BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 1237|
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UNFINISHED BUSINESS
Bill No: SB 1237
Author: Padilla (D), et al
Amended: 8/20/10
Vote: 21
SENATE HEALTH COMMITTEE : 5-0, 4/21/10
AYES: Alquist, Leno, Negrete McLeod, Pavley, Romero
NO VOTE RECORDED: Strickland, Aanestad, Cedillo, Cox
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SENATE FLOOR : 24-5, 5/28/10
AYES: Alquist, Calderon, Cedillo, Corbett, Correa,
DeSaulnier, Ducheny, Florez, Hancock, Kehoe, Leno, Liu,
Lowenthal, Negrete McLeod, Padilla, Pavley, Price,
Romero, Simitian, Steinberg, Strickland, Wolk, Wright,
Yee
NOES: Ashburn, Dutton, Hollingsworth, Huff, Runner
NO VOTE RECORDED: Aanestad, Cogdill, Cox, Denham, Harman,
Oropeza, Walters, Wiggins, Wyland, Vacancy, Vacancy
SENATE FLOOR : 22-10, 8/30/10 (Concurrence)
AYES: Alquist, Blakeslee, Calderon, Corbett, Correa,
DeSaulnier, Ducheny, Florez, Hancock, Kehoe, Leno, Liu,
Lowenthal, Negrete McLeod, Padilla, Pavley, Price,
Romero, Simitian, Steinberg, Strickland, Wolk
NOES: Aanestad, Cogdill, Denham, Dutton, Harman,
Hollingsworth, Huff, Runner, Walters, Wyland
NO VOTE RECORDED: Ashburn, Cedillo, Emmerson, Oropeza,
Wiggins, Wright, Yee, Vacancy
ASSEMBLY FLOOR : 70-4, 8/26/10 - See last page for vote
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SUBJECT : Radiation control: health facilities and
clinics: records
SOURCE : Consumer Attorneys of California
DIGEST : This bill 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, and 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.
Assembly Amendments delete the previous content and revised
and recast the measure related to the same subject matter.
The amendments require, commencing July 1, 2012, a person
that uses a CT X-ray system for human use to record the
dose of radiation on every CT study produced during CT
examination. The amendments require the facility
conducting the study to electronically send each CT study
and protocol page that lists the technical factors and dose
of radiation to electronic the electronic picture archiving
and communications system.
ANALYSIS : Existing law:
1. Under the Radiation Control Law, Department of Public
Health (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
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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.
This bill:
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 percent 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; and,
B. The dose unit as recommended by the American
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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 by a physician or radiologist, if the
following dose values are exceeded:
(1) 0.05 Sv (5 rem) effective dose equivalent;
(2) 0.5 Sv (50 rem) to an organ or tissue; or
(3) 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:
(1) 0.05 Sv (5 rem) effective dose equivalent;
(2) 0.5 Sv (50 rem) to an organ or tissue; or
(3) 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
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individual, or wrong treatment site; and,
F. The total dose from therapeutic ionizing radiation
delivered differs from the prescribed dose by 20
percent or more. Require a report 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. 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.
Requires 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.
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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
SUPPORT : (Verified 8/25/10)
Consumer Attorneys of California (source)
Breast Cancer Fund
California Nurses Association
Consumer Federation of California
ARGUMENTS IN SUPPORT : According to supporters,
Californians are at increasing risk of over radiation, and
cites statistics that total exposure to ionizing radiation
has nearly doubled over the past two decades, in large part
because of increased use of computed tomography scans for
medical diagnostic and treatment purposes. Medical
radiation can save lives, but can be deadly if improperly
administered, and can increase a person's lifetime risk of
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developing cancer. 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. Over radiation is difficult
to detect if there is no record of the dosage administered,
which this bill would ensure.
The Consumer Attorneys of California (CAC), the sponsor of
SB 1237, states that aside from the tragic incidents that
occurred at Cedars-Sinai Medical Center, Californians in
general are at increasing risk of over radiation that can
subsequently increase the risk of cancer. CAC states that
the surge in new technology provides many benefits for
diagnosing and treating disease; however, the increasing
dependence on it has created new avenues for errors in
software and operation, and those mistakes cannot only be
difficult to detect, but can become embedded in a treatment
plan and repeated over and over with patients. CAC states
that oversight of medical imaging is fragmented and SB 1237
is intended to take steps to protect patients, including
recording of radiation dosage and adoption of quality
assurance programs to prevent errors such as the ones that
have been recently reported.
The Consumer Federation of California (CFC) states that
this bill will increase patient safety by deterring
one-time over radiation errors, which can cause damage to
DNA and increase a person's lifetime risk for cancer,
especially for children and youth. The risk for over
radiation is becoming more and more likely, as the National
Council on Radiation Protection and Measurements reports
that US citizens are being exposed to ionizing radiation at
twice the level of two decades ago. CFC states that
one-time instances of over radiation may be difficult to
detect without proper documentation of the dosage
administered.
ASSEMBLY FLOOR :
AYES: Adams, Ammiano, Arambula, Bass, Beall, Bill
Berryhill, Tom Berryhill, Block, Blumenfield, Bradford,
Brownley, Buchanan, Caballero, Charles Calderon, Carter,
Chesbro, Conway, Cook, Coto, Davis, De La Torre, De Leon,
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Eng, Evans, Feuer, Fletcher, Fong, Fuentes, Furutani,
Galgiani, Garrick, Gatto, Hagman, Hall, Harkey, Hayashi,
Hernandez, Hill, Huber, Huffman, Jeffries, Jones, Lieu,
Logue, Bonnie Lowenthal, Ma, Mendoza, Miller, Monning,
Nava, Nestande, Niello, Nielsen, V. Manuel Perez,
Portantino, Ruskin, Salas, Saldana, Silva, Skinner,
Smyth, Solorio, Audra Strickland, Swanson, Torlakson,
Torres, Torrico, Villines, Yamada, John A. Perez
NOES: Anderson, DeVore, Fuller, Gaines
NO VOTE RECORDED: Gilmore, Knight, Norby, Tran, Vacancy,
Vacancy
CTW:nl 8/31/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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