BILL ANALYSIS Ó
AB 761
Page 1
Date of Hearing: January 10, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 761 (Roger Hernández) - As Amended: January 4, 2012
SUBJECT : Optometrists.
SUMMARY : Permits optometrists to serve as clinical laboratory
directors and specifies that optometrists can perform simple
laboratory examinations or tests to aid in the diagnosis of
conditions of the eye or adnexa (appendages of an organ such as
the eye). Specifically, this bill :
1)Adds a licensed optometrist to those health care provider
types who can perform waived (from licensure) clinical
laboratory tests or examinations.
2)Permits a duly licensed optometrist to be a laboratory
director for the purposes of a clinical laboratory test or
examination classified as waived.
3)Adds to the practice of optometry for those optometrists who
are certified to use therapeutic pharmaceutical agents, as
specified, authorization to perform a clinical laboratory test
or examination classified as waived under the federal Clinical
Laboratory Improvement Amendments of 1988 (CLIA) necessary for
the diagnosis of conditions and diseases of the eye or adnexa,
or if otherwise specifically authorized by law.
EXISTING LAW :
1)Regulates, pursuant to federal and state laws and regulations,
clinical laboratory testing and examinations of tests that are
classified as waived, moderately complex, and highly complex.
2)Defines clinical laboratory test or examination as the
detection, identification, measurement, evaluation,
correlation, monitoring, and reporting of any particular
analyte, entity, or substance within a biological specimen for
the purpose of obtaining scientific data which may be used as
an aid to ascertain the presence, progress, and source of a
disease or physiological condition in a human being, or used
as an aid in the prevention, prognosis, monitoring, or
treatment of a physiological or pathological condition in a
human being, or for the performance of nondiagnostic tests for
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assessing the health of an individual.
3)Defines laboratory director as 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.
4)Prohibits a person 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, as specified, and the test is performed by specified
health care professionals including a licensed physician and
surgeon, podiatrist, dentist, physician assistant, medical
assistant, and other health care personnel providing direct
patient care.
5)Permits an optometrist who is certified to use specified
therapeutic pharmaceutical agents to order smears, cultures,
sensitivities, complete blood count, mycobacterial culture,
acid fast stain, urinalysis, and X-rays necessary for the
diagnosis of conditions or diseases of the eye or adnexa.
Permits an optometrist to order other types of images subject
to prior consultation with an ophthalmologist or appropriate
physician and surgeon.
FISCAL EFFECT : This bill has not yet been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill
allows optometrists to administer simple CLIA waived tests
that are already within their scope of practice, and
designates optometrists as lab directors for CLIA waived tests
only, and not for other more complex types of testing. The
author states that this bill will not expand the type or the
number of tests that would be considered CLIA waived. The
author asserts that some tests are designed to diagnose
conditions optometrists are allowed to treat, like dry eye.
Others are needed to determine if the patient has a more
serious underlying condition that requires a referral. The
author states that sending CLIA waived tests to an outside lab
unnecessarily delays appropriate diagnosis and treatment.
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Tests that would be used in optometric offices, according to
the author, are tests for contagious viral conjunctivitits
(pink eye), blood glucose finger stick for diabetes, and
urinalysis to detect infection, bleeding, diabetes, and other
problems.
2)BACKGROUND . CLIA was enacted in 1988 when questions were
raised about quality control procedures resulting from reports
of inaccurate Pap smear testing. CLIA established quality
standards for all lab testing to ensure the accuracy,
reliability and timeliness of patient test results regardless
of where the test is performed. The Centers for Medicare and
Medicaid Services (CMS) oversees CLIA and delegates to the
federal Food and Drug Administration (FDA) classification
(categorization) of commercially marketed tests. The
California Department of Public Health (DPH) is responsible
for licensing, registering, and overseeing clinical
laboratories in California, although labs are also required to
be licensed or certified by CMS. DPH Laboratory Field
Services division is required to inspect licensed and
registered labs, monitor proficiency testing, investigate
complaints, and sanction labs that fail to correct
deficiencies. According to DPH, California regulates a total
of 20,297 labs, 11,007 of them are registered as waived labs.
Another 2,890 held a CLIA certificate prior to January 1, 1996
and their certificate serves as state registration.
3)WAIVED TESTS . Lab licensure and requirements are based on the
complexity of the test performed. Generally, waived tests are
simple laboratory examinations and procedures cleared 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 performed
incorrectly. Waivers are permitted: for tests specified in
federal regulation; in instances where the manufacturer has
provided scientifically valid data verifying that the waiver
criteria have been met; or, when cleared by the FDA for home
use. Examples of some of the tests identified in the federal
regulation include dipstick or tablet urinalysis, fecal occult
blood, and urine pregnancy tests. According to DPH, there are
not many complaints received by the department about waived
testing, however state inspectors have found deficiencies
where the lab does not have the manufacturer's instructions
available for testing personnel to follow the manufacturer's
instructions, or where they do, personnel are not following
manufacturer's instructions.
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4)SUPPORT . The California Optometric Association (COA) supports
this bill because they believe under the current law patient
safety is compromised when optometrists cannot legally perform
certain tests during an office visit. As an example, COA
indicates a specified test (RPS Adeno Detector) can diagnose
viral conjunctivitis while the patient is still in the office
allowing the provider to make an accurate diagnosis and limit
the spread of the disease while simultaneously reducing ocular
antibiotic resistance. The California Academy of Eye
Physicians and Surgeons also support this bill.
5)OPPOSED UNLESS AMENDED . The California Association for
Medical Laboratory Technology (CAMLT) is opposed unless
amended because of concerns about the broad range of testing
that would be permitted and because of the provisions
permitting optometrists to serve as lab directors. However,
CAMLT would change its position to neutral if the bill were
limited so that optometrists can only perform those lab tests
which current law authorizes optometrists to order under
Business and Professions Code §3041(e)(9).
6)PREVIOUS LEGISLATION . SB 1246 (Negrete McLeod), Chapter 523,
Statutes of 2010, includes naturopathic doctors in the list of
health care practitioners who could perform a clinical
laboratory test or examination classified as waived and
defines a naturopathic assistant for purposes of the
Naturopathic Doctors Act, and specifies certain functions for
naturopathic assistants.
7)DOUBLE REFERRAL . This bill has been double referred. It will
also be heard in the Assembly Business, Professions and
Consumer Protection Committee on January 10, 2012.
8)SUGGESTED AMENDMENTS .
a) To address the concerns raised by CAMLT, the author may
wish to amend this bill on page 14, line 25 as follows:
(10) Performing a clinical laboratory test or examination
classified as waived under CLIA and as designated in
3041(e)(9) necessary for the diagnosis of conditions and
diseases of the eye or adnexa, or if otherwise specifically
authorized by this chapter.
b) The term adnexa means appendages to an organ or
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anatomical part. To clarify that the term adnexa as used
in the optometry scope of practice refers to ocular adnexa
the author may wish to amend this bill on page 16, line 23
as follows:
(k) For purposes of this chapter "adnexa" refers to ocular
adnexa.
(l) In an emergency, an optometrist?.
9)POLICY QUESTION . Do optometrists have sufficient training to
serve as lab directors for waived testing? According to DPH,
there may be technical and policy issues related to allowing
optometrists to act as a director for other waived tests such
as HIV, infectious diseases or chemistry tests without having
the laboratory training or experience to serve as the
director.
REGISTERED SUPPORT / OPPOSITION :
Support
California Optometric Association (sponsor)
California Academy of Eye Physicians and Surgeons
Opposition
None on file.
Analysis Prepared by : Teri Boughton / HEALTH / (916) 319-2097