mqsa quality control manual - nds surgical imaging...1.0 overview 1.1 purpose this document provides...

MQSA Quality Control ManualDome® 5MP & 10MP Diagnostic Imaging Displays

USED FOR MAMMOGRAPHY

http://ndssi.com

© 2011 NDS Surgical Imaging, LLC. All rights reserved.

This document contains proprietary information of NDS Surgical Imaging. It is exclusive property of NDS Surgical Imaging. It may not be reproduced or transmitted, in whole or in part, without a written agreement from NDS Surgical Imaging. No patent or other license is granted to this information.

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Information in this document about products not manufactured by NDS Surgical Imaging is provided without warranty or representation of any kind, and NDS Surgical Imaging will not be liable for any damages resulting from the use of such information.

020-0517-02A

NDS Surgical Imaging, Dome, the NDSsi logo, the Dome by NDSsi logo, Dome CXtra, and RightLight are either registered trademarks or trademarks of NDS Surgical Imaging. All other trademarks are the property of their respective owners.

Contents

1.0 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.1 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.2 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.3 Materials/Equipment . . . . . . . . . . . . . . . . . . . . 1

2.0 QC Tests for Radiological Technologist . . . . 2

2.1 Quality Control Intervals . . . . . . . . . . . . . . . . . 2

2.2 Display Cleaning . . . . . . . . . . . . . . . . . . . . . . . . 2

2.3 Viewing Conditions Check . . . . . . . . . . . . . . . 4

2.4 CXtra Operation Verification . . . . . . . . . . . . . 5

2.5 Display Calibration Check . . . . . . . . . . . . . . . . 6

3.0 QC Tests for Medical Physicist . . . . . . . . . . 11

3.1 Quality Control Intervals . . . . . . . . . . . . . . . . 11

3.2 Viewing Conditions Check . . . . . . . . . . . . . . 12

3.3 Display Calibration . . . . . . . . . . . . . . . . . . . . . 14

3.4 Image Quality of SMPTE Pattern. . . . . . . . . 20

3.5 Visual Inspection for Display Defects . . . . 23

4.0 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

5.0 Evaluation Forms . . . . . . . . . . . . . . . . . . . . . . . 27

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

SMPTE pattern generated by Dome CXtra

1.0 Overview

1.1 PurposeThis document provides a procedure for performing quality control tests on Dome® 5MP and 10MP diagnostic imaging displays.

1.2 ScopeThe quality control tests are appropriately applied to the Dome 5MP and 10MP diagnostic imaging displays when they are specifically used for the clinical review of images acquired by full-field digital mammography systems, also called FFDM systems.

1.3 Materials/EquipmentThe following items are required for the quality control tests.

• Dome diagnostic imaging display system with graphics controller and driver installed

• Computer workstation running Microsoft Windows XP Service Pack 3 or later

• Dome CXtra software

• Calibrated external photometer

• Calibrated luxmeter with a minimum resolution of 1 lux

Reference the following U.S. Food and Drug Administration web site for any possible additions or changes that may not be covered in this document.

http://www.fda.gov/cdrh/mammography/guidance-rev.html

2.0 QC Tests for Radiological Technologist

Quality Control tests are simple checks that ensure the Dome 5MP and 10MP diagnostic imaging displays are operating to design standards. These tests are meant to detect any changes in settings that might compromise image quality, as well as any deterioration in equipment performance that may occur over time.

2.1 Quality Control IntervalsThe Quality Assurance procedures described here must be performed at least as frequently as the intervals specified in the test descriptions.

2.2 Display CleaningCare must be taken when cleaning the display screen not to press too hard. If you apply excessive pressure, you may affect the image view or damage the display.

Do not touch the LCD screen with your fingers. Skin oils are hard to remove from the screen.

Frequency Procedure

Daily Display cleaning

Daily CXtra operation verification

Monthly Display calibration check

2 | MQSA Quality Control

2.2.1 FrequencyClean the display daily or on days when clinical image reviews are planned.

2.2.2 ObjectiveTo ensure optimal image viewing, review conditions by keeping the display screen free of dust, fingerprints, and other marks.

2.2.3 Materials requiredYou need only a dry, soft, lint-free cloth or cleaning tissue.

If necessary, the cloth or tissue may be lightly dampened with water or a mild cleanser before use. Never apply water or other fluids directly to the display.

Do not use or spray liquid, aerosol, ammonia, or alcohol-based cleaners on the display or screen. Some chemical cleaners may damage the display.

Do not use chemically treated dust cloths, acetone, toluene, or harsh solvents on the display case or the screen. They can damage the polarizer and the display case.

NOTE: Any other cleaning methods may lead to damage of the anti-reflective screen coating.

2.2.4 Procedure2.2.4.1 Unplug the power supply before cleaning the display.

2.2.4.2 Gently clean all display screens using a dampened cloth or cleaning tissue to remove dust, fingerprints, and other marks.

2.2.4.3 Use a dry, soft, clean cloth to wipe off the residue.

NOTE: Always wipe off water and other stains immediately to avoid damage to the screen. Do not exert excessive pressure on the display screen as this can damage the LCD module.

Dome 5MP & 10MP Diagnostic Imaging Displays | 3

2.2.4.4 Check the screen to verify that it is free of dust, fingerprints, and other marks.

2.2.4.5 Record the completion of this check on the appropriate form.

The screen must be free of dust, fingerprints, and other marks. 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 Dome diagnostic imaging display.

2.3 Viewing Conditions Check2.3.1 FrequencyConduct a check daily or on days when image reviews or interpretations are planned.

2.3.2 ObjectiveThis check is to ensure optimal viewing conditions.

2.3.3 Equipment requiredNone.

2.3.4 Procedure2.3.4.1 Review the for Viewing Conditions Check and Setting posted

in the reading room during the most recent medical physicist’s evaluation. Observe reading room conditions established as optimal during the evaluation.

2.3.4.2 Compare the reading room configuration to the one described on the form.

2.3.4.3 If differences exist between this configuration and the actual one, adjust the room configuration to match that described on the form. For example, if desk lights were described to be turned off, turn them off. Or, if the curtains were described to be closed, close them.


2.3.4.4 Record the completion of this check on the appropriate form.

NOTE: On the form Viewing Conditions Check and Setting posted by the medical physicist, look for the nominal value of the ambient light. This is a record of the most recent measurement and provides a comparison value for the next medical physicist survey. The radiological technologist is not required to measure the ambient light level as part of the Viewing Conditions Check.

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 Dome diagnostic imaging display.

2.4 CXtra Operation Verification2.4.1 FrequencyConduct the verification daily or on days when clinical image reviews are planned.

NOTE: The Dome CXtra software is continually checking the calibration of the Dome diagnostic imaging display.

2.4.2 ObjectiveThis verification is to ensure that Dome CXtra is operational and that the display is calibrated.

2.4.3 Equipment requiredNone.


2.4.4 ProcedureCheck the Dome CXtra icon in the Windows task bar to ensure that the check mark is present. This icon verifies that the Dome CXtra software is operational and the display is calibrated.

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 Dome diagnostic imaging display.

2.5 Display Calibration Check2.5.1 FrequencyConduct the calibration check monthly.

NOTE: The Dome CXtra software is continually checking the calibration of the Dome diagnostic imaging display used for mammographic images.

2.5.2 ObjectiveThe calibration check is to ensure that the display is calibrated and the brightness and contrast settings are at an appropriate level for the reading of mammographic images on the Dome diagnostic imaging display.

2.5.3 Equipment requiredThe following items are required for the display calibration check.• Dome diagnostic imaging display system with graphics controller

and driver installed



NOTE: When performing this test, follow the instructions given below explicitly so that the source of the SMPTE pattern is the Dome CXtra application and not the image viewer.


These tests and associated specifications were designed to be performed with the SMPTE pattern that is accessible through Dome CXtra. Using any other pattern, particularly a pattern that is displayed with the usual image viewer tool, could result in failing the test and causing the display to be out of compliance with the requirements of this test.

2.5.4 Procedure2.5.4.1 Check to ensure that the Dome CXtra icon on the task bar is

verifying that the software is operational and that the display is calibrated.

2.5.4.2 Click the Dome CXtra icon in the task bar to open the menu. Select Test Patterns > View Test Patterns to open the Display Test Patterns dialog.

2.5.4.3 Click the plus sign (+) beside Miscellaneous to list the test patterns and select SMPTE. The pattern appears on both displays.


2.5.4.4 Examine the image carefully for the following features:

• Verify that the 0%-5% contrast is visible (area 1 on Illustration 1, page 10).

• Verify that the 95%-100% contrast is visible (area 14).

• Verify that each gray level step from 0% to 100% can be distinguished from the adjacent squares. Verify that you can, for example, distinguish the 0% square from the 10% square or the 90% square from the 100% square (areas 2 to 13).

• Verify that the alphanumeric characters that appear on the pattern are sharp and in focus. For example, examine the “%” signs that label the steps of the gray scale. (See Illustration 2, detail of the SMPTE pattern, on page 10).

• Verify that the high contrast line-pair images at the center and corners of the SMPTE pattern are distinguishable (areas A to E of Illustration 1).

NOTE: The SMPTE pattern shown via the Dome CXtra software has five sets of high-contrast and five sets of low-contrast line-pair patterns. One set of each is in the center of the image, and one set of each is in each corner of the image. The high-contrast patterns have frequencies of 3- pixels-on/3-pixels-off, 2-pixels-on/2-pixels-off, and 1-pixel-on/1-pixel-off. At each frequency, a set of line-pairs is oriented in the horizontal direction and a set is oriented in the vertical direction. Visibility of the low-contrast patterns is not evaluated in this test.


2.5.4.5 Record the results on the form Radiological Technologist Display Calibration Check (see page 27) or on the form your facility uses.

2.5.4.6 Repeat step 2.5.4.5 for any Dome diagnostic imaging display used for mammography readings.

2.5.4.7 To remove the SMPTE image and return to normal viewing mode, click Close on the Display Test Patterns dialog.

The 0%-5% contrast and the 95%-100% contrast shall be visible, and each step from 0% to 100% shall be distinguishable.

The alphanumeric characters shall appear sharply focused.

The high-contrast line-pair patterns representing 3-pixels-on/3-pixels-off and 2-pixels-on/2- pixels-off must be distinguishable at the center and the corners of the display for both the horizontal and vertical orientations of the line-pair patterns. The high-contrast line-pair patterns representing 1-pixel-on/1-pixel-off must be distinguishable at the center and the corners of the display for the horizontal orientation of the patterns. Failure to distinguish the 1-pixel-on/1-pixel-off, high-contrast, vertical line-pair patterns does not constitute failure of the test.

The ability to distinguish the low-contrast line-pair patterns is not a requirement for this test.

If these conditions are maintained, the displays are considered correctly calibrated.



SMPTE illustrations

Illustration 1. SMPTE pattern generated by Dome CXtra

Illustration 2. Detail of the central portion of the SMPTE pattern (above) generated by Dome CXtra, showing the high-contrast bar pattern and some of the alphanumeric characters


3.0 QC Tests for Medical Physicist

The Quality Control tests listed in this section must be performed by the medical physicist to ensure that the Dome 5MP and 10MP diagnostic imaging displays provide a high level of mammographic image quality.

These tests also establish the basis of the equipment evaluation that must be performed following the installation of a Dome diagnostic imaging display, the repair or replacement of a major component of the system, the relocation of a Dome diagnostic imaging display to another viewing location, or the substantial change of illumination in an existing viewing environment.

3.1 Quality Control IntervalsThe Quality Assurance procedures described here must be performed at least as frequently as the intervals specified in the test descriptions summarized below or as required by the U.S. Food and Drug Administration, or FDA.

Frequency Procedure

Annually Viewing Conditions Check and Setting

Annually Display Calibration

Annually Image Quality for SMPTE Pattern


3.2 Viewing Conditions Check3.2.1 FrequencyConduct the conditions check at least annually.

3.2.2 ObjectiveThe check is to ensure optimal viewing conditions.

3.2.3 Equipment requiredYou need a calibrated luxmeter with a minimum resolution of 1 lux.

3.2.4 Procedure3.2.4.1 In the reading room, turn the lights off and close any doors

and windows to make the room as dark as possible.

3.2.4.2 Turn on the displays at least 30 minutes before starting the measurement.

3.2.4.3 Position the displays used for reading digital images in optimal conditions.

3.2.4.4 Reduce to the minimum any lighting coming from other sources, such as view boxes, overhead or task lighting, to reproduce typical ambient lighting conditions that would be set for reading digital images on the Dome diagnostic imaging display.

3.2.4.5 Check that the ambient lighting set in the previous step is stable; that is, there are no flickering effects due to any of the lighting sources that are turned on.

3.2.4.6 Make the display screen as dark as possible by minimizing the image viewer and bottom toolbar on both displays (if shown).

3.2.4.7 Obtain the luxmeter readings, by facing the luxmeter away from each display near the plane of the unit.

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


3.2.4.8 Read the Illuminance on the luxmeter and verify that it does not exceed 20 lux. The ambient light value must be observed during one minute and maintain a tolerance of ± 5 lux variation over the measuring time with regards to the nominal value.

3.2.4.9 If the value is greater than 20 lux, adjust the room ambient light and/or the room configuration in such a way to have an Illuminance that does not exceed 20 lux.

3.2.4.10 Record (describe) the room configuration established as optimal on the form Viewing Conditions Check and Setting (see page 29), as detailed in following steps.

3.2.4.11 Complete a checklist on the condition of major elements in the reading room; for example, display locations, room lights, desk lights, curtains).

3.2.4.12 Record the nominal ambient light value on the form.

3.2.4.13 Draw the room layout on the form.

3.2.4.14 Post the form in the reading room so that it is available for the radiological technologist’s daily Viewing Conditions Check.

3.2.4.15 Restore the image viewer and toolbar to the normal size on each display (if shown).

The ambient light level must not exceed 20 lux. The measured value must be stable over one minute, with a tolerance of ± 5 lux over the measuring time with regards to the nominal lighting value. 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 Dome diagnostic imaging display.


3.3 Display Calibration3.3.1 FrequencyConduct the display calibration at least annually.

3.3.2 ObjectiveThe display calibration is to ensure that the display is calibrated for the reading of mammographic images on the Dome diagnostic imaging display.

NOTE: You must power on the Dome diagnostic imaging display at least 30 minutes before doing any measurements. This is mandatory to ensure that the backlight heating has reached steady state.

3.3.3 Equipment requiredThe following items are required for the display calibration.• Dome diagnostic imaging display system with graphics controller




• Calibrated external photometer

• Chart of baseline luminance levels


3.3.4 ProcedureNOTE: For this procedure you must be logged on as a Privileged user.

3.3.4.1 Click the Dome CXtra icon on the task bar and ensure that Privileged User is checked in the CXtra Services menu. If you are logged on as a Nonprivileged user, click Privileged User and enter the logon password. (If you cannot log on as a Privileged User, speak with your IT representative.)

• Verify the current luminance level settings. (Click the Dome CXtra icon on the task bar and select RightLight Panel Configuration from the menu.)

NOTE: The luminance levels are shown for the displays selected. If the values are different from the desired levels, select the proper value in the Target Luminance field and click Apply.

• Click the Calibration tab. Verify that check box next to DICOM Response is checked. Log the luminance values set for each display on the form Medical Physicist Medical Physicist Display Calibration Check.

• Click OK to exit the dialog.

Illustration 3. RightLight Panel Configuration dialog.


• Install the external photometer into an available USB slot, either on the back of the display stand or on the computer.

• Verify the DICOM conformance for each display. To do this, place Dome CXtra into manual conformance test mode.

• Click the Dome CXtra icon on the task bar and select RightLight Conformance > External Sensor Conformance Wizard from the popup menu.

• Follow the wizard instructions. (The conformance wizard moves through a number of center screen targets that are measured with the photometer on each display. When completed, the wizard shows a success dialog box if all measurements fall within DICOM tolerances. The results are automatically entered into the Reporting History log and the Conformance History log.)

Illustration 4. RightLight External Sensor Conformance Wizard for performing conformance tests.


If the manual conformance test produces a warning condition, the display is not in DICOM conformance. Speak with your IT representative or rerun the wizard.

3.3.4.2 Check the Current Conformance status. To view the results of your latest manual conformance test, open the RightLight Current Conformance Status dialog. Click the Dome CXtra icon on the task bar and select RightLight Conformance > Current Conformance Status from the menu. You can also view the results of the latest automatic conformance test in this dialog.

Illustration 5. RightLIght External Sensor Conformance Wizard for viewing or saving conformance test results.


3.3.4.3 Review or print conformance events:• Open the Dome CXtra services menu and click Reporting.

• Click the History tab to view a list of events. The conformance test just performed is listed at the top. Any automatic polling that has occurred since the conformance test was run also appears.

• Click Print List to output the report. Attach the report to the display forms.

Illustration 6. RightLIght Current Conformance status dialog.

Illustration 7. Event log on the History tab of the Reporting dialog.


3.3.4.4 Review the Manual Conformance data. To see a detailed account of a manual conformance event and to print a report, do the following:

• Click the Dome CXtra icon on the task bar and select RightLight Conformance > Conformance History from the menu. Select the Graphs tab.

• Choose the display desired and verify the test date and time selected. The Response graph consists of the luminance values specified by the DICOM standard and the luminance values measured during the conformance test. The closer the data points align with the curve, the better the DICOM conformance.

• Click Print Graph for an output of each display tested. Attach the report to the display forms.

• Click OK when finished to exit the procedure.

Illustration 8. Response graph.


3.4 Image Quality of SMPTE Pattern3.4.1 PrerequisiteComplete the preceding procedures for Viewing Conditions Check and Setting and for Display Calibration before you perform this test.

3.4.2 FrequencyConduct an image quality of the SMPTE pattern at least annually.

3.4.3 ObjectiveThe quality control of the SMPTE pattern is to ensure the display is calibrated and the brightness and contrast settings are at an appropriate level for the reading of mammographic images on the Dome diagnostic imaging display.

3.4.4 Equipment requiredThe following items are required for the evaluation of image quality.• Dome diagnostic imaging display system with graphics controller




NOTE: When performing this test, follow the instructions given below precisely so that Dome CXtra is the source of the SMPTE pattern and not the image viewer.

These tests and associated specifications were designed to be performed with the SMPTE pattern that is accessible through Dome CXtra. Using any other pattern, particularly a pattern that is displayed with the usual image viewer tool, could result in failing the test and being out of compliance with the requirements of this test.


3.4.5 Procedure3.4.5.1 Check to ensure that the Dome CXtra icon on the task bar is

verifying that the software is operational and that the display is calibrated.

3.4.5.2 Click the Dome CXtra icon and select Test Patterns > View Test Patterns to open the Display Test Patterns dialog.

3.4.5.3 Click the plus sign (+) beside Miscellaneous to list the test patterns and then select SMPTE. The pattern appears on both displays.

3.4.5.4 Examine the image carefully for the following features:

• Verify that the 0%-5% contrast is visible (area 1 on Illustration 1, page 10).

• Verify that the 95%-100% contrast is visible (area 14).

• Verify that each gray level step from 0% to 100% can be distinguished from the adjacent squares. Verify that you can, for example, distinguish the 0% square from the 10% square or the 90% square from the 100% square (areas 2 to 13).

• Verify that the alphanumeric characters that appear on the pattern are sharp and in focus. For example, examine the “%” signs that label the steps of the gray scale. (See Illustration 2, detail of the SMPTE pattern, on page 10).

• Verify that the high contrast line-pair images at the center and corners of the SMPTE pattern are distinguishable (areas A to E of Illustration 1).

NOTE: The SMPTE pattern shown via the Dome CXtra software has five sets of high-contrast and five sets of low-contrast line-pair patterns. One set of each is in the center of the image, and one set of each is in each corner of the image. The high-contrast patterns have frequencies of 3- pixels-on/3-pixels-off, 2-pixels-on/2-pixels-off, and 1-pixel-on/1-pixel-off. At each frequency, there is a set of line-pairs oriented in the horizontal direction and a set oriented in the vertical direction. Visibility of the low-contrast patterns is not evaluated in this test.


3.4.5.5 Record the results on the form Image Quality of SMPTE Pattern (see page 31) or on the form your facility uses.

3.4.5.6 Repeat step 3.4.5 for any Dome diagnostic imaging display used for mammography readings.

3.4.5.7 To remove the SMPTE image and return to normal viewing mode, close the dialog.

The 0%-5% contrast and the 95%-100% contrast shall be visible and each step from 0% to 100% shall be distinguishable from the adjacent ones.

The alphanumeric characters shall appear sharply focused.

The high-contrast line-pair patterns representing 3-pixels-on/3-pixels-off and 2- pixels-on/2-pixels-off must be distinguishable at the center and the corners of the display for both the horizontal and vertical orientations of the line-pair patterns. The high-contrast line-pair patterns representing 1-pixel-on/1-pixel-off must be distinguishable at the center and the corners of the display for the horizontal orientation of the patterns. Failure to distinguish the 1-pixel-on/1-pixel-off, high contrast, vertical line-pair patterns does not constitute failure of the test.

The ability to distinguish the low-contrast line-pair patterns is not a requirement for this test.



3.5 Visual Inspection for Display Defects3.5.1 FrequencyConduct the visual inspection during system acceptance and when necessary to isolate artifacts.

3.5.2 ObjectiveThe inspection is to determine if artifacts observed during system inspection can be attributed to the Dome diagnostic imaging display.

3.5.3 Equipment RequiredThe following items are required for the inspection of display defects.• Dome diagnostic imaging display system with graphics controller




3.5.4 Procedure3.5.4.1 Record the results from the following steps on the form

Analysis of Dome Display Screen Defects (see page 32) or on the form your facility uses.

3.5.4.2 With the displays off or in the dark state, view for scratches and gouges. Record on the form those that are not admissible for mammography reading.

3.5.4.3 With displays turned on, prepare the displays for the inspection of dots and debris. You can do this by using the Windows Desktop popup menu.

3.5.4.4 Place the cursor anywhere on the desktop. Right-click to open the popup menu and select Properties. Record the existing background selected for later reference.

3.5.4.5 Select None for background setting and select the color Black from the pull-down color palette. Click OK. All screens should display Black.


3.5.4.6 At a normal viewing distance (approximately from 13 to 20 inches) inspect each panel for visible white dots and other foreign debris. Record on the form those that are not admissible for mammography reading.

3.5.4.7 Place the cursor anywhere on the desktop. Right-click to open the popup menu and select Properties.

3.5.4.8 Select the color White from the pull-down color palette. Click OK. All screens should display White.

3.5.4.9 At a normal viewing distance (approximately from 13 to 20 inches) inspect each panel for visible black dots and other foreign debris. Record on the form those that are not admissible for mammography reading.

3.5.4.10 Place the cursor anywhere on the desktop. Right-click to open the popup menu and select Properties. Select the original background and click OK.

This completes the QA procedures for the Dome diagnostic imaging display.


4.0 References

DocumentsTitle Description

21CFR900.12 Quality standards.

DICOM Part 14 Grayscale Standard Display Function.

AAPM TG18 Assessment of Display Performance for Medical Imaging Systems.

European Commission, in cooperation with EUREF, EBCN, and EUSOMA

European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis.

JESRA X-0093 Quality Assurance (QA) Guideline for Medical Imaging Display Systems.

FDA MQSA Help FDA MQSA Policy Guidance Help System.

(http://www.fda.gov/cdrh/mammography/robohelp/START.HTM)

ACR Mammography Accreditation Program

The FDA has designated the American College of Radiology (ACR) as an accrediting body for both screen-film and full-field digital mammography units.

(http://www.acr.org/accreditation/mammography/mammography.html).

ACR Personnel, Testing, and QC forms

Mammography Personnel, Testing and QC Forms.

(http://www.acr.org/accreditation/mammography/mammo_qc_forms.html).

Diagnostic Imaging Display | 25

Definitions

Mammo Application package

New Mammography facility application package. These documents are for new mammography facilities that have never applied with the American College of Radiology for mammography accreditation.

(http://www.acr.org/accreditation/mammography/facility_package.html)

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.

Term Definition

MQSA Mammography Quality Standards Act.

lux One lux is the illuminance at the same point at a distance of 1 meter from the source. One lumen uniformly distributed over 1 square foot of surface provides an illumination of 1 foot-candle.

Title Description


5.0 Evaluation Forms

Radiological Technologist Display Calibration Check

Facility: Room:

Date: Initials:

Dome Display System Left Display Right Display

0% to 5% contrast

95% to 100% contrast

Gray steps

Alphanumerics

Line-pair images (center)

Line-pair images (corners)

Does the CXtra icon in the task bar indicate “operating normally”?

____Yes ____ No


Site and System Summary

Facility:

Address:

Date of Installation:

Date of Survey:

Room ID:

Display Serial Number

Left

Right

Medical Physicist:

Signature: Date:


Viewing Conditions Check and Setting

Facility:

Room:

Date:

Room Description

Display location:

Room lights:

Desk lights:

Others:

Room Trait

Ambient light value:

Layout:

The ambient light level must not exceed 20 lux. The measured value must be stable over one minute (with a tolerance of ± 5 lux over the measuring time with regards to the nominal lighting value). 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 Dome diagnostic imaging display.

NOTE: Confirmation of this value is not part of the daily check by the radiological technologist.


Medical Physicist Display Calibration Check

Facility: Room:

Date: Initials:

Dome Display System Left Display Right Display

Luminance value setting

Evaluation

Does the CXtra icon in the task bar indicate “operating normally”? ____Yes ____ No

Is the Manual Conformance report for both displays attached? ____Yes ____ No

Is the DICOM calibration graph for both displays attached? ____Yes ____ No


Image Quality of SMPTE Pattern

Evaluation Left Display Right Display

Is the 0%-5% contrast visible?

Is the 95%-100% contrast visible?

Is each gray level step of the pattern distinguishable?

Are alphanumeric characters sharply focused?

Are line pair images in center distinguishable?

Are line pair images in corners distinguishable?

Bleeding (gray levels degradation)?

Other?

Comment

Medical Physicist:

Signature: Date:

The SMPTE test pattern, low contrast targets and all gray level squares must be discernible. The alphanumeric characters shall appear sharply focused. The high-contrast line-pair patterns representing 3- pixels-on/3-pixels-off and 2-pixels-on/2-pixels-off must be distinguishable at the center and the corners of the display for both the horizontal and vertical orientations of the bar patterns. The high-contrast line-pair patterns representing 1-pixel-on/1-pixel-off must be distinguishable at the center and the corners of the display for the horizontal orientation of the bar patterns.

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 Dome diagnostic imaging display.


Analysis of Dome Display Screen Defects

Artifact Left Display Right Display

Visible scratch

Visible black point

Visible white point

Other

Description of artifact

Medical Physicist:

Signature: Date:

If an artifact or nonuniformity is present and is expected to mimic or obscure clinical information, the source of the problem must be identified and corrective actions taken within 30 days of the test date.



Index

Ccleaning screen 2Ddefinitions 26display cleaning 2document references 25

Eevaluation forms 27

Fforms 27

analysis of screen defects 32image quality of SMPTE pattern 31physicist display calibration check

30radiological display calibration

check 27site and system summary 28viewing conditions check and

setting 29

Mmaterials/equipment 1

Pphysicist testing 11

display calibration 14evaluating SMPTE pattern 20inspecting display defects visually

23viewing conditions 12

Qquality control testing

materials/equipment 1overview 1physicist tests 11radiologist tests 2

Rradiological testing

display calibration 6viewing conditions 4

radiological tests, running 2references 25

Sscope 1Ttesting scope 1

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