§ 221.204. Performance evaluations, routine QC and surveys.

 (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.

 (b)  Routine QC.

   (1)  Written routine QC procedures shall be developed by a QMP. These procedures shall be available for review by the Department.

   (2)  The routine QC procedures must include, at a minimum, all of the following using the facility’s performance phantom:

     (i)   Noise.

     (ii)   Mean CT number for water.

     (iii)   Artifact evaluation.

   (3)  The routine QC shall be performed at intervals not to exceed 1 week.

   (4)  The QMP need not be present during the routine QC.

   (5)  Routine QC shall include acquisition of images obtained with the performance phantom using the same processing mode and CT conditions of operation as are used to perform the measurements required by subsection (a).

 (c)  Radiation protection surveys.

   (1)  CT X-ray systems shall have a survey performed at the time of installation by or under the direction of a QMP. In addition, a survey shall be performed after a change in the facility or equipment which might cause a significant increase in radiation hazard.

   (2)  The registrant shall obtain a written report of the survey from the QMP, and a copy of the report shall be made available to the Department upon request.

 (d)  Records. Records of the performance evaluations and surveys shall be maintained for inspection by the Department for at least 5 years. Routine QC records shall be maintained for at least 1 year.

Authority

   The provisions of this §  221.204 issued and amended under sections 301 and 302 of the Radiation Protection Act (35 P.S. § §  7110.301 and 7110.302); and section 1920-A of The Administrative Code of 1929 (71 P.S. §  510-20).

Source

   The provisions of this §  221.204 adopted October 2, 1998, effective October 3, 1998, 28 Pa.B. 4894; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823; amended October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791. Immediately preceeding text appears at serial pages (304520) to (304522).

Cross References

   This section cited in 25 Pa. Code §  221.65 (relating to X-ray attenuation systems); 25 Pa. Code §  221.201 (relating to definitions); and 25 Pa. Code §  223.31 (relating to registrant responsibilities).



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