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Quality Control Program

R 333.5717 Quality control program.

Rule 717. (1) A CT facility shall establish and implement a quality control program under the supervision of the medical physicist. The documented program shall include evaluation of all of the following:

(a) Image quality.
(b) Patient radiation dose.
(c) Personnel radiation protection.
(d) Compliance with the provisions of this part.
(e) Ongoing quality control.

(2) Evaluations and tests shall be performed following written procedures and methods. Corrective action shall be taken and documented according to instructions provided by the medical physicist if the results of an evaluation or test fall outside the control limits.

(3) The medical physicist shall determine the frequency of each test and who may perform the test. An on-site CT radiologic technologist shall be identified to be responsible for the ongoing quality control testing. The tests shall be performed by this technologist or by other personnel qualified by training and experience following written procedures and methods under subrule (2) of this rule.

(4) The ongoing quality control evaluation should include the following:

(a) Image quality, including the following:
(i) High-contrast resolution.
(ii) Low-contrast resolution.
(iii) Image uniformity.
(iv) Noise.
(v) Artifact evaluation.
(b) Alignment light accuracy.
(c) Slice thickness.
(d) CT number accuracy.
(e) Dose display devices.

Discussion:
The rule was based on the quality control requirements of the American College of Radiology's CT Accreditation Program.

Question 1: The vendor for our CT machine keeps the phantoms locked up and we do not have access to them to perform daily QC. The vendor comes in every six months for PM's and uses those phantoms at that time. Will this meet the requirement of Rule 717(4)?

Question 2: We are upgrading our scanner with a new detector assembly. Do we need to have our medical physicist complete a performance evaluation of the upgraded CT scanner before use on human patients?


Question 1: The vendor for our CT machine keeps the phantoms locked up and we do not have access to them to perform daily QC. The vendor comes in every six months for PM's and uses those phantoms at that time. Will this meet the requirement of Rule 717(4)?

Rule 717(4) is guidance as to what might be included in the QC program. If your program specifies phantom imaging, then you will need access to the phantoms. You should make the vendor aware that the federal performance standard on CT, 21 CFR 1020.33(d), requires the manufacturer to provide a phantom with each CT system. That phantom must be capable of providing an indication of contrast scale, noise, nominal tomographic section thickness, the spatial resolution capability of the system for low and high contrast objects, and measuring the mean CT number of water or a reference material. That phantom should be the property of the facility.


Question 2: We are upgrading our scanner with a new detector assembly. Do we need to have our medical physicist complete a performance evaluation of the upgraded CT scanner before use on human patients?

Although upgrades and major repair are not directly addressed by rule, testing of components directly affected by the upgrade or repair is left to the discretion of the medical physicist under Rule 717. Rule 717 requires the medical physicist to determine the frequency of each quality control test and who may perform the test. In the case of upgrades or repairs made to an existing scanner, the medical physicist shall determine which tests are appropriate and whether testing needs to be performed prior to clinical use. For x-ray tube or detector assembly replacement the American College of Radiology's (ACR) CT accreditation program suggests that technologist quality control testing be performed prior to clinical use. The medical physicist should complete an appropriate performance evaluation as soon as possible but within 30 days.

The ACR has a FAQ page that provides the medical physicist with guidance regarding actions to take after repair or replacement of various CT components.


June 6, 2016