BILL NUMBER: SB 744 INTRODUCED
BILL TEXT
INTRODUCED BY Senator Strickland
FEBRUARY 27, 2009
An act to amend Sections 1206, 1223, 1246, 1300, 1301, and 1302 of
the Business and Professions Code, and to amend Section 101160 of,
and to add Sections 101151, 101152, 101161, and 101162 to, the Health
and Safety Code, relating to laboratories, making an appropriation
therefor, and declaring the urgency thereof, to take effect
immediately.
LEGISLATIVE COUNSEL'S DIGEST
SB 744, as introduced, Strickland. Clinical laboratories: public
health 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 also require the
laboratory to meet additional conditions, including authorizing the
private nonprofit organization to release specified performance
testing results and notification of condition-level requirement
violations or withdrawal of laboratory accreditation.
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 provide that
moneys deposited in the Clinical Laboratory Improvement Fund are
continuously appropriated to the department, thereby making an
appropriation.
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) Existing law requires city and county public health
laboratories and their personnel to be approved by the department and
to comply with the federal Clinical Laboratory Improvement
Amendments of 1988. Existing law prohibits a person from acting as a
public health microbiologist in a certified public health laboratory
without a certificate issued by the department, and requires the
applicant to pass certain examinations in order to obtain a
certificate. Existing law requires the director of a public health
laboratory to be certified as a public health microbiologist and to
have specified qualifications and experience.
This bill would require city and county public health laboratories
to obtain a certification or registration from the department, as
specified. The bill would require the laboratories, public health
microbiologists, and public health laboratory directors to pay
certain fees in order to be certified or registered. The bill would
authorize the department to issue certificates to public health
microbiologists and laboratory directors without examination to
applicants who have passed examinations of national accrediting
boards with equivalent or more stringent requirements, as specified.
The bill would require that the fees collected pursuant to these
provisions be deposited in the Clinical Laboratory Improvement Fund
and would continuously appropriate those fees to the department, as
specified.
By subjecting municipal and county laboratories to these new
requirements, this bill would impose a state-mandated local program.
(3) The California Constitution requires the state to reimburse
local agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that, if the Commission on State Mandates
determines that the bill contains costs mandated by the state,
reimbursement for those costs shall be made pursuant to these
statutory provisions.
(4) This bill would declare that it is to take effect immediately
as an urgency statute.
Vote: 2/3. Appropriation: yes. Fiscal committee: yes.
State-mandated local program: yes.
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 Chapter 7
(commencing with Section 1000) of Part 2 of Division 1
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 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.
(b)
(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 accreditation 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 HCFA 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 or licensure, as applicable.
(v) Procedures for making proficiency testing information
available, including explanatory information required to interpret
proficiency testing results, on a reasonable basis, upon request of
any person.
(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, interpret, or make
specific this section by means of an All Clinical Laboratories Letter
(ACLL) or similar instruction. The department shall post the ACLL or
similar instruction on its Internet Web site so that any person may
observe which California laws provide greater protection to its
residents or are more stringent than federal standards, and which
accreditation bodies impose those standards. Nothing in this
subdivision is intended to change existing statutory or regulatory
requirements governing the operation of clinical laboratories or
their personnel.
(C)
(D) Agrees to permit the department or its agents or
contractors to conduct random inspections of clinical laboratories
accredited by it in order to validate compliance with California law.
(2) The laboratory meets both 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 private, nonprofit organization the results of the laboratory's
participation in an approved proficiency testing program 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 the laboratory's proficiency test results that
constitute unsuccessful participation in an approved proficiency
testing program, as defined in 42 C.F.R. 493.2, when the laboratory
has failed to achieve successful participation in an approved
proficiency testing program.
(F) 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.
(G) 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
accreditation 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.
(c)
(e) A certificate of accreditation
of deemed status issued pursuant to subdivision (c) shall
be renewed annually provided that the conditions for issuance
specified in subdivision (b) (c) are
still met. Each application for a certificate of
accreditation 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 t hose certificate
of accreditation application and renewal fees
collected by the department shall be sufficient to cover the cost of
issuing the certificate of accreditation, the collection of
fees, the administrative costs associated with evaluating programs of
private, nonprofit organizations, and the costs to conduct sample
validation surveys of accredited laboratories . If the
department determines that the those
certificate of accreditation fees do not fully
support the costs of these activities, it shall report that
determination to the Legislature.
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
twenty-five dollars ($25) one hundred
dollars ($100) .
(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 thirty-eight dollars ($38). This fee shall be
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 thirty-eight dollars ($38). This fee shall be
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
twenty-three dollars ($23). This fee shall be thirty-eight
dollars ($38) commencing on July 1, 1983 .
(d) The application and annual renewal fee for a cytotechnologist'
s license shall be 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
fifteen dollars ($15). This fee shall be twenty-five
dollars ($25) commencing on July 1, 1983 .
(f) The application fee for a clinical laboratory license is six
hundred dollars ($600).
(g) The annual renewal fee for a clinical laboratory license is
five hundred fifty-seven dollars ($557).
(h) The application fee for a certificate of accreditation issued
pursuant to Section 1223 is one hundred fifty dollars ($150).
(i) The annual renewal fee for a certificate of accreditation
issued pursuant to Section 1223 is one hundred dollars ($100).
(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.
(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.
(j)
(h) In addition, clinical laboratories providing
cytology services shall pay an annual fee that shall be set by the
department in an amount needed to meet but not exceed the department'
s costs of proficiency testing and special site surveys for these
laboratories, and that shall be based upon the volume of cytologic
slides examined by a laboratory. If the amount collected is less than
or exceeds the amount needed for these purposes, the amount of fees
collected from those laboratories in the following year shall be
adjusted accordingly.
(k)
(i) The application fee for a trainee's license is
eight dollars ($8). This fee shall be thirteen
dollars ($13) commencing on July 1, 1983 .
(l)
(j) The annual renewal fee for a trainee's license is
five dollars ($5). This fee shall be eight dollars
($8) commencing on July 1, 1983 .
(m)
(k) The application fee for a duplicate license is
three dollars ($3). This fee shall be five dollars
($5) commencing on July 1, 1983 .
(n)
(l) The delinquency fee is equal to the annual renewal
fee.
(o)
(m) 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.
(p)
(n) The annual fee for a 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 is fifty dollars ($50) shall pay an
annual fee of one hundred dollars ($100) . The annual
fee for a 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 is seventy-five dollars ($75) , 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
seventy-five dollars ($75) one hundred fifty dollars
($150) .
(q)
(o) 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.
(r)
(p) 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.
(s)
(q) 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.
(t) Whenever a clinical laboratory has paid registration or
compliance fees, or both, to HCFA under CLIA for the same period of
time for which a license is issued under Section 1265, the fee
required for the clinical laboratory license under subdivision (f) or
(g), and as adjusted pursuant to Section 100450 of the Health and
Safety Code, shall be reduced by the percentage of the total of all
CLIA registration and compliance fees paid to HCFA by all California
laboratories that are made available to the department to carry out
its functions as a CLIA agent in the federal fiscal year immediately
prior to when the license fee is due.
(u)
(r) 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.
(s) The costs of the department to conduct any reinspections to
ensure compliance of a laboratory applying for 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.
(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.
SEC. 5. 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 said 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 () 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. 6. 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 , and Article 5 (commencing with
Section 101150) of Chapter 2 of Part 3 of Division 101 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, public health laboratories, blood banks, or
clinical or public health 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 Notwithstanding
Section 13340 of the Government Code, 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 are hereby continuously appropriated to
the state department to administer this
chapter and , Chapter 4 (commencing
with Section 1600) of Division 2 of the Health and Safety Code ,
and Article 5 (commencing with Section 101150) of Chapter 2 of Part
3 of Division 101 of the Health and Safety Code . All fees
collected pursuant to this chapter shall , upon
appropriation, be expended to administer this chapter. 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.
All fees collected pursuant to Article 5 (commencing with Section
101150) of Chapter 2 of Part 3 of Division 101 of the Health and
Safety Code shall be expended to administer that article.
SEC. 7. Section 101151 is added to the Health and Safety Code, to
read:
101151. For purposes of this article, "CLIA" means the federal
Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec.
263a; Public Law 100-578) and the regulations adopted thereunder by
the federal Health Care Financing Administration and effective on
January 1, 1994, or any later date, when adopted in California
pursuant to subdivision (b) of Section 1208 of the Business and
Professions Code.
SEC. 8. Section 101152 is added to the Health and Safety Code, to
read:
101152. (a) A city or county public health laboratory shall be
certified or registered with the State Department of Public Health
pursuant to this section.
(b) The department shall issue a certificate or registration to a
city or county public health laboratory that meets both of the
following requirements:
(1) Pays the fees required under subdivision (c).
(2) Is found to be in compliance with this article, the
regulations adopted hereunder, and the applicable requirements of
CLIA.
(c) A certificate or registration issued to a public health
laboratory shall be valid for one year.
(d) (1) A laboratory performing only those laboratory tests or
examinations considered waived under CLIA shall register with the
department and pay an annual registration fee of one hundred dollars
($100).
(2) A laboratory performing laboratory tests or examinations
considered waived under CLIA and provider-performed microscopy, as
defined under CLIA, shall register with the department and pay an
annual registration fee of one hundred fifty dollars ($150).
(3) A laboratory performing clinical laboratory tests or
examinations classified as of moderate or of high complexity under
CLIA shall obtain a certificate from the department.
(A) The application fee for the certificate shall be based on the
number of tests it performs or expects to perform in a year, as
follows:
(i) Less than 2,001 tests: two hundred seventy dollars ($270).
(ii) Between 2,001 and 10,000, inclusive, tests: eight hundred
twenty dollars ($820).
(iii) Between 10,001 and 25,000, inclusive, tests: one thousand
three hundred fifteen dollars ($1,315).
(iv) Between 25,001 and 50,000, inclusive, tests: one thousand
five hundred eighty dollars ($1,580).
(v) Between 50,001 and 75,000, inclusive, tests: one thousand nine
hundred sixty dollars ($1,960).
(vi) Between 75,001 and 100,000, inclusive, tests: two thousand
three hundred forty dollars ($2,340).
(vii) Between 100,001 and 500,000, inclusive, tests: two thousand
seven hundred forty dollars ($2,740).
(viii) Between 500,001 and 1,000,000, inclusive, tests: four
thousand nine hundred ten dollars ($4,910).
(ix) 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.
(B) The annual renewal fee for the certificate shall be based on
the number of tests the laboratory 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: four thousand nine hundred sixty
dollars ($4,960) plus three hundred fifty dollars ($350) for every
500,000 tests over 1,000,000.
SEC. 9. Section 101160 of the Health and Safety Code is amended to
read:
101160. (a) Any city or
county public health laboratory established for the purposes set
forth in this chapter and its personnel shall be approved by
the State Department of Health Services and shall comply with the
requirements of CLIA shall meet the requirements of
this article and the regulations adopted hereunder .
(b) For purposes of this section, "CLIA" means the federal
Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec.
263a; P.L. 100-578) and the regulations adopted thereunder by the
federal Health Care Financing Administration and effective on January
1, 1994, or any later date, when adopted in California pursuant to
subdivision (b) of Section 1208 of the Business and Professions Code.
SEC. 10. Section 101161 is added to the Health and Safety Code, to
read:
101161. (a) The State Department of Public Health shall issue a
public health microbiologist certificate to each person who has
applied for the certificate on forms provided by the department if
that person is found to be in compliance with this article and the
regulations adopted hereunder and has paid an application fee of
ninety-seven dollars ($97).
(b) The department shall issue a public health laboratory director
certificate to each person who has applied for the certificate on
forms provided by the department if that person is found to be in
compliance with this article and the regulations adopted hereunder
and has paid an application fee of one hundred sixty-two dollars
($162).
(c) A certificate issued to a public health microbiologist or a
public health laboratory director shall be valid for one year.
(d) A person certified as a public health microbiologist or a
public health laboratory director shall, as a condition of renewal of
that certificate, do both of the following:
(1) Complete 12 hours of continuing education.
(2) Pay a renewal fee of sixty-six dollars ($66) for a
microbiologist certificate or one hundred sixty-two dollars ($162)
for a public health laboratory director certificate.
(e) The department may issue public health microbiologist
certificates or public health laboratory director certificates
without examination to applicants who have passed examinations
offered by a national accrediting board whose requirements are equal
to or greater than those imposed by this article and the regulations
established by the department.
SEC. 11. Section 101162 is added to the Health and Safety Code, to
read:
101162. The fees imposed pursuant to this article shall be
deposited in the Clinical Laboratory Improvement Fund created under
Section 1302 of the Business and Professions Code and,
notwithstanding Section 13340 of the Government Code, shall be
continuously appropriated to the department for expenditure for
purposes of this article.
SEC. 12. If the Commission on State Mandates determines that this
act contains costs mandated by the state, reimbursement to local
agencies and school districts for those costs shall be made pursuant
to Part 7 (commencing with Section 17500) of Division 4 of Title 2 of
the Government Code.
SEC. 13. 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.