BILL ANALYSIS Ó
AB 761
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Date of Hearing: January 19, 2012
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Felipe Fuentes, Chair
AB 761 (Roger Hernández) - As Amended: January 12, 2012
Policy Committee: Health Vote: 17-0
Business and Professions Vote: 8-0
Urgency: No State Mandated Local Program:
No Reimbursable: No
SUMMARY
As proposed to be amended, this bill allows optometrists to
perform simple lab tests. Specifically, this bill:
1)Adds optometrists to the list of individuals authorized to
perform tests or exams classified as waived under the Clinical
Laboratory Improvement Amendments (CLIA), the federal act
establishing quality standards for laboratory testing.
2)Allows optometrists who are certified to use therapeutic
pharmaceutical agents (TPA-certified optometrists) to function
as laboratory directors, only for purposes of a clinical
laboratory test or exam classified as waived under CLIA and
necessary for the diagnosis of ocular conditions and diseases.
3)Adds performance of CLIA-waived tests or exams necessary for
the diagnosis of ocular conditions and diseases to the list of
activities constituting the practice of optometry, for
TPA-certified optometrists.
FISCAL EFFECT
This bill results in additional fee-supported workload at the
California Department of Public Health (CDPH) in the range of
$150,000 annually.
Under current law, to perform CLIA-waived tests, optometrists
would be required to register with CDPH as clinical laboratories
and pay annual fees of $100. Revenues would accrue to the
Clinical Laboratory Improvement Fund and would be used to fund
oversight of the individuals performing laboratory tests.
AB 761
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COMMENTS
1)Rationale . According to the author, there is a deficiency in
existing law that renders optometrists unable to perform very
simple tests that aid in diagnosing conditions optometrists
are allowed to treat, such as viral conjunctivitis (pink eye).
The author also contends that sending so-called CLIA-waived
tests to an outside lab unnecessarily delays appropriate
diagnosis and treatment.
2)CLIA-Waived Tests . Under CLIA, the federal Food and Drug
Administration (FDA) categorizes laboratory tests based on the
complexity of the test performed. Tests may be assigned to
one of three categories: high-complexity, moderate-complexity,
or waived from regulatory oversight. Waived tests are defined
in federal regulation as simple laboratory examinations and
procedures that are cleared by the 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. This legislation would allow
optometrists to perform eye-related CLIA-waived tests that
they currently are not authorized to perform.
One example of a CLIA-waived test that might be used in
optometric offices is the RPS Adeno Detector, which tests for
contagious viral conjunctivitis (pink eye). Another simple
test that may gain CLIA-waived status this year is TearLab, a
handheld device that diagnoses dry eye.
3)Regulation of Clinical Laboratories . Under current law, an
individual performing CLIA-waived clinical laboratory tests is
considered a clinical laboratory. Clinical laboratories that
perform only CLIA-waived tests are required to register with
the Laboratory Field Services unit within CDPH, and pay a
$100-per-year fee. The department's oversight workload
consists of reviewing registration applications and ensuring
that appropriate personnel are performing allowable types of
tests.
4)Proposed amendments . Section 2 of this bill includes an
erroneous reference to Section 3041(e)(9) of the Business and
Professions Code, instead of Section 3041(e)(10). The proposed
amendments correct this technical drafting error.
AB 761
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5)Policy Questions Resolved and Opposition Removed . A previous
analysis of this bill raised technical and policy questions
related to whether optometrists have sufficient training to
act as lab directors for certain types of CLIA-waived tests
that are unrelated to the eye, such as HIV or other infectious
disease tests. Recent amendments adopted in Health committee
restrict the tests that can be performed to those necessary to
diagnose ocular diseases and conditions, addressing this
concern. Adoption of those prior amendments and the technical
amendment proposed today removes all registered opposition to
the bill.
Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081