site quality control instructions - tmist qc · acr personnel must always refer to and ... 3.1...

Document ID: EA1151 TMIST MRT QC Manual Version: 3.4.4.1 Effective Date: 24 January 2020

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Printed and unapproved copies of this document are not considered official versions. ACR personnel must always refer to and follow the current official signed PDF version from the ACR central document repository or signed hard copy on file in the department. Disclaimer: This document is PROPRIETARY and ONLY available to ACR personnel and third parties subcontracted by the ACR for business purposes. Third party distribution without permission is prohibited

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ECOG-ACRIN

Tomographic Mammography Imaging Screening Trial

EA1151

Mammography Quality Control

Site Quality Control Instructions

DISTRIBUTION: All participating TMIST sites

Consultants:

M. Yaffe, Sunnybrook Research Institute, University of Toronto, Canada

A. Maki, Sunnybrook Research Institute, Canada

G. Mawdsley, Sunnybrook Research Institute, Canada

S. Shen, Sunnybrook Research Institute, Canada

J. Mainprize, Sunnybrook Research Institute, Canada

Physics Quality Control Core (PQCC)

[email protected]

www.TMISTQC.org

416 480 5724

mailto:[email protected]

http://www.tmistqc.org/


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Version # Revision Description Author Effective Date

1.0 New Policy Aili Maki 11-Apr-2016

2.0 Substantial rewrite E. Pisano/Gord Mawdsley 27-Apr-2017

3.0 Update after Physics SOP completed

Gord Mawdsley 6-June-2017

3.1 Improved connectivity instructions Gord Mawdsley 22-Nov-2017

3.2 Minor revisions, added detector replacement procedure and credentialing instructions

Gord Mawdsley 20-Mar-2018

3.3 Minor revisions, clarification for Annual QC

Gord Mawdsley 25-Oct- 2018

3.4 Edits to align with newer protocol where raw projections are optional.

Aili Maki 23-Jan-2019

3.4.1 Changed email address to TMISTQC.org from TMIST.org

Gord Mawdsley 14-Mar-2019

3.4.2 Modified to include foreign sites and ACR tomo QC program

Gord Mawdsley 28-May-2019

3.4.3 Modified to include gold status Gord Mawdsley 28-Oct-2019

3.4.4 U New Mexico review Gord Mawdsley 20-Nov-2019

3.4.4.1 Fix erroneous figure Aili Maki 24-Jan-2020


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Table of Contents

1 PURPOSE.......................................................................................................................... 5

2 BACKGROUND ............................................................................................................... 5

3 OUTLINE OF QC TESTS ................................................................................................ 5

4 RESPONSIBILITIES OF THE MAMMOGRAPHY QUALITY CONTROL

(MQC) TECHNOLOGIST ................................................................................................ 7

5 LIST OF TECHNOLOGIST/RADIOGRAPHER’S QUALITY CONTROL

TESTS ............................................................................................................................... 8

5.1 Gold Status .......................................................................................................... 9 5.1.1 Qualifying a Machine as “Gold Status” .................................................. 9 5.1.2 Loss of “Gold Status” (return to Weekly QC)....................................... 10

5.1.3 Regaining “Gold Status” ....................................................................... 10

6 VARIANCES .................................................................................................................. 10

7 WEEKLY TESTS (MONTHLY FOR GOLD STATUS) ............................................... 15

7.1 TMIST QC Phantom – Tomosynthesis Mode................................................... 16 7.2 Artifact Evaluation and SDNR – 2D Mode ...................................................... 20

8 MONTHLY TESTS (NOT REQUIRED FOR GOLD STATUS MACHINES) ............ 24

8.1 Tomosynthesis Artifact Evaluation ................................................................... 24

8.2 Gold Status ........................................................................................................ 26

9 ANNUAL TESTS ........................................................................................................... 27

9.1 AEC Evaluation ................................................................................................. 27 9.2 Resolution Evaluation ....................................................................................... 30 9.3 Noise– Tomosynthesis Mode ............................................................................ 32

9.4 Ghosting ............................................................................................................ 33 9.5 Slice Evaluation – Comprehensive ................................................................... 35

10 IMAGING EQUIPMENT ............................................................................................... 40

11 TMISTQC WEBSITE QUICK-START .......................................................................... 43

12 TMIST IMAGE TRANSFER SETUP ............................................................................ 44

12.1 Image types required ......................................................................................... 44 12.2 Image Submission ............................................................................................. 45 12.3 TRIAD Setup ..................................................................................................... 45 12.4 Setting up the Mammography Units: ................................................................ 46


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12.4.1 Hologic .................................................................................................. 46 12.4.2 GE Setting up a new host on an Essential ............................................. 48

13 EA1151 CREDENTIALING INSTRUCTIONS ............................................................. 52

13.1 CREDENTIALING IMAGE SUBMISSSION REQUIREMENTS ................. 52 13.2 2D IMAGE ACQUISITION ............................................................................. 53 13.3 3D TOMO IMAGE ACQUISITION ................................................................ 54 13.4 CREDENTIALING IMAGE UPLOAD VIA TRIAD ...................................... 55


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1 PURPOSE

This document sets out the procedures used by the site technologist for the TMIST QC

Physics QC Program and actions to be taken if results are not within standards. Some of the

tests and reporting procedures are specific to TMIST and in some cases are additional to

requirements under federal standards.

2 BACKGROUND

TMIST seeks to evaluate the contribution of digital breast tomosynthesis (TM) compared to

digital mammography (DM) for breast cancer screening. To ensure that the findings of the

trial reflect the capabilities of the two types of technologies it is important that all equipment

is operated within appropriate levels with respect to both image quality and dose.

The American College of Radiology (ACR) has recently introduced a standardized QC

program; however, at present, it is not used by all facilities, many of whom elect to use the

QC program developed by the unit manufacturer. Therefore, there is no way to test

performance consistently across systems.

The TMIST QC program was designed specifically for TMIST. It is complementary to

existing federal requirements in the United States in that it is designed to allow consistency in

testing of the physical aspects of imaging performance across systems, as well as within

systems from a given manufacturer and over time.

3 OUTLINE OF QC TESTS

All quality control tests for the DM and TM units as well as for review workstations required

to maintain accreditation are to be performed by the site technologist and site Qualified

Medical Physicist to ensure that image quality and accreditation are maintained.

To harmonize the quality control across sites and vendors, a limited number of QC images

taken in patient imaging mode is required. The images are automatically analyzed by the

Physics Quality Control Core (PQCC) server, and if a variance is detected, the PQCC will

assist in determining an appropriate plan of action to resolve of the variance.

Images for the QC tests are to be sent to the TRIAD server as soon as acquired and to be

uploaded as Site Qualification images. They will be analyzed by the PQCC, and results will

be available for viewing on the TMISTQC.org website.

Weekly

The automated evaluation of SDNR in the DM mode is required on all TM and DM units that

may be used to image TMIST participants.

For TM imaging, the TMISTQC phantom is imaged weekly by the technologist in the TM

mode and submitted to the TMIST Physics Core for image analysis.


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The images of the QC tests are to be reviewed on the technologist’s monitor, and results of

the analysis are to be viewed by the technologist on the QC website, to verify that all

measured parameters are in their expected operating range.

Monthly

One TM volume is to be taken of a uniform block using every available target/filter

combination, and sent through TRIAD, using the Site Qualification setting.

Annually

In addition to the regularly scheduled Annual Medical Physics Survey, annual “performance

evaluation” tests will be performed by the technologist. A set of phantoms will be couriered

to the site where-upon the phantoms will be imaged, and submitted to the TMIST Physics

Core using TRIAD.

Identifying images

We have suggested naming conventions for the QC images in order to make it easier to find

the correct images for uploading.

Since an accession number is required for most units, we suggest using an ID number

including the date and unit such as 99211UYYMMDD, with U being the unit identifier, after

ensuring that a numbering scheme such as this will likely not cause

PACS problems. Using an image numbering system that tracks your QC images over time in

a consistent manner will allow you to find your QC records more easily.

QC Actions and Follow-up

As described in the following sections, each test in the QC program has a specified tolerance

level for achievable and acceptable results. Should the results of a test fall outside the

specified acceptable tolerance, the test should be repeated to confirm the result before

corrective action is taken. Diagnosis and follow-up is discussed in further depth in Sections 6,

7 and 8. In no case should the facility continue to perform mammography if the equipment

has a Critical Variance because the diagnostic value of the procedure and/or its safety may be

considered unacceptable.

Tests have differing levels of “Criticality” and results are categorized into three levels with action levels and responses described in the following sections:

Critical Variance

Noncompliant

Full Compliance


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Initial indication of a variance could occur because of an intended change in operation,

improper performance of test or because of a problem.

Note that an apparent variance (exceeding limits) may result from the use of:

a different compression plate

variable compression pressure

a different image size

automatic selection of kV

different positioning of phantoms

use of different reconstruction algorithms or reconstruction setting parameters

equipment being serviced or adjusted since baseline setting or new baseline set

improper performance of test.

Before a variance is declared, repeating the test is important, ensuring that attention is paid to

the list above.

If one of the above reasons is determined to be the cause of an out of limit warning, proper

documentation of the reason for initial variance (comment on the website and/or email to

[email protected]) will allow us to tag the erroneous data point as a “removed data point –

with explanation”

4 RESPONSIBILITIES OF THE MAMMOGRAPHY QUALITY CONTROL

(MQC) TECHNOLOGIST

Responsibility for QC should be assigned to a mammography technologist with QC training.

The MQC Technologist is responsible for:

Ensuring that Weekly, Monthly and Annual QC tests are performed in a punctual

and consistent manner.

Monitoring the QC web site to ensure that the imaging performance is acceptable.

The TMIST QC website provides rapid feedback to the MQC technologist

through a display of most image quality parameters without the requirement of

analysis or graph plotting by the technologist

The QC technologist should review the website within 1 hour after submission of

QC tests. Both the 2D and 3D test results should be reviewed, and the thumbnail

images given a “Pass”, “Marginal” or “Fail” rating. In the event of image

transmission/processing delays, the QC system will send a reminder email if there

are any test results that have not been reviewed on the website a few hours after

results are available. QC data must be reviewed within 1 business day. Variances

which are outside limits will be displayed in RED, with an email being sent to the

MQC technologist at the site. The PQCC will follow up by cell phone or email

within 24 hours of the occurrence of a Critical Variance.

To respond to problems identified on the web site or in an email from the PQCC

by entering information in the “Comment” area on the web site


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Responding to emails and phone calls from PQCC describing how variance will

be or has been addressed.

Being the contact point for the TMIST PQCC.

Acting as a resource to the Lead Interpreting Physician (LIP).

Ensuring that the facility has current copies of pertinent ECOG-ACRIN and

TMIST documentation and, standard operating procedures (SOPs) dealing with

mammography to include: accreditation requirements, equipment QC, and

proficiency programs.

Providing input, as appropriate, to correct deficiencies noted during weekly QC

and to ensure that the noted deficiencies are addressed appropriately to ensure

correction and compliance.

Providing the TMIST QC core with reports of the annual physics survey including

supporting documentation for each unit being used for TMIST, throughout the

duration of the study. This is the same report that is already provided to the site by

a qualified physicist at sites under the Mammography Quality Standards Act

(MQSA). Sites outside of the USA and Canada should supply a sample annual

physics survey so PQC Core can determine if it is substantially equivalent.

Providing the TMIST QC core with a physics or service engineer’s testing report

after generator, tube or detector changes. For generator and tube changes, this

report must contain measurements of tube output and Half-Value Layer.

Notify the TMIST QC core of any Preventive Maintenance visits so baselines can

be changed if warranted (i.e. minor adjustments are made to the automated

exposure control or tube output, or software is updated).

Informing PQCC of changes in contact information or equipment changes.

5 LIST OF TECHNOLOGIST/RADIOGRAPHER’S QUALITY CONTROL TESTS

A description of performance of the technologist’s QC tests is provided in the next few

sections. Assistance is available by e-mail at [email protected]. Video demonstrations are

available at www.tmistqc.org in the “help” section. Click on the word “help” below the blue

login button.

Table 1. List of technologist’s quality control tests

Test Mode Frequency (regular units)

Frequency (Gold Status units)

Number of Exposures per unit

TMIST QC Phantom TM Weekly Monthly 1

Artifacts, SDNR DM Weekly Monthly 1

TM Artifact Test TM Monthly Not 1-3


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Test Mode Frequency (regular units)

Frequency (Gold Status units)

Number of Exposures per unit

Required

AEC Evaluation TM Annually Annually 4

Resolution Evaluation TM Annually Annually 1

NPS Evaluation TM Annually Annually 1

Ghosting Evaluation TM Annually Annually 2

Slice Evaluation TM Annually Annually 8

5.1 GOLD STATUS

Machines that continue to demonstrate QC stability and good compliance with the TMIST

QC program will allow the site to reduce the amount and frequency of the TMIST QC on

those machines.

“Weekly” Artifacts and SDNR test will be performed monthly

“Weekly” TMIST 3D and TMIST Synthetic 2D test will be performed monthly

“Monthly” TM Artifact tests will not be required.

Gold Status is conferred on an individual machine basis, not by site.

5.1.1 Qualifying a Machine as “Gold Status”

TMIST weekly QC must be promptly and consistently submitted and reviewed for one

calendar year.

No TMIST cases have been imaged on the machine when it is in “Action Required” or

“Under Maintenance/On Hold” state.

Allowed exceptions for timely weekly submission and review:

When a site requests a machine be put “Under Maintenance/On Hold” (this can be

done by emailing ([email protected]) or phoning TMIST PQCC)

Delays in submission due to network/technical problems (e.g. slow internet transfers

causes a test to show up 6 or more hours after image submitted via TRIAD)

Delays in ingestion of data from the TRIAD server to the ECOG-ACRIN TMIST

server

Any “Failed” test points (points outside a Critical Threshold) are commented on the website

and a passing test point submitted within 2 business days.

QC performance indicators must be “stable”

No trends up or down for these parameters:

SDNR


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Dose

Calcification Slice Height (all groups)

A “trend” is a steady change upwards or downwards in a plotted value over 3 months or

more.

When the site thinks a unit has achieved “Gold Status”, they should request a review by

PQCC ([email protected]).

5.1.2 Loss of “Gold Status” (return to Weekly QC)

If a machine ceases to be “Stable” or to have good compliance within the QC program, it will

be put back onto weekly QC schedule

2 or more “Failed” QC data points, no clear documentation (comments) on the

website and/or without a passing re-shoot within 2 business days.

Clear and consistent upward or downward trend over 3 months for any parameter with

“Fail” (red) limits

If QC is not submitted and reviewed consistently, the machines will be put back onto weekly

QC - either

2 or more “Overdue QC” emails not due to ACR/TRIAD or PQC Core software

malfunction

2 or more “Unreviewed QC” emails for QC when unit not on hold and not due to

“late” processing and posting of QC by PQC Core

5.1.3 Regaining “Gold Status”

Submit all service reports for adjustments made to equipment

Demonstrate stable QC behavior for 3 months

Any failed test points have an explanation/comment

Passing re-shoot within 2 business days

No trends over the 3 months

Demonstrated timely submission and review of weekly QC for 3 months

No Overdue QC emails except for ones aligned with monthly QC submission week, or ones

due to ACR/TRIAD or PQC Core software problems

6 VARIANCES

In Sections 7, 8 and 9, the performance of each of the above tests is described and a detailed

list of performance standards and action limits is included, along with the response required

for each variance. The limits indicated are based on limited experience with some vendor


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equipment and may need to be adapted if required by system changes. The PQCC website

will display up-to date limits.

Critical Variance

These are the most serious variances. When they are identified, the quality of mammography

may be compromised which may affect TMIST image interpretation.

A Critical Variance is only registered if, after repetition of the QC test, and discussion with

PQCC, going through a diagnostic process to determine if the baseline needs to be reset, the

system again registers a test point with values outside one or more Critical Operating

Thresholds.

Failing to reshoot a “Failing” test with results outside Critical Threshold(s) within one

business day when a critical threshold is crossed counts as a Critical Variance.

Subject imaging may not continue on the mammography DM or TM unit that generated the

Critical Variance result until the Critical Variance is corrected. TMIST QC core will provide

assistance to the MQC technologist in determining the best course for remediation of the

problem.

After corrective action is taken and documented on the TMISTQC website, the test that

yielded a Critical Variance should be performed two times, with either noncompliant or fully

compliant results. Duplicate testing allows the TMIST QC core to assure that the system

problems yielding the Critical Variance have been corrected. Only after results of these two

repeat tests are recorded should TMIST subjects again be imaged using the system that

yielded the Critical Variance result.

Noncompliant Variance

Noncompliant Variances (marginal) are those that would not be expected to seriously impact

diagnostic performance but where image quality may be reduced somewhat or where subject

doses are higher than optimal.

A Noncompliant Variance is only registered if upon repetition of the QC test, the system

again registers results outside the threshold for compliance.

Corrective action should be taken as soon as possible after a noncompliant variance is

recorded, but subject imaging may continue using the machine that yielded the noncompliant

results. All corrective actions taken must be documented on the TMISTQC website. If

needed, TMIST QC core will provide assistance to the MQC technologist in determining the

best course for remediation of the problem. Ideally, the noncompliant test result should be

corrected within 14 days of being recorded.


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By resolving the non-compliance, image quality will be at an optimal level, rather than at a

barely acceptable level.

No Variances - Full Compliance

The system meets TMIST mammography standards. No action is required.

Initial Response to a Variance

Most variances are likely to be Noncompliant Variances caused by incorrect imaging

technique or administrative error. Critical Variances are expected to be extremely rare in

TMIST.

Problems will most likely be detected either by the site technologists when the images are

produced (in the case of the weekly and monthly tests) or by the PQCC staff (in the case of

the annual and DICOM header tests), when analyzing the test results.

If a variance is detected by the site technologist during performance of QC tests:

The test should be immediately repeated to ensure that there is not a procedural error.

The website should have the “variance” recorded, with comments on how the

presumed variance was corrected. This data point may be “hidden” by PQCC if it was

not image quality related.

A corrective action plan should be prepared and implemented by the site.

If a problem is detected by a site technologist during subject imaging:

Appropriate QC tests should be performed to identify the problem.

The website should have the incident recorded, with comments on how the presumed

variance was corrected.

The PQCC should inform ACR Core Laboratory to perform a Directed IQA.

The Site Research Associate should be informed by the MQC technologist and

requested to enter a brief description of the problem and actions taken for resolution

on the TMIST client imaging form T0 – T5.

If a site MQC technologist or imaging technologist identifies a CRITICAL variance after

repeat testing, the person who noted the Critical Variance should immediately inform the site

RA and other site personnel that subjects cannot be imaged using the machine that yielded

that variance until the variance is corrected – a small sign placed on the console that indicates

“out of TMIST service” can be useful. In addition, for a CRITICAL variance, the MQC

technologist should contact the PQCC by phone and, if necessary, their local service support

to discuss a corrective action plan.

If a variance is detected by the QC Physics Core:


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The MQC technologist at the site and a PQCC staff member will be automatically contacted

by e-mail indicating that a variance has been detected within an hour of the abnormal test

result.

PQCC personnel will check the web-site to see if the technologist has repeated the test.

If the new results are acceptable and properly documented, no further action is required. The

original “bad point” will be no longer be displayed on the QC chart.

If there is a Critical Variance, PQCC will evaluate its severity, and contact the site

MQC technologist, ACR Core Laboratory and TMIST Study Chair Liaison and the

TMIST Study Chair who will follow up as described in Sections 13, 14 and 15.

For Critical Variances,

The equipment should be removed from use in imaging TMIST subjects until the

problems have been corrected. Local policies will determine whether non-TMIST

imaging should be performed on that unit. Of course, other available TMIST-qualified

DM and TM units can be utilized to image TMIST subjects until the machine that had a

Critical Variance test result again qualifies for TMIST subject imaging.

For Noncompliant variances,

Depending on the nature of the problem, the following additional steps may be required to

solve and/ or mitigate the problem:

(a) Initiating repairs or calibration;

(b) Re-reading mammograms;

(c) Providing additional documentation;

(d) Implementing further corrective action; or

(e) Ensuring additional staff training, as deemed appropriate

Corrective action will be documented by both the site MQC technologist and the Physics QC

core personnel on the website.

DICOM image header anomalies will immediately be sent to ACR Core Laboratory who will

perform a Directed IQA to evaluate the clinical images for the identified study ID and

communicate any problematic findings to the Study Chair Liaison. Detector Temperature

variances will be communicated immediately to the MQC technologist after the DICOM

header is determined to be out of limits. This will occur after the RA has uploaded the subject

images.

Corrective Action Plan

If a Critical Variance occurs, the MQC technologist must prepare a written response, on the

TMISTQC website, outlining the site’s corrective action plan that will be implemented in


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correcting the problem. After the corrective action plan is completed and the QC test is

brought back into compliance, any variations from the corrective action plan should be noted.

(1) A corrective action plan consists of:

(a) A written narrative describing the investigation of the variance(s),

including the conclusions as to the cause(s) of each unacceptable result;

(b) Specific actions taken to prevent recurrence; and

(c) Evidence that the problem has been corrected.

(2) The site may continue to perform TMIST DM/TM with a noncompliant

variance while corrective action is being reviewed and implemented, unless

otherwise directed by TMIST Study Chair.

b. If DM or TM imaging has been discontinued due to a Critical Variance test result,

resumption of TMIST imaging may only be authorized once the retesting yields

results that are no longer yielding a Critical Variance.

Potential Corrective Actions for QC Test Variances

Weekly Testing (Monthly for Gold Status Machines)

DM Tests

Test Type Possible Reason Possible corrective action

SDNR, mAs, Dose,

Background Signal

AEC change Check AEC settings, Service

SDNR, mAs, Dose,

Background Signal

Underlay improperly

positioned

Position correctly and re-shoot

SDNR, mAs, Dose,

Background Signal

Tube Output change Service

SDNR, Background

Signal

Software change Confirm with service, have PQC Core

trigger new baselines

Visual Inspection Dirty Bucky Clean

Visual Inspection Dirt on Filter Service

TM Tests


SDNR, mAs, Dose AEC change Check AEC settings, Service

SDNR, mAs, Dose Tube Output change Service

FWHM of point Gantry angle sensor Service

Spec slice level Gantry angle sensor Service

Radial average NNPS Grid, Software Service

SDNR, FWHM of

point, Radial average

NNPS


trigger new baselines.


Visual Inspection Dirt on Filter Service


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Synthesized 2D Tests


SDNR, mAs, Dose AEC change Check AEC settings, Service

SDNR, mAs, Dose Tube Output change Service

SDNR, FWHM of

point, NNPS


trigger new baselines.

FWHM of point Gantry angle sensor Service

Radial average NNPS Grid, Software Service

Monthly Artifact Test (Not Required for Gold Status Machines)

TM Tests


NNPS AEC change Check AEC settings, Service

NNPS Tube Output change Service


Annual Tests – TM

If any tests performed during Annual testing on the Tomo units have variances identified,

PQCC will provide recommendations and assistance in achieving appropriate corrective

action. Some tests do not have scientifically established limits or target values, and we will

track these through the TMIST study in order to determine their efficacy in a QC program.

Corrective action will be documented by both MQC and Physics support on the website.

Written narratives describing the investigation of the variance(s), the conclusions as to the

cause(s) of each unacceptable result, specific actions taken to prevent reoccurrence, and

evidence that the problem has been corrected.

7 WEEKLY TESTS (MONTHLY FOR GOLD STATUS)

The TMIST QC phantom is imaged every operational week (or month, for Gold Status

machines) as an RCC view on every TM unit used in TMIST, with a) the reconstructed

volumes and b) any synthetic 2D version (if available) being submitted to the TMIST physics

core using TRIAD. An underlay is imaged with the flat-field phantom in conventional (DM)

mode on every TM and DM unit used in TMIST and the processed mammogram is submitted

to the TMIST physics QC core using TRIAD. Automated calculations will take place to

determine pass / fail for all of the tests.

For DM systems, an underlay is added to the weekly (monthly for Gold Status) flat-field

image for every DM unit used in TMIST.


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The same exposure mode and large paddle should be used for the tests. Changing from

large to small, or from fixed to flex paddle can change operation enough that the test

results become inconsistent and go outside control limits. If the kV and filter change,

QC results will not pass. If that occurs, the site should use a fixed kV and filter

technique for QC. The technique and paddle to be used should be posted in the

mammography room for reference.

7.1 TMIST QC PHANTOM – TOMOSYNTHESIS MODE

7.1.1.1 Scope

Objective: To monitor consistency of imaging performance (e.g. variations in detector

performance) in terms of factors that affect dose and image quality. Comparison is

made with baseline performance levels.

Note that the analysis of the TMIST phantom is performed by PQCC software. The

technologist’s role is to submit the reconstructed volume and act appropriately upon

reviewing the test results.

7.1.1.2 Instrumentation

TMIST QC Phantom (see Figures 1, 2 and 3).

7.1.1.3 Methodology

1. Open a test client exam (Last Name = TMISTQC; First Name = TOMO; Middle Name =

MONTH). It is advisable to create a new patient for each month to ensure that too many

image studies do not accumulate under one patient name, which can cause difficulties

with some PACs.

2. Set the unit to its TM mode and the AEC mode most commonly used clinically for TM.

For units with a selectable “photocell” position, the same position should be used for all

QC images to maintain consistency.

3. If different reconstruction modes are available, the same reconstruction setting(s) should

be used each day. The reconstruction setting most commonly used to acquire patient

images should be posted in the mammography room for reference.

4. Place the QC phantom on the breast support centered left-right, pushing the lip against the

table edge, and apply the typical amount of compression used clinically (e.g. 8-10 daN or

13-18 lbs) with the large paddle. The compression force used should be the same each

time this test is performed. The label on the phantom should be readable.

5. Set the view to “RCC”


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6. Acquire the TM projection set.

7. Note the technique used to acquire the projection set (target, filter and kV). For systems

using automatic exposure control (AEC or AOP), the target material, filtration and kVp

should not change from one acquisition sequence to the next. If the target, filtration or kV

change, repeat the exposure, using a fixed technique matching the baseline technique as

seen on the QC chart on the website. Compression pressure variations may cause

selection of a different technique. If there is still a problem, either your medical physicist

or service organization should be contacted.

3D/Tomo with C-View/V-Preview

(if used), using AEC/Clinical

settings

8. Send the TM volume (BTO format) and the synthetic 2D image to the TRIAD server

using the Site Qualification mode.

9. Log into the TMISTQC website within 1 hour of submission of the images.

www.tmistqc.org

10. Review the charts for the TM test to ensure that the values from today’s image are within

control limits (kV, mAs, SDNR, ADU, slice heights, FWHM values, NPS at 1, 2 and 4

lp/mm). Note that there are plots for the parameters measured on the 3D volume, and

additional plots for the parameters measured on the synthetic 2D image (if available on

your system). The graph will display “Marginal” in orange if there is anything that needs

attention. Clicking on the arrow to the left side of the date will provide information on

problematic tests under Charts Status Details.


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11. If any of the parameters are outside of the control limits on the charts, repeat the

exposure.

12. Examine the four calcification cluster regions of interest shown for the 3D volume.

Record the absence or presence of artifacts using the comment feature and digitally

initial the 3D chart by clicking on “Pass” or “Fail”, as appropriate.

13. Examine the four calcification cluster regions of interest shown for the synthetic 2D

image. Record the absence or presence of artifacts using the comment feature and

digitally initial the synthetic 2D chart by clicking on “Pass” or “Fail”, as

appropriate.

7.1.1.4 Limits and corrective actions

1. All plotted parameters should be within the control limits indicated on the chart.

2. PQCC software automatically calculates any CRITICAL or NONCOMPLIANT variances

3. The mean glandular dose must be less than 3.0 mGy.

4. The four calcification clusters shown should each contain 5 calcifications, and should

look similar to prior test images.

TM Tests with Definitions of Variances

Test Type Critical Operating

Thresholds

Noncompliant Operating

Thresholds

SDNR Not within +/- 15% of

baseline value

Not within +/- 10% of baseline value

mAs Not within +/- 10% of baseline value

Signal around sphere Not within +/- 10% of baseline value

FWHM of point Not within +/- 15% of baseline in all 3

directions

Radial average NNPS Not within +/- 10% of baseline at 1, 2

and 4 cycles/mm

Spec slice level Not within +/- 5mm of

baseline

Not within +/- 2mm of baseline

Dose Not below 3 mGy Not within +/-10% of baseline value

Visual Inspection Obvious artifacts on any

target/filter combination

Greater than minor artifacts on any


SYNTHESIZED 2D Tests with Definitions of Variances


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Thresholds

Noncompliant Operating Thresholds

SDNR Not within +/- 10% of baseline value


Signal around

sphere


FWHM of point Not within +/- 15% of baseline in x & y

Radial average

NNPS

Not within +/- 10% baseline at 1, 2 and 4

cycles/mm

7.1.1.5 Timeframe for Corrective Action

Immediately repeat the test, ensuring correct phantom placement and compression force. If a

CRITICAL or NONCOMPLIANT variance still occurs, do not image clients until an

analysis of the problem and consultation with PQCC has been undertaken; and a plan of

action documented.

Figure 1: Isometric Schematic of TMIST QC Phantom Figure 2: Bird’s-Eye-View-of

TMIST QC Phantom

showing Microcalcification

Groups


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7.2 ARTIFACT EVALUATION AND SDNR – 2D MODE

7.2.1.1 Scope

Objectives: To ensure that clinical images produced are free from artifacts that might

interfere with image interpretation. To monitor consistency of imaging performance

(e.g. variations in detector performance) in terms of factors that affect dose and image

quality. Comparison is made with baseline performance levels. Quantitative

performance indicators are the mean pixel value (MPV), mAs employed for imaging

and signal difference to noise ratio (SDNR).

Frequency: weekly

7.2.1.2 Equipment

A uniform slab of PMMA, large enough to cover the entire imaging area, and free

from scratches or other radiologically visible imperfections or that mounts to the tube

port. This is usually supplied by the vendor of your tomosynthesis or mammography

unit.

Figure 3 Photo of TMIST QC phantom on table Note that the label is on top, and can be

read when standing in the patient location.


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SDNR disk underlay provided by PQCC.

7.2.1.3 Methodology

1. Open a test client exam (Last Name = TMISTQC; First Name = TOMO; Middle Name =

MONTH).

2. Place the SDNR disk underlay on the tabletop. The label on the underlay should be away

from the chest wall and legible. The chest-wall edge should be aligned with the edge of

the breast support plate, and the disk well centered between the left and right edges of the

breast support plate.

3. Place the uniform phantom on top of the underlay, or mount it at the tube port, as

specified in the manufacturer supplied QC program.

4. Using the large paddle, apply the typical amount of compression used clinically (e.g. 8

daN or 18 lb.). The compression force used should be the same each time this test is done.

5. Set the unit to its 2D (FFDM) acquisition mode and the AEC mode most commonly used

clinically. This test is intended to check equipment being operated using the settings that

are used clinically, for patient imaging, so do not use a “flat-field” setting on the AEC.

6. Set the view to “RCC”.

7. Acquire an image.

8. Note the technique used to acquire the image (target, filter and kV). For systems using

automatic exposure control (AEC or AOP), the target material, filtration and kVp should

not change from previous monthly values. If the target, filtration or kV is different from

that used for your last QC image, repeat the exposure using a fixed technique as close as

possible to a previous, passing QC image. Often compression force variations will cause

selection of a different technique. If there is still a problem, either your medical physicist

or service organization should be contacted.


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2D/Conventional Mammo, using

AEC/Clinical settings

9. Send the processed image to the TRIAD server and to the softcopy display station used

for your regular QC.

10. View the processed image on the softcopy display station. Use the window width (WW)

and window level (WL) as recommended by your physicist. These settings result in the

background of the phantom being displayed with a mid-grey. The same WW and WL

settings (+/- 10 ADU’s) should be used each time an image is evaluated. An

appropriate choice of window width is critical to catch artifacts yet not “fail” clinically

acceptable images. Window width choice should be based on what is appropriate/typical

for breast images or for a phantom with breast-like features. Only one display station

needs to be evaluated.

11. Evaluate the entire phantom image for artifacts. Examine the entire phantom for both

broad area artifacts (e.g., non-uniformities, blotches, and streaks), and for detailed

artifacts (e.g., black or white pixels, clusters of pixels, lines, or dust particles). Broad area

artifacts are typically best seen while observing the phantom image as a whole, not in

pieces. Detailed artifacts are typically best seen while observing the phantom image at

full spatial resolution, where one pixel on the display matches one pixel in the image, or

even in magnified form (with a magnification greater than 1.0).

12. Log in to the TMISTQC website within 1 hour of image submission.

13. Review the charts for the uniformity and SDNR test, to ensure that the values from

today’s image are within control limits (kV, mAs, SDNR and signal level).

14. Examine the thumbnail images. Record the absence or presence of artifacts using the

comment feature and digitally initial the chart by clicking on “Pass” or “Fail”, as

appropriate.


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7.2.1.4 Recommendations and corrective action

1. All plotted parameters should be within the control limits indicated on the chart.

2. The mean glandular dose must not exceed 3.0 mGy.

3. There should be no distracting artifacts.

DM Tests with Definitions of Variances

Test Type Critical Variances Noncompliant Variances

SDNR Not within +/- 20% of

baseline value



Background Signal Not within +/- 10% of baseline value

Dose Not below 3 mGy Not within +/- 10% of baseline value





7.2.1.5 Timeframe for corrective action


CRITICAL variance still occurs, do not image TMIST participants on the machine until

an analysis of the problem and consultation with PQCC has been undertaken; and a plan

of action documented.


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Figure 4. The underlay for the DM weekly QC test is placed on the table,

and then the site flat-field phantom is placed on top. Note that the label on

the underlay can be read from the patient location. Do not use “phantom” or

“Flat-Field” AEC setting.

Figure 5: Example image showing the image of a

flat-field with the underlay used to measure SDNR.

The yellow circle must be within the contrast disk,

and the red outer rings must be outside the disk, but

inside the phantom.

8 MONTHLY TESTS (NOT REQUIRED FOR GOLD STATUS MACHINES)

8.1 TOMOSYNTHESIS ARTIFACT EVALUATION

8.1.1.1 Scope

Objectives: To ensure that clinical tomosynthesis images produced are free from

artifacts that might interfere with image interpretation or tomosynthesis reconstruction

Frequency: monthly


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8.1.1.2 Equipment

Uniform slab of material, such as a 4 cm thick slab of PMMA, large enough to cover

the entire imaging area or mount at the tube port, and free from scratches or other

radiologically visible imperfections. This is usually supplied by the vendor of your

tomosynthesis unit.

8.1.1.3 Methodology

The same settings should be used each month for the test – take care to select use the

same kV and mAs

1. Open a test client exam (Last Name = TMISTQC; First Name = BLOCK).

2. Place the uniform phantom on the breast support or mount it at the tube port, as specified

in the manufacturer supplied QC program, and bring the large compression paddle down

to just touch the top of the phantom (or breast support, if the phantom mounts at the tube-

port).

3. Set the unit to its 3D (TM) RCC acquisition mode and a manual technique close to that

commonly used clinically.


3D/Tomo using MANUAL settings, all

Target/Filter combinations used in Tomo

mode

5. Send the resulting images reconstructed volume (and synthetic 2D if available) to the

TRIAD server.

6. Repeat steps 4 and 5 for any other anode/filter combinations available in the

Tomosynthesis mode. It may be necessary to use a manual technique in order to force the

unit to use the other anode/filter combinations available in Tomosynthesis mode. In that


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case manually select the kV and mAs that most closely match what the AEC selected for

the first image sequence.

7.

8.1.1.4 Interpretation of results and criteria

1. There should be no distracting artifacts.

TM Tests with Definitions of Variances


Thresholds

Noncompliant Operating

Thresholds

NNPS Not within 10% of baseline for each






A variance is registered if two test-points in a row exceed the critical or non-compliant

threshold. A Critical Variance is also registered if a test is not repeated within 1 business day

of a value exceeding a Critical Threshold being reported.

8.1.1.5 Timeframe for corrective action


CRITICAL or NONCOMPLIANT variance still occur, do not image TMIST participants

on the machine until an analysis of the problem and consultation with PQCC has been

undertaken; and a plan of action documented.

8.2 GOLD STATUS

When a unit is in Gold Status, the Monthly Tomosynthesis Artifact evaluation test is

not required. The PQCC may request that the test be performed during troubleshooting

of Non Compliant or Critical Variances.


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9 ANNUAL TESTS

Annual tests are performed by the MQC using a Phantom set provided in a shipping

case by PQCC. The set consists of:

o Black holder with steel pins to align sections of the phantom.

o SDNR insert - a 20 mm thick semi-circular slab of PMMA, into which a 15

mm diameter delrin sphere is embedded to use as the contrast object [SDNR].

o TMIST modular sections - six 10 mm thick semi-circular slabs of PMMA (top

[TOP], bottom [BOT] and 4 middle layers [L2, L3, L4 and L5]).

o u-shaped rigid spacers of radiolucent material to simulate breast thicknesses

when used with the PMMA slabs. Spacers of 5mm, 15 mm and 23 mm

thickness are provided.

o Resolution Phantom [MTF].

o ASF sheet containing BBs.

o Packing instructions.

o A mailing label will be e-mailed to you for shipping the phantom set to next

site.

All analysis is performed by PQCC and results will be sent to the MQC.

9.1 AEC EVALUATION

9.1.1.1 Scope

Objective: To ensure that the automatic exposure control (AEC) of the system is

functioning as expected, with appropriate reconstructed image quality and without

excessively high patient doses.

Frequency: Annually

9.1.1.2 Equipment

Phantom set

o SDNR insert – [SDNR].

o TMIST modular phantom - top [TOP], bottom [BOT] and 4 middle layers [L2,

L3, L4 and L5]).

o u-shaped rigid spacers of radiolucent material to simulate breast thicknesses

when used with the PMMA slabs. Spacers of 5mm, 15 mm and 23 mm

thickness are provided.

9.1.1.3 Methodology

1. Open a test client exam (Last Name = TMISTQC; First Name = AEC).

2. Place the 20 mm thick SDNR phantom with the contrast sphere on the breast support

plate.

3. Apply sufficient compression pressure with the large paddle to immobilize the phantom.


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4. Select the AEC mode used routinely for TM and acquire an RCC TM sequence.

5. Repeat the steps described previously for the other thicknesses of PMMA (40, 60 and 80

mm) and the appropriate spacer thicknesses.

i. Refer to Table 2 for the stacking of the slabs.

ii. The 20 mm thick PMMA slab with the sphere (TMIST SDNR Insert) should

be in the centre of the stack of slabs.

iii. An equal number of the 10 mm thick PMMA slabs should be above and below

the 20 mm thick slab.

iv. Because of the attenuation differences between the PMMA material used and

actual breast tissue, add the listed Styrofoam spacer on top of the PMMA and

apply 8-10 daN of compression.

6. Submit the reconstructed volumes to TMIST-TRIAD server.


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Table 2: Phantom thicknesses and assembly information for AEC evaluation. Components

to stack are ordered from top to bottom as phantom is seen when placed on breast support

plate. The thumbscrews do not need to be released more than ½ turn, and do not need to be

forcefully tightened.

mm PMMA

mm Spacer

mm Total

Components to Stack Labels

20 none 20 TMIST SDNR Insert SDNR

40 5 45 TMIST 5 mm Spacer TMIST Modular Phantom Top TMIST SDNR Insert TMIST Modular Phantom Bottom

5 mm TOP SDNR BOT

60 15 75 TMIST 15 mm Spacer TMIST Modular Phantom top TMIST Modular Phantom layer 2 TMIST SDNR Insert TMIST Modular Phantom layer 3 TMIST Modular Phantom Bottom

15 mm TOP L 2 SDNR L 3 BOT

80 23 103 TMIST 23 mm Spacer TMIST Modular Phantom Top TMIST Modular Phantom layer 2 TMIST Modular Phantom layer 3 TMIST SDNR Insert TMIST Modular Phantom layer 4 TMIST Modular Phantom layer 5 TMIST Modular Phantom Bottom

23 mm TOP L 2 L 3 SDNR L 4 L 5 BOT

Figure 6. Phantom stacking for the 60 mm thick test.


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Annual AEC Tests with Definitions of Variances


AEC / Thickness

Tracking: SDNR


AEC/ Thickness

Tracking: Dose

Greater than 1.5 x IAEA Acceptable dose

vs thickness (Appendix 1)

Dose - 20 mm equiv greater than 1.1 mGy

Dose - 45 mm equiv greater than 3.0 mGy greater than 2.0 mGy



9.1.1.5 Actions

PQCC will provide assistance in diagnosing the reason for the variance, and

recommendations for remediation.

9.2 RESOLUTION EVALUATION

9.2.1.1 Scope

Objective: To evaluate the resolution in the reconstructed image volume in the x and z

directions

9.2.1.2 Equipment

MTF evaluation phantom [MTF] from kit

9.2.1.3 Methodology

1. Open a test client exam with Last Name = TMISTQC; First Name = MTF.

2. Position the phantom on the breast support plate, centered between the left and right

edges of the active area of the detector. The label should be upright.

3. Compress the phantom sufficiently to immobilize it using the large paddle.


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4. Acquire a TM projection sequence using a manual technique matching the technique

selected for the 4 cm configuration of the SDNR phantom for the AEC test. 2D images

are not required.

5. Submit the reconstructed volume(s) to the TMIST-TRIAD server.

Figure 7. MTF test tool placed on bucky.


PQCC will analyse the images and report the results graphically.

Annual Tests with Definitions of Variances

Test Type Critical

Operating

Thresholds


MTF Not within 10% of baseline at 1, 2 and 3 cycles/mm -

x and y

MTF Not within 10% of baseline at 0.25, 0.5 and 1

cycle/mm for z


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9.3 NOISE– TOMOSYNTHESIS MODE

9.3.1.1 Scope

Objectives: To characterize the noise in the reconstructed image volume

9.3.1.2 Equipment

TMIST Modular Phantom configured to be 4 cm thick (Top [TOP], Bottom [BOT]

and 2 middle layers without the contrast sphere [L 2 and L 3]) see Figure 8.

Figure 8. Noise test. Note that the SDNR layer is not included.

9.3.1.3 Methodology

1. Open a test client exam (Last Name = TMISTQC; First Name = NOISE).

2. Place the phantom on the breast support and apply the typical amount of compression

used clinically (e.g. 8-10 daN) with the large paddle.

3. Set the unit to its TM acquisition mode (2 D imaging is not required).

4. Acquire a TM RCC projection sequence using a manual technique based on the AEC

selection for a 4.5 cm breast.


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5. Submit the reconstructed volume(s) to the TMIST-TRIAD server.



Test Type Critical

Operating

Thresholds


NNPS Not within 20% of baseline (x, y & radial avg 1,

2 & 4 c/mm)

9.4 GHOSTING

9.4.1.1 Scope

Objective: To verify that ghosting is not present in the projection images (where

applicable) and not affecting the quality of the tomosynthesis volume reconstruction

9.4.1.2 Equipment

TMIST Modular Phantom configured to be 8 cm thick (Bottom [BOT, 4 middle layers

[L2, L3, L4, L5] SNDR insert and Top [TOP].

23 mm thick Styrofoam spacer.

Watch or timer for timing the positioning delay.

9.4.1.3 Methodology

1. Determine whether this test is required. If routine FFDM (2D) images are not part of the

workflow for TMIST participants at this site, the test can be omitted.

2. Open a test client exam (Last Name = TMISTQC; First Name = GHOST).

3. Set the unit in 2D (FFDM) mode.

4. Place the 8 cm thick modular phantom on the breast support, shifted to the left as far as

possible without risking part of the phantom being out of the field of view. (See Figure 9).

Position the phantom with the lip flush against the chest wall edge of the detector. Place

the foam spacer on the phantom.

5. Bring down the large compression paddle and apply enough compression force to hold

the phantom securely in place.

6. Acquire the 2D (ghost-creating) image using AEC. As you push the button to trigger

image acquisition, start timing the positioning delay using your watch or timer.


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7. Set the unit in 3D (TM) mode.

8. Slide the 8 cm thick modular phantom on the breast support to the right as far as possible

without risking part of the phantom being out of the field of view. Place the foam spacer

on the phantom.

9. Bring down the compression paddle and apply enough compression force to hold the

phantom securely in place.

10. Wait until your watch or timer shows that 45 seconds (or the pre-determined, posted

minimum wait time) has elapsed since step 8.

11. Acquire the TM acquisition sequence. This is the ghost evaluation acquisition.

12. Submit all images (processed 2D mammograms and reconstructed volumes) to the

TMIST-TRIAD server.

Figure 9. Ghosting image collection. The tomo volume on the right was obtained with

an unreasonably quick imaging interval to demonstrate the appearance of ghosting.



Ghosting Obvious artifact in reconstructed volume

1. Consult your service representative if ghosting is evident in the ghost evaluation image.


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2. It may be necessary ensure a longer wait time between images to guarantee ghosting will

not be present in patient images, especially for patients with thick, dense breasts. The test

steps can be repeated using different positioning delay times to determine the required

minimum wait time. If the minimum wait time is determined to be greater than 45

seconds, a notice should be posted in the mammography room indicating the wait time

requirement.

9.5 SLICE EVALUATION – COMPREHENSIVE

9.5.1.1 Scope

Objective: To examine the artifact spread function (ASF, x and y directions) and slice

sensitivity profile (SSP, z direction) throughout the reconstructed volume, to verify

that objects in known locations are reconstructed in the correct location and to

characterize how the ASF, SSP and the magnitudes of errors in reconstructed object

location change throughout the reconstructed volume.

9.5.1.2 Equipment

semi-circular plastic sheet containing aluminum BB’s arranged in a 2 cm x 4 cm grid

(BB layer, see Figure 10).

TMIST Modular Phantom configured to be 4 cm thick (Top [TOP], Bottom [BOT]

and 2 middle layers [L2 , L3])


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Figure 10: BB layer placed at lowest level.

9.5.1.3 Methodology

This test involves taking 8 different TM acquisitions (2D modes not required), with

different configurations of the test phantom and different views. Please use Table 3 to

keep track of the phantom configuration and view being used.

1. Open a test client exam (Last Name = TMISTQC; First Name = ASF).

2. Ensure that automatic release of the compression paddle is disabled.

3. Consult Table 3 for the correct view and BB layer height for the current acquisition.

4. Adjust the angulation of the gantry to match the view specified on Table 3. For example,

if the view is RMLO, the gantry should be angled appropriately for an RMLO view

(around 45 degrees).

5. Place the BB layer at the desired height within the modular phantom. For 0 cm, place the

BB layer below the phantom, so it rests directly on the breast support plate. For 4 cm,

place the BB layer above the upper slab of the phantom, so that it will be between the

phantom and the large compression paddle.


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6. Position the phantom with the lip flush against the chest wall edge of the detector, and

centered between the left and right edges of the imaging field. It is important to try and

be consistent (+/- 5mm) about phantom positioning each time. It may be helpful to

measure and record the distance from one edge of the detector to one edge of the phantom

to ensure consistency from test to test.

7. Bring down the large compression paddle and apply enough compression force to hold

the phantom securely in place. Tape may also be used to ensure the phantom does not slip

during or at the end of exposure.

8. Use a manual technique based on the technique factors used in exposing the TMIST

Weekly QC phantom.

9. Acquire the projection images required to create the TM reconstruction.

10. Repeat steps 3-9 for all acquisitions specified in Table 3.

11. Submit the reconstructed volumes to the TMIST-TRIAD server.



Test Type Critical

Operating

Thresholds


FWHM not within 15% of baseline for each test

condition

FWHM COV greater than 10% for each test condition

Slice height not within 5

mm of expected

not within 1 mm of expected

BB spacing not within 0.5% of actual location

BB SD (x) greater than 0.15 mm

BB SD (y) greater than 0.10 mm

BB SD (z) greater than 1.00 mm

Geometric (x) max dev from avg spacing not less than 0.3 mm

Geometric (y) max dev from avg spacing not less than 0.2 mm

Geometric (z) max dev from avg spacing not less than 1.5 mm


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The ASF and PSF values measured should be consistent throughout the reconstructed

volume, regardless of view selected, and should stay constant over time. If PQCC identifies

unexplained changes or reconstruction errors, have the service person verify that the

angulation sensors (potentiometers) and gantry motors are functioning correctly.


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Table 3: Acquisition scenarios for comprehensive ASF evaluation. Use the frame (block

with rods) to hold the components together and reproducibly position the phantom during

imaging.

Acquisition View Height of BB Insert

Components to stack

Check here when completed

1 RCC 0 mm TOP L2 L3 BOT BB

2 RCC 10 mm TOP L2 L3 BB BOT

3 RCC 20 mm TOP L2 BB L3 BOT

4 LCC 20 mm TOP L2 BB no change L3 BOT

5 RMLO 20 mm TOP L2 BB no change L3 BOT

6 LMLO 20 mm TOP L2 BB no change L3 BOT

7 RCC 30 mm TOP BB L2 L3 BOT

8 RCC 40 mm BB TOP L2 L3 BOT


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10 IMAGING EQUIPMENT

The site must maintain documentation of QC in case there is a future technical audit of the

TMIST trial.

(1) Annual Medical Physics Survey must be performed by a qualified medical physicist

on all mammography equipment annually. Testing shall be in accordance with

regulatory requirements or based on commercial vendor documentation.

(a) Documentation must include HVL and tube output (mR/mAs at breast

entrance) values for typical target-filter and kVp techniques used for both DM

and TM modes.

(b) Copies of all documentation shall be forwarded to [email protected].

(2) Mammography Equipment Evaluation (MEE) must be performed by a qualified

medical physicist in accordance with regulatory requirements after moving unit,

disassembling/reassembling at the same location, or major component change.

(a) MEE is performed according to procedures defined by the manufacturer.

(b) MEE documentation must include HVL and tube output (mR/mAs at breast

entrance) values for typical target-filter and kVp techniques used for both DM

and TM modes if alteration is made to the generator or tube.

(c) MEE documentation must be maintained, including equipment identification

(ID), calibration results, actions taken, and follow-up.

(d) Copies of all MEE documentation is to be forwarded to

[email protected].

(3) Preventive Maintenance is performed by the manufacturer service representative or

a Bio-Medical engineer who has received training on the equipment, on a schedule

which meets manufacturer recommendations and all applicable regulatory

requirements and accreditation standards.

(a) Preventive maintenance documentation must be maintained, including

equipment ID, preventive maintenance results, actions taken (i.e., equipment

disposition), and follow-up.

(b) Preventive maintenance documentation is to be forwarded to

[email protected].

(c) Preventive maintenance activities which alter the operation of the equipment

may require a partial MEE to be performed and documented.

(4) Replacement of Detector. After Evaluation as required in (2) has been performed,

and MEE documentation submitted to PQCC, the unit must be re-credentialed.

(a) Take an RCC 2D image and RCC 3D (Tomo) image if applicable of the ACR

Accreditation Phantom, and upload to TRIAD under submission type Site

Credentialing (CR).

(b) Complete Weekly and Monthly QC on the unit so a baseline can be





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established. Upload these images under submission type Site Qualification

(SQ).

(5) Replacement of Tube. After Evaluation as required in (2) has been performed, and

MEE documentation submitted to PQCC, a new baseline must be established for the

unit.

(a) Complete Weekly and Monthly QC on the unit so a baseline can be

established. Upload these images under submission type Site Qualification

(SQ).

(6) QC is performed by the MQC and Medical Physicist on each type of equipment based

on manufacturer’s recommendations, regulatory requirements, accreditation

standards, and internal requirements.

(7) TMISTQC is performed by the MQC on each unit used to image participants in

TMIST.

(8) Quality control documentation is maintained by the MQC, including equipment ID,

QC results, actions taken, and equipment disposition.

(a) TMIST QC documentation is maintained on the website www.TMISTQC.org,

and must be kept up to date by the MQC.

(9) Image Acquisition System Upgrades. An MEE is required for most upgrades. The

Quality Control Manual for the upgraded system will normally indicate this if

required.

(10) Defective Equipment. Any defective equipment must be temporarily

removed from service and evaluated either by Bio-medical engineering or the

manufacturer’s service engineer. All defective equipment must be properly labeled.

After repair, all equipment must be calibrated before use and inspected by the medical

physicist (MEE).

(11) Computer Systems. FFDM computer systems (hardware and software) are to

be validated at the time of installation and must be appropriately maintained to ensure

functioning according to manufacturer’s recommendations.

(a) New hardware must be validated at the time of installation and after any

significant modification or change.

(b) New versions of software and changes (“patches”) must be validated by the

system manufacturer. Notification of software upgrades should be given to

PQCC and documented on the website. Often QC parameters will fail after

equipment maintenance, meaning that website baseline changes need to

be made.

(12) Display Monitors (a) The LIP at the site is responsible for ensuring all monitors used in the

interpretation of mammography are FDA or comparable country specific

http://www.tmistqc.org/


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agency mammography-approved and are included in a QA program that is

substantially the same as that recommended by the FFDM manufacturer.

(b) The image display device(s) used by the technologist(s) to check the quality of

the mammography images should be in a setting where the ambient lighting

conditions are similar to where the mammograms are interpreted.

(c) The image display device(s) used by the technologist(s) to check the quality of

the mammography images should have at least 1 3MP monitor.


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11 TMISTQC WEBSITE QUICK-START

All technologists performing QC should register on the TMIST QC website, and after

performing their Weekly or Monthly QC, they should check the graphs and images on the

website, and indicate if the QC images “Pass” or “Fail”.

The first time that you go to the website tmistqc.org, you will see a screen similar to this:

At the bottom of the Sign-in box, click on the word “Register”. This will take you to a

second page

You will then enter all of the data requested. The site location will not be available until after


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the site is credentialed. An e-mail will be sent to your e-mail address, which you must

respond to by clicking on the link. After that, there will be up to a two business day delay

until your account is approved, at which time you will receive a second e-email indicating

that you can now use the website.

From this point on – the Help button will provide instructions if operations are not

straightforward, or if you need additional assistance. Video presentations show how to use all

parts of the website, and how to perform Weekly and Monthly tests.

12 TMIST IMAGE TRANSFER SETUP

TMIST requires a specific set of images to be submitted for each study subject. If synthetic

2D images are used by the facility for diagnosis, they should also be sent.

Credentialing Images (ACR phantom) are meant to validate your image workflow, from

subject imaging to image submission. TMIST participant images and Weekly QC (TMIST

QC phantom) are to be sent using exactly the same methods.

12.1 IMAGE TYPES REQUIRED

For all 2D mammography systems in the department being used for TMIST screening

images:

• "processed" (DICOM "For Presentation") MG images

There is no requirement to send Diagnostic or workup images for TMIST participants.


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For Tomosynthesis systems being used for TMIST:

• "processed" (DICOM "For Presentation") mammogram images

• reconstructed tomosynthesis images in "Breast Tomosynthesis Object" (DICOM

BTO) file format.

For GE there will be the SlabView and the SliceView files.

For Hologic there's just a single file with the 1-mm thick slices (make sure this

file is sent in BTO format).

• if used at your site, the Synthetic 2D images created from the tomosynthesis scan

For GE Volume Preview (BTO or MG)

For Hologic C-View (BTO or MG)

For Hologic, Transfer syntax should be set to JPEG-2000 lossless

(1.2.840.10008.1.2.4.70).

12.2 IMAGE SUBMISSION

Images that are submitted under "Credentialing” or “Site Qualification" will get forwarded to

the TMIST Physics QC Core with their pixel data untouched, so we can assess image quality

as part of the on-boarding process, and perform automated QC on the images.

Images that are submitted as trial subjects will have portions of the headers sent to TMIST

Physics QC Core for dose tracking and checking to see that technical factors are reasonable.

All of the above images should be sent directly to the TRIAD workstation, rather than trying

to extract them from PACS if possible. This will reduce RA time querying PACS and waiting

for large image sets to transfer.

12.3 TRIAD SETUP

Following instructions in the TRIAD TMIST User Guide,

(https://triadinstall.acr.org/triadclient/resources/TRIAD%20V4%20Windows%20Client%20

User%20Guide%20for%20Clinical%20Trials.pdf), install TRIAD on the RAs computer,

which should be easily accessible, and close to both the mammography rooms and work area.

The computer running TRIAD must have a fixed IP address (one that never changes).

Go to the DICOM server setup on TRIAD, and record the IP address of the TRIAD

workstation. In this example we use: 10.3.17.81. You will need to substitute the IP address

of the TRIAD workstation at your location.

https://triadinstall.acr.org/triadclient/resources/TRIAD%20V4%20Windows%20Client%20User%20Guide%20for%20Clinical%20Trials.pdf

https://triadinstall.acr.org/triadclient/resources/TRIAD%20V4%20Windows%20Client%20User%20Guide%20for%20Clinical%20Trials.pdf


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Your IT department will need to open outbound traffic from the TRIAD IP address

10.3.17.81 on TCP (33001) and UDP (33001-33500) ports to permit fastest transfer speeds.

Both the computer and TRIAD must be running while the mammography units are

operational, until TRIAD is upgraded to run “in the background”.

In order to receive the data sent from PACS or from the mammography unit, TRIAD must be

running and the RA needs to open the “select images” window, which is when the DICOM

receiver port starts listening and incoming images will be displayed in the window.

Here are the steps to launch the Select Images window in TRIAD.

--> Launch TRIAD --> Login --> Select the trial and site details -->Now choose files from

PACS option --> Click on Choose Files --> You now see ‘Select Images” window

12.4 SETTING UP THE MAMMOGRAPHY UNITS:

12.4.1 Hologic

A service call needs to be logged to have the field engineer configure each mammography

unit to send images to TRIAD.

Give the service engineer the following information, substituting the IP Addresses of the

Mammography machine and computer running TRIAD in the region below:

Source Machine:

System Type: Selenia

Location: Room 1

SN: 28407083xxx

AET: DMAM

IP: 10.3.17.180

Port: 104


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New Destination:

IP Address: 10.3.17.81

Port: 50001

A.E. Title: TRIAD-DCM

Transfer Syntax: select

JPEG Lossless, Non-Hierarchical and

Explicit VR Little Endian only,

Unselect everything else.

Output mode: Send Images as Accepted.

Selected Support DICOM types:

Processed Conventional

Tomo Slices BTO

CView BTO, (or MG)

and unselect everything else.

Hologic setup of TMIST Output


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Unfortunately, the Tomosynthesis Volume on Hologic machines is sent to some PACS

systems as a "Secondary Capture" file (DICOM SC), which we are unable to handle.

The following table may help to select the proper series sets for submission.

Series Type Description DICOM TMIST Requirements

71000000 raw mammograms MG Optional

71100000 processed mammograms MG Essential

72000000 raw projections SC Optional

72100000 processed projections SC Not needed

72200000 C-View files SC Not Accepted

72300000 raw projections BPO Optional

72400000 proc projections BPO Not needed

73100000 reconstructed Tomo volume SC Not accepted

73200000 reconstructed Tomo volume BTO Essential

73300000 C-View files BTO Essential if C-View used

12.4.2 GE Setting up a new host on an Essential

The local technologist can configure the machine to send the 2D and 3D images to the

TRIAD workstation. A service call needs to be logged to have the synthesized images sent

from the IDI shuttle to the TRIAD workstation.

50001

10.3.17.81


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Give the service engineer the following information to configure the IDI, substituting the IP

address of the computer running TRIAD at your institution:

New Destination:

IP Address: 10.3.17.81

Port: 50001

A.E. Title: TRIAD-DCM

Click on the “Tools” button (hammer and saw) Select Network Management


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Add remote Host - Call it TMIST Blank Screen before entering

information

Fields for adding the TRIAD DICOM

receiver on a GE Essential.


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If the test hosts works, then all images can be pushed to TMIST/TRIAD

Enter appropriate IP Address, AE title

TRIAD-DCM and Port 50001

Select Medical Applications And Preferences

Select the TMIST server Click on Test Hosts


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If you are auto-pushing all cases on the machine, set it to send everything possible if the

server you are sending to will accept them, but minimally the “Proc, Planes and Slabs”

If individual TMIST subjects are pushed to TRIAD, then they must be selected from the

browser. Using the Middle patient selection box (Studies), you can select and send all image

sets created on the study date.

13 EA1151 CREDENTIALING INSTRUCTIONS

13.1 CREDENTIALING IMAGE SUBMISSSION REQUIREMENTS

The following images of the ACR phantom will represent a single view of a patient, and

enable the site to optimize workflow before imaging starts.

1. Images in DICOM format of the ACR mammography accreditation phantom (CIRS

Model 155 or Gammex/RMI mode l 156). Acquire the images using the RCC view

only. Do not use special Phantom Modes. Use the last name TMISTQC, and the first

name TEST.

a. One 2D R CC view: “processed” (“DICOM For Presentation”) image

b. One standard exam 3D volume, all standard outputs in DICOM‐BTO (not

secondary capture) format.


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This includes:

i. slice volume

ii. slab‐view volume (if available)

iii. synthetic 2D view (if available and used by the site). On GE

systems this is called the “Volume Preview” or “V‐Preview”. On

Hologic systems this is called the “C‐View”.

Expected 3D and 2D

Credentialing image

13.2 2D IMAGE ACQUISITION

1. Open a test client exam (Last Name = TMISTQC; First Name = TEST).

2. Set the unit to its 2D (FFDM) acquisition mode and the AAEC mode most commonly

used clinically.

3. Place the ACR mammography accreditation phantom on the breast support centered

left‐right, and aligning the “chest‐wall” edge of the phantom with the edge off the

table and apply the typical amount of compression used clinically (e.g. 8 daN or 18

lb). Either the Screen-film or Digital mammography accreditation phantoms are

acceptable.



6. Send the processed version of the image to the TRIAD server (preferred) or to PACS.


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Questions: Please send email to: [email protected]

Figure 1: The mammography accreditation phantom positioned for 2D and 3D imaging.

13.3 3D TOMO IMAGE ACQUISITION

1. Open a test client exam (Last Name = TMISTQC; First Name = TEST).

2. Set the unit to its tomographic acquisition mode and the AEC mode most commonly

used clinically for tomosynthesis mammography.

3. Place the ACR mammography accreditation phantom on the breast support centered

left‐right, aligning the edge of the phantom with the table edge, and apply thee typical

amount of compression used clinically (e.g. 8‐10 daN or 13‐18 lbs).


5. Acquire the tomographic projection set.

6. If necessary (i.e., if this step is not automatic), perform a reconstruction to produce

volumetric images.

7. Send the resulting tomosynthesis volumes, such as the reconstructed slices and the

slab‐view (BTO format) to the TRIAD server (preferred) or to PACS.

8. If the unit produces a synthetic 2D image (such as the Volume Preview/V‐Preview on

GE or the C‐View on Hologic), send the synthetic 2D image to the TRIAD server

(preferred) or to PACS.

Questions: Please send email to: [email protected]




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13.4 CREDENTIALING IMAGE UPLOAD VIA TRIAD

1. Push phantom exam (s) from your mammo unit to the TRIAD server or PACS

2. Open the TRIAD Client

3. On the TRIAD Home Page choose: `Clinical Trials (NCI Domain)’ from the drop‐

down menu

4. Login using your CTEP‐IAM Username and Password

5. Click on: `I Agree and Logon’

6. On the submission page click the tab `Choose Files from PACS’ if the images were

pushed to your PACS or ‘Choose Files from Computer’ if the images were pushed to

the TRIAD server.

7. Click ‘Choose Files’ button to open a new window to search for images

8. Select the device name from thee Remote Device dropdown

9. Provide the ‘Search’ details (Patient ID is mandatory) and click on ‘Search Images’

10. Select the images from the search results

11. Click on the ‘Select Images’ to load the selected files into the TRIAD preview panel

12. Select the series that are ready for submission by clicking the check boxes.

13. Click ‘Move to Submission Queue’ button to move the studies to Submission Queue

14. In the Submission Queue select Submission Type `Credentialing’ from the drop‐‐

down menu

15. Click `Submit’


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