Do Chiropractors Need a CLIA Waived Lab Certificate?

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.

A mini-course on obtaining your CLIA certificate is included in our DOT Mentor Course

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

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, the Doctor of Chiropractic should be provided a CLIA Waiver for the necessary urine dipstick tests. However, without a CLIA waiver, commercial driver’s 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 involves extra time and expense and possibly delays the completion of the required examination; therefore creating an extra barrier to employment.”
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Support and Position:

Support:
California Chiropractic Association (Sponsor)

Opposition:
None were received as of June 18, 2014.
Consultant:Le Ondra Clark, Ph.D.