900.12(e)(5): Annual quality control tests. Facilities with screen-film systems shall perform the following quality control tests at least annually.
These tests and their regulatory requirements are summarized in the Summary Table of Annual Quality Control Tests below. The test results must fall within the listed action levels. Results outside these action levels indicate the need for corrective action within the time periods specified in the table.
Summary Table of Annual Quality Control Tests
|Test||Final Regulation Citation||Regulatory Action Levels||Scope||Required Documentation||Timing of Required Corrective Action*|
|AEC||900.12(e)(5)(i)||O.D. exceeds the mean by more than ±0.15 (over 2-6 cm thickness range), or the phantom image density at center is less than 1.20||All x-ray units, 2-6 cm thickness range; using appropriate kVp’s. - required in contact mode only. - Mag. Mode testing is required only for equipment||The two most recent survey reports.||Within 30 days of the date of the test.|
|KVp||900.12(e)(5)(ii)||Exceeds ±5% of indicated or selected kVp C.O.V. exceeds 0.02||All x-ray units at 3 kVp’s – lowest measurable clinical , most frequently used clinically, and highest clinical obtainable||"||"|
|Focal spot condition||900.12(e)(5)(iii)||system resolution||All x-ray units, all clinically used target materials and focal spots Resolution measurement - Contact mode: At most used SID - Mag mode (if clinically used): At SID w/mag value closest to 1.5 - Must be done for all clinically used screen-film combinations||"||"|
|HVL||900.12(e)(5)(iv)||See table in regulations||All x-ray units, all clinically used target-filter combinations||"||"|
|Air Kerma and AEC reproducibility||900.12(e)(5)(iv)||Reproducibility C.O.V. exceeds 0.05||All x-ray units||"||"|
|Dose/td>||900.12(e)(5)(vi)||Exceeds 3.0 mGy (0.3 rad) per exposure||All x-ray units, all clinically used screen/film combinations, targets, and filters used for the standard breast||"||Before any further examinations are performed using the x-ray unit|
|X-ray field / light field / compression device alignment/td>||900.12(e)(5)(vii)||Exceeds 2% SID at chest wall|
Paddle visible on image
|All x-ray units, all combinations of collimators, image receptor sizes, targets, and focal spots clinically used for full-field imaging in the contact mode||"||Within 30 days of the date of the test|
|Screen speed uniformityt||900.12(e)(5)(viii)||O.D. variation exceeds 0.30 from the maximum to the minimum||All cassettes – may be grouped by size and speed – limit holds within groups – groups must be identifiable to the technologist||"||"|
|System artifacts||900.12(e)(5)(ix)||Determined by physicist||All x-ray units and processors, all clinically used cassette sizes, focal spots & target-filter combinations. Also see approved alternative standard substituting “all targets and filters” for all “target-filter combinations”||"||"|
|Radiation output||900.12(e)(5)(x)||Less than 7.0 mGy/sec (800 mR/sec)||All x-ray units||"||"|
|Automatic decompression control||900.12(e)(5)(x)||Failure of override or manual release||All x-ray units (if auto is provided)||"||"|
|Any applicable annual new mammographic modality tests||900.12(e)(6)||As specified by the equipment manufacturer||All x-ray units||"||Before any further examinations are performed|
|Phantom Image||900.12(e)(9) see (e)(2)||As specified by the facility’s accreditation body||All x-ray units, all target-filter and screen-film combinations used clinically for the standard breast||"||"|
* Refer to 900.12(e)(8)(ii)(A) or (B) as applicable.
- Who in the facility must conduct the annual QC tests listed above?
- Under the final regulations, must facilities chart the data for quality control tests, such as processor sensitometry or phantom image evaluation?