BILL ANALYSIS
SB 148
Page 1
Date of Hearing: June 30, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
SB 148 (Oropeza) - As Amended: May 20, 2009
SENATE VOTE : 34-2
SUBJECT : Mammogram machines: inspection: posting of results.
SUMMARY : Requires a facility that operates a mammogram machine
to post notices of serious violations, as specified, in an area
that is visible to patients. Specifically, this bill :
1)Requires a facility that operates a mammogram machine to post
notices of serious violations in an area that is visible to
patients.
2)Defines "serious violation" as a deviation, identified by an
inspector, from the federal Mammography Quality Standards Act
of 1992 (MQSA), in effect as of December 31, 2009, that may
seriously compromise the quality of mammography services that
are offered by the facility.
EXISTING LAW :
1)Under the Radiation Control Law, the California Department of
Public Health (DPH) administers provisions that establish
standards for, and regulate 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.
2)Establishes the Radiologic Health Branch 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)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.
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4)Under the federal MQSA, requires mammography facilities across
the nation to meet uniform quality standards.
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, a news story aired
in February 2008 on the Los Angeles CBS affiliate station which
reported on an examination of mammography facilities in the Los
Angeles area. CBS 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 information relating to the
results of state inspections is not readily made available to
patients and, as such, a woman cannot easily access information on
how well or how poorly her facility's mammogram machines did
during an inspection, or whether there are issues with performing
examinations. The author also argues 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.
2)MQSA . MQSA, enacted at the federal level in 1992, regulates the
quality of mammography care. According to the U.S. Food and Drug
Administration (FDA), MQSA requires mammography facilities across
the nation to meet uniform quality standards. Under MQSA, all
mammography facilities must: a) be accredited by an FDA-approved
accreditation body (Currently the only nationally-approved body is
the American College of Radiology (ACR)); b) be certified by FDA,
or by the state in which the facility is located, as meeting the
standards; c) undergo an annual MQSA inspection; and, d)
prominently display all certifications.
Under state law, before a facility performs any mammography
examinations in California, it must obtain: a) accreditation by
the ACR; b) certification from the FDA; and, c) certification by
DPH's Radiologic Health Branch (RHB). In the case that a notice
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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. Under current state law,
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. While a
conspicuous posting is not defined under the Radiation Control Law
or regulations, the regulations do state that notices are required
to appear in a sufficient number of places to permit individuals
engaged in work under the license to observe them on the way to or
from any particular work location to which the document applies.
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 observation" 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):
a) 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.
b) 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.
c) 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.
3)RHB. The RHB within DPH 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. According to the RHB, it certifies 80,000
physicians, technologists, and technicians who use X-ray machines
and radioactive materials on human beings, and issues certificates
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to 750 medical facilities to perform mammography. During the
period from January 1, 2007 to September 30, 2008, RHB issued 27
Level 1 violations issued in 17 facilities.
4)SUPPORT . The American Cancer Society, the California Commission
on the Status of Women (Commission) and the California Nurses
Association (CNA) write in support of the requirement in this bill
for a mammography facility to post notices of serious violations
in an area that is visible to patients. The Commission states
that more than 25,000 California women develop breast cancer and
more than 4,000 die from it each year. The Commission further
states that mammograms are one of the best methods to use for
early detection of breast cancer. The American Cancer Society and
the Commission argue that women should be able to make informed
decisions about which facility they use to conduct their breast
examination and mammograms and that requiring the notice of
violation to be visible to patients allows women to make these
informed decisions.
5)PRIOR LEGISLATION .
a) SB 1529 (Oropeza) of 2008 contained substantially
similar provisions to those in this bill, but was held on
suspense in the Senate Appropriations Committee.
b) SB 700 (Aanestad) of 2005 would have provided for the
certification of radiologist assistants (RAs). SB 700 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.
c) AB 623 (Lieu) of 2007 would have required DPH to provide
for the certification of RAs. AB 623 was held in the
Assembly Appropriations Committee under suspense.
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 provide the regulations
to the Health Committees of the Assembly and the Senate on
or before January 1, 2008.
6)DRAFTING CLARIFICATION .
a) As currently drafted, the bill defines a "serious
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violation" as a deviation, identified by an inspector, from
federal MQSA that may seriously compromise the quality of
mammography services that are offered at the facility.
This is also the definition of a Level 1 violation of MQSA.
To clarify the obligation proposed for facilities in this
bill, the author may wish to specifically require posting
of Level 1 violations where patients can see the
information.
b) As currently drafted, the bill does not indicate time
frames required for a facility to post notices of "serious
violations" in an area that is visible to patients. The
author may wish to add language clarifying the time frames
to eliminate confusion.
REGISTERED SUPPORT / OPPOSITION :
Support
American Cancer Society
California Commission on the Status of Women
California Nurses Association
Opposition
None on file.
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097