California Business and Professions Code § 1206

(a) For the purposes of this chapter the following definitions are applicable: (1) “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. (2) “Biological specimen” means any material that is derived from the human body. (3) “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. (4) “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. (5) “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 that 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. (6) “Clinical laboratory science” means any of the sciences or scientific disciplines used to perform a clinical laboratory test or examination. (7) “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. (8) “Clinical laboratory” means a place used, or an 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. (9) “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. (10) “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. (11) “Licensed laboratory” means a clinical laboratory licensed pursuant to paragraph (1) of subdivision (a) of Section 1265. (12) “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. (13) “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 p

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