SECTIONS 1240-1246.5 - California Statutes

BUSINESS AND PROFESSIONS CODE

SECTION 1240-1246.5

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.

1241.1. (a) A primary care clinic, licensed pursuant to subdivision
(a) of Section 1204 of the Health and Safety Code, that is operating
within a network of primary care clinics, may be issued a license to
operate a clinical laboratory pursuant to Section 1265, which
authorizes the conduct of clinical laboratory tests and examinations
from its network of primary care clinics, if all of the following
conditions are met:
(1) The central laboratory's sole purpose is performing moderate
or high complexity clinical laboratory tests and examinations, or
both, for the patients of the clinics in the network.
(2) Prior to performing any tests or examinations, the central
laboratory obtains a certificate under the federal Clinical
Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) (CLIA) and
a state laboratory license for the appropriate complexity level of
clinical laboratory testing pursuant to Section 1265.
(b) For purposes of this section, "network of primary care clinics"
means two or more primary care clinics operated by the same
nonprofit corporation with the same board of directors and the same
corporate officers, and operating under the same procedures and
protocols.

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 for waived testing.
(2) The purpose of the program is to screen asymptomatic
individuals for chronic health disorders and to refer individuals to
licensed sources of care as indicated.
(3) The program does not test for human immunodeficiency virus or
any reportable disease or condition identified in Section 120130 of
the Health and Safety Code or the regulations adopted under that
section.
(4) 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.
(E) Are approved as waived tests and are used according to the
manufacturer's instructions.
(5) Blood collection is performed by skin puncture only.
(6) Testing of a urine specimen is performed by the dipstick
method only.
(7) Testing is performed on site and reported directly to the
person requesting the test.
(8) The program maintains a supervisory committee consisting of,
at a minimum, a licensed physician and surgeon and a clinical
laboratory scientist licensed pursuant to this code.
(9) 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 collecting 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. These procedures shall comply with all
county and city ordinances for medical waste management and
blood-borne pathogen control that apply to the location where the
program operates.
(E) Proper procedures to be employed in response to fainting,
excessive bleeding, or other medical emergencies.
(F) Documentation that the testing personnel are following the
instructions of the instrument's manufacturer, are trained in the
performance of the test, and are competent to perform the testing
without supervision.
(G) Reporting of assessment results to the individual being
assessed.
(H) 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 authorized to
perform skin puncture under this chapter.
(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.
(f) A program for a health fair providing diagnostic or screening
tests is not a nondiagnostic general health assessment program if all
of the requirements of this chapter are met, and the laboratory
performing the testing is licensed or registered under subdivision
(a) of Section 1265. For a test that is not authorized for
self-ordering pursuant to Section 1246.5 and that is not for a
nondiagnostic general health assessment pursuant to this section, the
licensed or registered clinical laboratory participating in the
health fair shall assure that the test is ordered on-site only by a
person licensed under this division who is authorized under his or
her scope of practice to order the test or by a person authorized by
that licensee. The results of a test performed at a health fair shall
be provided to the test subject along with an explanation of the
results.

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 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 department 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.
(C) 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.
(D) He or she has been found to be competent in phlebotomy by a
licensed physician and surgeon or person licensed pursuant to this
chapter.
(E) 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.
(3) 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.
(4) The department shall adopt regulations establishing standards
for approving national accreditation agencies to administer
certification examinations and tests pursuant to this section.
(5) 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.

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. A program for nondiagnostic general health assessment that
includes a laboratory test specified in this section shall comply
with the provisions of Section 1244. 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. A
test approved only as an over-the-counter collection device may not
be conducted pursuant to this section.