Quality Control Manual

for
Mammography

DRYVIEW 5950 Laser Imager

Publication No.: AA4663, Rev. B

2012-12-31
 Contents

Foreword........................................................................................................................................................ 3
Section 1 Overview..................................................................................................................................... 4
1.1 Scope.......................................................................................................................................... 4
1.2 Regulatory Considerations .......................................................................................................... 4
1.3 Structure of the Document ......................................................................................................... 4
1.4 Elements of a Quality Control Test .............................................................................................. 4
1.5 Imager Calibration ...................................................................................................................... 5
1.6 Web Portal Use and Configuration.............................................................................................. 5
1.7 Test Summary ............................................................................................................................. 7
Section 2 QC Procedures for the Radiologic Technologist ........................................................................... 8
2.1 Calibrating the Imager ................................................................................................................ 8
2.2 Weekly Density Constancy Test ................................................................................................... 8
Section 3 QC Procedures for the Medical Physicist.................................................................................... 11
3.1 Density Constancy Overview for the DRYVIEW 5950 Laser Imager ............................................ 11
3.2 Establishing Baseline Operating Levels....................................................................................... 12
3.3 Performing the Annual Density Constancy Test ......................................................................... 14
3.4 Performing Artifact Test ............................................................................................................ 16
3.5 Phantom Image Quality Test ..................................................................................................... 18
Section 4 Guidance .................................................................................................................................. 19
4.1 QC Test Images......................................................................................................................... 19
4.2 Mammography Equipment Evaluation (MEE)............................................................................. 19
Appendix A—Quality Control Forms for the Radiologic Technologist ............................................................ 21
Appendix B—Quality Control Forms for the Medical Physicist ....................................................................... 24
Appendix C—Alternative Weekly “Density Constancy Test” for use with an External Densitometer.............. 27
Appendix D—Alternative “Establishing Baseline Operating Levels” procedure using an
External Densitometer .................................................................................................................................. 30
Appendix E—Alternative Annual “Density Constancy Test” for use with an External Densitometer .............. 34
 Foreword

Quality Control (QC) is important in any imaging system, but it is especially important in mammography.
When full-field digital mammography (FFDM) systems - including Computed Radiography (CR)
Mammography and Digital Radiography (DR) Mammography - were first introduced, all components (for
example, image receptor, acquisition workstation, diagnostic workstation/monitor, hardcopy output device)
were provided or qualified for use by the Image Receptor Manufacturer (IRM). The IRM also provided a
comprehensive QC plan to enable mammography facilities to meet their responsibilities under the
Mammography Quality Standards Act 1 (MQSA).

Subsequently, the FDA approved manufacturers other than IRMs to market hardcopy and softcopy displays
for FFDM images. This has made system QC more challenging since, under MQSA regulations, the facility is
required to follow a quality assurance program substantially the same as the one recommended by
the IRM.

For the IRMs, the 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. This manual provides such procedures for the DRYVIEW 5950 Laser Imaging System, a
hardcopy output device that receives images from a FFDM system, and reproduces them on film for final
interpretation. The procedures in this manual cover grayscale fidelity. The grayscale dimension addresses the
ability of the hardcopy device to achieve and maintain constancy in its tone reproduction characteristics
relative to established baseline operating levels.

For the FFDM systems in your facility, please reference your Image Receptor Manufacturer (IRM) Quality
Control documentation to determine if the IRM provides recommended QC procedures for the DRYVIEW
5950 Laser Imaging System, or if they have deferred these procedures to the hardcopy output device
manufacture (and the use of this Quality Control Manual for Mammography).

1
The United States Mammography Quality Standards Act of 1992, as amended by the Mammography
Quality Standards Reauthorization Acts of 1998 and 2004 (MQSRA).

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 Section 1 Overview

1.1 Scope
This document defines the minimum set of quality control (QC) tests to be applied to the DRYVIEW
5950 Laser Imaging System, a hardcopy output device that receives images from a FFDM system,
and reproduces them on film for final interpretation. It should be considered as one element of a
mammography facility Quality Assurance Plan.
The tests in this manual generally focus on device constancy, that is, the ability of the hardcopy
device to maintain its expected imaging performance over time. They do not address system quality
control, for example, the ability of the various system components (image receptor, acquisition
workstation, diagnostic workstation/monitor, hardcopy output device) to communicate properly
with each other, and to use the communicated information correctly. Such system QC activities are
assumed to have occurred during initial system installation, initial system acceptance, or as part of a
Mammography Equipment Evaluation (MEE).

1.2 Regulatory Considerations

Facilities subjected 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
is the facility's responsibility to check the Image Receptor Manufacturer (IRM) Quality
Control manual to determine which QC procedure to follow: the IRM or the hardcopy
output device manufacturer.
(Note that Hologic currently requires the facility to follow their IRM QC procedure for hardcopy
devices used with their system.)

1.3 Structure of the Document

This Quality Control Manual for Mammography is categorized with the following Sections:
• Overview (Section 1)
• QC Procedures for the Radiologic Technologist (Section 2)
• QC Procedures for the Medical Physicist (Section 3)
• Guidance (Section 4) summarizes current Carestream recommendations for various QC tests
• Appendix A/B contain the various QC test charts and tools required to log the data
captured during tests. These charts can be printed and used by the facility performing the
QC tests.
• Appendix C/D/E contain an alternative procedure for Density Constancy Testing that utilizes
a calibrated external densitometer rather than the built-in imager densitometer.

1.4 Elements of a Quality Control Test

Each Quality Control test contains a set of standard elements consistent with the requirements and
intent of the MQSA:
• Objective of the test
• Frequency of testing

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 • Equipment and test patterns/images required for the test (beyond the calibrated hardcopy
output device)
• Procedures and conditions to perform the test
• Action limits, or tolerances, for the test results
• Use of test results (see 21 CFR 900.12(e)(8))
Note that if test results fall outside of action limits, necessary actions are specified.
In general, the action is to stop further printing of mammograms with the failing
device until the source of the problem has been identified and corrected.
Procedures and options based on state-of-the-art devices and current practice are
provided.

1.5 Imager Calibration

All test procedures in this manual assume a properly calibrated hardcopy output device. The imager
calibration procedure is provided in Section 2.1 of this document and in the imager User Manual.
The user shall ensure that the hardcopy device (DRYVIEW 5950 Laser Imager) is calibrated
any time operating levels are established, and any time QC Density Constancy testing is
performed. This is especially important as the DRYVIEW 5950 Laser Imager uses a built-in
densitometer to measure specific density patches on mammography QC test images.

1.6 Web Portal Use and Configuration

To perform the Artifact Test procedure, the built-in Imager Web Portal must be accessed (via an IP
Address) through a workstation on the customer network running WINDOWS EXPLORER. The Web
Portal provides a user interface for launching the Mid-Density_FlatField test image, which is used
for performing the Artifact Test. Select this image from the drop-down on the “Pattern List” menu
item. (See Figure 1-1.) Click the “Set QC Image” button, then to initiate a test print, click the “Issue
Print” button.

The Web Portal is also used to set the QC_Wedges test image as the “default” test image for the
Density Constancy Test (see Figure 1-2). Once configured, the operator can print the test image
directly from the Imager user panel as the procedures in this manual outline.

Note: If the QC_Wedges test image is not produced as expected when the procedures in
this manual are followed, the Imager Web Portal must be used to (re)configure the
QC_Wedges image as the “default” Current Image (see Figure 1-1).

The Web Portal QC Monitor screen is accessed via the Mammo Quality Control selection item on the
left side of the screen (under Monitoring and Control).

Note: If using the alternative procedures noted in Appendix C/D/E that utilize an external
densitometer rather than the built-in imager densitometer, the “Density_QC” test image is
used rather than the “QC_Wedges” test image and the user must configure the Web Portal
accordingly.

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 Figure 1-1: Web Portal Access Menu on Networked User Workstation

Figure 1-2: QC_Wedges Test Image

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 1.7 Test Summary
Table 1-1 summarizes the tests covered in this manual and includes minimum performance
frequencies, the person typically responsible for each test, and where to locate the full description of
each test in this manual.

Table 1-1: Quality Control Tests

When to When to
Test Name Test Type Responsibility (re)establish perform QC Section
operating levels test
Radiologic
Technologist Weekly,
Density See 3.3 for
Grayscale annually, Section 3.3
Constancy Medical triggering events
and during MEE
Physicist
Verify no
Medical See 3.4 for Annually
Artifact Test artifacts in Section 3.4
Physicist triggering events and during MEE
image area
Mammography
Phantom
Medical Equipment Annually
Image Quality System Section 4.2
Physicist Evaluation (MEE) and during MEE
Test
(see 4.2)

Note: All of the above QC tests must be done as part of any Mammography Equipment Evaluation (MEE)
involving the hardcopy device. An MEE must be done, for example, when new equipment is installed, or
when existing equipment undergoes changes or repairs that might affect imaging performance. Reference
the Guidance Section (see Section 4) for additional information.

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 Section 2 QC Procedures for the Radiologic Technologist

2.1 Calibrating the Imager

This procedure ensures that the Imager is calibrated to the film being used for Density Constancy
Tests and for subsequent Mammography imaging. The Imager uses a built-in calibration process to
automatically update imager calibration.

1. Using the Imager display screen (Figure 2-1), press and hold the Calibrate button the film for
cartridge (upper or lower) where the mammography film is loaded.
2. Release the button when the imager emits one audible tone.
3. Wait for the calibration film to exit the imager. The Imager uses this film internally to adjust
calibration and the film has no further use (can be discarded).

4. Press the Pause button to return to normal operation.

Figure 2-1: Imager User Display Screen

5. If the imager reports a Calibration Failure on the display screen, repeat steps 1-4. If the condition
persists, load a different cartridge of Mammography film and repeat steps 1-4. If this does not
resolve the issue, a Service Call will be necessary. Further printing of mammograms with the
device must stop until the source of the problem is identified and corrected.

2.2 Weekly Density Constancy Test

(Note that an alternative “Weekly Density Constancy Test” using an external densitometer
is available in Appendix C.)

2.2.1Objective
To ensure that the hardcopy output device consistently reproduces a representative set of densities
within its output density range, verify at minimum on a weekly basis.

2.2.2Frequency
Weekly

2.2.3Equipment Required
• QC_Wedges test image (see Section 1.6 Web Portal Use and Configuration)
• Current Laser Imager Mammo Quality Control Chart containing the most recent Baseline
Operating Levels and most recent Operating Level plots

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 Figure 2-2: QC_Wedges Test Image

2.2.4Procedure
1. Ensure that the Imager has been calibrated for the Mammography film cartridge
(upper or lower) being used for QC Testing (see Section 2.1).
2. At the Imager display screen (Figure 2-1), press and hold for approximately THREE
seconds the Calibrate button for the film cartridge (upper or lower) where the
mammography film is loaded. The imager emits one audible tone, and as you hold
the button, a second tone is emitted. Release the button.
3. After the QC_Wedges test image exits the imager, the display screen indicates the
Step Number and Density Value determined from the printed QC_Wedges test
image. In Figure 2-3, Step #1 Density is indicated with a value of 0.51.
4. Date the film print with a permanent marker pen.
5. Record the density value for Step #1 on the film in the space to the right of the
“Step #1 – Low Density” patch.
6. Continue displaying the density Step values on the film by pressing the Calibrate
button repeatedly, moving through the results of Step #2, Step #3 and Step #4.
Record the density value for each Step on the film.

7. Press the Pause button to return to normal operation.

8. On the Laser Imager Mammo Quality Control Chart, plot, in the next open column,
the difference between these new Density Operating Values and the Baseline
Operating Levels.

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 Figure 2-3: Imager Display Screen after printing QC_Wedges Test
Image from upper Mammography film cartridge

2.2.5Action Limits
Step #1 — Low Density must be within: ±0.07 of the Baseline Operating Level
Step #2 — High Density must be within: ±0.15 of the Baseline Operating Level
Step #3 — Dmin must be within: +0.06 of the Baseline Operating Level
Step #4 — Mid-Density must be within: ±0.15 of the Baseline Operating Level

2.2.6Use of Test Results

If any values fall outside of the Action Limits, further printing of mammograms with the device
must stop until the source of the problem is identified and corrected.
As a first step towards correcting the problem, initiate an imager calibration sheet (Section 2.1),
making certain that the same Mammography film cartridge is being used for both the Calibration
procedure and the Density Constancy Test. Then repeat the Density Constancy Test (Section 2.2)
and check the four Step densities against the current Action Limits.
If the four new measured reference values are all within the current Action Limits, Mammogram
printing can continue. The recalibration of the imager must be noted in the Quality Control Log
File.
If any of the four new measured reference values fall outside the current Action Limits, replace
the film cartridge (verifying that the film is not expired) and initiate an imager calibration sheet
(Section 2.1), followed by a repeat of the Density Constancy Test. If the issue is resolved, the
recalibration of the imager must be noted in the Quality Control Log File. If the issue remains, a
Service Call will be necessary. Further printing of mammograms with the device must stop until the
source of the problem is identified and corrected.

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 Section 3 QC Procedures for the Medical Physicist

3.1 Density Constancy Overview for the DRYVIEW 5950 Laser Imager
The following QC tests shall be done by a Medical Physicist or by an individual under the direct
supervision of a Medical Physicist, typically in conjunction with an annual mammography facility
survey. These QC tests also form the basis of a Mammography Equipment Evaluation (MEE) (see
Section 4.2).

For the Density Constancy procedure, an internally generated QC_Wedges test image is printed
(see Figure 3-1). The Density Constancy procedure checks the tone reproduction consistency of the
imager at four output densities.

The internal densitometer in the Imager provides this density feedback to the Imager display screen
at the conclusion of the QC_Wedges test image print cycle, letting the user track and record
density variations on mammography film without the need for an external densitometer. Writing
space is provided on the right side of each density step on these films where you can record the
densitometer measurements of each of the four steps.

Figure 3-1: QC_Wedges Test Image

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 3.2 Establishing Baseline Operating Levels
(Note that an alternative “Establishing Baseline Operating Levels” procedure using an external
densitometer is available in Appendix D.)

3.2.1Objective
To ensure that the hardcopy output device consistently reproduces a representative set of densities
within its output density range.

3.2.2Triggering Events
Equipment installation/acceptance, major changes to the hardcopy device’s exposure and
processing hardware components, software, image processing parameters or other events that
would necessitate a Mammography Equipment Evaluation (MEE). The imager operating levels must
also be reestablished if the imager internal densitometer is replaced, repaired, or changed in any
way.

3.2.3Preparation
• QC_Wedges test image (see Section 1.6 Web Portal Use and Configuration)
Print a copy of the following forms, located in Appendix B:
• Worksheet for Determining Baseline Operating Levels
• Laser Imager Mammo Quality Control Chart
• Quality Control Log File
These documents must be completed and maintained with the Mammography QC records for each
imager being tested. These will also be referred to and/or used to document further weekly and
annual Mammography QC Density Constancy Testing.

3.2.4Printing QC_Wedges Test Images

This procedure will enable the user to make two QC_Wedges test image film prints for use in
determining Baseline Operating Level densities.
1. Ensure that the Imager has been calibrated for the Mammography film cartridge (upper or lower)
being used for QC Testing (see Section 2.1).
2. At the Imager display screen (Figure 2-1), press and hold for approximately THREE seconds the
Calibrate button for the film cartridge (upper or lower) where the mammography film is
loaded. The imager emits one audible tone, and as you hold the button, a second tone is
emitted. Release the button.
3. After the QC_Wedges test image exits the imager, the display screen indicates the Step Number
and Density Value determined from the printed QC_Wedges test image. In Figure 3-2, Step #1
Density is indicated with a value of 0.51.
4. Date and mark the film print as “Film #1” with a permanent marker pen.
5. Record the density value for Step #1 on the film in the space to the right of the “Step #1 – Low
Density” patch.

6. Continue displaying the Step density values on the film by pressing the Calibrate button
repeatedly, moving through the results of Step #2, Step #3 and Step #4. Record the density
value for each Step on the film.

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 7. Press the Pause button to return to normal operation.
8. Print a SECOND QC_Wedges image from the same mammography film cartridge used to
calibrate the imager by repeating Procedure step 2 above.
9. Date and mark the film print as “Film #2” with a permanent marker pen and repeat Procedure
steps 5 and 6 above.

10. Press the Pause button to return to normal operation.

Figure 3-2: Imager User Display Screen after printing QC_Wedges Test
Image from upper Mammography film cartridge

3.2.5Using the Worksheet for Determining Baseline Operating Levels

1. Using the “Film #1” QC_Wedges image printed in Section 3.2.4 above, enter the four density
values onto the worksheet in the column labeled “Measured Density Film #1”.
2. Using the “Film #2“ QC_Wedges image printed in Section 3.2.4 above, enter the four density
values onto the worksheet in the column labeled “Measured Density Film #2”.
3. For each density step on the worksheet, determine the average density value by adding the two
entries recorded in steps 1 and 2 - and then dividing by 2 (rounding up the numbers to two
decimal places). Record this value in the column labeled “Measured Density Average”. These
four average values form “Baseline Operating Levels” and will be used for subsequent
comparisons.

3.2.6Creating the Laser Imager Mammo Quality Control Chart

Using the Worksheet for Determining Baseline Operating Levels completed in Section 3.2.5
above, record the “Measured Density Average” values for Step #1 thru Step #4 onto the
Laser Imager Mammo Quality Control Chart immediately to the right of the corresponding Step
descriptions. These density averages will be used as the Baseline Operating Levels for all
subsequent Density Constancy measurement comparisons, until operating levels are
reestablished and a new Laser Imager Mammo Quality Control Chart is started.

3.2.7Action Limits
• Step #1 — Low Density, not less than, 0.45
• Step #2 — High Density, not less than, 2.20

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 • Step #3 — Dmin, minimum density (base + fog), actual level is recorded
• Step #4 — Mid-Density, not less than, 1.20
If any values are outside of the Action Limits, further printing of mammograms with the device
must stop until the source of the problem is identified and corrected.
As a first step towards correcting the problem, initiate an imager calibration sheet (Section 2.1),
making certain that the same Mammography film cartridge is being used for both the Calibration
procedure and the Density Constancy Test. Then repeat the Density Constancy Test (Section 2.2)
and check the four Step densities against the current Action Limits.
If the four new measured reference values are all within the current Action Limits, Mammogram
printing can continue. The recalibration of the imager must be noted in the Quality Control Log
File.
If any of the four new measured reference values fall outside the current Action Limits, replace
the film cartridge (verifying that the film is not expired) and initiate an imager calibration sheet
(Section 2.1) followed by a repeat of the Density Constancy Test. If the issue is resolved, the
recalibration of the imager must be noted in the Quality Control Log File. If the issue remains, a
Service Call will be necessary. Further printing of mammograms with the device must stop until the
source of the problem is identified and corrected.

3.3 Performing the Annual Density Constancy Test

(Note that an Alternative Density Constancy Test using an external densitometer is available in
Appendix E.)

3.3.1Objective
To ensure that the hardcopy output device consistently reproduces a representative set of densities
within its output density range, verified at minimum on an annual basis.

3.3.2Frequency
Annually

3.3.3Equipment Required
• QC_Wedges test image (see Section 1.6 Web Portal Use and Configuration).
• Current Laser Imager Mammo Quality Control Chart containing the most recent Baseline
Operating Levels and most recent Operating Level plots
• Print a copy of the following forms, located in Appendix B: Worksheet for Annual Density
Constancy Test

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 3.3.4Procedure
1. Ensure that the Imager has been calibrated for the Mammography film cartridge
(upper or lower) being used for QC Testing (see Section 2.1).
2. At the Imager display screen (Figure 2-2), press and hold for approximately THREE
seconds the Calibrate button for the film cartridge (upper or lower) where the
mammography film is loaded. The imager emits one audible tone, and as you hold
the button, a second tone is emitted. Release the button.
3. After the QC_Wedges test image exits the imager, the display screen indicates the
Step Number and Density Value determined from the printed QC_Wedges test
image. In Figure 3-2, Step #1 Density is indicated with a value of 0.51.
4. Date the film print with a permanent marker pen.
5. Record the density value for Step #1 on the film in the space to the right of the “Step
#1 – Low Density” patch.
6. Continue displaying the Step density values on the film by pressing the Calibrate
button repeatedly, moving through the results of Step #2, Step #3 and Step #4.
Record the density value for each Step on the film.

7. Press the Pause button to return to normal operation.

8. Record the values for each Step Density on the Worksheet for Annual Constancy
Test.
9. Determine whether the values are within the Action Limits for each Step Density.

3.3.5Action Limits
• Step #1 — Low Density must be within: ±0.07 of the Baseline Operating Level
• Step #2 — High Density must be within: ±0.15 of the Baseline Operating Level
• Step #3 — Dmin must be within: +0.06 of the Baseline Operating Level
• Step #4 — Mid-Density must be within: ±0.15 of the Baseline Operating Level

3.3.6Use of Test Results

If any values are outside of the Action Limits, further printing of mammograms with the device
must stop until the source of the problem is identified and corrected.
As a first step towards correcting the problem, initiate an imager calibration sheet (Section 2.1)
making certain that the same Mammography film cartridge is being used for both the Calibration
procedure and the Density Constancy Test. Then repeat the Density Constancy Test (Section 2.2)
and check the four Step densities against the current Action Limits.
If the four new measured reference values are all within the current Action Limits, Mammogram
printing can continue. The recalibration of the imager must be noted in the Quality Control Log
File.
If any of the four new measured reference values fall outside the current Action Limits, replace
the film cartridge (verifying that the film is not expired) and initiate an imager calibration sheet
(Section 2.1), followed by a repeat of the Density Constancy Test. If the issue is resolved, the
recalibration of the imager must be noted in the Quality Control Log File. If the issue remains, a
Service Call will be necessary. Further printing of mammograms with the device must stop until the
source of the problem is identified and corrected.

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 3.4 Performing Artifact Test
This test is triggered by equipment installation/acceptance, major changes to the hardcopy device
hardware or software, or other events that would necessitate a Mammography Equipment
Evaluation (MEE). This test may also be triggered by an observation of a possible artifact on a
printed clinical film.

3.4.1Objective
To assess the ability of the hardcopy output device to produce images free from clinically significant
artifacts (that is, artifacts that mimic or obscure clinical information).

3.4.2Frequency
Annually

3.4.3Equipment Required
• Mid-Density_FlatField test image accessed via the imager Web Portal (see Section 1.6 Web
Portal Use and Configuration).
This image is an internally generated digital image that aids in detecting relevant artifacts.
Specifically, the Mid-Density_FlatField image is a medium density, uniform, full-field area printed
at approximately 1.7 Optical Density. Performing the artifact test requires that this test image be
printed and checked for artifacts. The image is shown in Figure 3-3.

3.4.4Procedure
From the imager Web Portal (see Section 1.6), print the Mid-Density_FlatField test image and
evaluate for any artifacts seen in the hardcopy output that mimic or obscure clinical information.

3.4.5Action Limits
There must be no artifacts that mimic or obscure clinical information.
It will be helpful to use the concept of ALARA (as low as reasonably achievable) when judging
artifacts. The medical physicist should consult with the interpreting physician as to whether or not
an artifact seen on the Mid-Density_FlatField can be seen and is tolerable on a clinical image.

3.4.6Use of Test Results

If the imager fails the artifact test, further printing of mammograms with the device must stop until
the source of the problem is identified and corrected.
If artifacts mimic or obscure clinical information, load a different mammography film cartridge in
the imager and repeat the test to determine if the artifact is associated with a particular film
cartridge. If the artifact still occurs, the imager may require cleaning or other maintenance. A
Service Call will be necessary.
If the artifact goes away after the original film cartridge is replaced, the original film cartridge must
no longer be used for clinical printing.

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Figure 3-3: Mid-density Flat Field Image

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 3.5 Phantom Image Quality Test

3.5.1Objective
To ensure that the quality of images acquired at the acquisition workstation remains adequate after the
images are transmitted to and printed on the hardcopy output device.

3.5.2Frequency
Annually

3.5.3Equipment Required
Calibrated FFDM system, including at minimum:
• an acquisition workstation or acquisition modality (needed only if the acquisition workstation that will
send clinical images to the hardcopy device does not contain a phantom image that has recently been
acquired from the modality and that has met the image quality requirements of the image receptor
manufacturer) – must be DICOM OUTPUT and able to send the phantom image to the Imager
• FDA approved mammographic accreditation phantom or as regulated

3.5.4Procedure
Acquire an image of the accreditation phantom on each full-field digital mammography (FFDM) image
acquisition system from which images will be sent to the hardcopy device, and send the image(s) to the
hardcopy device for printing. Alternatively, if such an image already exists on the acquisition workstation,
send that image to the hardcopy device for printing. Score the output image according to the image quality
criteria specified by the local, regional or country Regulatory or Accreditation bodies for each FFDM system
that will send images to the hardcopy device.

3.5.5Action Limits
The printed image must meet local, regional or country Regulatory or Accreditation bodies image quality
criteria/action limits for each FFDM system that will send images to the hardcopy device.

3.5.6Use of Test Results

If the imager fails the phantom test for a particular FFDM system from which it will receive images for
printing and final interpretation, further printing of mammograms with the device from that FFDM system
must stop until the source of the problem is identified and corrected.
If the imager passes all other applicable QC tests described in this manual, it is likely that this image quality
failure is the result of either (1) a problem in the acquisition system or (2) a configuration issue such as the
choice of the selected grayscale lookup table (Transfer Function Table or TFT) being used in the imager.
The first possibility may be investigated by carefully reviewing the same acquired image on a softcopy display
(preferably at a fixed grayscale window setting) to verify that the image itself is satisfactory.
The second possibility may be investigated by switching to alternative lookup tables (TFTs), or an alternate
printing mode (Presentation LUT mode), as may be recommended by Carestream, especially if acquisition
system parameters have changed. A Service Call will be necessary.

2012-12-31 Page 18
 Section 4 Guidance
MQSA final regulations consider performance of the Image Receptor Manufacturer (IRM) 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 when an Image Receptor Manufacturer QC Test Procedures indicate that
the Imager QC procedures should be used. It represents the equipment manufacturer’s current thinking on appropriate
procedures for conducting 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 only those ways. 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 than those specified under MQSA and its
implementing regulations. A facility must check with the state or local authorities regarding their requirements. Tests
may need to be performed more frequently than specified in this manual if required by local regulations or the facility’s
standard operating procedures.

4.1 QC Test Images

The “Equipment Required” section of each described QC test specifies one or more test images appropriate for
that test. The following table lists test images that can be used for this purpose.

Table 4-1: QC Test Images

Test Image Source/Information/Description
QC_Wedges test image • Internally generated image named “QC_Wedges”; checks the tone
reproduction consistency at four output densities; used for the Density
Constancy Test
Mid-Density_FlatField test • Internally generated uniform density test image with a uniform
image mid-density named “Mid-Density_FlatField”; used for the Artifact Test

4.2 Mammography Equipment Evaluation (MEE)

Section 2 and Section 3 describe periodic QC tests. There are other occasions when QC/acceptance tests must
be done ad hoc after interventions that might affect imaging performance, such as installation of a new device,
or equipment changes/repairs (hardware or software). In addition, certain other changes, such as selecting new
image processing parameters in an image acquisition system, may cause significant changes to occur in overall
system image quality, unless compensating changes are also made to the printing parameters (for example, the
lookup table (TFT) used in the imager), as may be recommended by Carestream. In order to verify that all
functions that may have been affected by the change or repair have been successfully restored or initialized,
the hardcopy output device must pass a mammography equipment evaluation (MEE). MEEs “shall be
performed by a medical physicist or by an individual under the direct supervision of a medical physicist” and
“all problems shall be corrected before the new or changed equipment is put into service for examinations...”
(21 CFR 900.12(e) (10)).

2012-12-31 Page 19
 If the MEE is for the purpose of evaluating/accepting a newly installed hardcopy output device, first verify that
the installer has completed all tasks defined by the manufacturer as necessary for proper installation. These
include:
• Out-of-box equipment inspection
• Equipment setup
• Equipment configuration
• Equipment verification testing

Once the hardcopy device is functional and communicating with the rest of the FFDM system, the MEE consists
of the following tests:

MEE Test Name Section

Establishing Baseline
3.2
Operating Levels

Density Constancy Test 3.3

Artifact Test 3.4

Phantom Image Quality Test 3.5

Note that after the performance of an MEE, both the old and the newly created Quality Control Log
Files should be updated with the current date and should indicate that new Baseline Operating
Levels have been established.

2012-12-31 Page 20
Appendix A—Quality Control Forms for the Radiologic Technologist
Contains printable forms for:

1. Laser Imager Mammo Quality Control Chart

2. Quality Control Log File

2012-12-31 Page 21
 Laser Imager Mammo Quality Control Chart
Imager S/N: ____________________________________ Institution:_____________________________________
Month/Year:_____________________________________ Baseline Date:__________ Baseline Initials:_______
Weekly QC Initials:
Weekly QC Date:
Baseline Values

+ 0.07

Step #1
Low D=
Wedge # __

- 0.07

+ 0.15

Step #2
High D=
Wedge # __

- 0.15

+ 0.06
Step #3
Dmin=
Wedge # __

+ 0.15

Step #4
Mid D=
Wedge # __

- 0.15

2012-12-31 Page 22
 Quality Control Log File

Date / Initials
Action Comments / Remarks

2012-12-31 Page 23
 Appendix B—Quality Control Forms for the Medical Physicist

Contains printable forms for:

1. Worksheet for Determining Baseline Operating Levels

2. Worksheet for Annual Density Constancy Test

2012-12-31 Page 24
2012-12-31 Page 25
 Worksheet for Annual Density Constancy Test
Institution: ________________________________________________

Imager S/N: ________________________________________________

Date/ Measured Density,

Density Step Tolerance Pass/Fail
Initials Test Image
±0.07 of the
Step #1 – Low Density
operating level
±0.15 of the
Step #2 – High Density
operating level
+0.06 of the
Step #3 – Dmin
operating level
±0.15 of the
Step #4 – Mid-Density
operating level
Date/ Measured Density,
Density Step Tolerance Pass/Fail
Initials Test Image
±0.07 of the
Step #1 – Low Density
operating level
±0.15 of the
Step #2 – High Density
operating level
+0.06 of the
Step #3 – Dmin
operating level
±0.15 of the
Step #4 – Mid-Density
operating level
Date/ Measured Density,
Density Step Tolerance Pass/Fail
Initials Test Image
±0.07 of the
Step #1 – Low Density
operating level
±0.15 of the
Step #2 – High Density
operating level
+0.06 of the
Step #3 – Dmin
operating level
±0.15 of the
Step #4 – Mid-Density
operating level
Date/ Measured Density,
Density Step Tolerance Pass/Fail
Initials Test Image
±0.07 of the
Step #1 – Low Density
operating level
±0.15 of the
Step #2 – High Density
operating level
+0.06 of the
Step #3 – Dmin
operating level
±0.15 of the
Step #4 – Mid-Density
operating level

2012-12-31 Page 26
 Appendix C—Alternative Weekly “Density Constancy Test” for use
with an External Densitometer
C.1 Objective
To ensure that the hardcopy output device consistently reproduces a representative set of densities
within its output density range using an External Densitometer verified at minimum on a weekly
basis.

C.2 Frequency
Weekly

C.3 Equipment Required

• Density_QC test image (see Section 1.6 Web Portal Use and Configuration)
• Current Laser Imager Mammo Quality Control Chart containing the most recent Baseline
Operating Levels and most recent Operating Level plots
• Calibrated, external densitometer (preferably the same unit used to determine
Baseline Operating Levels). Using the Density_QC test image, the step wedge that is
closest to the film edge can be read, in its entirety, with an automatic strip-reading
densitometer such as the X-RITE Model 391 Densitometer. Alternatively, the step wedge
that is closest to the middle of the film can be read, one step at a time, with a densitometer
such as the X-RITE Model 301.

2012-12-31 Page 27
 Density_QC Test Image

2012-12-31 Page 28
 C.4 Procedure
1. Ensure that the Imager has been calibrated for the Mammography film cartridge (upper
or lower) being used for QC Testing (see Section 2.1).
2. At the Imager display screen (Figure 2-1), press and hold for approximately THREE
seconds the Calibrate button for the film cartridge (upper or lower) where the
mammography film is loaded. The imager emits one audible tone, and as you hold the
button, a second tone is emitted. Release the button.
3. Date the film print with a permanent marker pen.

4. Press the Pause button to return to normal operation.

5. Measure and record the relevant Density Wedges identified previously during the
creation of the Baseline Operating Levels.
6. On the Laser Imager Mammo Quality Control Chart, plot, in the next open column, the
difference between these new Density Operating Values and the Baseline Operating
Levels.

C.5 Action Limits

Step #1 — Low Density must be within: ±0.07 of the Baseline Operating Level
Step #2 — High Density must be within: ±0.15 of the Baseline Operating Level
Step #3 — Dmin must be within: +0.06 of the Baseline Operating Level
Step #4 — Mid-Density must be within: ±0.15 of the Baseline Operating Level

C.6 Use of Test Results

If any values are outside of the Action Limits, further printing of mammograms with the device
must stop until the source of the problem is identified and corrected.
As a first step towards correcting the problem, initiate an imager calibration sheet (Section 2.1)
making certain that the same Mammography film cartridge is being used for both the Calibration
procedure and the Density Constancy Test. Then repeat the Density Constancy Test (Section 2.2)
and check the four Step densities against the current Action Limits.
If the four new measured reference values are all within the current Action Limits, Mammogram
printing can continue. The recalibration of the imager must be noted in the Quality Control Log
File.
If any of the four new measured reference values fall outside the current Action Limits, replace
the film cartridge (verifying that the film is not expired) and initiate an imager calibration sheet
(Section 2.1) followed by a repeat of the Density Constancy Test. If the issue is resolved, the
recalibration of the imager must be noted in the Quality Control Log File. If the issue remains, a
Service Call will be necessary. Further printing of mammograms with the device must stop until the
source of the problem is identified and corrected.

2012-12-31 Page 29
 Appendix D—Alternative “Establishing Baseline Operating Levels”
procedure using an External Densitometer
D.1 Objective
To ensure that the hardcopy output device consistently reproduces a representative set of densities
within its output density range.

D.2 Triggering Events

Equipment installation/acceptance, major changes to the hardcopy device’s exposure and
processing hardware components, software, image processing parameters or other events that
would necessitate a Mammography Equipment Evaluation (MEE). Baseline Operating Levels must
also be reestablished if the densitometer used in these tests is replaced, repaired or changed in any
way other than normal user-performed calibration using a valid (not expired) density step tablet.

D.3 Preparation
• Density_QC test print (see Section 1.6 Web Portal Use and Configuration)
• Calibrated, external densitometer. Using the Density_QC test image, the step wedge that is
closest to the film edge can be read, in its entirety, with an automatic strip-reading
densitometer such as the X-RITE Model 391 Densitometer. Alternatively, the step wedge
that is closest to the middle of the film can be read, one step at a time, with a densitometer
such as the X-RITE Model 301.
Print a copy of the following forms, located in Appendix A/B:
• Worksheet for Determining Baseline Operating Levels
• Laser Imager Mammo Quality Control Chart
• Quality Control Log File
These documents must be completed and maintained with the Mammography QC records for each
imager being tested. These will also be referred to and/or used to document further weekly and
annual Mammography QC Density Constancy Testing.

D.4 Printing Density_QC Test Images

This procedure will enable the User to make two Density_QC test image film prints for use in
determining Baseline Operating Level densities using an external densitometer.
1. Ensure that the Imager has been calibrated for the Mammography film cartridge (upper
or lower) being used for QC Testing (see Section 2.1).
2. At the Imager display screen (Figure 2-1), press and hold for approximately THREE
seconds the Calibrate button for the film cartridge (upper or lower) where the
mammography film is loaded. The imager emits one audible tone, and as you hold the
button, a second tone is emitted. Release the button.
3. Date and mark the film print as “Film #1” with a permanent marker pen.

4. Press the Pause button to return to normal operation.

5. Print a SECOND Density_QC image from the same mammography film cartridge used to
calibrate the imager by repeating Procedure step 2 above.
6. Date and mark the film print as “Film #2” with a permanent marker pen.

7. Press the Pause button to return to normal operation.

2012-12-31 Page 30
 D.5 Using the Worksheet for Determining Baseline Operating
Levels

1. Starting with a new, blank worksheet such as that included at the end of this procedure,
record all 21 densities from the wedge being used on each of the two films just printed
and enter those data into the second and third columns of the worksheet.

2. For each density step on the worksheet, determine the average density value by adding
the two entries recorded in columns 1 and 2 - and then dividing by 2 (rounding up the
numbers to two decimal places). Record this value in the column labeled “Measured
Density Average”.

3. To determine which step wedge to use as the “Low Density” Step, scan, from the top
through the data in the second and third columns, stopping at the first step in which
the measured densities in both of the two columns are at least 0.45. On the worksheet,
write “Low Density” in the “Step Usage” column on the row for this step number.

4. To determine which step to use as the “Mid-Density” step, scan, from the top through
the data in the second and third columns, stopping at the first step in which the
measured densities in both of the two columns are at least 1.20. On the worksheet,
write “Mid- Density” in the “Step Usage” column on the row for this step number.

5. To determine which step to use as the “High Density” step, scan, from the top through
the data in the second and third columns, stopping at the first step in which the
measured densities in both of the two columns are at least 2.20. On the worksheet,
write “High Density” in the “Step Usage” column on the row for this step number.

2012-12-31 Page 31
 Worksheet for Determining Baseline Operating Levels

Wedge Measured Measured Measured Step Usage

Step # Density_QC Density_QC Density
Test Print #1 Test Print #2 Average
1 Dmin – always
Wedge #1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21

2012-12-31 Page 32
 D.6 Creating the Laser Imager Mammo Quality Control Chart

Using the Worksheet for Determining Baseline Operating Levels completed above, record the
“Measured Density Average” values for Step #1 thru Step #4 onto the Laser Imager Mammo
Quality Control Chart immediately to the right of the corresponding Step descriptions. In
addition, note the Wedge # in the space provided. These density averages will be used as the
Baseline Operating Levels for all subsequent Density Constancy measurement comparisons,
until operating levels are reestablished and a new Laser Imager Mammo Quality Control Chart is
started.

D.7 Action Limits

• Step #1 — Low Density, not less than, 0.45
• Step #2 — High Density, not less than, 2.20
• Step #3 — Dmin, minimum density (base + fog), actual level is recorded
• Step #4 — Mid-Density, not less than, 1.20
If any values are outside of the Action Limits, further printing of mammograms with the device
must stop until the source of the problem is identified and corrected.
As a first step towards correcting the problem, initiate an imager calibration sheet (Section 2.1)
making certain that the same Mammography film cartridge is being used for both the Calibration
procedure and the Density Constancy Test. Then repeat the Density Constancy Test (Section 2.2)
and check the four Step densities against the current Action Limits.
If the four new measured reference values are all within the current Action Limits, Mammogram
printing can continue. The recalibration of the imager must be noted in the Quality Control Log
File.
If any of the four new measured reference values fall outside the current Action Limits, replace
the film cartridge (verifying that the film is not expired) and initiate an imager calibration sheet
(Section 2.1) followed by a repeat of the Density Constancy Test. If the issue is resolved, the
recalibration of the imager must be noted in the Quality Control Log File. If the issue remains, a
Service Call will be necessary. Further printing of mammograms with the device must stop until the
source of the problem is identified and corrected.

2012-12-31 Page 33
 Appendix E—Alternative Annual “Density Constancy Test” for use
with an External Densitometer
E.2 Objective
To ensure that the hardcopy output device consistently reproduces a representative set of densities
within its output density range using an External Densitometer verified at minimum on an annual
basis.

E.3 Frequency
Weekly

E.4 Equipment Required

• Density_QC test image (see Section 1.6 Web Portal Use and Configuration)
• Current Laser Imager Mammo Quality Control Chart containing the most recent Baseline
Operating Levels and most recent Operating Level plots
• Calibrated, external densitometer (preferably the same unit used to determine
Baseline Operating Levels). Using the Density_QC test image, the step wedge that is
closest to the film edge can be read, in its entirety, with an automatic strip-reading
densitometer such as the X-RITE Model 391 Densitometer. Alternatively, the step wedge
that is closest to the middle of the film can be read, one step at a time, with a densitometer
such as the X-RITE Model 301.
Print a copy of the following forms, located in Appendix B:
• Worksheet for Annual Density Constancy Test

E.5 Procedure
1. Ensure that the Imager has been calibrated for the Mammography film cartridge (upper
or lower) being used for QC Testing (see Section 2.1).
2. At the Imager display screen (Figure 2-1), press and hold for approximately THREE
seconds the Calibrate button for the film cartridge (upper or lower) where the
mammography film is loaded. The imager emits one audible tone, and as you hold the
button, a second tone is emitted. Release the button.
3. Date the film print with a permanent marker pen.

4. Press the Pause button to return to normal operation.

5. Measure and record the relevant Density Wedges identified previously during the
creation of the Baseline Operating Levels.
6. Record the values for each relevant Step Density on the Worksheet for Annual
Constancy Test.
7. Determine whether the values are within the Action Limits for each Step Density

2012-12-31 Page 34
 E.6 Action Limits
Step #1 — Low Density must be within: ±0.07 of the Baseline Operating Level
Step #2 — High Density must be within: ±0.15 of the Baseline Operating Level
Step #3 — Dmin must be within: +0.06 of the Baseline Operating Level
Step #4 — Mid-Density must be within: ±0.15 of the Baseline Operating Level

E.7 Use of Test Results

If any values fall outside of the Action Limits, further printing of mammograms with the device
must stop until the source of the problem is identified and corrected.
As a first step towards correcting the problem, initiate an imager calibration sheet (Section 2.1)
making certain that the same Mammography film cartridge is being used for both the Calibration
procedure and the Density Constancy Test. Then repeat the Density Constancy Test (Section 2.2)
and check the four Step densities against the current Action Limits.
If the four new measured reference values are all within the current Action Limits, Mammogram
printing can continue. The recalibration of the imager must be noted in the Quality Control Log
File.
If any of the four new measured reference values fall outside the current Action Limits, replace
the film cartridge (verifying that the film is not expired) and initiate an imager calibration sheet
(Section 2.1) followed by a repeat of the Density Constancy Test. If the issue is resolved, the
recalibration of the imager must be noted in the Quality Control Log File. If the issue remains, a
Service Call will be necessary. Further printing of mammograms with the device must stop until the
source of the problem is identified and corrected.

2012-12-31 Page 35
Carestream Health, Inc.
150 Verona Street
Rochester, NY 14608
United States

DRYVIEW is a trademark of Carestream Health.

© Carestream Health, Inc.

Printed in China.

Pub No. AA4663, Rev B

2012-12-31 Page 36