BILL ANALYSIS Ó
Senate Appropriations Committee Fiscal Summary
Senator Christine Kehoe, Chair
AB 761 (Roger Hernandez) - Optometrists.
Amended: June 4, 2012 Policy Vote: BP&ED 9-0
Urgency: No Mandate: No
Hearing Date: July 2, 2012 Consultant: Jennifer Douglas
This bill does not meet the criteria for referral to the
Suspense File.
Bill Summary: AB 761 would allow optometrists to independently
perform waived clinical laboratory tests to aid in the diagnosis
of conditions and diseases of the eye and would permit
optometrists to serve as clinical laboratory directors.
Fiscal Impact:
Personnel costs of an estimated $128,000 in 2012-13, offset
by fees payable to the Clinical Laboratory Improvement Fund
for registration of optometrists to perform waived testing.
Personnel costs of an estimated $124,000 annually, offset
by fees payable to the Clinical Laboratory Improvement Fund.
Background: Existing law provides for the regulation and
licensure of clinical laboratories and clinical laboratory
personnel by the State Department of Public Health (CDPH).
Existing law prohibits the performance of a clinical laboratory
test or examination classified as waived under the federal
Clinical Laboratory Improvement Amendments (CLIA) of 1988 unless
the test or examination is performed under the overall operation
and administration of a laboratory director, as defined, and is
performed by specified persons, including certain health care
personnel.
Waived tests are simple laboratory examinations and procedures
cleared 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
performed incorrectly. Currently optometrists cannot legally
perform certain tests during an office visit, such as the Rapid
Pathogen Screening Adeno Detector, which tests for pink eye or a
Tear Osmolarity Test, for the diagnosis of dry eye disease.
AB 761 (Roger Hernandez)
Page 1
Proposed Law: This bill permits optometrists to serve as
clinical laboratory directors and specifies that optometrists
can perform waived laboratory examinations or tests to aid in
the diagnosis of conditions and diseases of the eye or ocular
adexa. This bill would also allow optometrists who are
certified to use therapeutic pharmaceutical agents to perform
waived clinical laboratory tests or examinations necessary for
the diagnosis of conditions and diseases of the eye.
Related Legislation: SB 1246 (Negrete McLeod) Chapter 523/2010
included naturopathic doctors in the list of health care
practitioners who could perform a clinical laboratory test or
examination classified as waived under CLIA and designates
naturopathic doctors as clinical laboratory directors for
CLIA-waived tests only.
Staff Comments: There are approximately 6,400 active, licensed
optometrists in California. Optometrist wanting to perform
CLIA-waived tests would need to register with Laboratory Field
Services (LFS) under CDHP as clinical laboratories and pay an
annual fee of $100. Because the bill expands the number of
persons that can perform CLIA-waived tests additional staff will
be needed by LFS to process applications and subsequent renewals
each year. This analysis estimates personnel costs for two
program technicians of $128,000 in 2012-2013 and $124,000
annually thereafter. If 20 percent of the current 6,400 active,
licensed optometrists applied as a laboratory for waived
testing, all costs would be offset by new fee revenue.