BILL NUMBER: SB 1809	AMENDED
	BILL TEXT

	AMENDED IN SENATE  APRIL 15, 2002
	AMENDED IN SENATE  APRIL 4, 2002

INTRODUCED BY   Senator Machado

                        FEBRUARY 22, 2002

   An act to amend Section 1300 of, and to add Section 1260.3 to, the
Business and Professions Code, relating to healing arts, and
declaring the urgency thereof, to take effect immediately.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1809, as amended, Machado.  Clinical laboratories.
   Existing law provides for the licensure and regulation of clinical
laboratories and various clinical laboratory health care personnel
by the State Department of Health Services.
   This bill would create a new license category for a medical
laboratory technician who would be authorized to perform waived and
moderate complexity tests or examinations  under supervision
  while working under the supervision of a physician and
surgeon or certain other licensed persons  , and to report the
test results.  The bill would require the department to issue a
medical laboratory technician license to each person who pays the
license fee and meets specified licensure requirements.  The bill
would also require the department to adopt emergency regulations to
implement licensure of medical laboratory technicians as soon as
possible, and would authorize the department to establish licensing
and renewal fees that do not exceed the costs of the department for
the program.
   The bill would declare that it is to take effect immediately as an
urgency statute.
   Vote:  2/3.  Appropriation:  no.  Fiscal committee:  yes.
State-mandated local program:  no.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:


  SECTION 1.  It is the intent of the Legislature, in enacting this
act, to begin to address the critical laboratory personnel shortage
in California.  The Legislature further finds and declares the
following:
   (a) Between 70 percent and 85 percent of all physician diagnosis
and treatment decisions are based upon clinical laboratory test
results.
   (b) California faces a shortage of over 7,000 laboratory personnel
over the next 10 years.
   (c) Current California training programs supply fewer than 100 new
laboratory staff persons per year.
   (d) There is a lack of public understanding of clinical laboratory
science and a need for better educational counseling of potential
laboratory personnel.
   (e) The absence of qualified persons conducting clinical
laboratory tests would have life or death consequences for the
public.
   (f) The demand for clinical laboratory services is real and
growing with the aging of our population.  At the same time, a
majority of the qualified clinical laboratory personnel in the state
are reaching retirement age.
   (g) The shortage of personnel in the clinical laboratory
profession necessitates the development of a career ladder to develop
a supply of personnel to the clinical laboratory field.
   In light of the above findings, the Legislature recognizes that
creation of the medical laboratory technician category is a small but
necessary step to address the severe clinical laboratory personnel
shortages in California.
  SEC. 2.  Section 1260.3 is added to the Business and Professions
Code, to read:
   1260.3.  (a) The department shall issue a medical laboratory
technician license to each person who meets the following
requirements:
   (1) Lawfully holds an associate of science degree or an equivalent
or higher degree from an accredited institution.
   (2) Has met the requirements of this chapter and any reasonable
qualifications established by regulations of the department,
including, but not limited to, any of the following:
   (A) The completion of 60 semester (90 quarter) units from an
accredited college or university, with 36 semester units in physical
or biological sciences with an emphasis in applied sciences.
   (B) Graduation from a medical laboratory technician training
program accredited by the National Accrediting Agency for Clinical
Laboratory Sciences or other recognized accrediting program approved
by the department.
   (C) Graduation from an advanced military medical laboratory
specialist program approved by the department.
   (3) Has applied for the license on forms provided by the
department.
   (4) Has paid a license fee established in regulations of the
department in accordance with subdivision (v) of Section 1300.
   (b) A licensed medical laboratory technician may perform clinical
laboratory tests or examinations classified as waived or of moderate
complexity under CLIA, and may report the test results.  However, a
licensed medical laboratory technician shall not perform microscopic
analysis or immunohematology procedures.   A clinical
laboratory test or examination performed by a licensed medical
laboratory technician shall be performed under the supervision of a
clinical laboratory scientist or any other appropriate laboratory
personnel, as defined in the regulations of the department. 
 The medical laboratory technician shall work under the
supervision of a licensed physician and surgeon or a baccalaureate,
masters, or doctoral level person licensed pursuant to this chapter.
The supervision shall be required during the entire time a medical
laboratory technician performs clinical laboratory tests or
examinations. 
   (c) The department shall adopt emergency regulations to implement
this section as soon as possible.
  SEC. 3.  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 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).
   (j) 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) 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) 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) The application fee for a duplicate license is three dollars
($3).  This fee shall be five dollars ($5) commencing on July 1,
1983.
   (n) The delinquency fee is equal to the annual renewal fee.
   (o) 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) The certification and renewal fees for hemodialysis
technicians certified under subdivision (a) of Section 1247.6 shall
be fifty dollars ($50).
   (q) The annual fee for 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).  The annual fee
for 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).  A clinical laboratory performing both waived and
provider-performed microscopy shall pay an annual registration fee of
seventy-five dollars ($75).
   (r)  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.
   (s) 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.
   (t) 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.
   (u) 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.
   (v) 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.
  SEC. 4.  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:
   The severe shortage of clinical laboratory personnel, especially
personnel licensed as clinical laboratory scientists or limited
clinical laboratory scientists is creating the potential for a crisis
in clinical laboratory testing capacity.  A new licensure category
for laboratory personnel qualified to perform waived and moderately
complex testing in a clinical laboratory, the medical laboratory
technician, is needed to allow sufficient personnel capacity to deal
with the current testing needs of the public.  In addition, any
catastrophic biological event, event of bioterrorism, or public
health epidemic could not be optimally handled given the current
shortage of clinical laboratory testing capacity.
   In order for the residents of the state to benefit from additional
qualified personnel to perform appropriate testing activities in
clinical laboratories as soon as possible, and in order to provide
sufficient personnel to deal with these events  biological
events  , it is necessary that this act take effect
immediately.