| (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 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 this paragraph in its operating and safety procedures.
(iii) The registrant shall document the frequency at
which the QA/QC 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 certificate of registration condition
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 chapter shall be accurate
and factual.
(C) Records are only valid if stamped, initialed, or
signed and dated by authorized personnel or otherwise authenticated.
Records, such as letters, drawings, and specifications, shall include
all pertinent information, such as stamps, initials, and signatures.
(D) Each registrant shall use the SI units Gy, Sv,
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 chapter.
(E) 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, or deep dose equivalent.
(F) Each record required by this section shall be legible
throughout the specified retention period.
(G) The record shall be the original or a reproduced
copy or a microfilm provided that the copy or microform is authenticated
by authorized personnel and that the microfilm is capable of producing
a clear copy throughout the required retention period.
(H) The record may also be stored in electronic format
with the capability for producing legible, accurate, and complete
records during the required retention period.
(I) The registrant shall maintain adequate safeguards
against tampering with and loss of records.
(J) Copies of records required in subsections (i)(5)(I)
and (J), and (j)(10)(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 paragraph (2) of this subsection.
(K) Records of surveys.
(i) Each registrant shall make and maintain records
showing the results of surveys required by subsection (j)(4)(E) of
this section for inspection by the agency. The registrant shall retain
these records in accordance with paragraph (2) of this subsection.
(ii) The registrant shall retain the results of surveys
to determine the dose from external sources of radiation used, in
the absence of or in combination with individual monitoring data,
in the assessment of individual dose equivalents in accordance with
paragraph (2) of this subsection.
(L) Records of individual monitoring results.
(i) Each registrant shall make or cause to be made
and maintain records in accordance with subsection (j)(3)(F) of this
section of the doses received by all individuals for whom monitoring
was required in accordance with subsection (j)(3)(F) of this section,
and records of doses received during accidents, and emergency conditions.
Assessments of dose equivalent and records made using units in effect
before January 1, 1994, need not be changed. These records shall include,
when applicable:
(I) the deep dose equivalent to the whole body, lens
dose equivalent, shallow dose equivalent to the skin of the whole
body, and shallow dose equivalent to the skin of any extremities;
and
(II) the data used to make occupational dose assessments
in accordance with subsection (j)(3)(F)(v) of this section.
(ii) The registrant shall make entries of the records
specified in clause (i) of this subparagraph at intervals not to exceed
one year and within 90 days of the end of the year.
(iii) The registrant shall make or cause to be made
and maintain the records specified in clause (i) of this subparagraph
on RC Form 233-1 in accordance with the instructions for RC Form 233-1,
or in clear and legible records containing all the information required
by RC Form 233-1.
(iv) The registrant shall make or cause to be made
and maintain the records of dose to an embryo/fetus with the records
of dose to the declared pregnant woman. The declaration of pregnancy,
including the estimated date of conception, shall also be kept on
file, but may be maintained separately from the dose records.
(v) The registrant shall retain each required form
or record required by this subsection in accordance with paragraph
(2) of this subsection for inspection by the agency. The registrant
shall retain records used in preparing RC Form 233-1 or equivalent
in accordance with paragraph (2) of this subsection.
(M) Records of dose to individual members of the public.
(i) Each registrant shall make and maintain records
sufficient to demonstrate compliance with the dose limit for individual
members of the public for inspection by the agency. See subsection
(j)(3)(C) and (D) of this section.
(ii) The registrant shall retain the records required
by clause (i) of this subparagraph in accordance with paragraph (2)
of this subsection.
(2) Record or document requirements. Each registrant
shall maintain the following records at each site, including authorized
records sites for mobile services, at the time intervals specified
and make available to the agency for inspection.
Attached Graphic
(3) Reports.
(A) Reports of stolen, lost, or missing radiation machines.
(i) Each registrant shall report to the agency by telephone
a stolen, lost, or missing radiation machine immediately after its
occurrence becomes known to the registrant.
(ii) Each registrant required to make a report in accordance
with clause (i) of this subparagraph shall, within 30 days after making
the telephone report, make a written report to the agency that includes
the following information:
(I) a description of the radiation machine involved,
including the manufacturer, model, and serial number;
(II) a description of the circumstances under which
the loss or theft occurred;
(III) exposures of individuals to radiation, circumstances
under which the exposures occurred, and the possible TEDE to persons
in unrestricted areas;
(IV) actions that have been taken, or will be taken,
to recover the radiation machine; and
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