Annual Equipment 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 evaluations

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

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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

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HVL

900.12(e)(5)(iv)

See table in regulations

All x-ray units, all clinically used target-filter combinations

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Air Kerma and AEC reproducibility

900.12(e)(5)(v)

Reproducibility C.O.V. exceeds 0.05

All x-ray units

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Dose

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

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Before any further examinations are performed using the x-ray unit

X-ray field / light field / compression device alignment

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

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Within 30 days of the date of the test

Screen speed uniformity

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

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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”

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Radiation output

900.12(e)(5)(x)

Less than 7.0 mGy/sec (800 mR/sec)

All x-ray units

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Automatic decompression control

900.12(e)(5)(xi)

Failure of override or manual release

All x-ray units (if auto is provided)

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Any applicable annual new mammographic modality tests

900.12(e)(6)

As specified by the equipment manufacturer

All x-ray units

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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

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