BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 761|
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THIRD READING
Bill No: AB 761
Author: Roger Hernández (D)
Amended: 6/4/12 in Senate
Vote: 21
SENATE BUSINESS, PROF.& ECON. DEV. COMM. : 9-0, 6/11/12
AYES: Price, Emmerson, Corbett, Correa, Hernandez, Negrete
McLeod, Strickland, Vargas, Wyland
SENATE APPROPRIATIONS COMMITTEE : 7-0, 7/2/12
AYES: Kehoe, Walters, Alquist, Dutton, Lieu, Price,
Steinberg
ASSEMBLY FLOOR : 74-0, 1/26/12 - See last page for vote
SUBJECT : Optometrists
SOURCE : California Optometric Association
DIGEST : This bill provides that a laboratory director
may include a licensed optometrist and authorizes an
optometrist to perform certain clinical laboratory tests or
examinations classified as waived under the Clinical
Laboratory Improvement Act (CLIA).
ANALYSIS :
Existing law:
1. Provides for the licensure and regulation of
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optometrists by the Board of Optometry (Board).
(Business and Professions Code (BPC) Section 3010)
2. Requires certification by the Board for a licensed
optometrist to use therapeutic pharmaceutical agents.
(BPC Section 3041.3)
3. Authorizes a licensed optometrist certified to use
therapeutic pharmaceutical agents to diagnose and treat
specific conditions. (BPC Section 3041(a)(5); Section
3041(b)(2)(c) et seq.)
4. Provides for the licensure and regulation of clinical
laboratories and personnel by the Department of Public
Health (DPH). (Division 2, Chapter 3, Articles 4-7,
Section 1260 et seq. of BPC; California Code of
Regulations (CCR) Title 17, Division 1, Chapter 2.
Often referred to as the "CLIA Law.")
5. Prohibits the performance of a clinical laboratory test
or examination classified as waived under the federal
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.
This bill:
1. Expands the category of persons who may perform CLIA
waived tests to include licensed optometrists if the
results of the tests can be lawfully utilized within
their practice.
2. Provides that a laboratory director may include a
licensed optometrist serving as the director of a
laboratory which only performs specified CLIA waived
tests including the Rapid Pathogen Screening (RPS) Adeno
Detector and Tear Osmolarity Test (TOT).
3. Authorizes a licensed optometrist certified to use
therapeutic pharmaceutical agents to additionally
perform specified CLIA waived tests and examinations
that are necessary for the diagnosis of conditions and
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diseases of the eye or ocular adnexa defined as the
adjacent structures of the eye including the extraocular
muscles and the eyelids, eyelashes, eyebrows and the
conjunctiva.
Background
Federal CLIA of 1988 . CLIA law specified that laboratory
requirements be based on the complexity of the test
performed. It also established provisions for categorizing
a test as waived. Tests may be waived from regulatory
oversight if they meet certain requirements established by
the statute. On February 28, 1992, regulations were
published to implement CLIA.
Federal definition of CLIA waived tests . According to
Federal Regulation 493.15, CLIA-waived tests are test
systems that are simple laboratory examinations and
procedures which are cleared by 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.
California clinical laboratory personnel requirements . All
persons performing, supervising, consulting on, or
directing clinical laboratory tests or examinations in
California must meet the requirements outlined in the BPC
irrespective of whether the clinical laboratory is operated
under a CLIA certificate or under a state license or
registration. (CCR Title 17 Section 1039.2 (a))
Currently, optometrists are certified to perform a number
of procedures, such as blood draws for patients suspected
of having diabetes, suture removal with prior approval of
the treating physician and use of an epinephrine
auto-injector to counteract anaphylactic reaction.
Center for Medicaid Services (CMS) . The CMS issued a memo
in September of 2006 to provide clarification regarding
optometrists serving as laboratory directors of moderate
complexity testing under CLIA. The memo states, "The
Doctor of Optometry (OD) degree is suitable to meet the
personnel qualifications for laboratory director of
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moderate complexity testing provided the testing is limited
to tests related to the medical specialty of optometry."
This bill allows optometrists to administer tests of simple
complexity including the RPS Adeno Detector and TOT.
RPS Adeno Detector . The RPS Adeno Detector quickly detects
the presence of adenovirus in the tear fluid. Adenoviral
conjunctivitis, such as "pink eye," repre?sents the most
common external ocular infection. This in-office test
allows for the rap?id detection of Adenoviral antigens
directly from human eye fluid on the lower conjunctiva.
RPS Adeno Detector kits do not require additional equipment
to administer or interpret. Results are achieved in 10
minutes allowing the optometrist to provide a diagnosis and
implement a treatment plan before patients leave the
office.
TOT . Dry eye disease is a common condition in which the
eye does not produce enough tears to keep the surface of
the eye sufficiently lubricated. The TOT, produced by
TearLab Corporation, requires less than 50 nanoliters of
tear fluid in order to measure tear osmolarity or fluid of
the eye. The TOT can produce a sample and test result in
less than 30 seconds.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Senate Appropriations Committee:
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.
SUPPORT : (Verified 7/3/12)
California Optometric Association (source)
AFSCME
California Academy of Eye Physicians and Surgeons
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California Board of Optometry
TearLab Corporation
United Nurses Associations of California/Union of Health
Care Professionals
ARGUMENTS IN SUPPORT : California Optometric Association,
the sponsor of this bill, asserts that this bill will allow
optometrists to provide better care to their patients.
Currently, patient safety is compromised because
optometrists cannot legally perform these tests during an
office visit. For example, the RPS Adeno Detector can
diagnose viral conjunctivitis while the patient is still in
the office, which allows the doctor to make an accurate
diagnosis and limit spread of disease while simultaneously
reducing ocular antibiotic resistance.
ASSEMBLY FLOOR : 74-0, 1/26/12
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall,
Bill Berryhill, Block, Blumenfield, Bonilla, Bradford,
Brownley, Buchanan, Butler, Charles Calderon, Campos,
Carter, Cedillo, Chesbro, Conway, Cook, Dickinson,
Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Beth
Gaines, Galgiani, Garrick, Gatto, Gordon, Grove, Hagman,
Hall, Hayashi, Roger Hernández, Hill, Huber, Hueso,
Huffman, Jeffries, Jones, Knight, Lara, Logue, Bonnie
Lowenthal, Ma, Mansoor, Mendoza, Miller, Mitchell,
Monning, Morrell, Nestande, Nielsen, Norby, Olsen, Pan,
Perea, V. Manuel Pérez, Portantino, Silva, Skinner,
Solorio, Swanson, Torres, Valadao, Wagner, Wieckowski,
Williams, Yamada, John A. Pérez
NO VOTE RECORDED: Davis, Furutani, Gorell, Halderman,
Harkey, Smyth
JJA:k 7/5/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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