BILL NUMBER: AB 549 AMENDED
BILL TEXT
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 Section Sections 1206,
1207, and 1264 of 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 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. 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
and in the subspecialty of biochemical
genetics. For these specialities and subspecialties, it would
specify that written documentation from an accredited training
program indicating that an applicant completed the program , and
written do cumentation 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 administered by
one of several accrediting bodies
specified as an appropriate accrediting body
recognized by the department. The bill would also make conforming
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 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) "Biological specimen" means any material that is derived from
the human body.
(2) "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.
(3) "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.
(4) "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.
(5) "Clinical laboratory science" means any of the sciences or
scientific disciplines used to perform a clinical laboratory test or
examination.
(6) "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.
(7) "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.
(8) "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.
(9) "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.
(10) "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.
(11) "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.
(12) "Specialty" means histocompatibility, microbiology,
diagnostic immunology, chemistry, hematology, immunohematology,
pathology, genetics, or other specialty specified by regulation
adopted by the department.
(13) "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,
biochemical genetics, cytogenetics, or other subspecialty
specified by regulation adopted by the department.
(14) "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.
(15) "Licensed laboratory" means a clinical laboratory licensed
pursuant to paragraph (1) of subdivision (a) of Section 1265.
(16) "Registered laboratory" means a clinical laboratory
registered pursuant to paragraph (2) of subdivision (a) of Section
1265.
(17) "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 CLIA.
(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.
(18) "Analyte" means the substance or constituent being measured
including, but not limited to, glucose, sodium, or theophyline, or
any substance or property whose presence or absence, concentration,
activity, intensity, or other characteristics are to be determined.
(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. 2. 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 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 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 biochemical genetics
within the specialty of genetics or other speciality or subspecialty
specified by regulation adopted by the department.
SECTION 1. SEC. 3. 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) The 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) Written A formal letter or other
written documentation from an accredited training program
indicating an applicant's completion of 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. 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. For purposes of this section,
the following accrediting bodies shall be considered appropriate
accrediting bodies:
(A) The American Board of Medical Microbiology.
(B) The American Board of Clinical Chemistry.
(C) The American Board of Bioanalysis.
(D) The American Board of Forensic Toxicology.
(E) The American Board of Medical Genetics.
(F) The Canadian Council of Medical Genetics.
(G) The American Academy of Clinical Toxicology
(H) The American Board of Histocompatibility and Immunogenetics.
(I) The American
Board of Medical Laboratory Immunology. body
recognized by the department. In order to constitute sufficient
evidence for this purpose, formal letters or other documentation
required by this paragraph must 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 adopt regulations to conform to this
section.