BILL ANALYSIS �
SB 38
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Date of Hearing: June 14, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 38 (Padilla) - As Amended: March 29, 2011
SENATE VOTE : 36-4
SUBJECT : Radiation control: health facilities and clinics:
records.
SUMMARY : Makes July 1, 2012 the effective date by which health
facilities, imaging centers and the California Department of
Public Health (DPH) must comply with reporting requirements in
existing law for inappropriate or excessive radiation occurring
during computed tomography (CT) examinations or radiation
therapy. Contains an urgency clause to ensure that the
provisions of this bill go into immediate effect upon enactment.
EXISTING LAW :
1)Establishes the Radiologic Health Branch (RHB) within DPH,
which is responsible for the 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.
2)Requires DPH to license persons who receive, possess, or
transfer radioactive materials, and devices or equipment
utilizing these materials.
3)Requires a health facility to report to DPH effective January
1, 2011, except as specified, an event in which the
administration of radiation results in any of the following:
a) Repeating of a CT examination, unless otherwise ordered
by a physician or radiologist, if 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
specified dose values are exceeded;
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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,
except in any instance where the radiation was utilized for
palliative care; however, the radiation oncologist would be
required to notify the referring physician that the dose
was exceeded.
4)Requires the facility, no later than five business days after
discovery of an event, to notify DPH and the referring
physician of the person who is the subject to the event, and,
no later than 15 business days after discovery of an event, to
provide written notification to the person who is the subject
of the event.
FISCAL EFFECT . According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill
provides technical clean-up language to clarify the effective
date that health facilities, imaging centers and DPH must
comply with reporting requirements regarding excess radiation
exposure that were signed into law under SB 1237 (Padilla),
Chapter 521, Statutes of 2010. The author maintains that the
intent of SB 1237 was to establish July 1, 2012 as the
effective date for the mandated reporting, however, the bill
did not include an effective date. Absent a specific date,
the reporting requirements in SB 1237 took effect on January
1, 2011 which did not allow sufficient time for DPH to
determine the appropriate reporting standards and requirements
SB 38
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of excess radiation exposure for health facilities and imaging
centers.
2)BACKGROUND . The author states Californians are at increasing
risk of overexposure to 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 CT scans for medical diagnostic and treatment purposes.
The author states that medical radiation can save lives, but
can be deadly if improperly administered, and can increase a
person's lifetime risk of developing cancer. The author cites
problems at Cedars-Sinai Medical Center in 2009, in which 206
patients were exposed to excess radiation over an 18-month
period, roughly eight times the recommended level of
radiation, when a scanner used for brain scans was
inappropriately reconfigured. The author argues that excess
exposure to radiation is difficult to detect if there is no
record of the dosage administered. The Legislature passed SB
1237 to address this issue.
3)DPH RESPONSE TO SB 1237 . To date, DPH has posted on its
Website and disseminated to the radiological industry a
Frequently-Asked-Questions (FAQ) document that informs health
facilities how to report and what information should be
reported. The following information must be provided to the
RHB of DPH in a timely fashion when reporting events for
inappropriate or excessive radiation occurring during CT
examinations or radiation therapy:
a) Person making report, job title, and contact
information;
b) Date(s) of event;
c) Facility information;
d) Radiation generating equipment specifics (i.e.
manufacturer, model number, and software version);
e) Operator's name;
f) Patient's physician name and contact information;
g) Copy of physician's order for CT or radiation therapy
treatment plan;
h) Explanation as to reason for reporting event;
i) Copies of internal investigation reports (include cause
and corrective action to prevent reoccurrence);
j) Patient dose calculations (include methodology); and,
aa) Copies of letters sent to the patient and physician.
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4)SUPPORT . The California Hospital Association (CHA) writes in
support that SB 1237 makes significant changes in the
reporting requirements of hospitals when a patient has
received excessive radiation exposure during a CT examination
and allows DPH to track incidences of overexposure and respond
to them immediately. CHA, the California Radiological
Society, Consumer Attorneys of California, and the University
of California Davis Health System all write that as
stakeholders of SB 1237 it was the intent that the provisions
would have a delayed operative date in order to allow the
medical and physicist community time to develop reporting
parameters and implement those standards. Supporters maintain
that this bill would move the date for implementing SB 1237
forward 18 months to allow DPH time to establish appropriate
reporting standards.
5)PREVIOUS LEGISLATION :
a) SB 1237 requires health facilities and clinics that use
imaging procedures that involve CT X-ray systems for human
use to record the dose of radiation on every CT study
produced during a CT examination. Requires facilities that
furnish CTs to be accredited, and to report to DPH an event
in which the administration of radiation results in an
overdose, as specified.
b) SB 148 (Oropeza), Chapter 169, Statutes of 2009,
requires a facility that operates a mammogram machine to
post notices of serious violations, as defined, in an area
that is visible to patients.
c) AB 929 (Oropeza), Chapter 427, Statutes of 2005,
requires the RHB to adopt regulations regarding quality
assurance standards for facilities using specified
radiation-producing equipment and to provide the
regulations to the Health Committees of the Assembly and
the Senate on or before January 1, 2008.
REGISTERED SUPPORT / OPPOSITION :
Support
Advanced Medical Technology Association
California Hospital Association
California Radiological Society
Consumer Attorneys of California
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Consumer Federation of California
University of California Davis Health System
Opposition
None on file.
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097