Amended in Senate July 14, 2015

Amended in Senate July 1, 2015

Amended in Assembly April 23, 2015

Amended in Assembly March 23, 2015

California Legislature—2015–16 Regular Session

Assembly BillNo. 940


Introduced by Assembly Members Ridley-Thomas and Waldron

February 26, 2015


An act to amend Sections 1203,begin delete 1204, 1205, 1206, 1207,end delete 1209,begin delete 1210,end delete 1260,begin delete 1261.5, 1264,end delete and 1300 of the Business and Professions Code, relating to healing arts.

LEGISLATIVE COUNSEL’S DIGEST

AB 940, as amended, Ridley-Thomas. Clinical laboratories.

Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of a laboratory director. Existing law defines “laboratory director,” for purposes of a clinical laboratory test or examination classified as waived, as any person who, among others, is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under CLIA.

This bill would delete the requirement that a laboratory director substantially meet the laboratory director qualifications under CLIA. The bill would instead limit the CLIA qualification requirements to a person serving as the CLIA laboratory director, as defined, in a laboratory that performs tests classified as moderate or high complexity.

Existing law authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, and other persons licensed in specified clinical specialties, to perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, within the area of the licensee’s specialty.

This bill would specify that this authorization extends to a person who is not the CLIA laboratory director under specified circumstances.

begin delete

Existing law defines a “clinical laboratory scientist” as any person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed, as specified, to engage in a clinical laboratory practice under the overall operation and administration of a laboratory director.

end delete
begin delete

The bill would add “reproductive biology” to the list of specialties that a clinical laboratory scientist may perform. The bill would make conforming changes.

end delete

Existing law requires an applicant for a clinical laboratory bioanalyst’s license to meet specified requirements for education and experience, including that the applicant have a minimum of 4 years’ experience as a licensed clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the State Department of Public Health.

This bill would revise the application requirements to provide that an applicant’s minimum of 4 years’ experience be in a clinical laboratory certified under CLIA.

Existing law authorizes the State Department of Public Health to issue specified licenses, including limited clinical laboratory scientist licenses and clinical licenses in specified fields, and establishes application and annual renewal fees for the clinical licenses. Existing law deposits those fees in the Clinical Laboratory Improvement Fund for use, upon appropriation by the Legislature, for regulatory purposes relating to clinical laboratories, blood banks, or clinical laboratory personnel, as provided.

This bill wouldbegin delete authorize the department to issue limited clinical laboratory scientist licenses and clinical licenses in reproductive biology and biochemical genetics, as provided, and wouldend delete apply existingbegin delete application andend delete license renewal fees to personsbegin delete applying for additional clinical licenses.end deletebegin insert renewing a clinical cytogeneticist’s or clinical molecular biologist’s license.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:

P3    1

SECTION 1.  

Section 1203 of the Business and Professions
2Code
is amended to read:

3

1203.  

As used in this chapter, “clinical laboratory bioanalyst”
4or “bioanalyst” means a person licensed under Section 1260 to
5engage in clinical laboratory practice and direction of a clinical
6laboratory.

7(a) A person licensed as a clinical laboratory bioanalyst or
8bioanalyst and qualified under CLIA, who is not the CLIA
9laboratory director, may perform clinical laboratory tests or
10examinations classified as of high complexity under CLIA and the
11duties and responsibilities of a laboratory director in the specialties
12of histocompatibility, microbiology, diagnostic immunology,
13chemistry, hematology, immunohematology, genetics, or other
14specialty or subspecialty specified in regulations adopted by the
15department.

16(b) A person licensed as a clinical laboratory bioanalyst or
17bioanalyst and qualified under CLIA may perform the duties and
18responsibilities of a CLIA laboratory director, technical consultant,
19clinical consultant, technical supervisor, and general supervisor,
20as specified under CLIA, in the specialties of histocompatibility,
21microbiology, diagnostic immunology, chemistry, hematology,
22immunohematology, genetics, or other specialty or subspecialty
23specified in regulations adopted by the department.

24(c) A person licensed as a clinical laboratory bioanalyst or
25bioanalyst may perform any clinical laboratory test or examination
26classified as waived or of moderate complexity under CLIA.

begin delete
27

SEC. 2.  

Section 1204 of the Business and Professions Code is
28amended to read:

29

1204.  

As used in this chapter, “clinical laboratory scientist”
30means any person, other than a licensed clinical laboratory
31bioanalyst or trainee, who is licensed under Sections 1261 and
321262 to engage in clinical laboratory practice under the overall
33operation and administration of a laboratory director, unless serving
P4    1as a director of a waived laboratory as provided in Section 1209.
2A person licensed as a clinical laboratory scientist and qualified
3under CLIA may perform clinical laboratory tests or examinations
4classified as of high complexity under CLIA and the duties and
5responsibilities of a waived laboratory director, as specified under
6CLIA, technical consultant, clinical consultant, technical
7supervisor, and general supervisor, as specified under CLIA, in
8the specialties of histocompatibility, microbiology, diagnostic
9immunology, chemistry, hematology, immunohematology,
10genetics, reproductive biology, or other specialty or subspecialty
11specified by regulation adopted by the department. A person
12licensed as a “clinical laboratory scientist” may perform any
13clinical laboratory test or examination classified as waived or of
14moderate complexity under CLIA.

15

SEC. 3.  

Section 1205 of the Business and Professions Code is
16amended to read:

17

1205.  

As used in this chapter, “trainee” means any person
18licensed under this chapter for the purpose of receiving
19comprehensive practical experience and instruction in clinical
20laboratory procedures in one of the sciences or in general clinical
21laboratory science. The training provided to a trainee shall be
22provided under the direct and responsible supervision of any of
23the following individuals: a person authorized to direct a laboratory
24under the provisions of this chapter, a clinical laboratory scientist,
25clinical chemist scientist, clinical microbiologist scientist, clinical
26toxicologist scientist, clinical immunohematologist scientist,
27clinical genetic molecular biologist scientist, clinical cytogeneticist
28scientist, clinical biochemical geneticist scientist, clinical
29reproductive biologist scientist, clinical histocompatibility scientist,
30or other equivalent licensee in the science or specialty or
31subspecialty for which he or she is licensed in a clinical laboratory
32certified for this purpose by the department under this chapter.

33

SEC. 4.  

Section 1206 of the Business and Professions Code is
34amended to read:

35

1206.  

(a) For the purposes of this chapter the following
36definitions are applicable:

37(1) “Analyte” means the substance or constituent being
38measured, including, but not limited to, glucose, sodium, or
39theophylline, or any substance or property whose presence or
P5    1absence, concentration, activity, intensity, or other characteristics
2are to be determined.

3(2) “Biological specimen” means any material that is derived
4from the human body.

5(3) “Blood electrolyte analysis” means the measurement of
6electrolytes in a blood specimen by means of ion selective
7electrodes on instruments specifically designed and manufactured
8for blood gas and acid-base analysis.

9(4) “Blood gas analysis” means a clinical laboratory test or
10examination that deals with the uptake, transport, and metabolism
11of oxygen and carbon dioxide in the human body.

12(5) “Clinical laboratory test or examination” means the
13detection, identification, measurement, evaluation, correlation,
14monitoring, and reporting of any particular analyte, entity, or
15substance within a biological specimen for the purpose of obtaining
16scientific data which may be used as an aid to ascertain the
17presence, progress, and source of a disease or physiological
18condition in a human being, or used as an aid in the prevention,
19prognosis, monitoring, or treatment of a physiological or
20pathological condition in a human being, or for the performance
21of nondiagnostic tests for assessing the health of an individual.

22(6) “Clinical laboratory science” means any of the sciences or
23scientific disciplines used to perform a clinical laboratory test or
24examination.

25(7) “Clinical laboratory practice” means the application of
26clinical laboratory sciences or the use of any means that applies
27the clinical laboratory sciences within or outside of a licensed or
28registered clinical laboratory. Clinical laboratory practice includes
29consultation, advisory, and other activities inherent to the
30profession.

31(8) “Clinical laboratory” means any place used, or any
32establishment or institution organized or operated, for the
33performance of clinical laboratory tests or examinations or the
34practical application of the clinical laboratory sciences. That
35application may include any means that applies the clinical
36laboratory sciences.

37(9) “Direct and constant supervision” means personal
38observation and critical evaluation of the activity of unlicensed
39laboratory personnel by a physician and surgeon, or by a person
40licensed under this chapter other than a trainee, during the entire
P6    1time that the unlicensed laboratory personnel are engaged in the
2duties specified in Section 1269.

3(10) “Direct and responsible supervision” means both of the
4following:

5(A) Personal observation and critical evaluation of the activity
6of a trainee by a physician and surgeon, or by a person licensed
7under this chapter other than a trainee, during the entire time that
8the trainee is performing clinical laboratory tests or examinations.

9(B) Personal review by the physician and surgeon or the licensed
10person of all results of clinical laboratory testing or examination
11performed by the trainee for accuracy, reliability, and validity
12before the results are reported from the laboratory.

13(11) “Licensed laboratory” means a clinical laboratory licensed
14pursuant to paragraph (1) of subdivision (a) of Section 1265.

15(12) “Location” means either a street and city address, or a site
16or place within a street and city address, where any of the clinical
17laboratory sciences or scientific disciplines are practiced or applied,
18or where any clinical laboratory tests or examinations are
19performed.

20(13) “Physician office laboratory” means a clinical laboratory
21that is licensed or registered under Section 1265, and that is either:
22(A) a clinical laboratory that is owned and operated by a partnership
23or professional corporation that performs clinical laboratory tests
24or examinations only for patients of five or fewer physicians and
25surgeons or podiatrists who are shareholders, partners, or
26employees of the partnership or professional corporation that owns
27and operates the clinical laboratory; or (B) a clinical laboratory
28that is owned and operated by an individual licensed physician
29and surgeon or a podiatrist, and that performs clinical laboratory
30tests or examinations only for patients of the physician and surgeon
31or podiatrist who owns and operates the clinical laboratory.

32(14) “Point-of-care laboratory testing device” means a portable
33laboratory testing instrument to which the following applies:

34(A) It is used within the proximity of the patient for whom the
35test or examination is being conducted.

36(B) It is used in accordance with the patient test management
37system, the quality control program, and the comprehensive quality
38assurance program established and maintained by the laboratory
39pursuant to paragraph (2) of subdivision (d) of Section 1220.

40(C) It meets the following criteria:

P7    1(i) Performs clinical laboratory tests or examinations classified
2as waived or of moderate complexity under the federal Clinical
3Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C.
4Sec. 263a).

5(ii) Performs clinical laboratory tests or examinations on
6biological specimens that require no preparation after collection.

7(iii) Provides clinical laboratory tests or examination results
8without calculation or discretionary intervention by the testing
9personnel.

10(iv) Performs clinical laboratory tests or examinations without
11the necessity for testing personnel to perform calibration or
12maintenance, except resetting pursuant to the manufacturer’s
13instructions or basic cleaning.

14(15) “Public health laboratory” means a laboratory that is
15operated by a city or county in conformity with Article 5
16(commencing with Section 101150) of Chapter 2 of Part 3 of
17Division 101 of the Health and Safety Code and the regulations
18adopted thereunder.

19(16) “Registered laboratory” means a clinical laboratory
20registered pursuant to paragraph (2) of subdivision (a) of Section
211265.

22(17) “Specialty” means histocompatibility, microbiology,
23diagnostic immunology, chemistry, hematology,
24immunohematology, pathology, genetics, reproductive biology,
25or other specialty specified by regulation adopted by the
26department.

27(18) “Subspecialty” for purposes of microbiology, means
28bacteriology, mycobacteriology, mycology, parasitology, virology,
29molecular biology, and serology for diagnosis of infectious
30diseases, or other subspecialty specified by regulation adopted by
31the department; for purposes of diagnostic immunology, means
32syphilis serology, general immunology, or other subspecialty
33specified by regulation adopted by the department; for purposes
34of chemistry, means routine chemistry, clinical microscopy,
35endocrinology, toxicology, or other subspecialty specified by
36regulation adopted by the department; for purposes of
37immunohematology, means ABO/Rh Type and Group, antibody
38detection for transfusion, antibody detection nontransfusion,
39antibody identification, compatibility, or other subspecialty
40specified by regulation adopted by the department; for pathology,
P8    1means tissue pathology, oral pathology, diagnostic cytology, or
2other subspecialty specified by regulation adopted by the
3department; for purposes of genetics, means molecular biology
4related to the diagnosis of human genetic abnormalities,
5cytogenetics, biochemical genetics, or other subspecialty specified
6by regulation adopted by the department.

7(b) Nothing in this chapter shall restrict, limit, or prevent any
8person licensed to provide health care services under the laws of
9this state, including, but not limited to, licensed physicians and
10surgeons and registered nurses, from practicing the profession or
11occupation for which he or she is licensed.

12(c) Nothing in this chapter shall authorize any person to perform
13or order health care services, or utilize the results of the clinical
14laboratory test or examination, unless the person is otherwise
15authorized to provide that care or utilize the results. The inclusion
16of a person in Section 1206.5 for purposes of performing a clinical
17laboratory test or examination shall not be interpreted to authorize
18a person, who is not otherwise authorized, to perform venipuncture,
19arterial puncture, or skin puncture.

20

SEC. 5.  

Section 1207 of the Business and Professions Code is
21amended to read:

22

1207.  

(a) (1) (A) As used in this chapter, “clinical chemist,”
23or “clinical microbiologist,” or “clinical toxicologist,” or “clinical
24genetic molecular biologist,” or “clinical cytogeneticist,” or
25“clinical reproductive biologist,” or “clinical biochemical
26geneticist,” or “oral and maxillofacial pathologist” means any
27person licensed by the department under Section 1264 to engage
28in, or supervise others engaged in, clinical laboratory practice
29limited to his or her area of specialization or to direct a clinical
30laboratory, or portion thereof, limited to his or her area of
31specialization.

32(B) A person described in subparagraph (A) may perform the
33duties and responsibilities of a laboratory director, who is not the
34CLIA laboratory director, limited to his or her area of specialty or
35subspecialty as described in subdivision (b), and shall only direct
36a clinical laboratory providing service within those specialties or
37subspecialties.

38(C) If a person described in subparagraph (A) is qualified under
39 CLIA, he or she may perform clinical laboratory tests or
40examinations classified as of high complexity under CLIA, and
P9    1the duties and responsibilities of a CLIA laboratory director,
2technical consultant, clinical consultant, technical supervisor, and
3general supervisor, as specified under CLIA, limited to his or her
4area of specialty or subspecialty as described in subdivision (b),
5and shall only direct a clinical laboratory providing service within
6those specialties or subspecialties.

7(2) A person licensed as a “clinical chemist,” or “clinical
8microbiologist,” or “clinical toxicologist,” or “clinical genetic
9molecular biologist,” or “clinical cytogeneticist,” or “clinical
10reproductive biologist,” or “clinical biochemical geneticist,” or
11“oral and maxillofacial pathologist” may perform any clinical
12laboratory test or examination classified as waived or of moderate
13complexity under CLIA.

14(b) The specialty or subspecialty for each of the limited license
15categories identified in subdivision (a), and the clinical laboratories
16that may be directed by persons licensed in each of those
17categories, are the following:

18(1) For a person licensed under this chapter as a clinical chemist,
19the specialty of chemistry and the subspecialties of routine
20chemistry, endocrinology, clinical microscopy, toxicology, or other
21specialty or subspecialty specified by regulation adopted by the
22department.

23(2) For a person licensed under this chapter as a clinical
24microbiologist, the specialty of microbiology and the subspecialties
25of bacteriology, mycobacteriology, mycology, parasitology,
26virology, molecular biology, and serology for diagnosis of
27infectious diseases, or other specialty or subspecialty specified by
28regulation adopted by the department.

29(3) For a person licensed under this chapter as a clinical
30toxicologist, the subspecialty of toxicology within the specialty of
31chemistry or other specialty or subspecialty specified by regulation
32adopted by the department.

33(4) For a person licensed under this chapter as a clinical genetic
34molecular biologist, the subspecialty of molecular biology related
35to diagnosis of human genetic abnormalities within the specialty
36of genetics or other specialty or subspecialty specified by regulation
37adopted by the department.

38(5) For a person licensed under this chapter as a clinical
39cytogeneticist, the subspecialty of cytogenetics within the specialty
P10   1of genetics or other specialty or subspecialty specified by regulation
2adopted by the department.

3(6) For a person licensed under this chapter as a clinical
4biochemical geneticist, the subspecialty of biochemical genetics
5within the specialty of genetics or other specialty or subspecialty
6specified by regulation adopted by the department.

7(7) For a person licensed under this chapter as a clinical
8reproductive biologist, the specialty of reproductive biology or
9other specialty or subspecialty specified by regulation adopted by
10the department.

11(8) For a person licensed under this chapter as an oral and
12maxillofacial pathologist, the subspecialty of oral pathology within
13the specialty of pathology or other specialty or subspecialty
14specified by regulation adopted by the department.

end delete
15

begin deleteSEC. 6.end delete
16begin insertSEC. 2.end insert  

Section 1209 of the Business and Professions Code is
17amended to read:

18

1209.  

(a) As used in this chapter, “laboratory director” means
19any person who is any of the following:

20(1) A duly licensed physician and surgeon.

21(2) Only for purposes of a clinical laboratory test or examination
22classified as waived, is any of the following:

23(A) A duly licensed clinical laboratory scientist.

24(B) A duly licensed limited clinical laboratory scientist.

25(C) A duly licensed naturopathic doctor.

26(D) A duly licensed optometrist serving as the director of a
27laboratory that only performs clinical laboratory tests authorized
28in paragraph (10) of subdivision (e) of Section 3041.

29(3) Licensed to direct a clinical laboratory under this chapter.

30(b) (1) A person defined in paragraph (1) or (3) of subdivision
31(a) who is identified as the CLIA laboratory director of a laboratory
32that performs clinical laboratory tests classified as moderate or
33high complexity shall also meet the laboratory director
34qualifications under CLIA for the type and complexity of tests
35being offered by the laboratory.

36(2) As used in this subdivision, “CLIA laboratory director”
37means the person identified as the laboratory director on the CLIA
38certificate issued to the laboratory by the federal Centers for
39Medicare and Medicaid Services (CMS).

P11   1(c) The laboratory director, if qualified under CLIA, may
2perform the duties of the technical consultant, technical supervisor,
3clinical consultant, general supervisor, and testing personnel, or
4delegate these responsibilities to persons qualified under CLIA.
5If the laboratory director reapportions performance of those
6responsibilities or duties, he or she shall remain responsible for
7ensuring that all those duties and responsibilities are properly
8performed.

9(d) (1) The laboratory director is responsible for the overall
10operation and administration of the clinical laboratory, including
11administering the technical and scientific operation of a clinical
12laboratory, the selection and supervision of procedures, the
13reporting of results, and active participation in its operations to
14the extent necessary to ensure compliance with this act and CLIA.
15He or she shall be responsible for the proper performance of all
16laboratory work of all subordinates and shall employ a sufficient
17number of laboratory personnel with the appropriate education
18and either experience or training to provide appropriate
19consultation, properly supervise and accurately perform tests, and
20report test results in accordance with the personnel qualifications,
21duties, and responsibilities described in CLIA and this chapter.

22(2) Where a point-of-care laboratory testing device is utilized
23and provides results for more than one analyte, the testing
24personnel may perform and report the results of all tests ordered
25for each analyte for which he or she has been found by the
26laboratory director to be competent to perform and report.

27(e) As part of the overall operation and administration, the
28laboratory director of a registered laboratory shall document the
29adequacy of the qualifications (educational background, training,
30and experience) of the personnel directing and supervising the
31laboratory and performing the laboratory test procedures and
32examinations. In determining the adequacy of qualifications, the
33laboratory director shall comply with any regulations adopted by
34the department that specify the minimum qualifications for
35personnel, in addition to any CLIA requirements relative to the
36education or training of personnel.

37(f) As part of the overall operation and administration, the
38laboratory director of a licensed laboratory shall do all of the
39following:

P12   1(1) Ensure that all personnel, prior to testing biological
2specimens, have the appropriate education and experience, receive
3the appropriate training for the type and complexity of the services
4offered, and have demonstrated that they can perform all testing
5operations reliably to provide and report accurate results. In
6determining the adequacy of qualifications, the laboratory director
7shall comply with any regulations adopted by the department that
8specify the minimum qualifications for, and the type of procedures
9that may be performed by, personnel in addition to any CLIA
10requirements relative to the education or training of personnel.
11Any regulations adopted pursuant to this section that specify the
12type of procedure that may be performed by testing personnel shall
13be based on the skills, knowledge, and tasks required to perform
14the type of procedure in question.

15(2) Ensure that policies and procedures are established for
16monitoring individuals who conduct preanalytical, analytical, and
17postanalytical phases of testing to ensure that they are competent
18and maintain their competency to process biological specimens,
19perform test procedures, and report test results promptly and
20proficiently, and, whenever necessary, identify needs for remedial
21training or continuing education to improve skills.

22(3) Specify in writing the responsibilities and duties of each
23individual engaged in the performance of the preanalytic, analytic,
24and postanalytic phases of clinical laboratory tests or examinations,
25including which clinical laboratory tests or examinations the
26individual is authorized to perform, whether supervision is required
27for the individual to perform specimen processing, test
28performance, or results reporting, and whether consultant,
29supervisor, or director review is required prior to the individual
30reporting patient test results.

31(g) The competency and performance of staff of a licensed
32laboratory shall be evaluated and documented by the laboratory
33director, or by a person who qualifies as a technical consultant or
34a technical supervisor under CLIA depending on the type and
35complexity of tests being offered by the laboratory.

36(1) The procedures for evaluating the competency of the staff
37shall include, but are not limited to, all of the following:

38(A) Direct observations of routine patient test performance,
39including patient preparation, if applicable, and specimen handling,
40processing, and testing.

P13   1(B) Monitoring the recording and reporting of test results.

2(C) Review of intermediate test results or worksheets, quality
3control records, proficiency testing results, and preventive
4maintenance records.

5(D) Direct observation of performance of instrument
6maintenance and function checks.

7(E) Assessment of test performance through testing previously
8analyzed specimens, internal blind testing samples, or external
9proficiency testing samples.

10(F) Assessment of problem solving skills.

11(2) Evaluation and documentation of staff competency and
12performance shall occur at least semiannually during the first year
13an individual tests biological specimens. Thereafter, evaluations
14shall be performed at least annually unless test methodology or
15instrumentation changes, in which case, prior to reporting patient
16test results, the individual’s performance shall be reevaluated to
17include the use of the new test methodology or instrumentation.

18(h) The laboratory director of each clinical laboratory of an
19acute care hospital shall be a physician and surgeon who is a
20qualified pathologist, except as follows:

21(1) If a qualified pathologist is not available, a physician and
22surgeon or a clinical laboratory bioanalyst qualified as a laboratory
23director under subdivision (a) may direct the laboratory. However,
24a qualified pathologist shall be available for consultation at suitable
25intervals to ensure high-quality service.

26(2) If there are two or more clinical laboratories of an acute care
27hospital, those additional clinical laboratories that are limited to
28the performance of blood gas analysis, blood electrolyte analysis,
29or both, may be directed by a physician and surgeon qualified as
30a laboratory director under subdivision (a), irrespective of whether
31a pathologist is available.

32As used in this subdivision, a qualified pathologist is a physician
33and surgeon certified or eligible for certification in clinical or
34anatomical pathology by the American Board of Pathology or the
35American Osteopathic Board of Pathology.

36(i) Subdivision (h) does not apply to any director of a clinical
37laboratory of an acute care hospital acting in that capacity on or
38before January 1, 1988.

P14   1(j) A laboratory director may serve as the director of up to the
2maximum number of laboratories stipulated by CLIA, as defined
3under Section 1202.5.

begin delete
4

SEC. 7.  

Section 1210 of the Business and Professions Code is
5amended to read:

6

1210.  

(a) As used in this chapter, “clinical chemist scientist,”
7“clinical microbiologist scientist,” “clinical toxicologist scientist,”
8“clinical immunohematologist scientist,” “clinical genetic
9molecular biologist scientist,” “clinical biochemical geneticist
10scientist,” “clinical reproductive biologist scientist,” “clinical
11cytogeneticist scientist,” and “clinical histocompatibility scientist”
12means any person, other than a person licensed to direct a clinical
13laboratory, or licensed as a clinical laboratory scientist or trainee,
14who is licensed under Sections 1261, 1261.5, and 1262 to engage
15in clinical laboratory practice. Such a licensed person who is
16qualified under CLIA may perform clinical laboratory tests
17classified as of high complexity under CLIA and the duties and
18responsibilities of a technical consultant, clinical consultant,
19technical supervisor, and general supervisor limited to the specialty
20or subspecialty as identified in subdivision (b) for which he or she
21is licensed by the department. A person licensed as a “clinical
22chemist scientist,” or “clinical microbiologist scientist,” or “clinical
23toxicologist scientist,” or “clinical immunohematologist scientist,”
24or “clinical genetic molecular biologist scientist,” or “clinical
25biochemical geneticist scientist,” or “clinical reproductive biologist
26scientist,” or “clinical cytogeneticist scientist,” or a “clinical
27histocompatibility scientist” may perform any clinical laboratory
28test or examination classified as waived or of moderate complexity
29under CLIA.

30(b) The specialties and subspecialties included in each of the
31license categories identified in subdivision (a), are the following:

32(1) For a person licensed under this chapter as a clinical chemist
33scientist, the specialty of chemistry and the subspecialties of routine
34chemistry, endocrinology, clinical microscopy, toxicology, or other
35specialty or subspecialty specified by regulation adopted by the
36department.

37(2) For a person licensed under this chapter as a clinical
38microbiologist scientist, the specialty of microbiology and the
39subspecialties of bacteriology, mycobacteriology, mycology,
40parasitology, virology, or molecular biology and serology for
P15   1diagnosis of infectious diseases, or other specialty or subspecialty
2specified by regulation adopted by the department.

3(3) For a person licensed under this chapter as a clinical
4toxicologist scientist, the subspecialty of toxicology within the
5specialty of chemistry or other specialty or subspecialty specified
6by regulation adopted by the department.

7(4) For a person licensed under this chapter as a clinical genetic
8molecular biologist scientist, the subspecialty of molecular biology
9related to the diagnosis of human genetic abnormalities within the
10specialty of genetics, or other specialty or subspecialty specified
11by regulation adopted by the department.

12(5) For a person licensed under this chapter as a clinical
13cytogeneticist scientist, the subspecialty of cytogenetics within the
14specialty of genetics or other specialty or subspecialty specified
15by regulation adopted by the department.

16(6) For a person licensed under this chapter as a clinical
17biochemical geneticist scientist, the subspecialty of biochemical
18genetics within the specialty of genetics or other specialty or
19subspecialty specified by regulation adopted by the department.

20(7) For a person licensed under this chapter as a clinical
21reproductive biologist scientist, the specialty of reproductive
22biology, or other specialty or subspecialty specified by regulation
23adopted by the department.

24(8) For a person licensed under this chapter as a clinical
25immunohematologist scientist, the specialty of immunohematology
26or other specialty or subspecialty specified by regulation adopted
27by the department.

28(9) For a person licensed under this chapter as a clinical
29histocompatibility scientist, the specialty of histocompatibility or
30other specialty or subspecialty specified by regulation adopted by
31the department.

32(c) Clinical chemist scientists, clinical microbiologist scientists,
33clinical toxicologist scientists, clinical immunohematologist
34scientists, clinical genetic molecular biologist scientists, clinical
35cytogeneticist scientists, and clinical histocompatibility scientists
36shall engage in clinical laboratory practice authorized by their
37licensure only under the overall operation and administration of a
38laboratory director.

end delete
P16   1

begin deleteSEC. 8.end delete
2begin insertSEC. 3.end insert  

Section 1260 of the Business and Professions Code is
3amended to read:

4

1260.  

The department shall issue a clinical laboratory
5bioanalyst’s license to each person who is a lawful holder of a
6degree of master of arts, master of science, or an equivalent or
7higher degree as determined by the department with a major in
8chemical, physical, biological, or clinical laboratory sciences. This
9education shall have been obtained in one or more established and
10reputable institutions maintaining standards equivalent, as
11determined by the department, to those institutions accredited by
12the Western Association of Schools and Colleges or an essentially
13equivalent accrediting agency, as determined by the department.
14The applicant also shall have a minimum of four years’ experience
15as a clinical laboratory scientist performing clinical laboratory
16work embracing the various fields of clinical laboratory activity
17in a clinical laboratory certified under CLIA. The quality and
18variety of this experience shall be satisfactory to the department
19and shall have been obtained within the six-year period
20immediately antecedent to admission to the examination. The
21applicant shall successfully pass a written examination and an oral
22examination conducted by the department or a committee
23designated by the department to conduct the examinations,
24indicating that the applicant is properly qualified. The department
25may issue a license without conducting a written examination to
26an applicant who has passed a written examination of a national
27accrediting board having requirements that are, in the determination
28of the department, equal to or greater than those required by this
29chapter and regulations adopted by the department. The department
30shall establish by regulation the required courses to be included
31in the college or university training.

begin delete
32

SEC. 9.  

Section 1261.5 of the Business and Professions Code
33 is amended to read:

34

1261.5.  

The department may issue limited clinical laboratory
35scientist’s licenses in chemistry, microbiology, toxicology,
36histocompatibility, immunohematology, reproductive biology,
37biochemical genetics, genetic molecular biology, cytogenetics, or
38other areas of laboratory specialty or subspecialty when determined
39to be necessary by the department in order for licensure categories
40to keep abreast of changes in laboratory or scientific technology.
P17   1Whenever the department determines that a new limited clinical
2laboratory scientist license category is necessary, it shall adopt
3regulations identifying the category and the areas of specialization
4included within the category.

5To qualify for admission to the examination for a special clinical
6laboratory scientist’s license, an applicant shall have all the
7following:

8(a) Have graduated from a college or university maintaining
9standards equivalent, as determined by the department, to those
10institutions accredited by the Western Association of Schools and
11Colleges or an essentially equivalent accrediting agency with a
12baccalaureate or higher degree with a major appropriate to the
13field for which a license is being sought.

14(b) Have one year of full-time postgraduate training or
15experience in the various areas of analysis in the field for which
16a license is being sought in a laboratory that has a license issued
17under this chapter or which the department determines is equivalent
18thereto.

19(c) Whenever a limited clinical laboratory scientist’s license is
20established for a specific area of specialization, the department
21may issue the license without examination to applicants who had
22met standards of education and training, defined by regulations,
23prior to the date of the adoption of implementing regulations.

24(d) The department shall adopt regulations to implement this
25section.

26

SEC. 10.  

Section 1264 of the Business and Professions Code
27 is amended to read:

28

1264.  

The department shall issue a clinical chemist, clinical
29microbiologist, clinical toxicologist, clinical reproductive biologist,
30clinical biochemical geneticist, clinical molecular biologist, or
31clinical cytogeneticist license to each person who has applied for
32the license on forms provided by the department, who is a lawful
33holder of a master of science or doctoral degree in the specialty
34for which the applicant is seeking a license and who has met such
35additional reasonable qualifications of training, education, and
36experience as the department may establish by regulations. The
37department shall issue an oral and maxillofacial pathologist license
38to every applicant for licensure who has applied for the license on
39forms provided by the department, who is a registered Diplomate
40of the American Board of Oral and Maxillofacial Pathology, and
P18   1who meets any additional and reasonable qualifications of training,
2education, and experience as the department may establish by
3regulation.

4(a) The graduate education shall have included 30 semester
5hours of coursework in the applicant’s specialty. Applicants
6possessing only a master of science degree shall have the equivalent
7of one year of full-time, directed study or training in procedures
8and principles involved in the development, modification, or
9evaluation of laboratory methods, including training in complex
10methods applicable to diagnostic laboratory work. Each applicant
11must have had one year of training in his or her specialty in a
12clinical laboratory acceptable to the department and three years of
13experience in his or her specialty in a clinical laboratory, two years
14of which must have been at a supervisory level. The education
15shall have been obtained in one or more established and reputable
16institutions maintaining standards equivalent, as determined by
17the department, to those institutions accredited by an agency
18acceptable to the department. The department shall determine by
19examination that the applicant is properly qualified. Examinations,
20training, or experience requirements for specialty licenses shall
21cover only the specialty concerned.

22(b) The department may issue licenses without examination to
23applicants who have passed examinations of other states or national
24accrediting boards whose requirements are equal to or greater than
25those required by this chapter and regulations established by the
26department. The evaluation of other state requirements or
27requirements of national accrediting boards shall be carried out
28by the department with the assistance of representatives from the
29licensed groups. This section shall not apply to persons who have
30passed an examination by another state or national accrediting
31board prior to the establishment of requirements that are equal to
32or exceed those of this chapter or regulations of the department.

33(c) The department may issue licenses without examination to
34applicants who had met standards of education and training, defined
35by regulations, prior to the date of the adoption of implementing
36regulations.

37(d) The department shall adopt regulations to conform to this
38section.

end delete
P19   1

begin deleteSEC. 11.end delete
2begin insertSEC. 4.end insert  

Section 1300 of the Business and Professions Code is
3amended to read:

4

1300.  

The amount of application, registration, and license fees
5under this chapter shall be as follows:

6(a) The application fee for a histocompatibility laboratory
7director’s, clinical laboratory bioanalyst’s, clinical chemist’s,
8clinical microbiologist’s, clinical laboratory toxicologist’s,begin delete clinical
9reproductive biologist’s, clinical biochemical geneticist’s,end delete
clinical
10cytogeneticist’s, or clinical molecular biologist’s license is
11sixty-three dollars ($63) commencing on July 1, 1983.

12(b) The annual renewal fee for a histocompatibility laboratory
13director’s, clinical laboratory bioanalyst’s, clinical chemist’s,
14clinical microbiologist’s, clinical laboratory toxicologist’s,begin delete clinical
15reproductive biologist’s, clinical biochemical geneticist’s,end delete
clinical
16cytogeneticist’s, or clinical molecular biologist’s license is
17sixty-three dollars ($63) commencing on July 1, 1983.

18(c) The application fee for a clinical laboratory scientist’s or
19limited clinical laboratory scientist’s license is thirty-eight dollars
20($38) commencing on July 1, 1983.

21(d) The application and annual renewal fee for a
22cytotechnologist’s license is fifty dollars ($50) commencing on
23January 1, 1991.

24(e) The annual renewal fee for a clinical laboratory scientist’s
25or limited clinical laboratory scientist’s license is twenty-five
26dollars ($25) commencing on July 1, 1983.

27(f) A clinical laboratory applying for a license to perform tests
28or examinations classified as of moderate or of high complexity
29under CLIA and a clinical laboratory applying for certification
30under subdivision (c) of Section 1223 shall pay an application fee
31for that license or certification based on the number of tests it
32performs or expects to perform in a year, as follows:

33(1) Less than 2,001 tests: two hundred seventy dollars ($270).

34(2) Between 2,001 and 10,000, inclusive, tests: eight hundred
35twenty dollars ($820).

36(3) Between 10,001 and 25,000, inclusive, tests: one thousand
37three hundred fifteen dollars ($1,315).

38(4) Between 25,001 and 50,000, inclusive, tests: one thousand
39five hundred eighty dollars ($1,580).

P20   1(5) Between 50,001 and 75,000, inclusive, tests: one thousand
2nine hundred sixty dollars ($1,960).

3(6) Between 75,001 and 100,000, inclusive, tests: two thousand
4three hundred forty dollars ($2,340).

5(7) Between 100,001 and 500,000, inclusive, tests: two thousand
6seven hundred forty dollars ($2,740).

7(8) Between 500,001 and 1,000,000, inclusive, tests: four
8thousand nine hundred ten dollars ($4,910).

9(9) More than 1,000,000 tests: five thousand two hundred sixty
10dollars ($5,260) plus three hundred fifty dollars ($350) for every
11 500,000 tests over 1,000,000, up to a maximum of 15,000,000
12tests.

13(g) A clinical laboratory performing tests or examinations
14classified as of moderate or of high complexity under CLIA and
15a clinical laboratory with a certificate issued under subdivision (c)
16of Section 1223 shall pay an annual renewal fee based on the
17number of tests it performed in the preceding calendar year, as
18follows:

19(1) Less than 2,001 tests: one hundred seventy dollars ($170).

20(2) Between 2,001 and 10,000, inclusive, tests: seven hundred
21twenty dollars ($720).

22(3) Between 10,001 and 25,000, inclusive, tests: one thousand
23one hundred fifteen dollars ($1,115).

24(4) Between 25,001 and 50,000, inclusive, tests: one thousand
25three hundred eighty dollars ($1,380).

26(5) Between 50,001 and 75,000, inclusive, tests: one thousand
27seven hundred sixty dollars ($1,760).

28(6) Between 75,001 and 100,000, inclusive, tests: two thousand
29forty dollars ($2,040).

30(7) Between 100,001 and 500,000, inclusive, tests: two thousand
31four hundred forty dollars ($2,440).

32(8) Between 500,001 and 1,000,000, inclusive, tests: four
33thousand six hundred ten dollars ($4,610).

34(9) More than 1,000,000 tests per year: four thousand nine
35 hundred sixty dollars ($4,960) plus three hundred fifty dollars
36($350) for every 500,000 tests over 1,000,000, up to a maximum
37of 15,000,000 tests.

38(h) The application fee for a trainee’s license is thirteen dollars
39($13) commencing on July 1, 1983.

P21   1(i) The annual renewal fee for a trainee’s license is eight dollars
2($8) commencing on July 1, 1983.

3(j) The application fee for a duplicate license is five dollars ($5)
4commencing on July 1, 1983.

5(k) The personnel licensing delinquency fee is equal to the
6annual renewal fee.

7(l) The director may establish a fee for examinations required
8under this chapter. The fee shall not exceed the total cost to the
9department in conducting the examination.

10(m) A clinical laboratory subject to registration under paragraph
11(2) of subdivision (a) of Section 1265 and performing only those
12 clinical laboratory tests or examinations considered waived under
13CLIA shall pay an annual fee of one hundred dollars ($100). A
14clinical laboratory subject to registration under paragraph (2) of
15subdivision (a) of Section 1265 and performing only
16provider-performed microscopy, as defined under CLIA, shall pay
17an annual fee of one hundred fifty dollars ($150). A clinical
18laboratory performing both waived and provider-performed
19microscopy shall pay an annual registration fee of one hundred
20fifty dollars ($150).

21(n) The costs of the department in conducting a complaint
22investigation, imposing sanctions, or conducting a hearing under
23this chapter shall be paid by the clinical laboratory. The fee shall
24be no greater than the fee the laboratory would pay under CLIA
25for the same type of activities and shall not be payable if the
26clinical laboratory would not be required to pay those fees under
27CLIA.

28(o) The state, a district, city, county, city and county, or other
29political subdivision, or any public officer or body shall be subject
30to the payment of fees established pursuant to this chapter or
31regulations adopted thereunder.

32(p) In addition to the payment of registration or licensure fees,
33a clinical laboratory located outside the State of California shall
34reimburse the department for travel and per diem to perform any
35necessary onsite inspections at the clinical laboratory in order to
36ensure compliance with this chapter.

37(q) The department shall establish an application fee and a
38renewal fee for a medical laboratory technician license, the total
39fees collected not to exceed the costs of the department for the
40implementation and operation of the program licensing and
P22   1regulating medical laboratory technicians pursuant to Section
21260.3.

3(r) The costs of the department to conduct any reinspections to
4ensure compliance of a laboratory applying for initial licensure
5shall be paid by the laboratory. This additional cost for each visit
6shall be equal to the initial application fee and shall be paid by the
7laboratory prior to issuance of a license. The department shall not
8charge a reinspection fee if the reinspection is due to error or
9omission on the part of the department.

10(s) A fee of twenty-five dollars ($25) shall be assessed for
11approval of each additional location authorized by paragraph (2)
12of subdivision (d) of Section 1265.

13(t) On or before July 1, 2013, the department shall report to the
14Legislature during the annual legislative budget hearing process
15the extent to which the state oversight program meets or exceeds
16federal oversight standards and the extent to which the federal
17Department of Health and Human Services is accepting exemption
18applications and the potential cost to the state for an exemption.



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