Slide 1
Slide 2
Introduction
Digital
Mammography
Detector QC
z What is FFDM QC and why is it
Eric A. Berns, Ph.D.
z What to know before you start
important?
z Overview and compare QC tests
eric.berns@gmail.com
University of Colorado at Denver and HSC
Denver, CO
Slide 3
z Key take home points
Slide 4
Introduction
Introduction
5,911 SFM Units
Certified Statistics – Past Year
July 1, 2007
July 1, 2008
Difference
Total Certified
Mammo
Facilities
8,837
8,714
-123
Total Accredited
Mammo Units
13,450
12,875
-575
Certified
Facilities with
FFDM units
3,366
4,659
+1,293
Accredited
FFDM units
5,119
6,964
+1,845
Slide 5
z MQSA
– Mammography Quality Standards Act
z ACR
– American College of Radiology
Slide 6
ScreenScreen-Film
FFDM
z
z
In FFDM, the manufacturer designs and mandates their
own QC program and action limits
In FFDM, you must the manufacturers’
manufacturers’ QC program
1
Slide 7
Slide 8
z
AGFA IMPAX MA3000
–
–
–
–
–
–
–
z
Barco
Clean monitor surface
Measure display white & black
Measure quality level
Measure uniformity
Calibrate displays
View SMPTE pattern
Viewing conditions
z
–
–
–
–
I-Guard Check
Quality Level
Display White
Calibration Settings Check
z
GE Seno Advantage
–
–
–
–
z
Geometric distortion
Reflection
Luminance Response
Luminance Uniformity
Resolution
Noise
Overall Evaluation
Slide 9
z
Planar
–
–
–
–
–
Monitor Cleaning
Viewing Conditions Check
Monitor Calibration Check
Image Quality – SMPTE
Visual Inspection for Display
Defects
Slide 10
Quality Control: Why?
Reduce exposure to patients and
personnel
z
Pattern Check
Luminance Check
Grayscale Check
Uniformity Check
Siemens MammoReport Plus
–
–
–
–
–
–
–
z
Eizo
–
–
–
–
Viewing conditions check and setting
Monitor calibration
Image quality – SMPTE pattern
Analysis of screen uniformity
Consistent image quality
z Detect and correct for potential problems,
before they impact image quality
What is Quality Control?
z Determination
of what is “Normal”
Normal”
z Detection of what is “Abnormal”
Abnormal”
z Understanding of how to return to “Normal”
Normal”
from “Abnormal”
Abnormal”
z In particular, in FFDM, how do you know
what you are seeing is what it is supposed to
be?
Slide 11
Slide 12
Before You Begin QC
Before You Begin
z Golden Rules for FFDM QC
– Must use manufacturer’
manufacturer’s QC procedures
• Mandate action limits
– Manufacturers’
Manufacturers’ QC may refer to Monitor & Printer
Manufacturers’
Manufacturers’ QC
z Obtain proper training &
– HandsHands-on training on actual unit:
• Mechanics
– Multimodality Workstations have own separate QC
• Software
– Printers may have their own QC
• Artifacts
– Most failures result in stopping clinical imaging
until failure can be corrected
CE credits (8 hours)
• Learn vendor specific tests and tricks
2
Slide 13
Slide 14
Before You Begin
z Must have proper continuing experience:
Before You Begin
z Note:
– For new unit:
unit: Must use most current
– 2 facilities
version
– 6 units
– For renewal unit:
unit: Can use older
– Within last 2 years
version (version used when tested
previously)
Slide 15
Slide 16
Before You Begin
z
Before You Begin
ACR Accreditation - www.acr.org
– Physics forms
• http://acr.org/accreditation/mammography/mammo_qc_forms.aspx
–
–
–
–
–
GE Senographe 2000D, DS, and Essential
Fischer Senoscan
Lorad Selenia
Siemens Novation
Fuji FCRm
• Note:
Note: if using unit for both screenscreen-film & CR, you must accredit for
both
z
FDA Accreditation
– www.fda.gov/cdrh/mammography/
www.fda.gov/cdrh/mammography/
– Other vendors when approved
Slide 17
Slide 18
Before You Begin
Before You Begin
3
Slide 19
Slide 20
Before You Begin
Before You Begin
Slide 21
Slide 22
Collimation
z
Limiting Spatial Resolution
ScreenScreen-Film Mammo
z ScreenScreen-Film
– Assure XX-ray field aligns with the light field
– LineLine-pair test tool
– Collimator allows full coverage of receptor
• Focal spot
– Chest wall edge of compression paddle aligns with chest
wall of receptor
z
Mammo
z FFDM
FFDM
– LineLine-pair test tool
– Same
• Focal spot
– Multiple target/filters and/or multiple paddle positions
• Detector & imaging chain
– Chest Wall Missed Tissue
– Compression Plate Overlap on the Chest Wall Side
Slide 23
Slide 24
Spatial Resolution
Fuji FCRm
GE
2000D,
DS,
Essential
Fischer
Senoscan
AEC Performance
Lorad
Selenia
Siemens
Novation
z ScreenScreen-Film
Mammo
– Measure optical densities
• Different thicknesses using clinical modes
Same as ScreenScreen-Film
(Focal Spot Eval)
Eval)
Measure using LP
phantom on top of
acrylic
MTF
X
• Different density settings ((-2, -1, 0, +1, +2, etc.)
z FFDM
X
X
X
– Measure resultant techniques
X
X
– Measure signal, exposure, & SNR values
4
Slide 25
Slide 26
AEC
GE 2000D
Fuji FCRm
GE
2000D,
DS,
Essential
Fischer
Senoscan
Lorad
Selenia
Siemens
Novation
z
AOP Mode and SNR Check
– Variable thicknesses of acrylic
– Std, Auto
– Evaluate:
Same as ScreenScreen-Film
Density Control
Function
X
ACR Reproducibility
X
Image Mode Tracking
X
CNR
X
SNR
• Correct techniques?
• Adequate SNR?
X
X
X
X
X
Acrylic
Thickness
2.5 cm
TargetFilter
Mo-Mo
Selected
kVp
27 kVp
Selected
mAs
20-60
X
X
X
4.0 cm
Mo-Rh
28 kVp
35-90
6.0 cm
Rh-Rh
32 kVp
35-90
4.0 cm
Acrylic
Each “raw”
raw” image must have a measured SNR of
at least 50
Slide 27
6.0 cm Acrylic
Slide 28
GE DS & Essential
z
Lorad Selenia
DS specific QC tests
z
– AOP Mode and SNR Check
Automatic Exposure Control
– AUTOAUTO-FILTER – 2, 4, 6, 8 cm
• Use builtbuilt-in software for image acquisition
– 4 cm ((-5 thru +5, or -3 to +4)
• AOP: STD/Auto
– Use ROI to measure mean pixel value
inside virtual AEC detector
Exposure Parameters
For AOP STD mode oly
Acrylic Thickness
(mm)
Track/Filter
mAs
kV
25
Mo/Mo
2020-60
26
50
Rh/Rh
4040-90
29
60
Rh/Rh
4545-95
31
z
Slide 29
Performance Criteria
– Pixel value should not vary by more
than 10% of mean
– Exposure compensation steps shall
SNR must be > 50
meet requirements in pixel value table
Slide 30
Siemens Novation
z
2.5 cm
Acrylic
AEC Image Stability and Reproducibility and SNR
– ACR Phantom
Siemens Novation DR
z
AEC Thickness Tracking
– 2, 4, and 6 cm
– “H” mode
– Mo/Mo, 28 kV, “H”, sensor 1
– Max deviation = (Max difference / mean value ) * 100
– Record mAs,
mAs, SNR, Mean, Entrance Exposure (5 times)
z
Action Limits:
– Coef.
Coef. of Var for mAS and X < 5%
– SNR and Mean shall not vary by + 15% of Mean
5
Slide 31
Slide 32
Fuji FCRm
Fuji FCRm
z
z Density Control Function
Reproducibility & Image Mode Tracking
– 4 cm acrylic with clinical technique
– Position ion chamber in beam
– 4 cm acrylic, ACR phantom technique
– Record mAs and X
– Repeat 3 times
– Repeat at -2, -1, 0, +1, +2 etc. density
– Repeat in each mode (small, large, mag,
mag, no grid)
– Action Limits:
Limits:
– Record mAs
• Coefficient of variation for Exposure or mAs must not exceed
0.05
– mAs change should be 5 to 15% per step
• No significant difference in exposure between small and large
bucky when using similar grids
Slide 33
Slide 34
Uniformity of Screen Speed &
Detector Performance
Fuji FCRm
z
z CNR Per Object Thickness
– Measure if OD’
OD’s are consistent
– Check for artifacts
– CNR using clinical technique for 2 cm
z
– Repeat for 4 and 6 cm
FFDM
– FlatFlat-field uniformity
– Action Limits:
Limits:
– Detector calibration
• CNR of 2 cm relative to 4 cm must be > 100%
– Pixel correction test
• CNR of 6 cm relative to 4 cm must be > 75%
Slide 35
– CR Reader Scanner Performance
Slide 36
Detector Performance
GE
Fuji FCRm
2000D,
DS,
Essential
Fischer
Senoscan
Image Quality
Lorad
Selenia
Siemens
Novation
Same as ScreenScreen-Film
(Screen Uniformity)
X
Detector Calibration
X
X
CR Reader Scanner
Performance
X
Dynamic Range
X
Primary Erasure
X
InterInter-Plate
Consistency
X
Geometric Distortion
z ScreenScreen-Film
Mammo
– ACR Phantom Scores
FlatFlat-Field Uniformity
X
X
– Optical Density & Contrast
z FFDM
– ACR Phantom Scores
• Pass/fail requirements differ by vendor
– SignalSignal-toto-Noise Ratio (SNR)
X
Pixel Correction
Ghosting
ScreenScreen-Film Mammo
X
X
– ContrastContrast-toto-Noise Ratio (CNR)
X
6
Slide 37
Slide 38
Image Quality
Fuji FCRm
Image Quality
GE
2000D,
DS,
Essential
Fischer
Senoscan
X
X
X
X
Lorad
Selenia
ACR Phantom Imaging
Siemens
Novation
GE & Fischer &
Fuji
Lorad &
Siemens
Fibers
4
5
Specks
3
4
Masses
3
4
Same as ScreenScreen-Film
Manual Techniques
Clinical Technique
X
CNR
X
X
Partial
X
X
Slide 39
Slide 40
GE 2000D
ACR Phantom Imaging
z
GE 2000D
z
– Manual technique (Mo/Mo, 26
ContrastContrast-toto-Noise Test (CNR)
– To examine consistency of CNR
ratio measured over time
kVp, 125 mAS)
mAS)
– Use the raw image
– Score the processed image
– + 20% of baseline
– Acquisition workstation
Background ROI
– Each monitor of the RWS
Mass ROI
– Laser imager
CNR = (Mean
(Meanbackground - Meanmass)/SDbackground
Slide 41
Slide 42
GE DS
z
DS specific QC tests
– Phantom Image Quality
• Manual technique: Rh/Rh,
Rh/Rh, 29 kVp, 56 mAs
– MTF and CNR Measurement
• Use IQST test tool
• Use builtbuilt-in software for image acquisition
• Manual technique: Rh/Rh 30 kVp, 56 mAs
Lorad Selenia
z
Phantom Image Quality
– Select clinical exposure mode (i.e. AUTOAUTO-FILTER)
– Print film
– Measure background OD and density difference –
Plot on tech worksheets
• Background must be > 1.20 OD + 0.20
• DD must be > 0.40 + 0.05
– Score on each Soft Copy Workstation
• 5 fibers
• Results are automatically displayed (pass/fail)
• 4 speck groups
• Same action limits as 2000D
• 4 masses
7
Slide 43
Slide 44
Siemens Novation DR
z
Lorad & Siemens
Phantom Image Quality
– Position phantom 1 cm
over chest wall edge
z SNR and CNR Measurements
– Select: 28 kV, AECAEC-Auto,
Mo/Mo
– SNR at least > 40
– Score on RWS or Film
– CNR should stay within ±15% of baseline
– Fiber > 5
• Obtained during acceptance testing
– Specks > 4
– Masses > 4
Slide 45
Slide 46
Fuji FCRm
z
ContrastContrast-toto-Noise Test (CNR)
Dose
z ScreenScreen-Film
– To examine consistency of CNR ratio measured over time
Mammo
– Dose for single CC view of ACR phantom shall
– Use 4 cm acrylic & 0.2 mm Al
not exceed 3.0 mGy per exposure per FDA
– Manual technique (Mo/Mo, 26 kVp, 125 mAs)
mAs)
– Calculate CNR using software
z FFDM
– + 20% of baseline
Slide 47
Slide 48
Film Processing
z
– Same
Film Processor QC
ScreenScreen-Film Mammo
Fuji FCRm
– Measure optical densities
• Density difference, midmid-density, base+fog
• Measures consistency
Follow Printer
Manufacturers QC
If Not, Use Theirs
Follow FFDMs’
FFDMs’ QC
z
GE
2000D,
DS,
Essential
Fischer
Senoscan
X
X
X
X
X
X
Lorad
Selenia
Siemens
Novation
X
X
FFDM
– Manufacturers’
Manufacturers’ recommendations
– Some refer to printer manufacturers’
manufacturers’ recommendations
– Typically identical to ACR SFM Manual
8
Slide 49
Slide 50
Film Processing
Film Processing
z MidMid-Density
z Density Difference
Wet Processing
Laser Printer
Northwestern Memorial Hospital - Processor ID: 2 - MAR 2006
Mid-Density
Northwestern Memorial Hospital - Processor ID: Kodak 8900 - Oct 2006
Mid-Density
Wet Processing
2.30
2.20
Laser Printer
Northwestern Memorial Hospital - Processor ID: 2 - MAR 2006
Density Difference
Northwestern Memorial Hospital - Processor ID: Kodak 8900 - Oct 2006
Density Difference
2.60
1.70
2.50
1.60
2.40
1.50
2.30
1.40
2.20
HD Step=13
2.00
LD Step=10
MD Step=12
1.90
2.10
2.00
1.90
1.30
1.80
1.20
1.70
1.10
1.80
1.70
1.60
2.10
1.50
2.00
1.40
Mid-Density Upper Control Limit = 1.48
1.90
Mid-Density Daily Value
1.00
Mid-Density Upper Control Limit = 2.06
Mid-Density Daily Value Operating Level = 1.33
Mid-Density Daily Value
Density Difference Upper Control Limit = 1.77
1.30
Density Difference Upper Control Limit = 2.25
Mid-Density Lower Control Limit = 1.18
0.90
Mid-Density Daily Value Operating Level = 1.91
1.50
1.80
Density Difference Daily Value
Density Difference Daily Value
1.20
Density Difference Daily Value Operating Level = 1.62
1.70
Mid-Density Lower Control Limit = 1.76
Density Difference Daily Value Operating Level = 2.1
0.80
1.60
1.40
1.50
1-M
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Density Difference Lower Control Limit = 1.47
1.00
0.70
1.30
1.10
Density Difference Lower Control Limit = 1.95
Date
Date
Date
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Slide 51
Date
Slide 52
Artifacts
Film Processing
z Dmax
z ScreenScreen-Film
Mammo
Laser Printer
Northwestern Memorial Hospital - Processor ID: Kodak 8900 - Oct
2006
Dmax
– Evaluate cassettes
4.00
3.90
3.80
z FFDM
3.70
3.60
3.50
3.40
3.30
3.20
– Evaluate detector
3.10
3.00
Dmax Daily Value
2.90
Dmax - Operating Level = 3.44
2.80
Dmax Action Limit = 3.19
2.70
2.60
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– CR: Imaging Plates
Date
Slide 53
Artifacts
Artifacts
Fuji FCRm
GE
2000D,
DS,
Essential
Fischer
Senoscan
Lorad
Selenia
Siemens
Novation
X
X
X
X
X
Same as ScreenScreen-Film
Expose Using Acrylic
9
Artifacts
Artifacts
¾ Description:
Description:
¾ Description:
Description:
Hologic Good Flat
GE Good FlatFlat-field
Field
Image
Artifacts
Artifacts
¾ Description:
Description: Good
¾ Description:
Description: Acceptable
image
ACR Phantom image
¾ Raw image
¾ WW = 200
Artifacts
¾
Artifacts
Artifact evaluation – Contact Mode GE 2000D
¾ Artifact evaluation - windowing
Window width = 30
Mo/Mo
Mo/Rh
Mo/Rh
Window width = 200
Window width = 1000
Rh/Rh
10
Artifacts
Artifacts
¾ Description:
Description: NonNon-
¾ Description:
Description: Low
uniform background
¾ Possible Cause:
Cause:
Calibration file
¾ Solution:
Solution: Recalibrate
contrast overall
¾ Possible Cause:
Cause:
Window width too
wide – (~750)
¾ Solution:
Re-window
Solution: Re-
Artifacts
Artifacts
¾ Description:
Description: Poor
¾ Description:
Description: Vertical
contrast, fibers and
masses failing
¾ Possible Cause:
Cause: Ultra low
dose – Mo/Mo, 29 kVp,
25 mAs,
mAs, 0.58 mGy
¾ Solution:
Solution: Increase
techniques
Artifacts
and horizontal lines
¾ Possible Cause:
Cause:
Gridlines, grid
artifacts in in cal file
¾ Solution:
Solution: Check grid
mechanism,
recalibrate
Artifacts
¾ Description:
Description:
White vertical bands
¾ Possible Cause:
Cause:
Calibration file
¾ Solution:
Solution:
Recalibrate detector
11
Artifacts
Artifacts
¾ Description:
Description:
Magnification image,
¾ Description:
Description: White
several small flecks,
pixels
grayscale gradation
¾ Possible Cause:
Cause:
¾ Possible Cause:
Cause:
Detector going bad
Object calibrated into
Cal file, grayscale
¾ Solution:
Solution: New
gradation ~ normal
Detector
¾ Solution:
Solution: Clean
detector and tube
head, recalibrate
detector
Artifacts
¾ 2x
Artifacts
¾ 4x
Artifacts
¾ 6x
Artifacts
¾ 8x
12
Artifacts
Artifacts
¾ Description:
Description:
¾ Description:
Description: Image
Gridlines, black flecks
¾ Possible Cause:
Cause: Grid
failure, calibration file
¾ Solution:
Solution: Grid repair,
clean the imaging
chain, and recalibrate
Artifacts
processing around
wax insert
¾ Possible Cause:
Cause:
Image processing
algorithm
¾ Solution:
Solution: None
Artifacts
¾ Description:
Description: Washed out Image
¾ Cause:
Cause: Phantom not at chest wall edge
¾ Solution:
Re-position the phantom
Solution: Re-
¾ Description:
Description:
Linear and
rectangular
banding
¾ Possible Cause:
Cause:
Calibration file
¾ Solution:
ReSolution: Recalibrate
Artifacts
¾ Description:
Description: Shadows just
outside of breast skin line
¾ Possible Cause:
Cause: Saturated
detector due to overexposure
from dense breast
¾ Solution:
Solution: Siemens
recommends to increase kVp
to reduce exposure time
Artifacts
¾ Description:
Description: CR Noisy Background,
dark speck
¾ Possible Cause:
Cause:
Background
somewhat normal
¾ Solution:
Solution: Check
screen and system to
identify black speck
13
Artifacts
¾ Description:
Description:
Horizontal, vertical,
and curved lines
multiple density
differences – printed
from “flatflat-field”
field” menu
on Lorad Selenia
¾ Possible Cause:
Cause: Dirty
spinner assembly in
optics casting
shadows
¾ Solution:
Solution: Clean
spinner assembly
Printer
Artifacts
Readout Line Artifact
Collimator needs adjustment at chest wall edge
Artifacts
¾ Description:
Description:
Artifacts
Processing Steps for Digital Images
Horizontal and
curving lines
Image
Detection
Image
Correction
Raw
Image
Processing
Processed
Image
Display
¾ Possible Cause:
Cause:
Readout error,
ghosting
Calibration
File
¾ Solution:
Solution: Recalibrate,
let detector sit idle,
replace detector
14
Slide 86
Key Take Home Points
Summary on Artifacts
•Most artifacts due to calibration file
z Obtain relevant handshands-on training
•Window/level adjustments can appear as AEC and/or
exposure problems
z Must perform manufacturer specific QC tests
•Printers can cause fine, linear streaking artifacts - rare
•Look at technique factors, breast thickness, and breast
density for clues
•Objects on bucky, mag stand, and up in tube head often
make their way into the image – dust on accessories
z Artifacts – most problems can be seen here
z ReRe-booting and/or rere-calibrating fixes most
problems
z Laser Printer
– Dmax at least 3.5 OD
– MidMid-density about 1.5 OD
•Detectors can, and do, fail
Slide 87
Slide 88
SAMs Questions
20%
20%
20%
20%
20%
In digital mammography, who
mandates the pass/fail criteria for site
QC?
1. The American College of Radiology
2. The FDA
3. The FFDM unit manufacturer
4. NEMA
5. MQSA
10
Slide 89
Slide 90
Answer: 3 - The FFDM unit
manufacturer
Answer 3: The FFDM unit
manufacturer
References
Explanation
z
“the quality assurance program shall be
substantially the same as the quality
assurance program recommended by the
image receptor manufacturer, except that
the minimum allowable dose for screenscreenfilm systems in this section”
section”
z
MQSA Regulations 900.12(e)(6)
http://www.fda.gov/CDRH/MAMMOGRA
PHY/frmamcom2.html#s90012
15
Slide 91
Slide 92
How do you accredit a Fuji CR
Mammography system which uses
both CR and screenscreen-film on the same
x-ray system?
25%
1.
As 1 mammography unit?
25%
2.
As 2 mammography units?
3.
You cannot use CR and film on the same
unit.
CR is exempt from accreditation
25%
25%
4.
Answer: 2 – As 2 mammography
units
References
z
http://www.acr.org/accreditation/mammography/
mammo_faq/mammo_faq_mamac.aspx#8.0.1
10
Slide 93
Slide 94
What are the minimum passing ACR
phantom scores for the Siemens Novation
DR for weekly QC?
Answer: 2 - As 2 mammography
units
Explanation
As of November 15, 2006 facilities using
both screenscreen-film and CR on the same
mammography units must accredit these
2 systems as 2 separate units.
5 Fibers, 4 Speck Groups, 3 Masses
4 Fibers, 3 Speck Groups, 3 Masses
3. 5 Fibers, 4 Speck Groups, 4 Masses
4. 4 Fibers, 4 Speck Groups, 3 Masses
5. 4 Fibers, 4 Speck Groups, 4 Masses
20%
1.
20%
2.
20%
20%
20%
10
Slide 95
Slide 96
Answer 3: 5 Fibers, 4 Speck Groups, 4
Masses
Answer 3: 5 Fibers, 4 Speck Groups, 4
Masses
References
Explanation
z
The Siemens Novation DR QC manual states that
the ACR Phantom minimum passing scores
are as follows:
Siemens. Siemens Quality Control
Manual Version 05, Erlangan,
Erlangan, Germany.
2007
z
z
z
5 Fibers
4 Speck Groups
4 Masses
16
Slide 97
Slide 98
Answer 4: 3.00 mGy/exposure
mGy/exposure
For FFDM, the exposure for a single CC
view of the ACR Phantom shall not exceed?
References
z
0.75 mGy/exposure
mGy/exposure
1.25 mGy/exposure
mGy/exposure
20% 3. 2.00 mGy/exposure
mGy/exposure
20% 4. 3.00 mGy/exposure
mGy/exposure
20% 5. 4.00 mGy/exposure
mGy/exposure
20% 1.
20% 2.
900.12(e)(5)(vi): Dosimetry.
Dosimetry. The
average glandular dose delivered during
a single craniocaudal view of an FDAFDAaccepted phantom simulating a standard
breast shall not exceed 3.0 milligray
(mGy)
mGy) (0.3 rad)
rad) per exposure. The dose
shall be determined with technique
factors and conditions used clinically for
a standard breast.
10
Slide 99
Slide 100
Answer 4: 3.00 mGy/exposure
mGy/exposure
To meet the FDA requirement for continuing
experience, how many mammography
facilities and mammography unit surveys
must be performed within the previous 24
months?
Explanation
The FDA requires:
z
3.00 mGy/exposure
mGy/exposure
20%
1.
20%
2.
20%
3.
20%
4.
20%
5.
6 Facilities and 2 mammography units
4 Facilities and 12 mammography units
2 Facilities and 6 mammography units
1 Facilities and 6 mammography units
2 Facilities and 12 mammography units
10
Slide 101
Slide 102
Answer 3: 2 Facilities and 6 Mammography
Units
References
z
z
http://www.fda.gov/CDRH/MAMMOGRAPHY/robohelp/
START.HTM
900.12(a)(3)(iii)(B): Continuing experience. Following
the second anniversary date of the end of the calendar
quarter in which the requirements of paragraphs
(a)(3)(i) and (a)(3)(ii) of this section were completed or
of April 28, 1999, whichever is later, the medical
physicist shall have surveyed at least two
mammography facilities and a total of at least six
mammography units during the 24 months immediately
preceding the date of the facility’
facility’s annual MQSA
inspection or the last day of the calendar quarter
preceding the inspection or any date in between the
two. The facility shall choose one of these dates to
determine the 2424-month period. No more than one
survey of a specific facility within a 1010-month period or
a specific unit within a period of 60 days can be
counted towards this requirement.
Answer 3: 2 Facilities and 6 Mammography
Units
Explanation
The FDA requires:
z
z
z
2 Facilities
6 Mammography Units
Within past 24 months
17
Slide 103
Thank You
18