BILL ANALYSIS
SB 1237
Page 1
Date of Hearing: June 29, 2010
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
SB 1237 (Padilla) - As Amended: June 23, 2010
SENATE VOTE : 24-5
SUBJECT : Radiation control: health facilities and clinics:
records.
SUMMARY : Requires health facilities, as specified, that use
computed tomography (CT) X-ray systems for diagnostic and
therapeutic purposes to record the dose of radiation used on a
patient and alert the affected patient, the Department of Public
Health (department), and the patient's treating physician if
certain events occur during the administration of an X-ray
examination. Specifically, this bill :
1)Requires general acute care, acute psychiatric hospitals,
special hospitals, and clinics, as specified, that use CT
X-ray systems for diagnostic purposes to record the dose of
radiation, if technically possible, produced during the
administration of a CT X-ray examination by January 1, 2012.
Exempts the following entities until January 1, 2013:
a) Small and rural hospitals, as specified; and,
b) Health facilities and clinics located in areas
designated as a medically underserved pursuant to federal
law.
2)Requires the dosage to be recorded using both dose length
product (DLP) and volume computed tomography index (CTDI vol),
as defined by the International Electrotechnical Commission
(IEC) and recognized by the federal Food and Drug
Administration (FDA). The health facility shall ensure that
the CTDI vol is recorded in the patient's medical record and
on any image produced from the examination.
SB 1237
Page 2
3)Requires facilities that furnish CT X-ray services to be
accredited by an organization approved by the federal Centers
for Medicare and Medicaid Services or an accrediting agency
approved by the Medical Board of California (MBC) by January
1, 2012.
4)Requires a facility that uses CT X-ray systems to notify the
department, the affected patient, and the patient's treating
physician immediately, in writing, of the occurrence of any of
the following events:
a) Repetition of a CT X-ray exposure due to equipment
defect or malfunction;
b) Irradiation of the wrong patient or irradiation of a
body part other than that intended by the ordering
physician and surgeon; or,
c) A diagnostic dosage that exceeds protocols by 50% or
more.
5)Requires each facility that utilizes therapeutic X-ray systems
operating at energies below one million electron volts (MeV)
to notify and report to the department, in accordance with
department regulations, and notify the affected patient and
his or her treating physician within 10 days, in writing, of
the occurrence of any of the following events:
a) Irradiation of the wrong individual or wrong treatment
site;
b) Any treatment consisting of three or fewer fractions,
with the calculated total administered dose differing from
the total prescribed dose by more than 10% of the total
prescribed dose; or,
SB 1237
Page 3
c) Any exposure resulting in a calculated total
administered dose differing from the total prescribed dose
by more than 10% of the total prescribed dose.
6)Requires each facility that utilizes therapeutic X-ray systems
operating with energies at or above one MeV to notify and
report to the department, in accordance with department
regulations, and notify the affected patient and his or her
treating physician within 10 days, in writing, of the
occurrence of any of the following events:
a) Any event involving irradiation of the wrong individual,
administration of the wrong type of radiation or the wrong
energy, or irradiation of the wrong treatment site;
b) Any treatment consisting of three or fewer fractions,
with the calculated total administered dose differing from
the total prescribed dose by more than 10% of the total
prescribed dose; or,
c) Any exposure resulting in a calculated total
administration dose differing from the total prescribed
dose by more than 20% of the total prescribed dose.
EXISTING LAW :
1)Requires the department to license persons who receive,
possess, or transfer radioactive materials, and devices or
equipment utilizing these materials.
2)Requires the department to adopt registration and
certification regulations for mammography equipment.
3)Requires the department to develop and enforce standards for
the education, training, and experience of persons who use
radiologic technology on human beings.
4)Requires the department to adopt regulations that require
personnel and facilities using radiation-producing equipment
for medical and dental purposes to maintain and implement
SB 1237
Page 4
medical and dental quality assurance standards reducing
unnecessary exposure to ionizing radiation while ensuring that
images are of diagnostic quality.
5)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.
6)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.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author's office, "In
2009, Cedars-Sinar Medical Center in Los Angeles revealed that
260 patients who received CT brain perfusion scans for the
purpose of diagnosing strokes had been exposed to eight times
the maximum recommended dosage. For 18 months, the excessive
radiation being administered went unchecked and undisclosed.
The problem wasn't revealed until after a patient demanded
answers from the hospital, after he had lost a ring of hair
around his head, his skin reddened and vision became blurry.
But by the time the hospital discovered the error, 260 patients
had already been harmed.
"After the incident at Cedars-Sinai was discovered, the
department issued a statement that advised hospitals to double
check their safety protocols. Yet, oversight for radiation
scans is currently very fragmented; the FDA oversees the
approval of medical devices, such as CT scanners, but does not
regulate how diagnostic tests are used in clinical practice.
"Existing federal regulations require outpatient centers that
seek reimbursement from Medicare to adopt and comply with a
quality assurance program, and have been applauded as the most
aggressive accreditation standards in force. [This bill] adopts
the same quality assurance program in order to prevent cases of
radiation misadministrations from happening in the future."
SB 1237
Page 5
Background . CT imaging is a diagnostic procedure that uses
X-ray equipment to obtain cross-sectional pictures of the body
that provides detailed images of organs, bones, and other
tissues. A University of California at San Francisco (UCSF)
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 UCSF study found that
significant variation in the radiation doses for the same type
of CT scans within and across institutions.
Problems with computer software were most frequently cited as a
cause for errors, according to the letter sent Thursday by Dr.
Jeffrey Shuren, director of the FDA's Center for Devices and
Radiological Health (Center). The Center's analysis, Dr. Shuren
said, "revealed device problems that appear to be the result of
faulty design or use error that could be mitigated by the
incorporation of additional safeguards."
More than 300 patients in four hospitals - and possibly many
more - were overradiated by powerful CT scans used to detect
strokes, government health officials announced late last year.
The overdoses were first discovered at Cedars-Sinai Medical
Center, a major Los Angeles hospital, where 260 patients
received up to eight times as much radiation as intended.
Those errors continued for 18 months and were detected only
after patients started losing their hair. FDA is still
struggling to understand and untangle the physics underlying the
flawed protocols, and has issued a nationwide alert for
hospitals to be especially careful when using CT scans on
possible stroke victims.
Although the overdoses at Cedars-Sinai were displayed on
SB 1237
Page 6
computer screens, technicians administering the scans did not
notice. In New York City, technologists contributed to two
devastating radiation injuries by not watching their treatment
computers.
Serious radiation injuries are still infrequent, and the new
equipment is undeniably successful in diagnosing and fighting
disease. But the technology introduces its own risks: it has
created new avenues for error in software and operation, and
those mistakes can be more difficult to detect. As a result, a
single error that becomes embedded in a treatment plan can be
repeated in multiple radiation sessions.
Current California law requires a health care facility to report
certain adverse events, but does not require reporting of report
a radiation misadministration. This bill would require health
facilities, as specified, that use CT X-ray systems for
diagnostic and therapeutic purposes to record the dose of
radiation used on a patient and alert the affected patient, the
department, and the patient's treating physician if certain
adverse events occur during the administration of an X-ray.
Arguments in support . The bill's sponsor, Consumer Attorneys of
California, write, "[This bill] adopts a thorough quality
assurance accreditation program to prevent errors like the ones
that occurred in our California hospitals. Congress has already
adopted such accreditation requirements for medical centers that
perform diagnostic imaging services for Medicare. SB 1237 also
requires the radiation dosage to be printed on the patient's
medical record in order to better track one-time overexposures
and a patient's lifetime cumulative exposure. Lastly, SB 1237
requires a facility to report radiation misadministration to an
affected patient, referring physician, and the department. SB
1237 will bring California to the forefront of consumer
protection."
Arguments in opposition . California Radiological Society
writes, "Though we have been working constructively with the
author and sponsors for several months to establish new
requirements for users of CT scanners, the most recent
amendments have addressed other forms of ionizing radiation and
SB 1237
Page 7
raised a host of concerns regarding the breadth of the
requirements. We would suggest that the focus of the bill needs
to return to the original purpose of enhanced regulation and
safety in the operation of CT equipment."
REGISTERED SUPPORT / OPPOSITION :
Support
Consumer Attorneys of California (sponsor)
AARP
Breast Cancer Fund
California Nurses Association
Children's Advocacy Institute
Congress of California Seniors
Consumer Federation of California
An Individual
Opposition
California Radiological Society
California Hospital Association
Analysis Prepared by : Sarah Weaver / B.,P. & C.P. / (916)
319-3301