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

NOTE: There are more recent revisions of this legislation. Read Latest Draft
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-Amended.html
BILL NUMBER: AB 549	AMENDED
	BILL TEXT

	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 1206, 1207,  and 1264 
 1264, and 1300  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  , 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
in the subspecialty of biochemical genetics. For these specialities
and subspecialties, it would specify that  a formal letter or
 written documentation from an accredited training program
indicating that an applicant completed the program, and 
written documentation  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. 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 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 biochemical genetics
within the specialty of genetics or other speciality or subspecialty
specified by regulation adopted by the department.
  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) 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 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 recognized by the department. In order to constitute sufficient
evidence for this purpose, formal letters or other documentation
required by this paragraph  must   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 adopt regulations to conform to this
section.
   SEC. 4.    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 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,  or  clinical laboratory
toxicologist's  , or clinical biochemical geneticist'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.
               
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