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 theophylline, or any substance or property whose presence or absence, concentration, activity, intensity, or other characteristics are to be determined.

(2) “Assistance” means acting under the direction of a licensed physician and surgeon or personnel licensed under this chapter, other than a trainee, under direct and constant supervision, and during which time no independent decisionmaking or judgment is exercised.

(3) “Biological specimen” means any material that is derived from the human body.

(4) “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.

(5) “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.

(6) “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.

(7) “Clinical laboratory science” means any of the sciences or scientific disciplines used to perform a clinical laboratory test or examination.

(8) “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.

(9) “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.

(10) “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.

(11) “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.

(12) “Licensed laboratory” means a clinical laboratory licensed pursuant to paragraph (1) of subdivision (a) of Section 1265.

(13) “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.

(14) “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 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.

(15) “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 the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).

(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.

(16) “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.

(17) “Registered laboratory” means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.

(18) “Specialty” means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.

(19) “Subspecialty” means all of the following:

(A) 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.

(B) For purposes of diagnostic immunology, means syphilis serology, general immunology, or other subspecialty specified by regulation adopted by the department.

(C) For purposes of chemistry, means routine chemistry, clinical microscopy, endocrinology, toxicology, or other subspecialty specified by regulation adopted by the department.

(D) 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.

(E) For pathology, means tissue pathology, oral pathology, diagnostic cytology, or other subspecialty specified by regulation adopted by the department.

(F) For purposes of genetics, means molecular biology related to the diagnosis of human genetic abnormalities, cytogenetics, biochemical genetics, laboratory genetics, or other subspecialty specified by regulation adopted by the department.

(G) For purposes of reproductive biology, means andrology and embryology, including diagnostic testing for management of primary and secondary infertility, fertility assessment, and fertility preservation, as well as the evaluation and assessment of gametes and embryos and their associated fluids and tissues, or other subspecialty specified by regulation adopted by the department. Reproductive biology does not include the qualitative assessment of sperm in preparation for intrauterine insemination.

(20) (A) “Supervision and control” means direction, management, and awareness of the activity of unlicensed laboratory personnel by a physician and surgeon or by a person licensed under this chapter other than a trainee, who must be physically present in the laboratory and readily available for consultation during the entire time that the unlicensed laboratory personnel are engaged in the duties specified in Section 1269.

(B) The laboratory director shall designate the supervisor and shall maintain overall responsibility for the supervision and performance of the unlicensed laboratory personnel.

(b) This chapter does not restrict, limit, or prevent a person licensed to provide health care services under the laws of this state, including, but not limited to, physicians and surgeons and registered nurses, from practicing the profession or occupation for which the person is licensed.

(c) This chapter does not authorize a 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 does not authorize a person, who is not otherwise authorized, to perform venipuncture, arterial puncture, or skin puncture.

1269.

 (a) (1) Unlicensed laboratory personnel may perform any of the activities identified in subdivision (b) under the direct and constant supervision of, or any of the activities identified in subdivision (c) under the supervision and control of, a physician and surgeon, or a person licensed under this chapter other than a trainee, in a clinical laboratory upon meeting all of the following criteria:

(A) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.

(B) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:

(i) The skills required for proper specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens.

(ii) The skills required for assisting a physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.

(iii) The skills and working knowledge required for performing preventive maintenance and troubleshooting.

(iv) A working knowledge of reagent stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.

(v) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.

(vi) An awareness of the factors that influence test results.

(vii) A working knowledge of the medical terminology necessary for the transcription of results.

(2) The laboratory director shall maintain responsibility for the performance of unlicensed laboratory personnel and any delegated supervision or training of the unlicensed personnel.

(b) The activities that may be performed under direct and constant supervision are:

(1) (A) Assisting a physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.

(B) In the case of qualitative and semiquantitative “spot, tablet, or stick” tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter.

(2) Assisting in preventive maintenance and troubleshooting.

(3) Assisting in the performance of quality control procedures.

(c) Unlicensed laboratory personnel may, under the supervision and control of a physician and surgeon or person licensed under this chapter, do all of the following activities:

(1) Perform biological specimen collection, including patient preparation, specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens if the collection activities do not require a certificate or license under this division.

(2) Preparation and storage of reagents and culture media.

(3) Transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed under this chapter, or automatically by a testing instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test.

(4) Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media for microbiological tests.

(d) Unlicensed laboratory personnel shall not do any of the following:

(1) Record test results, except as authorized under paragraph (3) of subdivision (c).

(2) Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure, unless they are assisting a physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.

(3) Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, unless they are assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.

(4) Release results of waived, moderate-, or high-complexity testing.

(e) When any of the following mechanical or electronic instruments are employed, unlicensed laboratory personnel shall not perform any of the following activities:

(1) Standardizing or calibrating the instrument or assessing its performance by monitoring results of appropriate standards and control.

(2) Reading or recording test results, except as authorized under paragraph (3) of subdivision (c).

(3) Quantitatively measuring any sample or reagents unless done automatically by the instrument in the course of its normal operation or by the use of previously calibrated and approved automatic syringes or other dispensers.