AB 2143,
as amended, Williams. begin deleteHealing arts. end deletebegin insertClinical laboratories: chiropractors.end insert
Under existing law, the State Department of Public Health licenses and regulates clinical laboratories and certain clinical laboratory personnel performing clinical laboratory tests or examinations, subject to certain exceptions, including individuals who perform clinical laboratory tests or examinations approved by the federal Food and Drug Administration for sale as an over-the-counter test kit. Under the Chiropractic Act, enacted by an initiative measure, the State Board of Chiropractic Examiners licenses and regulates chiropractors.
end insertbegin insertThis bill would exempt chiropractors listed on the federal Department of Transportation National Registry of Certified Medical Examiners who perform urine specific gravity, urine protein, urine blood, and urine sugar tests as those tests relate to the National Registry of Certified Medical Examiners, as adopted by the United States Department of Transportation, that are classified as waived clinical laboratory tests under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the sole purpose of completing the Department of Motor Vehicles 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. The bill would require a chiropractor who receives an abnormal finding, to refer the applicant to the applicant’s primary care physician and surgeon.
end insertExisting law provides for the licensure and regulation of various healing arts professions and vocations by boards within the Department of Consumer Affairs. Existing law generally prohibits a healing arts board or examining committee within the Department of Consumer Affairs from requiring, by regulation, an applicant for licensure or certification to be a member of, to be certified by, to be eligible to be certified or registered by, or otherwise meet the standards of a specified private voluntary association or professional society.
end deleteThis bill would make a technical, nonsubstantive change to these provisions.
end deleteVote: majority.
Appropriation: no.
Fiscal committee: begin deleteno end deletebegin insertyesend insert.
State-mandated local program: no.
The people of the State of California do enact as follows:
begin insertSection 1241 of the end insertbegin insertBusiness and Professions
2Codeend insertbegin insert is amended to read:end insert
(a) This chapter applies to all clinical laboratories in
4California or receiving biological specimens originating in
5California for the purpose of performing a clinical laboratory test
6or examination, and to all persons performing clinical laboratory
7tests or examinations or engaging in clinical laboratory practice
8in California or on biological specimens originating in California,
9except as provided in subdivision (b).
10(b) This chapter shall not apply to any of the following clinical
11laboratories, or to persons performing clinical laboratory tests or
12examinations in any of the following clinical laboratories:
13(1) Those owned and operated by the United States
of America,
14or any department, agency, or official thereof acting in his or her
15official capacity to the extent that the Secretary of the federal
16Department of Health and Human Services has modified the
17application of CLIA requirements to those laboratories.
18(2) Public health laboratories, as defined in Section 1206.
19(3) Those that perform clinical laboratory tests or examinations
20for forensic purposes only.
P3 1(4) Those that perform clinical laboratory tests or examinations
2for research and teaching purposes only and do not report or use
3patient-specific results for the diagnosis, prevention, or treatment
4of any disease or impairment of, or for the assessment of the health
5of, an individual.
6(5) Those that perform clinical laboratory tests or examinations
7
certified by the National Institutes on Drug Abuse only for those
8certified tests or examinations. However, all other clinical
9laboratory tests or examinations conducted by the laboratory are
10subject to this chapter.
11(6) Those that register with the State Department of Healthbegin insert Careend insert
12 Services pursuant to subdivision (c) to perform blood glucose
13testing for the purposes of monitoring a minor child diagnosed
14with diabetes if the person performing the test has been entrusted
15with the care and control of the child by the child’s parent or legal
16guardian and provided that all of the following occur:
17(A) The blood glucose monitoring test is performed with a blood
18glucose monitoring instrument that has been approved by the
19federal Food and Drug Administration for sale over the counter
to
20the public without a prescription.
21(B) The person has been provided written instructions by the
22child’s health care provider or an agent of the child’s health care
23provider in accordance with the manufacturer’s instructions on the
24proper use of the monitoring instrument and the handling of any
25lancets, test strips, cotton balls, or other items used during the
26process of conducting a blood glucose test.
27(C) The person, receiving written authorization from the minor’s
28parent or legal guardian, complies with written instructions from
29the child’s health care provider, or an agent of the child’s health
30care provider, regarding the performance of the test and the
31operation of the blood glucose monitoring instrument, including
32how to determine if the results are within the normal or therapeutic
33range for the child, and any restriction on activities or diet that
34may be necessary.
35(D) The person complies with specific written instructions from
36the child’s health care provider or an agent of the child’s health
37care provider regarding the identification of symptoms of
38hypoglycemia or hyperglycemia, and actions to be taken when
39 results are not within the normal or therapeutic range for the child.
40The instructions shall also contain the telephone number of the
P4 1child’s health care provider and the telephone number of the child’s
2parent or legal guardian.
3(E) The person records the results of the blood glucose tests and
4provides them to the child’s parent or legal guardian on a daily
5basis.
6(F) The person complies with universal precautions when
7performing the testing and posts a list of the universal precautions
8in a prominent place within the proximity where the test is
9conducted.
10(7) Those individuals who perform clinical laboratory tests or
11examinations, approved by the federal Food and Drug
12Administration for sale to the public without a prescription in the
13form of an over-the-counter test kit, on their own bodies or on their
14minor children or legal wards.
15(8) Those certified emergency medical technicians and licensed
16paramedics providing basic life support services or advanced life
17support services as defined in Section 1797.52 of the Health and
18Safety Code who perform only blood glucose tests that are
19classified as waived clinical laboratory tests under CLIA, if the
20provider of those services obtains a valid certificate of waiver and
21complies with all other requirements for the performance of waived
22clinical laboratory tests under applicable federal regulations.
23(9) Those doctors of chiropractic listed on the most current
24federal Department of Transportation National Registry of
25Certified Medical Examiners that perform urine specific gravity,
26urine protein, urine blood, and urine sugar tests as those tests
27relate to the National Registry of Certified Medical Examiners, as
28adopted by the United States Department of Transportation, as
29published by the notice in the Federal Register, Volume 77, Number
3077, Friday, April 20, 2012, on pages 24104 to 24135, inclusive,
31and pursuant to Section 391.42 of Title 49 of the Code of Federal
32Regulations, that are classified as waived clinical laboratory tests
33under CLIA for the sole purpose of completing the Department of
34Motor Vehicles Medical Examination Report, if the doctor of
35chiropractic obtains a valid certificate of waiver and complies
36with all other requirements for the performance of waived clinical
37laboratory tests under applicable federal regulations. If a doctor
38of chiropractic receives an abnormal
finding, the doctor of
39chiropractic shall refer the applicant to the applicant’s primary
40care physician.
P5 1(c) Any place where blood glucose testing is performed pursuant
2to paragraph (6) of subdivision (b) shall register by notifying the
3State Department of Healthbegin insert Careend insert Services in writing no later than
430 days after testing has commenced. Registrants pursuant to this
5subdivision shall not be required to pay any registration or renewal
6fees nor shall they be subject to routine inspection by the State
7Department of Healthbegin insert Careend insert Services.
Section 850 of the Business and Professions Code
9 is amended to read:
No healing arts licensing board or examining committee
11within the Department of Consumer Affairs shall by regulation
12require an applicant for licensure or certification to be a member
13of, to be certified by, to be eligible to be certified or registered by,
14or otherwise meet the standards of a specified private voluntary
15association or professional society except as provided for in this
16article.
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