BILL NUMBER: AB 549 AMENDED
BILL TEXT
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 1206, 1207, 1209.1, 1264, and 1300 of,
and to add Sections 1263.5 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 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, as defined. For the
above-enumerated specialities and subspecialties, the 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, within 30 days of filing,
whether the application is complete or requires additional
documentation to become complete, and to process each completed
application within 90 days. The bill would specify periods of
eligibility for an applicant to take a required examination. 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 receiving a completed application.
The bill would also make conforming changes.
Existing law requires the department to license as trainees those
individuals desiring to train for a clinical laboratory scientist's
license or a limited clinical laboratory scientist's license,
provided those individuals meet certain academic requirements.
This bill would require the department to adopt emergency
regulations creating a trainee license in enumerated specialties and
subspecialties for applicants who meet specified requirements.
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) "Biochemical genetics" means techniques used to analyze human
proteins and certain metabolites from physiological samples for the
primary purpose of detecting inborn errors of metabolism, heritable
genotypes or gene products of genetic variations or mutations for
clinical purposes that include, but are not limited to, the use of
these test results to aid in the evaluation and diagnosis of
patients, predicting risk of disease, identifying carriers, and
establishing prenatal or clinical diagnoses or prognoses in
individuals, families, and populations.
(15) "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.
(16) "Licensed laboratory" means a clinical laboratory licensed
pursuant to paragraph (1) of subdivision (a) of Section 1265.
(17) "Registered laboratory" means a clinical laboratory
registered pursuant to paragraph (2) of subdivision (a) of Section
1265.
(18) "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.
(19) "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 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 receiving a completed
application, issue a temporary license to any applicant seeking
licensure pursuant to this section, provided that the applicant meets
the following requirements:
(1) The applicant has at least two years of experience as a
histocompatibility laboratory director in another state of the United
States or in Canada.
(2) The applicant has board certification from 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.
(e)
(f) A temporary license issued pursuant to subdivision
(d) shall remain valid until the department completes evaluating and
processing the applicant's completed application, the applicant has
passed any required examinations, and the department has issued a
permanent license. If the applicant fails to pass the required
examinations, the department may revoke the temporary license upon
notice to the applicant sent by first-class mail.
SEC. 4. Section 1263.5 is added to the Business and Professions
Code, to read:
1263.5. The department shall, no later than April 1, 2011, adopt
emergency regulations creating a trainee license in clinical
chemistry, clinical microbiology, clinical toxicology, clinical
molecular biology, clinical biochemical genetics, and clinical
cytogenetics, and as a clinical histocompatibility and immunology
laboratory director for applicants holding an earned doctoral degree
in a biological science or field related to genetics from an
accredited university and who provide evidence of satisfactory
performance on a written examination in the area of specialty that is
administered by the American Board of Medical Genetics, the Canadian
Council of Medical Genetics, or the appropriate accrediting body for
the area of specialty for which the applicant is seeking licensure.
The adoption of these emergency regulations shall be considered by
the Office of Administrative Law to be necessary to avoid serious
harm to the public health, safety, or general welfare.
SEC. 5. 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 receiving a completed
application, issue a temporary license to any applicant seeking
licensure pursuant to this section, provided that the applicant meets
the following requirements:
(1) The applicant has at least two years of experience as a
licensed clinical chemist, clinical microbiologist, clinical
toxicologist, clinical molecular biologist, clinical biochemical
geneticist, or clinical cytogeneticist in another 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.
(e)
(f) A temporary license issued pursuant to subdivision
(d) shall remain valid until the department completes the evaluation
and processing of the applicant's completed application, the
applicant has passed each required examination, 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.
(f)
(g) The department shall adopt regulations to conform
to this section.
SEC. 6. 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) Within 30 calendar days 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 process each completed application within
90 calendar days following receipt of the completed application.
(d) An applicant for licensure in clinical laboratory practice
shall be eligible for any required examinations upon notification by
the department that the applicant's application has been approved. An
applicant shall be eligible for the required examinations for 180
calendar days following the date eligibility begins. Eligibility
shall be extended for an additional 180 calendar days if a required
examination has not been offered or scheduled by the department
within the original 180-day period.
SEC. 7. 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, 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.