BILL ANALYSIS Ó
SB 1481
Page 1
SENATE THIRD READING
SB 1481 (Negrete McLeod)
As Amended August 20, 2012
Majority vote
SENATE VOTE :36-0
BUSINESS & PROFESSIONS 9-0 HEALTH
16-0
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|Ayes:|Hayashi, Bill Berryhill, |Ayes:|Monning, Logue, Atkins, |
| |Allen, Butler, Eng, | |Bonilla, Eng, Garrick, |
| |Hagman, Hill, Ma, Smyth | |Gordon, Hayashi, |
| | | |Roger Hernández, Bonnie |
| | | |Lowenthal, Mansoor, |
| | | |Mitchell, Nestande, |
| | | |V. Manuel Pérez, Silva, |
| | | |Williams |
|-----+--------------------------+-----+--------------------------|
| | | | |
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APPROPRIATIONS 17-0
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|Ayes:|Gatto, Harkey, | | |
| |Blumenfield, Bradford, | | |
| |Charles Calderon, Campos, | | |
| |Davis, Donnelly, Fuentes, | | |
| |Hall, Hill, Cedillo, | | |
| |Mitchell, Nielsen, Norby, | | |
| |Solorio, Wagner | | |
|-----+--------------------------+-----+--------------------------|
| | | | |
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SUMMARY : Allows pharmacists to perform over-the-counter blood
glucose, hemoglobin A1c (blood sugar), or cholesterol tests
classified as waived under the federal Clinical Laboratory
Improvement Amendments (CLIA) of 1988. Specifically, this bill :
1)Provides that statutes requiring CLIA waived tests to be
performed under the operation and administration of a
laboratory director, as specified, do not apply to a
SB 1481
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pharmacist at a community pharmacy who, upon customer request,
performs only blood glucose, hemoglobin A1c (blood sugar), or
cholesterol tests classified as waived under CLIA and are
approved by the federal Food and Drug Administration for sale
to the public without a prescription in the form of an
over-the-counter test kit, provided that all of the following
requirements are satisfied:
a) The pharmacy obtains a valid CLIA certificate of waiver
and complies with all other requirements for the
performance of waived clinical laboratory tests under
applicable federal regulations. For purposes of CLIA, the
person identified as responsible for directing and
supervising testing oversight and decision-making shall be
the pharmacist-in-charge, as specified;
b) The pharmacy obtains a registration from the Department
of Public Health pursuant to current law, as specified;
and,
c) The tests are performed only by a pharmacist, as defined
under the Pharmacy Law, in the course of performing routine
patient assessment procedures in compliance with their
scope of practice as specified under the Pharmacy Law.
2)Makes conforming and technical changes.
FISCAL EFFECT : According to the Assembly Appropriations
Committee:
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; and,
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.
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COMMENTS : According to the author, "This bill is intended to
remove burdensome and unnecessary government regulations to
improve efficiency in the health-care delivery system.
Specifically, 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. Pharmacies are not interested in becoming
laboratories, and 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. Passage of
this legislation will result in easier access to safe, simple,
and economic 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."
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301
FN: 0005539