Oregon
Rule Rule 333-106-0363
Computed Tomography X-ray Systems: Quality Control Program


(1)

The registrant shall ensure that a CT quality assurance phantom is available for testing the CT system.

(2)

Instructions on the use of the phantom shall be provided. The instructions shall include a schedule of tests appropriate for the CT system, the allowable variations for the test parameters, and a method to store the test results.

(3)

Within six months following the effective date of these rules, a CT facility shall establish and implement a quality control program under the direction of a CT medical physicist.

(4)

Evaluations and tests shall be performed following written procedures and methods.

(5)

Corrective action shall be taken and documented according to instructions provided by the qualified CT medical physicist if the results of an evaluation or test fall outside the control limits.

(6)

The qualified CT medical physicist shall determine the frequency of each test. An on-site CT Radiologic Technologist shall be identified to be responsible for the ongoing quality control testing.

(7)

The ongoing quality control evaluation must include, at a minimum, the following:

(a)

Water CT number accuracy check and standard deviation (noise);

(b)

Artifact evaluation;

(c)

Visual checklist; and

(d)

Printer quality control (if used for primary interpretation).
Source
Last accessed
Jul. 9, 2020