BILL ANALYSIS Ó
AB 761
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Date of Hearing: April 26, 2011
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
AB 761 (Roger Hernandez) - As Introduced: February 17, 2011
SUBJECT : Optometrists
SUMMARY : Allows optometrists to independently perform waived
clinical laboratory tests if the results can be used within the
optometrist's scope of practice. Specifically, this bill :
1)Allows a licensed optometrist to perform clinical laboratory
tests or examinations that are classified as waived under the
federal Clinical Laboratory Improvement Amendments (CLIA) of
1988, if the results of the tests can be lawfully utilized
within his or her practice.
2)Includes licensed optometrists in the definition of
"laboratory director" for purposes of clinical laboratory
tests or examinations classified as waived under CLIA.
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.
3)Provides for the licensure and regulation of clinical
laboratories and their personnel by the State Department of
Health Services, and requires clinical laboratories to be
operated under the supervision of a laboratory director, as
specified.
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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, 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.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill .
According to the author's office, "Doctors of optometry can
already perform waived tests in a lab under the supervision of a
laboratory director. The intent of this bill is to improve
patient care and public health by allowing optometrists to be
laboratory directors and perform the tests independently.
"As new CLIA waived tests are developed, the ability to perform
these tests is becoming necessary for any doctor providing
primary care?.Sending CLIA waived tests to an outside lab
unnecessarily delays appropriate diagnosis and treatment."
Background .
California clinical laboratories are subject to both federal and
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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.
The California Department of Public Health (DPH) regulates about
19,000 clinical labs and their personnel statewide, monitors
proficiency testing, investigates complaints, and sanctions labs
that violate the law or regulations.
Like 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
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. 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.
Podiatrists, dentists, and naturopathic doctors can perform
waived tests under a lab director's oversight and if the test
results can be lawfully utilized within their practice. This
bill extends this authority to optometrists.
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Current law also defines "laboratory director" for purposes of
waived tests to include a licensed naturopathic doctor. 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. The bill also conforms to the
federal requirement that testing be allowed only if test results
can be used within the optometrist's scope of practice.
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 Society of Pathologists writes,
"Current law requires the laboratory director to have education
and training on laboratory operation and management and the
requirement to oversee and approve personnel who actually
perform the waived testing. We are not aware of specific
training for optometrists that would justify that designation."
Suggested Committee amendment . The Committee may wish to
consider the following amendment to address concerns raised by
physician groups:
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On page 6, line 38, after "or" insert:
, only for purposes of a clinical laboratory test or examination
classified as waived involving conditions related to the eye, is
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.
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 :
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Support
California Optometric Association (sponsor)
Opposition
California Association for Medical Laboratory Technology
California Society of Pathologists
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301