BILL ANALYSIS
------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 148|
|Office of Senate Floor Analyses | |
|1020 N Street, Suite 524 | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
------------------------------------------------------------
THIRD READING
Bill No: SB 148
Author: Oropeza (D), et al
Amended: 5/20/09
Vote: 21
SENATE HEALTH COMMITTEE : 10-1, 04/01/09
AYES: Alquist, Strickland, Cedillo, Cox, DeSaulnier, Leno,
Maldonado, Negrete McLeod, Pavley, Wolk
NOES: Aanestad
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SUBJECT : Mammogram machines: inspection: posting of
results
SOURCE : Author
DIGEST : This bill 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 to post on its website the
inspection results for each facility that provides
mammography services.
ANALYSIS : Under the Radiation Control Law, the Department
of Public Health (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.
CONTINUED
SB 148
Page
2
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:
1.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.
2.Defines "serious violation" as a deviation, identified by
an inspector, form federal Mammography Quality Standards
Act of 1992 standards, in effect as of December 31, 2009,
that may seriously compromise the quality of mammography
services that are offered by the facility.
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.
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
CONTINUED
SB 148
Page
3
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): (1) 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, (2) 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,
(3) 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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
SUPPORT : (Verified 5/19/09)
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
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
CONTINUED
SB 148
Page
4
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.
CTW:do 5/19/2009 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
**** END ****
CONTINUED