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ACR 2018 Digital Mammography Quality Control

Program
Objectives

• Provide Overview of ACR DM 2018 QC Manual


• Review QC Hologic Related Testing for Medical
Physicist
• Review Hologic Related QC Testing for
Technologist

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Quality Control: Why Is It Important?

• Ensure Dose to Patient is not Excessive


• Insure Adequate, Consistent Image Quality
• Detect Potential Issues Prior to Affecting Patient Care

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ACR 2018 DM QC Manual

• 2nd Edition Published November 19,


2018
• The 2nd Edition now includes QC
testing for Digital Breast
Tomosynthesis (DBT)
• No hardcopy version sold. It can be
purchased and downloaded at the
ACR store:
https://shop.acr.org/Default.aspx?Tab
ID=55&ProductId=730400133

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2018 ACR DM QC Manual

Purpose Use
• Standardized QC Testing for all • Can Only Be Used for Sites Performing Standard
2D and DBT Exams Only.
Manufacturers that are Clinically
Relevant • No Contrast Enhancement – If the site uses I-
View, they must use Hologic’s QC Manual for
• Standardized Test Frequencies all QC Testing

• The customer in consultation with their Medical


• Standardized Performance Criteria Physicist will decide which QC Manual to use with
each unit

o Cannot Mix and Match ACR and Hologic QC


Testing on one unit

• Requires Site to Purchase


New ACR Phantom
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ACR 2018 DM QC Tests – Medical Physicist

Testing is broken down in three


categories:
o MEE
o Annual
o Troubleshooting

Resolution time varies by type:


o Critical - Before Clinical Use
o Non-Critical – 30 Days

Changes from ACR 2016 QC Manual are Highlighted in Yellow

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Medical Equipment Evaluation (MEE)

• To Verify System Meets • Verify System • Visual Indication of Use • For Flat Paddles, Chest
Section 900.12(b) of Anchoring of Large or Small Focal Wall Edge shall be
FDA’s Final Rule for Spot (Pre and Post Straight and Parallel to
Mammography • Can Recover from Exposure) the Edge of the Image
Power Interruption Receptor and not
• To Comply with MEE- • Visual Indication of deflect more than 1cm
Only Required Tests • Grid is Out for Target Material Used when compressed.
Magnification (Pre and Post
Procedures Exposure) • Manual Selection of
mAs
• Magnification Value is • Compression Device
Between 1.4 to 2.0 • Manual Technique
• Power and Fine Factors shall be
• Collimator Light Output Adjustments displayed prior to
is Minimum 160 Lux making an exposure
(15 Foot-Candles) at • Compression Paddles
100 cm or maximum – Sizes and Special • AEC Technique Factors
SID (whichever is less) Purpose Displayed after the
Exposure has been
Made
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ACR DM Phantom Image Quality

• To Verify Image Acquisition 18 Test Objects Present • Images shall be taken for both 2D • CNR and SNR - 2D Only
Chain is Providing and DBT. (If DBT is installed) The • Measurements are Made
Consistent Image Quality • 6 Fibers Window Width (WW) and Window Manually
Level (WL) settings shall be • SNR ≥ 40.0
• 6 Speck Groups optimized for visualization and • CNR ≥ 2.0
• To Verify No Clinically recorded for future evaluations. • CNR to be ≥ 85% of
Significant Artifacts Exist • 6 Masses Previous Year’s CNR
for both 2D and DBT • Minimum Score of 2 Fibers, 3 • Distance Measurement - 2D and
modes. Speck Groups, and 2 Masses DBT
Required for 2D and DBT images.
• Use Capture App Digital Ruler
The DBT image is scored using the
• To Verify that SNR and slice in which the test objects are
to Verify Phantom Width
CNR Values are Adequate best visualized. • 70.0 mm ± 14.0 mm

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DBT Z-Resolution (New for 2018 QC Manual)

• Test to ensure blurring in the z-direction


is not excessive

• Physicist will use DBT ACR Phantom


image and take the sharpest image
along with 2 consecutive slices in each
direction and measure the maximum
signal value in each speck of the largest
speck group along with the background
signal to determine Full Width at Half
Maximum (FWHM) for Z-Resolution

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DBT Z-Resolution (cont.)

• A baseline FWHM is determined at


installation that is to be used to compare
on future Medical Equipment
Evaluations (MEEs)

• The FWHM measured on future MEEs


must be within ± 30% of the baseline
value

• Failures must be corrected within 30


days.

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Spatial Resolution

• Spatial Resolution Measurement done


with Line Pair Phantom at 45° Angle at
Manual Technique closest to ACR
Phantom
• SR ≥ 4.0 lp/mm – Large Focal Spot – 2D

• SR ≥ 4.0 lp/mm – Small Focal Spot – 2D

• SR ≥ 2.0 lp/mm – Large Focal Spot – DBT

• Failures must corrected within 30 days

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DBT Volume Coverage
(New for 2018 QC Manual)
• Test to assure that the entire breast volume
is imaged during DBT acquisition

• Two 0.1 mm sheets of aluminum are


placed above and below the ACR DM
Phantom as shown.

• The closest manual DBT technique to the


ACR DM Phantom is used to make an DBT
image using the largest paddle.

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DBT Volume Coverage (cont.)

• Verify that the slices for the top and


bottom sheets of aluminum are well
defined and in focus in their respective
planes.

• Failures must be corrected before


clinical use.

Slice for Top Sheet

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AEC Performance

• Verify AEC Performance for 2D and DBT


with 2 cm, 4 cm, and 6 cm of BR-12
Material. Record Technique and
determine SNR

• Perform 2D exposure with Mag Stand


and 4 cm of BR-12 Material

• Pass/Fail Criteria:
• 4 cm SNR ≥ 40

• All SNRs must within 15% of previous year’s


values.

• Failures must be corrected within 30


Days

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Average Glandular Dose (AGD)

• Measure Entrance Exposure for Average


Patient

• Determine HVL and Dose at Technique


for ACR Phantom for 2D and DBT to
Calculate AGD.

• Place Dosimeter Under Paddle at ACR


Phantom Height of 4.2 cm.

• Pass/Fail Criteria:
• AGD ≤ 3.0 - Failure must be Corrected
Immediately

• If available, Unit-Indicated AGD must be within


25% of Calculated AGD. - Failure must be
corrected within 30 days

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Unit Checklist

• To Ensure all Locks, Detents, Indicators, and Mechanical Support


Devices for the X-Ray Tube and Breast Support Assembly are
Operating Correctly

• Verify DICOM Image File Headers are Correctly Populated

• Critical Failures to be Corrected Immediately

• Non-Critical Failures to be Corrected Within 30 Days

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AWS Monitor QC

• Verify Monitor is clean from anything that


may interfere with Clinical Information

• Verify Monitor Luminance, Luminance


Uniformity are Correct (If Available)

• Evaluate DICOM Grayscale Display


Function (GSDF) to verify it does not
deviate by more than 10% of the
targeted response (If Available)

• Verify Monitor meets Manufacture Specs


through Automated Testing
(If Available)

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AWS Monitor QC

• Use of TG18-QC Pattern to Evaluate


Monitor
(If Available)

• Use of TG18-LN01 & TG18-LN18


Patterns to Measure Luminance
(If Available)

• Use of TG18-UNL80 Pattern to Measure


Uniformity (If Available)

Refer to TB-01364 - Setup of Barco


QAWeb on Dimensions/3Dimensions AWS
for further details

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AWS Monitor QC

• Any large significant blemish that


interferes with the visualization or QC of
images is considered a failure and must
be corrected prior to clinical use

• Failure of Test Pattern Image Quality,


Luminance Check, Luminance
Uniformity, DICOM GSDF, or Monitor
Manufacturer Automated Test(s) must be
corrected within 30 days.

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RWS Monitor QC

• Verify Monitor is clean from anything that may


interfere with Clinical Information

• Verify Monitor is Calibrated Correctly and


Brightness & Contrast Settings are Correct (If
Available)

• Verify Image Quality and No Artifacts Present

• Evaluate DICOM Grayscale Display Function


(GSDF) to verify it does not deviate by more
than 10% of the targeted response (If Available)

• Verify Monitor meets Manufacture Specs


through Automated Testing
(If Available)

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RWS Monitor QC

• Evaluate ACR DM Phantom Image for


Artifacts and Score it (2 Fibers, 3 Speck
Groups, 2 Masses Minimum)

• Use Measurement Tool to Measure


Distance Across Wax Insert (70mm ±
14mm)

• Evaluate Ambient Light In Reading


Room. (Typically 20 – 45 lux)

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RWS Monitor QC

• Use of TG18-QC Pattern to Evaluate Monitor

• Use of TG18-LN01 & TG18-LN18 Patterns to


Measure Luminance

• Use of TG18-UNL80 Pattern to Measure


Uniformity

• Failures must Corrected Prior to Clinical Use

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RWS Monitor QC

• Any large significant blemish that interferes


with the visualization or QC of images is
considered a failure and must be corrected
prior to clinical use

• Failure of ACR DM Phantom Evaluation and


Distance Measurement must be corrected
prior to clinical use

• Failure of Test Pattern Image Quality,


Luminance Check, Luminance Uniformity,
DICOM GSDF, or Monitor Manufacturer
Automated Test(s) must be corrected within
30 days.

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RWS Monitor QC (Monthly)

• Evaluate ACR DM Phantom Image for


Artifacts and Score it (2, 3, 2 Minimum)

• Use of TG18-QC Pattern to Evaluate


Monitor (If Available)

• Type of Failure Determines if it is to be


Corrected Immediately or Within 30
Days

• Evaluate ACR DM Phantom Image for


Artifacts and Score it (2 Fibers, 3 Speck
Groups, 2 Masses Minimum)

• Use of TG18-QC Pattern to Evaluate


Monitor (If Available)

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RWS Monitor QC (Monthly)

• Any large significant blemish that


interferes with the visualization or QC of
images is considered a failure and must
be corrected prior to clinical use

• Failure of ACR DM Phantom Evaluation


must be corrected prior to clinical use

• Failure of Test Pattern Image Quality or


Monitor Manufacturer Automated Test(s)
must be corrected within 30 days.

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AWS Monitor QC (Monthly)

• Verify Monitor is clean from anything that may


interfere with Clinical Information

• Verify Monitor meets Manufacture Specs through


Automated Testing
(If Available)

• Use of TG18-QC Pattern to Evaluate Monitor


(If Available)

• Any large significant blemish that interferes with


the visualization or QC of images is considered a
failure and must be corrected prior to clinical use

• Failure of Test Pattern or Monitor Manufacturer


Automated Test(s) must be corrected within
30 days.

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RWS Monitor QC (Monthly)

• Verify Monitor is clean from anything that


may interfere with Clinical Information

• Verify Image Quality and No Artifacts


Present

• Verify Monitor meets Manufacture Specs


through Automated Testing
(If Available)

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Manufacturer Calibrations (if applicable)

• To ensure the DBT system is calibrated


properly according to the manufacturer’s
recommendations

• Applicable if manufacturer’s
documentation includes routine
calibration(s)

• Unit must meet prescribed periodic


calibrations

• Failures must be corrected prior to


clinical use

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Collimation Assessment

• 2D – To be performed on initial MEE,


relevant service or component
replacement

• DBT – To be performed on initial


MEE, annually and after relevant
service or component replacement

• Verify Light Field to Radiation Field


Alignment

• Sum of misalignments of opposite sides


is within 2% of SID (14 mm)

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MEE or Troubleshooting – Collimation Assessment

• Verify X-ray to Image Receptor Alignment


• X-Ray should not extend beyond receptor on
any side by more than 2% of SID (14 mm)
• Maximum cutoff of -2% of SID (14 mm) on
Left and Right Sides
• Maximum cutoff of -4% of SID (28 mm) on
Anterior (Nipple)
• No Cutoff on Chest Wall Edge

• For MEEs, failures must be corrected prior to


clinical use

• For Troubleshooting, failures must be corrected


within 30 days

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MEE or Troubleshooting – Beam Quality (HVL)

• Verify X-Ray Beam is Adequate for


Patient Dose, but not Excessive so
Contrast is Lost in the Image

• Determine HVL at Technique for ACR


Phantom.

• Dosimeter at ACR Phantom Height of


4.2 cm. Paddle Closest to X-Ray Tube

• Test is performed on all target/filter


combinations (including tomo)

• Pass/Fail Criteria:

• HVL ≥ kVp/100 - Failure must be corrected


before clinical use

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MEE or Troubleshooting – kVp Accuracy & Reproducibility

• Make 3 Exposures at the Most Commonly Used kVp.

• Make 1 Exposure at the Lowest Clinically Used kVp that


can be Measured

• Make 1 Exposure at the Highest Clinically Used kVp


(includes tomo)

• Pass/Fail Criteria:

• Verify kVp is Accurate within


± 5% of Indicated kVp

• Verify Coefficient of Variation is ≤ 0.02

• For MEEs, failures must be corrected prior to clinical use

• For Troubleshooting, failures must be corrected within


30 days
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Troubleshooting – Ghost Image Evaluation

• Verify latent images are not present on


current image that impacts usage.

• Make 1 AEC Exposure with ACR DM


Phantom covering half of detector (AEC
Cells to be covered)

• After 1 minute, make 1 Manual


Exposure closest to AEC exposure with
ACR Phantom covering entire detector
and 0.1 mm Al (10 cm x 10 cm) in center
of imaging field.

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Troubleshooting – Ghost Image Evaluation

• Use ROI tool and measure mean signal


values in the raw version of the second image.
Calculate Ghosting Index
• S1 – Value over the uniform attenuator on the side
where the attenuator was present in the 1st image

• S2 - Value over the uniform attenuator plus the


aluminum square on the side where the attenuator
was present in the 1st image

• S3 - Value over the uniform attenuator plus the


aluminum square on the side where no attenuator
was present in the 1st image

• Pass/Fail Criteria:
• Ghosting Index must be less than ± 0.3
• Failures must be corrected prior to clinical use

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MP Involvement in
Equipment
Adjustments,
Changes, or Repairs

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ACR 2018 DM QC Tests - Technologist

• Frequency of Test Vary by Type


o Weekly
o Monthly
o Quarterly
o Semi-Annually
o As Needed – Optional
o Per Mftr. Recommendation
• Detector Calibration

• Resolution Time Varies by Type


o Critical - Before Clinical Use
o Non-Critical – 30 Days

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ACR DM Phantom Image Quality (Weekly)

• To be performed on 2D and DBT Modes

• Verify No Clinically Significant Artifacts Exist

• Minimum Score of 2 Fibers, 3 Speck


Groups, and 2 Masses Required

• Failures to be corrected prior to clinical use.

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Compression Thickness Verification (Monthly)

• Use Smallest Non-Flex Paddle Available


on an item 10 cm long x 10 cm wide (or
less) Measure height with ruler.

• With 10 – 15 lbs applied, verify accuracy


is within ± 5 mm of measured

• Failures to be corrected within 30 days

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Visual Checklist (Monthly)

• *Cleaning solution available

• *Locks operate

• *Paddles and Breast support have no cracks

• Verify room and equipment are dust free

• Verify Indicators, and Collimator Light are working

• Cables are safely positioned

• C-Arm and Compression Assembly Travel is Smooth

• *Critical Failures to be Corrected Immediately

• Non-Critical Failures to be Corrected Within 30 Days

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Compression Force Verification (Semi-Annually)

• Verify manually, that the compression


device can meet 25 lb. minimum
requirement.

• Verify using initial power drive mode,


that the compression is between
25 and 45 lbs.

• Verify compression device maintains


compression

• Failures to be corrected prior to clinical


use.

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Manufacturer’s Detector Calibration (if applicable)

• Verify detector is calibrated properly


according to manufacturer’s
recommendations.

• Failures to be corrected prior to clinical use.

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Repeat Analysis (Optional)

• To determine number and cause of


repeated mammogram images

• Repeat rate to be 2% or less, but 5% is


allowed if agreed to by Medical Physicist
and Radiologist.

• Source of problem should be identified


and corrected within 30 days.

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Thank You

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