BILL ANALYSIS Ó
AB 2143
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Date of Hearing: April 29, 2014
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Susan A. Bonilla, Chair
AB 2143 (Williams) - As Amended: March 28, 2014
SUBJECT : Clinical laboratories: chiropractors.
SUMMARY : Exempts certain Doctors of Chiropractic (DC) who
perform specified laboratory tests from clinical laboratory
requirements, and requires a DC who receives an abnormal test
reading to refer the applicant to his or her primary care
physician. Specifically, this bill :
1)Exempts DCs listed on the most current federal Department of
Transportation (DOT) and National Registry of Certified
Medical Examiners (National Registry) from specified clinical
laboratory requirements when performing urine specific
gravity, urine protein, urine blood, and urine sugar tests
that are classified as waived clinical laboratory tests under
CLIA for the sole purpose of completing the Department of
Motor Vehicles Medical Examination Report, as specified.
2)Requires a DC to obtain a valid certificate of waiver and
comply with all other requirements for the performance of
waived clinical laboratory tests under applicable federal
regulations.
3)Requires a DC who receives an abnormal finding to refer the
applicant to the applicant's primary physician.
EXISTING LAW:
1)Defines "CLIA" to mean the federal Clinical Laboratory
Improvement Amendments of 1988. (Business and Professions Code
(BPC) Section 1202.5)
2)Defines a "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 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
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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 non-diagnostic tests
for assessing the health of an individual. (BPC 1206 (a)(5))
3)Defines a "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. (BPC 1206 (a)(8))
4)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.
(BPC 1206.5)
5)Defines a "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. (BPC 1209)
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill will exempt those DCs who are
listed on the current National Registry from the requirement
to be a laboratory director in order to obtain a CLIA
certificate to perform specific urine gravity, protein, and
sugar dipstick tests for the sole purpose of completing a
medical examination for the DOT commercial drivers' license
medical examination. AB 2143 would also require a DC who
receives a test with an abnormal reading to refer the
test-taker to their primary care physician. This bill is
sponsored by the California Chiropractic Association.
2)Author's statement . According to the author, "[DCs] regularly
perform pre-employment physicals. More specifically, they are
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included on the list of providers who are authorized to
perform the DOT medical examination for commercial drivers'
license holders. The federal government expects a shortage of
providers available to perform the DOT examination. The reason
is, beginning May of 2014, all providers who perform the
examination must be listed on the [National Registry] further
limiting those who can perform these tests. In fact, [DCs]
are the only providers on the National Registry who cannot
perform the urine dipstick test on site. Further, the extra
step for scheduling an additional appointment means extra
time, extra expense and delays for completion of the required
examination.
"By granting [DCs] the CLIA waiver for this specific dipstick
test, [this bill] will help fill the impending shortage of
providers and reduce delays for those commercial drivers'
license holders who choose to have a [DCs] perform their
physical."
3)Clinical laboratory oversight . California clinical
laboratories are subject to both federal and state oversight.
The federal CLIA regulates clinical labs based on the
complexity (low, moderate or high) of the tests offered.
Congress passed CLIA in 1988, which established quality
standards for all laboratories testing to ensure the accuracy,
reliability and timeliness of patient test results regardless
of where the test was performed.
State oversight of clinical labs is administered by the
California Department of Public Health's (DPH's) Laboratory
Field Services (LFS), which regulates clinical labs and their
personnel statewide, monitors proficiency testing,
investigates complaints, and sanctions labs that violate the
law or regulations. LFS provides licensing, registration, and
certification services for clinical laboratory facilities,
blood banks, tissue banks and the testing personnel who
perform professional pre-analytical, analytical, and post
analytical testing services for these facilities.
In conformity with CLIA, DPH licenses or registers clinical
labs according to the complexity of the tests they perform.
Labs must be licensed for moderately or highly complex
procedures, and registered for low complexity.
This bill deals specifically with tests that are "waived", or
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exempt from regulatory oversight, because they are approved by
the FDA for home use, utilize simple and accurate methods that
make the possibility of error negligible, or pose no
significant risk of harm to the patient if incorrectly
performed. These "waived" tests are to be used by DCs for a
specific medical examination necessary for individuals seeking
a commercial motor vehicle license.
4)National Registry of Certified Medical Examiners . The
majority of commercial motor vehicles drivers are required to
meet DOT requirements which include obtaining a valid medical
certificate. In an effort to provide a consistent and uniform
standard for the medical evaluations, DOT set the guidelines
for the medical personnel that are authorized to perform these
types of examinations. In 2012, the Federal Motor Coach Safety
Administration (FMCSA) established the National Registry to
provide uniform requirements that all medical examiners who
conduct physical examinations for interstate commercial motor
vehicle drivers must meet.
Following establishment of the National Registry and a
transition period, FMCSA will require that motor carriers and
drivers seeking a medical examination to use only those
medical examiners on the National Registry, and it will only
accept as valid those medical examiner's certificates issued
by medical examiners listed on the National Registry. The new
requirements are scheduled to go into effect on May 21, 2014.
Until that time, it is unclear how may DCs in California will
be certified on the new National Registry.
There are numerous components to the medical certification
including vision, hearing, blood pressure, physical
examination, and certain laboratory tests which include
"specific gravity, protein, blood and glucose" testing
through the administration of a dipstick test. This bill
would authorize DCs to perform a specific dipstick test (as a
CLIA waived test) without the requirement of becoming a
clinical laboratory director. In order to be licensed,
clinical laboratory directors are required to meet certain
educational standards and satisfy examination requirements,
in addition to paying a fee.
The National Registry authorizes DCs along with other health
care professionals including, but not limited to, Doctors of
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Osteopathy, Medical Doctors, Nurse Practitioners, and
Physician Assistants to register as certified medical
examiners. However, according to the author and the sponsor,
DCs are the only medical professionals on the certification
list who are not authorized to perform the required dipstick
test. This means that individuals seeking a medical
evaluation from a DC will need to take the dipstick test
separately which could potentially increase the cost and delay
the examination process.
This bill would authorize DCs to perform the dipstick test
only, as a certified provider on the National Registry. This
bill also specifies that if a DC receives an abnormal finding,
the DC must refer the applicant to his or her primary care
physician. This bill does not authorize a DC to administer
the dipstick test for any reason other than performing the
specified medical examination as prescribed by DOT.
5)Arguments in support . The California Chiropractic Association
writes in support, "This measure would exempt [DCs] listed on
the federal [DOT, NRCME] from the requirement of using or
becoming a laboratory director in order to obtain a CLIA
certificate of waiver of which is necessary in order to
perform required urine dipstick tests for DOT commercial
drivers' license medical examination. [DCs] perform
commercial drivers' license medical examinations and
pre-employment physicals. As with every other health care
provider conducting the examinations and physicals, [DCs]
should be provided a CLIA Waiver for the necessary urine
dipstick tests."
6)Previous legislation . AB 1215 (Hagman), Chapter 199, Statutes
of 2013, expands the definition of "laboratory director" to
include a duly licensed clinical laboratory scientist and a
duly licensed limited clinical laboratory scientist and
authorizes these individuals to perform the duties and
responsibilities of a waived laboratory director, as
specified, under CLIA.
SB 1481 (Negrete McLeod), Chapter 874, Statutes of 2012,
exempts a community pharmacy which solely provides CLIA-waived
tests from the clinical laboratory regulations requiring that
the pharmacy hire a laboratory director who is a licensed
physician. This bill requires that the CLIA-waived test be
administered by a pharmacist in the course of performing
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routine patient assessment procedures, and also requires the
pharmacy to obtain a Certificate of Waiver from the DPH and
comply with all CLIA requirements. SB 1481 exempts a
pharmacist from state laboratory licensing requirements if the
pharmacist only performs CLIA-waived tests.
AB 761 (Roger Hernández) of 2011 would have allowed
optometrists to independently perform waived clinical
laboratory tests if the results can be used within the
optometrist's scope of practice, as specified. This bill was
held in the Assembly Business, Professions and Consumer
Protection Committee.
AB 1328 (Pan) of 2011 would have allowed DPH to issue a
clinical laboratory scientist's license to an applicant who
completes at least two years of full-time employment as a
clinical laboratory scientist at a CLIA certified laboratory,
who possesses a baccalaureate or an equivalent or higher
degree from an accredited institution, and who passes a
national examination approved by DPH, subject to the payment
of a licensing fee. This bill was held in the Assembly
Business, Professions and Consumer Protection Committee.
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.
7)Double-referral . This bill was heard by the Assembly Health
Committee on April 22, 2014, and approved by a (19-0) vote.
REGISTERED SUPPORT / OPPOSITION :
Support
California Chiropractic Association
Opposition
None on file.
Analysis Prepared by : Elissa Silva / B.,P. & C.P. / (916)
319-3301
AB 2143
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