BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 510
AUTHOR: Lowenthal
AMENDED: March 29, 2012
HEARING DATE: April 11, 2012
CONSULTANT: Marchand/Rubin
SUBJECT : Radiation control: health facilities and clinics:
records.
SUMMARY : Makes technical and clarifying changes to existing
reporting requirements for facilities using computed tomography
(CT) X-ray systems when a patient receives excessive or
unnecessary doses of radiation.
Existing law:
1.Establishes the Radiation Control Law and the goal of
effectively regulating sources of ionizing radiation for the
protection of public health.
2.Establishes the Radiologic Health Branch (RHB) within the
Department of Public Health (DPH) in order to administer a
radiation control program.
3.Requires DPH to license devices or equipment utilizing
radioactive materials, and persons who operate these devices.
4.Requires, commencing July 1, 2012, a person that operates a CT
X-ray system for human use to record the dose of radiation on
every CT study produced during a CT examination if the CT
system is capable of displaying the dose.
5.Requires, commencing July 1, 2013, facilities that furnish CT
services 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.
6.Requires a facility to report to DPH an event in which the
administration of radiation results in any of the following,
except events that result from patient movement or
interference:
a) Repeating of a CT examination, unless otherwise
ordered by a physician or radiologist, if three specified
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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
one of three 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 a specified dose value, 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 qualifying physician;
e) Therapeutic ionizing irradiation of the wrong
individual or wrong treatment site; or
f) The total dose from therapeutic ionizing radiation
delivered differs from the prescribed dose by 20 percent
or more, unless the radiation was used for palliative
care, in which case the radiation oncologist is required
to notify the referring physician if the dose was
exceeded.
1.Requires a facility, no later than five business days after
the discovery of an event, to provide notification of the
event to DPH and the referring physician, and, no later than
15 business days after the discovery of an event, to provide
written notification to the person subject to the event.
This bill:
1.Limits the requirement that the dose of radiation be recorded
on every CT study to only "diagnostic" CT studies, and
specifically excludes CT studies used for therapeutic
radiation treatment planning or delivery.
2.Clarifies that the definition of "CT X-ray system," for
purposes of the requirement that the X-ray systems record the
dose of radiation, is the same as the definition under
existing federal regulations, as specified.
3.Clarifies that facilities are required to report when a CT
X-ray examination is repeated if any one of three types of
dose values are exceeded, rather than when all three are
exceeded.
4.Clarifies that facilities are required to report when a CT
X-ray exceeded certain specified doses, and "did not include"
AB 510 | Page 3
the intended area of the body, rather than when the X-ray
irradiated a body part "other than that intended."
5.Excludes from the requirement that facilities report
therapeutic ionizing irradiation of the wrong treatment site
instances in which adjacent body parts are irradiated during
the same treatment, unless they exceed specified values.
6.Extends the deadline for a facility to report non-therapeutic
irradiation adverse events to DPH and the referring physician
from no later than five business days after discovery of the
event to no later than 10 business days after discovery of an
event.
7.Clarifies that it is the CT X-ray systems that have to be
accredited by July 1, 2013, rather than the facilities that
furnish the X-ray systems.
8.Makes a technical, clarifying change to the CT X-ray system
accreditation requirement, by specifying that a medical
physicist is only required to annually verify the accuracy of
a CT X-ray system's displayed dose until the accreditation
requirement takes effect on July 1, 2013. Also clarifies that
if the X-ray system is already accredited, the verification by
the medical physicist is not required.
9.Makes other minor technical and clarifying changes to existing
requirements for the reporting of events related to the
administration of CT X-ray radiation and therapeutic radiation
that are scheduled to take effect on July 1, 2012.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
PRIOR VOTES :
Assembly Health: 16- 0
Assembly Appropriations:17- 0
Assembly Floor: 75- 0
COMMENTS :
1.Author's statement. According to the author, AB 510 would
ensure that California's hospitals and freestanding clinics
are capable of fully complying with the requirements of SB
1237 (Padilla), Chapter 521, Statutes of 2010, upon
AB 510 | Page 4
implementation on July 1, 2012, by clarifying that the
recording requirements are specific to the diagnostic CT X-Ray
systems capable of recording dosage, and not CT simulators
that do not have that capability; aligning the verification
process to the accreditation standards of the American College
of Radiology; clarifying that the verification process
exemption for accredited facilities requires the CT systems
themselves are accredited, and not just the hospital or
facility in general; and adjusting the reporting timelines to
accommodate smaller or rural facilities that do not have a
physicist on staff to measure and verify dosage. The technical
changes in this bill are consistent with the accrediting
standards, and the initial guidance provided to facilities by
DPH.
2.Background. SB 1237 established new requirements for
hospitals and clinics that use CT systems in response to
concerns of over radiation. According to the Senate Health
Committee analysis, the author of SB 1237 argued that
Californians were at increasing risk of radiation overdoses,
and cited 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 of SB 1237 cited problems
at Cedars-Sinai Medical Center in 2009, in which 206 patients
were exposed to overdoses of radiation over an 18-month
period. The author of SB 1237 stated that patients were
exposed to roughly 8 times the recommended level of radiation
when a scanner used for brain scans was reconfigured.
According to the author of this bill, while SB 1237 outlined
the various requirements related to adverse radiation events,
as providers move toward the implementation deadline, a number
of areas in need of clarification have emerged, and this bill
would make the necessary clarifications.
3.DPH implementation guidance on SB 1237. On January 14, 2011,
DPH released a Questions and Answers (Q&A) regarding the
provisions of SB 1237 to help providers comply with the new
law. In this nine-page Q&A, DPH described how it was
interpreting various specific provisions of the new law,
defined terms and phrases, and answered frequently asked
questions from radiologists and hospitals. For example,
although "body part other than that intended by the ordering
physician or radiologist" was not defined in statute, DPH
stated in its Q&A that it is recognized that body parts that
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are adjacent or opposite to the intended body part will
receive some exposure, and this is not reportable. Rather,
reporting is required if the intended body part is not imaged.
This bill is proposing to codify this interpretation of when
irradiation of an unintended body part triggers a requirement
to report.
In other instances, the Q&A exposed ambiguities that this bill
is seeking to clarify. For example, under SB 1237 a report is
required when a CT examination is repeated unnecessarily and
certain doses are exceeded. The Q&A said that for a report to
be triggered by a repeat CT examination, all three specified
types of doses had to be exceeded: a .05 Sievert (Sv)
effective dose; a 0.5 Sv dose to an organ or tissue; and a 0.5
shallow dose to the skin. This bill would clarify that a
report is triggered if any one of these doses is exceeded.
4.Prior legislation. SB 38 (Padilla), Chapter 139, Statutes of
2011, makes July 1, 2012, the effective date by which health
facilities, imaging centers and DPH must comply with reporting
requirements in existing law for inappropriate or excessive
radiation occurring during CT examinations or radiation
therapy.
SB 1237 (Padilla), Chapter 521, Statutes of 2010, 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.
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.
5.Support. The California Hospital Association (CHA) is the
sponsor of this bill, and writes in support that questions
have risen as a result of the interpretation and anticipated
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implementation of SB 1237. CHA states that this bill is
intended to address these questions and provide clarity to the
affected facilities. CHA states that this bill will clarify
that certain requirements apply to CT exams that are for
diagnostic purposes only, and that certain types of reports
are only required if an exam is done on parts of the body not
intended to be scanned. According to CHA, this bill will
prevent unnecessary reporting while focusing on the critical
reporting requirements of excessive radiation exposure that
can put a patient at risk. The California Radiological Society
writes in support that this bill will provide necessary
clarification for the implementation of SB 1237 and is
consistent with the policies underlying the passage of that
bill.
6.Urgency clause amendment. Because the underlying law that this
bill is seeking to amend is scheduled to take effect on July
1, 2012, the author is proposing to add an urgency clause so
that this bill would take effect immediately upon being signed
by the Governor. The author intends to offer this urgency
clause amendment in committee. The urgency clause has been
approved by the Senate Rules Committee.
SUPPORT AND OPPOSITION :
Support: California Hospital Association (sponsor)
American Federation of State, County and Municipal
Employees, AFL-CIO
California Radiological Society
Oppose: None received.
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