BILL NUMBER: AB 510 AMENDED
BILL TEXT
AMENDED IN SENATE JUNE 15, 2012
AMENDED IN SENATE APRIL 16, 2012
AMENDED IN SENATE MARCH 29, 2012
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, and declaring the urgency
thereof, to take effect immediately.
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
the 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 require the facility to record the dose of
radiation on every diagnostic CT study in each patient's record
and would exempt the dose of radiation i n
specified CT studies from being required to record the
dose having to be recorded . This bill would
delete the exemption for accredited facilities and would authorize a
facility with an accredited CT X-ray system 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 eliminate the requirement that the facilities be
accredited and instead would require the CT X-ray
systems , with specified exceptions, 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 instead require instead
a facility to report a CT X-ray irradiation
examination for any individual for whom a physician
did not provide approval for the examination, as well as a CT X-ray
examination that does not include the intended area of the body
, if specified dose values are exceeded. This
bill would provide that reporting is not required if adjacent body
parts are irradiated during the same treatment, unless specified does
values are exceeded. This bill would require that these
reports be made within 5 business days of the discovery of a
therapeutic event and within 10 business days of the discovery of a
CT 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.
This bill would declare that it is to take effect immediately as
an urgency statute.
Vote: 2/3. 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 for human
use shall record the dose of radiation on every diagnostic CT study
produced during a CT examination in the patient's record, as
defined in Section 123105 . CT studies used for therapeutic
radiation treatment planning or delivery or for calculating
attenuation coefficients for nuclear medication studies shall
not be required to record the dose.
(b) The facility conducting the study shall send electronically
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) Until July 1, 2013, 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 CT X-ray system that is 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 may
elect not to perform the verification described in paragraph (1).
(d) Subject to subdivision (e), the radiology
interpretive 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.
(g) For purposes of this section, "CT X-ray system" means the same
as provided in Section 892.1750 of Title 21 of the Code of Federal
Regulations.
SEC. 2. Section 115112 of the Health and Safety Code is amended to
read:
115112. (a) Commencing Except
as provided in subdivision (b), commencing July 1, 2013, CT
X-ray systems shall be accredited by an accrediting
organization that is approved by the federal Centers for Medicare and
Medicaid Services, an accrediting agency
organization approved by the Medical Board of
California, or the State Department of Public Health. A CT X-ray
system may be accredited through a single accreditation survey that
includes the CT service by the accrediting organization.
(b) A CT X-ray system shall not be subject to accreditation if any
of the following apply:
(1) The system is used for therapeutic radiation treatment
planning or delivery.
(2) The system is used for calculating attenuation coefficients
for nuclear medicine studies.
(3) The system is dedicated for image guidance for interventional
radiologic procedures.
SEC. 3. Section 115113 of the Health and Safety Code 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 is 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 examination
that does not include the intended area of the body by the ordering
physician or a radiologist for any individual for whom
a physician did not provide approval for the examination
if one of the following dose values are
is 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) A CT X-ray for an examination that does not include the area
of the body that was intended to be imaged by the ordering physician
or radiologist if one of the following dose values is 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)
(4) 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)
(5) 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)
(6) Therapeutic ionizing irradiation of the wrong
individual or the wrong 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 site, excluding the area of the body that
was authorized to be irradiated .
(6)
(7) 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 if the dose administered
exceeds 20 percent of the amount prescribed in a situation
where if 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 the
discovery of a therapeutic event described in paragraphs (3) to
(6) (7) , inclusive, of subdivision (a)
and no later than 10 business days after discovery of an event
described in paragraphs (1) to (4), inclusive, of 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. 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.
SEC. 5. This act is an urgency statute necessary for the immediate
preservation of the public peace, health, or safety within the
meaning of Article IV of the Constitution and shall go into immediate
effect. The facts constituting the necessity are:
In order to protect the health and safety of Californians and
ensure that these certain facilities
using a computed tomography (CT) X-ray system fully comply
with the reporting requirements that go into effect on July 1, 2012,
it is necessary for this act to take effect immediately.