BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SB 148
S
AUTHOR: Oropeza
B
AMENDED: As Introduced
HEARING DATE: April 1, 2009
1
CONSULTANT:
4
Moreno/
8
SUBJECT
Mammogram machines: inspection: posting of results
SUMMARY
Requires facilities that operate mammogram machines to post
notices of "serious violations" in an area that is visible
to patients. Requires the Department of Public Health
(DPH) to post on its web site the inspection results for
each facility that provides mammography services.
CHANGES TO EXISTING LAW
Existing law:
Under the Radiation Control Law, DPH administers provisions
that establish standards for, and regulates sources of,
ionizing radiation. Existing law requires DPH to license
persons who receive, possess, or transfer radioactive
materials, and devices or equipment utilizing these
materials.
Existing law 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.
This bill:
Continued---
STAFF ANALYSIS OF SENATE BILL SB 148 (Oropeza)Page 2
Requires facilities that operate a mammogram machines to
post notices of "serious violations" (defined as a
violation that poses a significant threat to public health)
in an area that is visible to patients.
Requires DPH, no later than January 1, 2012, to post the
inspection results on its web site, for each facility that
provides mammography services.
FISCAL IMPACT
Unknown.
BACKGROUND AND DISCUSSION
According to the author, a news story aired in February 2009 on
the Los Angeles CBS affiliate station which reported on an
examination of mammography facilities in the Los Angeles area.
It was reported that, despite being in violation of federal
safety standards, many facilities were still conducting exams on
women. The author states that facilities conducting mammogram
examinations are inspected annually by the state, and if an
inspector finds anything awry, a Notice of Violation will be
issued, but no direction is given as to where these notices
should be posted. The author contends that the absence of such
postings puts a women's health at risk. The author states that,
any facility that is cited for a violation that could pose a
serious threat to the patient's health should make that
information readily available, and that patients should be given
sufficient information to make an informed and educated decision
about whether to use the facility or not.
Background
Under the federal Mammography Quality Standards Act (MQSA), a
mammography facility must be certified as providing quality
mammography services. For a facility to be certified, it must
be accredited by a federally approved private nonprofit or state
accreditation body. The Food and Drug Administration (FDA) has
approved the American College of Radiology (ACR) and the States
of Arkansas, Iowa, and Texas as accreditation bodies. The
facility must also undergo an annual inspection conducted by
federally trained and certified federal or state personnel.
STAFF ANALYSIS OF SENATE BILL SB 148 (Oropeza)Page 3
Before a facility performs any mammography examinations in
California, it must obtain: 1) accreditation by the ACR; 2)
certification from the FDA; and 3) certification by the DPH's
Radiologic Health Branch (RHB). In the case that a notice of
violation is issued regarding radiological working conditions
(or any other order issued pursuant to the Radiation Control
Law), regulations require the facility to conspicuously post the
notice within two working days after receipt. The facility's
response, if any, must be posted within two working days after
it is sent to RHB. These documents must remain posted for a
minimum of five working days or until action correcting the
violation has been completed, whichever is later. A conspicuous
posting is not defined under the Radiation Control Law or
regulations, and according to the author, it is common practice
to post notices in an area only visible to facility staff, so
that they are aware of necessary corrective action.
There are three possible "levels of observations" resulting from
an MQSA inspection, ranging from Level 1 (representing the most
serious noncompliance's with MQSA standards) to Level 3
(representing minor deviations from MQSA standards):
o A Level 1 observation indicates that the inspector found one
or more deviations from MQSA standards that may seriously
compromise the quality of mammography services offered by the
facility.
o A Level 2 observation indicates that the facility's
performance is generally acceptable. However, the inspector
did find one or more deviations from MQSA standards that may
compromise the quality of mammography services offered by the
facility.
o A Level 3 observation indicates that the facility's
performance is generally satisfactory. However, the
inspection did show one or more minor deviations from MQSA
standards.
Radiologic Health Branch
The RHB 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
STAFF ANALYSIS OF SENATE BILL SB 148 (Oropeza)Page 4
contamination in the environment. According to the RHB, it
certifies 62,000 physicians, technologists, and technicians
who use X-ray machines and radioactive materials on human
beings, accredits 500 mammography facilities for federal
certification under the MQSA, and issues certificates to
850 medical facilities to perform mammography.
Prior legislation
SB 1529 (Oropeza of 2008) contained substantially similar
provisions to those in this bill. SB 1529 was held on
suspense in the Senate Appropriations Committee.
SB 700 (Aanestad of 2005) would have provided for the
certification of radiologist assistants (RAs). This bill
was scheduled to be heard in the Senate Business,
Professions and Economic Development Committee, but the
hearing was cancelled at the request of the author.
AB 623 (Lieu of 2007) would have required the DPH to
provide for the certification of RAs. This bill was held
in the Assembly Appropriations Committee under suspense.
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 provide the regulations
to the Health Committees of the Assembly and the Senate on
or before January 1, 2008.
Arguments in support
The California Nurses Association states that, when a
facility that has been issued a notice of violation
continues to perform exams, it places a woman's health at
risk if a misdiagnosis is made. Breast Cancer Action, the
Breast Cancer Fund, the Disability Rights Legal Center, and
the Latino Health Alliance states women should be able to
make conscious and educated decisions about which facility
they use to conduct their breast examination and mammogram.
Supporters further state that breast cancer diagnosis and
treatment can be devastating for women, and it is unfair to
keep them in the dark about the results of a facility's
annual inspection.
Concerns
The California Radiological Society (CRS) writes with
concerns about this bill, stating that all facilities and
STAFF ANALYSIS OF SENATE BILL SB 148 (Oropeza)Page 5
personnel must meet rigorous standards under MQSA and must
be accredited by the state or under an accreditation
program operated by their parent organization, the American
College of Radiology. CRS writes that MQSA and the FDA
already require posting of Level 1 violations, and MQSA is
perhaps the most complete and specific delineation of
equipment and personnel standards for the performance of
this valuable screening procedure. CRS contends that some
of these elements, such as logging of technologist CE
credits, are important, but the temporary failure to do so
would not impair the quality of the screening mammogram.
CRS suggests that the definition of "serious violations" be
amended to coincide with the FDA Level 1 violations as
follows:
On page 2, strike line 6 and insert:
"deviations from MQSA standards that may seriously
compromise the quality of mammography services offered by
the facility."
COMMENTS
On page 2, beginning on line 5, "serious violation" is
defined as "?a violation that poses a significant threat to
public health." This phrase is not defined elsewhere in
statute or regulations, but according to DPH, violations
are classified as follows:
o A violation is a finding that clearly violates a
regulation and/or the Health and Safety Code, and must be
corrected within 30 days. Violations typically do not
pose a significant public health impact. They result in
the issuance of a Notice of Violation. No penalties are
typically accessed if the violations are corrected within
the 30-day period. Suitable for minor infractions.
o A serious violation is one that clearly violates a
regulation and/or the Health and Safety Code, AND is of
such a nature that its continuance poses a significant
consequence to public health . These result in the
issuance of a Notice of Violation and Radiation User's
Declaration that allows the facility to voluntarily take
immediate corrective action. Actions noted as a serious
violation require immediate suspension and correction of
the activity in violation.
STAFF ANALYSIS OF SENATE BILL SB 148 (Oropeza)Page 6
POSITIONS
Support: American Cancer Society
American Federation of State, County and
Municipal Employees
Breast Cancer Action
Breast Cancer Fund
California Nurses Association
Disability Rights Legal Center
Latino Health Alliance
Oppose: None received
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