BILL ANALYSIS Ó
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THIRD READING
Bill No: AB 510
Author: Bonnie Lowenthal (D)
Amended: 6/15/12 in Senate
Vote: 27-Urgency
SENATE HEALTH COMMITTEE : 9-0, 4/11/12
AYES: Hernandez, Harman, Alquist, Anderson, Blakeslee, De
León, DeSaulnier, Rubio, Wolk
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
ASSEMBLY FLOOR : 75-0, 1/26/12 (Consent) - See last page
for vote
SUBJECT : Radiation control: health facilities and
clinics: records
SOURCE : California Hospital Association
DIGEST : This bill makes technical and clarifying changes
to existing reporting requirements for facilities using
computed tomography X-ray systems when a patient receives
excessive or unnecessary doses of radiation.
ANALYSIS : Existing law:
1. Establishes the Radiation Control Law and the goal of
effectively regulating sources of ionizing radiation for
the protection of public health.
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2. Establishes the Radiologic Health Branch within the
Department of Public Health (DPH) in order to administer
a radiation control program.
3. Requires DPH to license devices or equipment utilizing
radioactive materials, and persons who operate these
devices.
4. Requires, commencing July 1, 2012, a person that
operates a computed tomography (CT) X-ray system for
human use to record the dose of radiation on every CT
study produced during a CT examination if the CT system
is capable of displaying the dose.
5. Requires, commencing July 1, 2013, facilities that
furnish CT services to 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 DPH.
6. Requires a facility to report to DPH an event in which
the administration of radiation results in any of the
following, except events that result from patient
movement or interference:
A. Repeating of a CT examination, unless otherwise
ordered by a physician or radiologist, if three
specified dose values are exceeded;
B. CT X-ray irradiation of a body part other than
that intended by the ordering physician or a
radiologist if one of three specified dose values are
exceeded;
C. 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;
D. A CT or therapeutic dose to an embryo or fetus
that is greater than a specified dose value, 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 qualifying
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physician;
E. Therapeutic ionizing irradiation of the wrong
individual or wrong treatment site; or
F. The total dose from therapeutic ionizing radiation
delivered differs from the prescribed dose by 20% or
more, unless the radiation was used for palliative
care, in which case the radiation oncologist is
required to notify the referring physician if the
dose was exceeded.
7. Requires a facility, no later than five business days
after the discovery of an event, to provide notification
of the event to DPH and the referring physician, and, no
later than 15 business days after the discovery of an
event, to provide written notification to the person
subject to the event.
This bill:
1. Limits the requirement that the dose of radiation be
recorded on every CT study to only "diagnostic" CT
studies, and specifically excludes CT studies used for
therapeutic radiation treatment planning or delivery.
2. Clarifies that the definition of "CT X-ray system," for
purposes of the requirement that the X-ray systems
record the dose of radiation, is the same as the
definition under existing federal regulations, as
specified.
3. Clarifies that facilities are required to report when a
CT X-ray examination is repeated if any one of three
types of dose values are exceeded, rather than when all
three are exceeded.
4. Clarifies that facilities are required to report when a
CT X-ray exceeded certain specified doses, and "did not
include" the intended area of the body, rather than when
the X-ray irradiated a body part "other than that
intended."
5. Excludes from the requirement that facilities report
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therapeutic ionizing irradiation of the wrong treatment
site instances in which adjacent body parts are
irradiated during the same treatment, unless they exceed
specified values.
6. Extends the deadline for a facility to report
non-therapeutic irradiation adverse events to DPH and
the referring physician from no later than five business
days after discovery of the event to no later than 10
business days after discovery of an event.
7. Clarifies that it is the CT X-ray systems that have to
be accredited by July 1, 2013, rather than the
facilities that furnish the X-ray systems.
8. Allows for the accreditation of a CT X-ray system to be
included as part of a single accreditation survey, so
long as that survey includes the CT service, and
clarifies that systems that are used for therapeutic
radiation treatment planning or delivery, calculating
attenuation coefficients for nuclear medicine studies,
or those that are dedicated for image guidance for
interventional radiological procedures are not required
to be accredited.
9. Makes a technical, clarifying change to the CT X-ray
system accreditation requirement, by specifying that a
medical physicist is only required to annually verify
the accuracy of a CT X-ray system's displayed dose until
the accreditation requirement takes effect on July 1,
2013. Also clarifies that if the X-ray system is
already accredited, the verification by the medical
physicist is not required.
10.Makes other minor technical and clarifying changes to
existing requirements for the reporting of events
related to the administration of CT X-ray radiation and
therapeutic radiation that are scheduled to take effect
on July 1, 2012.
Background
SB 1237 (Padilla), Chapter 521, Statutes of 2010,
established new requirements for hospitals and clinics that
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use CT systems in response to concerns of over radiation.
Comments
According to the Senate Health Committee analysis, the
bill's author argued that Californians were at increasing
risk of radiation overdoses, and cited statistics that
total exposure to ionizing radiation has nearly doubled
over the past two decades, in large part because of
increased use of CT scans for medical diagnostic and
treatment purposes. The bill's author cited problems at
Cedars-Sinai Medical Center in 2009, in which 206 patients
were exposed to overdoses of radiation over an 18-month
period. The bill's author stated that patients were
exposed to roughly eight times the recommended level of
radiation when a scanner used for brain scans was
reconfigured.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
SUPPORT : (Verified 6/25/12)
California Hospital Association (source)
AFSCME, AFL-CIO
California Radiological Society
ARGUMENTS IN SUPPORT : The California Hospital
Association (CHA) is the sponsor of this bill, and writes
in support that questions have risen as a result of the
interpretation and anticipated implementation of SB 1237.
CHA states that this bill is intended to address these
questions and provide clarity to the affected facilities.
CHA states that this bill will clarify that certain
requirements apply to CT exams that are for diagnostic
purposes only, and that certain types of reports are only
required if an exam is done on parts of the body not
intended to be scanned. According to CHA, this bill will
prevent unnecessary reporting while focusing on the
critical reporting requirements of excessive radiation
exposure that can put a patient at risk.
The California Radiological Society writes in support that
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this bill will provide necessary clarification for the
implementation of SB 1237 and is consistent with the
policies underlying the passage of that bill.
ASSEMBLY FLOOR : 75-0, 1/26/12
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall,
Bill Berryhill, Block, Blumenfield, Bonilla, Bradford,
Brownley, Buchanan, Butler, Charles Calderon, Campos,
Carter, Cedillo, Chesbro, Conway, Cook, Dickinson,
Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Furutani,
Beth Gaines, Galgiani, Garrick, Gatto, Gordon, Grove,
Hagman, Hall, Hayashi, Roger Hernández, Hill, Huber,
Hueso, Huffman, Jeffries, Jones, Knight, Lara, Logue,
Bonnie Lowenthal, Ma, Mansoor, Mendoza, Miller, Mitchell,
Monning, Morrell, Nestande, Nielsen, Norby, Olsen, Pan,
Perea, V. Manuel Pérez, Portantino, Silva, Skinner,
Solorio, Swanson, Torres, Valadao, Wagner, Wieckowski,
Williams, Yamada, John A. Pérez
NO VOTE RECORDED: Davis, Gorell, Halderman, Harkey, Smyth
CTW:k 6/26/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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