| (5) Corrections or repairs of the light leaks or other
deficiencies in paragraphs (2) - (4) of this subsection shall be initiated
within 72 hours of discovery and completed no longer than 15 days
from detection of the deficiency unless a longer time is authorized
by the agency. The registrant shall make a record of the correction
or repairs to include the date and initials of the individual performing
these functions. The records shall be maintained in accordance with
subsection (s)(1) of this section for inspection by the agency.
(6) Documentation of the items in paragraphs (2), (3),
and (5) of this subsection shall include the date and initials of
the individual completing these items. The registrant shall maintain
these records at the site where performed in accordance with subsection
(s)(1) of this section for inspection by the agency.
(q) Alternative processing systems. Users of daylight
processing systems, laser processors, self-processing film units,
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
maintained at the site where performed in accordance with subsection
(s)(1) of this section for inspection by the agency.
(r) Digital imaging acquisition systems. Users of digital
imaging acquisition systems shall follow quality assurance/quality
control protocol for image processing established by the manufacturer
or, if no manufacturer's protocol is available, by the registrant.
The registrant shall include the protocols, whether established by
the registrant or the manufacturer, in its operating and safety procedures.
The registrant shall document the frequency at which the quality assurance/quality
control protocol is performed. Documentation shall include the date
and initials of the individual completing the document and shall be
maintained at the site where performed in accordance with subsection
(s)(1) of this section for inspection by the agency.
(s) Record/document requirements for mobile services
and authorized use locations.
(1) Each registrant shall maintain the following records/documents
at each site, including authorized records sites for mobile services
at the time intervals specified, for inspection by the agency. The
records may be maintained in electronic format.
Attached Graphic
(2) Records required in item F of the table in paragraph
(1) of this subsection shall include the following:
(A) manufacturer's name, model and serial number;
(B) unique identification of the calibrated dosimetry
system; and
(C) name of the individual recording the information.
(3) Copies of the records/documents in items (A) -
(D), (H), (J), and (N) - (Q) of the table in paragraph (1) of this
subsection shall be kept with radiation machines authorized to be
used for mobile services. Mobile services with on-board film processors
shall maintain the records in items (O) - (Q) of the table in paragraph
(1) of this subsection, as applicable, with the processor or system
for a period of no less than 1 year.
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