1240.  This chapter does not authorize any person to practice
medicine and surgery or to furnish the services of physicians for the
practice of medicine and surgery.  This chapter does not repeal or
in any manner affect any provision of this code relating to the
practice of medicine.  This chapter does not prohibit the performance
of tests not covered in Section 1206.



1241.  (a) This chapter applies to all clinical laboratories in
California or receiving biological specimens originating in
California for the purpose of performing a clinical laboratory test
or examination, and to all persons performing clinical laboratory
tests or examinations or engaging in clinical laboratory practice in
California or on biological specimens originating in California,
except as provided in subdivision (b).
   (b) This chapter shall not apply to any of the following clinical
laboratories, or to persons performing clinical laboratory tests or
examinations in any of the following clinical laboratories:
   (1) Those owned and operated by the United States of America, or
any department, agency, or official thereof acting in his or her
official capacity to the extent that the Secretary of the federal
Department of Health and Human Services has modified the application
of CLIA requirements to those laboratories.
   (2) Public health laboratories, as defined in Section 1206.
   (3) Those that perform clinical laboratory tests or examinations
for forensic purposes only.
   (4) Those that perform clinical laboratory tests or examinations
for research and teaching purposes only and do not report or use
patient-specific results for the diagnosis, prevention, or treatment
of any disease or impairment of, or for the assessment of the health
of, an individual.
   (5) Those that perform clinical laboratory tests or examinations
certified by the National Institutes on Drug Abuse only for those
certified tests or examinations.  However, all other clinical
laboratory tests or examinations conducted by the laboratory are
subject to this chapter.
   (6) Those that register with the State Department of Health
Services pursuant to subdivision (c) to perform blood glucose testing
for the purposes of monitoring a minor child diagnosed with diabetes
  if the person performing the test has been entrusted with the care
and control of the child by the child's parent or legal guardian and
provided that all of the following occur:
   (A) The blood glucose monitoring test is performed with a blood
glucose monitoring instrument that has been approved by the federal
Food and Drug Administration for sale over the counter to the public
without a prescription.
   (B) The person has been provided written instructions by the child'
s health care provider or an agent of the child's health care
provider in accordance with the manufacturer's instructions on the
proper use of the monitoring instrument and the handling of any
lancets, test strips, cotton balls, or other items used during the
process of conducting a blood glucose test.
   (C) The person, receiving written authorization from the minor's
parent or legal guardian, complies with written instructions from the
child's health care provider, or an agent of the child's health care
provider, regarding the performance of the test and the operation of
the blood glucose monitoring instrument, including how to determine
if the results are within the normal or therapeutic range for the
child, and any restriction on activities or diet that may be
necessary.
   (D) The person complies with specific written instructions from
the child's health care provider or an agent of the child's health
care provider regarding the identification of symptoms of
hypoglycemia or hyperglycemia, and actions to be taken when results
are not within the normal or therapeutic range for the child.  The
instructions shall also contain the telephone number of the child's
health care provider and the telephone number of the child's parent
or legal guardian.
   (E) The person records the results of the blood glucose tests and
provides them to the child's parent or legal guardian on a daily
basis.
   (F) The person complies with universal precautions when performing
the testing and posts a list of the universal precautions in a
prominent place within the proximity where the test is conducted.
   (7) Those individuals who perform clinical laboratory tests or
examinations, approved by the federal Food and Drug Administration
for  sale to the public without a prescription in the form of an
over-the-counter test kit, on their own bodies or on their minor
children or legal wards.
   (8) Those certified emergency medical technicians and licensed
paramedics providing basic life support services or advanced life
support services as defined in Section 1797.52 of the Health and
Safety Code who perform only blood glucose tests that are classified
as waived clinical laboratory tests under CLIA, if the provider of
those services obtains a valid certificate of waiver and complies
with all other requirements for the performance of waived clinical
laboratory tests under applicable federal regulations.
   (c) Any place where blood glucose testing is performed pursuant to
paragraph (6) of subdivision (b) shall register by notifying the
State Department of Health Services in writing no later than 30 days
after testing has commenced.  Registrants pursuant to this
subdivision shall not be required to pay any registration or renewal
fees nor shall they be subject to routine inspection by the State
Department of Health Services.



1242.  Any person duly licensed under the provisions of this chapter
to perform tests called for in a clinical laboratory may perform
skin tests for specific diseases, arterial puncture, venipuncture, or
skin puncture for purposes of withdrawing blood or for clinical
laboratory test purposes as defined by regulations established by the
department and upon specific authorization from any person in
accordance with the authority granted under any provisions of law
relating to the healing arts.



1242.5.  Notwithstanding paragraphs (2) and (3) of subdivision (b)
of Section 1241, the department may by regulation authorize
laboratory personnel certified pursuant to Section 1246 to perform
venipuncture, arterial puncture, or skin puncture for the purposes of
withdrawing blood or for clinical laboratory test purposes, as
defined by regulations established by the department.



1242.6.  (a) Any registered nurse licensed under the provisions of
Chapter 6 (commencing with Section 2700) of Division 2 may perform
arterial puncture, venipuncture, or skin puncture for the purposes of
withdrawing blood or for test purposes upon authorization from any
licensed physician and surgeon or any licensed dentist.
   (b) Any licensed vocational nurse licensed under the provisions of
Chapter 6.5 (commencing with Section 2840) of Division 2 may perform
arterial puncture, venipuncture, or skin puncture for the purposes
of withdrawing blood or for test purposes upon authorization from any
licensed physician and surgeon, or any licensed dentist if prior
thereto the licensed vocational nurse has been instructed by a
physician and surgeon and has demonstrated competence to the
physician and surgeon in the proper procedure to be employed when
withdrawing blood, or has satisfactorily completed a prescribed
course of instruction approved by the Board of Vocational Nursing and
Psychiatric Technicians or has demonstrated competence to the
satisfaction of that board.
   (c) Any respiratory care practitioner certified under the
provisions of Chapter 8.3 (commencing with Section 3700) of Division
2 may perform arterial puncture, venipuncture, or skin puncture for
the purposes of withdrawing blood or for test purposes upon
authorization from any licensed physician and surgeon.



1243.  A student regularly matriculated in any college or university
accredited by an accrediting agency acceptable to the department, or
in any legally chartered school approved by the department for
training purposes may perform arterial puncture, venipuncture, or
skin puncture as a part of the necessary training program when done
under the direct and responsible supervision of a person licensed to
perform tests under the provisions of this chapter or a licensed
physician and surgeon.



1244.  (a) Nothing in this chapter shall restrict, limit, or prevent
a program of nondiagnostic general health assessment provided that:

   (1) The program meets the requirements of Section 1265 and
complies with the requirements of CLIA.
   (2) The purpose of the program is to refer individuals to licensed
sources of care as indicated.
   (3) The program utilizes only those devices that comply with all
of the following:
   (A) Meet all applicable state and federal performance standards
pursuant to Section 111245 of the Health and Safety Code.
   (B) Are not adulterated as specified in Article 2 (commencing with
Section 111250) of Chapter 6 of Part 5 of Division 104 of the Health
and Safety Code.
   (C) Are not misbranded as specified in Article 3 (commencing with
Section 111330) of Chapter 6 of Part 5 of Division 104 of the Health
and Safety Code.
   (D) Are not new devices unless they meet the requirements of
Section 111550 of the Health and Safety Code.
   (4) The program maintains a supervisory committee consisting of,
at a minimum, a licensed physician and surgeon and a laboratory
technologist licensed pursuant to this chapter.
   (5) The supervisory committee for the program adopts written
protocols that shall be followed in the program and that shall
contain all of the following:
   (A) Provision of written information to individuals to be assessed
that shall include, but not be limited to, the following:
   (i) The potential risks and benefits of assessment procedures to
be performed in the program.
   (ii) The limitations, including the nondiagnostic nature, of
assessment examinations of biological specimens performed in the
program.
   (iii) Information regarding the risk factors or markers targeted
by the program.
   (iv) The need for followup with licensed sources of care for
confirmation, diagnosis, and treatment as appropriate.
   (B) Proper use of each device utilized in the program including
the operation of analyzers, maintenance of equipment and supplies,
and performance of quality control procedures including the
determination of both accuracy and reproducibility of measurements in
accordance with instructions provided by the manufacturer of the
assessment device used.
   (C) Proper procedures to be employed when drawing blood, if blood
specimens are to be obtained.
   (D) Proper procedures to be employed in handling and disposing of
all biological specimens to be obtained and material contaminated by
those biological specimens.
   (E) Proper procedures to be employed in response to fainting,
excessive bleeding, or other medical emergencies.
   (F) Reporting of assessment results to the individual being
assessed.
   (G) Referral and followup to licensed sources of care as
indicated.
   The written protocols adopted by the supervisory committee shall
be maintained for at least one year following completion of the
assessment program during which period they shall be subject to
review by department personnel and the local health officer or his or
her designee, including the public health laboratory director.
   (b) If skin puncture to obtain a blood specimen is to be performed
in a program of nondiagnostic general health assessment, the
individual performing the skin puncture shall be either:
   (1) Authorized to perform skin puncture under this chapter.
   (2) Any person who possesses a statement signed by a licensed
physician and surgeon that attests that the named person has received
adequate training in the proper procedure to be employed in skin
puncture.
   (c) A program of nondiagnostic general health assessment that
fails to meet the requirements set forth in subdivisions (a) and (b)
shall not operate.
   (d) For purposes of this section, "skin puncture" means the
collection of a blood specimen by the finger prick method only and
does not include venipuncture, arterial puncture, or any other
procedure for obtaining a blood specimen.
   (e) Nothing in this chapter shall be interpreted as prohibiting a
licensed clinical laboratory from operating a program of
nondiagnostic general health assessment provided that the clinical
laboratory complies with the requirements of this section.



1244.1.  Thirty days prior to operating a program of nondiagnostic
general health assessment, the entity or person operating that
program shall file the following documentation with the local health
officer in each county in which the program shall operate:
   (a) The location of the program, the type and kind of
nondiagnostic general health assessments being conducted, the dates
and times of operation of programs, and evidence that the program
shall be operated in compliance with Section 1244.
   (b) The local health officer shall be notified in writing of any
changes to occur in locations, dates, or times indicated in the
documentation required in subdivision (a).  The local health officer
shall be notified of any changes at least 24 hours prior to the
program operating at the different locations, dates, or times.



1244.3.  Responsibility for enforcement of Sections 1244 and 1244.1
shall be with the local health officer or his or her authorized
designee, including public health laboratory directors.  Nothing in
this section shall prevent the department from using any necessary
enforcement actions for the protection of the public health and
safety.



1244.4.  Any fee for the filing of documentation and related
enforcement activities pursuant to Section 1244, 1244.1, and 1244.3
shall be determined by the local enforcement agency  and shall not
exceed one hundred dollars ($100) except that those fees shall be
adjusted annually by any annual increase in the California Consumer
Price Index as determined pursuant to Section 2212 of the Revenue and
Taxation Code.  All moneys collected as fees pursuant to this
section shall be deposited in the appropriate city, county, or city
and county treasury and shall only be expended in carrying out
Sections 1244, 1244.1, and 1244.3.


1245.  (a) Any individual may perform a blood gas analysis if all
the following conditions exist:
   (1) He or she has earned a high school diploma or equivalent, as
determined by HCFA pursuant to CLIA.
   (2) He or she performs the blood gas analysis in a clinic or a
general acute care hospital, as defined respectively in Sections 1202
and 1250 of the Health and Safety Code.
   (3) He or she has been instructed by a physician and surgeon
licensed in this state, who is in charge of a department of pulmonary
physiology or clinical pathology in licensed clinics or hospitals,
as defined respectively in Sections 1202 and 1250 of the Health and
Safety Code, in the proper procedure to be employed when performing a
blood gas analysis.
   (4) He or she performs the blood gas analysis under the direction
and supervision of the physician and surgeon.
   (5) He or she submits the analysis for interpretation to the
physician and surgeon under whose direction and supervision he or she
performed the analysis.
   (b) After September 1, 1997, any person may perform a blood gas
analysis classified as of high complexity under CLIA, if, in addition
to the requirements of subdivision (a), he or she has earned an
associate degree related to pulmonary function from an accredited
institution as determined by HCFA pursuant to CLIA.
   (c) Nothing contained in this section shall be construed as
authorizing any individual, not otherwise authorized, to withdraw
blood.
   (d) Nothing contained in this section is applicable to a person
licensed as a respiratory care practitioner under Chapter 8.3
(commencing with Section 3700).  Those persons are authorized to
perform those functions set forth in that chapter.



1246.  (a) Except as provided in subdivision (b), 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 or 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 Health Services
and has a statement signed by the instructing physician and surgeon
or by the instructing clinical laboratory bioanalyst that such
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 comply with
this requirement within three years after the effective date of those
regulations.
   (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).
   (c) 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.


1246.5.  Notwithstanding any other provision of law, any person may
request, and any licensed clinical laboratory or public health
laboratory may perform, the laboratory tests specified in this
section.  A registered clinical laboratory may perform the laboratory
tests specified in this section if the test is subject to a
certificate of waiver under CLIA and the laboratory has registered
with the department under paragraph (2) of subdivision (a) of Section
1265. The results from any test may be provided directly to the
person requesting the test if the test is on or for his or her own
body.  These test results shall be provided in a manner that presents
clear information and that identifies results indicating the need
for referral to a physician and surgeon.
   The tests that may be conducted pursuant to this section are:
pregnancy, glucose level, cholesterol, occult blood, and any other
test for which there is a test for a particular analyte approved by
the federal Food and Drug Administration for sale to the public
without a prescription in the form of an over-the-counter test kit.