BILL ANALYSIS
SB 1237
Page 1
SENATE THIRD READING
SB 1237 (Padilla)
As Amended June 23, 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 diagnostic purposes to record the dose of
radiation produced during the administration of a CT examination
in the patient's medical record and on the image produced by the
examination. Specifically, this bill :
1)Requires general acute care hospitals, acute psychiatric
hospitals, and special hospitals (collectively health
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facilities), as specified, that use CT for diagnostic purposes
to record the dose of radiation produced during the
administration of CT examination in the patient's medical
record and on the image produced by the examination,
commencing January 1, 2012.
2)Requires the dosage to be recorded using both dose length
product (DLP) and volume CT index (CTDI vol), as defined by
the International Electrotechnical Commission (IEC) and
recognized by the federal Food and Drug Administration (FDA).
3)Requires the health facility to ensure that the CTDI vol is
recorded in the patient's medical record and on any image
produced from the examination.
4)Clarifies that the requirements in 1) above be limited to CT
examinations performed on equipment where it is currently
possible to record the CTDI vol directly or through the
addition of updates that have been approved or cleared by the
FDA.
5)Exempts small and rural hospitals and those facilities
specified in 1) above, that are located in an area that is
designated as a federal medically underserved area, from the
provisions of this bill until January 1, 2013.
6)Requires health facilities that furnish CT services to be
accredited by an organization that is approved by the federal
Centers for Medicare and Medicaid Services or an accrediting
agency approved by the Medical Board of California, commencing
January 1, 2012.
7)Requires a health facility that uses CT to notify the
California Department of Public Health (DPH), the affected
patient, and the patient's treating physician immediately, in
writing, of the occurrence of any of the following events:
a) Repetition of CT exposure due to equipment defect or
malfunction;
b) Irradiation of the wrong patient or irradiation of a
body part other than that intended by the ordering
physician and surgeon; or,
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c) A diagnostic dosage that exceeds by 50% or more the
protocols referenced in 2) above;
8)Requires each facility that utilizes therapeutic X-ray systems
operating at energies below one million electron volts (MeV)
to notify and report to DPH, in accordance with DPH
regulations, and to also notify the affected patient and his
or her treating physician within 10 days, in writing, of the
occurrence of any of the following events:
a) Irradiation of the wrong individual or wrong treatment
site;
b) Any treatment consisting of three or fewer fractions,
with the calculated total administered dose differing from
the total prescribed dose by more than 10% of the total
prescribed dose; or,
c) Any exposure resulting in a calculated total
administration dose differing from the total prescribed
dose by more than 10% of the total prescribed dose.
9)Requires each facility that utilizes therapeutic X-ray systems
operating with energies at or above one Mev to notify and
report to DPH, in accordance with DPH regulations, and to
notify the affected patient and his or her treating physician
within 10 days, in writing, of the occurrence of any of the
following events:
a) Any event involving irradiation of the wrong individual,
administration of the wrong type of radiation or the wrong
energy, or irradiation of the wrong treatment site;
b) Any treatment consisting of three of fewer fractions,
with the calculated total administered dose differing from
the total prescribed dose by more than 10% of the total
prescribed dose; or,
c) Any exposure resulting in a calculated total
administration dose differing from the total prescribed
dose by more than 20% of the total prescribed dose.
EXISTING LAW :
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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 : According to the Assembly Appropriations
Committee analysis, this bill would result in no direct fiscal
impact to DPH to continue oversight of radiology professionals.
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
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
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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: 0005629