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 Bill No. 940

Introduced by Assembly Members Ridley-Thomas and Waldron

February 26, 2015

An act to amend Sections 1203, 1204, 1205, 1206, 1207, 1209, 1210, 1260, 1261.5, 1264, 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 begin delete the end delete 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.

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.

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

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 begin delete the end delete 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 would authorize the department to issue limited clinical laboratory scientist licenses and clinical licenses in reproductive biology and biochemical genetics, as provided, and would apply existing application and license renewal fees to persons applying for additional clinical licenses.

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

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

SECTION 1.  

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

1203.  

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

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

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

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

SEC. 2.  

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

1204.  

As used in this chapter, “clinical laboratory scientist”
means any person, other than a licensed clinical laboratory
bioanalyst or trainee, who is licensed under Sections 1261 and
1262 to engage in clinical laboratory practice under the overall
operation and administration of a laboratory director, unless serving
as a director of a waived laboratory as provided in Section 1209.
A person licensed as a clinical laboratory scientist and qualified
under CLIA may perform clinical laboratory tests or examinations
classified as of high complexity under CLIA and the duties and
responsibilities of a waived laboratory director, as specified under
CLIA, technical consultant, clinical consultant, technical
supervisor, and general supervisor, as specified under CLIA, in
the specialties of histocompatibility, microbiology, diagnostic
immunology, chemistry, hematology, immunohematology,
genetics, reproductive biology, or other specialty or subspecialty
specified by regulation adopted by the department. A person
licensed as a “clinical laboratory scientist” may perform any
clinical laboratory test or examination classified as waived or of
moderate complexity under CLIA.

SEC. 3.  

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

1205.  

As used in this chapter, “trainee” means any person
licensed under this chapter for the purpose of receiving
comprehensive practical experience and instruction in clinical
laboratory procedures in one of the sciences or in general clinical
laboratory begin delete science end delete begin insert science. The training provided to a trainee shall
be provided end insert under the direct and responsible supervision of begin insert any
of the following individuals: end insert a person authorized to direct a
laboratory under the provisions of this chapter, begin insert a end insert clinical laboratory
scientist, clinical chemist scientist, clinical microbiologist scientist,
clinical toxicologist scientist, clinical immunohematologist
scientist, clinical genetic molecular biologist scientist, clinical
cytogeneticist scientist, clinical biochemical geneticist scientist,
clinical reproductive biologist scientist, clinical histocompatibility
scientist, or other equivalent licensee in the science or specialty
or subspecialty for which he or she is licensed in a clinical
laboratory certified for this purpose by the department under this
chapter.

SEC. 4.  

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

1206.  

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

(1) “Analyte” means the substance or constituent being begin delete measured end delete
begin insert measured, end insert including, but not limited to, glucose, sodium, or
begin delete theophyline, end delete begin insert theophylline, end insert or any substance or property whose
presence or absence, concentration, activity, intensity, or other
characteristics are to be determined.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(C) It meets the following criteria:

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

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

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

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

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

(16) “Registered laboratory” means a clinical laboratory
registered pursuant to paragraph (2) of subdivision (a) of Section
1265.

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

(18) “Subspecialty” for purposes of microbiology, means
bacteriology, mycobacteriology, mycology, parasitology, virology,
molecular biology, and serology for diagnosis of infectious
diseases, or other subspecialty specified by regulation adopted by
the department; for purposes of diagnostic immunology, means
syphilis serology, general immunology, or other subspecialty
specified by regulation adopted by the department; for purposes
of chemistry, means routine chemistry, clinical microscopy,
endocrinology, toxicology, or other subspecialty specified by
regulation adopted by the department; for purposes of
immunohematology, means ABO/Rh Type and Group, antibody
detection for transfusion, antibody detection nontransfusion,
antibody identification, compatibility, or other subspecialty
specified by regulation adopted by the department; for pathology,
means tissue pathology, oral pathology, diagnostic cytology, or
other subspecialty specified by regulation adopted by the
department; for purposes of genetics, means molecular biology
related to the diagnosis of human genetic abnormalities,
cytogenetics, biochemical genetics, or other subspecialty specified
by regulation adopted by the department.

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

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

SEC. 5.  

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

1207.  

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

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

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

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

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

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

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

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

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

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

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

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

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

SEC. 6.  

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

1209.  

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

(1) A duly licensed physician and surgeon.

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

(A) A duly licensed clinical laboratory scientist.

(B) A duly licensed limited clinical laboratory scientist.

(C) A duly licensed naturopathic doctor.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(F) Assessment of problem solving skills.

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

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

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

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

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

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

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

SEC. 7.  

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

1210.  

(a) As used in this chapter, “clinical chemist scientist,”
“clinical microbiologist scientist,” “clinical toxicologist scientist,”
“clinical immunohematologist scientist,” “clinical genetic
molecular biologist scientist,” “clinical biochemical geneticist
scientist,” “clinical reproductive biologist scientist,” “clinical
cytogeneticist scientist,” and “clinical histocompatibility scientist”
means any person, other than a person licensed to direct a clinical
laboratory, or licensed as a clinical laboratory scientist or trainee,
who is licensed under Sections 1261, 1261.5, and 1262 to engage
in clinical laboratory practice. Such a licensed person who is
qualified under CLIA may perform clinical laboratory tests
classified as of high complexity under CLIA and the duties and
responsibilities of a technical consultant, clinical consultant,
technical supervisor, and general supervisor limited to the specialty
or subspecialty as identified in subdivision (b) for which he or she
is licensed by the department. A person licensed as a “clinical
chemist scientist,” or “clinical microbiologist scientist,” or “clinical
toxicologist scientist,” or “clinical immunohematologist scientist,”
or “clinical genetic molecular biologist scientist,” or “clinical
biochemical geneticist scientist,” or “clinical reproductive biologist
scientist,” or “clinical cytogeneticist scientist,” or a “clinical
histocompatibility scientist” may perform any clinical laboratory
test or examination classified as waived or of moderate complexity
under CLIA.

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

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

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

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

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

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

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

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

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

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

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

SEC. 8.  

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

1260.  

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

SEC. 9.  

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

1261.5.  

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

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

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

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

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

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

SEC. 10.  

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

1264.  

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

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

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

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

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

SEC. 11.  

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

1300.  

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(q) The department shall establish an application fee and a
renewal fee for a medical laboratory technician license, the total
fees collected not to exceed the costs of the department for the
implementation and operation of the program licensing and
regulating medical laboratory technicians pursuant to Section
1260.3.

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

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

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