BILL NUMBER: AB 399	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Fox

                        FEBRUARY 15, 2013

   An act to amend Sections 1202 and 1300 of the Business and
Professions Code, relating to clinical laboratories.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 399, as introduced, Fox. Clinical laboratories.
   Existing law provides for the licensure, registration, and
regulation of clinical laboratories and various clinical laboratory
personnel by the State Department of Public Health. Existing law
prescribes various fees applicable to clinical laboratories and
laboratory personnel, and requires the deposit of those fees in the
Clinical Laboratory Improvement Fund. Existing law authorizes the
department to collect application fees, annual renewal fees, and fees
associated with enforcements, and to establish the fees for
licensing examinations and for medical laboratory technician
licenses.
   This bill would authorize the department to charge appropriate
license fees whenever it determines that a new category of licensure
is necessary. This bill would also make a technical, nonsubstantive
change to these provisions.
   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 1202 of the Business and Professions Code is
amended to read:
   1202.  As used in this chapter, "department" means the State
Department of  Health Services   Public Health
 .
  SEC. 2.  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 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
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 department may establish an application fee and a renewal
fee for any new category of license adopted pursuant to Section 1208.
The total fees collected shall not exceed the costs to the
department for the implementation and operation of the program
licensing and regulating persons issued the new category of license.
 
   (r) 
    (s)  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) 
    (t)  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) 
    (u)  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.