MEDICAL PHYSICIST'S MAMMOGRAPHY QC TEST SUMMARY
Full-Field Digital – Konica Minolta
Site Name Report Date
Address Survey Date
Medical Physicist's Name Signature
X-Ray Unit Manufacturer Model
Date of Installation Room ID
CR Image Receptor Mfr Konica Minolta CR Model
QC Manual Version #: (use version applicable to unit tested; contact mfr if questions)
Accessory Equipment: Manufacturer Model Location QC Manual Version #
Review Workstation* On-site Off-site
Laser Film Printer* On-site Off-site
*FDA recommends that only monitors and printers specifically cleared for FFDM use by FDA’s Office of Device Evaluation (ODE) be used. See FDA's Policy
Guidance Help System www.fda.gov/CDRH/MAMMOGRAPHY/robohelp/START.HTM.
Survey Type: Mammo Eqpt Evaluation of new unit (include MQSA Rqmts for Mammo Eqpt checklist) Annual Survey
Medical Physicist's QC Tests
("Pass" means all components of the test passes; indicate "Fail" if any component fails. Tests must be done for both on and off-site equipment.)
PASS/FAIL
1. Physical Inspection
2. Tube Voltage Measurement and Reproducibility
3. Beam Quality
4. Radiation Output Rate
5. Average Glandular Dose
Average glandular dose for average breast is ≤3 mGy (300 mrad) mrad
6. View Boxes and Viewing Conditions
7. Monitor QC (CR Console Monitor)
8. Dark Noise
9. Ghost Image Evaluation
10. S value Response Indicator
S value variation: ±20%
11. AEC Performance Checks
Stability and Reproducibility: mAs CV ≤5%
Thickness Tracking: CNR (2cm) >100%, CNR (6cm) >75%, S value variation ≤20%
12. Collimation Assessment
13. CR Reader Scanner Performance
14. Spatial Resolution
15. Artifact Evaluation
16. Inter-Plate Consistency
SNR variation: ±15%
S value variation: ±15%
17. Phantom Image Quality
Phantom image scores: Fibers Specks Masses
Density Check: S value variation ±20%; background density change ±20;
density difference change ±0.05
Thickness Check: ±0.5 cm
18. Review Workstation QC-Overall
19. Film Printer QC-Overall
file:///conversion/tmp/activity_task_scratch/902720020.xls
*** YOUR MEDICAL PHYSICIST MUST SUMMARIZE HIS/HER RESULTS ON THIS FORM ***
file:///conversion/tmp/activity_task_scratch/902720020.xls
MEDICAL PHYSICIST'S MAMMOGRAPHY QC TEST SUMMARY
(Konica Minolta, continued)
Evaluation of Technologist QC Program
New units: Medical physicists must review the technologist QC within 45 days of installation and complete this section. The facility is required to submit the en
Mammography Equipment Evaluation report (including this form) along with their testing materials for accreditation.
Existing units: Medical physicists must complete this section as part of the unit's annual survey.
Relocating units: This section is not required if the medical physicist does not conduct a complete annual survey after relocation.
FREQUENCY PASS/FAIL
1. Daily Operational Checks Daily
2. View Boxes and Viewing Conditions Weekly
3. Monitor QC (CR Console Monitor) Weekly
4. CNR Check Weekly
5. Phantom Image Quality Weekly
6. Visual Inspection Monthly
7. Repeat Analysis Quarterly
8. Compression Force Test Semi-annually
9. Image Plate Fog Semi-annually
10. Review Workstation QC* See FDA guidance
11. Film Printer QC* See FDA guidance
Medical Physicist's Recommendations for Quality Improvement
Important:
1. The facility's "quality assurance program shall be substantially the same as the quality assurance program
recommended by the image receptor [digital detector] manufacturer." This is required by the FDA.
2. Use the QC manual version provided by the manufacturer for the digital system surveyed.
3. If the RWS or printer is FDA-cleared for FFDM, their QC manual is considered to be "substantially the same" and may
be followed. (Check with the manufacturers for the QC manual and clearance status of their products.)
4. If the RWS or printer is not cleared by the FDA for FFDM, follow the QC manual provided by the image receptor
manufacturer. (Check with the image receptor manufacturer for their required tests.)
5. All tests must be evaluated for the facility's on and off-site equipment. If the evaluation was done on a different day
than the survey date, note the date above.
6. See the FDA-approved alternative standard for Konica Minolta FFDM regarding corrective action periods when
components fail QC. However, if these tests are performed as part of a Mammography Equipment Evaluation (e.g., for a
new system), corrective action must be taken before mammographic images are acquired.
file:///conversion/tmp/activity_task_scratch/902720020.xls
Models
Pass/Fail
Pass
Fail
Pass/Fail/NA
Pass
Fail
NA
Phantom Scores
6.0
5.5
5.0
4.5
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.5
