Bill Text: CA AB549 | 2009-2010 | Regular Session | Enrolled


Bill Title: Licensure: clinical laboratory personnel.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Vetoed) 2010-09-29 - Vetoed by Governor. [AB549 Detail]

Download: California-2009-AB549-Enrolled.html
BILL NUMBER: AB 549	ENROLLED
	BILL TEXT

	PASSED THE SENATE  AUGUST 25, 2010
	PASSED THE ASSEMBLY  AUGUST 26, 2010
	AMENDED IN SENATE  AUGUST 20, 2010
	AMENDED IN SENATE  AUGUST 17, 2010
	AMENDED IN SENATE  AUGUST 2, 2010
	AMENDED IN SENATE  JULY 15, 2010
	AMENDED IN SENATE  JUNE 17, 2010
	AMENDED IN ASSEMBLY  JANUARY 25, 2010
	AMENDED IN ASSEMBLY  JANUARY 6, 2010
	AMENDED IN ASSEMBLY  JANUARY 4, 2010
	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 1209.1 and 1264 of, and to add Section
1264.5 to, the Business and Professions Code, relating to healing
arts.



	LEGISLATIVE COUNSEL'S DIGEST


   AB 549, 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 requires the department to
issue a clinical chemist, clinical microbiologist, clinical
toxicologist, clinical molecular biologist, or clinical
cytogeneticist license to each person who has applied for the license
on a specified form, who also holds a master of science or doctoral
degree in the specialty for which the applicant is seeking a license,
and who has met other requirements, including the payment of
specified application and license fees. Existing law requires the
department to determine by examination, except as specified, whether
an applicant is qualified. Existing law requires the graduate
education to have included 30 semester hours of coursework in the
applicants's specialty.
   This bill would require the department to issue a clinical
biochemical geneticist license to a person meeting these
requirements. For the above-enumerated specialities and
subspecialties, this bill would specify that a formal letter or other
official written documentation issued by an accredited training
program indicating that an applicant completed the program, and from
a clinical laboratory confirming the applicant's employment
experience, shall constitute sufficient evidence. The bill would also
require an applicant to provide evidence of satisfactory performance
on a written examination in the applicant's specialty or
subspecialty administered by an appropriate accrediting body
recognized by the department.
   This bill would require the department to post application forms
and instructions for licensure in clinical laboratory practice on its
Internet Web site, to notify an applicant whether the application is
complete or requires additional documentation to become complete.
The bill would also require the department to issue a temporary
license to an applicant meeting specified experience and
certification requirements, within 30 days of determining an
application is complete. The bill would also make conforming changes.

   The bill would require the department to set and charge
application fees sufficient to recover the costs of implementing the
provisions of the bill.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  Section 1209.1 of the Business and Professions Code is
amended to read:
   1209.1.  (a) As used in this chapter, "histocompatibility
laboratory director" means a physician and surgeon licensed to
practice medicine pursuant to Chapter 5 (commencing with Section
2000) who is qualified pursuant to Section 1209, a bioanalyst
licensed pursuant to Section 1260 who is qualified pursuant to
Sections 1203 and 1209, or a person who has earned a doctoral degree
in a biological science, who has completed, subsequent to graduation,
four years of experience in immunology, two of which have been in
histocompatibility testing.
   (b) On and after January 1, 2007, in order to be eligible for
licensure as a histocompatibility laboratory director, an applicant
who is not a duly licensed physician and surgeon or a duly licensed
bioanalyst shall provide evidence of satisfactory performance on a
written examination in histocompatibility administered by the
American Board of Histocompatibility and Immunogenetics, and have
demonstrated satisfactory performance on an oral examination
administered by the department regarding this chapter and Part 493
(commencing with Section 493.1) of Subchapter G of Chapter IV of
Title 42 of the Code of Federal Regulations.
   (c) A person licensed under Section 1260.1 as a histocompatibility
laboratory director 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 laboratory
director, technical consultant, clinical consultant, technical
supervisor, and general supervisor, as specified under CLIA, in the
specialty of histocompatibility, immunology, or other specialty or
subspecialty specified by regulation adopted by the department. A
person licensed as a "histocompatibility laboratory director" may
perform any clinical laboratory test or examination classified as
waived or of moderate complexity under CLIA.
   (d) The department shall, within 30 days of determining that an
application is complete, issue a temporary license to any applicant
seeking licensure pursuant to this section, when the applicant meets
the following requirements:
   (1) The applicant has earned a doctoral degree in a biological
science and has completed, subsequent to graduation, four years of
training and experience in immunology, of which two years shall have
been in histocompatibility testing in a laboratory in any state of
the United States or in Canada.
   (2) The applicant provides evidence of satisfactory performance on
a written examination in histocompatibility administered by the
American Board of Histocompatibility and Immunogenetics.
   (e) An applicant issued a temporary license pursuant to
subdivision (d) shall work only under the supervision of an
individual licensed pursuant to Section 1209.
   (f) A temporary license issued pursuant to subdivision (d) shall
remain valid until the applicant has taken the oral examination
offered by the department, the department completes evaluating and
processing of the applicant's results and licensure, and the
department has issued a permanent license. If the applicant fails to
pass the required oral examinations, the department may revoke the
temporary license upon notice to the applicant sent by first-class
mail.
   (g) The department shall set and charge an application fee in an
amount sufficient to recover the costs of issuing a temporary license
pursuant to subdivision (d).
  SEC. 2.  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) (1) Unless otherwise required by regulation, 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.
   (2) A formal letter or other official written documentation issued
by an accredited training program indicating that the applicant has
completed the program, and from a clinical laboratory or laboratories
confirming the applicant's employment experience as required by
regulation, shall constitute sufficient evidence for the purpose of
this subdivision. Each applicant shall also provide evidence of
satisfactory performance on a written examination in the applicant's
specialty or subspecialty administered by an appropriate accrediting
body recognized by the department. In order to constitute sufficient
evidence for this purpose, formal letters or other documentation
required by this paragraph shall be provided directly by the
examining agency or appropriate accrediting body to the department.
   (b) The department may issue licenses without the examination
required by paragraph (1) of subdivision (a) to applicants who have
passed examinations of other states or an appropriate accrediting
body 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 appropriate
accrediting bodies 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 appropriate accrediting body 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, within 30 days of determining that an
application is complete, issue a temporary license to any applicant
seeking licensure pursuant to this section, when the applicant meets
the following requirements:
   (1) The applicant has earned a doctoral degree in a biological
science and has completed, subsequent to graduation, four years of
training and experience in the area of specialty or subspecialty for
which he or she is seeking licensure in any state of the United
States or in Canada and the applicant's license remains in good
standing.
    (2) The applicant has board certification from an appropriate
body recognized by the United States Department of Health and Human
Services in the area of specialty or subspecialty for which he or she
is seeking licensure.
   (e) An applicant issued a temporary license pursuant to
subdivision (d) shall work only under the supervision of an
individual licensed pursuant to Section 1209.
   (f) A temporary license issued pursuant to subdivision (d) shall
remain valid until the applicant has taken the oral examination
offered by the department, the department completes the evaluation
and processing of the applicant's results and licensure, and the
department has issued a permanent license. If the applicant fails to
pass a required examination, the department may revoke the temporary
license upon notice sent to the applicant by first-class mail.
   (g) The department shall adopt regulations to conform to this
section.
   (h) The department shall set and charge an application fee in an
amount sufficient to recover the costs of issuing a temporary license
pursuant to subdivision (d).
  SEC. 3.  Section 1264.5 is added to the Business and Professions
Code, to read:
   1264.5.  (a) The department shall maintain an expeditious process
for licensing applicants for licensure in clinical laboratory
practice. Application forms and instructions for each category of
licensure shall be posted on the department's Internet Web site.
   (b) After receiving an application for licensure in clinical
laboratory practice, including a resubmission of an application, the
department shall notify the applicant in writing or by electronic
mail that the application is complete and shall be processed by the
department or that the application is incomplete. If the application
is incomplete, the department shall specify in the notification the
transcripts, board certification, verification of training, or other
documents required to complete the application for licensure that
have not been received by the department.
   (c) The department shall set and charge application fees in
amounts sufficient to recover the costs of implementing this section.
                                      
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