BILL NUMBER: AB 510 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JANUARY 13, 2012
AMENDED IN ASSEMBLY JANUARY 4, 2012
AMENDED IN ASSEMBLY MARCH 31, 2011
INTRODUCED BY Assembly Member Bonnie Lowenthal
FEBRUARY 15, 2011
An act to amend Sections 115111 , 115112, and 115113 of
the Health and Safety Code, relating to public health.
LEGISLATIVE COUNSEL'S DIGEST
AB 510, as amended, Bonnie Lowenthal. Radiation control: health
facilities and clinics: records.
Under existing law, the State Department of Public Health licenses
and regulates health facilities and clinics, as defined. Under
existing law, the Radiation Control Law, the department licenses and
regulates persons that use devices or equipment utilizing radioactive
materials. Under existing law, the department is authorized to
require registration and inspection of sources of ionizing radiation,
as defined. Existing law, commencing July 1, 2012, requires that a
facility using a computed tomography (CT) X-ray system record the
dose of radiation on every CT study produced. Existing law requires
that the displayed dose of radiation be verified annually by a
medical physicist to ensure the accuracy of the displayed dose unless
the facility is accredited. Violations of these provisions are a
crime.
This bill would exempt specified CT studies from
being required to record the dose. This bill would delete the
exemption for accredited facilities and authorize accredited
facilities would authorize a facility that has an
accredited machine to elect not to annually verify the
displayed dose of radiation, as specified. Because accredited
facilities could now be subject to these provisions, and because a
violation of these provisions is a crime, the bill would impose a
state-mandated local program by expanding the scope of a crime. The
bill also would require the dose to be verified for the facility's
standard adult brain, adult abdomen, and pediatric brain protocols.
Existing law, commencing July 1, 2013, requires facilities that
furnish CT X-ray services to be accredited by an approved
organization, as specified.
This bill would not require the facilities to be accredited, but
instead would require the CT X-ray systems to be accredited by an
approved organization, as specified.
Existing law, commencing July 1, 2012, requires a facility to
report the discovery of certain information about an event in which
the administration of radiation results in prescribed occurrences,
including the CT X-ray irradiation of an area of the body other
than that intended, within 5 business days of the discovery of
the event, to the department and the patient's referring physician.
This bill would require instead a facility to report a CT
X-ray irradiation image that does not include the intended anatomic
area. This bill would provide that reporting is not required if
adjacent body parts are irradiated during the same treatment, unless
specified. This bill would instead require that this report be
made within 10 business days of the discovery of the event.
The bill would also make technical and clarifying changes.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 115111 of the Health and Safety Code is amended
to read:
115111. (a) Commencing July 1, 2012, subject to subdivision (e),
a person that uses a computed tomography (CT) X-ray system
dedicated to only diagnostic for human use shall
record the dose of radiation on every CT study produced during a CT
examination on a system . CT studies used for
therapeutic radiation treatment planning or image guidance for
interventional radiol ogic procedures shall not be
required to record the dose.
(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) (1) The displayed dose shall be verified annually by a medical
physicist for the facility's standard adult brain, adult abdomen,
and pediatric brain protocols, to ensure the displayed doses are
within 20 percent of the true measured dose measured in accordance
with subdivision (f).
(2) A facility that has a machine that is accredited
may elect not to perform the verification described in paragraph (1).
(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.
SEC. 2. Section 115112 of the Health
and Safety Code is amended to read:
115112. Commencing July 1, 2013, facilities that furnish
CT X-ray services CT X-ray systems 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.
SEC. 2. SEC. 3. Section 115113 of
the Health and Safety Code, as amended by Section 1 of Chapter 139 of
the Statutes of 2011, is amended to read:
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 any of
the following:
(1) Repeating of a CT examination, unless otherwise ordered by a
physician or a radiologist, if one of the following dose
values are exceeded:
(A) 0.05 Sv (5 rem) effective dose.
(B) 0.5 Sv (50 rem) to an organ or tissue.
(C) 0.5 Sv (50 rem) shallow dose to the skin.
(2) A CT X-ray irradiation of an area of the
body other than that intended image that does not
include the intended anatomic area by the ordering physician or
a radiologist if at least one of the following
dose values are exceeded:
(A) 0.05 Sv (5 rem) effective dose.
(B) 0.5 Sv (50 rem) to an organ or tissue.
(C) 0.5 Sv (50 rem) shallow dose 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, 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
the wrong nonoverlapping treatment site.
Reporting is not required if adjacent body parts are irradiated
during the same treatment, unless they exceed the values in paragraph
(6) of this subdivision.
(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 10 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) This section shall become inoperative on the effective date of
the act that added this subdivision, and shall remain inoperative
until July 1, 2012.
SEC. 3. SEC. 4. No reimbursement is
required by this act pursuant to Section 6 of Article XIII B of the
California Constitution because the only costs that may be incurred
by a local agency or school district will be incurred because this
act creates a new crime or infraction, eliminates a crime or
infraction, or changes the penalty for a crime or infraction, within
the meaning of Section 17556 of the Government Code, or changes the
definition of a crime within the meaning of Section 6 of Article XIII
B of the California Constitution.