BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SB 1237
S
AUTHOR: Padilla
B
AMENDED: August 20, 2010
HEARING DATE: August 30, 2010
1
CONSULTANT:
2
Hansel/cjt
3
7
PURSUANT TO S.R. 29.10
SUBJECT
Radiation control: health facilities and clinics: records
SUMMARY
Requires health facilities and clinics that use imaging
procedures that involve computed tomography X-ray systems
(CT) 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.
CHANGES TO EXISTING LAW
Existing law:
Establishes the Radiologic Health Branch within the
Department of Public Health (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
Continued---
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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 DPH, on or before January 1, 2008, to adopt
regulations that require personnel and facilities using
radiation-producing equipment for medical and dental
purposes to maintain and implement medical and dental
quality assurance standards that reduce unnecessary
exposure to ionizing radiation while ensuring that images
are of diagnostic quality.
Requires ionizing radiation machines to be inspected once
each year for mammography X-ray units, once every three
years for high-priority sources of ionizing radiation,
and once every four and one-quarter years for
medium-priority sources, as specified.
Requires a facility that operates a mammogram machine to
post notices of serious violations in an area that is
visible to patients within two working days after receipt
of the documents from the department, as specified.
Requires general acute care hospitals, acute psychiatric
hospitals, and special hospitals to report adverse
events, as defined, to DPH no later than five days after
the adverse event has been detected, or, if that event is
an ongoing urgent or emergency threat to the welfare,
health or safety of patients, personnel, or visitors, not
later than 24 hours after the adverse event has been
detected.
Requires DPH to make information regarding reports of
substantiated adverse
events, and outcomes of inspections and investigations,
readily accessible to consumers throughout California,
including on the department's website by January 1, 2015.
This bill:
Requires, commencing July 1, 2012, a person that uses a
CT exam for human use to record the dose of radiation on
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every CT study produced during a CT examination.
Requires the facility conducting CT exams to
electronically send each CT study and protocol page,
which lists the technical factors and dose of radiation,
to the electronic picture archiving and communications
system.
Requires the displayed dose to be verified annually by a
medical physicist to ensure the displayed doses are
within 20 percent of the true measured dose, as defined,
unless the facility is accredited.
Requires the radiology report of a CT study to include
the dose of radiation, by either recording the dose
within the patient's radiology report or attaching the
protocol page, as specified.
Limits the requirements of the bill to CT systems capable
of calculating and displaying the dose.
Establishes, for the purposes of the bill, a definition
of dose of radiation, as specified.
Requires, commencing July 1, 2013, facilities that
furnish CT exams 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 or DPH.
Requires a health facility to report to DPH, except as
specified, an event in which 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;
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--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.
Provides that the information required to be reported
include, but are not limited to, information hospitals
must currently report regarding substantiated adverse
events, and may include compliance information history.
FISCAL IMPACT
According to the Assembly Appropriations Committee
analysis, this bill would result in no direct fiscal impact
to DPH to continue oversight of radiology professionals.
BACKGROUND AND DISCUSSION
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
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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 8 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 would ensure.
Medical imaging technology
Medical imaging procedures, which are used to view
different areas inside the human body, can provide
physicians with important clinical information. Imaging
exams can allow for noninvasive diagnosis of disease and
monitoring of therapy, and can support medical and surgical
treatment planning. For many diseases, early detection,
more effective diagnosis, and improved monitoring of
therapy through the use of imaging exams may contribute to
reduced morbidity, additional treatment options, and
increased life expectancy. Image-guided techniques are
also commonly used in a variety of procedures, such as
putting in place catheters or stents, or removing blood
clots or other blockages.
According to the National Council on Radiation Protection
and Measurements, in 2006 Americans received 67 million CT
scans, 18 million nuclear medicine procedures, and 17
million interventional fluoroscopy procedures. According
the federal Food and Drug Administration (FDA), the average
American's total radiation exposure has nearly doubled over
the past two decades, largely because of CT scans. Medical
radiation now accounts for more than half of the total
radiation that Americans are exposed to.
FDA white paper
In February 2010, the FDA issued a white paper and launched
a collaborative Initiative to Reduce Unnecessary Radiation
Exposure from Medical Imaging, with a focus on the types of
imaging procedures that are associated with the highest
radiation doses--CT, fluoroscopy, and nuclear medicine.
The initiative is designed to reduce factors contributing
to unnecessary radiation exposure by focusing on
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requirements for manufacturers of CT and fluoroscopic
devices pertaining to the design and dose recording
capabilities of the machines, and increasing patient and
physician awareness of exposure risks and monitoring of
cumulative exposure.
According to the FDA, like all medical procedures, CT,
fluoroscopy, and nuclear medicine imaging exams present
both benefits and risks. Managing the risks of CT,
fluoroscopy, and nuclear medicine imaging procedures
depends on two principles of radiation protection: (1)
Appropriate justification for ordering and performing each
procedure; and (2) Careful optimization of the radiation
dose used during each procedure.
UCSF study
According to a recent study conducted at the University of
California-San Francisco, the use of CT scans in medicine
to diagnose disease, and in many cases save lives, has
exploded in recent decades. The down side, a new study
concludes, is that the radiation US patients receive from
these medical exams will eventually result in 29,000 new
cancer cases and 15,000 new cancer deaths each year at
current levels of CT usage and cancer cure rates.
Furthermore, the dose of radiation delivered during CT
exams is wildly variable, the researchers found, even
within the same type of exam. In general, the radiation
dosages delivered to patients were substantially higher
than expected. The research findings are published in the
current issue of the Archives of Internal Medicine.
CMS accreditation process
Pursuant to requirements in the Medicare Improvements for
Patients and Providers Act of 2008 (Act), the federal
Centers for Medicare and Medicaid Services (CMS) has begun
accrediting Medicare providers of advanced imaging
services, including physicians and physician organizations.
For purposes of the Act, advanced imaging services are
defined to include computerized tomography, nuclear
medicine, positron emission tomography, and magnetic
resonance imaging. To date, CMS has recognized three
accrediting organizations, the American College of
Radiology, the Intersocietal Accreditation Commission, and
The Joint Commission. The accreditation organizations will
require providers to meet established criteria regarding
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the qualifications of technologists and other medical
staff, procedures to ensure the safety of persons who
furnish advanced imaging services and patients who receive
these services, and procedures to ensure reliability and
accuracy of diagnostic images.
Recent incidents
In October 2009, Cedars-Sinai Medical Center in Los Angeles
disclosed that it had mistakenly administered up to 8 times
the normal radiation dose to 206 possible stroke patients
over an 18-month period. At Mad River Hospital in Arcata
another case was reported involving a 2 year old child,
who was subjected to 151 CT scans on the same area, well in
excess of the 25 images that would normally be taken. The
incident led to the revocation of the X-ray technician's
license.
Based on these incidents and others nationwide, the FDA has
begun an investigation of more than 300 cases of radiation
overdoses at four hospitals, including Cedars-Sinai. The
FDAs investigation will try to determine whether the
radiation overdoses have been the result of design problems
with the scanners, human error, or a combination of the
two.
The FDA is urging hospitals to follow up with patients who
have received scans, check the dosage levels provided, make
sure protocols are strictly adhered to, and verify that the
scanners are working properly.
In November 2009, DPH issued an advisory to all facilities
to immediately review CT brain perfusion study protocols in
consultation with a medical physicist. Brain perfusion
studies are performed using multi-slice CT scanners to aid
in the diagnosis and treatment of stroke. The advisory
asks facilities performing CT scans to be aware that the
newer machines may be configured to display dose estimates
for a given examination, which provides a valuable
reference for patient exposure. The advisory states that
staff technologists should be trained to check dose
estimates before and after scanning patients, and routine
recording of this information should be considered.
Arguments in support
The Consumer Attorneys of California (CAC), the sponsor of
SB 1237, states that aside from the tragic incidents that
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occurred at Cedars-Sinai Medical Center, Californians in
general are at increasing risk of over radiation that can
subsequently increase the risk of cancer. CAC states that
the surge in new technology provides many benefits for
diagnosing and treating disease; however, the increasing
dependence on it has created new avenues for errors in
software and operation, and those mistakes cannot only be
difficult to detect, but can become embedded in a treatment
plan and repeated over and over with patients. CAC states
that oversight of medical imaging is fragmented and SB 1237
is intended to take steps to protect patients, including
recording of radiation dosage and adoption of quality
assurance programs to prevent errors such as the ones that
have been recently reported.
The Consumer Federation of California states that SB 1237
will increase patient safety by deterring one-time over
radiation errors, which can cause damage to DNA and
increase a person's lifetime risk for cancer, especially
for children and youth. The risk for over radiation is
becoming more and more likely, as the National Council on
Radiation Protection and Measurements reports that US
citizens are being exposed to ionizing radiation at twice
the level of two decades ago. CFC states that one-time
instances of over radiation may be difficult to detect
without proper documentation of the dosage administered.
Arguments in Opposition
Taking an oppose unless amended position, the California
Hospital Association (CHA) states that it supports the
intent of SB 1237 but has significant concerns about the
reporting requirements in the bill. CHA states that
deviations from planned doses of radiation may be required
due to changes in therapeutic needs, which would not be
captured in the reporting thresholds. Given the complexity
of this issue, and the fact the reporting requirements were
added to the bill just recently and that national standards
are being discussed, CHA requests that the reporting
provisions be removed from the bill. CHA also states that
it is working with the author on a number of technical
issues, such as clarification of the meaning of phrases
such as "irradiation of a body part other than that
intended".
Related bills
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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.
Prior legislation
SB 1301 (Alquist) Chapter 647, Statutes of 2006 requires
general acute care hospitals, acute psychiatric hospitals,
and special hospitals to report adverse events, as defined,
to the Department of Public Health. Requires DPH to make
onsite inspections or investigations of reported adverse
event, as specified. Requires DPH, by January 1, 2013, to
provide information regarding reports of substantiated
adverse events and the outcomes of inspections on the
department's website.
AB 929 (Oropeza) Chapter 427, Statutes of 2005, requires
the Radiologic Health Branch (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.
COMMENTS
1. Assembly amendments. SB 1237 was heard by this
committee on April 21, 2010. As it left the Senate, SB
1237 required, commencing January 1, 2012, health
facilities and clinics that use imaging procedures that
involve computed tomography for diagnostic purposes to
record the dose of radiation used during the administration
of the radiation on the radiology image. The bill delayed
these requirements for small and rural hospitals and health
facilities and clinics in medically underserved areas,
until January 1, 2013. The bill additionally required,
commencing January 1, 2012, physicians or other
practitioners, facilities, or other entities that furnish
diagnostic magnetic resonance imaging, computed tomography,
and nuclear medicine services, including positron emission
tomography, to be accredited by an organization that is
approved by the federal Centers for Medicare and Medicaid
Services.
The Assembly amendments:
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Clarify and specify in greater detail the requirements of
facilities and individuals who use or provide CT systems
regarding recording and verifying radiation dosage;
Eliminate the delayed operative date of the bill's
requirements for small and rural hospitals and health
facilities and clinics in medically underserved areas;
Define dose of radiation;
Limit the accreditation requirements to health
facilities, but include facilities accredited by
organizations approved by the Medical Board of California
or DPH; and,
Add requirements that health facilities report specified
adverse events involving radiation to DPH, referring
physicians, and patients.
2. Author's intent regarding reporting requirements and
definition of "dose of radiation". As drafted, the bill
does not specify an operative date for the mandatory
reporting requirements in the bill. However, the dose
recording requirements would take effect on July 1, 2012
and the accreditation requirements would take effect on
July 1, 2013. The author has indicated that his intent is
for the reporting requirements to take effect on July 1,
2012, and is submitting a letter to the Senate Journal to
clarify the intent.
The author is additionally clarifying his intent that the
definition of "dose of radiation" in the bill is not
intended to conflict with federal regulations or
international standards dealing with reporting or recording
of radiation doses.
PRIOR ACTIONS
Senate Health: 5-0
Senate Floor: 24-0
Assembly Health: 19-0
Assembly B.P. & C.P.11-0
Assembly Appropriations17-0
Assembly Floor 70-4
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POSITIONS
Support: Consumer Attorneys of California (sponsor)
AARP
Breast Cancer Fund
California Nurses Association
Children's Advocacy Institute
Congress of California
Consumer Federation of California
Medical Imaging and Technology Alliance
Healthcare Solutions Institute
Philips Healthcare
Siemens
Oppose: California Hospital Association (unless amended)