Bill Text: CA AB510 | 2011-2012 | Regular Session | Chaptered
Bill Title: Radiation control: health facilities and clinics:
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2012-07-13 - Chaptered by Secretary of State - Chapter 106, Statutes of 2012. [AB510 Detail]
Download: California-2011-AB510-Chaptered.html
BILL NUMBER: AB 510 CHAPTERED
BILL TEXT
CHAPTER 106
FILED WITH SECRETARY OF STATE JULY 13, 2012
APPROVED BY GOVERNOR JULY 13, 2012
PASSED THE SENATE JULY 5, 2012
PASSED THE ASSEMBLY JULY 5, 2012
AMENDED IN SENATE JULY 2, 2012
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, 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 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 in specified CT studies from
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 instead would require 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 a facility to report a CT X-ray
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 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.
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 may 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 interpretive report of a
diagnostic CT study shall include the dose of radiation by either
recording the dose within the patient's report or attaching the
protocol page that includes the dose of radiation to the 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) 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 organization approved by the
Medical Board of California, or the State Department of Public
Health. A facility that is subject to accreditation may elect to have
the CT X-ray system accredited pursuant to 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 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 examination for any individual for whom a physician
did not provide approval for the examination 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) 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.
(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.
(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.
(6) Therapeutic ionizing irradiation of the wrong individual or
the wrong treatment site, excluding the area of the body that was
intended to be irradiated.
(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 if
the dose administered exceeds 20 percent of the amount prescribed in
a situation 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 (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 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.
