Current through Register Vol. 38, No. 18, March 15, 2024
(a)
This Rule provides special requirements for human diagnostic use of computed
tomography (CT) x-ray equipment. The uses of Cone Beam CT, Veterinary CT, CT
Simulation, and CT attenuation correction shall be exempt from this Rule. The
provisions of this Rule are in addition to, and not in substitution for, the
Rules in Sections.0100,.0200,.0600,.0900,.1000, and.1600 of this
Chapter.
(b) The following
definitions shall apply to this Rule:
(1) "CT
qualified expert (CT QE)" means an individual who is registered or is providing
service for a registered facility where they are employed, as required by
Section.0200 of this Chapter. The individual shall have the following education
and experience:
(A) a master's or doctoral
degree in physics, medical physics, biophysics, radiological physics, medical
health physics, or equivalent disciplines from a college or university
accredited by an agency recognized by the U.S. Department of Education, and
three years work experience in a clinical CT environment. The work experience
shall be supervised and documented by a medical physicist certified in the
specialty area of diagnostic medical physics by the American Board of
Radiology, the Canadian College of Physicists in Medicine, or the American
Board of Medical Physics; or
(B)
certification in the specialty area of diagnostic medical physics by the
American Board of Radiology, the Canadian College of Physicists in Medicine, or
the American Board of Medical Physics and shall abide by the certifying body's
requirements for continuing education.
(2) "general supervision" means the activity
is performed under the qualified supervisor's overall direction and control but
the qualified supervisor's physical presence shall not be required during the
activity.
(3) "personal
supervision" means overall direction, control, and training of an individual by
a qualified supervisor who shall be physically present during the activities
performed by the supervised individual.
(c) Equipment and Installation Requirements
(1) CT x-ray systems shall meet the
requirements of 21 CFR
1020.33 as incorporated by reference in
Rule.0117(a)(3) of this Chapter.
(2) The operator of a CT scanner shall be
able to maintain aural communication with the patient from a shielded position
at the control panel.
(d) Personnel Requirements. Individuals who
operate CT x-ray systems shall be specifically trained on the operational
features of the unit and:
(1) hold (CT)
registration with the American Registry of Radiologic Technologists (ARRT);
or
(2) be a Registered Technologist
(R.T.) by the ARRT with registration in radiography (R) or a Certified Nuclear
Medicine Technologist by the Nuclear Medicine Technology Certification Board;
these individuals shall document training and experience that is equivalent to
that required to attain (CT) registration with the ARRT; or
(3) be in training under the personal
supervision of an individual that meets the requirements of Subparagraph (d)(1)
or (d)(2) of this Rule.
(e) System Performance Evaluations
(1) Performance evaluations of the CT x-ray
system shall be performed by, or under the general supervision of, a CT QE who
assumes the responsibility for the evaluation.
(2) The performance evaluation of a CT x-ray
system shall be performed within 30 days of installation and at least every 14
months.
(3) Performance evaluation
standards and tolerances shall meet manufacturer's specifications or standards
and tolerances for the CT x-ray system from the American College of Radiology
(ACR) and the American Association of Physicists in Medicine (AAPM)
incorporated herein by reference including subsequent amendments and editions.
These standards and tolerances may be found at no charge on the ACR website at
https://www.acr.org and the AAPM
website at www.aapm.org.
(4) The
performance evaluation shall include the following as applicable to the design
of the scanner:
(A) geometric factors and
alignment including alignment light accuracy, and table increment
accuracy;
(B) image localization
from a scanned projection radiograph (localization image);
(C) radiation beam width;
(D) image quality including high-contrast
(spatial) resolution, low-contrast resolution, image uniformity, noise, and
artifact evaluation;
(E) CT number
accuracy;
(F) image quality for
acquisition workstation display devices; and
(G) a review of the results of the routine
QC, as set forth in Paragraph (f) of this Rule;
(5) The performance evaluation shall also
include the evaluation of radiation output and patient dose indices for the
following clinical protocols if performed:
(A)
pediatric head;
(B) pediatric
abdomen;
(C) adult head;
(D) adult abdomen; and
(E) brain perfusion.
(6) Evaluation of radiation output shall be
performed with a dosimetry system that is calibrated. The dosimetry system
shall have been calibrated within the preceding two years by persons registered
to provide such services pursuant to Rule.0205 of this Chapter.
(7) The performance evaluation shall be
documented and maintained for inspection by the Agency. The documentation shall
include the name of the CT QE performing or supervising the evaluation, as well
as any other individuals participating in the evaluation under the general
supervision of the CT QE. The documentation shall be retained for 14
months.
(f) Routine
Quality Control (QC)
(1) A routine QC program
for the CT system shall be developed by or have written approval by a CT QE and
include:
(A) instructions for the routine
QC;
(B) intervals for QC
testing;
(C) acceptable tolerances
for the QC tests;
(D) use of a
water equivalent phantom to evaluate each day of clinical use: noise, CT number
accuracy, and artifacts; and
(E)
routine QC tests that may be performed in place of system performance
evaluations after equipment repairs or maintenance. This shall include the
process for obtaining approval from the CT QE prior to conducting
testing.
(2) The duties
in the routine QC program, as described in Subparagraph (f)(1) of this Rule,
shall be conducted by individuals that meet the requirements of Parargraph (d)
of this Rule or individuals approved by the CT QE.
(3) The routine QC shall be documented and
maintained for inspection by the Agency. The records shall be retained for 14
months.
(g) Operating
Requirements. The following information shall be accessible to the CT operator
during use of the machine and while performing routine QC:
(1) instructions on performing routine
QC;
(2) a schedule of routine
QC;
(3) any allowable variations
set by the CT QE for the indicated parameters;
(4) the results of the most recent routine QC
completed on the system; and
(5)
established scanning protocols.
Authority
G.S.
104E-7;
104E-11;
104E-12;
Eff.
October 1, 2017.