BILL ANALYSIS Ó
AB 2143
Page 1
Date of Hearing: April 22, 2014
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
AB 2143 (Williams) - As Amended: March 28, 2014
SUBJECT : Clinical laboratories: chiropractors.
SUMMARY : Allows doctors of chiropractic (D.C.) to perform
specified laboratory (lab) tests as part of the qualifications
examinations for commercial drivers. Specifically, this bill :
1)Provides a waiver for D.C.s from state requirements for clinical
labs when performing specified tests, provided the D.C.s are
on the federal Department of Transportation (DOT) national
registry of examiners for administering tests for
qualification examinations for commercial drivers.
2)Provides the waiver is valid only for those D.C.s who are listed
on the National Registry of Certified Medical Examiners for
the purpose of completing the Department of Motor Vehicles
medical examination report for commercial drivers.
3)Provides the waiver is valid only for specific tests, namely
urine specific gravity, urine protein, urine blood, and urine
sugar tests that are classified as waived clinical lab tests
under the federal Clinical Laboratory Improvement Amendments
(CLIA) of 1988.
4)Requires a D.C. to obtain a waiver and comply with all applicable
requirements for performing waived lab tests.
5)Requires the D.C. to refer an applicant who has an abnormal
reading to the applicant's primary care physician.
EXISTING STATE LAW :
1)Requires a clinical lab that performs tests of moderate or high
complexity to be licensed by the Department of Public Health
(DPH). Requires a clinical lab that performs "waived tests,"
which are tests of low complexity, to be registered, rather
than licensed, by DPH.
2)Prohibits anyone from performing a clinical lab test or
examination classified as waived under CLIA, unless the
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clinical lab test or examination is performed under the
overall operation and administration of the lab director, and
the test is performed by specified persons, including
physicians and surgeons, podiatrists, dentists, physician
assistants, or respiratory care practitioners.
EXISTING FEDERAL LAW :
1)Establishes CLIA, which regulates clinical labs that perform
tests on human specimens and sets standards for facility
administration, personnel qualifications and quality control.
These standards apply to all lab settings, including
commercial, hospital or physician office labs.
2)Defines CLIA waived tests as simple lab examinations and
procedures that are approved by the Food and Drug
Administration (FDA) for home use, employ methodologies that
are simple, and have a low risk of rendering erroneous results
or pose a small risk of harm to the patient if the test is
performed incorrectly.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill
grants D.C.s who meet federal requirements the CLIA waiver so
they can perform specified waived tests. The author argues
the bill contains safeguards because it requires applicants to
be referred to their primary care physicians should the urine
dipstick test return an abnormal result. The author concludes
this bill will help fill the impending shortage of providers
and reduce delays for those commercial drivers' license
holders who choose to have a D.C. perform their physical.
2)BACKGROUND . Waived tests include test systems cleared by the
FDA for home use and those tests approved for waiver under the
CLIA criteria. Although CLIA requires that waived tests must
be simple and have a low risk for erroneous results, this does
not mean that waived tests are completely error-proof. FDA
states some waived tests have potential for serious health
impacts if performed incorrectly and to decrease the risk of
erroneous results, the test needs to be performed correctly,
by trained personnel and in an environment where good lab
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practices are followed. Errors can occur anywhere in the
testing process, particularly when the manufacturer's
instructions are not followed and when testing personnel are
not familiar with all aspects of the test system.
Waived tests include dipstick or tablet reagent urinalysis (used
to test glucose, hemoglobin, and protein, among other things);
fecal occult blood; ovulation tests; urine pregnancy tests;
and, blood glucose by glucose monitoring devices cleared by
the FDA specifically for home use. Amendments adopted for
CLIA state that tests approved by the FDA for home use
automatically qualify for CLIA waiver. Professional use
versions of home use tests are not automatically waived.
However, such professional versions do qualify for expedited
waiver review since the only differences between the home use
and professional use versions need to be examined to determine
whether the professional version qualifies for waiver.
3)CLINICAL LAB REGULATION . California clinical labs are subject
to both federal and state oversight. Congress passed CLIA in
1988, which established quality standards for all lab testing
to ensure the accuracy, reliability, and timeliness of patient
test results, regardless of where the test was performed.
CLIA regulates clinical labs based on the complexity (low,
moderate, or high) of the tests offered. 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. DPH provides
licensing, registration, and certification services for
clinical lab 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
procedures, including waived tests. 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.
4)FEDERAL REGULATION OF COMMERCIAL DRIVERS . Most commercial
motor vehicle drivers must meet DOT requirements. Among the
requirements, commercial drivers must obtain a valid medical
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certificate. DOT establishes requirements for healthcare
professionals that perform physical qualification examinations
for interstate commercial drivers. The federal requirements
have been strengthened recently in an effort to improve
medical oversight of commercial drivers and lessen the chances
of commercial motor vehicle-related crashes, injuries, and
fatalities. This new effort was in response to findings from
the National Transportation Safety Board that their crash
investigations indicate that improper medical certification of
commercial drivers was directly contributing to both fatal and
injury crashes.
The new strengthened program creates a National Registry of
Certified Medical Examiners. The new programs requires all
medical examiners (M.E.s) who want to perform physical
examinations for interstate commercial motor vehicle drivers
to be trained and certified in DOT physical qualification
standards. M.E.s that have completed the training and
successfully passed the test are included in an online
directory. All M.E.s must be licensed, certified and/or
registered, in accordance with applicable state laws and
regulations, to perform physical examinations. M.Es include,
but are not limited to, doctors of medicine, doctors of
osteopathy, physician assistants, advanced practice nurses,
and D.C.s. The federal program requires M.E.s to be
knowledgeable of the specific physical and mental demands
associated with operating a commercial motor vehicle and the
specific requirements of federal guidelines. The new
requirements go into effect on May 21, 2014.
5)SUPPORT . According to the California Chiropractic
Association, the bill's sponsor, D.C.s perform commercial
driver's license medical examinations and pre-employment
physicals. As with every other health care provider
conducting the exams and physicals, the D.C.s should be
provided a CLIA waiver for the necessary urine dipstick tests.
They note that without this bill, commercial drivers license
holders who choose a D.C. to perform their required medical
examination will have to make a separate appointment with a
lab to get the urine dipstick performed, the test will require
additional expense, and delay which will be barriers to
employment.
6)PREVIOUS LEGISLATION .
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a) AB 1215 (Hagman), Chapter 199, Statutes of 2013, expands
the definition of lab director to include licensed clinical
lab scientists and limited clinical lab scientists and
authorizes these individuals to perform the duties and
responsibilities of a waived lab director under CLIA.
b) SB 1481 (Negrete McLeod), Chapter 874, Statutes of 2012,
allows pharmacists to perform specific CLIA waived tests
without the supervision of a lab director provided the
pharmacist is reading results from a test cleared for home
use and the pharmacists complies with all other lab
requirements.
c) AB 761 (Roger Hernández), Chapter 714, Statutes of 2012,
includes a licensed optometrist in the definition of lab
director and authorizes a licensed optometrist to perform
CLIA waived tests, as necessary for the diagnosis of
conditions and disease of the eye, as specified.
d) SB 1246 (Negrete McLeod), Chapter 523, Statutes of 2010,
includes naturopathic doctors in the list of health care
practitioners who can perform a clinical lab test or
examination classified as waived under CLIA, and designates
naturopathic doctors as clinical lab directors for CLIA
waived tests only.
e) SB 1174 (Polanco), Chapter 640, Statutes of 2001,
exempts certified emergency medical technicians and
licensed paramedics providing life support who perform only
CLIA-waived blood glucose tests from state law governing
the licensure and regulation of clinical labs, as
specified.
7)POLICY ISSUE. There has been recent legislation allowing
health care professionals to administer specified waived lab
tests, including optometrists and naturopathic doctors.
Although authorization was granted to perform these tests, the
health care professional was named as lab director and
required to comply with existing law regulating labs and lab
directors. Requiring the health care professional to be lab
director means they assume responsibility for the clinical lab
and the training and competency of any staff. Recent
legislation regarding pharmacists was handled somewhat
differently, the pharmacists was authorized to read tests, as
specified, was not made a laboratory director but had to
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comply with other laws and regulations for labs. This bill
represents a third approaching to address the issue, the bills
exempts D.C.s from being a lab director or complying with
state laws and regulations for labs. A policy issue the
Legislature may want to address at some point is how best to
regulate and oversee testing, especially with the growth in
waived tests that are very similar to home tests that
consumers can use.
8)DOUBLE REFERRAL . This bill has been double referred, if it
passes out of this Committee it will be referred to the
Assembly Business, Professions and Consumer Protection
Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
California Chiropractic Association (sponsor)
Opposition
None on file.
Analysis Prepared by : Roger Dunstan / HEALTH / (916) 319-2097