I was at a chiropractic board meeting yesterday and one of the doctors stated that we all had to have a CLIA waiver to perform Dip Stix urine test in our office or to collect urine to send it out to a lab.


I understand CLIA works with labs such as Quest, Lab Corp etc, but do private doctors need a CLIA waiver to perform drug test in the office or urine dip stix test for blood, glucose and protein in the office.

CLIA requires every facility that tests human specimens for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of a human being to meet certain Federal requirements.
If your facility performs tests for these purposes, it is considered, under the law, to be a laboratory.

Facilities only collecting or preparing specimens (or both) or only serving as a mailing service are not considered laboratories. CLIA does not apply to a facility that only performs forensic testing.

CLIA applies even if only one or a few basic tests are performed, and even if you are not charging for testing. In addition the CLIA legislation requires financing of all regulatory costs through fees assessed to affected facilities.

NOTE: WAIVED TESTS ARE NOT EXEMPT FROM CLIA. FACILITIES PERFORMING ONLY THOSE TESTS CATEGORIZED AS WAIVED MUST APPLY FOR A CLIA CERTIFICATE OF WAIVER.
CA Chiro DOT CLIA law (see highlighted areas)

https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201320140AB2143

https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201320140AB2143

BILL ANALYSIS Ó

———————————————————————–
|Hearing Date:June 23, 2014 |Bill No:AB |
| |2143 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Ted W. Lieu, Chair

Bill No: AB 2143Author:Williams
As Amended:May 27, 2014 Fiscal: Yes

SUBJECT: Clinical laboratories: chiropractors. (Urgency)

SUMMARY: Exempts chiropractors listed on the federal Department of
Transportation National Registry of Certified Medical Examiners, who
perform specific waived clinical laboratory tests for the sole purpose
of completing the Department of Motor Vehicles medical examination
report, if they obtain a valid certificate of waiver, for the
performance of waived clinical laboratory tests. Requires a
chiropractor who receives an abnormal finding to refer the applicant
to the their primary care physician.

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.
(Business and Professions Code (BPC) § 1000 et seq.).

2)Defines “CLIA” to mean the federal Clinical Laboratory Improvement
Amendments of 1988. (BPC § Section 1202.5)

3)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 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

 

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non-diagnostic tests for assessing the health of an individual.
(BPC § 1206 (a)(5))

4)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))

5)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)

6)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)

This bill:

1) Exempts chiropractors listed on the federal Department of
Transportation (DOT) National Registry of Certified Medical
Examiners (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 United States DOT, that are
classified as waived clinical laboratory tests under CLIA for the
sole purpose of completing the Department of Motor Vehicles (DMV)
medical examination report, if the chiropractor obtains a valid
certificate of waiver and complies with all other requirements for
the performance of 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.

3) Declares that this measure is to take effect immediately as an
urgency statute.

 

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FISCAL EFFECT: According the May 14, 2014 Assembly Appropriations
Committee analysis, this bill would result in potential minor revenue
loss to the Department of Public Health Laboratory Field Services, if
individuals no longer choose to register as CLIA-waived labs as a
result of this bill’s exemption.

COMMENTS:

1.Purpose. This bill is sponsored by the California Chiropractic
Association . 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 DOT medical examination for commercial
drivers’ license holders. In fact, doctors of chiropractic are the
only providers on the National Registry 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.”

2.Background.

a) Federal Clinical Laboratory Improvement Amendments of 1988
(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.

b) 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 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

 

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rate-non-automated; 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
would permit chiropractors listed on the federal Department of
Transportation National Registry of Certified Medical Examiners
to perform a urine dipstick test for the sole purpose of
completing the Department of Motor Vehicles medical examination
report.

c) 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.
(CCR Title 17 § 1039.2 (a)).

This bill would grant chiropractors the CLIA waiver.

3.Prior Related Legislation. AB 1215 (Hagman, Chapter 199, Statutes
of 2013) expanded the definition of “laboratory director” to include
a duly licensed clinical laboratory scientist and a duly licensed
limited clinical laboratory scientist and authorized 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) exempted
community pharmacies which solely provided CLIA-waived tests from
the clinical laboratory regulations requiring that the pharmacy
hire a laboratory director who is a licensed physician. This bill
required that the CLIA-waived test be administered by a pharmacist
in the course of performing routine patient assessment procedures,
and also requires the pharmacy to obtain a Certificate of Waiver
from the DPH and comply with all CLIA requirements. This measure
also exempted a pharmacist from state laboratory licensing
requirements if the pharmacist only performed 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. ( Status : 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

 

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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. ( Status: This bill was
held in the Assembly Business, Professions and Consumer Protection
Committee.)

SB 1246 (Negrete McLeod, Chapter 523, Statutes of 2010) included
naturopathic doctors in the list of health care practitioners who
can perform a clinical laboratory test or examination classified as
waived under CLIA, and designated naturopathic doctors as clinical
laboratory directors for CLIA waived tests only.

SB 585 (Chesbro, Chapter 70, Statutes of 1999) permitted a
certified nurse midwife, a licensed nurse practitioner, a licensed
physician assistant acting under the supervision of a licensed
physician, or a licensed dentist to perform clinical laboratory
examinations classified as provider-performed microscopy under the
federal CLIA of 1988.

SB 366 (Maddy, Chapter 1141, Statutes of 1994) extended the
exemption from state clinical laboratory laws to facilities owned
and operated by a partnership or professional corporation of five
or fewer physicians and surgeons or podiatrists. The exemption
applies only if the clinical laboratory tests or examinations are
performed for the patients of the physician, podiatrist,
partnership or a professional corporation. This law repealed the
exemption upon U.S. Department of Health and Human Services
recognition of California’s conformity with the requirements of
federal CLIA of 1988.

4.Arguments in Support. The California Chiropractic Association as
the sponsors of this measure 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.”

 

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SUPPORT AND OPPOSITION:

Support:

California Chiropractic Association (Sponsor)

Opposition:

None received as of June 18, 2014.

Consultant:Le Ondra Clark, Ph.D.