BILL ANALYSIS Ó
AB 510
Page 1
Date of Hearing: January 10, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 510 (Bonnie Lowenthal) - As Amended: January 4, 2012
SUBJECT : Radiation control: health facilities and clinics:
records.
SUMMARY : Makes technical and clarifying changes to existing
requirements that are to become effective July 1, 2012, relating
to computed tomography (CT) X-ray. Specifically, this bill :
1)Limits the requirement that persons using CT systems record
the dose of radiation to CT systems used only for diagnosis.
2)Limits the requirement that the displayed dose be verified
annually to ensure the displayed doses are within 20% of the
true measured dose to the facility's standard adult brain,
adult abdomen, and pediatric brain protocols and deletes the
automatic exemption from this annual verification for
accredited facilities, but instead allows an accredited
facility to elect not to perform the verification.
3)Deletes the requirement to report events of irradiation of a
body part other than intended and replaces it with a
requirement to report an irradiation of an area of the body
other than intended.
4)Modifies the requirement to report therapeutic ionizing
irradiation of the wrong treatment site by specifying that it
must be nonoverlapping.
5)Changes from five to 10 business days, the amount of time a
facility has to report any of the specified events of
radiation dosage.
6)Makes other technical and clarifying changes.
EXISTING LAW :
1)Establishes the Radiologic Health Branch (RHB) 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
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material users, inspection of facilities using radiation,
investigation of radiation incidents, and surveillance of
radioactive contamination in the environment.
2)Requires DPH to license persons who receive, possess, or
transfer radioactive materials, and devices or equipment
utilizing these materials.
3)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.
4)Requires a health facility to report to DPH effective July 1,
2012, except as specified, an event in which the
administration of radiation results in any of the following:
a) Repeating of a CT examination, unless otherwise ordered
by a physician or radiologist, if specified 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
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 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;
e) Therapeutic ionizing irradiation of the wrong
individual, or wrong treatment site; and,
f) The total dose from therapeutic ionizing radiation
delivered differs from the prescribed dose by 20% 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.
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5)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.
6)Requires facilities that provide CT X-ray services to be
accredited by an organization approved by the federal Centers
for Medicare and Medicaid Services (CMS), an accrediting
agency approved by the Medical Board of California, or DPH.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill
clarifies requirements that health facilities and imaging
centers must meet regarding excess radiation exposure that
were enacted in SB 1237 (Padilla), Chapter 521, Statutes of
2010 and SB 38 (Padilla), Chapter 139, Statutes of 2011. The
clarification is needed for the facilities and DPH to meet the
implementation dates of July 1, 2012. The author asserts that
limiting record keeping of a CT scan to those used only for
diagnosis is necessary because the American College of
Radiology (ACR) has not developed standards for therapeutic
functions. Therefore, according to the author, there is no
set standard for how these machines will report the dose to
the user. The author further states that the requirement
relating to verification of displayed doses must be limited to
the facility's standard adult brain, adult abdomen, and
pediatric brain procedures because these are the three most
common with established standards used by the ACR. According
to the author, there could otherwise be 200 or more that could
be requested which is inefficient and costly. The author
further states that the "area of the body" is substituted for
"body part" because due to the nature of a CT scan, a
neighboring body part will be irradiated from time to time.
The author argues that the concern should focus on irradiating
an area of the body that was not intended to be irradiated,
not one that is automatically irradiated due to its location.
The author points out that the intent of SB 1237 was to
require the hospital to report procedures that were done
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incorrectly and on the wrong body part. The author states
that there are instances where a neighboring body part may be
affected by the treatment in the normal course of the
procedure. According to the author, this amendment is
intended to further specify that the reporting is related to
incorrect procedures.
2)BACKGROUND . SB 1237 was enacted in part due to studies
showing the increased use of CT scanners over traditional
X-ray for medical diagnostic and treatment purposes was
increasing the risk of over exposure to radiation and that
total exposure to ionizing radiation has nearly doubled over
the past two decades. In support of SB 1237, it was stated
that medical radiation can save lives, but can be deadly if
improperly administered, and can increase a person's lifetime
risk of developing cancer. SB 1237 was also intended to bring
some uniform regulatory oversight to a fragmented system of
medical practice. For instance; 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. One-time instances of
over exposure to radiation were difficult to detect as there
was no record of the dosage administered and exposure to
radiation has a cumulative effect over a lifetime. In
addition, a number of cases of exposure to overdoses came to
light in 2009. 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.
3)CT . According to a study conducted by the University of
California San Francisco (UCSF), 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 UCSF study
reported that CT X-ray 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
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70 million CT scans. The study reported 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 asserted 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 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.
4)REGULATORY FRAMEWORK . As stated above, the FDA's role is
limited to approval of CT scan as a medical device. However,
in October 2009 the FDA began an investigation of more than
300 cases of excess radiation during brain perfusion scans at
four hospitals, including Cedars-Sinai. Brain perfusion
studies are performed using multi-slice CT scanners to aid in
the diagnosis and treatment of stroke. The FDA's
investigation was to determine whether the radiation overdose
was the result of design problems with the scanners, human
error, or a combination of the two. In the meantime, the FDA
encouraged CT facilities to review their protocols and make
sure that the values displayed on the control panel
corresponded to the doses normally associated with the
protocol, to follow up with patients who have received scans,
and verify that the scanners are working properly.
The FDA issued an update in November 2009 reporting that it
found no violations with regard to the machines and that when
used according to the manufacturer's specifications they did
not result in overdose. The FDA stated that the investigation
did reveal improvements that could be made to equipment and
user information and training. The FDA updated its safety
recommendations with guidelines for facilities to follow with
regard to monitoring dosage, implementing quality controls,
and training of CT operators. The FDA also recommended that
each facility set an alert level triggering further review by
a physicist, radiologist, and quality assurance committee.
Although the study was specific to CT perfusion scans, the FDA
stated that some of the safety practices were critical for all
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CT procedures. Finally, the FDA encouraged voluntary
reporting to help the FDA better identify and understand
risks. Reported data should include the protocol, the CT
conditions of operation and the dose-index values displayed.
In November 2009, DPH also issued an advisory to all
facilities to immediately review CT brain perfusion study
protocols in consultation with a medical physicist. The
advisory asked 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 stated 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 noted 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 noted
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 concluded 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 noted 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.
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 ACR, 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 furnish advanced imaging services
and patients who receive these services, and procedures to
ensure reliability and accuracy of diagnostic images. CMS is
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requiring freestanding facilities to be accredited by January
1, 2012 and hospitals by January 1, 2013 for Medicare
reimbursement. SB 1237 applied this requirement to all
facilities commencing July 1, 2013.
5)DPH IMPLEMENTATION . SB 38, an urgency measure effective
August of 2011, clarified that the implementation date of the
reporting requirements of SB 1237 were intended to become
effective July 1, 2012. However, absent a specific date, the
reporting requirements took effect January 1, 2011. In
anticipation of the January 1, 2011 effective date, DPH posted
on its Website and disseminated to the radiological industry a
Frequently-Asked-Questions document that informed health
facilities how to report and what information should be
reported. It provided clarification of a number of provisions
relating to reportable events such as how to determine if
there was "unanticipated permanent functional damage" and
"wrong treatment site." In some cases, the further
elaboration provided enough guidance for implementation. In
other cases, it exposed additional ambiguities such as whether
events related to therapeutic treatment were included as
reportable as well as those in the diagnostic context. This
bill is intended to further clarify these ambiguities.
6)PREVIOUS LEGISLATION .
a) SB 38 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.
b) SB 1237 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.
c) 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.
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d) 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.
7)SUPPORT . The California Hospital Association (CHA), sponsor
of this bill, writes in support that the changes proposed by
this bill were developed in collaboration with radiation
physicists from health systems, universities, medical centers,
and smaller community hospitals. According to CHA, these
changes are intended to clarify that recording requirements
apply only to CT X-ray exams that are for diagnostic purposes,
that the dose verification process applies only to particular
listed studies and that a reportable event is triggered when
an exam is done on an anatomic area that was not intended and
not an area that is commonly recognized as receiving exposure
due to proximity to the intended area. The sponsor states
that 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, also in support, states that
radiologists, hospitals and medical physicists have continued
to discuss the best means to implement these patient
safeguards and agree to the need for the changes proposed in
this bill.
8)TECHNICAL AMENDMENTS . The author is proposing the following
technical amendments for further clarification:
a) Amendment 1.
Section 115111 of the Health and Safety Code is amended to
read:
115111. (a) Commencing July 1, 2012, subject to subdivision
(e), a person that uses a computed tomography (CT) X-ray
system for dedicated to only diagnostic human use shall record
the dose of radiation on every CT study produced during a CT
examination on a system . CT studies used for therapeutic
radiation treatment planning or image guidance for
interventional radiologic procedures shall not be required to
record the dose.
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(b) The facility conducting the study shall electronically
send each CT study and protocol page that lists the technical
factors and dose of radiation to the electronic picture
archiving and communications system.
(c) (1) The displayed dose shall be verified annually by a
medical physicist for the facility's standard adult brain,
adult abdomen, and pediatric brain protocols, to ensure the
displayed doses are within 20 percent of the true measured
dose measured in accordance with subdivision (f) unless the
facility is accredited .
(2) A facility that has a machine that is accredited may elect
not to perform the verification described in paragraph (1).
(d) Subject to subdivision (e), the radiology report of a CT
study shall include the dose of radiation by either recording
the dose within the patient's radiology report or attaching
the protocol page that includes the dose of radiation to the
radiology report.
(e) The requirements of this section shall be limited to CT
systems capable of calculating and displaying the dose.
(f) For the purposes of this section, dose of radiation shall
be defined as one of the following:
(1) The computed tomography index volume (CTDI vol) and dose
length product (DLP), as defined by the International
Electrotechnical Commission (IEC) and recognized by the
federal Food and Drug Administration (FDA).
(2) The dose unit as recommended by the American Association
of Physicists in Medicine.
b) Amendment 2.
Section 115112 of the Health and Safety Code, is amended to
read:
115112. Commencing July 1, 2013, facilities that furnish CT
X-ray systems services shall 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 the State Department of Public
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Health
c) Amendment 3
Section 115113 of the Health and Safety Code, as amended by
Section 1 of Chapter 139 of the Statutes of 2011, is amended
to read:
115113. (a) Except for an event that results from patient
movement or interference, a facility shall report to the
department an event in which the administration of radiation
results in any of the following:
(1) Repeating of a CT examination, unless otherwise ordered by
a physician or a radiologist, if one of the following dose
values are exceeded:
(A) 0.05 Sv (5 rem) effective dose equivalent , or
(B) 0.5 Sv (50 rem) to an organ or tissue , or
(C) 0.5 Sv (50 rem) shallow dose equivalent to the skin.
(2) CT X-ray irradiation of a body part an area of the body
image that does not include the intended anatomic area other
than that intended by the ordering physician or a radiologist
if at least one of the following dose values are exceeded:
(A) 0.05 Sv (5 rem) effective dose equivalent , or
(C) 0.5 Sv (50 rem) shallow dose equivalent to the skin , or
(3) 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.
(4) 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.
(5) Therapeutic ionizing irradiation of the wrong individual,
or the wrong nonoverlapping treatment site. Reporting is not
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required if adjacent body parts are irradiated during the same
treatment, unless they exceed the values in subsections (6).
(6) The total dose from therapeutic ionizing radiation
delivered differs from the prescribed dose by 20 percent or
more. A report shall not be required pursuant to this
paragraph in any instance where the dose administered exceeds
20 percent of the amount prescribed in a situation where the
radiation was utilized for palliative care for the specific
patient. The radiation oncologist shall notify the referring
physician that the dose was exceeded.
(b) The facility shall, no later than five 10 business days
after discovery of an event described in subdivision (a),
provide notification of the event to the department and the
referring physician of the person subject to the event and
shall, no later than 15 business days after discovery of an
event described in subdivision (a) provide written
notification to the person who is subject to the event.
(c) This section shall become inoperative on the effective
date of the act that added this subdivision, and shall remain
inoperative until July 1, 2012.
REGISTERED SUPPORT / OPPOSITION :
Support
California Hospital Association (sponsor)
California Radiological Society
Opposition
None on file.
Analysis Prepared by : Marjorie Swartz / HEALTH / (916) 319-2097