BILL ANALYSIS Ó
AB 761
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Date of Hearing: January 10, 2012
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
AB 761 (Roger Hernandez) - As Amended: January 4, 2012
SUBJECT : Optometrists
SUMMARY : Allows optometrists to independently perform waived
clinical laboratory tests necessary for the diagnosis of
conditions and diseases of the eye. Specifically, this bill :
1)Adds licensed optometrists to the list of persons who are
authorized under current law to perform a clinical laboratory
test or examination classified as waived under the federal
Clinical Laboratory Improvement Amendments (CLIA) of 1988.
2)Includes licensed optometrists in the definition of
"laboratory director" for purposes of a clinical laboratory
test or examination classified as waived.
3)Allows optometrists who are certified to use therapeutic
pharmaceutical agents (TPAs) to perform a clinical laboratory
test or examination classified as waived under CLIA necessary
for the diagnosis of conditions and diseases of the eye or
adnexa, or if otherwise specifically authorized by the
Optometry Practice Act.
EXISTING LAW
1)Establishes CLIA under federal law, which regulates clinical
laboratories that perform tests on human specimens and sets
standards for facility administration, personnel
qualifications and quality control. These standards apply to
all settings, including commercial, hospital or physician
office laboratories.
2)Defines CLIA waived tests as simple laboratory examinations
and procedures that are approved by the Food and Drug
Administration (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.
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3)Provides for the licensure and regulation of clinical
laboratories and their personnel by the State Department of
Health Services (now the Department of Public Health (DPH)),
and requires clinical laboratories to be operated under the
supervision of a laboratory director, as specified.
4)Defines "laboratory director" to mean any person who is a duly
licensed physician and surgeon, or, only for purposes of a
clinical laboratory test or examination classified as waived,
is a duly licensed naturopathic doctor, or is licensed to
direct a clinical laboratory and who substantially meets the
laboratory director qualifications under CLIA for the type and
complexity of tests being offered by the laboratory.
5)Prohibits anyone from performing a clinical laboratory test or
examination classified as waived under CLIA unless the
clinical laboratory test or examination is performed under the
overall operation and administration of the laboratory
director and the test is performed by specified health care
practitioners for specified purposes.
6)Establishes the Optometry Practice Act, administered by the
State Board of Optometry (Board), to regulate the practice of
optometry.
7)Defines the practice of optometry to include the prevention
and diagnosis of disorders and dysfunctions of the visual
system, and the treatment and management of certain disorders
and dysfunctions of the visual system, as well as the
provision of rehabilitative optometric services.
8)Requires optometrists to apply for a certificate from the
Board and meet specified requirements in order to be certified
to use TPAs and authorized to treat specified conditions.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill .
According to the author, "State law prohibits the performance of
a clinical laboratory test or examination classified as waived
under the federal CLIA law unless the test or examination is
performed under the overall operation and administration of a
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laboratory director...Optometrists are not considered or
classified as a laboratory director, therefore cannot administer
these simple CLIA waived tests related to the eye.
"AB 761 will allow optometrists to administer simple CLIA waived
tests that are already within their scope of their practice.
This legislation will designate optometrists as lab directors
for CLIA waived tests only and not for other more complex types
of testing?This will not expand the type or the number of tests
that would be considered CLIA waved."
Background .
California clinical laboratories are subject to both federal and
state oversight. Federal oversight falls under CLIA, which is
administered by the Centers for Medicare and Medicaid Services
(CMS) within the U.S. Department of Health and Human Services.
CLIA regulates clinical labs based on the complexity of tests
the lab offers.
"Waived" tests are approved by FDA for home use, use simple and
accurate methods that make the possibility of error negligible,
or pose no significant risk of harm to the patient if
incorrectly performed. Clinical labs performing only "waived"
tests must register with the CLIA program, pay biennial
certificate fees, allow inspections, and perform tests according
to manufacturers' instructions.
"Moderate" or "high" tests, which are more complex, may be
performed by clinical labs that pay higher fees, undergo
biennial inspections, and meet tougher standards for personnel,
supervision, quality assurance and proficiency testing.
State oversight of clinical labs is administered by DPH, which
regulates about 19,000 clinical labs and their personnel
statewide, monitors proficiency testing, investigates
complaints, and sanctions labs that violate the law or
regulations.
In conformance with CLIA, DPH licenses or registers clinical
labs according to the complexity of testing they perform. Labs
must be licensed for moderately or highly complex procedures,
and registered for low complexity. About 3,000 clinical labs
are licensed for moderate and/or high complexity testing. The
remaining are registered labs performing waived tests and/or
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provider-performed microscopy.
Waived tests can be performed under the supervision of a lab
director and other specific conditions by a number of health
care practitioners, including physicians, podiatrists, dentists,
naturopathic doctors, physician assistants, nurses, respiratory
care practitioners, and others. This bill adds licensed
optometrists to this list.
A lab director must be a licensed physician and surgeon or meet
other licensure requirements, and is responsible for overseeing
the overall operation and administration of the lab. For
purposed of waived tests, a lab director can also include a
licensed naturopathic doctor or a person licensed to direct a
clinical laboratory and who substantially meets the laboratory
director qualifications under CLIA for the type and complexity
of tests being offered by the laboratory. This bill includes
optometrists in this definition, thereby allowing optometrists
to independently perform waived tests without supervision by a
separate lab director.
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 moderate
complexity testing provided the testing is limited to tests
related to the medical specialty of optometry."
This bill allows optometrists to serve as a lab director for
waived tests, which are simpler than the moderate complexity
testing that the CMS memo allows.
Many states, including California, require additional
certification for optometrists who wish to administer,
prescribe, and dispense medications or "TPAs." In California,
this certification requires additional education, examination
and experience.
Current law allows optometrists who are certified to use TPAs 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 auto-injector to
counter allergic reaction. This bill allows optometrists who
are certified to use TPAs to also perform waived tests or
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examinations that are necessary for the diagnosis of conditions
and diseases of the eye or its appendages.
Support . The California Optometric Association states,
"Currently, patient safety is compromised because optometrists
cannot legally perform (CLIA waived) 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. This legislation would designate optometrists as
lab directors for CLIA waived tests only (not for more complex
tests). Specifically, it adds optometrists to the category of
lab directors that currently includes medical doctors,
osteopaths and naturopaths. The bill does not expand the type or
number of tests that would be considered waived."
Opposition . The California Association for Medical Laboratory
Technology (CAMLT) states, "CAMLT recognizes the ability of
optometrists to perform certain waived tests limited to their
scope of practice pertaining to the eye, but had concerns about
the broad range of testing that the bill's sponsors have
indicated interest in, such blood and urine tests or those
relating to conditions, such as diabetes and infections, not
treatable by optometrists. CAMLT?feels that a technical,
clarifying amendment?is still in order.
"As previously stated, of greater concern is whether or not
optometrists receive the proper education and training to
perform as a laboratory director and those attendant functions
outlined in Section 1209 of the Business and Professions Code.
A review of Section 1209, designed to protect patient health and
safety, clearly defines and outlines the many duties and
significant responsibilities required to direct a clinical
laboratory in California."
Previous legislation .
SB 1246 (Negrete McLeod), Chapter 523, Statutes of 2010 includes
naturopathic doctors in the list of health care practitioners
who can 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.
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AB 1442 (Feuer) of 2007 requires clinical laboratories that
perform tests to screen for human immunodeficiency virus (HIV)
that are classified as waived under CLIA to enroll in a
proficiency testing program and to obtain the appropriate
license or registration from DPH, as specified. This bill was
held on the Assembly Floor.
AB 185 (Dymally) of 2007 expands the duties that unlicensed
personnel are authorized to perform in a clinical laboratory and
revises the levels of supervision required when unlicensed
personnel perform them. This bill was held in Assembly Business
and Professions Committee.
AB 1370 (Matthews) of 2005 includes a pharmacist within the
definition of laboratory director if the clinical laboratory
test or examination is a routine patient assessment procedure,
as defined. This bill was held in Assembly Business and
Professions Committee.
AB 433 (Nava) of 2005 exempts physician office laboratories from
licensure and regulatory requirements governing clinical
laboratories and their personnel by the Department of Health
Services. This bill was held in Assembly Health Committee.
Double referred . This bill is double-referred to Assembly
Health Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
California Optometric Association (sponsor)
California Academy of Eye Physicians and Surgeons
California State Board of Optometry
Opposition
California Clinical Laboratory Association (CCLA)
California Association for Medical Laboratory Technology
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301
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