BILL ANALYSIS �
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CONSENT
Bill No: AB 2143
Author: Williams (D)
Amended: 5/27/14 in Assembly
Vote: 27 - Urgency
SENATE BUSINESS, PRO. & ECON. DEV. COMM. : 8-0, 6/23/14
AYES: Lieu, Wyland, Berryhill, Corbett, Galgiani, Hernandez,
Hill, Torres
NO VOTE RECORDED: Block
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
ASSEMBLY FLOOR : 79-0, 5/29/14 - See last page for vote
SUBJECT : Clinical laboratories: chiropractors
SOURCE : California Chiropractic Association
DIGEST : This bill exempts chiropractors listed on the federal
Department of Transportation National Registry of Certified
Medical Examiners (NRCME), who perform specific waived clinical
laboratory tests for the sole purpose of completing the
Department of Motor Vehicles (DMV) medical examination report,
if they obtain a valid certificate of waiver, for the
performance of waived clinical laboratory tests; and requires a
chiropractor who receives an abnormal finding to refer the
applicant to the their primary care physician.
ANALYSIS :
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Existing law:
1. Authorizes the California Board of Chiropractic Examiners,
under the Department of Consumer Affairs, to license
chiropractors and regulate the practice of chiropractic.
2. Defines "CLIA" to mean the federal Clinical Laboratory
Improvement Amendments of 1988; "clinical laboratory test or
examination" to mean 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, as specified; "clinical laboratory" to mean
any place used, or any establishment, or institution
organized or operated, for the performance of clinical
laboratory tests or examinations or the practical application
of the clinical laboratory sciences which may include any
means that applies the clinical laboratory sciences; and
"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 clinical laboratory scientist, a duly
licensed limited clinical laboratory scientist, a duly
licensed naturopathic doctor or a duly licensed optometrist
serving as the director of a laboratory which only performs
clinical laboratory tests, as specified.
3. Prohibits, except as otherwise specified, 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.
This bill:
1. Exempts chiropractors listed on the NRCME who perform urine
specific gravity, urine protein, urine blood and urine sugar
tests, as those tests relate to the NRCME, as adopted by the
federal Department of Transportation, that are classified as
waived clinical laboratory tests under CLIA for the sole
purpose of completing the DMV medical examination report, if
the chiropractor obtains a valid certificate of waiver and
complies with all other requirements for the performance of
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waived clinical laboratory tests under applicable federal
regulations.
2. Requires a chiropractor who receives an abnormal finding, to
refer the applicant to the applicant's primary care physician
and surgeon.
Background
CLIA . 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 the United States Food and Drug Agency (FDA) for home use,
employ methodologies that are simple and accurate so 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. Waived tests include dipstick or reagent
tablet urinalysis (used to test glucose, hemoglobin, and protein
among other things); fecal occult blood; ovulation tests; urine
pregnancy tests; erythrocyte sedimentation rate-non-automated;
and blood glucose by glucose monitoring devices cleared by the
FDA specifically for home use.
Amendments adopted for CLIA states that tests approved by the
FDA for home use automatically qualify for a CLIA waiver. This
bill permits chiropractors listed on the NRCME to perform a
urine dipstick test for the sole purpose of completing the DMV
medical examination report.
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 Business and Professions
Code irrespective of whether the clinical laboratory is operated
under a CLIA certificate or under a state license or
registration.
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This bill grants chiropractors the CLIA waiver.
Comments
According to the author, "California is one of three states that
have not granted doctors of chiropractic a CLIA waiver. This
means the pool of people who can perform CLIA waived tests is
smaller in California than most other states. Doctors of
chiropractic regularly perform pre-employment physicals. More
specifically, they are included on the list of providers who are
authorized to perform the federal Transportation Department
medical examination for commercial drivers' license holders. In
fact, doctors of chiropractic are the only providers on the
NRCME who cannot perform the urine dipstick test on site.
Further, the extra step for [a patient to schedule] an
additional appointment means extra time, extra expense and
delays for completion of the required examination."
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 7/31/14)
California Chiropractic Association (source)
Board of Chiropractic Examiners
ARGUMENTS IN SUPPORT : The California Chiropractic Association
as the sponsor of this bill states that, "Doctors of
chiropractic perform commercial drivers' license medical
examinations and pre-employment physicals. As with every other
health care provider conducting the examinations and physicals,
doctors of chiropractic should be provided a CLIA Waiver for the
necessary urine dipstick tests. However, without a CLIA
waiver[,] commercial drivers' license holders who choose a
doctor of chiropractic to perform their required medical
examination will have to make a separate appointment with a lab
to get the urine dipstick test performed. This additional step
involve extra time and expense and possibly delay the completion
of the required examination; therefore creating an extra barrier
to employment."
ASSEMBLY FLOOR : 79-0, 5/29/14
AYES: Achadjian, Alejo, Allen, Ammiano, Bigelow, Bloom,
Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian
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Calderon, Campos, Chau, Ch�vez, Chesbro, Conway, Cooley,
Dababneh, Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox,
Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon,
Gorell, Gray, Grove, Hagman, Hall, Harkey, Roger Hern�ndez,
Holden, Jones, Jones-Sawyer, Levine, Linder, Logue, Lowenthal,
Maienschein, Mansoor, Medina, Melendez, Mullin, Muratsuchi,
Nazarian, Nestande, Olsen, Pan, Patterson, Perea, John A.
P�rez, V. Manuel P�rez, Quirk, Quirk-Silva,
Rendon, Ridley-Thomas, Rodriguez, Salas, Skinner, Stone, Ting,
Wagner, Waldron, Weber, Wieckowski, Wilk, Williams, Yamada,
Atkins
NO VOTE RECORDED: Vacancy
MW:d 8/5/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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