Title BPC — California Bus. & Prof. Code

As used in this chapter, “person” includes firm, association, partnership, individual, limited liability company, and corporation.

As used in this chapter, “department” means the State Department of Public Health.

(a) For purposes of this chapter “CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; P.L. 100-578) and the regulations adopted thereunder by the federal Health Care Financing Administration and effective on January 1, 1994, or any lat…

As used in this chapter, “clinical laboratory bioanalyst” or “bioanalyst” means a person licensed under Section 1260 to engage in clinical laboratory practice and direction of a clinical laboratory. (a) A person licensed as a clinical laboratory bioanalyst or bioanalyst and quali…

As used in this chapter, “clinical laboratory scientist” means a person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed under Sections 1261 and 1262 to engage in clinical laboratory practice under the overall operation and administration of a lab…

As used in this chapter, “trainee” means a person licensed under this chapter for the purpose of receiving comprehensive practical experience and instruction in clinical laboratory procedures in one of the sciences or in general clinical laboratory science under the direct and re…

(a) For the purposes of this chapter the following definitions are applicable: (1) “Analyte” means the substance or constituent being measured, including, but not limited to, glucose, sodium, or theophyline, or any substance or property whose presence or absence, concentration, a…

(a) Notwithstanding subdivision (b) of Section 1206 and except as otherwise provided in Sections 1206.6 and 1241, no person shall perform a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed unde…

Subdivision (a) of Section 1206.5 shall not apply to a pharmacist at a community pharmacy who, upon customer request, performs only blood glucose, hemoglobin A1c, or cholesterol tests that are classified as waived under CLIA and are approved by the federal Food and Drug Administr…

(a) Notwithstanding Section 1206.5, a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of t…

(a) As used in this chapter, “clinical chemist,” “clinical microbiologist,” “clinical toxicologist,” “clinical genetic molecular biologist,” “clinical cytogeneticist,” “clinical laboratory geneticist,” “clinical reproductive biologist,” or “oral and maxillofacial pathologist” mea…

(a) For the purposes of this chapter whenever the department determines that a new category of license is necessary, either to direct a laboratory, or to perform clinical laboratory tests or examinations in specific specialties or subspecialties, or that the specialties or subspe…

(a) As used in this chapter, “laboratory director” means any person who is any of the following: (1) A duly licensed physician and surgeon. (2) Only for purposes of a clinical laboratory test or examination classified as waived, except as provided in paragraph (G), is any of the …

(a) As used in this chapter, “histocompatibility laboratory director” means a physician and surgeon licensed to practice medicine pursuant to Chapter 5 (commencing with Section 2000) who is qualified pursuant to Section 1209, a bioanalyst licensed pursuant to Section 1260 who is …

(a) “Autoverification” means the use of a computer algorithm in conjunction with automated clinical laboratory instrumentation to review and verify the results of a clinical laboratory test or examination for accuracy and reliability. (b) The laboratory director or authorized des…

(a) As used in this chapter, “clinical chemist scientist,” “clinical microbiologist scientist,” “clinical toxicologist scientist,” “clinical immunohematologist scientist,” “clinical genetic molecular biologist scientist,” “clinical cytogeneticist scientist,” “clinical laboratory …

(a) As used in this chapter, “owner” means any person with an ownership or control interest in a clinical laboratory. (b) “Person with an ownership or control interest” means a person, partnership, or corporation that meets any of the following descriptions: (1) Has an ownership …

For the purposes of this chapter, “cytological slides” shall refer to cellular materials submitted for preliminary cytologic examination.

(a) As used in this chapter, “unlicensed laboratory personnel” means a laboratory aide, histocompatibility technician, cardiopulmonary technician, or other person performing the activities authorized by Section 1269. (b) Any person who is authorized under California law or regula…

As used in this chapter, “school” means any place, establishment, or institution organized and operated to offer training for one or more of the personnel classifications included in this chapter or the regulations pertaining thereto.

As used in this chapter, “health fair” means a program of health assessment procedures offered to the general public that may include screening, self-ordered, or diagnostic clinical laboratory tests or examinations performed by a clinical laboratory licensed or registered under s…

(a) (1) Each clinical laboratory shall maintain records, equipment, and facilities that are adequate and appropriate for the services rendered. (2) (A) Except for tests or examinations classified as waived under CLIA, each clinical laboratory shall enroll, and demonstrate success…

(a) The Department of Health Services shall develop, and provide to all licensed clinical laboratories, a form in triplicate to be used by employees, agents, and couriers of licensed clinical laboratories to give notice when a specimen storage container has been improperly secure…

The department may employ special examiners, and may make regulations for the conduct of examinations under this chapter.

The department may approve schools that are accredited by the National Accrediting Agency for Clinical Laboratory Sciences.

(a) The department may approve any of the following seeking to provide clinical laboratory scientist programs for instruction in clinical laboratory technique that, in the judgment of the department, will provide instruction adequate to prepare individuals to meet the requirement…

(a) The Legislature finds and declares that it is the public policy of the state to ensure that California’s laboratory standards, including its laboratory personnel standards, be sustained in order to provide accurate, reliable, and necessary test results. The Legislature furthe…

The department may, pursuant to Chapter 3.5 (commencing with Section 11340) of Division 3 of Title 2 of the Government Code, adopt, amend, or repeal any regulations necessary for the administration or enforcement of this chapter.

The department shall conduct a study to determine whether the persons conducting tests in physician office laboratories under paragraph (12) of subdivision (b) of, and paragraph (10) of subdivision (c) of Section 1206.5, produce accurate, reliable, and necessary test results comp…

(a) In order to carry out this chapter, any duly authorized representative of the department may do any of the following: (1) Enter or inspect on an announced or unannounced basis any building, premise, equipment, materials, records, or information at any reasonable time to secur…

Annually the department may compile and may thereafter publish and sell a directory of persons within the state licensed under the provisions of this chapter who hold unsuspended, unforfeited and unrevoked licenses. The directory may also contain a copy of the provisions of this …

Every person or clinical laboratory licensed or registered under this chapter shall report to the department, within 30 days thereof, any change of name or address.

The department shall appoint a multidisciplinary committee to assist, advise, and make recommendations for the establishment of rules and regulations necessary to insure proper administration and enforcement of the provisions of this chapter and to assist and advise the departmen…

This chapter does not authorize any person to practice medicine and surgery or to furnish the services of physicians for the practice of medicine and surgery. This chapter does not repeal or in any manner affect any provision of this code relating to the practice of medicine. Thi…

(a) This chapter applies to all clinical laboratories in California or receiving biological specimens originating in California for the purpose of performing a clinical laboratory test or examination, and to all persons performing clinical laboratory tests or examinations or enga…

(a) A primary care clinic, licensed pursuant to subdivision (a) of Section 1204 of the Health and Safety Code, that is operating within a network of primary care clinics, may be issued a license to operate a clinical laboratory pursuant to Section 1265, which authorizes the condu…

Any person duly licensed under the provisions of this chapter to perform tests called for in a clinical laboratory may perform skin tests for specific diseases, arterial puncture, venipuncture, or skin puncture for purposes of withdrawing blood or for clinical laboratory test pur…

Notwithstanding paragraphs (2) and (3) of subdivision (b) of Section 1241, the department may by regulation authorize laboratory personnel certified pursuant to Section 1246 to perform venipuncture, arterial puncture, or skin puncture for the purposes of withdrawing blood or for …

(a) Any registered nurse licensed under the provisions of Chapter 6 (commencing with Section 2700) of Division 2 may perform arterial puncture, venipuncture, or skin puncture for the purposes of withdrawing blood or for test purposes upon authorization from any licensed physician…

A student regularly matriculated in any college or university accredited by an accrediting agency acceptable to the department, or in any legally chartered school approved by the department for training purposes may perform arterial puncture, venipuncture, or skin puncture as a p…

(a) Nothing in this chapter shall restrict, limit, or prevent a program of nondiagnostic general health assessment provided that: (1) The program meets the requirements of Section 1265 and complies with the requirements of CLIA for waived testing. (2) The purpose of the program i…

Thirty days prior to operating a program of nondiagnostic general health assessment, the entity or person operating that program shall file the following documentation with the local health officer in each county in which the program shall operate: (a) The location of the program…

Responsibility for enforcement of Sections 1244 and 1244.1 shall be with the local health officer or his or her authorized designee, including public health laboratory directors. Nothing in this section shall prevent the department from using any necessary enforcement actions for…

Any fee for the filing of documentation and related enforcement activities pursuant to Section 1244, 1244.1, and 1244.3 shall be determined by the local enforcement agency and shall not exceed one hundred dollars ($100) except that those fees shall be adjusted annually by any ann…

(a) Any individual may perform a blood gas analysis if all the following conditions exist: (1) He or she has earned a high school diploma or equivalent, as determined by HCFA pursuant to CLIA. (2) He or she performs the blood gas analysis in a clinic or a general acute care hospi…

(a) (1) On and after the effective date of the regulations specified in paragraph (2), any unlicensed person employed by a clinical laboratory performing the duties described in this section shall possess a valid and current certification as a certified phlebotomy technician issu…

Notwithstanding any other provision of law, any person may request, and any licensed clinical laboratory or public health laboratory may perform, the laboratory tests specified in this section. A registered clinical laboratory may perform the laboratory tests specified in this se…

(a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection center in this state, if the department, as part of its routine, fee-supported inspection of the licensed plasma collection center, including…

This article shall be known and may be cited as the Hemodialysis Technician Training Act.

For the purpose of this article, the following terms have the following meaning: (a) “Immediate supervision” means supervision of dialysis treatment in the same room in which the dialysis treatment is being performed. (b) “Department” means the State Department of Public Health. …