BILL NUMBER: SB 744 ENROLLED
BILL TEXT
PASSED THE SENATE SEPTEMBER 8, 2009
PASSED THE ASSEMBLY SEPTEMBER 2, 2009
AMENDED IN ASSEMBLY JULY 14, 2009
AMENDED IN ASSEMBLY JULY 1, 2009
AMENDED IN SENATE MAY 21, 2009
AMENDED IN SENATE MAY 14, 2009
AMENDED IN SENATE APRIL 22, 2009
INTRODUCED BY Senator Strickland
FEBRUARY 27, 2009
An act to amend Sections 1206, 1223, 1246, 1300, 1301, and 1302
of, and to add Section 1300.2 to, the Business and Professions Code,
relating to clinical laboratories, and declaring the urgency thereof,
to take effect immediately.
LEGISLATIVE COUNSEL'S DIGEST
SB 744, Strickland. Clinical laboratories.
(1) Existing law provides for the licensure, registration, and
regulation of clinical laboratories and various clinical laboratory
personnel by the State Department of Public Health and makes a
violation of those provisions a crime.
Existing law requires the department to deem certain laboratories
accredited by private, nonprofit organizations as meeting state
licensure or registration requirements if certain conditions are met.
Under existing law, the private, nonprofit organization must, among
other things, be approved by the Health Care Financing Administration
(HCFA) of the federal Department of Health and Human Services and
must be approved by the department as having accreditation standards
that are equal to, or more stringent than, state requirements for
licensure or registration. The laboratory must meet the accreditation
standards of that organization and must agree to permit the
organization to provide records or other information to the
department.
This bill would require the private, nonprofit organization to be
approved by the federal Center for Medicare and Medicaid Services
instead of HCFA, to conduct inspections of clinical laboratories in a
manner that will determine compliance with existing law, as
specified, and to provide the department with additional information
including, among other things, a detailed description of the
inspection process and a description of the process for monitoring
proficiency testing performance. The bill would require the
organization to be approved by the department as meeting these
requirements and would require the department to begin accepting
applications for approval by January 1, 2011. The bill would also
require the laboratory to meet additional conditions, including
authorizing the private, nonprofit organization to release specified
proficiency testing results and notification of condition-level
requirement violations or withdrawal of laboratory accreditation. The
bill would prohibit the department from conducting routine
inspections of laboratories receiving a certificate pursuant to these
provisions.
Existing law specifies various fees applicable to clinical
laboratories and laboratory personnel and requires the deposit of
those fees in the Clinical Laboratory Improvement Fund. Existing law
requires that, upon appropriation, moneys deposited in that fund be
expended by the department to administer these provisions. Existing
law requires the issuance of a separate license for each laboratory
location, except as specified. Among other entities, not-for-profit,
or federal, state, or local government laboratories engaging in
limited public health testing are authorized to apply for a single
license or registration, as specified.
This bill would impose a fee for approval of each of those
laboratories and would increase certain other fees applicable to
laboratories and laboratory personnel. The bill would prohibit the
fees imposed from exceeding the costs incurred by the department in
regulating clinical laboratories and their personnel. The bill would
require all interest earned on moneys deposited in the Clinical
Laboratory Improvement Fund to be maintained in the fund and would
prohibit the redirection of moneys in the fund for any other purpose.
The bill would require the department to report to the Legislature
by July 1, 2013, on the extent to which the state clinical laboratory
oversight program meets or exceeds federal standards, the extent to
which the federal government is accepting exemption applications from
states relative to federal CLIA oversight, and the potential cost to
the state for an exemption.
Existing law provides for the renewal of a clinical laboratory
license or registration and requires that the renewal fee be paid
during the 30-day period before the expiration of the license or
registration. Existing law specifies that failure to pay the renewal
fee results in forfeiture of the license or registration after a
period of 60 days from the expiration date.
This bill would require a licensee or registrant that fails to
renew a license or registration before the expiration date to pay a
specified delinquency fee for up to 60 days after the expiration
date, in addition to the renewal fee.
(2) This bill would declare that it is to take effect immediately
as an urgency statute.
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,
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 1223 of the Business and Professions Code is
amended to read:
1223. (a) The Legislature finds and declares that it is the
public policy of the state to ensure that California's laboratory
standards, including its laboratory personnel standards, be sustained
in order to provide accurate, reliable, and necessary test results.
The Legislature further finds that inspections are the most effective
means of furthering this policy. It is not the intent of the
Legislature to reduce in any way the resources available to the
department for inspections, but rather to provide the department with
the greatest flexibility to concentrate its resources where they can
be most effective. It is the intent of the Legislature to provide
for an inspection process that includes state-based inspection
components and that determines compliance with federal and state
requirements for clinical laboratories.
(b) The department shall employ, or contract for, inspectors,
special agents, and investigators, and provide any clerical and
technical assistance as necessary to administer this chapter and may
incur other expenses as necessary.
(c) Laboratories accredited by a private, nonprofit organization
shall be deemed by the department to meet state licensure or
registration requirements, and shall be issued a certificate of that
deemed status by the department, provided that both of the following
conditions are met:
(1) The private, nonprofit organization meets all of the following
requirements:
(A) Is approved by the federal Center for Medicare and Medicaid
Services as an accreditation body under CLIA and provides the
department with the following information:
(i) A detailed comparison of the individual accreditation or
approval requirements, with the comparable condition-level
requirements.
(ii) A detailed description of its inspection process, including
all of the following:
(I) Frequency of inspections.
(II) Copies of inspection forms.
(III) Instructions and guidelines.
(IV) A description of the review and decisionmaking process of
inspections.
(V) A statement concerning whether inspections are announced or
unannounced.
(VI) A description of the steps taken to monitor the correction of
deficiencies.
(iii) A description of the process for monitoring proficiency
testing performance, including action to be taken in response to
unsuccessful participation.
(iv) A list of all of its current California licensed or
registered laboratories and the expiration date of their
accreditation, licensure, or registration, as applicable.
(B) Is approved by the department as having accreditation
standards that are equal to, or more stringent than, state
requirements for licensure and registration.
(C) Conducts inspections of clinical laboratories in a manner that
will determine compliance with federal standards and California laws
to the extent that California laws provide greater protection to
residents, or are more stringent than federal standards, as
determined by the department. Notwithstanding any other provision of
law, the department may, without taking regulatory action pursuant to
Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3
of Title 2 of the Government Code, implement or interpret this
section by means of an All Clinical Laboratories Letter (ACLL). The
department shall post the ACLL on its Internet Web site so that any
person may observe which California laws are more stringent than
federal standards, and which accreditation bodies have been approved
to conduct inspections. Public comment on the ACLL shall be accepted
by the department for 30 days after posting and shall become final 45
days after the posting. Comments received shall be considered by the
department. Nothing in this subdivision is intended to change
existing statutory or regulatory requirements governing the operation
of clinical laboratories or their personnel.
(D) Is approved by the department as meeting the requirements of
this paragraph. The department shall begin accepting applications for
approval, in a form and manner prescribed by the department, by
January 1, 2011. The department shall make a determination on an
application submitted pursuant to this subparagraph within 180 days
of receiving the application.
(2) The laboratory meets all of the following requirements:
(A) Meets the accreditation standards of the private, nonprofit
organization.
(B) Agrees to permit the private, nonprofit organization to
provide any records or other information to the department, its
agents, or contractors, as the department may require.
(C) Pays the applicable fees required under Section 1300.
(D) Authorizes its proficiency testing organization to furnish to
the department and the private, nonprofit organization the results of
the laboratory's participation in an approved proficiency testing
program, as defined in 42 C.F.R. 493.2, for the purpose of monitoring
the laboratory's proficiency testing, along with explanatory
information needed to interpret the proficiency testing results, upon
request of the department.
(E) Authorizes the private, nonprofit organization to release to
the department a notification of every violation of condition-level
requirements, including the actions taken by the organization as a
result of the violation, within 30 days of the initiation of the
action.
(F) Authorizes the private, nonprofit organization to give notice
to the department of any withdrawal of the laboratory's
accreditation.
(d) If the private, nonprofit organization described in
subdivision (c) has withdrawn or revoked its accreditation of a
laboratory, the laboratory shall retain its certificate of deemed
status issued pursuant to subdivision (c) for 45 days after the
laboratory receives notice of the withdrawal or revocation of the
accreditation, or the effective date of any action taken by the
department, whichever is earlier.
(e) A certificate of deemed status issued pursuant to subdivision
(c) shall be renewed annually provided that the conditions for
issuance specified in subdivision (c) are still met. Except as
authorized under subdivision (f), the department shall not conduct
routine inspections of a laboratory issued a certificate of deemed
status pursuant to subdivision (c). Each application for a
certificate of deemed status issued under subdivision (c) and each
request for renewal of that certificate shall be accompanied by the
fees set forth in Section 1300. The total of those certificate
application and renewal fees collected by the department shall be
sufficient to cover the cost of issuing the certificate. If the
department determines that those certificate fees do not fully
support the costs of these activities, it shall report that
determination to the Legislature.
(f) Nothing in this section shall be construed to prohibit the
exercise of the department's authority to conduct complaint
investigations, sample validation inspections, or require submission
of proficiency testing results to the department to ensure compliance
of any clinical laboratory with state standards.
SEC. 3. Section 1246 of the Business and Professions Code is
amended to read:
1246. (a) Except as provided in subdivisions (b) and (c), and in
Section 23158 of the Vehicle Code, an unlicensed person employed by a
licensed clinical laboratory may perform venipuncture or skin
puncture for the purpose of withdrawing blood or for clinical
laboratory test purposes upon specific authorization from a licensed
physician and surgeon provided that he or she meets both of the
following requirements:
(1) He or she works under the supervision of a person licensed
under this chapter or of a licensed physician and surgeon or of a
licensed registered nurse. A person licensed under this chapter, a
licensed physician or surgeon, or a registered nurse shall be
physically available to be summoned to the scene of the venipuncture
within five minutes during the performance of those procedures.
(2) He or she has been trained by a licensed physician and surgeon
or by a clinical laboratory bioanalyst in the proper procedure to be
employed when withdrawing blood in accordance with training
requirements established by the State Department of Public Health and
has a statement signed by the instructing physician and surgeon or
by the instructing clinical laboratory bioanalyst that the training
has been successfully completed.
(b) (1) On and after the effective date of the regulations
specified in paragraph (2), any unlicensed person employed by a
clinical laboratory performing the duties described in this section
shall possess a valid and current certification as a certified
phlebotomy technician issued by the department. However, an
unlicensed person employed by a clinical laboratory to perform these
duties pursuant to subdivision (a) on that date shall have until
January 1, 2007, to comply with this requirement, provided that he or
she has submitted the application to the department on or before
July 1, 2006.
(2) The department shall adopt regulations for certification by
January 1, 2001, as a certified phlebotomy technician that shall
include all of the following:
(A) The applicant shall hold a valid, current certification as a
phlebotomist issued by a national accreditation agency approved by
the department, and shall submit proof of that certification when
applying for certification pursuant to this section.
(B) The applicant shall complete education, training, and
experience requirements as specified by regulations that shall
include, but not be limited to, the following:
(i) At least 40 hours of didactic instruction.
(ii) At least 40 hours of practical instruction.
(iii) At least 50 successful venipunctures.
However, an applicant who has been performing these duties
pursuant to subdivision (a) may be exempted from the requirements
specified in clauses (ii) and (iii), and from 20 hours of the 40
hours of didactic instruction as specified in clause (i), if he or
she has at least 1,040 hours of work experience, as specified in
regulations adopted by the department.
It is the intent of the Legislature to permit persons performing
these duties pursuant to subdivision (a) to use educational leave
provided by their employers for purposes of meeting the requirements
of this section.
(3) Each certified phlebotomy technician shall complete at least
three hours per year or six hours every two years of continuing
education or training. The department shall consider a variety of
programs in determining the programs that meet the continuing
education or training requirement.
(4) He or she has been found to be competent in phlebotomy by a
licensed physician and surgeon or person licensed pursuant to this
chapter.
(5) He or she works under the supervision of a licensed physician
and surgeon, licensed registered nurse, or person licensed under this
chapter, or the designee of a licensed physician and surgeon or the
designee of a person licensed under this chapter.
(6) The department shall adopt regulations establishing standards
for approving training programs designed to prepare applicants for
certification pursuant to this section. The standards shall ensure
that these programs meet the state's minimum education and training
requirements for comparable programs.
(7) The department shall adopt regulations establishing standards
for approving national accreditation agencies to administer
certification examinations and tests pursuant to this section.
(8) The department shall charge fees for application for and
renewal of the certificate authorized by this section of no more than
one hundred dollars ($100) for a two-year period.
(c) (1) (A) A certified phlebotomy technician may perform
venipuncture or skin puncture to obtain a specimen for nondiagnostic
tests assessing the health of an individual, for insurance purposes,
provided that the technician works under the general supervision of a
physician and surgeon licensed under Chapter 5 (commencing with
Section 2000). The physician and surgeon may delegate the general
supervision duties to a registered nurse or a person licensed under
this chapter, but shall remain responsible for ensuring that all
those duties and responsibilities are properly performed. The
physician and surgeon shall make available to the department, upon
request, records maintained documenting when a certified phlebotomy
technician has performed venipuncture or skin puncture pursuant to
this paragraph.
(B) As used in this paragraph, general supervision requires the
supervisor of the technician to determine that the technician is
competent to perform venipuncture or skin puncture prior to the
technician's first blood withdrawal, and on an annual basis
thereafter. The supervisor is also required to determine, on a
monthly basis, that the technician complies with appropriate
venipuncture or skin puncture policies and procedures approved by the
medical director and required by state regulations. The supervisor,
or another designated licensed physician and surgeon, registered
nurse, or person licensed under this chapter, shall be available for
consultation with the technician, either in person or through
telephonic or electronic means, at the time of blood withdrawal.
(2) (A) Notwithstanding any other provision of law, a person who
has been issued a certified phlebotomy technician certificate
pursuant to this section may draw blood following policies and
procedures approved by a physician and surgeon licensed under Chapter
5 (commencing with Section 2000), appropriate to the location where
the blood is being drawn and in accordance with state regulations.
The blood collection shall be done at the request and in the presence
of a peace officer for forensic purposes in a jail, law enforcement
facility, or medical facility, with general supervision.
(B) As used in this paragraph, "general supervision" means that
the supervisor of the technician is licensed under this code as a
physician and surgeon, physician assistant, clinical laboratory
bioanalyst, registered nurse, or clinical laboratory scientist, and
reviews the competency of the technician before the technician may
perform blood withdrawals without direct supervision, and on an
annual basis thereafter. The supervisor is also required to review
the work of the technician at least once a month to ensure compliance
with venipuncture policies, procedures, and regulations. The
supervisor, or another person licensed under this code as a physician
and surgeon, physician assistant, clinical laboratory bioanalyst,
registered nurse, or clinical laboratory scientist, shall be
accessible to the location where the technician is working to provide
onsite, telephone, or electronic consultation, within 30 minutes
when needed.
(d) The department may adopt regulations providing for the
issuance of a certificate to an unlicensed person employed by a
clinical laboratory authorizing only the performance of skin
punctures for test purposes.
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 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 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.
SEC. 5. Section 1300.2 is added to the Business and Professions
Code, to read:
1300.2. Notwithstanding any other provision of this article, the
total fees collected under this chapter shall not exceed the costs
incurred by the department for licensing, certification, inspection,
or other activities relating to the regulation of clinical
laboratories and their personnel.
SEC. 6. Section 1301 of the Business and Professions Code is
amended to read:
1301. (a) The annual renewal fee for a clinical laboratory
license or registration set under this chapter shall be paid during
the 30-day period before the expiration date of the license or
registration. If the license or registration is not renewed before
the expiration date, the licensee or registrant, as a condition
precedent to renewal, shall pay a delinquency fee equal to 25 percent
of the annual renewal fee for up to 60 days after the expiration
date, in addition to the annual renewal fee in effect on the last
preceding regular renewal date. Failure to pay the annual renewal fee
in advance during the time the license or registration remains in
force shall, ipso facto, work a forfeiture of the license or
registration after a period of 60 days from the expiration date of
the license or registration.
(b) (1) The department shall give written notice to all persons
licensed pursuant to Sections 1260, 1260.1, 1261, 1261.5, 1262, 1264,
or 1270 30 days in advance of the regular renewal date that a
renewal fee has not been paid. In addition, the department shall give
written notice to licensed clinical laboratory bioanalysts or
doctoral degree specialists and clinical laboratory scientists or
limited clinical laboratory scientists by registered or certified
mail 90 days in advance of the expiration of the fifth year that a
renewal fee has not been paid and if not paid before the expiration
of the fifth year of delinquency the licensee may be subject to
reexamination.
(2) If the renewal fee is not paid for five or more years, the
department may require an examination before reinstating the license,
except that no examination shall be required as a condition for
reinstatement if the original license was issued without an
examination. No examination shall be required for reinstatement if
the license was forfeited solely by reason of nonpayment of the
renewal fee if the nonpayment was for less than five years.
(3) If the license is not renewed within 60 days after its
expiration, the licensee, as a condition precedent to renewal, shall
pay the delinquency fee identified in subdivision (l) of Section
1300, in addition to the renewal fee in effect on the last preceding
regular renewal date. Payment of the delinquency fee will not be
necessary if within 60 days of the license expiration date the
licensee files with the department an application for inactive
status.
SEC. 7. Section 1302 of the Business and Professions Code is
amended to read:
1302. (a) There is hereby established in the State Treasury, the
Clinical Laboratory Improvement Fund.
(b) All fees established under this chapter and Chapter 4
(commencing with Section 1600) of Division 2 of the Health and Safety
Code shall be collected by and paid to the department, and shall be
deposited by the department in the Clinical Laboratory Improvement
Fund, along with any other moneys received by the department for the
purpose of licensing, certification, inspection, proficiency testing,
or other regulation of clinical laboratories, blood banks, or
clinical laboratory personnel. Notwithstanding Section 16305.7 of the
Government Code, all interest earned on moneys deposited in the fund
shall be maintained in the fund.
(c) Moneys deposited in the Clinical Laboratory Improvement Fund
that are appropriated in the annual Budget Act, or any other
appropriation, for support of, or expenditure by, the state
department shall, upon appropriation, be expended by the state
department to administer this chapter and Chapter 4 (commencing with
Section 1600) of Division 2 of the Health and Safety Code. All fees
collected pursuant to this chapter shall, upon appropriation, be
expended to administer this chapter and shall not be redirected for
any other purpose. All fees collected pursuant to Chapter 4
(commencing with Section 1600) of Division 2 of the Health and Safety
Code shall, upon appropriation, be expended to administer that
chapter and shall not be redirected for any other purpose.
SEC. 8. This act is an urgency statute necessary for the immediate
preservation of the public peace, health, or safety within the
meaning of Article IV of the Constitution and shall go into immediate
effect. The facts constituting the necessity are:
In order to protect the public health by providing strong clinical
laboratory oversight as soon as possible, it is necessary that this
act take effect immediately.