Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › COMPUTED TOMOGRAPHY X-RAY SYSTEMS › Section 221.204 - Performance evaluations, routine QC and surveys

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Performance evaluations.
(1) The performance evaluation of the CT
						X-ray system shall be performed by or under the direction of a QMP.
(2) Evaluation standards and tolerances shall
						be established by a QMP and maintained by the facility. These standards and
						tolerances must meet nationally-recognized standards and tolerances for the CT
						X-ray system.
(3) The performance
						evaluation of a CT X-ray system shall be performed after initial installation
						and before use on human patients. Thereafter, the evaluation shall be made at
						intervals not to exceed 14 months.
(4) The performance evaluation must include
						all of the following:
(i) Geometric factors
						and alignment, including alignment light accuracy and table incrementation
						accuracy.
(ii) Slice localization
						from scanned projection radiograph (localization image).
(iii) Slice thickness.
(iv) Image quality including high-contrast
						(spatial) resolution, low-contrast resolution, image uniformity, noise and
						artifact evaluation.
(v) CT number
						accuracy.
(vi) Image quality for
						acquisition workstation display devices (video and hard copy when
						applicable).
(vii) A review of the
						results of the routine QC required under subsection (b).
(viii) A safety evaluation of audible and
						visual signals and posting requirements.
(ix) A review of commonly used CT protocols
						along with the evaluation for appropriateness of dose and image quality, in
						comparison with the older protocols. The review should be by the QMP along with
						the radiologist and lead CT technologist.
(x) For dosimetry, a review of the protocols
						deemed appropriate by the QMP which could result in significant doses. This
						review must include acquisition and reconstruction parameters, and radiation
						dose. At a minimum, the QMP shall review the following clinical protocols, if
						performed, at intervals not to exceed 14 months:
(A) Pediatric head (1 year of age).
(B) Pediatric abdomen (5 years of age; 40-50
						lbs. (about 20 kg)).
(C) Adult
						head.
(D) Adult abdomen (70
						kg).
(E) Brain perfusion.
(xi) Review DRL, notification
						values and alert values for the procedures reviewed under subparagraph
						(x).
(xii) Review actions to be
						taken when a dose alert value is exceeded including patient
						follow-up.
(xiii) Review the
						process determining who has access and authority to make changes to the
						protocol management systems, including a policy or procedure to prevent
						inadvertent or unauthorized modifications to a CT protocol.
(5) A performance evaluation shall
						be made within 30 days after any change or replacement of components which, in
						the opinion of the QMP, could cause a change in the radiation output or image
						quality.
(6) Dose measurements of a
						CT unit shall be performed with a calibrated dosimetry system. The calibration
						of the system shall be traceable to a national standard. The dosimetry system
						must have been calibrated within the preceding 2 years.