BILL ANALYSIS �
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 38
S
AUTHOR: Padilla
B
AMENDED: As Introduced
HEARING DATE: March 23, 2011
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CONSULTANT:
8
Trueworthy
SUBJECT
Radiation control: health facilities and clinics records
SUMMARY
Technical clean-up to clarify 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.
SB 38 clarifies the reporting date to be effective on July
1, 2012 rather than January 1, 2011.
CHANGES TO EXISTING LAW
Existing law:
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.
Requires DPH to license persons who receive, possess, or
transfer radioactive materials, and devices or equipment
utilizing these materials.
Requires a health facility to report to DPH effective
January 1, 2011, except as specified, an event in which
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the administration of radiation results in any of the
following:
--Repeating of a CT examination, unless otherwise
ordered by a physician or radiologist, if specified
dose values are exceeded;
--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;
--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;
--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;
--Therapeutic ionizing irradiation of the wrong
individual, or wrong treatment site; and,
--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.
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.
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FISCAL IMPACT
This bill has not been analyzed by a fiscal committee.
However, according to the Assembly Appropriations Committee
analysis of SB 1237 in 2010, which requires hospitals and
imaging centers to report to DPH an event in which the
administration of radiation results in an overdose, the
reporting requirements resulted in no direct fiscal impact
to DPH.
BACKGROUND AND DISCUSSION
The author 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 and sponsor state that 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 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. 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. The author and sponsor argue
that over radiation is difficult to detect if there is no
record of the dosage administered, which SB 1237 of 2010
will ensure.
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
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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 (FAQ) document that
informs 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:
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
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physician.
Prior legislation
SB 1237 (Padilla) Chapter 521, Statues of 2010, requires
health facilities and clinics that use imaging procedures
that involve computed tomography (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 the
Department of Public Health (DPH) an event in which the
administration of radiation results in an overdose, as
specified.
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.
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.
Arguments in support
AdvaMed argues SB 38 is needed to allow the regulatory and
clinical communities' time to prepare and be in full
compliance with the reporting requirements enacted in SB
1237. The California Hospital Association writes that SB
38 would provide sufficient time to determine the
appropriate reporting standards and requirements for
hospitals and radiology facilities.
COMMENTS
1. Adverse events and radiation errors. In response
to growing evidence concerning the prevalence and
seriousness of preventable medical errors in health
care facilities, California enacted legislation in
2006 (SB 1301-Alquist, Chapter 647, Statutes of 2006).
SB 1301 requires general acute care hospitals, acute
psychiatric hospitals, and special hospitals to report
27 nationally recognized adverse events to DPH and
requires DPH to make information regarding reports of
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substantiated adverse events readily accessible to
consumers throughout California.
SB 1237 (Padilla) includes language requiring the
reporting requirements for inappropriate or excessive
radiation occurring during CT examinations or
radiation therapy to include information regarding
each substantiated adverse event, as defined in Health
and Safety Code Section 1279.1, reported to the DPH
and include compliance history information.
The inclusion of this adverse event language appears
to be a drafting error and the author may wish to
delete this section (Health and Safety Code 115113
(c)).
POSITIONS
Support: AdvaMed
California Hospital Association
California Radiological Society
Consumer Attorneys of California
One Individual
Oppose: None received
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