BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 38|
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THIRD READING
Bill No: SB 38
Author: Padilla (D)
Amended: 3/29/11
Vote: 27 - Urgency
SENATE HEALTH COMMITTEE : 8-1, 3/23/11
AYES: Hernandez, Strickland, Alquist, Blakeslee, De León,
DeSaulnier, Rubio, Wolk
NOES: Anderson
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SUBJECT : Radiation control: health facilities and
clinics: records
SOURCE : Author
DIGEST : This bill clarifies the effective dates
hospitals, imaging centers and the California Department of
Public Health (DPH) must comply with reporting requirements
for inappropriate or excessive radiation occurring during
computed tomography (CT) examinations or radiation therapy,
and clarifies the reporting date to be effective on July 1,
2012 rather than January 1, 2011.
ANALYSIS : 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
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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;
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
percent 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.
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1.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.
This bill requires facilities to report events for
inappropriate or excessive radiation occurring during CT
examinations or radiation therapy, as defined, beginning
July 1, 2012, rather than January 1, 2011.
Background
SB 1237 (Padilla, Chapter 521, Statutes of 2010) added 3
new sections to the Health and Safety Code relating to CT
X-rays. Section 1 required, as of July 1, 2012, that
facilities using CT for diagnostic purposes, record the
dose of radiation used during the administration of the
radiation in the patient's medical record. Section 2
required, as of July 1, 2013, facilities that furnish CT
X-ray services to be accredited by an organization that is
approved by the Centers for Medicare and Medicaid Services,
the Medical Board of California, or DPH. Section 3 stated
that a facility is required to report to DPH an event in
which the misadministration of radiation occurs on a
patient. Section 3 did not include a delayed
implementation date and, therefore, became effective
January, 1, 2011.
On August 30, 2010, Senator Padilla submitted a letter to
the Senate Daily Journal that stated his intent to
implement the effective date of Section 3 of SB 1237 as
July 1, 2012. This bill is intended to correct this error
by changing the effective date. Extending the date allows
facilities the time needed to implement internal procedures
needed for reporting inappropriate or excessive radiation
that occurred during CT examinations or radiation therapy
procedures to DPH.
DPH has posted on its website and disseminated to the
industry a Frequently-Asked-Questions document that informs
facilities how to report and what information should be
reported. The following information must be provided to
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the Radiologic Health Branch of DPH in a timely fashion
when reporting events for inappropriate or excessive
radiation occurring during CT examinations or radiation
therapy:
1. Person making report, job title, contact information
2. Date(s) of event
3. Facility information
4. Radiation generating equipment specifics (i.e.
manufacturer, model number, and software version)
5. Radiation generating equipment settings
6. Operator's name
7. Patient's physician name and contact information
8. Copy of physician's order for CT or radiation therapy
treatment plan
9. Explanation as to reason for reporting event
10. Copies of internal investigation reports (include
cause and corrective action to prevent reoccurrence)
11. Patient dose calculations (include methodology)
12. Copies of letters sent to the patient and physician.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 4/11/11)
AdvaMed
California Hospital Association
California Radiological Society
Consumer Attorneys of California
ARGUMENTS IN SUPPORT : The author's office and supporters
state this bill is a technical clean-up measure to SB 1237
(Padilla) 2010, Chapter 52l to clarify the effective date
for reporting requirements for inappropriate or excessive
radiation occurring during CT examinations or radiation
therapy is July 1, 2012, as opposed to January 1, 2011.
The author's office states, Californians are at increasing
risk of over radiation, and cite statistics that total
exposure to ionizing radiation has nearly doubled over the
past two decades, in large part because of increased use of
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CT 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 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. Supporters state that over radiation is
difficult to detect if there is no record of the dosage
administered, which SB 1237 of 2010 will ensure.
CTW:nl 4/11/11 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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