Establishment and Review of Scanning Protocols

R 333.5713 Conditions of operation.

Rule 713. (1) The CT facility shall establish scanning protocols in consultation with the medical physicist.

Discussion:
This rule was based on a recommendation of the Food and Drug Administration (FDA). The FDA became aware of radiation overexposures during perfusion CT imaging to aid in the diagnosis and treatment of stroke. Their investigation lead to this and other recommendations for CT facilities. This rule applies to all CT procedures, not just brain perfusion scans.

It is very important that a CT interpreting physician review the scanning protocols in consultation with the medical physicist to ensure they are appropriate for the purpose.

Question 1: The regulations require that CT protocols be reviewed by the Medical Physicist and Physician. Can you provide any additional details regarding your expectations of this review? Does this apply to all protocols? To what standard should the protocols be compared?

Question 2: Is a written statement signed by the medical physicist that says "All CT protocols reviewed in consultation with medical physicist" adequate documentation to demonstrate compliance with Rule 713(1)?

Question 1: The new regulations require that CT protocols be reviewed by the Medical Physicist and Physician. Can you provide any additional details regarding your expectations of this review? Does this apply to all protocols? To what standard should the protocols be compared?

We feel it is important for a CT interpreting physician to review the scanning protocols in consultation with a medical physicist to ensure the correct dose is planned for each study. How that review is accomplished and the determination of what is appropriate is left to the experience, knowledge and professional judgment of both the physician and medical physicist. We will expect to see documentation that the protocols have been reviewed and determined to be appropriate. Protocols for each study performed at the facility need to be reviewed.

Question 2: Is a written statement signed by the medical physicist that says "All CT protocols reviewed in consultation with medical physicist" adequate documentation to demonstrate compliance with Rule 713(1)?

We do not believe a blanket statement that the physicist reviewed the CT protocols is adequate documentation of the review. The statement could be included in the physicist's summary of tests performed (as in the new ACR CT quality control manual) but other documentation needs to be shown to back up that statement. For instance, the physicist and the radiologist could sign and date each protocol in a hardcopy binder of all protocols. This binder does not need to be posted, just kept as a record of the protocols. Other methods of documentation may also be acceptable, if they demonstrate that all of the clinically used protocols have been established in consultation with the medical physicist.

June 6, 2016