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 tobegin insert amend Section 1206.5 of the Business and Professions Code, and toend insert 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.

begin delete

Existing

end delete

begin insert 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. Existingend insert law establishes the Office of AIDS in thebegin delete State Department of Public Healthend deletebegin insert departmentend insert 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 who receives specified training and works in described counseling and testing sites to perform HCVbegin delete tests.end deletebegin insert tests, and add hepatitis C counselors performing those tests to the specified professionals and others referred to above.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    1begin insert

begin insertSECTION 1.end insert  

end insert

begin insertSection 1206.5 of the end insertbegin insertBusiness and Professions
2Code
end insert
begin insert is amended to read:end insert

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 a 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.

20(4) A person authorized to perform tests pursuant to a certificate
21issued under Article 5 (commencing with Section 101150) of
22Chapter 2 of Part 3 of Division 101 of the Health and Safety Code.

23(5) A licensed physician assistant if authorized by a supervising
24physician and surgeon in accordance with Section 3502 or 3535.

25(6) A person licensed under Chapter 6 (commencing with
26Section 2700).

27(7) A person licensed under Chapter 6.5 (commencing with
28Section 2840).

P3    1(8) A perfusionist if authorized by and performed in compliance
2with Section 2590.

3(9) A respiratory care practitioner if authorized by and
4performed in compliance with Chapter 8.3 (commencing with
5Section 3700).

6(10) A medical assistant, as defined in Section 2069, if the
7waived test is performed pursuant to a specific authorization
8meeting the requirements of Section 2069.

9(11) A pharmacist, as defined in Section 4036, if ordering drug
10therapy-related laboratory tests in compliance with paragraph (2)
11of subdivision (a) of Section 4052.1 or paragraph (2) of subdivision
12(a) of Section 4052.2, or if performing skin puncture in the course
13of performing routine patient assessment procedures in compliance
14with Section 4052.1.

15(12) A naturopathic assistant, as defined in Sections 3613 and
163640.2, if the waived test is performed pursuant to a specific
17authorization meeting the requirements of Sections 3613 and
183640.2.

19(13) A licensed optometrist as authorized under Chapter 7
20(commencing with Section 3000).

21(14) Other health care personnel providing direct patient care.

22(15) Any other person performing nondiagnostic testing pursuant
23to Section 1244.

begin insert

24
(16) A hepatitis C counselor performing a hepatitis C virus
25(HCV) test pursuant to Section 122440 of the Health and Safety
26Code.

end insert

27(b) Notwithstanding subdivision (b) of Section 1206, no person
28shall perform clinical laboratory tests or examinations classified
29as of moderate complexity under CLIA unless the clinical
30laboratory test or examination is performed under the overall
31operation and administration of the laboratory director, as described
32in Section 1209, including, but not limited to, documentation by
33the laboratory director of the adequacy of the qualifications and
34competency of the personnel, and the test is performed by any of
35the following persons:

36(1) A licensed physician and surgeon holding a M.D. or D.O.
37degree.

38(2) A licensed podiatrist or a licensed dentist if the results of
39the tests can be lawfully utilized within his or her practice.

P4    1(3) A person licensed under this chapter to engage in clinical
2laboratory practice or to direct a clinical laboratory.

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

6(5) A licensed physician assistant if authorized by a supervising
7physician and surgeon in accordance with Section 3502 or 3535.

8(6) A person licensed under Chapter 6 (commencing with
9Section 2700).

10(7) A perfusionist if authorized by and performed in compliance
11with Section 2590.

12(8) A respiratory care practitioner if authorized by and
13performed in compliance with Chapter 8.3 (commencing with
14Section 3700).

15(9) A person performing nuclear medicine technology if
16authorized by and performed in compliance with Article 6
17(commencing with Section 107150) of Chapter 4 of Part 1 of
18Division 104 of the Health and Safety Code.

19(10) Any person if performing blood gas analysis in compliance
20with Section 1245.

21(11) (A) A person certified or licensed as an “Emergency
22Medical Technician II” or paramedic pursuant to Division 2.5
23(commencing with Section 1797) of the Health and Safety Code
24while providing prehospital medical care, a person licensed as a
25psychiatric technician under Chapter 10 (commencing with Section
264500) of Division 2, as a vocational nurse pursuant to Chapter 6.5
27(commencing with Section 2840), or as a midwife licensed pursuant
28to Article 24 (commencing with Section 2505) of Chapter 5, or
29 certified by the department pursuant to Division 5 (commencing
30with Section 70001) of Title 22 of the California Code of
31Regulations as a nurse assistant or a home health aide, who
32provides direct patient care, if the person is performing the test as
33an adjunct to the provision of direct patient care by the person, is
34utilizing a point-of-care laboratory testing device at a site for which
35a laboratory license or registration has been issued, meets the
36minimum clinical laboratory education, training, and experience
37requirements set forth in regulations adopted by the department,
38and has demonstrated to the satisfaction of the laboratory director
39that he or she is competent in the operation of the point-of-care
40laboratory testing device for each analyte to be reported.

P5    1(B) Prior to being authorized by the laboratory director to
2perform laboratory tests or examinations, testing personnel
3identified in subparagraph (A) shall participate in a preceptor
4program until they are able to perform the clinical laboratory tests
5or examinations authorized in this section with results that are
6deemed accurate and skills that are deemed competent by the
7preceptor. For the purposes of this section, a “preceptor program”
8means an organized system that meets regulatory requirements in
9which a preceptor provides and documents personal observation
10and critical evaluation, including review of accuracy, reliability,
11and validity, of laboratory testing performed.

12(12) Any other person within a physician office laboratory if
13the test is performed under the supervision of the patient’s
14physician and surgeon or podiatrist who shall be accessible to the
15laboratory to provide onsite, telephone, or electronic consultation
16as needed, and shall: (A) ensure that the person is performing test
17methods as required for accurate and reliable tests; and (B) have
18personal knowledge of the results of the clinical laboratory testing
19or examination performed by that person before the test results are
20reported from the laboratory.

21(13) A pharmacist, if ordering drug therapy-related laboratory
22tests in compliance with paragraph (2) of subdivision (a) of Section
234052.1 or paragraph (2) of subdivision (a) of Section 4052.2.

24(c) Notwithstanding subdivision (b) of Section 1206, no person
25shall perform clinical laboratory tests or examinations classified
26as of high complexity under CLIA unless the clinical laboratory
27test or examination is performed under the overall operation and
28administration of the laboratory director, as described in Section
291209, including, but not limited to, documentation by the laboratory
30director of the adequacy of the qualifications and competency of
31the personnel, and the test is performed by any of the following
32persons:

33(1) A licensed physician and surgeon holding a M.D. or D.O.
34degree.

35(2) A licensed podiatrist or a licensed dentist if the results of
36the tests can be lawfully utilized within his or her practice.

37(3) A person licensed under this chapter to engage in clinical
38laboratory practice or to direct a clinical laboratory if the test or
39examination is within a specialty or subspecialty authorized by
40the person’s licensure.

P6    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
4if the test or examination is within a specialty or subspecialty
5authorized by the person’s certification.

6(5) A licensed physician assistant if authorized by a supervising
7physician and surgeon in accordance with Section 3502 or 3535.

8(6) A perfusionist if authorized by and performed in compliance
9with Section 2590.

10(7) A respiratory care practitioner if authorized by and
11performed in compliance with Chapter 8.3 (commencing with
12Section 3700).

13(8) A person performing nuclear medicine technology if
14authorized by and performed in compliance with Article 6
15(commencing with Section 107150) of Chapter 4 of Part 1 of
16Division 104 of the Health and Safety Code.

17(9) Any person if performing blood gas analysis in compliance
18with Section 1245.

19(10) Any other person within a physician office laboratory if
20the test is performed under the onsite supervision of the patient’s
21physician and surgeon or podiatrist who shall: (A) ensure that the
22person is performing test methods as required for accurate and
23reliable tests; and (B) have personal knowledge of the results of
24clinical laboratory testing or examination performed by that person
25before the test results are reported from the laboratory.

26(d) Clinical laboratory examinations classified as
27provider-performed microscopy under CLIA may be personally
28performed using a brightfield or phase/contrast microscope by one
29of the following practitioners:

30(1) A licensed physician and surgeon using the microscope
31during the patient’s visit on a specimen obtained from his or her
32own patient or from a patient of a group medical practice of which
33the physician is a member or employee.

34(2) A nurse midwife holding a certificate as specified by Section
352746.5, a licensed nurse practitioner as specified in Section 2835.5,
36or a licensed physician assistant acting under the supervision of a
37physician pursuant to Section 3502 using the microscope during
38the patient’s visit on a specimen obtained from his or her own
39patient or from the patient of a clinic, group medical practice, or
40other health care provider of which the certified nurse midwife,
P7    1licensed nurse practitioner, or licensed physician assistant is an
2employee.

3(3) A licensed dentist using the microscope during the patient’s
4visit on a specimen obtained from his or her own patient or from
5a patient of a group dental practice of which the dentist is a member
6or an employee.

7

begin deleteSECTION 1.end delete
8
begin insertSEC. 2.end insert  

Section 122440 is added to the Health and Safety Code,
9to read:

10

122440.  

(a) A hepatitis C counselor who meets the
11requirements of subdivision (d) may do all of the following:

12(1) Perform any hepatitis C virus (HCV) test that is classified
13as waived under the federal Clinical Laboratory Improvement Act
14(CLIA) (42 U.S.C. Sec. 263a et seq.) if all of the following
15conditions exist:

16(A) The performance of the HCV test meets the requirements
17of CLIA and Chapter 3 (commencing with Section 1200) of
18Division 2 of the Business and Professions Code.

19(B) Notwithstanding Section 1246 of the Business and
20Professions Code, a hepatitis C counselor may perform skin
21punctures for the purpose of withdrawing blood forbegin insert waivedend insert HCV
22testing, upon specific authorization from a licensed physician and
23surgeon, provided that the person meets both of the following
24requirements:

25(i) He or she works under the direction of a licensed physician
26and surgeon.

27(ii) He or she has been trained in rapid test proficiency for skin
28puncture blood tests and in universal infection control precautions,
29consistent with best infection control practices established by the
30Division of Occupational Safety and Health in the Department of
31Industrial Relations and the federal Centers for Disease Control
32and Prevention.

33(C) The person performing the HCV test meets the requirements
34for the performance of waived laboratory testing pursuant to
35subdivision (a) of Section 1206.5 of the Business and Professions
36Code. For purposes of this subdivision and subdivision (a) of
37Section 1206.5 of the Business and Professions Code, a hepatitis
38C counselor who meets the requirements of subdivision (d) shall
39be “other health care personnel providing direct patient care” as
P8    1referred to in paragraph (13) of subdivision (a) of Section 1206.5
2of the Business and Professions Code.

3(D) The patient is informed that the preliminary result of the
4test is indicative of the likelihood of HCV exposure and that the
5result must be confirmed by an additional more specific test, or,
6if approved by the federal Centers for Disease Control and
7Prevention for that purpose, a second, different rapid HCV test.
8This subdivision does not allow a hepatitis C counselor to perform
9any HCV test that is not classified as waived under CLIA.

10(2) Notwithstanding Section 1246.5 of the Business and
11Professions Code, order and report HCV test results from tests
12performed pursuant to paragraph (1) to patients without
13authorization from a licensed health care practitioner or his or her
14authorized representative. A patient who has an indeterminate or
15positive test result from tests performed pursuant to paragraph (1)
16shall be referred to a licensed health care practitioner whose scope
17of practice includes the authority to refer a patient for laboratory
18testing for further evaluation.

19(b) A hepatitis C counselor who meets the requirements of this
20section with respect to performing any HCV test that is classified
21as waived under CLIA may not perform any other test unless that
22person meets the statutory and regulatory requirements for
23performing that other test.

24(c) Compliance with this section does not fulfill any
25requirements for certification as a phlebotomy technician or a
26limited phlebotomy technician, unless the hepatitis C counselor
27has otherwise satisfied the certification requirements imposed
28pursuant to Section 1246 of the Business and Professions Code.

29(d) A hepatitis C counselor shall meet one of the following
30criteria:

31(1) Is trained by the Office of AIDS and working in an HIV
32counseling and testing site funded by the department through a
33local health jurisdiction, or its agents.

34(2) Is working in an HIV counseling and testing site that meets
35both of the following criteria:

36(A) Utilizes HIV counseling staff who are trained by the Office
37of AIDS or its agents to provide both HIV counseling and testing
38and hepatitis C counseling and testing.

39(B) Hasbegin insert and retainsend insert a quality assurance plan approved by the
40local health department in the jurisdiction where the site is located
P9    1and has HIV counseling and testing staff who comply with the
2quality assurance requirements as specified by the State Department
3of Public Health.

4(3) Is working at a site approved by the local health department
5to provide hepatitis C rapid testing and counseling, and has been
6trained using a curriculum approved by the local healthbegin delete departmentend delete
7begin insert department, and retained by the site,end insert orbegin insert approved byend insert the State
8Department of Public Health, which, at a minimum, provides
9training in universal precautions, safe working conditions, proper
10running and reading of hepatitis C rapid test kit technology, and
11providing accurate information to clients including the importance
12of confirmatory tests, linkages to medical care, and the prevention
13of hepatitis C transmission.



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