| (i) 2.0% of the source-to-image receptor distance for
the length or width of the image receptor for rectangular collimation;
or
(ii) 2.0% of the source-to-image receptor distance
for the diagonal of the image receptor for circular or polygon collimation.
(11) Additional operational controls.
(A) When a patient or image receptor must be held in
position during radiography, mechanical supporting or restraining
devices shall be used when the exam permits except in individual cases
in which the registrant has determined that the holding devices are
contraindicated.
(B) The registrant's written operating and safety procedures
required by paragraph (2) of this subsection shall include the following:
(i) a list of circumstances in which mechanical holding
devices cannot be routinely utilized; and
(ii) a procedure used for selecting an individual to
hold or support the patient or image receptor.
(C) The operator position during the exposure shall
be such that the operator's exposure is as low as reasonably achievable
and the operator is a minimum of six feet from the useful beam or
behind a protective barrier. The operator shall maintain verbal, aural,
and visual contact with the patient.
(12) Automatic and manual film processing for dental
facilities and mobile dental services.
(A) Films shall be developed in accordance with the
time-temperature relationships recommended by the film manufacturer.
The specified developer temperature for automatic processing and the
time-temperature chart for manual processing shall be posted in the
processing area. If the registrant determines an alternate time-temperature
relationship is more appropriate for a specific facility, that time-temperature
relationship shall be documented and posted.
(B) Chemicals shall be replaced according to the chemical
manufacturer or supplier's recommendations or at an interval not to
exceed three months.
(C) Darkroom light leak tests shall be performed at
intervals not to exceed six months.
(D) Lighting in the film processing/loading area shall
be maintained with the filter, bulb wattage, and distances recommended
by the film manufacturer for that film emulsion or with products that
provide an equivalent level of protection against fogging.
(E) Corrections or repairs of the light leaks or other
deficiencies in subparagraphs (B) - (D) of this paragraph shall be
initiated within 72 hours after discovery and completed no longer
than 15 days from detection of the deficiency unless a longer time
is authorized by the agency. Records of the corrections or repairs
shall include the date and initials of the individual performing these
functions and the registrant shall maintain the records in accordance
with subsection (k)(2) of this section for inspection by the agency.
(F) Documentation of the items in subparagraphs (B),
(C), and (E) of this paragraph shall be maintained at the site where
performed and shall include the date and initials of the individual
completing these items. These records shall be made and maintained
in accordance with subsection (k)(2) of this section for inspection
by the agency.
(13) Alternative processing systems. Users of daylight
processing systems, laser processors, self-processing film systems,
or other alternative processing systems shall follow manufacturer's
recommendations for image processing. Documentation that the registrant
is following manufacturer's recommendations shall include the date
and initials of the individual completing the document and shall be
made and maintained at the authorized use location where performed
in accordance with subsection (k)(2) of this section for inspection
by the agency.
(14) Digital imaging acquisition systems.
(A) Users of digital imaging acquisition systems shall
follow quality assurance/quality control (QA/QC) protocol for digital
imaging established by the manufacturer.
(i) The registrant shall include the protocols established
in paragraph (2) of this subsection in its operating and safety procedures.
(ii) The registrant shall document the frequency at
which the quality assurance/quality control protocol is performed.
Documentation shall:
(I) include the date and initials of the individual
completing the document and the images acquired; and
(II) be maintained and available at the authorized
use location where performed in accordance with subsection (k)(2)
of this section for inspection by the agency.
(B) If a protocol cannot be established by the manufacturer,
it shall be developed and implemented by the registrant.
(i) The QA/QC protocol, as developed and implemented
by the registrant, shall include image quality testing for, but not
limited to, spatial resolution, noise, artifacts and contrast by using
a commercially purchased testing tool or an inanimate object of at
least three varying densities.
(I) Images shall be acquired with each x-ray image
receptor at an interval not to exceed three months.
(II) Test images shall be compared to previous test
images to assess degradation of image quality.
(III) If a radiation machine or components of the digital
imaging acquisition system require correction or repair following
a quality test, the correction or repair shall begin within 30 days
following the failure and the registrant shall perform or cause to
be performed the correction or repair according to a designated plan.
Correction or repair shall be completed no longer than 90 days from
discovery unless authorized in writing by the agency.
(ii) The registrant shall include the protocols established
in paragraph (2) of this subsection in its operating and safety procedures.
(iii) The registrant shall document the frequency at
which the quality assurance/quality control protocol is performed.
Documentation shall:
(I) include the date and initials of the individual
completing the document and the images acquired; and
(II) be maintained and available at the authorized
use location where performed in accordance with subsection (k)(2)
of this section for inspection by the agency.
(k) Records and reports.
(1) General provisions for records and reports.
(A) Each registrant shall maintain records at each
site, including sites authorized by the certificate of registration,
conditions, and records sites for mobile services. The records shall
include those specified in paragraph (2) of this subsection and shall
be maintained at the time interval indicated for inspection by the
agency. These records may be maintained in electronic format. These
records shall be accessible to radiation machine operators during
working hours.
(B) All records required by this section shall be accurate
and factual.
(C) Each registrant shall use the SI units gray, sievert,
and coulomb per kilogram, or the special units rad, rem, and roentgen,
including multiples and subdivisions, and shall clearly indicate the
units of all quantities on records required by this section.
(D) The registrant shall make a clear distinction among
the quantities entered on the records required by this section, such
as, total effective dose equivalent, shallow dose equivalent, lens
dose equivalent, and deep dose equivalent.
(E) Each record required by this section shall be legible
throughout the specified retention period.
(F) The record shall be the original, a reproduced
copy, or a microform, if the authorized personnel authenticate the
copy or microform and that the microform is capable of producing a
clear copy throughout the required retention period.
(G) The record may also be stored in electronic format
with the capability for producing legible, accurate, and complete
records during the required retention period.
(H) The registrant shall maintain adequate safeguards
against tampering with and loss of records.
(I) Copies of records required in subsections (i)(5)(I)
and (J), (j)(5)(J), and (j)(12)(F) of this section and by certificate
of registration condition that are relevant to operations at an additional
authorized use location shall be maintained at that location in addition
to the main site specified on a certificate of registration in accordance
with subsection (k)(2) of this section.
(J) Subject to the limitations provided in the Texas
Public Information Act, Government Code, Chapter 552, all information
and data collected, assembled, or maintained by the agency are public
records open to inspection and copying during regular office hours.
Cont'd... |
