BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SB 1237
S
AUTHOR: Padilla
B
AMENDED: As Introduced
HEARING DATE: April 21, 2010
1
CONSULTANT:
2
Hansel/
3 7
SUBJECT
Radiation control: health facilities and clinics: records
SUMMARY
Requires health facilities and clinics that use imaging
procedures that involve ionizing radiation for diagnostic
purposes to record the dose of radiation used during the
administration of the radiation on the radiology film.
CHANGES TO EXISTING LAW
Existing law:
Requires the Department of Public Health (DPH) to license
persons who receive, possess, or transfer radioactive
materials, and devices or equipment utilizing these
materials.
Requires DPH to adopt registration and certification
regulations for mammography equipment.
Requires DPH to develop and enforce standards for the
education, training, and experience of persons who use
radiologic technology on human beings.
Requires DPH, on or before January 1, 2008, to adopt
regulations that require personnel and facilities using
Continued---
STAFF ANALYSIS OF SENATE BILL SB 1237 (Padilla)Page 2
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.
This bill:
Requires health facilities and clinics that use imaging
procedures that involve ionizing radiation for diagnostic
purposes to record the dose of radiation used during the
administration of the radiation on the radiology film.
FISCAL IMPACT
This bill has not been analyzed by a fiscal committee.
BACKGROUND AND DISCUSSION
According to the author and sponsor, 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 computed tomography (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
STAFF ANALYSIS OF SENATE BILL SB 1237 (Padilla)Page 3
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 three
areas:
Requirements for manufacturers of CT and fluoroscopic
devices to incorporate important additional safeguards
into the design of these machines, develop safer
technologies, and provide additional training to support
safe use by practitioners;
Requirements for manufacturers of CT and fluoroscopic
STAFF ANALYSIS OF SENATE BILL SB 1237 (Padilla)Page 4
devices to incorporate equipment features that will
provide clinicians with more information to guide their
decision making, which may include requirements that CT
and fluoroscopic devices be capable capturing the
radiation dose value from each exam and linking it with
the study image to facilitate the storage of dose
information in a patient's paper or electronic medical
record or requiring that devices be capable of
automatically recording radiation dose information in a
standardized Digital Imaging and Communications in
Medicine (DICOM) structured report, and transmitting this
information to a patient's electronic medical record or a
dose registry; and
Increasing patient awareness by giving them information
and tools to help them and their physicians manage their
exposure to radiation from medical procedures, which may
include development of a patient medical imaging record
card.
According to the FDA, like all medical procedures, computed
tomography (CT), fluoroscopy, and nuclear medicine imaging
exams present both benefits and risks. Managing the risks
of computed tomography (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.
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
the qualifications of technologists and other medical
staff, procedures to ensure the safety of persons who
STAFF ANALYSIS OF SENATE BILL SB 1237 (Padilla)Page 5
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 eight
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 overdoes 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 Computed Tomography (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.
The advisory notes that use of CT scanners in brain
perfusion studies results in a patient dose of radiation
about ten times higher than that for a routine head CT
scan, and also notes that in the Cedars-Sinai case,
unauthorized or unannounced changes may have been made,
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resulting in the CT scanner continuing to operate at or
near maximum strength.
The advisory concludes by saying that recent incidents may
be an indicator of deficiencies in CT quality assurance
programs in general, and not limited to a particular
facility or imaging procedure, and notes that if patient
doses are higher than expected levels, but not high enough
to produce obvious signs of radiation injury, problems may
go undetected, putting patients at increased risk for
long-term radiation effects.
Arguments in support
The Consumer Attorneys of California (CAC), the sponsor of
SB 1237, states that aside from the tragic incidents that
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.
Related bills
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
STAFF ANALYSIS OF SENATE BILL SB 1237 (Padilla)Page 7
visible to patients.
Prior legislation
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.
COMMENTS
1. Scope of sources of ionizing radiation may be too
broad. As drafted, SB 1237 would require health facilities
and clinics that use any form of ionizing radiation to
record the dose on the radiology film. As noted above,
problems with over radiation have been associated with
certain types of machines and procedures, such as CTs. A
suggested amendment would be to limit the requirement to
record dosage to sources of ionizing radiation that produce
the highest radiation levels, such as CTs.
2. Dose recording requirements may be difficult with older
machines. While most newer machines have the capability to
measure and record the radiation dose, and some older
machines can be adapted to do so through the use of
supplemental software or features, there may be some older
machines that do not have this capability. A suggested
amendment would be to limit the requirement to record
dosage to machines for which it is technologically feasible
to do so, either directly or through the use of added
software or features.
3. Bill should encourage use of safety protocols to reduce
of errors. Arguably, most cases of over radiation in
medical settings are the result of medical errors or poor
quality assurance procedures. While requiring radiation
dosage to be recorded could be helpful in alerting medical
staff to situations in which a higher dose of radiation is
administered than is necessary, and particularly to
systemic problems where a higher dose is consistently
applied over time, requiring the adoption of protocols for
safe administration of radiation in medical settings could
also be effective in reducing the incidence of over
radiation errors. A number of protocols for this purpose
STAFF ANALYSIS OF SENATE BILL SB 1237 (Padilla)Page 8
are evolving. A recommended amendment would be, at a
minimum, to require providers who furnish advanced imaging
services, such as magnetic resonance imaging, CT, and
nuclear medicine to be accredited by an organization that
is approved by the federal Centers for Medicare and
Medicaid Services, as will be required for Medicare
providers of these services, starting 2012.
POSITIONS
Support: Consumer Attorneys of California (sponsor)
Consumer Federation of California (CFC)
Oppose: None received
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