|
Test & Frequency |
Requirements for
Acceptable
Operation |
Guidance for
Acceptable
Documentation
Retention |
Timing of Required
Corrective
Action |
|
Processor QC—Daily |
Established operating
level for B+F up to .03 OD |
QC records for the last 12
months or since the last inspection, whichever
is longer. QC test films for the last 30 days. |
Before any further
clinical films are processed |
|
|
Established operating
level for MD, +/- 0.15 OD |
Established operating
level for DD. +/- 0.15 OD |
|
|
Phantom QC—Weekly |
Established operating
level for OD at center of image> 1.2 +/- 0.20
but the minimum OD must be> 1.2 at any time. |
QC charts & records for
the last 12 months or since the last inspection,
whichever is longer. Phantom images for the last
12 weeks. |
Before any further exams
are performed using the mammo machine. |
|
|
Established operating
level for contrast +/- 0.05 OD |
|
|
|
|
Minimum score of 4 fibers,
3 specks, 3 masses. |
|
|
|
Fixer retention –Quarterly |
Below 5 µg per square cm
of residual fixer. |
QC records since the last
inspection or for the past 3 tests, whichever is
longer. |
Within 30 days of the date
of the test. |
|
Repeat Analysis –Quarterly |
Operating level for repeat
or reject rate is < 2% change from previous
rate. |
QC records since the last
inspection or for the past 3 tests, whichever is
longer. |
Within 30 days of the date
of the test. |
|
Darkroom Fog
–Semi-Annually |
OD < 0.05 |
QC records & films since
the last inspection or for the past 3 tests,
whichever is longer. |
Before any further
clinical films are processed. |
|
Screen-Film Contact
–Semi-Annually |
All mammography cassettes
used must be tested with a 40-meshcopper screen. |
QC records & films since
the last inspection or for the past 3 tests,
whichever is longer. |
Before any further
examinations are performed using the cassettes. |
|
Compression Device
–Semi-Annually |
Compression force >111
newtons (25 pounds) |
QC records since the last
inspection or for the past 3 tests, whichever is
longer. |
Before examinations are
performed using the compression device. |
