BILL ANALYSIS
SB 1237
Page 1
SENATE THIRD READING
SB 1237 (Padilla)
As Amended August 20, 2010
Majority vote
SENATE VOTE :24-5
HEALTH 19-0 BUSINESS & PROFESSIONS
11-0
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|Ayes:|Monning, Fletcher, |Ayes:|Hayashi, Conway, Eng, |
| |Ammiano, Carter, Conway, | |Hernandez, Hill, Ma, |
| |De La Torre, De Leon, | |Nava, Niello, Ruskin, |
| |Eng, Gaines, Hayashi, | |Smyth, Nestande |
| |Hernandez, Jones, Bonnie | | |
| |Lowenthal, Nava, | | |
| |V. Manuel Perez, Salas, | | |
| |Smyth, Audra Strickland, | | |
| |Gilmore | | |
| | | | |
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APPROPRIATIONS 17-0
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|Ayes:|Fuentes, Conway, |
| |Bradford, |
| |Charles Calderon, Coto, |
| |Davis, |
| |De Leon, Gatto, Hall, |
| |Harkey, Miller, Nielsen, |
| |Norby, Skinner, Solorio, |
| |Torlakson, Torrico |
| | |
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SUMMARY : Requires health facilities and clinics that use
imaging procedures that involve computed tomography X-ray
systems (CT) for human use to record the dose of radiation on
every CT study produced during a CT examination. Requires,
commencing July 1, 2013, facilities that furnish CT to be
accredited and to report to the State Department of Public
Health (DPH) an event in which the administration of radiation
results in an overdose, as specified. Specifically, this bill :
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1)Requires, commencing July 1, 2012, a person that uses a CT for
human use to record the dose of radiation on every CT study
produced during a CT examination.
2)Requires the facility conducting the study referenced in 1)
above to 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.
3)Requires the displayed dose to be verified annually by a
medical physicist to ensure the displayed doses are within 20%
of the true measured dose measured in accordance with 6) below
unless the facility is accredited.
4)Requires the radiology report of a CT, in accordance with 5)
below, to 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.
5)Requires the provisions in this bill to be limited to CT
systems capable of calculating and displaying the dose.
6)Requires, for the purposes of this bill, that dose radiation
be defined as one of the following:
a) The computed tomography index volume and dose length
product, as defined by the International Electrotechnical
Commission and recognized by the federal Food and Drug
Administration (FDA); and,
b) The dose unit as recommended by the American Association
of Physicists in Medicine.
7)Requires, commencing July 1, 2013, facilities that furnish CT
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.
8)Requires a health facility, except for an event that results
from patient movement or interference, to report to DPH an
event in which the administration of radiation results in and
of the following:
a) Repeating of a CT examination, unless otherwise ordered
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by a physician or radiologist, if the following dose values
are exceeded:
i) 0.05 Sv (5 rem) effective dose equivalent;
ii) 0.5 Sv (50 rem) to an organ or tissue; or
iii) 0.5 Sv (50 rem) shallow dose equivalent to the skin.
b) 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:
i) 0.05 Sv (5 rem) effective dose equivalent;
ii) 0.5 Sv (50 rem) to an organ or tissue; or
iii) 0.05 Sv (50 rem) shallow dose equivalent to the
skin.
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 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;
e) Therapeutic ionizing irradiation of the wrong
individual, or wrong treatment site; and,
f) The total dose from therapeutic ionizing radiation
delivered differs from the prescribed dose by 20% or more.
Require a report in any instance where the dose
administered exceeds 20% of the amount prescribed in a
situation where the radiation was utilized for palliative
care for the specific patient. Require the radiation
oncologist to notify the referring physician that the dose
was exceeded.
9)Requires the facility, no later than five business days after
discovery of an event described in 1) above, to provide
notification of the event to DPH and the referring physician
of the person subject to the event. Require the facility, no
later than 15 business days after discovery of an event
described in 1) above, to provide written notification to the
person who is subject to the event.
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10)Requires the information required in the provisions of this
bill to include, but not be limited to, information regarding
each substantiated adverse event, as defined in existing law,
reported to DPH, and may include compliance information
history.
EXISTING LAW :
1)Under the Radiation Control Law, DPH administers provisions
that establish standards for, and regulate sources of,
ionizing radiation. Requires DPH to license persons who
receive, possess, or transfer radioactive materials, and
devices or equipment utilizing these materials.
2)Establishes the Radiologic Health Branch within DPH, which is
responsible for licensing of radioactive materials,
registration of X-ray producing machines, certification of
X-ray and radioactive material users, inspection of facilities
using radiation, investigation of radiation incidents, and
surveillance of radioactive contamination in the environment.
3)Gives DPH, or any state or local agency with which an
agreement has been made, the power to enter property, within
the jurisdiction of the agency, in order to inspect and
determine whether there is compliance with the state's
standards and requirements.
FISCAL EFFECT : The provisions of this bill have not yet been
analyzed by a fiscal committee.
COMMENTS : According to the author and sponsor, Californians are
at increasing risk of over exposure to radiation, and they cite
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 author and sponsor state that medical radiation
can save lives, but can be deadly if improperly administered,
and can increase a person's lifetime risk of developing cancer.
According to the author, oversight for radiation scans is
currently very fragmented; the FDA oversees the approval of
medical devices, such as CT scanners, but does not regulate how
diagnostic tests are used in clinical practice. The author
maintains that one-time instances of over exposure to radiation
are difficult to detect if there is no record of the dosage
administered and exposure to radiation has a cumulative effect
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over a lifetime. The author and sponsor cite problems at
Cedars-Sinai Medical Center in 2009, in which 206 patients were
exposed to overdoses of radiation over an 18-month period,
roughly eight times the recommended level of radiation, when a
scanner used for brain scans was reconfigured. By requiring
health facilities to record CT radiation dosages in a patient's
health record and requiring quality assurance accreditation of
practitioners and health facilities that use diagnostic
radiation, this bill addresses the serious risks associated with
over exposure to radiation.
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097
FN: 0006512