Amended in Senate August 16, 2016

Amended in Senate June 22, 2016

Amended in Assembly April 14, 2016

Amended in Assembly March 30, 2016

Amended in Assembly March 28, 2016

California Legislature—2015–16 Regular Session

Assembly BillNo. 2179


Introduced by Assembly Member Gipson

February 18, 2016


An act to amend Section 1206.5 of the Business and Professions Code, and to add Section 122440 to the Health and Safety Code, relating to public health.

LEGISLATIVE COUNSEL’S DIGEST

AB 2179, as amended, Gipson. Hepatitis C testing.

Under existing law, the State Department of Public Health licenses, registers, and regulates clinical laboratories and various clinical laboratory personnel. Existing law prohibits a person from performing a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 unless the test or examination is performed under the overall operation and administration of a laboratory director and the test or examination is performed by any one of specified professionals and others, including a licensed physician and surgeon or pharmacist. Existing law establishes the Office of AIDS in the department and defines human immunodeficiency virus (HIV) as the etiologic agent of acquired immunodeficiency syndrome (AIDS). Existing law authorizes an HIV counselor who receives specified training and works in specified counseling and testing sites to perform HIV, hepatitis C virus (HCV), or combined HIV/HCV tests, including performing skin punctures for purposes of withdrawing blood for purposes of these tests, as specified.

This bill would authorize a hepatitis C counselor whobegin delete receives specified training and works in described counseling and testing sites to perform HCV tests, andend deletebegin insert meets specified requirements to perform an HCV test and to order and report HCV test results. The bill would authorize the State Department of Public Health to implement and administer these provisions by means of a bulletin or similar instructions. The bill would alsoend insert add hepatitis C counselors performingbegin delete those tests to the specified professionals and others referred to above.end deletebegin insert an HCV test to the list of professionals authorized to perform a test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988, as specified.end insert

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

P2    1

SECTION 1.  

Section 1206.5 of the Business and Professions
2Code
is amended to read:

3

1206.5.  

(a) Notwithstanding subdivision (b) of Section 1206
4and except as otherwise provided in Sections 1206.6 and 1241, no
5person shall perform a clinical laboratory test or examination
6classified as waived under CLIA unless the clinical laboratory test
7or examination is performed under the overall operation and
8administration of the laboratory director, as described in Section
91209, including, but not limited to, documentation by the laboratory
10director of the adequacy of the qualifications and competency of
11the personnel, and the test is performed by any of the following
12persons:

13(1) A licensed physician and surgeon holding an M.D. or D.O.
14degree.

15(2) A licensed podiatrist, a licensed dentist, or a licensed
16naturopathic doctor, if the results of the tests can be lawfully
17utilized within his or her practice.

18(3) A person licensed under this chapter to engage in clinical
19laboratory practice or to direct a clinical laboratory.

P3    1(4) A person authorized to perform tests pursuant to a certificate
2issued under Article 5 (commencing with Section 101150) of
3Chapter 2 of Part 3 of Division 101 of the Health and Safety Code.

4(5) A licensed physician assistant if authorized by a supervising
5physician and surgeon in accordance with Section 3502 or 3535.

6(6) A person licensed under Chapter 6 (commencing with
7Section 2700).

8(7) A person licensed under Chapter 6.5 (commencing with
9Section 2840).

10(8) A perfusionist if authorized by and performed in compliance
11with Section 2590.

12(9) A respiratory care practitioner if authorized by and
13performed in compliance with Chapter 8.3 (commencing with
14Section 3700).

15(10) A medical assistant, as defined in Section 2069, if the
16waived test is performed pursuant to a specific authorization
17meeting the requirements of Section 2069.

18(11) A pharmacist, as defined in Section 4036, if ordering drug
19therapy-related laboratory tests in compliance with paragraph (2)
20of subdivision (a) of Section 4052.1 or paragraph (2) of subdivision
21(a) of Section 4052.2, or if performing skin puncture in the course
22 of performing routine patient assessment procedures in compliance
23with Section 4052.1.

24(12) A naturopathic assistant, as defined in Sections 3613 and
253640.2, if the waived test is performed pursuant to a specific
26authorization meeting the requirements of Sections 3613 and
273640.2.

28(13) A licensed optometrist as authorized under Chapter 7
29(commencing with Section 3000).

30(14) Other health care personnel providing direct patient care.

31(15) Any other person performing nondiagnostic testing pursuant
32to Section 1244.

33(16) A hepatitis C counselor performing a hepatitis C virus
34(HCV) test pursuant to Section 122440 of the Health and Safety
35Code.

36(b) Notwithstanding subdivision (b) of Section 1206, no person
37shall perform clinical laboratory tests or examinations classified
38as of moderate complexity under CLIA unless the clinical
39laboratory test or examination is performed under the overall
40operation and administration of the laboratory director, as described
P4    1in Section 1209, including, but not limited to, documentation by
2the laboratory director of the adequacy of the qualifications and
3competency of the personnel, and the test is performed by any of
4the following persons:

5(1) A licensed physician and surgeon holding an M.D. or D.O.
6 degree.

7(2) A licensed podiatrist or a licensed dentist if the results of
8the tests can be lawfully utilized within his or her practice.

9(3) A person licensed under this chapter to engage in clinical
10laboratory practice or to direct a clinical laboratory.

11(4) A person authorized to perform tests pursuant to a certificate
12issued under Article 5 (commencing with Section 101150) of
13Chapter 2 of Part 3 of Division 101 of the Health and Safety Code.

14(5) A licensed physician assistant if authorized by a supervising
15physician and surgeon in accordance with Section 3502 or 3535.

16(6) A person licensed under Chapter 6 (commencing with
17Section 2700).

18(7) A perfusionist if authorized by and performed in compliance
19with Section 2590.

20(8) A respiratory care practitioner if authorized by and
21performed in compliance with Chapter 8.3 (commencing with
22Section 3700).

23(9) A person performing nuclear medicine technology if
24authorized by and performed in compliance with Article 6
25(commencing with Section 107150) of Chapter 4 of Part 1 of
26Division 104 of the Health and Safety Code.

27(10) Any person if performing blood gas analysis in compliance
28with Section 1245.

29(11) (A) A person certified or licensed as an “Emergency
30Medical Technician II” or paramedic pursuant to Division 2.5
31(commencing with Section 1797) of the Health and Safety Code
32while providing prehospital medical care, a person licensed as a
33psychiatric technician under Chapter 10 (commencing with Section
344500) of Division 2, as a vocational nurse pursuant to Chapter 6.5
35(commencing with Section 2840), or as a midwife licensed pursuant
36to Article 24 (commencing with Section 2505) of Chapter 5, or
37 certified by the department pursuant to Division 5 (commencing
38with Section 70001) of Title 22 of the California Code of
39Regulations as a nurse assistant or a home health aide, who
40provides direct patient care, if the person is performing the test as
P5    1an adjunct to the provision of direct patient care by the person, is
2utilizing a point-of-care laboratory testing device at a site for which
3a laboratory license or registration has been issued, meets the
4minimum clinical laboratory education, training, and experience
5requirements set forth in regulations adopted by the department,
6and has demonstrated to the satisfaction of the laboratory director
7that he or she is competent in the operation of the point-of-care
8laboratory testing device for each analyte to be reported.

9(B) Prior to being authorized by the laboratory director to
10perform laboratory tests or examinations, testing personnel
11identified in subparagraph (A) shall participate in a preceptor
12program until they are able to perform the clinical laboratory tests
13or examinations authorized in this section with results that are
14deemed accurate and skills that are deemed competent by the
15preceptor. For the purposes of this section, a “preceptor program”
16means an organized system that meets regulatory requirements in
17which a preceptor provides and documents personal observation
18and critical evaluation, including review of accuracy, reliability,
19and validity, of laboratory testing performed.

20(12) Any other person within a physician office laboratory if
21the test is performed under the supervision of the patient’s
22physician and surgeon or podiatrist who shall be accessible to the
23laboratory to provide onsite, telephone, or electronic consultation
24as needed, and shall: (A) ensure that the person is performing test
25methods as required for accurate and reliable tests; and (B) have
26personal knowledge of the results of the clinical laboratory testing
27or examination performed by that person before the test results are
28reported from the laboratory.

29(13) A pharmacist, if ordering drug therapy-related laboratory
30tests in compliance with paragraph (2) of subdivision (a) of Section
314052.1 or paragraph (2) of subdivision (a) of Section 4052.2.

32(c) Notwithstanding subdivision (b) of Section 1206, no person
33shall perform clinical laboratory tests or examinations classified
34as of high complexity under CLIA unless the clinical laboratory
35test or examination is performed under the overall operation and
36administration of the laboratory director, as described in Section
371209, including, but not limited to, documentation by the laboratory
38director of the adequacy of the qualifications and competency of
39the personnel, and the test is performed by any of the following
40persons:

P6    1(1) A licensed physician and surgeon holding an M.D. or D.O.
2degree.

3(2) A licensed podiatrist or a licensed dentist if the results of
4the tests can be lawfully utilized within his or her practice.

5(3) A person licensed under this chapter to engage in clinical
6laboratory practice or to direct a clinical laboratory if the test or
7examination is within a specialty or subspecialty authorized by
8the person’s licensure.

9(4) A person authorized to perform tests pursuant to a certificate
10issued under Article 5 (commencing with Section 101150) of
11Chapter 2 of Part 3 of Division 101 of the Health and Safety Code
12if the test or examination is within a specialty or subspecialty
13authorized by the person’s certification.

14(5) A licensed physician assistant if authorized by a supervising
15physician and surgeon in accordance with Section 3502 or 3535.

16(6) A perfusionist if authorized by and performed in compliance
17with Section 2590.

18(7) A respiratory care practitioner if authorized by and
19performed in compliance with Chapter 8.3 (commencing with
20Section 3700).

21(8) A person performing nuclear medicine technology if
22authorized by and performed in compliance with Article 6
23(commencing with Section 107150) of Chapter 4 of Part 1 of
24Division 104 of the Health and Safety Code.

25(9) Any person if performing blood gas analysis in compliance
26with Section 1245.

27(10) Any other person within a physician office laboratory if
28the test is performed under the onsite supervision of the patient’s
29physician and surgeon or podiatrist who shall: (A) ensure that the
30person is performing test methods as required for accurate and
31reliable tests; and (B) have personal knowledge of the results of
32clinical laboratory testing or examination performed by that person
33before the test results are reported from the laboratory.

34(d) Clinical laboratory examinations classified as
35provider-performed microscopy under CLIA may be personally
36performed using a brightfield or phase/contrast microscope by one
37of the following practitioners:

38(1) A licensed physician and surgeon using the microscope
39during the patient’s visit on a specimen obtained from his or her
P7    1own patient or from a patient of a group medical practice of which
2the physician is a member or employee.

3(2) A nurse midwife holding a certificate as specified by Section
42746.5, a licensed nurse practitioner as specified in Section 2835.5,
5or a licensed physician assistant acting under the supervision of a
6physician pursuant to Section 3502 using the microscope during
7the patient’s visit on a specimen obtained from his or her own
8patient or from the patient of a clinic, group medical practice, or
9other health care provider of which the certified nurse midwife,
10licensed nurse practitioner, or licensed physician assistant is an
11employee.

12(3) A licensed dentist using the microscope during the patient’s
13visit on a specimen obtained from his or her own patient or from
14a patient of a group dental practice of which the dentist is a member
15or an employee.

16

SEC. 2.  

Section 122440 is added to the Health and Safety Code,
17to read:

18

122440.  

(a) A hepatitis C counselor who meets the
19requirements of subdivision (d) may do all of the following:

20(1) Perform any hepatitis C virus (HCV) test that is classified
21as waived under the federal Clinical Laboratory Improvement Act
22(CLIA) (42 U.S.C. Sec. 263a et seq.) if all of the following
23conditions exist:

24(A) The performance of the HCV test meets the requirements
25of CLIA and Chapter 3 (commencing with Section 1200) of
26Division 2 of the Business and Professions Code.

27(B) Notwithstanding Section 1246 of the Business and
28Professions Code, a hepatitis C counselor may perform skin
29punctures for the purpose of withdrawing blood for waived HCV
30testing, upon specific authorization from a licensed physician and
31surgeon, provided that the person meets both of the following
32requirements:

33(i) He or she works under the direction of a licensed physician
34and surgeon.

35(ii) He or she has been trained in rapid test proficiency for skin
36puncture blood tests and in universal infection control precautions,
37consistent with best infection control practices established by the
38Division of Occupational Safety and Health in the Department of
39Industrial Relations and the federal Centers for Disease Control
40and Prevention.

P8    1(C) The person performing the HCV test meets the requirements
2for the performance of waived laboratory testing pursuant to
3subdivision (a) of Section 1206.5 of the Business and Professions
4Code.

5(D) The patient is informed that the preliminary result of the
6test is indicative of the likelihood of HCV exposure and that the
7result must be confirmed by an additional more specific test, or,
8if approved by the federal Centers for Disease Control and
9Prevention for that purpose, a second, different rapid HCV test.
10This subdivision does not allow a hepatitis C counselor to perform
11any HCV test that is not classified as waived under CLIA.

12(2) Notwithstanding Section 1246.5 of the Business and
13Professions Code, order and report HCV test results from tests
14performed pursuant to paragraph (1) to patients without
15authorization from a licensed health care practitioner or his or her
16authorized representative. A patient who has an indeterminate or
17positive test result from tests performed pursuant to paragraph (1)
18shall be referred to a licensed health care practitioner whose scope
19of practice includes the authority to refer a patient for laboratory
20testing for further evaluation.

21(b) A hepatitis C counselor who meets the requirements of this
22section with respect to performing any HCV test that is classified
23as waived under CLIA may not perform any other test unless that
24person meets the statutory and regulatory requirements for
25performing that other test.

26(c) Compliance with this section does not fulfill any
27requirements for certification as a phlebotomy technician or a
28limited phlebotomy technician, unless the hepatitis C counselor
29has otherwise satisfied the certification requirements imposed
30pursuant to Section 1246 of the Business and Professions Code.

31(d) A hepatitis C counselor shall meet one of the following
32criteria:

begin delete

33(1) Is trained by the Office of AIDS and working in an HIV
34counseling and testing site funded by the department through a
35local health jurisdiction, or its agents.

end delete
begin insert

36
(1) Is authorized to perform an HCV test in accordance with
37paragraph (1) of subdivision (a) of Section 120917.

end insert

38(2) Is working inbegin delete an HIVend deletebegin insert a hepatitis Cend insert counseling and testing
39site that meets both of the following criteria:

P9    1(A) Utilizesbegin delete HIV counseling staffend deletebegin insert hepatitis C counselorsend insert who
2are trained by thebegin delete Office of AIDSend deletebegin insert State Department of Public
3Healthend insert
or its agents to providebegin delete both HIV counseling and testing
4andend delete
hepatitis C counseling and testing.begin insert For the purposes of this
5subparagraph, a training agent may include, but is not limited to,
6a local health department or its designee, an academic medical
7center, or a community-based organization.end insert

8(B) Has and retains a quality assurance planbegin delete approved by the
9local health department in the jurisdiction where the site is located
10and has HIVend delete
begin insert and has hepatitis Cend insert counseling and testing staff who
11comply with the quality assurancebegin delete requirements as specified by
12the State Department of Public Health.end delete
begin insert protocols and guidelines
13made available by the State Department of Public Health in
14accordance with Section 122410.end insert

begin delete

15(3) Is working at a site approved by the local health department
16to provide hepatitis C rapid testing and counseling, and has been
17trained using a curriculum approved by the local health department,
18and retained by the site, or approved by the State Department of
19Public Health, which, at a minimum, provides training in universal
20precautions, safe working conditions, proper running and reading
21of hepatitis C rapid test kit technology, and providing accurate
22information to clients including the importance of confirmatory
23tests, linkages to medical care, and the prevention of hepatitis C
24transmission.

end delete


O

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