3/14/12
ACR MAP QC in
the Digital Era
Douglas Pfeiffer, MS, DABR
Boulder Community Hospital
Some New Additions
To The Fold
✦
Agfa CR Mammography
✦
Carestream CR Mammography
✦
Giotto FFDM
✦
And
t
c
o
ntin he conf
Lorad Dimensions
u
ues
to g sion
r
Philips/Secta
ow…
Fuji FDR Mammography
✦
Planmed monitor
✦
✦
ACR Subcommittee on Quality Assurance
✦
Clinical Representatives
✦
MITA Representatives
✦
ACR Representatives
Clinical Representatives
✦
Chris Adent-Delaney, RT - Northwestern Memorial Hospital
✦
Jay Baker, MD – Duke University Medical Center
✦
✦
Shelli Dixon, RT – The Women’s Imaging Center of Denver
✦
R. Edward Hendrick, PhD
✦
✦
Lawrence Bassett, MD – UCLA Medical Center
✦
Chair, Joint Committee on Breast Imaging for Appropriateness
Criteria and Guidelines
Chaired by Eric Berns, PhD (Denver Health)
Debra Monticciolo, MD – Texas A&M Health Sciences Center
✦
Chair of ACR Accreditation Program Chairs
✦
Chair of ACR Mammography Accreditation
✦
Douglas Pfeiffer, MS – Boulder Community Hospital
✦
Margarita Zuley, MD – University of Pittsburgh Medical Center
1
3/14/12
MITA Representatives
✦
ACR Representatives
Medical Imaging & Technology Alliance
✦
[John Sandrik, PhD (Ret.) – GE Medical Systems]
✦
Robert Uzenoff – FUJIFILM Medical Systems
✦
[Stephen Vastagh – MITA (now in new position)]
✦
✦
✦
Moustafa Zerhouni – Computerized Imaging
References Systems
Subcommittee Charge
✦
✦
✦
Update the 1999 ACR Screen-Film QC Manual
Priscilla Butler, MS – Senior Director, ACR
Breast Imaging Accreditation Programs
Subcommittee Goals
Design ACR Accreditation Phantom for FFDM
Write QC Manual for ACR FFDM
Mammography Accreditation Program
Marion Boston, RT – Manager, ACR Breast
Imaging Accreditation
✦
Standardize all QC tests for all digital
manufacturers
✦
Standardize test frequencies
✦
Standardize performance criteria
✦
ACR FFDM QC Manual to become basis of
new regulations
2
3/14/12
QC Tests
✦
Process
Based on a variety of sources
✦
MQSA
✦
SFM
✦
ACRIN DMIST
✦
Manufacturer’s QC programs
✦
MITA
✦
Subcommittee clinical experience ✦
Apply to all manufacturers
✦
Be clinically relevant
✦
Be user friendly
Phantom Design Goals
✦
More challenging targets
✦
More sensitive to changes
✦
Fewer digital processing artifacts
✦
Full field
✦
Same attenuation as current phantom
✦
Same Pass/Fail targets as current phantom
✦
Design & build new phantom
✦
Write QC Manual
✦
✦
When complete, draft will be sent to
manufacturers for their input
When final, ACR will apply for the
alternative standard under current
regulations
Current Phantom
3
3/14/12
Everything I
Say From Now
On Might Be A
Lie Cousins
Prototype Phantom
Prototype in Clinical Environment
4
3/14/12
ACR Phantom Prototype
Wax Insert Specifications with Virtual “Placement Grid”
ID Tag Specs
Depth of CNR Cavity = 0.1 + 0.005 cm
Wax = 0.70 cm + 0.02 cm
Total Insert Depth = 0.75 cm
1.5 cm
Tolerances (Insert Well & CNR Cavity)
Compensator = 0.023 cm
Total Thickness Under Insert
= 3.05 cm
•
Wax insert well depth : ±0.005 cm (+ 2 mils).
•
Wax insert well width and length : +0.04 / -0.00 cm
•
CNR cavity depth : ±0.005 cm (+ 2 mils).
•
CNR diameter : ± 0.05 cm.
Location of Virtual Box
0.49 cm
ID Tag
2.0 cm
6.98 cm
Test object distance from
base of wax = 0.35 + 0.10 cm
Total Thickness =
4.10 + 0.03 cm
Virtual Box: height = 0.5 cm, length = 1.8 cm
12.98 cm (+ 0.00, - 0.04 cm)
Cover =Nominal 0.3
cm
Air Gap = 0.027 cm Nominal
(+ 0.00, - 0.04 cm)
2.0 cm
31.0 + 0.1 cm
2.0 cm
0.49 cm
2.0 + 0.05 cm
CNR Cavity (0.1 + 0.005 cm Deep)
Centered Left to Right
19.0 + 0.1 cm
1.0 + 0.05 cm
9.5 cm
0.49 cm
Milled out wax insert
area
13.0 cm
(+0.04, -0.00 cm)
2.0 cm each
0.49 cm
Notes:
Test objects to be centered on their respective “placement grid” locations.
0.49 cm perimeter around test object “placement grid”.
ID Tag
0.635 cm (1/4 inch) radius on corners of wax insert.
Milled out wax
insert area
7.0 cm
(+0.04, -0.00 cm)
Fiber Placement specs
Fiber specifications
Speck Placement & Specs
1.
Specks to be placed at points on
star and middle of star
2.
Speck Size (spherical) = See Table
3.
Center speck placement to be within
+ 0.1 cm of center of virtual grid
4.
Distance from center speck to
center of speck on perimeter = 0.5
cm + 0.1 cm
Fiber Length = 1.0 cm + 0.1 cm
Screws
Fiber
Fiber
Fiber Diameter = See Table
2.5 + 0.05 cm
1.0 + 0.05 cm
o
o
45 + 5
45o + 5o
Mass Placement & Specs
1.
Mass pre-cut sphere diameter = 5/8 inch
2.
Mass placement to be within + 0.1 cm of
center of virtual grid
1.0 + 0.05 cm
Attenuation Compensator
Compensator is 9 mil polyvinylidene (C2H2Cl2)
Clinical Unit Image
Lorad/Hologic Digital Mo/Mo
Auto-Filter
52 mm
Mo/Mo
29 kVp
66 mAs
1.64 mGy
5
3/14/12
The New Insert
Attenuation Equalization
Specks are lime glass spheres
Expanded View of Specks
Insert Design
0.89
0.75
0.61
0.54
0.40
0.30
(mm)
Fiber Diameter 0.33
0.28
0.23
0.20
0.17
0.14
(mm)
Speck Diameter 1.00
0.75
0.50
0.38
0.25
0.20
(mm)
Mass Sliver Thickness 6
3/14/12
Test
Visual
Object Comparison
^!
Fibers
(mm)
Specks
(mm)
Fibers
(mm)
Masses
(mm)
FFDM
ACR 156
FFDM
(Glass Spheres)
ACR 156
Specks
(mm)
Masses
(mm)
Test Object
Test Object
ACR 156
Pass/Fail Criteria
ACR 156
FFDM
FFDM
ACR 156
FFDM
ACR 156
FFDM
1.56
1.56
2.00
0.89
0.40
1.00
1.00
0.75
0.75
0.32
0.33
0.75
0.75
0.28
0.50
0.50
0.61
0.54
0.54
0.40
0.40
0.30
0.24
0.23
0.20
0.16
0.25
0.17
0.14
Phantom Scoring
0.54
1.12
0.54
0.89
1.12
Fail
Pass
4 0.89
0.89
0.40
0.75
0.75
0.32
2 1.00
0.33
0.28
0.61
0.38
0.54
0.54
0.25
0.40
0.40
0.20
3 2.00
0.30
0.24
3 0.50
0.23
0.20
0.16
3 0.75
1.00
2 0.75
0.50
0.38
0.25
0.17
0.25
0.20
0.14
CR Imaging
7
3/14/12
CR Imaging
Screen-Film Imaging
Screen-Film Imaging
AEC Technique Comparison
Heel effect
Screen defects
Mode
Dark center to
light edge
Roller marks
Lorad – Mo
Lorad - W
Fuji CR
18 x 24 cm
Fischer
Auto-Filter
Auto-Filter
AA
Auto-Technique
Phantom
FFDM
SFM
FFDM
SFM
FFDM
SFM
FFDM
SFM
Compression
Thickness
(cm)
5.2
5.2
5.2
5.2
4.0
4.0
5.74
4.05
Target/Filter
Mo/Mo
Mo/Mo
W/Rh
W/Rh
Mo/Mo
Mo/Mo
W/Al
W/Al
kVp
29
29
28
28
27
27
31
27
mAs
66.4
65.4
92.5
97.6
90
89
177 mA
158 mA
Machine
Reported
Dose (mGy)
1.64
1.61
1.03
1.08
**
**
0.954
1.211
Dust
8
3/14/12
Manual Technique Signal
Comparison
Measurements Using Phantom
Lorad/Hologic – Mo/Mo
✦
ACR Phantom Image Quality
Manual
✦
Compression Thickness Consistency & Verification
Mode
Phantom
FFDM
SFM
✦
Phantom AGD Check
Target/Filter
Mo/Mo
Mo/Mo
✦
AEC Consistency
kVp
29
29
✦
Phantom Scoring on Monitors
mAs
65
65
✦
SNR/CNR Consistency
Signal in Wax
542.0
546.5
✦
Artifact Evaluation
✦
Exposure Duration
St. Dev. In Wax
9.7
9.7
Measurements Using Phantom
✦
Laser Printer QC
Measurements Using Phantom
✦
Monitors
Phantom Scoring ✦
✦
ACR Phantom Scoring
Artifact Evaluation
✦
✦
Artifact Check
✦
Background OD Check
✦
Dmax OD Check
✦
Contrast OD
✦
ACR Phantom Printed Size Check
50%
41% RT tes
ts
Phy
si
use t cs tests
he
new
phan tom
✦
Ghost Image Evaluation
✦
Spatial Resolution
✦
Average Glandular Dose
✦
CR Artifact Evaluation (if applicable)
✦
CR SNR Inter-Plate Consistency (if applicable)
9
3/14/12
QC Manual
ACR Digital QC Draft Manual
•  Structure of Manual:
–  Radiologist’s Section
✦
Focussing on FFDM
✦
Selective, high-yield tests
✦
Applicable to all units
✦
Will eventually unify with screen-film manual
–  Clinical Image Quality Section
–  Radiologic Technologist’s Section
–  Medical Physicist’s Section
–  Educational, Guidance, and Troubleshooting Section
–  Glossary
–  References
–  Index
What Will Be New?
•  Radiologist Section
–  Image ID regulations
–  Hanging protocols (left vs. right)
–  Monitor and viewing conditions guidance
–  Section on diagnostic tools for analyzing poor images
What Will Be New?
•  Tech Section
–  Enhanced positioning and image quality section
–  New Test: Monitor QC for the Radiologist
–  New Test: Facility QC Review
–  New Format: Corrective Action Log
–  New Documentation: Facility Equipment Inventory
–  How to score the ACR FFDM Phantom
–  Improved QC Forms
–  Guides for understanding their role and responsibility for
–  Instructions for Mobile Units
overseeing the QC program
–  Eliminate calculations (TBD)
10
3/14/12
What Will Be New?
•  Medical Physicist Section
–  Theme: provide better documentation and communication
– Single MP Summary Form
What Will Be New?
•  Medical Physicist Section
–  Provide QC forms in both PDF and Excel Worksheets
– For Facility, ACR, State and MQSA Inspectors
– Include an Action Item Summary
– MP form for Tech for Operating Levels (if app.) and QC
instructions
–  Will include guidance on how to test
– Multiple units (FFDMs, AWs, RWs, Printers, etc)
– Procedures for evaluating and documenting Tech QC
– MP letter to the Radiologist
– Multiple facilities
– MP to use same Corrective Action Log form as Techs
What Will Be New?
•  Facility
–  Guidance on how to handle multiple units at multiple
locations
–  Guidance on who/what/when tests need to be performed
when “major” and “minor” repairs are performed on unit
Technologist QC
Tests
–  Facility QC Review (Tech Test) – Quarterly
11
3/14/12
ACR Digital QC Draft Manual
Tech Tests
Frequency: Quarterly
Objective
Name (# of Test Elements)
Frequency: Tech Quarterly
Facility
MAP ID-Unit# (00000-00)
Procedure
Technologist QC Tests
Test
Number
8. Monitor QC For The Radiologist
1. This test is to be performed or supervised by the Lead Interpreting Radiologist.
2. The Technologist should deliver this form to the Radiologist, ensure correct completion,
follow-up on any failures, and place the form into QC notebook.
3. This test should be performed for each FFDM or CR unit within a facility on a quarterly basis.
4. This test can be performed on the same workstation for multiple FFDM or CR units.
5. Example: A Radiologist can sit at one workstation and view the images for all the FFDM and/or
CR units within a facility. The Radiologist does not need to evaluate every monitor at every workstation.
This test is for the Radiologist to perform an evalution of the entire mammographic imaging chain with the
focus being primarily on the detector and secondarily on the monitors.
This test is not intended to evaluate technologist issues such as positioning, compression, etc.
Minimum Frequency
Required Corrective Action
1
ACR Phantom Image Quality (5)
Weekly
Before Clinical Use
Procedure for Radiologist
2
Acquisition Workstation (AW) Monitor QC (3)
Weekly
Before Clinical Use
Step 1:
3
Radiologist Workstation (RW) Monitor QC (5)
Weekly
Before Clinical Use
4
Laser Printer QC (5)
Weekly
Before Clinical Use
5
Viewbox Cleanliness (1)
Weekly
Before Clinical Use
6
Visual Checklist (1)
Monthly
Before Clinical Use
7
Repeat Analysis (1)
Quarterly
Within 30 Days
8
Monitor QC for the Radiologist (1)
Quarterly
Before Clinical Use
9
Facility QC Review (1)
Quarterly
Not Applicable
10
Compression Force (1)
Semiannual
Before Clinical Use
Room ID
FFDM Unit Mfr & Model
Monitor ID
Complete the demographics:
Radiologist Name
Date of Evaluation
Step 2.
Pull up a any recent
mammographic study from the
above listed FFDM unit and
record ID & Study Date.
Step 3.
Place the same LMLO image on
each monitor.
Step 4.
Evaluate the images for the
following artifacts and check the
appropriate boxes.
Image ID:
Study Date:
Left Monitor Right Monitor
Yes
No
Comparing the monitors, do the background area (outside of
breast tissue) appear different (darker or lighter, etc…)
Is there a difference in contrast within the breast between monitors?
Does the image contain excessive noise (not patient motion)?
Manufacturer Detector Calibration (If Applicable)
Per Mfr Recommendation
For examples and more detailed
descriptions, please see the
Guide on Identifying Artifacts.
Before Clinical Use
Do you see ghosting?
Do you see "bad pixels" (singular or clusters) (white or black)?
Do you see white dots that could be from excessive dust?
Do you see any form of image distortion (not architectural distortion)?
Supplemental Forms
Do you see gridlines?
Step 5.
If necessary, document any
Do you see artifacts that could be due to image processing?
failures on the "Corrective
Corrective Action Log
Do you see "line artifacts" (single or multiple pixels that form lines
extending across image - horizontally or vertically)?
Action Log" form and ensure
Are there any other artifacts that are present and clinically
significant (impeding interpretation)?
items are resolved.
Facility Equipment Inventory Form
If any box is checked "Yes", then seek service.
Action Limits
Timeframe:
If an image quality problem or artifact impedes clinical interpretation, then seek service
immediately or before further imaging or interpretations are performed.
If the artifact does not impede clinical interpretation, then seek service within 30 days.
Tech Tests
9. Facility QC Review
Frequency: Tech Quarterly
Facility:
Date of QC Mtg:
Reviewed
1. Review and update "Facility Equipment Form"
Tech Tests
9. Facility QC Review - Cont'd
Facility:
Frequency: Tech Quarterly
Date of QC Mtg:
QC Meeting Notes
2. Review Medical Physics Surveys and Results
Room 1
Room 2
Room 3
Room 4
Room 5
Room ID
Date of last Medical Physicist (MP) survey
Written survey results communicated to Radiologist by MP?
6. Significant or notable findings during QC meeting
"Executive Summarey for Facility" reviewed by Radiologist?
Follow-up
Confirmed
(If App.)
11
All MP corrective action completed?
ACR Phantom Dose (mGy)
Fibers
Specks
Masses
3. Review Tech QC
Test
Frequency
1 ACR Phantom Image Quality
Summary Comments from Last Quarter
Weekly
Room 1
Scores of most recent
phantom image:
Room 2
Room 3
Room 4
Room 5
Room ID
7. Items for quality improvement from QC Meeting
Fibers
Specks
Masses
Artifacts? (Yes/No)
2 AW Monitor QC
3 RW Monitor QC
4 Laser Printer QC
Weekly
Weekly
Weekly
5 Viewbox Cleanliness Check
Weekly
6 Visual Checklist
Monthly
7 Repeat Analysis
Quarterly
8 Monitor QC for the Radiologist
% Repeats
8. Other QC Notes:
Quarterly
9 Facility QC Review
Quarterly
10 Compression Force
Semiannual
11 Manufacturer Detector Calibration (If App.)
4. Review and verify completion of all "Corrective Action".
5. Technique Chart review for each room (see MP report for recommended chart) - (Annually).
6. Offsite RW(s) & Laser Printer(s) QC Reviewed.
7. Recent past and future service or service upgrades reviewed and discussed (if app).
8. Recent past and future State and/or MQSA inspections reviewed and discussed (if app).
9. ACR Accreditation issues discussed (if app.)
Supervising radiologist and facility manager must review QC quarterly.
Technologist should update the Facility Summary Form at least annually.
Action Limit:
Technologist and Lead Intepreting Radiologist should review technique charts at least annually
for each FFDM system.
Timeframe: NA
Lead Interpreting Radiologist
Facility Manager (If App)
Lead QC Tech
12
3/14/12
Tech Tests
11. Manufacturer Detector Calibration (If Applicable)
Facility
MAP ID-Unit# (00000-00)
Corrective Action Log
Facility Name
MAP ID# (00000-00)
Date
Room or Equipment ID
QC Test Name and # (if app.):
Frequency: _________________________
Description:
Frequency: Per Manufacturer Recommendations (If Applicable).
Manufacturer Procedure
Tech Tests
Note: See Medical Physicist for instructions (if any).
Relevant Personnel Notified:
Year
Personnel Name:
Date/Time of Call/Notification:
(Rad, MP, Tech, Manager,
Service Engineer)
Date (Month & Day)
Describe Actions Taken:
Tech Initials
Unit Description
Confirmation of Resolution:
Yes
To Be
Monitored
NA
Event resolved?
Tech Signature
Documentation from Service Engineer Obtained?:
Date
Date
Room or Equipment ID
QC Test Name and # (if app.):
Description:
Relevant Personnel Notified:
Personnel Name:
Date/Time of Call/Notification:
(Rad, MP, Tech, Manager,
Service Engineer)
Describe Actions Taken:
Pass = P
Action Limits
Fail = F
Unit must pass manufacturer's prescribed periodic calibration test.
Confirmation of Resolution:
Yes
Event resolved?
Timeframe: Immediately
Documentation from Service Engineer Obtained?:
To Be
Monitored
NA
Tech Signature
Date
Facility Equipment Inventory Form
Tech Tests
Facility
Address
Address
Address
QC Technologist:
Lead Interpreting Radiologist
Medical Physicist:
Facility Manager
Date Last Updated:
List facility and equipment data for entire breast imaging network.
Facility Location
Example: Main
Breast Center
MAP ID
Medical Physicist
QC Tests
12345
Location Designation
Room 3
Device (See Key Below)
FFDM
Manufacturer
GE
Model
2000D
Serial Number
1234-56-7890
Customer Service ID
111-222-333
Service Telephone #
800-123-4567
Date of Manufacture
December-09
MP Survey Date
9/17/2011
MP Survey Date
9/23/2012
MP Survey Date
9/5/2013
MP Survey Date
9/13/2014
MP Survey Date
etc…
MP Survey Date
MP Survey Date
MP Survey Date
MP Survey Date
MP Survey Date
MP Survey Date
Device Key
FFDM = Full Field Digital Unit
SFM = Screen-Film Unit
CR = Computed Radiography Unit
LP = Laser Printer
FP = Film Processor for Screen-Film Unit
AW = Acquisition Workstation
RW = Radiologist Workstation.
13
3/14/12
ACR Digital QC Draft Manual
ACR Digital QC Draft Manual
Medical Physicists QC Tests
Medical Physicists QC Tests
Test
Number
Name (# of Test Elements)
Test
Number
Minimum Frequency
Required Corrective Action
1
ACR Phantom Image Quality (6)
Annual
Before Clinical Use
2
Ghost Image Evaluation (1)
Annual
Before Clinical Use
1
Medical Physicist Summary Report
3
Spatial Resolution (1)
Annual
Before Clinical Use
2
Technologist Operating Level Information and QC Instruction Form
4
Automatic Exposure Control System Performance (2)
Annual
Before Clinical Use
3
Medical Physicist Summary Letter for the Radiologist
5
Collimation Assessment (3)
Annual
Within 30 Days
4
Mammography Corrective Action Log
6
kVp Accuracy and Reproducibility (1)
MEE Only
Before Clinical Use
5
Technologist Pre-Inspection Interview Form
7
Beam Quality (Half-Value Layer) Assessment (1)
Annual
Within 30 Days
6
Technique Chart
8
Average Glandular Dose (2)
Annual
Before Clinical Use
Before Clinical Use
9
Unit Checklist (1)
Annual
10
Evaluation of Site’s Technologist QC Program (1)
Annual
Within 30 Days
11
MQSA Equipment Requirements (1)
MEE Only
Before Clinical Use
12
Computed Radiography (If Applicable) (3)
Annual
Before Clinical Use
13
Acquisition Workstation (AW) Monitor QC (6)
Annual
Before Clinical Use
14
Radiologist Workstation (RW) Monitor QC (11)
Annual
Before Clinical Use
15
Laser Printer QC (7)
Annual
Before Clinical Use
16
Viewbox Luminance and Room Illuminance (2)
Annual
Before Clinical Use
17
Evaluation of Off-Site Technologist QC Program (If
Applicable)
Annual
Before Clinical Use
Supplemental Forms
ACR Digital QC Draft Manual
Challenges
Tech & MP
Test
Number
✦
Name
Educational and Example Forms
1
Complete set of forms with example data, scores, and calculations
2
ACR Phantom Scoring Guide
3
SNR & CNR Calculation Guide
4
Monitor Test Pattern Evaluation Guide
5
Printed Film Evaluation Guide
6
FFDM Artifact Guide
Name
✦
✦
✦
Accounting for, and incorporating, all the
different FFDM technologies
Handling offsite equipment
Predicting and accounting for future FFDM
systems
Ensuring all necessary tests are included,
meaningful, and relevant
14
3/14/12
What’s Next
3 Steps
✦
Preemptive Questions
Cost of phantom?
✦
When ready, draft will be sent to manufacturers, FDA, and
Implementation and roll-out?
✦
✦
Subcommittee to review comments and edit manual
✦
Final draft to be sent to FDA from ACR to apply for alternative
Don’t know. Reason to believe it will be affordable.
✦
select reviewers for preliminary feedback
ACR to develop a plan to include some sort of training.
✦
standard under current regulations
✦
When?
✦
Goes to FDA Summer 2012 for review as alternative
standard
✦
Alternative standard will allow facilities to use this instead of the
manufacturer’s manuals
✦
Potential for ACR QC Manual to be basis for new MQSA Regulations
Future Efforts
Summary
✦
✦
Finish manual
✦
Submit to MITA for comments
✦
✦
✦
Submit to FDA for approval as an alternative
standard under current regulations
✦
The only way for this to be effective is to make QC
phantom and manual a requirement
Having a single phantom with a unified QC manual
and program solves many problems Tests designed to be:
✦
User friendly
✦
Organized to maximize efficiency ✦
Provide data to reflect performance of systems
Remember, the above tests still have to undergo two
more reviews
15
3/14/12
Many Thanks...
✦
Eric Berns, PhD
✦
Penny Butler, MS
16