Amended IN Assembly April 27, 2023 CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 1741Introduced by Assembly Member WaldronFebruary 17, 2023An act to amend Sections 1206, 1261, 1261.5, 1206 and 1269 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 1741, as amended, Waldron. Healing arts: clinical laboratories: personnel.Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law requires the department to issue a clinical laboratory scientists or a limited clinical laboratory scientists license in specified areas of laboratory specialty or subspecialty. Existing law requires an applicant to meet both an educational requirement and a training or experience requirement to qualify for admission to the examination for this license.This bill would allow a persons experience as an unlicensed person performing specified duties in a California-licensed laboratory for at least 18 months to count toward qualification of licensure.Existing law authorizes unlicensed laboratory personnel who have earned a high school diploma or its equivalent and who meet specified training requirements to perform specified activities in a licensed clinical laboratory under the direct and constant supervision of a physician and surgeon or licensed person, including biological specimen collection, assisting in preventive maintenance, and preparing and storing reagents and culture media. Existing law authorizes unlicensed laboratory personnel who do not meet the specified training requirements only to perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing. A violation of these provisions is a crime. This bill would revise the activities that may be performed by an unlicensed person to specify those activities that may be performed under direct and constant supervision of a physician and surgeon or licensed person, those activities that may be performed under supervision and control, as defined, and those activities that may not be performed by an unlicensed person. Existing law prohibits unlicensed laboratory personnel from performing 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 validity of a test procedure. The bill would provide an exception to this prohibition if the unlicensed person is assisting a licensed physician and surgeon or a licensed person, other than a trainee, in a licensed clinical laboratory. The bill would also prohibit unlicensed laboratory personnel from releasing waived, moderate-, or high-complexity testing. testing and from performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, as specified. The bill would make conforming changes.By expanding the scope of an existing crime, this bill would create a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 1206 of the Business and Professions Code is amended to read: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, theophylline, 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 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.(14) 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 manufacturers instructions or basic cleaning.(15) 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.(16) Registered laboratory means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.(17) Specialty means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.(18) 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.(19)Supervision and control means a qualified supervisor who is a physician and surgeon licensed under Chapter 5 (commencing with Section 2000) or a person licensed under Chapter 3 (commencing with Section 1200), other than a certified phlebotomy technician or a licensed trainee, is designated by the laboratory director to provide supervision, and is physically present onsite at the location where the unlicensed person is working. The supervisor shall be available for consultation as needed.(19) (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, licensed 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.SEC. 2.Section 1261 of the Business and Professions Code is amended to read:1261.(a)(1)The department shall issue a clinical laboratory scientists or a limited clinical laboratory scientists license to each person who is a lawful holder of a baccalaureate or an equivalent or higher degree, who has applied for the license on forms provided by the department and has met the requirements of this chapter and any reasonable qualifications established by regulations of the department. However, an exception to the degree requirement may be made by the department for the clinical laboratory scientists license only if the applicant for the license has completed a minimum of two years of experience as a licensed trainee or the equivalent thereof, as determined by the department, doing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the department. In addition, the applicant applying under this section must have 90 semester hours or equivalent quarter hours of university or college work or the equivalent thereof, as may be determined by the department, which shall have included at least 23 semester hours or equivalent quarter hours of science courses as specified by regulations of the department. Additional college or university work that includes courses in the fundamental sciences may be substituted for one of the two years of experience in the ratio of 30 semester hours or equivalent quarter hours for each year of experience. This exception shall not apply to the limited clinical laboratory scientists license. The department shall hold examinations to aid it in judging the qualifications of applicants. Licenses may be issued in any or all of the sciences applied in a clinical laboratory as determined by regulation established by the department. The department shall establish by regulation the college courses or majors to be included in the college or university training and the amount and kind of training or experience required. Examinations, training, or experience requirements for limited licenses shall cover only the science concerned. The department may identify by regulation the appropriate sciences and shall establish the minimum requirements for training and experience and required courses or major for each. Experience as an unlicensed person performing those duties permitted in Section 1269 in a California laboratory licensed under this chapter for at least 18 months shall count toward qualification of licensure.(2)Prior to the adoption of implementing regulations and notwithstanding subdivision (c) of Section 1261.5, the department shall issue a clinical reproductive biologist scientist license to every applicant for licensure who has applied for the license on forms provided by the department, who holds a baccalaureate or an equivalent or higher degree in a chemical, physical, or biological science or clinical laboratory science, who is certified as an andrology laboratory scientist, an embryology laboratory scientist, or a technical supervisor of andrology or embryology by a certifying board in the specialty of reproductive biology, clinical andrology, or clinical embryology approved by the department, and who meets the qualifications of training, education, and experience specified in Section 1261.5.(3)Prior to the adoption of implementing regulations and notwithstanding subdivision (c) of Section 1261.5, the department shall issue a clinical laboratory geneticist scientist license to every applicant for licensure who has applied for the license on forms provided by the department, who holds a baccalaureate or an equivalent or higher degree in a chemical, physical, or biological science, clinical laboratory science, or a field related to genetics, who is certified in biochemical genetics or laboratory genetics and genomics by a certifying board in the specialty of genetics approved by the department, and who meets the qualifications of training, education, and experience specified in Section 1261.5.(4)Experience as a clinical laboratory technician in any branch of the Armed Forces of the United States may be considered equivalent to the experience as a trainee, if the experience is approved by the department. Each year of training and experience as a clinical laboratory technician in the armed forces shall be equivalent to 15 semester hours, which shall be credited to the minimum number of hours required to qualify for licensure as a trainee. The semester hours acquired in this manner shall not consist of the science courses required by the department under this section. The maximum number of hours granted shall not exceed 60 semester hours or its equivalent.(b)(1)Notwithstanding subdivision (a), the department shall establish an MLT-to-CLS pathway program by January 1, 2022, that would authorize a licensed MLT to apply their work experience and training from a department-approved MLT training program towards the completion of a CLS training program. The work experience and training may only be eligible for the pathway program upon approval by the department.(2)For purposes of this subdivision:(A)CLS means a clinical laboratory scientist.(B)MLT means a medical laboratory technician.SEC. 3.Section 1261.5 of the Business and Professions Code is amended to read:1261.5.(a)The department may issue limited clinical laboratory scientists licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, genetic molecular biology, cytogenetics, laboratory genetics, reproductive biology, or other areas of laboratory specialty or subspecialty when determined to be necessary by the department in order for licensure categories to keep abreast of changes in laboratory or scientific technology. Whenever the department determines that a new limited clinical laboratory scientist license category is necessary, it shall adopt regulations identifying the category and the areas of specialization included within the category.(b)To qualify for admission to the examination for a special clinical laboratory scientists license, an applicant shall have both the following:(1)Graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate or higher degree with a major appropriate to the field for which a license is being sought.(2)Either of the following: (A)One year of full-time postgraduate training or experience in the various areas of analysis in the field for which a license is being sought in a laboratory that has a license issued under this chapter or which the department determines is equivalent thereto.(B)Eighteen months of full-time training or experience as an unlicensed person performing duties specified in Section 1269 in a laboratory licensed under this chapter appropriate to the field for which a license is being sought.(c)Whenever a limited clinical laboratory scientists license is established for a specific area of specialization, the department may issue the license without examination to applicants who had met standards of education and training, defined by regulations, and to applicants certified by a board approved for that certification by the department, prior to the date of the adoption of implementing regulations.(d)The department shall adopt regulations to implement this section.SEC. 4.SEC. 2. Section 1269 of the Business and Professions Code is amended to read: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:(1)(A) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.(2)(B) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:(A)(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.(B)(ii) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.(C)(iii) The skills and working knowledge required for performing preventive maintenance, maintenance and troubleshooting.(D)(iv) A working knowledge of reagent stability and storage. stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.(E)(v) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.(F)(vi) An awareness of the factors that influence test results.(G)The skills to perform waived testing.(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) (1) The activities that may be performed under direct and constant supervision are:(1)(A) (i) Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory with the performance of moderate- or high-complexity testing. laboratory.(ii) 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)(B) Assisting in troubleshooting.(3)(C) Assisting in the performance of quality control procedures.(c) An unlicensed laboratory personnel, other than a trainee, 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. specimens if the collection activities do not require a certificate or license under this division.(2) Perform preventive maintenance.(3) Preparation and storage of reagents and culture media.(4) 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. instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test.(5)Perform waived testing, but the results shall be read by a physician and surgeon or person licensed under this chapter.(6)When any of the following manual methods are employed, the activities shall be limited as follows:(A)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.(B)In the case of microbiological tests, the unlicensed laboratory personnel may make(5) Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. media for microbiological tests.(d) Unlicensed laboratory personnel shall not do any of the following:(1) Record test results, but they may 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. except as authorized under paragraph (4) 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 licensed 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. (3)(4) Release results of waived, moderate, moderate-, or high-complexity testing.(e)When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows:(1)In the case of qualitative and semi-quantitative 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)In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media.(f)(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 that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. as authorized under paragraph (4) 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.SEC. 5.SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
Amended IN Assembly April 27, 2023 CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 1741Introduced by Assembly Member WaldronFebruary 17, 2023An act to amend Sections 1206, 1261, 1261.5, 1206 and 1269 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 1741, as amended, Waldron. Healing arts: clinical laboratories: personnel.Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law requires the department to issue a clinical laboratory scientists or a limited clinical laboratory scientists license in specified areas of laboratory specialty or subspecialty. Existing law requires an applicant to meet both an educational requirement and a training or experience requirement to qualify for admission to the examination for this license.This bill would allow a persons experience as an unlicensed person performing specified duties in a California-licensed laboratory for at least 18 months to count toward qualification of licensure.Existing law authorizes unlicensed laboratory personnel who have earned a high school diploma or its equivalent and who meet specified training requirements to perform specified activities in a licensed clinical laboratory under the direct and constant supervision of a physician and surgeon or licensed person, including biological specimen collection, assisting in preventive maintenance, and preparing and storing reagents and culture media. Existing law authorizes unlicensed laboratory personnel who do not meet the specified training requirements only to perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing. A violation of these provisions is a crime. This bill would revise the activities that may be performed by an unlicensed person to specify those activities that may be performed under direct and constant supervision of a physician and surgeon or licensed person, those activities that may be performed under supervision and control, as defined, and those activities that may not be performed by an unlicensed person. Existing law prohibits unlicensed laboratory personnel from performing 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 validity of a test procedure. The bill would provide an exception to this prohibition if the unlicensed person is assisting a licensed physician and surgeon or a licensed person, other than a trainee, in a licensed clinical laboratory. The bill would also prohibit unlicensed laboratory personnel from releasing waived, moderate-, or high-complexity testing. testing and from performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, as specified. The bill would make conforming changes.By expanding the scope of an existing crime, this bill would create a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES
Amended IN Assembly April 27, 2023
Amended IN Assembly April 27, 2023
CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION
Assembly Bill
No. 1741
Introduced by Assembly Member WaldronFebruary 17, 2023
Introduced by Assembly Member Waldron
February 17, 2023
An act to amend Sections 1206, 1261, 1261.5, 1206 and 1269 of the Business and Professions Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 1741, as amended, Waldron. Healing arts: clinical laboratories: personnel.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law requires the department to issue a clinical laboratory scientists or a limited clinical laboratory scientists license in specified areas of laboratory specialty or subspecialty. Existing law requires an applicant to meet both an educational requirement and a training or experience requirement to qualify for admission to the examination for this license.This bill would allow a persons experience as an unlicensed person performing specified duties in a California-licensed laboratory for at least 18 months to count toward qualification of licensure.Existing law authorizes unlicensed laboratory personnel who have earned a high school diploma or its equivalent and who meet specified training requirements to perform specified activities in a licensed clinical laboratory under the direct and constant supervision of a physician and surgeon or licensed person, including biological specimen collection, assisting in preventive maintenance, and preparing and storing reagents and culture media. Existing law authorizes unlicensed laboratory personnel who do not meet the specified training requirements only to perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing. A violation of these provisions is a crime. This bill would revise the activities that may be performed by an unlicensed person to specify those activities that may be performed under direct and constant supervision of a physician and surgeon or licensed person, those activities that may be performed under supervision and control, as defined, and those activities that may not be performed by an unlicensed person. Existing law prohibits unlicensed laboratory personnel from performing 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 validity of a test procedure. The bill would provide an exception to this prohibition if the unlicensed person is assisting a licensed physician and surgeon or a licensed person, other than a trainee, in a licensed clinical laboratory. The bill would also prohibit unlicensed laboratory personnel from releasing waived, moderate-, or high-complexity testing. testing and from performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, as specified. The bill would make conforming changes.By expanding the scope of an existing crime, this bill would create a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law requires the department to issue a clinical laboratory scientists or a limited clinical laboratory scientists license in specified areas of laboratory specialty or subspecialty. Existing law requires an applicant to meet both an educational requirement and a training or experience requirement to qualify for admission to the examination for this license.
This bill would allow a persons experience as an unlicensed person performing specified duties in a California-licensed laboratory for at least 18 months to count toward qualification of licensure.
Existing law authorizes unlicensed laboratory personnel who have earned a high school diploma or its equivalent and who meet specified training requirements to perform specified activities in a licensed clinical laboratory under the direct and constant supervision of a physician and surgeon or licensed person, including biological specimen collection, assisting in preventive maintenance, and preparing and storing reagents and culture media. Existing law authorizes unlicensed laboratory personnel who do not meet the specified training requirements only to perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing. A violation of these provisions is a crime.
This bill would revise the activities that may be performed by an unlicensed person to specify those activities that may be performed under direct and constant supervision of a physician and surgeon or licensed person, those activities that may be performed under supervision and control, as defined, and those activities that may not be performed by an unlicensed person.
Existing law prohibits unlicensed laboratory personnel from performing 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 validity of a test procedure.
The bill would provide an exception to this prohibition if the unlicensed person is assisting a licensed physician and surgeon or a licensed person, other than a trainee, in a licensed clinical laboratory. The bill would also prohibit unlicensed laboratory personnel from releasing waived, moderate-, or high-complexity testing. testing and from performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation, as specified. The bill would make conforming changes.
By expanding the scope of an existing crime, this bill would create a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 1206 of the Business and Professions Code is amended to read: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, theophylline, 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 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.(14) 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 manufacturers instructions or basic cleaning.(15) 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.(16) Registered laboratory means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.(17) Specialty means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.(18) 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.(19)Supervision and control means a qualified supervisor who is a physician and surgeon licensed under Chapter 5 (commencing with Section 2000) or a person licensed under Chapter 3 (commencing with Section 1200), other than a certified phlebotomy technician or a licensed trainee, is designated by the laboratory director to provide supervision, and is physically present onsite at the location where the unlicensed person is working. The supervisor shall be available for consultation as needed.(19) (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, licensed 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.SEC. 2.Section 1261 of the Business and Professions Code is amended to read:1261.(a)(1)The department shall issue a clinical laboratory scientists or a limited clinical laboratory scientists license to each person who is a lawful holder of a baccalaureate or an equivalent or higher degree, who has applied for the license on forms provided by the department and has met the requirements of this chapter and any reasonable qualifications established by regulations of the department. However, an exception to the degree requirement may be made by the department for the clinical laboratory scientists license only if the applicant for the license has completed a minimum of two years of experience as a licensed trainee or the equivalent thereof, as determined by the department, doing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the department. In addition, the applicant applying under this section must have 90 semester hours or equivalent quarter hours of university or college work or the equivalent thereof, as may be determined by the department, which shall have included at least 23 semester hours or equivalent quarter hours of science courses as specified by regulations of the department. Additional college or university work that includes courses in the fundamental sciences may be substituted for one of the two years of experience in the ratio of 30 semester hours or equivalent quarter hours for each year of experience. This exception shall not apply to the limited clinical laboratory scientists license. The department shall hold examinations to aid it in judging the qualifications of applicants. Licenses may be issued in any or all of the sciences applied in a clinical laboratory as determined by regulation established by the department. The department shall establish by regulation the college courses or majors to be included in the college or university training and the amount and kind of training or experience required. Examinations, training, or experience requirements for limited licenses shall cover only the science concerned. The department may identify by regulation the appropriate sciences and shall establish the minimum requirements for training and experience and required courses or major for each. Experience as an unlicensed person performing those duties permitted in Section 1269 in a California laboratory licensed under this chapter for at least 18 months shall count toward qualification of licensure.(2)Prior to the adoption of implementing regulations and notwithstanding subdivision (c) of Section 1261.5, the department shall issue a clinical reproductive biologist scientist license to every applicant for licensure who has applied for the license on forms provided by the department, who holds a baccalaureate or an equivalent or higher degree in a chemical, physical, or biological science or clinical laboratory science, who is certified as an andrology laboratory scientist, an embryology laboratory scientist, or a technical supervisor of andrology or embryology by a certifying board in the specialty of reproductive biology, clinical andrology, or clinical embryology approved by the department, and who meets the qualifications of training, education, and experience specified in Section 1261.5.(3)Prior to the adoption of implementing regulations and notwithstanding subdivision (c) of Section 1261.5, the department shall issue a clinical laboratory geneticist scientist license to every applicant for licensure who has applied for the license on forms provided by the department, who holds a baccalaureate or an equivalent or higher degree in a chemical, physical, or biological science, clinical laboratory science, or a field related to genetics, who is certified in biochemical genetics or laboratory genetics and genomics by a certifying board in the specialty of genetics approved by the department, and who meets the qualifications of training, education, and experience specified in Section 1261.5.(4)Experience as a clinical laboratory technician in any branch of the Armed Forces of the United States may be considered equivalent to the experience as a trainee, if the experience is approved by the department. Each year of training and experience as a clinical laboratory technician in the armed forces shall be equivalent to 15 semester hours, which shall be credited to the minimum number of hours required to qualify for licensure as a trainee. The semester hours acquired in this manner shall not consist of the science courses required by the department under this section. The maximum number of hours granted shall not exceed 60 semester hours or its equivalent.(b)(1)Notwithstanding subdivision (a), the department shall establish an MLT-to-CLS pathway program by January 1, 2022, that would authorize a licensed MLT to apply their work experience and training from a department-approved MLT training program towards the completion of a CLS training program. The work experience and training may only be eligible for the pathway program upon approval by the department.(2)For purposes of this subdivision:(A)CLS means a clinical laboratory scientist.(B)MLT means a medical laboratory technician.SEC. 3.Section 1261.5 of the Business and Professions Code is amended to read:1261.5.(a)The department may issue limited clinical laboratory scientists licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, genetic molecular biology, cytogenetics, laboratory genetics, reproductive biology, or other areas of laboratory specialty or subspecialty when determined to be necessary by the department in order for licensure categories to keep abreast of changes in laboratory or scientific technology. Whenever the department determines that a new limited clinical laboratory scientist license category is necessary, it shall adopt regulations identifying the category and the areas of specialization included within the category.(b)To qualify for admission to the examination for a special clinical laboratory scientists license, an applicant shall have both the following:(1)Graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate or higher degree with a major appropriate to the field for which a license is being sought.(2)Either of the following: (A)One year of full-time postgraduate training or experience in the various areas of analysis in the field for which a license is being sought in a laboratory that has a license issued under this chapter or which the department determines is equivalent thereto.(B)Eighteen months of full-time training or experience as an unlicensed person performing duties specified in Section 1269 in a laboratory licensed under this chapter appropriate to the field for which a license is being sought.(c)Whenever a limited clinical laboratory scientists license is established for a specific area of specialization, the department may issue the license without examination to applicants who had met standards of education and training, defined by regulations, and to applicants certified by a board approved for that certification by the department, prior to the date of the adoption of implementing regulations.(d)The department shall adopt regulations to implement this section.SEC. 4.SEC. 2. Section 1269 of the Business and Professions Code is amended to read: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:(1)(A) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.(2)(B) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:(A)(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.(B)(ii) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.(C)(iii) The skills and working knowledge required for performing preventive maintenance, maintenance and troubleshooting.(D)(iv) A working knowledge of reagent stability and storage. stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.(E)(v) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.(F)(vi) An awareness of the factors that influence test results.(G)The skills to perform waived testing.(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) (1) The activities that may be performed under direct and constant supervision are:(1)(A) (i) Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory with the performance of moderate- or high-complexity testing. laboratory.(ii) 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)(B) Assisting in troubleshooting.(3)(C) Assisting in the performance of quality control procedures.(c) An unlicensed laboratory personnel, other than a trainee, 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. specimens if the collection activities do not require a certificate or license under this division.(2) Perform preventive maintenance.(3) Preparation and storage of reagents and culture media.(4) 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. instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test.(5)Perform waived testing, but the results shall be read by a physician and surgeon or person licensed under this chapter.(6)When any of the following manual methods are employed, the activities shall be limited as follows:(A)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.(B)In the case of microbiological tests, the unlicensed laboratory personnel may make(5) Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. media for microbiological tests.(d) Unlicensed laboratory personnel shall not do any of the following:(1) Record test results, but they may 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. except as authorized under paragraph (4) 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 licensed 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. (3)(4) Release results of waived, moderate, moderate-, or high-complexity testing.(e)When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows:(1)In the case of qualitative and semi-quantitative 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)In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media.(f)(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 that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. as authorized under paragraph (4) 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.SEC. 5.SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Section 1206 of the Business and Professions Code is amended to read: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, theophylline, 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 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.(14) 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 manufacturers instructions or basic cleaning.(15) 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.(16) Registered laboratory means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.(17) Specialty means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.(18) 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.(19)Supervision and control means a qualified supervisor who is a physician and surgeon licensed under Chapter 5 (commencing with Section 2000) or a person licensed under Chapter 3 (commencing with Section 1200), other than a certified phlebotomy technician or a licensed trainee, is designated by the laboratory director to provide supervision, and is physically present onsite at the location where the unlicensed person is working. The supervisor shall be available for consultation as needed.(19) (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, licensed 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.
SECTION 1. Section 1206 of the Business and Professions Code is amended to read:
### SECTION 1.
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, theophylline, 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 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.(14) 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 manufacturers instructions or basic cleaning.(15) 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.(16) Registered laboratory means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.(17) Specialty means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.(18) 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.(19)Supervision and control means a qualified supervisor who is a physician and surgeon licensed under Chapter 5 (commencing with Section 2000) or a person licensed under Chapter 3 (commencing with Section 1200), other than a certified phlebotomy technician or a licensed trainee, is designated by the laboratory director to provide supervision, and is physically present onsite at the location where the unlicensed person is working. The supervisor shall be available for consultation as needed.(19) (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, licensed 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.
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, theophylline, 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 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.(14) 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 manufacturers instructions or basic cleaning.(15) 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.(16) Registered laboratory means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.(17) Specialty means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.(18) 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.(19)Supervision and control means a qualified supervisor who is a physician and surgeon licensed under Chapter 5 (commencing with Section 2000) or a person licensed under Chapter 3 (commencing with Section 1200), other than a certified phlebotomy technician or a licensed trainee, is designated by the laboratory director to provide supervision, and is physically present onsite at the location where the unlicensed person is working. The supervisor shall be available for consultation as needed.(19) (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, licensed 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.
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, theophylline, 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 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.(14) 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 manufacturers instructions or basic cleaning.(15) 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.(16) Registered laboratory means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.(17) Specialty means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.(18) 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.(19)Supervision and control means a qualified supervisor who is a physician and surgeon licensed under Chapter 5 (commencing with Section 2000) or a person licensed under Chapter 3 (commencing with Section 1200), other than a certified phlebotomy technician or a licensed trainee, is designated by the laboratory director to provide supervision, and is physically present onsite at the location where the unlicensed person is working. The supervisor shall be available for consultation as needed.(19) (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, licensed 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.
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, theophylline, 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 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.
(14) 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 manufacturers instructions or basic cleaning.
(15) 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.
(16) Registered laboratory means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.
(17) Specialty means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.
(18) 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.
(19)Supervision and control means a qualified supervisor who is a physician and surgeon licensed under Chapter 5 (commencing with Section 2000) or a person licensed under Chapter 3 (commencing with Section 1200), other than a certified phlebotomy technician or a licensed trainee, is designated by the laboratory director to provide supervision, and is physically present onsite at the location where the unlicensed person is working. The supervisor shall be available for consultation as needed.
(19) (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, licensed 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.
(a)(1)The department shall issue a clinical laboratory scientists or a limited clinical laboratory scientists license to each person who is a lawful holder of a baccalaureate or an equivalent or higher degree, who has applied for the license on forms provided by the department and has met the requirements of this chapter and any reasonable qualifications established by regulations of the department. However, an exception to the degree requirement may be made by the department for the clinical laboratory scientists license only if the applicant for the license has completed a minimum of two years of experience as a licensed trainee or the equivalent thereof, as determined by the department, doing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the department. In addition, the applicant applying under this section must have 90 semester hours or equivalent quarter hours of university or college work or the equivalent thereof, as may be determined by the department, which shall have included at least 23 semester hours or equivalent quarter hours of science courses as specified by regulations of the department. Additional college or university work that includes courses in the fundamental sciences may be substituted for one of the two years of experience in the ratio of 30 semester hours or equivalent quarter hours for each year of experience. This exception shall not apply to the limited clinical laboratory scientists license. The department shall hold examinations to aid it in judging the qualifications of applicants. Licenses may be issued in any or all of the sciences applied in a clinical laboratory as determined by regulation established by the department. The department shall establish by regulation the college courses or majors to be included in the college or university training and the amount and kind of training or experience required. Examinations, training, or experience requirements for limited licenses shall cover only the science concerned. The department may identify by regulation the appropriate sciences and shall establish the minimum requirements for training and experience and required courses or major for each. Experience as an unlicensed person performing those duties permitted in Section 1269 in a California laboratory licensed under this chapter for at least 18 months shall count toward qualification of licensure.
(2)Prior to the adoption of implementing regulations and notwithstanding subdivision (c) of Section 1261.5, the department shall issue a clinical reproductive biologist scientist license to every applicant for licensure who has applied for the license on forms provided by the department, who holds a baccalaureate or an equivalent or higher degree in a chemical, physical, or biological science or clinical laboratory science, who is certified as an andrology laboratory scientist, an embryology laboratory scientist, or a technical supervisor of andrology or embryology by a certifying board in the specialty of reproductive biology, clinical andrology, or clinical embryology approved by the department, and who meets the qualifications of training, education, and experience specified in Section 1261.5.
(3)Prior to the adoption of implementing regulations and notwithstanding subdivision (c) of Section 1261.5, the department shall issue a clinical laboratory geneticist scientist license to every applicant for licensure who has applied for the license on forms provided by the department, who holds a baccalaureate or an equivalent or higher degree in a chemical, physical, or biological science, clinical laboratory science, or a field related to genetics, who is certified in biochemical genetics or laboratory genetics and genomics by a certifying board in the specialty of genetics approved by the department, and who meets the qualifications of training, education, and experience specified in Section 1261.5.
(4)Experience as a clinical laboratory technician in any branch of the Armed Forces of the United States may be considered equivalent to the experience as a trainee, if the experience is approved by the department. Each year of training and experience as a clinical laboratory technician in the armed forces shall be equivalent to 15 semester hours, which shall be credited to the minimum number of hours required to qualify for licensure as a trainee. The semester hours acquired in this manner shall not consist of the science courses required by the department under this section. The maximum number of hours granted shall not exceed 60 semester hours or its equivalent.
(b)(1)Notwithstanding subdivision (a), the department shall establish an MLT-to-CLS pathway program by January 1, 2022, that would authorize a licensed MLT to apply their work experience and training from a department-approved MLT training program towards the completion of a CLS training program. The work experience and training may only be eligible for the pathway program upon approval by the department.
(2)For purposes of this subdivision:
(A)CLS means a clinical laboratory scientist.
(B)MLT means a medical laboratory technician.
(a)The department may issue limited clinical laboratory scientists licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, genetic molecular biology, cytogenetics, laboratory genetics, reproductive biology, or other areas of laboratory specialty or subspecialty when determined to be necessary by the department in order for licensure categories to keep abreast of changes in laboratory or scientific technology. Whenever the department determines that a new limited clinical laboratory scientist license category is necessary, it shall adopt regulations identifying the category and the areas of specialization included within the category.
(b)To qualify for admission to the examination for a special clinical laboratory scientists license, an applicant shall have both the following:
(1)Graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate or higher degree with a major appropriate to the field for which a license is being sought.
(2)Either of the following:
(A)One year of full-time postgraduate training or experience in the various areas of analysis in the field for which a license is being sought in a laboratory that has a license issued under this chapter or which the department determines is equivalent thereto.
(B)Eighteen months of full-time training or experience as an unlicensed person performing duties specified in Section 1269 in a laboratory licensed under this chapter appropriate to the field for which a license is being sought.
(c)Whenever a limited clinical laboratory scientists license is established for a specific area of specialization, the department may issue the license without examination to applicants who had met standards of education and training, defined by regulations, and to applicants certified by a board approved for that certification by the department, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to implement this section.
SEC. 4.SEC. 2. Section 1269 of the Business and Professions Code is amended to read: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:(1)(A) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.(2)(B) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:(A)(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.(B)(ii) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.(C)(iii) The skills and working knowledge required for performing preventive maintenance, maintenance and troubleshooting.(D)(iv) A working knowledge of reagent stability and storage. stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.(E)(v) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.(F)(vi) An awareness of the factors that influence test results.(G)The skills to perform waived testing.(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) (1) The activities that may be performed under direct and constant supervision are:(1)(A) (i) Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory with the performance of moderate- or high-complexity testing. laboratory.(ii) 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)(B) Assisting in troubleshooting.(3)(C) Assisting in the performance of quality control procedures.(c) An unlicensed laboratory personnel, other than a trainee, 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. specimens if the collection activities do not require a certificate or license under this division.(2) Perform preventive maintenance.(3) Preparation and storage of reagents and culture media.(4) 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. instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test.(5)Perform waived testing, but the results shall be read by a physician and surgeon or person licensed under this chapter.(6)When any of the following manual methods are employed, the activities shall be limited as follows:(A)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.(B)In the case of microbiological tests, the unlicensed laboratory personnel may make(5) Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. media for microbiological tests.(d) Unlicensed laboratory personnel shall not do any of the following:(1) Record test results, but they may 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. except as authorized under paragraph (4) 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 licensed 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. (3)(4) Release results of waived, moderate, moderate-, or high-complexity testing.(e)When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows:(1)In the case of qualitative and semi-quantitative 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)In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media.(f)(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 that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. as authorized under paragraph (4) 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.
SEC. 4.SEC. 2. Section 1269 of the Business and Professions Code is amended to read:
### SEC. 4.SEC. 2.
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:(1)(A) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.(2)(B) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:(A)(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.(B)(ii) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.(C)(iii) The skills and working knowledge required for performing preventive maintenance, maintenance and troubleshooting.(D)(iv) A working knowledge of reagent stability and storage. stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.(E)(v) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.(F)(vi) An awareness of the factors that influence test results.(G)The skills to perform waived testing.(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) (1) The activities that may be performed under direct and constant supervision are:(1)(A) (i) Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory with the performance of moderate- or high-complexity testing. laboratory.(ii) 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)(B) Assisting in troubleshooting.(3)(C) Assisting in the performance of quality control procedures.(c) An unlicensed laboratory personnel, other than a trainee, 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. specimens if the collection activities do not require a certificate or license under this division.(2) Perform preventive maintenance.(3) Preparation and storage of reagents and culture media.(4) 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. instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test.(5)Perform waived testing, but the results shall be read by a physician and surgeon or person licensed under this chapter.(6)When any of the following manual methods are employed, the activities shall be limited as follows:(A)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.(B)In the case of microbiological tests, the unlicensed laboratory personnel may make(5) Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. media for microbiological tests.(d) Unlicensed laboratory personnel shall not do any of the following:(1) Record test results, but they may 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. except as authorized under paragraph (4) 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 licensed 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. (3)(4) Release results of waived, moderate, moderate-, or high-complexity testing.(e)When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows:(1)In the case of qualitative and semi-quantitative 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)In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media.(f)(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 that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. as authorized under paragraph (4) 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.
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:(1)(A) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.(2)(B) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:(A)(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.(B)(ii) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.(C)(iii) The skills and working knowledge required for performing preventive maintenance, maintenance and troubleshooting.(D)(iv) A working knowledge of reagent stability and storage. stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.(E)(v) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.(F)(vi) An awareness of the factors that influence test results.(G)The skills to perform waived testing.(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) (1) The activities that may be performed under direct and constant supervision are:(1)(A) (i) Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory with the performance of moderate- or high-complexity testing. laboratory.(ii) 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)(B) Assisting in troubleshooting.(3)(C) Assisting in the performance of quality control procedures.(c) An unlicensed laboratory personnel, other than a trainee, 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. specimens if the collection activities do not require a certificate or license under this division.(2) Perform preventive maintenance.(3) Preparation and storage of reagents and culture media.(4) 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. instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test.(5)Perform waived testing, but the results shall be read by a physician and surgeon or person licensed under this chapter.(6)When any of the following manual methods are employed, the activities shall be limited as follows:(A)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.(B)In the case of microbiological tests, the unlicensed laboratory personnel may make(5) Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. media for microbiological tests.(d) Unlicensed laboratory personnel shall not do any of the following:(1) Record test results, but they may 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. except as authorized under paragraph (4) 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 licensed 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. (3)(4) Release results of waived, moderate, moderate-, or high-complexity testing.(e)When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows:(1)In the case of qualitative and semi-quantitative 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)In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media.(f)(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 that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. as authorized under paragraph (4) 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.
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:(1)(A) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.(2)(B) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:(A)(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.(B)(ii) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.(C)(iii) The skills and working knowledge required for performing preventive maintenance, maintenance and troubleshooting.(D)(iv) A working knowledge of reagent stability and storage. stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.(E)(v) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.(F)(vi) An awareness of the factors that influence test results.(G)The skills to perform waived testing.(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) (1) The activities that may be performed under direct and constant supervision are:(1)(A) (i) Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory with the performance of moderate- or high-complexity testing. laboratory.(ii) 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)(B) Assisting in troubleshooting.(3)(C) Assisting in the performance of quality control procedures.(c) An unlicensed laboratory personnel, other than a trainee, 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. specimens if the collection activities do not require a certificate or license under this division.(2) Perform preventive maintenance.(3) Preparation and storage of reagents and culture media.(4) 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. instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test.(5)Perform waived testing, but the results shall be read by a physician and surgeon or person licensed under this chapter.(6)When any of the following manual methods are employed, the activities shall be limited as follows:(A)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.(B)In the case of microbiological tests, the unlicensed laboratory personnel may make(5) Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. media for microbiological tests.(d) Unlicensed laboratory personnel shall not do any of the following:(1) Record test results, but they may 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. except as authorized under paragraph (4) 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 licensed 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. (3)(4) Release results of waived, moderate, moderate-, or high-complexity testing.(e)When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows:(1)In the case of qualitative and semi-quantitative 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)In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media.(f)(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 that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. as authorized under paragraph (4) 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.
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:
(1)
(A) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.
(2)
(B) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:
(A)
(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.
(B)
(ii) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.
(C)
(iii) The skills and working knowledge required for performing preventive maintenance, maintenance and troubleshooting.
(D)
(iv) A working knowledge of reagent stability and storage. stability, storage, and safety requirements related to chemical, biochemical, and electrical hazards and biohazardous materials.
(E)
(v) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.
(F)
(vi) An awareness of the factors that influence test results.
(G)The skills to perform waived testing.
(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) (1) The activities that may be performed under direct and constant supervision are:
(1)
(A) (i) Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory with the performance of moderate- or high-complexity testing. laboratory.
(ii) 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)
(B) Assisting in troubleshooting.
(3)
(C) Assisting in the performance of quality control procedures.
(c) An unlicensed laboratory personnel, other than a trainee, 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. specimens if the collection activities do not require a certificate or license under this division.
(2) Perform preventive maintenance.
(3) Preparation and storage of reagents and culture media.
(4) 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. instrument, with documented verification by the physician and surgeon or licensed personnel who reports the test.
(5)Perform waived testing, but the results shall be read by a physician and surgeon or person licensed under this chapter.
(6)When any of the following manual methods are employed, the activities shall be limited as follows:
(A)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.
(B)In the case of microbiological tests, the unlicensed laboratory personnel may make
(5) Make primary or subsequent inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. media for microbiological tests.
(d) Unlicensed laboratory personnel shall not do any of the following:
(1) Record test results, but they may 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. except as authorized under paragraph (4) 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 licensed 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.
(3)
(4) Release results of waived, moderate, moderate-, or high-complexity testing.
(e)When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows:
(1)In the case of qualitative and semi-quantitative 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)In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media.
(f)
(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 that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. as authorized under paragraph (4) 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.
SEC. 5.SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SEC. 5.SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SEC. 5.SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
### SEC. 5.SEC. 3.