.g., luminance uniformity or artifact evaluation, may also be included. The
manufacturer must provide procedure steps and action limits appropriate for the display hardware and
software used in the display or workstation. The procedure must have the capability to achieve the
manufacturer’s specified level of accuracy for the luminance levels independent of confounding factors
such as variation of brightness uniformity or photometer calibration.]

3.3.5 Action Limits

[Manufacturer to provide action limits regarding black and white levels, the gray-scale display function,
and other characteristics evaluated in the test.]

3.3.6 Use of Test Results

If the system fails the test, the failing measurement shall be repeated. If a display fails only at the lowest
luminance level, first ensure that the ambient illuminance level requirement is met (see Section 3.2
Viewing Conditions Check and Setting), then repeat the measurement. If the failure persists, the source
of the problem must be identified and corrective action taken within 30 days of the test date. See Section
4.5.

3.4 IMAGE QUALITY CHECK

3.4.1 Frequency
Annually

3.4.2 Objective
To ensure the display is calibrated for the reading of mammographic images.

3.4.3 Equipment Required

None.

3.4.4 Procedure
Complete Section 3.2, Viewing Conditions Check and Setting, and Section 3.3, Display Luminance and
Gray-Scale Calibration Check, before performing this test.

The remainder of this test is the same as the Radiologic Technologist’s test “Image Quality Check,” Sec.
2.5.

NOTE—It is intended that the test pattern be viewed without modification of its size or gray scale. The pattern is displayed with
each pixel of the pattern represented by one pixel of the display. For the test to remain valid, magnification or zoom features of the
display must not be used when evaluating the appearance of the features described below. Additionally, the intensity levels used in
the pattern are intended to enable evaluation of the gray scale calibration of the display. Adjustment of contrast, brightness, window
width, window level, or other gray scale modifications must not be applied.

3.4.5 Action Limits

See Sec. 2.5.5.

3.4.6 Use of Test Results

If the system fails the test, the source of the problem must be identified, and corrective action taken,
before any further mammographic images are reviewed or interpreted using the display. See Section 4.3.

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3.5 PHANTOM IMAGE QUALITY TEST

3.5.1 Frequency
The test is to be performed when a display or diagnostic workstation is added to a mammography
imaging network and during specified mammography equipment evaluations (MEEs). See Section 4.7.

3.5.2 Objective
To ensure that the quality of images acquired at the acquisition work station remains adequate after the
images are transmitted to and presented on the display.

3.5.3 Equipment Required

FDA-approved mammographic phantom.

3.5.4 Procedure
1. Acquire an image of the mammographic phantom at the acquisition workstation using the procedure
specified in the quality assurance plan of the image receptor manufacturer.
2. Apply the same image processing to the image as applied to a phantom image that would be
analyzed at the acquisition workstation.
3. Send the image to the display and present it.
4. Score the phantom image using the procedures specified by the image receptor manufacturer for
scoring a phantom image displayed on the acquisition workstation.

3.5.5 Action Limit

The score of the phantom image presented on the display must meet the respective action limits set by
the image receptor manufacturer of each FFDM system whose images are to be presented for
mammographic final interpretation.

3.5.6 Use of Test Results

If the system fails the test, the source of the problem must be identified and corrective action taken,
before any further mammographic images are reviewed or interpreted using the [Manufacturer to specify
display or workstation]. See Section 4.6.

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3.6 MEDICAL PHYSICIST QC TEST RESULTS RECORD FORMS

3.6.1 Chart 3 – Site and System Summary

Facility Name: _______________________________________________________

Address: _______________________________________________________
_______________________________________________________
_______________________________________________________
Room: _______________________________________________________

Date of Installation: ________________________________________________

Date of Test: _______________________________________________________
Type of Test: Annual Survey Mammography Equipment Evaluation
(circle the applicable one)
Room ID: _______________________________________________________

Serial Numbers
Mammographic Unit: __________________________________________
Diagnostic Workstation: __________________________________________

Left Display: __________________________________________

Right Display: __________________________________________

Medical Physicist: ____________________________________________________

Signature: __________________________________________________________

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3.6.2 Chart 4 – Viewing Conditions Check and Setting

Facility: _________________________________________________________
Room: __________________________________ Date: ________________

Room description
Display positions: ________________________________________________
_____________________________________________________________
Room lights: _____________________________________________________
_____________________________________________________________
Desk Lights: _____________________________________________________
_____________________________________________________________
Others: __________________________________________________________
______________________________________________________________

Ambient Illuminance: _____________________

NOTE—Confirmation of this value is not part of the daily check by the Radiologic Technologist.

Requirement: Display Type Ambient Illuminance Pass Fail

CRT [Mfr. to specify]
LCD [Mfr. to specify]
Other (specify) [Mfr. to specify]

Room layout

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3.6.3 Chart 5 – Display Luminance and Gray-Scale Calibration Check

[Manufacturer to provide a table for recording the data acquired in the procedure and to indicate by
means of Pass/Fail checkboxes whether or not the results meet the action limits. An example follows.]

Facility: _____________________________________________________________
Room: ____________________________________ Date: _________________
Luminance Photometer: Model: ____________________ Ser. No. __________
NOTE—Use the display serial number if the photometer is internal to the display or does not have its own serial number.

Photometer calibration date: ___________________

NOTE—Calibration may be established by intercomparison of the photometer reading with another photometer known to be in
calibration.

Left Display Right Display

Required Measured Required Measured
DDL Luminance Luminance Pass Fail Luminance Luminance Pass Fail
(cd/m2) (cd/m2) (cd/m2) (cd/m2)
0
…
…
255
…

3.6.4 Chart 6 – Image Quality Check

[Manufacturer to provide a table for recording the data acquired in the procedure and to indicate by
means of Pass/Fail checkboxes whether or not the results meet the action limits. An example follows.]

Facility: _________________________________________________________
Room: __________________________________ Date: ________________

Left Display Right Display

Test Pass Fail Pass Fail
Artifacts, non-uniformities

Gray-scale continuity

Borders, lines, centering

0%-5% contrast

95%-100% contrast

Gray steps

Alphanumerics

Line-pair images (center)

Line-pair images (corners)

© Copyright 2006 by the National Electrical Manufacturers Association.

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3.6.5 Chart 7 – Phantom Image Quality Test

[Manufacturer to provide a table for recording the data acquired in the procedure and to indicate by
means of Pass/Fail checkboxes whether or not the results meet the action limits. An example follows.]

Facility: _________________________________________________________
Room: __________________________________ Date: ________________

FFDM system sending images:

Manufacturer: ______________________________________
Model: ______________________________________
Room: ______________________________________

Left Display Right Display

Test Required Observed Required Observed
Pass Fail Pass Fail
Object Score Score Score Score
…
…
…
…
…

Requirement: The score of the image presented on the display must meet the respective action limits set
by the image receptor manufacturer of each FFDM system that will send images to the display for final
interpretation.

This test is not required for the annual survey.

© Copyright 2006 by the National Electrical Manufacturers Association.

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Section 4
GUIDANCE

MQSA final regulations consider performance of the image receptor manufacturer’s QC Test procedures
to be a requirement for compliance with the regulations. This Guidance section is not considered an
element of those regulations. It is intended to provide guidance to mammography facilities and their
personnel. It represents the equipment manufacturer’s current thinking on appropriate procedures for
conducting the QC tests. Procedures described in guidance represent supplementary information on
acceptable ways of doing a test but, unlike regulations, do not bind the facility to using that way only. An
alternative procedure may be used if such a procedure satisfies the requirements of the applicable
statute, regulations, or both. Mandatory language, such as “shall,” “must,” and “require,” is used when
referring to statutory or regulatory requirements. Non-mandatory language, such as “should,” “may,”
“can,” and “recommend” is used when referring to guidance. It is the responsibility of the facility to read,
understand, and follow the final regulations.

Under its own authority, a state may impose more stringent requirements beyond those specified under
MQSA and its implementing regulations. A facility may want to check with the state or local authorities
regarding their requirements. Tests may be performed more frequently than specified in the QC tests if
required by local regulations or hospital requirements.

QC tests may be used as a check for correct operation, for example, after a change of operating
parameters.

The following sections provide specific guidance for sections in the QC tests.

4.1 DISPLAY SCREEN CLEANLINESS

If a display cannot be satisfactorily cleaned, it is recommended that you contact your field service
engineer.

4.2 VIEWING CONDITIONS CHECK FOR THE DISPLAY

Particular attention should be given to changes that substantially affect the illuminance at the display
screens, for example, moving the display to a new location in the room, moving the display to another
room, or introducing new light sources into the room such as view boxes or room lighting. If the
illumination condition has changed and cannot be reset to the original condition, have your Medical
Physicist or your field service engineer check the illuminance level. The procedure given in Section 3.2
can be performed.

4.3 IMAGE QUALITY CHECK

If the system fails the Image Quality Check, it is possible that re-calibration of the display is needed. It is
recommended to have your Medical Physicist or your field service engineer perform the display
calibration check described in Section 3.3. If the display does not pass the display calibration check, it is
recommended that you contact your field service engineer to re-calibrate the display or identify any other
source of the problem and plan corrective action.

4.4 VIEWING CONDITIONS CHECK AND SETTING

For a workstation incorporating more than one display it is recommended that the displays be positioned
at angles such that the light from one screen does not illuminate the adjacent screen. For reading, it is
recommended that the distance between the user and a display be approximately 50 cm. In order to

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obtain the optimum ambient illuminance, it is recommended to check artificial lighting, the adjustment of
variable lighting, natural lighting, and main lighting (curtains or door openings, environmental conditions).
If the system fails the Viewing Conditions Check and Setting, it is recommended that you contact your
field service engineer.

4.5 DISPLAY LUMINANCE AND GRAY-SCALE CALIBRATION CHECK

If the system fails the Display Luminance and Gray-Scale Calibration Check, it is recommended to
contact your field service engineer for re-calibration of the display.

4.6 PHANTOM IMAGE QUALITY TEST

If the system fails the Phantom Image Quality Test, you should ensure that all test conditions are met and
then repeat the test. If the system still fails, it is recommended that you contact your field service
engineer.

4.7 MAMMOGRAPHY EQUIPMENT EVALUATIONS

The Food and Drug Administration (FDA) requires a mammography facility to have a medical physicist
perform a Mammography Equipment Evaluation (MEE) when a new mammography unit is installed, a unit
is disassembled and reassembled at the same or a new location, or major components of a
mammography unit are changed or repaired. This MEE must determine whether the system meets the
MQSA requirements for mammography equipment [21 CFR 900.12(b)] in addition to the quality
assurance requirements [21 CFR 900.12(e)]. Note that the allowance of 30 days to take corrective action
in the event of failure of specified quality control tests applies only to an annual QC survey. In the case of
an MEE, “All problems shall be corrected before the new or changed equipment is put into service for
examinations...” [21 CFR 900.12(e)(10)].

The MQSA Quality Mammography Standard on MEEs [21 CFR 900.12(e)(10)] states that when “major”
repairs are performed on existing equipment, an MEE must be performed by a medical physicist or under
the direct supervision of a medical physicist, i.e., the medical physicist must be in the room during the
performance of the individual equipment tests. In its guidance, the FDA has classified particular repairs
as being “major,” and for repairs not considered major (and thus not requiring an MEE) has identified the
level of medical physicist involvement required. Table 4-1 provides similar information for repairs to the
[Manufacturer to specify display or workstation]. The results of the MEE may be recorded in the charts in
Section 3.6.

[Manufacturer to review Table 4-1 and provide content appropriate to the display workstation.]

FDA Guidance states “there are adjustments, changes, or repairs for which verification ... can be
performed by other qualified personnel (e.g., radiologic technologist or service representative with
appropriate training/experience) without involving the medical physicist.” Generally, in the event of a
system repair or upgrade, if actions supplemental to the procedures in this manual are required to be
taken by “other qualified personnel,” those actions will be specified in documentation to be provided by
the field service engineer. However, the calibration of the display—setting the black and white levels and
performing the grayscale display function calibration—is intended to remain the responsibility of the field
service engineer.

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Table 4-1
MEDICAL PHYSICIST INVOLVEMENT IN DISPLAY OR WORKSTATION REPAIRS

Item Major Medical Tests to Comments

Repair Physicist Perform
Involvement*
Graphics display driver N MP Oversight Sec. 2.5 [Manufacturer may add
replacement comments as necessary.]
Luminance photometer N MP Oversight [Manufacturer
replacement to specify.]
Display replacement N MP Oversight Sec. 2.5
Addition of display or Y MP conducts Secs. 3.2,
workstation to a evaluation in 3.3, 3.4, and
mammography imaging person 3.5
facility or network
Changes of illumination Y MP conducts Secs. 3.2, Such changes include, but
in viewing area that evaluation in 3.3, 3.4, and are not limited to, installing
prevent the Radiologic person 3.5 new room lighting, adding
Technologist from viewboxes to the room,
reproducing the changing the color or
conditions last set by the reflectivity of the walls or
Medical Physicist ceiling, installing new
windows or doors in the
room.
Moving the display or Y MP conducts Secs. 3.2,
workstation to a new evaluation in 3.3, 3.4, and
viewing area person 3.5
Software modifications Y MP conducts See The tests to perform will
evaluation in Comments. depend on the nature of the
person (see software modification. Under
Comments) defined circumstances, the
MEE following a software
modification may be
performed under MP
Oversight. Consult your Field
Service Engineer for
instructions.
*FDA Guidance defines "MP oversight" as meaning “that the medical physicist should be consulted as to whether an on-site visit is
required or if other personnel can verify that the standards are met, with direction by telephone or printed material from the medical
physicist if needed.”

© Copyright 2006 by the National Electrical Manufacturers Association.