California Legislature—2013–14 Regular Session

Assembly Bill No. 399

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 begin delete Health Services end delete begin insert Public Health end insert .

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.

begin insert

(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.

end insert begin delete

(r)

end delete

begin insert (s) end insert  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.

begin delete

(s)

end delete

begin insert (t) end insert  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.

begin delete

(t)

end delete

begin insert (u) end insert  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.