BILL ANALYSIS �
SB 1481
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Date of Hearing: August 16, 2012
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Mike Gatto, Chair
SB 1481 (Negrete McLeod) - As Amended: August 7, 2012
Policy Committee: HealthVote:16-0
Business and Professions Vote: 9-0
Urgency: No State Mandated Local Program:
No Reimbursable: No
SUMMARY
As proposed to be amended, this bill exempts from existing
clinical laboratory requirements and regulations community
pharmacies that provide simple blood glucose, hemoglobin A1c, or
cholesterol tests, as specified, if the pharmacy obtains a
registration from the Department of Public Health (DPH) and
other requirements are met.
FISCAL EFFECT
1)Assuming 20% of pharmacies register as clinical labs:
a) This bill would result in additional fee-supported
workload at the DPH of $50,000 annually.
b) Revenue of $120,000 would be generated by existing fees.
1)Regardless of the final number of pharmacies that register as
clinical laboratories, additional fee revenue will be adequate
to fund additional workload. Revenues will accrue to the
Clinical Laboratory Improvement Fund and be used to fund
oversight of the individuals performing laboratory tests.
COMMENTS
1)Rationale . This bill would allow pharmacists to perform
specific over-the-counter laboratory tests, such as glucose
level or cholesterol tests, without the need to hire a
laboratory director. This bill would allow pharmacists to
perform only specific tests that are already recognized by the
law as safe to be performed with little or no oversight. The
SB 1481
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author contends this bill will result in easier access to
safe, simple, and economical tests, especially for low income
individuals, less crowding in physicians' offices, and an
improved ability of pharmacists to provide meaningful feedback
to their patients when providing drug consultations required
by law.
The California Pharmacists Association is the sponsor of this
bill.
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
pharmacists to perform three types of CLIA-waived tests.
Under current law, with certain exceptions, these tests can
only be performed under the oversight of a qualified
laboratory director.
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 (a) remove the provision making an
registration an biennial requirement for pharmacies (thereby
conforming to existing law making registration an annual
requirement), and (b) make technical, clarifying, and
chaptering changes.
Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081
SB 1481
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