BILL NUMBER: AB 549	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  APRIL 21, 2009
	AMENDED IN ASSEMBLY  APRIL 14, 2009

INTRODUCED BY   Assembly Member Furutani

                        FEBRUARY 25, 2009

   An act to amend Sections 1207, 1261.5, and 1264 of, and to add
Sections 1261.7, 1261.8, 1261.9, 1261.10, 1264.1, 1264.2, 1264.3,
1264.4, and 1264.5 to, the Business and Professions Code, relating to
healing arts.



	LEGISLATIVE COUNSEL'S DIGEST


   AB 549, as amended, Furutani. Licensure: clinical laboratory
personnel.
   Existing law provides for the regulation and licensure of clinical
laboratories and clinical laboratory personnel by the State
Department of Public Health.
   Existing law authorizes the department to issue limited clinical
laboratory scientist's licenses in chemistry, microbiology,
toxicology, histocompatibility, immunohematology, genetic molecular
biology, cytogenetics, or other areas of laboratory specialty or
subspecialty when determined necessary by the department, as
specified. Existing law requires an applicant to meet various
requirements in order to qualify for admission to the examination for
a special clinical laboratory scientist's license.
   This bill would revise these requirements by requiring an
applicant to either (1) have graduated from an educational
institution maintaining standards equivalent to specified accredited
institutions and have one year of full-time postgraduate specified
training or experience or (2) have a doctoral degree from an
accredited institution and provide evidence of completion of 2 years
of postdoctoral training in a training program accredited by an
approved accrediting body for the specialty, as specified. The bill
would also authorize the department to issue a limited clinical
laboratory scientist's license in biochemical genetics.
   The bill would also, commencing January 1, 2010, require the
department to issue a limited clinical laboratory scientist's license
in cytogenetics, genetic molecular biology, biochemical genetics,
and chemistry, to any person possessing a doctoral degree from an
accredited institution who provides evidence of completing 2 years of
 post-doctoral   postdoctoral  training in
a specified training program.
   Existing law also requires the department to issue a clinical
chemist, clinical microbiologist, clinical toxicologist, clinical
molecular biologist, clinical biochemical geneticist, or clinical
cytogeneticist license to each person who has applied for the license
on a specified form who is also the holder of a master of science or
doctoral degree in the specialty for which the applicant is seeking
a license and who has met other requirements. Existing law requires
the graduate education to have included 30 semester hours of
coursework in the applicant's specialty.
   This bill would specify that applicants possessing a doctoral
degree from an accredited institution shall have the equivalent of 2
years of postdoctoral training in a training program accredited by a
relevant accrediting body for the specialty and would also require
each applicant to provide evidence of satisfactory performance on a
specified written examination.
   The bill would also, commencing January 1, 2010, require the
department to issue a provisional license as a clinical
cytogeneticist, clinical genetic molecular biologist, or a clinical
biochemical geneticist to any person possessing a doctoral degree
from an accredited institution who provides evidence of completing 2
years of postdoctoral training in a specified training program and
would also require each applicant to provide evidence of satisfactory
performance on a specified written examination.
   Under existing law, a histocompatibility lab director, as defined,
in order to be eligible for licensure, as a histocompatibility lab
director, is required to provide evidence of satisfactory performance
on a specified written and oral examination.
   The bill would also, commencing January 1, 2010, require the
department to issue a provisional license as a histocompatibility
laboratory director to any person possessing a doctoral degree from
an accredited institution who provides evidence of completing 2 years
of postdoctoral training in a specified training program and would
also require each applicant to provide evidence of satisfactory
performance on a specified written examination.
   The bill would authorize the department to adopt emergency
regulations with respect to some of these provisions.
   The bill would make other related changes.
   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 1207 of the Business and Professions Code is
amended to read:
   1207.  (a) As used in this chapter, "clinical chemist," or
"clinical microbiologist," or "clinical toxicologist," or "clinical
genetic molecular biologist," or "clinical biochemical geneticist" or
"clinical cytogeneticist," 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. Such a licensed person who is qualified under CLIA
may perform clinical laboratory tests or examinations classified as
of high complexity under CLIA, and shall have the duties and
responsibilities of a 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. A person licensed as a "clinical chemist," or
"clinical microbiologist," or "clinical toxicologist," or "clinical
genetic molecular biologist," or "clinical biochemical geneticist" or
"clinical cytogeneticist," 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 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.
   (7) For a person licensed under this chapter as a clinical
biochemical geneticist, the subspecialty of genetics or other
specialty or subspecialty specified by regulation adopted by the
department.
  SEC. 2.  Section 1261.5 of the Business and Professions Code is
amended to read:
   1261.5.  (a) The department may issue limited clinical laboratory
scientist's licenses in chemistry, microbiology, toxicology,
histocompatibility, immunohematology, 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.
   (b) To qualify for admission to the examination for a special
clinical laboratory scientist's license, an applicant shall have met
the requirements of either paragraph (1) or (2).
   (1) (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.
   (2) Have a doctoral degree from an accredited institution and
provide evidence of completion of two years of postdoctoral training
in a training program accredited by an approved accrediting body for
the specialty. Each applicant shall also provide evidence of
satisfactory performance on a written examination approved by the
department relevant to each limited clinical laboratory scientist's
license. The following accrediting bodies shall be  deemed
approved   considered appropriate  for the purposes
of this paragraph:
   (A) The American Board of Medical Microbiology.
   (B) The American Board of Clinical Chemistry.
   (C) The American Board of Medical Genetics.
   (D) The Canadian Council of Medical Genetics.
   (E) The American Academy of Clinical Toxicology.
   (F) Any board approved by the United States Department of Health
and Human Services pursuant to paragraph (3) of subsection (b) of
Section 493.1443 of Title 42 of the Code of Federal Regulations.
   (c) Written documentation from the accredited training program
indicating an applicant's completion of the program shall constitute
sufficient evidence for the purposes of subdivision (b).
   (d) 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.
   (e) The department shall adopt regulations to implement this
section.
  SEC. 3.  Section 1261.7 is added to the Business and Professions
Code, to read:
   1261.7.  (a) Commencing January 1, 2010, the department shall
issue a limited clinical laboratory scientist's license in
cytogenetics to any person possessing a doctoral degree from an
accredited institution who provides evidence of completing two years
of postdoctoral cytogeneticist training in a training program
accredited by a relevant accrediting body for the specialty. Written
documentation from the accredited training program indicating an
applicant's completion of the program shall constitute sufficient
evidence for this purpose. Each applicant shall also provide evidence
of satisfactory performance on a written examination administered by
the National Credentialing Agency for Laboratory Personnel in the
specialty of cytogenetic scientist. Written documentation from the
National Credentialing Agency for Laboratory Personnel indicating an
applicant's satisfactory performance on the written examination shall
constitute sufficient evidence for this purpose.
   (b) Nothing in this section shall alter the licensure requirements
for a limited clinical laboratory scientist pursuant to Section
1261.5.
  SEC. 4.  Section 1261.8 is added to the Business and Professions
Code, to read:
   1261.8.  (a) Commencing January 1, 2010, the department shall
issue a limited clinical laboratory scientist's license in genetic
molecular biology to any person possessing a doctoral degree from an
accredited institution who provides evidence of completing two years
of postdoctoral molecular biologist training in a training program
accredited by a relevant accrediting body for the specialty. Written
documentation from the accredited training program indicating an
applicant's completion of the program shall constitute sufficient
evidence for this purpose. Each applicant shall also provide evidence
of satisfactory performance on a written examination administered by
the National Credentialing Agency for Laboratory Personnel in the
specialty of genetic molecular biologist scientist. Written
documentation from the National Credentialing Agency for Laboratory
Personnel indicating an applicant's satisfactory performance on the
written examination shall constitute sufficient evidence for this
purpose.
   (b) Nothing in this section shall alter the licensure requirements
for a limited clinical laboratory scientist pursuant to Section
1261.5.
  SEC. 5.  Section 1261.9 is added to the Business and Professions
Code, to read:
   1261.9.  (a) Commencing January 1, 2010, the department shall
issue a limited clinical laboratory scientist's license in
biochemical genetics to any person possessing a doctoral degree from
an accredited institution who provides evidence of completing two
years of postdoctoral training in a biochemical genetics training
program accredited by a relevant accrediting body for the specialty.
Written documentation from the accredited training program indicating
an applicant's completion of the program shall constitute sufficient
evidence for this purpose. Each applicant shall also provide
evidence of satisfactory performance on a written examination
administered by the National Credentialing Agency for Laboratory
Personnel in the specialty of biochemical geneticist scientist.
Written documentation from the National Credentialing Agency for
Laboratory Personnel indicating an applicant's satisfactory
performance on the written examination shall constitute sufficient
evidence for this purpose.
   (b) Nothing in this section shall alter the licensure requirements
for a limited clinical laboratory scientist pursuant to Section
1261.5.
  SEC. 6.  Section 1261.10 is added to the Business and Professions
Code, to read:
   1261.10.  (a) Commencing January 1, 2010, the department shall
issue a limited clinical chemist scientist license to any person
possessing a doctoral degree from an accredited institution who
provides evidence of completing two years of postdoctoral training in
clinical chemistry in a training program accredited by a relevant
accrediting body for the specialty. Written documentation from the
accredited training program indicating an applicant's completion of
the program shall constitute sufficient evidence for this purpose.
Each applicant shall also provide evidence of satisfactory
performance on a written examination administered by the American
Society for Clinical Pathology, the National Registry in Certified
Chemistry, the American Board of Clinical Chemistry, or other
certification agency approved by the department. Written
documentation from the certification agency indicating an applicant's
satisfactory performance on the written examination shall constitute
sufficient evidence for this purpose.
   (b) Nothing in this section shall alter the licensure requirements
for a limited clinical laboratory scientist pursuant to Section
1261.5.
  SEC. 7.  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 molecular biologist,
clinical biochemical geneticist, 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.
   (1) 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.
   (2) (A) Applicants possessing a doctoral degree from an accredited
institution shall have the equivalent of two years of postdoctoral
training in a training program accredited by a relevant accrediting
body for the specialty. Written documentation from the accredited
training program indicating an applicant's completion of the program
shall constitute sufficient evidence for this purpose. Each applicant
shall also provide evidence of satisfactory performance on a written
examination in the applicant's specialty administered by an
appropriate accrediting body. Written documentation from the 
National Credentialing Agency for Laboratory Personnel 
 accrediting body  indicating an applicant's satisfactory
performance on the written examination shall constitute sufficient
evidence for this purpose.
   (B) For purposes of this subdivision, the following accrediting
bodies shall be  deemed   considered 
appropriate accrediting bodies.  Postdoctoral training
programs approved by these accrediting bodies shall be deemed
approved by the department. 
   (i) The American Board of Medical Microbiology.
   (ii) The American Board of Clinical Chemistry.
   (iii) The American Board of Bioanalysis.
   (iv) The American Board of Medical Laboratory Immunology.
   (v) The American Board of Forensic Toxicology.
   (vi) The American Board of Medical Genetics.
   (vii) The Canadian Council of Medical Genetics.
   (viii) The American Academy of Clinical Toxicology.
   (ix) The American Board of Pathology.
   (x) The American Board of Histocompatibility and Immunogenetics.
   (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. 8.  Section 1264.1 is added to the Business and Professions
Code, to read:
   1264.1.  (a) Commencing January 1, 2010, the department shall
issue a provisional license as a clinical cytogeneticist to any
person possessing a doctoral degree from an accredited institution
who also provides evidence of completing two years of postdoctoral
training in cytogenetics in a training program accredited by a
relevant accrediting body for that specialty. Written documentation
from the accredited training program indicating an applicant
completed the program shall constitute sufficient evidence for this
purpose. Each applicant shall also provide evidence of satisfactory
performance on a written examination administered by the American
Board of Medical Genetics or the Canadian Council of Medical Genetics
in the specialty of cytogenetics. Written documentation from either
of these bodies indicating an applicant's satisfactory performance on
the written examination shall constitute sufficient evidence for
this purpose.
   (b) Each person licensed pursuant to this section shall work under
the supervision of a laboratory director. If the licensee is
qualified under CLIA, he or she may perform clinical laboratory tests
or examinations classified as of high complexity under CLIA, and
shall have the duties and responsibilities of a technical supervisor
and general supervisor, as specified under CLIA, limited to the
specialty of cytogenetics.
   (c) Any person licensed pursuant to this section shall be eligible
for licensure as a laboratory director within the meaning of Section
1209, upon the completion of two years of experience supervising or
performing clinical laboratory tests or examinations in clinical
cytogenetics in a clinical laboratory that possesses a certificate
issued under CLIA for performing high-complexity testing, provided
his or her license is not then suspended or revoked.
  SEC. 9.  Section 1264.2 is added to the Business and Professions
Code, to read:
   1264.2.  (a) Commencing January 1, 2010, the department shall
issue a provisional license as a clinical genetic molecular biologist
to any person possessing a doctoral degree from an accredited
institution who also provides evidence of completing two years of
postdoctoral training in molecular biology in a training program
accredited by a relevant accrediting body for that specialty. Written
documentation from the accredited training program indicating an
applicant completed the program shall constitute sufficient evidence
for this purpose. Each applicant shall also provide evidence of
satisfactory performance on a written examination administered by the
American Board of Medical Genetics or the Canadian Council of
Medical Genetics in the specialty of molecular biology. Written
documentation from either of these bodies indicating an applicant's
satisfactory performance on the written examination shall constitute
sufficient evidence for this purpose.
   (b) Each person licensed pursuant to this section shall work under
the supervision of a laboratory director. If the licensee is
qualified under CLIA, he or she may perform clinical laboratory tests
or examinations classified as of high complexity under CLIA, and
shall have the duties and responsibilities of a technical supervisor
and general supervisor, as specified under CLIA, limited to the
specialty of genetic molecular biology.
   (c) Any person licensed pursuant to this section shall be eligible
for licensure as a laboratory director within the meaning of Section
1209, upon the completion of two years of experience supervising or
performing clinical laboratory tests or examinations in genetic
molecular biology in a clinical laboratory that possesses a
certificate issued under CLIA for performing high-complexity testing,
provided his or her license is not then suspended or revoked.
  SEC. 10.  Section 1264.3 is added to the Business and Professions
Code, to read:
   1264.3.  (a) Commencing January 1, 2010, the department shall
issue a provisional license as a clinical biochemical geneticist to
any person possessing a doctoral degree from an accredited
institution who also provides evidence of completing two years of
postdoctoral training in biochemical genetics in a training program
accredited by a relevant accrediting body for the specialty. Written
documentation from the accredited training program indicating an
applicant completed the program shall constitute sufficient evidence
for this purpose. Each applicant shall also provide evidence of
satisfactory performance on a written examination administered by the
American Board of Medical Genetics or the Canadian Council of
Medical Genetics in the specialty of biochemical genetics. Written
documentation from either of these bodies indicating an applicant's
satisfactory performance on the written examination shall constitute
sufficient evidence for this purpose.
   (b) Each person licensed pursuant to this section shall work under
the supervision of a laboratory director. If the licensee is
qualified under CLIA, he or she may perform clinical laboratory tests
or examinations classified as of high complexity under CLIA, and
shall have the duties and responsibilities of a technical supervisor
and general supervisor, as specified under CLIA, limited to the
specialty of biochemical genetics.
   (c) Any person licensed pursuant to this section shall be eligible
for licensure as a laboratory director within the meaning of Section
1209, upon the completion of two years of experience supervising or
performing clinical laboratory tests or examinations in clinical
biochemical genetics in a clinical laboratory that possesses a
certificate issued under CLIA for performing high-complexity testing,
provided his or her license is not then suspended or revoked.
  SEC. 11.  Section 1264.4 is added to the Business and Professions
Code, to read:
   1264.4.  (a) Commencing January 1, 2010, the department shall
issue a provisional license as a histocompatibility laboratory
director to any person possessing a doctoral degree from an
accredited institution who also provides evidence of completing two
years of postdoctoral training in histocompatibility and immunology
in a training program accredited by a relevant accrediting body for
the specialty. Written documentation from the accredited training
program indicating an applicant completed the program shall
constitute sufficient evidence for this purpose. Each applicant shall
also provide evidence of satisfactory performance on a written
examination administered by the American Board of Histocompatibility
and Immunogenetics in the specialty of histocompatibility. Written
documentation from that board indicating an applicant's satisfactory
performance on the written examination shall constitute sufficient
evidence for this purpose.
   (b) Each person licensed pursuant to this section shall work under
the supervision of a laboratory director. If the licensee is
qualified under CLIA, he or she may perform clinical laboratory tests
or examinations classified as of high complexity under CLIA, and
shall have the duties and responsibilities of a technical supervisor
and general supervisor, as specified under CLIA, limited to the
specialty of histocompatibility and immunology.
   (c) Any person licensed pursuant to this section shall be eligible
for licensure as a histocompatibility laboratory director pursuant
to Section 1209.1, upon the completion of two years of experience
supervising or performing clinical laboratory tests or examinations
in histocompatibility and immunology in a clinical laboratory that
possesses a certificate issued under CLIA for performing
high-complexity testing, provided his or her license is not then
suspended or revoked.
  SEC. 12.  Section 1264.5 is added to the Business and Professions
Code, to read:
   1264.5.  The department may adopt emergency regulations in
accordance with the Administrative Procedure Act (Chapter 3.5
(commencing with Section 11340) of Part 1 of Division 3 of Title 2 of
the Government Code) to implement Sections 1264, 1264.1, 1264.2,
1264.3, and 1264.4 if the department deems necessary to implement
these sections. The adoption of the regulations shall be considered
by the Office of Administrative Law to be necessary for the immediate
preservation of the public peace, health and safety, or general
welfare. The emergency regulations shall be submitted to the Office
of Administrative Law for filing with the Secretary of State and
publication in the California Code of Regulations, and shall be
replaced with final, permanent regulations within 120 days following
the date of their adoption.