Title BPC — California Bus. & Prof. Code

Notwithstanding Section 135, an applicant for a clinical laboratory or limited technologist license who fails to pass the written examination two times shall not be eligible to be reexamined a third time until at least one year has elapsed from the date of the second examination.…

The department shall license as trainees those individuals desiring to train for either a clinical laboratory scientist’s license or a limited clinical laboratory scientist’s license, providing those individuals meet the academic requirements. No trainee license shall be issued u…

(a) (1) The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical genetic molecular biologist, clinical laboratory geneticist, clinical reproductive biologist, or clinical cytogeneticist license to each person who has applied for the …

(a) (1) A clinical laboratory performing clinical laboratory tests or examinations classified as of moderate or of high complexity under CLIA shall obtain a clinical laboratory license pursuant to this chapter. The department shall issue a clinical laboratory license to any perso…

(a) A primary care clinic that submits an application to the State Department of Public Health for clinic licensure pursuant to subdivision (a) of Section 1204 of the Health and Safety Code may submit prior to that submission, or concurrent therewith, an application for licensure…

(a) For purposes of this section, “digital materials” means digital laboratory data, digital results, and digital images that do not require a microscope or other equipment essential to a separate laboratory. (b) A pathologist who is performing pathology services at a primary lab…

(a) On or before June 30, 2025, the department shall consult with the federal Centers for Medicare and Medicaid Services for the purpose described in subdivision (b). (b) (1) On or before January 1, 2026, the department, in consultation with the federal Centers for Medicare and M…

The clinical laboratory license and the license or current renewal permit of each person performing tests shall be conspicuously posted in the clinical laboratory.

Any denial, suspension, or revocation of a license under this chapter shall be conducted in compliance with Section 100171 of the Health and Safety Code.

Upon filing application therefor, containing such information as the department may require, and the payment of the license fee, the department shall issue to any person duly licensed under this chapter a duplicate license for one previously issued or, where there has been a chan…

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

(a) Notwithstanding Sections 1206.5 and 1269, within the specialty of pathology, a person certified as a pathologists’ assistant by the American Association of Pathologists’ Assistants, the Board of Registry of the American Society for Clinical Pathology, or another national accr…

The department may deny, suspend, or revoke any license, registration, or certificate issued under this chapter for performance by unlicensed laboratory personnel of any activity that is not authorized by Section 1269.

(a) On and after January 1, 1991, no person may perform examinations of cytological slides without first obtaining a license as a cytotechnologist from the department, except that those persons employed by licensed clinical laboratories as cytotechnologists and certified as cytot…

(a) Notwithstanding Section 1301, an application for the renewal of, and payment of the renewal fees for, a cytotechnologist license shall be governed by this section. (b) Application for renewal of a cytotechnologist license, accompanied by the fee set forth in Section 1300, sha…

(a) A cytotechnologist shall not examine more than 80 gynecologic slides in a 24-hour period when performing a manual review of slides. (b) The maximum workload limit in subdivision (a) is the maximum number of gynecologic slides that a cytotechnologist shall examine in a 24-hour…

(a) Clinical laboratories which are licensed pursuant to this chapter and provide cytology services shall, if the licensee ceases operation, preserve records, reports, cytology slides, and cell blocks as prescribed in subdivision (g) of Section 1271 and Section 1274. (b) Any pers…

A clinical laboratory shall participate in a state-approved proficiency testing program and demonstrate satisfactory performance in all of the laboratory specialities that include tests performed in the laboratory. Proficiency shall be tested in the following specialties: microbi…

The department shall establish standards for the evaluation of cytologic slides, for reporting the adequacy of cytologic slides, for a cytotechnologist competency program, and for a proficiency testing program for clinical laboratories providing cytology services.

The department shall, on or before January 1, 1992, develop or adopt a proficiency testing program for laboratories providing cytology services which may be administered by the department or by a proficiency testing service or program approved by the department. The proficiency p…

(a) A laboratory shall document to persons submitting cytologic samples for evaluation, on a quarterly basis, informational letters on all cases of HSIL (high-grade squamous intraepithelial lesions), adenocarcinoma, or other malignant neoplasm. Documentation may consist of follow…

The department shall develop and implement regulations for continuing education for persons licensed pursuant to this chapter on or before January 1, 1992, after consulting with the multidisciplinary committee established pursuant to Section 1228, and other appropriate organizati…

It is unlawful for any person to represent himself or act as a licensed individual under this chapter unless he is, in fact, duly licensed under this chapter.

It is unlawful for any person to own, operate, maintain, direct, or engage in the business of operating a clinical laboratory, as defined in this chapter, unless he or she possesses a valid clinical laboratory license issued by the department. In the event a health facility does …

It is unlawful for any person, including a person who owns, operates, or directs a clinical laboratory, to provide, offer, or solicit, any form of payment or gratuity for human blood or any other biological specimen provided for the purpose of clinical laboratory testing or clini…

It is unlawful for any person to engage in clinical laboratory practice in a clinical laboratory unless he or she is a duly licensed physician and surgeon or is duly authorized to do so under this chapter.

It is unlawful for any person to perform venipuncture, skin puncture, or arterial puncture to collect a biological specimen unless he or she is authorized to do so under this chapter, the regulations adopted thereunder, or under other provisions of law.

(a) It is unlawful for any person to act with willful or wanton disregard for a person’s safety that exposes the person to a substantial risk of, or that causes, great bodily injury by affecting the integrity of a clinical laboratory test or examination result through improper co…

It is unlawful for any person to conduct, maintain, or operate a clinical laboratory unless he is a duly licensed physician and surgeon or is duly authorized to do so under the provisions of this chapter.

It is unlawful for a duly licensed physician and surgeon, or any person authorized to serve as director under this chapter, to serve only as a nominal director.

It is unlawful for any person conducting, maintaining, or operating a clinical laboratory to employ any person to perform clinical laboratory procedures unless the person is a duly licensed physician and surgeon or is duly authorized to do so under the provisions of this chapter.

It is unlawful for any person to operate a school or conduct any course for the purpose of training or preparing persons to perform duties, as defined under this chapter and regulations of the department, without having first secured the approval of the department as herein provi…

(a) Any person who violates any provision of this chapter is guilty of a misdemeanor punishable upon conviction by imprisonment in the county jail for a period not exceeding six months or by fine not exceeding one thousand dollars ($1,000) or by both. (b) (1) Notwithstanding subd…

Any person conducting or operating a clinical laboratory may accept assignments for tests only from and make reports only to persons licensed under the provisions of law relating to the healing arts or their representatives. This section does not prohibit the acceptance of evalua…

(a) If a clinical laboratory employee, agent, or courier retrieves biological specimens located in a public place outside of the custodial control of a licensee, or his or her employee, agent, or contractor, and those specimens are not secured in a locked container, the clinical …

No person may solicit or accept any biological specimen for clinical laboratory testing or examination unless there is in effect for the clinical laboratory where the test or examination is to be performed a license or registration issued pursuant to this chapter applicable to th…

The violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of or conspiring to violate any provision or term of this chapter or regulations promulgated thereunder constitutes unprofessional conduct within the meaning of this chapter.

With the exception of narcotics and dangerous drugs stored on the licensed clinical laboratory premises for use exclusively as standards for the purpose of testing, the violation of any of the statutes of this state regulating narcotics and dangerous drugs constitutes unprofessio…

Nothing in this chapter shall prohibit a licensed physician and surgeon from instructing or training any person employed by him to work in a laboratory maintained by such physician and surgeon as an incident of his own medical practice.

The amount of application, registration, certification, and license fees under this chapter shall be as follows: (a) The application fee for a histocompatibility laboratory director’s, clinical laboratory bioanalyst’s, clinical chemist’s, clinical microbiologist’s, clinical labor…

(a) The application, registration, certification, and license fees specified in Section 1300 shall be adjusted annually in the manner specified in Section 100450 of the Health and Safety Code. The adjustments shall be rounded off to the nearest whole dollar amount. (b) This secti…

Notwithstanding any other provision of this article, the total fees collected under this chapter shall not exceed the costs incurred by the department for licensing, certification, inspection, or other activities relating to the regulation of clinical laboratories and their perso…

(a) The annual renewal fee for a clinical laboratory license or registration set under this chapter shall be paid during the 30-day period before the expiration date of the license or registration. If the license or registration is not renewed before the expiration date, the lice…

Notwithstanding any other provision of this chapter, the department may establish such license periods and renewal dates for all licenses issued under this chapter in a manner as to best distribute the license renewal process throughout a given year, or longer period, if necessar…

(a) There is hereby established in the State Treasury, the Clinical Laboratory Improvement Fund. (b) All fees established under this chapter and Chapter 4 (commencing with Section 1600) of Division 2 of the Health and Safety Code shall be collected by and paid to the department, …

If the department determines that a laboratory that has been issued a license or registration under this chapter, except for a laboratory only performing tests or examinations classified as waived under CLIA, no longer substantially meets the requirements of this chapter or the r…

The department shall have three years from the date of a violation of this chapter or of a regulation adopted thereunder to file a civil or administrative action.

The department may deny, suspend, or revoke any license or registration issued under this chapter for any of the following reasons: (a) Conduct involving moral turpitude or dishonest reporting of tests. (b) Violation by the applicant, licensee, or registrant of this chapter or an…

For purposes of this chapter, a conviction means a plea or verdict of guilty or a conviction following a plea of nolo contendere. An action to deny, revoke, or suspend the license or registration may be taken when the time for appeal has elapsed or the judgment of conviction has …

The proceedings under this chapter for the suspension or revocation of a license or registration shall be conducted in accordance with Section 100171 of the Health and Safety Code.