Bill Text

Bill Information


PDF |Add To My Favorites | print page

AB-399 Clinical laboratories.(2013-2014)

SHARE THIS:share this bill in Facebookshare this bill in Twitter
AB399:v99#DOCUMENT


CALIFORNIA LEGISLATURE— 2013–2014 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   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.