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Cal. Bus. & Prof. Code § 1206

Cal. Bus. & Prof. Code § 1206 – On-Site Testing

1206.  (a) For the purposes of this chapter the following
definitions are applicable:
   (1) "Biological specimen" means any material that is derived from
the human body.
   (2) "Blood electrolyte analysis" means the measurement of
electrolytes in a blood specimen by means of ion selective electrodes
on instruments specifically designed and manufactured for blood gas
and acid-base analysis.
   (3) "Blood gas analysis" means a clinical laboratory test or
examination that deals with the uptake, transport, and metabolism of
oxygen and carbon dioxide in the human body.
   (4) "Clinical laboratory test or examination" means the detection,
identification, measurement, evaluation, correlation, monitoring,
and reporting of any particular analyte, entity, or substance within
a biological specimen for the purpose of obtaining scientific data
which may be used as an aid to ascertain the presence, progress, and
source of a disease or physiological condition in a human being, or
used as an aid in the prevention, prognosis, monitoring, or treatment
of a physiological or pathological condition in a human being, or
for the performance of nondiagnostic tests for assessing the health
of an individual.
   (5) "Clinical laboratory science" means any of the sciences or
scientific disciplines used to perform a clinical laboratory test or
examination.
   (6) "Clinical laboratory practice" means the application of
clinical laboratory sciences or the use of any means that applies the
clinical laboratory sciences within or outside of a licensed or
registered clinical laboratory. Clinical laboratory practice includes
consultation, advisory, and other activities inherent to the
profession.
   (7) "Clinical laboratory" means any place used, or any
establishment or institution organized or operated, for the
performance of clinical laboratory tests or examinations or the
practical application of the clinical laboratory sciences. That
application may include any means that applies the clinical
laboratory sciences.
   (8) "Direct and constant supervision" means personal observation
and critical evaluation of the activity of unlicensed laboratory
personnel by a physician and surgeon, or by a person licensed under
this chapter other than a trainee, during the entire time that the
unlicensed laboratory personnel are engaged in the duties specified
in Section 1269.
   (9) "Location" means either a street and city address, or a site
or place within a street and city address, where any of the clinical
laboratory sciences or scientific disciplines are practiced or
applied, or where any clinical laboratory tests or examinations are
performed.
   (10) "Physician office laboratory" means a clinical laboratory
that is licensed or registered under Section 1265, and that is
either: (A) a clinical laboratory that is owned and operated by a
partnership or professional corporation that performs clinical
laboratory tests or examinations only for patients of five or fewer
physicians and surgeons or podiatrists who are shareholders,
partners, or employees of the partnership or professional corporation
that owns and operates the clinical laboratory; or (B) a clinical
laboratory that is owned and operated by an individual licensed
physician and surgeon or a podiatrist, and that performs clinical
laboratory tests or examinations only for patients of the physician
and surgeon or podiatrist who owns and operates the clinical
laboratory.
   (11) "Public health laboratory" means a laboratory that is
operated by a city or county in conformity with Article 5 (commencing
with Section 101150) of Chapter 2 of Part 3 of Division 101 of the
Health and Safety Code and the regulations adopted thereunder.
   (12) "Specialty" means histocompatibility, microbiology,
diagnostic immunology, chemistry, hematology, immunohematology,
pathology, genetics, or other specialty specified by regulation
adopted by the department.
   (13) "Subspecialty" for purposes of microbiology, means
bacteriology, mycobacteriology, mycology, parasitology, virology,
molecular biology, and serology for diagnosis of infectious diseases,
or other subspecialty specified by regulation adopted by the
department; for purposes of diagnostic immunology, means syphilis
serology, general immunology, or other subspecialty specified by
regulation adopted by the department; for purposes of chemistry,
means routine chemistry, clinical microscopy, endocrinology,
toxicology, or other subspecialty specified by regulation adopted by
the department; for purposes of immunohematology, means ABO/Rh Type
and Group, antibody detection for transfusion, antibody detection
nontransfusion, antibody identification, compatibility, or other
subspecialty specified by regulation adopted by the department; for
pathology, means tissue pathology, oral pathology, diagnostic
cytology, or other subspecialty specified by regulation adopted by
the department; for purposes of genetics, means molecular biology
related to the diagnosis of human genetic abnormalities,
cytogenetics, or other subspecialty specified by regulation adopted
by the department.
   (14) "Direct and responsible supervision" means both of the
following:
   (A) Personal observation and critical evaluation of the activity
of a trainee by a physician and surgeon, or by a person licensed
under this chapter other than a trainee, during the entire time that
the trainee is performing clinical laboratory tests or examinations.
   (B) Personal review by the physician and surgeon or the licensed
person of all results of clinical laboratory testing or examination
performed by the trainee for accuracy, reliability, and validity
before the results are reported from the laboratory.
   (15) "Licensed laboratory" means a clinical laboratory licensed
pursuant to paragraph (1) of subdivision (a) of Section 1265.
   (16) "Registered laboratory" means a clinical laboratory
registered pursuant to paragraph (2) of subdivision (a) of Section
1265.
   (17) "Point-of-care laboratory testing device" means a portable
laboratory testing instrument to which the following applies:
   (A) It is used within the proximity of the patient for whom the
test or examination is being conducted.
   (B) It is used in accordance with the patient test management
system, the quality control program, and the comprehensive quality
assurance program established and maintained by the laboratory
pursuant to paragraph (2) of subdivision (d) of Section 1220.
   (C) It meets the following criteria:
   (i) Performs clinical laboratory tests or examinations classified
as waived or of moderate complexity under CLIA.
   (ii) Performs clinical laboratory tests or examinations on
biological specimens that require no preparation after collection.
   (iii) Provides clinical laboratory tests or examination results
without calculation or discretionary intervention by the testing
personnel.
   (iv) Performs clinical laboratory tests or examinations without
the necessity for testing personnel to perform calibration or
maintenance, except resetting pursuant to the manufacturer's
instructions or basic cleaning.
   (18) "Analyte" means the substance or constituent being measured
including, but not limited to, glucose, sodium, or theophyline, or
any substance or property whose presence or absence, concentration,
activity, intensity, or other characteristics are to be determined.
   (b) Nothing in this chapter shall restrict, limit, or prevent any
person licensed to provide health care services under the laws of
this state, including, but not limited to, licensed physicians and
surgeons and registered nurses, from practicing the profession or
occupation for which he or she is licensed.
   (c) Nothing in this chapter shall authorize any person to perform
or order health care services, or utilize the results of the clinical
laboratory test or examination, unless the person is otherwise
authorized to provide that care or utilize the results. The inclusion
of a person in Section 1206.5 for purposes of performing a clinical
laboratory test or examination shall not be interpreted to authorize
a person, who is not otherwise authorized, to perform venipuncture,
arterial puncture, or skin puncture.

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