BILL ANALYSIS
SB 1237
Page 1
Date of Hearing: June 22, 2010
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 1237 (Padilla and Alquist) - As Amended: April 28, 2010
SENATE VOTE : 24-5
SUBJECT : Radiation control: health facilities and clinics:
records.
SUMMARY : Requires health facilities and clinics that use
imaging procedures that involve computed tomography (CT) for
diagnostic purposes to record the dose of radiation used during
the CT scan on the radiology image and in the patient's medical
record, if technologically feasible. Specifically, this bill :
1)Requires general acute care hospitals, acute psychiatric
hospitals, and special hospitals, as specified, that use CT
for diagnostic purposes to record the dose of radiation used
during the CT scan on the radiology image and in the patient's
medical record, commencing January 1, 2012.
2)Clarifies that the requirements in 1) above be limited to CT
machines for which it is technologically feasible to record
the dose of radiation directly or through the use of added
software or features.
3)Exempts small and rural hospitals and those facilities
specified in 1) above, that are located in an area that is
designated as a federal medically underserved area, from the
provisions of this bill until January 1, 2013.
4)Requires physicians or other practitioners, facilities, or
other entities that furnish diagnostic magnetic resonance
imaging, CT, and nuclear medical services, including positron
emission tomography, to be accredited by an organization that
is approved by the federal Centers for Medicare and Medicaid
Services (CMS), commencing January 1, 2012.
EXISTING LAW :
1)Under the Radiation Control Law, the California Department of
Public Health (DPH) administers provisions that establish
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standards for, and regulate sources of, ionizing radiation.
Requires DPH to license persons who receive, possess, or
transfer radioactive materials, and devices or equipment
utilizing these materials.
2)Establishes the Radiologic Health Branch (RHB) within DPH,
which is responsible for 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.
3)Gives DPH, or any state or local agency with which an
agreement has been made, the power to enter property, within
the jurisdiction of the agency, in order to inspect and
determine whether there is compliance with the state's
standards and requirements.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author and sponsor,
Californians are at increasing risk of over exposure to
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. According to the
author, oversight for radiation scans is currently very
fragmented; the federal Food and Drug Administration (FDA)
oversees the approval of medical devices, such as CT scanners,
but does not regulate how diagnostic tests are used in
clinical practice. The author maintains that one-time
instances of over exposure to radiation are difficult to
detect if there is no record of the dosage administered and
exposure to radiation has a cumulative effect over a lifetime.
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. By requiring health
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facilities to record CT radiation dosages in a patient's
health record and requiring quality assurance accreditation of
practitioners and health facilities that use diagnostic
radiation, this bill addresses the serious risks associated
with over exposure to radiation.
2)CT . According to a study conducted by the University of
California, San Francisco (UC San Francisco), CT imaging is a
diagnostic procedure that uses special x-ray equipment to
obtain cross-sectional pictures of the body that provides
detailed images of organs, bones, and other tissues. The UC
San Francisco study reports that CT is associated with higher
radiation exposure than conventional X-rays, yet radiation
dosages that patients receive from the newer CT scanners have
gone largely unregulated. According to the study, since 1980,
the yearly number of CT exams has increased from about three
million to 70 million CT scans. The study reports that the
technology has changed significantly over that time, improving
the quality of imaging, and increasing the clinical questions
that can be answered using CT, therefore leading to
improvements in patient care. However, the study further
asserts that one of the improvements in CT technology has been
a double-edged sword because the images can be obtained so
quickly, it has been very tempting to perform multiple CTs.
The study maintains that this results in increased
information, but raises safety concerns about increased risk
for cancer. The UC San Francisco study found that significant
variation in the radiation doses for the same type of CT scans
within institutions and across institutions and that
documenting the actual doses that patients are exposed to is
the first step to reducing those doses and any attendant risk.
3)RECENTS 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
two and a half 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
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FDA's 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.
4)DPH ADVISORY . 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.
The advisory notes that use of CT scanners in brain perfusion
studies results in a patient dose of radiation about 10 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, 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.
5)CMS ACCREDITATION PROCESS . Pursuant to requirements in the
Medicare Improvements for Patients and Providers Act of 2008
(Act), 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 CT, 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
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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 furnish advanced imaging services and patients who
receive these services, and procedures to ensure reliability
and accuracy of diagnostic images.
6)SUPPORT . The Consumer Attorneys of California (CAC), the
sponsors of this bill, maintain that this bill will increase
patient safety by implementing safeguards which will reduce
the risk of over exposure to radiation and by requiring an
accurate record of radiation dosages administered to patients.
CAC argues that one-time instances of over exposure to
radiation are difficult to detect if there is no record of the
dosage administered. CAC further maintains that exposure to
radiation has a cumulative effective over a lifetime and that
doctors are particularly concerned that children and young
adults could be exposed to enough radiation to increase their
risk of cancer if they need multiple scans. The Congress of
California Seniors argues in support that this bill will
reduce the risk of over exposure to radiation to seniors who
undergo CT scans for the diagnosis of disease and that recent
events concerning the recalibrating of CT devices and the
subsequent over exposure to radiation of patients highlights
the need to document radiation exposure for each CT scan.
7)RELATED AND PREVIOUS LEGISLATION .
a) SB 1332 (Dutton) of 2010, would require, until January
1, 2015, DPH to approve schools for radiologic
technologists that meet the Standards for an Accredited
Educational Program in Radiologic Sciences, as published by
the Joint Review Committee on Education in Radiologic
Technology, subject to certain conditions, and pursuant to
a modified rulemaking process. SB 1332 is scheduled to be
heard by the Assembly Health Committee on June 29, 2010.
b) 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.
c) AB 929 (Oropeza), Chapter 427, Statutes of 2005,
requires the RHB to adopt regulations regarding quality
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assurance standards for facilities using specified
radiation-producing equipment and to provide the
regulations to the Health Committees of the Assembly and
Senate on or before January 1, 2008.
8)FEDERAL LEGISLATION . H.R. 3652, the Consistency, Accuracy,
Responsibility, and Excellence in Medical Imaging and
Radiation Therapy Act of 2009, introduced by House
Representative John Barrow from Georgia, amends the Public
Health Service Act and Title XVIII of the Social Security Act
to make the provisions of technical services for medical
imaging examinations and radiation therapy treatment safer,
more accurate and less costly. H.R. 3652 is currently under
review by the Committee on Energy and Commerce as well as the
Committee on Ways and Means.
9)DOUBLE REFERRAL . This bill has been double-referred. Should
this bill pass out of the Assembly Health Committee, it will
be referred to the Assembly Business, Professions and Consumer
Protection Committee.
10)POLICY COMMENTS : This bill language requires health
facilities that use CTs for diagnostic purposes to record the
dose of radiation used during the administration on the
radiology image and in the patient's medical record, if
"technologically feasible." The author may wish to explain
what is meant by the terminology "technology feasible."
11)PLANNED AMENDMENTS . Due to legislative deadlines, this bill
will not be amended in the Assembly Health Committee, the
author has indicated, however, that he has been working with
experts in the field and plans to amend this bill in the
Business, Professions and Consumer Protection Committee. The
amendments will include: radiation recording standards;
reporting requirements to DPH, the treating physician and the
patient for radiation misadministration; and, clarifying and
technical changes.
REGISTERED SUPPORT / OPPOSITION :
Support
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Consumer Attorneys of California (sponsor)
Breast Cancer Fund
California Nurses Association
Children's Advocacy Institute
Congress of California Seniors
Consumer Federation of California
Opposition
None on file.
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097