SECTIONS 115105-115115 - California Statutes

HEALTH AND SAFETY CODE

SECTION 115105-115115

115105. The department shall require each person who acquires,
possesses or uses a source of ionizing radiation to maintain records
relating to its receipt, storage, transfer or disposal, and other
records as the department may require, subject to exemptions as may
be provided by regulations.

115110. The department shall require each person who possesses or
uses a source of ionizing radiation to maintain appropriate records
showing the radiation exposure of all individuals for whom personnel
monitoring is required by regulations of the department. Copies of
these records and those required to be kept in accordance with
Section 115105 shall be submitted to the department upon request.
The department shall adopt reasonable regulations, compatible with
those of the United States Atomic Energy Commission, pertaining to
reports of exposure of personnel. The regulations shall require that
reports of excessive exposure be made to the individual exposed and
to the department, and shall make provision for periodic and terminal
reports to individuals for whom personnel monitoring is required.
Section 6411 of the Labor Code shall not be construed as exempting
any person from making any report required by this section.

115111. (a) Commencing July 1, 2012, subject to subdivision (e), a
person that uses a computed tomography (CT) X-ray system for human
use shall record the dose of radiation on every CT study produced
during a CT examination.
(b) The facility conducting the study shall electronically send
each CT study and protocol page that lists the technical factors and
dose of radiation to the electronic picture archiving and
communications system.
(c) The displayed dose shall be verified annually by a medical
physicist to ensure the displayed doses are within 20 percent of the
true measured dose measured in accordance with subdivision (f) unless
the facility is accredited.
(d) Subject to subdivision (e), the radiology report of a CT study
shall include the dose of radiation by either recording the dose
within the patient's radiology report or attaching the protocol page
that includes the dose of radiation to the radiology report.
(e) The requirements of this section shall be limited to CT
systems capable of calculating and displaying the dose.
(f) For the purposes of this section, dose of radiation shall be
defined as one of the following:
(1) The computed tomography index volume (CTDI vol) and dose
length product (DLP), as defined by the International
Electrotechnical Commission (IEC) and recognized by the federal Food
and Drug Administration (FDA).
(2) The dose unit as recommended by the American Association of
Physicists in Medicine.

115112. Commencing July 1, 2013, facilities that furnish CT X-ray
services shall be accredited by an organization that is approved by
the federal Centers for Medicare and Medicaid Services, an
accrediting agency approved by the Medical Board of California, or
the State Department of Public Health.

115113. (a) Except for an event that results from patient movement
or interference, a facility shall report to the department an event
in which the administration of radiation results in and of the
following:
(1) Repeating of a CT examination, unless otherwise ordered by a
physician or a radiologist, if the following dose values are
exceeded:
(A) 0.05Sv (5 rem) effective dose equivalent.
(B) 0.5 Sv (50 rem) to an organ or tissue.
(C) 0.5 Sv (50 rem) shallow dose equivalent to the skin.
(2) CT X-ray irradiation of a body part other than that intended
by the ordering physician or a radiologist if one of the following
dose values are exceeded:
(A) 0.05 Sv (5 rem) effective dose equivalent.
(B) 0.5 Sv (50 rem) to an organ or tissue.
(C) 0.5 Sv (50 rem) shallow dose equivalent to the skin.
(3) CT or therapeutic exposure that results in unanticipated
permanent functional damage to an organ or a physiological system,
hair loss, or erythema, as determined by a qualified physician.
(4) A CT or therapeutic dose to an embryo or fetus that is greater
than 50 mSv (5 rem) dose equivalent, that is a result of radiation
to a known pregnant individual unless the dose to the embryo or fetus
was specifically approved, in advance, by a qualified physician.
(5) Therapeutic ionizing irradiation of the wrong individual, or
wrong treatment site.
(6) The total dose from therapeutic ionizing radiation delivered
differs from the prescribed dose by 20 percent or more. A report
shall not be required pursuant to this paragraph in any instance
where the dose administered exceeds 20 percent of the amount
prescribed in a situation where the radiation was utilized for
palliative care for the specific patient. The radiation oncologist
shall notify the referring physician that the dose was exceeded.
(b) The facility shall, no later than five business days after
discovery of an event described in subdivision (a), provide
notification of the event to the department and the referring
physician of the person subject to the event and shall, no later than
15 business days after discovery of an event described in
subdivision (a) provide written notification to the person who is
subject to the event.
(c) The information required pursuant to this section shall
include, but not be limited to, information regarding each
substantiated adverse event, as defined in Section 1279.1, reported
to the department, and may include compliance information history.

115115. The person responsible for registering mammographic X-ray
equipment or a certified supervisor, as defined in subdivision (i) of
Section 114850, shall establish and maintain a Mammography Quality
Assurance Program that includes:
(a) A Mammography Quality Assurance Manual for the identification
of mammography quality assurance tests performed, test frequency,
test equipment used, maintenance and calibration of test equipment,
and the qualifications of individuals who perform the tests in order
to ensure compliance with the May 1990 version of "Rules of Good
Practice for Supervision and Operation of Mammographic X-Ray
Equipment" or the regulations of the department.
(b) A "Mammography X-Ray Equipment and Facility Accreditation
Certificate" issued by the department that shall be posted on each
X-ray machine specifically dedicated for the purpose of mammography.