BILL ANALYSIS Ó
AB 761
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ASSEMBLY THIRD READING
AB 761 (Roger Hernández)
As Amended January 23, 2012
Majority vote
BUSINESS & PROFESSIONS 8-0 HEALTH 17-0
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|Ayes:|Hayashi, Bill Berryhill, |Ayes:|Monning, Logue, Ammiano, |
| |Allen, Butler, Eng, Hill, | |Atkins, Bonilla, Eng, |
| |Ma, Smyth | |Garrick, Gordon, Hayashi, |
| | | |Bonnie Lowenthal, |
| | | |Mansoor, Mitchell, Pan, |
| | | |V. Manuel Pérez, Silva, |
| | | |Smyth, Williams |
|-----+--------------------------+-----+--------------------------|
| | | | |
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APPROPRIATIONS 17-0
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|Ayes:|Fuentes, Harkey, | | |
| |Blumenfield, Bradford, | | |
| |Charles Calderon, Campos, | | |
| |Chesbro, Donnelly, Gatto, | | |
| |Hall, Hill, Ammiano, | | |
| |Mitchell, Nielsen, Norby, | | |
| |Solorio, Wagner | | |
| | | | |
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SUMMARY : Allows optometrists to independently perform waived
clinical laboratory tests necessary for the diagnosis of conditions
and diseases of the eye. Specifically, this bill :
1)Adds licensed optometrists to the list of persons who are
authorized under current law to perform a clinical laboratory test
or examination classified as waived under the federal Clinical
Laboratory Improvement Amendments (CLIA) of 1988.
2)Includes, in the definition of "laboratory director" for purposes
of a clinical laboratory test or examination classified as waived,
a duly licensed optometrist serving as the director of a
laboratory, which only performs clinical laboratory testing as
authorized in 3), below.
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3)Allows optometrists who are certified to use therapeutic
pharmaceutical agents (TPAs) to perform a clinical laboratory test
or examination classified as waived under CLIA and as designated
under current law, as specified, necessary for the diagnosis of
conditions and diseases of the eye or adnexa, or if otherwise
specifically authorized by the Optometry Practice Act.
4)Specifies that, for purposes of the Optometry Practice Act,
"adnexa" means ocular adnexa.
EXISTING LAW :
1)Establishes CLIA under federal law, which regulates clinical
laboratories that perform tests on human specimens and sets
standards for facility administration, personnel qualifications
and quality control.
2)Defines CLIA waived tests as simple laboratory examinations and
procedures that are approved by the Food and Drug Administration
(FDA) for home use, employ methodologies that are so simple and
accurate as to render the likelihood of erroneous results
negligible, or pose no reasonable risk of harm to the patient if
the test is performed incorrectly.
3)Provides for the licensure and regulation of clinical laboratories
and their personnel by the State Department of Health Services
(now the Department of Public Health (DPH)), and requires clinical
laboratories to be operated under the supervision of a laboratory
director.
4)Defines "laboratory director" to mean any person who is a duly
licensed physician and surgeon, or only for purposes of a clinical
laboratory test or examination classified as waived, is a duly
licensed naturopathic doctor, or is licensed to direct a clinical
laboratory and who substantially meets the laboratory director
qualifications under CLIA for the type and complexity of tests
being offered by the laboratory.
5)Prohibits anyone from performing a clinical laboratory test or
examination classified as waived under CLIA unless the clinical
laboratory test or examination is performed under the overall
operation and administration of the laboratory director and the
test is performed by specified health care practitioners for
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specified purposes.
6)Establishes the Optometry Practice Act, administered by the State
Board of Optometry (Board), to regulate the practice of optometry.
7)Defines the practice of optometry to include the prevention and
diagnosis of disorders and dysfunctions of the visual system, the
treatment and management of certain disorders and dysfunctions of
the visual system, and the provision of rehabilitative optometric
services.
8)Requires optometrists to apply for a certificate from the Board
and meet specified requirements in order to be certified to use
TPAs and authorized to treat specified conditions and perform
certain procedures.
FISCAL EFFECT : According to Assembly Appropriations Committee, this
bill results in additional fee-supported workload at the California
Department of Public Health (CDPH) in the range of $150,000
annually.
COMMENTS : According to the author, "State law prohibits the
performance of a clinical laboratory test or examination classified
as waived under the federal CLIA law unless the test or examination
is performed under the overall operation and administration of a
laboratory director...Optometrists are not considered or classified
as a laboratory director, therefore cannot administer these simple
CLIA waived tests related to the eye.
"AB 761 will allow optometrists to administer simple CLIA waived
tests that are already within their scope of their practice. This
legislation will designate optometrists as lab directors for CLIA
waived tests only and not for other more complex types of
testing?This will not expand the type or the number of tests that
would be considered CLIA waved."
This bill allows licensed optometrists to perform waived tests and
to serve as the director of a lab that only performs tests
classified as waived and designated in current law for TPA-certified
optometrists, thereby allowing these optometrists to independently
perform these tests.
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916) 319-3301
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FN: 0003077