citation: BPC § 1265

text:
(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 person who has applied for the license on forms provided by the department and who is found to be in compliance with this chapter and the regulations pertaining thereto. No clinical laboratory license shall be issued by the department unless the clinical laboratory and its personnel meet the CLIA requirements for laboratories performing tests or examinations classified as of moderate or high complexity, or both.

(2) A clinical laboratory performing clinical laboratory tests or examinations subject to a certificate of waiver or a certificate of provider-performed microscopy under CLIA, shall register with the department. The department shall issue a clinical laboratory registration to any person who has applied for the registration on forms provided by the department and is found to be in compliance with this chapter, the regulations pertaining thereto, and the CLIA requirements for either a certificate of waiver or a certificate of provider-performed microscopy.

(b) An application for a clinical laboratory license or registration shall include the name or names of the owner or the owners, the name or names of the laboratory director or directors, the name and location of the laboratory, a list of the clinical laboratory tests or examinations performed by the laboratory by name and total number of test procedures and examinations performed annually (excluding tests the laboratory may run for quality control, quality assurance, or proficiency testing purposes). The application shall also include a list of the tests and the test kits, methodologies, and laboratory equipment used, and the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and test procedures, and any other relevant information as may be required by the department. If the laboratory is performing tests subject to a provider-performed microscopy certificate, the name of the provider or providers performing those tests shall be included on the application. Application shall be made by the owners of the laboratory and the laboratory directors prior to its opening. A license or registration to conduct a clinical laboratory if the owners are not the laboratory directors shall be issued jointly to the owners and the laboratory directors and the license or registration shall include any information as may be required by the department. The owners and laboratory directors shall be severally and jointly responsible to the department for the maintenance and conduct thereof or for any violations of this chapter and regulations pertaining thereto.

(c) The department shall not issue a license or registration until it is satisfied that the clinical laboratory will be operated within the spirit and intent of this chapter, that the owners and laboratory directors are each of good moral character, and that the granting of the license will not be in conflict with the interests of public health.

(d) A separate license or registration shall be obtained for each laboratory location, with the following exceptions:

(1) Laboratories that are not at a fixed location, that is, laboratories that move from one testing site to another, such as mobile units providing laboratory testing, health screening fairs, or other temporary testing locations, may apply for and obtain one license or registration for the designated primary site or home base, using the address of that primary site.

(2) Not-for-profit, or federal, state, or local government laboratories that engage in limited (not more than a combination of 15 moderately complex or waived tests, as defined under CLIA, per license) public health testing may apply for and obtain a single license or registration.

(3) Laboratories within a hospital that are located at contiguous buildings on the same campus and under common direction, may file a single application or multiple applications for a license or registration of laboratory locations within the same campus or street address.

(4) Locations within a single street and city address that are under common ownership may apply for and obtain a single license or registration or multiple licenses or registrations, at the discretion of the owner or owners.

(e) (1) A license or registration shall be valid for one year unless revoked or suspended. A clinical laboratory license or registration shall be automatically revoked 30 days from a major change of laboratory directorship or ownership. The clinical laboratory shall be required to submit a completed application for a new clinical laboratory license or registration within those 30 days or cease engaging in clinical laboratory practice.

(2) If a clinical laboratory intends to continue to engage in clinical laboratory practice during the 30 days after a major change in directorship occurs and before the laboratory license or registration is automatically revoked, the laboratory owner may appoint an interim director who meets the requirements of this chapter and CLIA. The interim director shall be appointed within five business days of the major change of the directorship. Written notice shall be provided to the department of the appointment of the laboratory director pursuant to this paragraph within five business days of the appointment.

(f) If the department does not within 60 days after the date of receipt of the application issue a license or registration, it shall state the grounds and reasons for its refusal in writing, serving a copy upon the applicant by certified mail addressed to the applicant at their last known address.

(g) The department shall be notified in writing by the laboratory owners or delegated representatives of the owners and the laboratory directors of any change in ownership, directorship, name, or location, including the addition or deletion of laboratory owners or laboratory directors within 30 days. However, notice of change in ownership shall be the responsibility of both the current and new owners. Laboratory owners and directors to whom the current license or registration is issued shall remain jointly and severally responsible to the department for the operation, maintenance, and conduct of the clinical laboratory and for any violations of this chapter or the regulations adopted thereunder, including any failure to provide the notifications required by this subdivision, until proper notice is received by the department. In addition, failure of the laboratory owners and directors to notify the department within 30 days of any change in laboratory directors, including any additions or deletions, shall result in the automatic revocation of the clinical laboratory’s license or registration.

(h) The withdrawal of an application for a license or registration or for a renewal of a license, or registration, issuable under this chapter, shall not, after the application has been filed with the department, deprive the department of its authority to institute or continue a proceeding against the applicant for denial of the license, registration, or renewal upon any ground provided by law or to enter an order denying the license, registration, or renewal upon any such ground, unless the department consents in writing to the withdrawal.

(i) The suspension, expiration, or forfeiture by operation of law of a license or registration issued under this chapter, or its suspension, forfeiture, or cancellation by order of the department or by order of a court of law, or its surrender without the written consent of the department, shall not deprive the department of its authority to institute or continue an action against a license or registration issued under this chapter or against the laboratory owner or laboratory director upon any ground provided by law or to enter an order suspending or revoking the license or registration issued under this chapter.

(j) (1) Whenever a clinical laboratory ceases operations, the laboratory owners, or delegated representatives of the owners, and the laboratory directors shall notify the department of this fact, in writing, within 30 calendar days from the date a clinical laboratory ceases operation. For purposes of this subdivision, a laboratory ceases operations when it suspends the performance of all clinical laboratory tests or examinations for 30 calendar days at the location for which the clinical laboratory is licensed or registered.

(2) (A) Notwithstanding any other provision of law, owners and laboratory directors of all clinical laboratories, including those laboratories that cease operations, shall preserve medical records and laboratory records, as defined in this section, for three years from the date of testing, examination, or purchase, unless a longer retention period is required pursuant to any other provision of law, and shall maintain an ability to provide those records when requested by the department or any duly authorized representative of the department.

(B) For purposes of this subdivision, “medical records” means the test requisition or test authorization, or the patient’s chart or medical record, if used as the test requisition, the final and preliminary test or examination result, and the name of the person contacted if the laboratory test or examination result indicated an imminent life-threatening result or was of panic value.

(C) For purposes of this subdivision, “laboratory records” means records showing compliance with CLIA and this chapter during a laboratory’s operation that are actual or true copies, either photocopies or electronically reproducible copies, of records for patient test management, quality control, quality assurance, and all invoices documenting the purchase or lease of laboratory equipment and test kits, reagents, or media.

(D) Information contained in medical records and laboratory records shall be confidential, and shall be disclosed only to authorized persons in accordance with federal, state, and local laws.

(3) The department or any person injured as a result of a laboratory’s abandonment or failure to retain records pursuant to this section may bring an action in a court of proper jurisdiction for any reasonable amount of damages suffered as a result thereof.

(k) For purposes of this section, in the case of a pharmacy that applies for a registration pursuant to Section 1206.6, “laboratory director” means the pharmacist-in-charge identified pursuant to subdivision (a) of Section 1206.6.

(l) For the purposes of this section, a location where digital materials, as defined in Section 1265.2, are accessed by pathologists through virtual private networks, or other secure method, and for which no additional laboratory equipment is required, shall be interpreted as an extension of a primary site’s CLIA certificate and that remote location shall not require a separate license or registration, consistent with the interpretation of CLIA regulations by the federal Centers for Medicare and Medicaid Services guidelines, and as may be amended or updated from time to time.

history: (History: Amended by Stats. 2024, Ch. 699, Sec. 2. (AB 2107) Effective January 1, 2025.)

article: 4. Licensing


kind: section

code: BPC

text:
(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 or registration of a clinical laboratory to be operated by the clinic.

(b) An application for licensure of a clinical laboratory submitted pursuant to this section shall be subject to all applicable laboratory licensing laws and regulations, including, but not limited to, any statutory or regulatory timelines and processes for review of a clinical laboratory application.

history: (History: Amended by Stats. 2008, Ch. 179, Sec. 5. Effective January 1, 2009.)

division: 2. HEALING ARTS

chapter: 3. Clinical Laboratory Technology

article: 4. Licensing

path: 2. HEALING ARTS > 3. Clinical Laboratory Technology > 4. Licensing


text:
(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 laboratory site licensed by the state may review digital materials at a remote location under a primary site’s CLIA certificate pursuant to subdivision (l) of Section 1265.

(c) This section shall become operative if the department determines, pursuant to Section 1265.3, that this section conforms to the federal Clinical Laboratory Improvement Amendments of 1988 as amended by Section 353 of the federal Public Health Service Act.

history: (History: Added by Stats. 2024, Ch. 699, Sec. 3. (AB 2107) Effective January 1, 2025. Conditionally operative as prescribed by its own provisions.)

article: 4. Licensing


text:
(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 Medicaid Services, shall make a determination whether Section 1265.2 conforms to the federal Clinical Laboratory Improvement Amendments of 1988 as amended by Section 353 of the federal Public Health Service Act.

(2) If the department determines Section 1265.2 conforms to the federal Clinical Laboratory Improvement Amendments of 1988 as amended by Section 353 of the federal Public Health Service Act, it shall communicate this finding in a letter to the Legislature and to the Legislative Counsel Bureau.

(c) This section shall remain in effect only until January 1, 2027, and as of that date is repealed.

history: (History: Added by Stats. 2024, Ch. 699, Sec. 4. (AB 2107) Effective January 1, 2025. Repealed as of January 1, 2027, by its own provisions.)

article: 4. Licensing


citation: BPC § 1266

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

history: (History: Amended by Stats. 1970, Ch. 1377.)

article: 4. Licensing


citation: BPC § 1267

text: 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.

history: (History: Amended by Stats. 1997, Ch. 220, Sec. 5. Effective August 4, 1997.)

article: 4. Licensing


citation: BPC § 1268

text: 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 change of name, another license in lieu of one previously issued.

article: 4. Licensing


citation: BPC § 1269

text:
(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 all of the following criteria:

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

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

(A) 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) 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) The skills required for performing preventive maintenance, and troubleshooting.

(D) A working knowledge of reagent stability and storage.

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

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

(b) The activities that may be performed are:

(1) Biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens.

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

(3) Assisting in preventive maintenance, and troubleshooting.

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

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

(c) Notwithstanding subdivision (a), unlicensed laboratory personnel, other than a trainee, may, under the supervision and control of a physician and surgeon or person licensed under this chapter, perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing if he or she meets the requirements of subparagraph (A) of paragraph (2) of, and paragraph (1) of, subdivision (a).

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

(1) Record test results, but he or she 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.

(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.

(3) Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation.

(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) 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.

(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.

history: (History: Amended by Stats. 1999, Ch. 695, Sec. 4. Effective January 1, 2000.)

article: 4. Licensing


text:
(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 accrediting agency approved by the department, who demonstrates competency to perform all job duties and responsibilities before an assignment to those duties and responsibilities, at the completion of six months of performing those duties and responsibilities, and annually thereafter, may perform the following activities under the supervision and control of a pathologist:

(1) Prepare human surgical specimens for gross description and dissection, including, but not limited to, description of gross features and selection of tissues for histological examination.

(2) Prepare and perform human postmortem examinations, including, but not limited to, selection of tissues and fluids for further examination.

(3) Gather other information necessary for an autopsy report.

(4) Prepare a body for release.

(b) Notwithstanding Section 1206.5 or subdivisions (b), (c), and (d) of Section 1269, the following persons may prepare human surgical specimens for gross description and dissection under the direct supervision of a qualified pathologist, including, description of gross features and selection of tissues for histological examination, if they meet the requirements specified in subdivision (a) of Section 1269 and the minimum education and training requirements for high complexity testing personnel under the CLIA:

(1) A pathologists’ assistant who does not meet the certification requirements of subdivision (a).

(2) A histologic technician.

(3) A histotechnologist.

(c) For the purposes of subdivision (b), direct supervision means that a qualified pathologist shall be physically present onsite in the vicinity of the clinical laboratory where the specialty of pathology is performed and shall be available for consultation and direction during the time the personnel specified in subdivision (b) are engaged in the processing of specimens that involve dissection. For tissue processing that does not involve dissection, a qualified pathologist may be available by telephone or other electronic means.

(d) A histologic technician or histotechnologist who meets the requirements specified in subdivision (a) of Section 1269, may accession specimens, perform maintenance of equipment, stain, cover slip, label slides, and process tissues by embedding in paraffin or performing microtomy.

(e) On and after January 1, 2011, the department may adopt regulations establishing additional qualification requirements to perform the duties described in this section.

history: (History: Added by Stats. 2006, Ch. 319, Sec. 3. Effective January 1, 2007.)

article: 4. Licensing


text: 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.

history: (History: Added by Stats. 2000, Ch. 322, Sec. 3. Effective January 1, 2001.)

article: 4. Licensing


citation: BPC § 1270

text:
(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 cytotechnologists by the department on or before January 1, 1991, shall be licensed by the department on or before January 1, 1993. Cytotechnologist licenses shall be issued and renewed by the department for periods of two years. This subdivision shall not apply to persons holding a valid, unrevoked, unsuspended physician’s and surgeon’s certificate issued pursuant to Chapter 5 (commencing with Section 2000).

(b) The issuance of a cytotechnologist license shall be contingent upon the applicant’s satisfactory performance, as defined in regulation, in a competency testing program for cytotechnologists which may be administered by the department or by a competency testing service or program approved by the department. The competency testing program established pursuant to this section shall be periodically reviewed and revised by the department, if necessary, to ensure that the program is consistent with federal competency testing requirements issued under the federal Clinical Laboratory Improvement Amendments of 1988 (Public Law 100-578; 42 U.S.C. Sec. 263a, Section 353 of the Public Health Service Act).

(c) Notwithstanding subdivision (b), the department may issue a temporary cytotechnologist license to a person who satisfies the requirements for admission to the examination unless the person has failed a previous examination for a cytotechnologist license. A temporary license issued by the department pursuant to this subdivision shall be valid for a period of time not exceeding 90 days after the date the department has adopted a competency testing program pursuant to subdivision (b).

(d) The department may issue a cytotechnologist license without examination to an applicant who satisfies one of the following:

(1) Passage of an examination of a national accrediting board whose requirements are equal to or greater than those required by this chapter or by regulations adopted pursuant to this chapter, as determined by the department.

(2) Passage of an examination of another state in which the requirements imposed by laws and regulations regarding the examination are equal to or greater than those required by this chapter or by regulations adopted pursuant to this chapter, as determined by the department.

This subdivision shall not apply to a person who has passed an examination of a national accrediting board or another state prior to that board’s or state’s establishment of requirements which are equal to or greater than those required by this chapter or by regulations adopted pursuant to this chapter, as determined by the department. The department may, however, make exceptions to the requirements of this subdivision in cases where the department determines that the applicant is otherwise qualified for licensure.

(e) The department shall not issue any temporary cytotechnologist license pursuant to subdivision (c) or any cytotechnologist license without examination pursuant to subdivision (d) after the department adopts a competency testing program pursuant to subdivision (b).

(f) (1) A licensed cytotechnologist may perform all tests and procedures pertaining to cytology, including, but not limited to, microscopic and nonmicroscopic methodologies and tests and procedures that utilize molecular or genetic methodologies, that are performed on cytologic specimens related to infectious disease or cancer diagnosis, under the overall operation and administration of a laboratory director, who shall be a qualified pathologist. As used in this paragraph, a “qualified pathologist” means a physician and surgeon who is certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.

(2) Any tests or procedures performed by a licensed cytotechnologist pursuant to this subdivision shall be performed in a licensed clinical laboratory certified in the subspecialty of diagnostic cytology.

history: (History: Amended by Stats. 2015, Ch. 300, Sec. 1. (AB 599) Effective January 1, 2016.)

article: 4. Licensing


text:
(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, shall be filed with the department not less than 30 days prior to the expiration date.

(c) If the renewal fee is not paid during the 30 days prior to the expiration date, the license shall automatically expire at midnight on the expiration date. However, a cytotechnologist who has failed to timely pay a renewal fee may have his or her license reinstated, without completing a competency testing program, provided that he or she mails to the department a written request for reinstatement postmarked no later than the 60th day after the expiration date of the license and a reinstatement fee equal to two times the annual renewal fee set forth in Section 1300. The license shall be reinstated on the date the request for reinstatement and fee are received by the department. If the request for reinstatement and fee are received prior to the expiration date of the license, there shall be no lapse in licensure. No cytotechnologist shall perform services for which a license or certification is required under this chapter during any period for which licensure or certification has lapsed.

history: (History: Amended by Stats. 1990, Ch. 1019, Sec. 2.)

article: 4. Licensing


citation: BPC § 1271

text:
(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 period without regard to the number of clinical laboratories or other persons for which the work is performed. Cytotechnologists, who examine both gynecologic and nongynecologic slides, shall do so on a pro rata basis so that the maximum workload limit in subdivision (a) is not exceeded, and so that the number of gynecologic slides examined is reduced proportionally if both gynecologic and nongynecologic slides are examined in a 24-hour period.

(c) The maximum workload limit in subdivision (a) is for a cytotechnologist who has no duties other than the evaluation of gynecological slides. Cytotechnologists who have other duties, including, but not limited to, the preparation and staining of cytologic slides, shall decrease on a pro rata basis the number of slides examined.

(d) All cytologic slides shall be examined in a clinical laboratory that has been licensed by the department, or in a municipal or county laboratory established under Section 101150 of the Health and Safety Code. All slides examined under the name of a clinical laboratory shall be examined on the premises of that laboratory.

(e) Each clinical laboratory shall maintain records of the number of cases and slides for gynecologic and nongynecologic samples examined on a monthly and annual basis.

(f) Each cytotechnologist shall maintain current records in a form prescribed by the department of hours worked and the names and addresses of the clinical laboratories or other persons for whom slides are examined.

(g) Each clinical laboratory shall retain all cytology slides and cell blocks examined for a minimum of five years and all cytology reports for a minimum of 10 years.

(h) The presence of any factor that would prohibit the proper examination of a cytologic slide, including, but not limited to, damaged slides or inadequate specimens, as determined by the director of the laboratory, shall result in the issuance of a statement of inadequacy to the referring physician and no report of cytologic findings shall be issued on that slide.

(i) Each clinical laboratory shall maintain records of the number of cases and slides for gynecologic and nongynecologic slides each cytotechnologist in the laboratory reads each 24-hour period, the number of hours devoted during each 24-hour period to screening cytology slides by each individual, and shall determine weekly and cumulatively the frequency of abnormal slides found by each cytotechnologist employed.

(j) Ten percent of the negative or normal slides examined by each cytotechnologist employed by a clinical laboratory shall be rescreened at least weekly by a cytopathologist or supervising cytotechnologist other than the original examiner.

(k) When reviewing gynecologic slides using automated or semiautomated screening devices approved by the federal Food and Drug Administration, a laboratory shall follow the workload requirements established by Section 493.1274 of Title 42 of the Code of Federal Regulations.

(1) Any slide reviewed using automated or semiautomated screening devices approved by the federal Food and Drug Administration that requires full manual review shall be counted against the applicable limits established in subdivision (a) and this subdivision.

(2) On or before June 30, 2007, the State Department of Health Services shall review published evidence-based peer review journal articles that review the performance of both automated and semiautomated screening devices, subsequent to the approval of the device by the federal Food and Drug Administration, and shall determine whether increasing the number of slides reviewed on a daily basis increases the rate of error. If the department determines that the volume of screening on these devices increases the rate of error, the department may issue new regulations in that regard that are consistent with Section 493.1274 of Title 42 of the Code of Federal Regulations.

(l) The technical supervisor of an individual who performs primary screening shall establish the maximum workload limit for the individual, based on the individual’s performance, in accordance with the criteria set forth in Section 493.1274(d)(1) of Title 42 of the Code of Federal Regulations.

(m) Where cytotechnologists are represented by a labor organization, the maximum workload limitations otherwise established pursuant to this section shall be contained in a collective bargaining agreement or memorandum of understanding negotiated between the employer and the labor organization.

history: (History: Amended (as amended by Stats. 2004, Ch. 735, Sec. 1) by Stats. 2007, Ch. 198, Sec. 1. Effective January 1, 2008.)

article: 4. Licensing


text:
(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 person injured as a result of the licensee’s abandonment of records may bring an action in any court of competent jurisdiction for the amount of any damages suffered as a result. In the event the licensee was a corporation or partnership which has been dissolved, the person injured may bring an action against that corporation’s or partnership’s principal officers of record at the time of the dissolution.

(c) For purposes of this section, the following definitions shall apply:

(1) “Abandonment of records” means violating subdivision (a) and thereby leaving patients and physicians and surgeons without access to information to which they are entitled pursuant to this chapter.

(2) “Principal officers” means:

(A) In the case of a partnership other than a limited partnership, any partner.

(B) In the case of a limited partnership, any general partner, as defined in subdivision (i) of Section 15611 of the Corporations Code.

(C) In the case of a corporation, the chairperson of the board, the chief executive officer, and the president of the corporation.

history: (History: Added by Stats. 1991, Ch. 243, Sec. 2. Effective July 29, 1991.)

article: 4. Licensing


citation: BPC § 1272

text: 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: microbiology, serology, clinical chemistry, hematology, cytology, and immunohematology.

history: (History: Added by Stats. 1989, Ch. 927, Sec. 7.)

article: 4. Licensing


text: 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.

history: (History: Added by Stats. 1989, Ch. 927, Sec. 8.)

article: 4. Licensing


text: 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 program established pursuant to this section shall include announced and unannounced onsite proficiency testing, with that testing to take place, to the extent practicable, under normal working conditions.

history: (History: Amended by Stats. 1990, Ch. 1019, Sec. 5.)

article: 4. Licensing


citation: BPC § 1274

text:
(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 followup correspondence, telephone calls, or requests included in the report. Copies of that documentation, and any responses received to those letters, shall be maintained on file by the laboratories for a period of five years.

(b) Whenever it becomes known to a clinical laboratory that an abnormality of HSIL (high-grade squamous intraepithelial lesions, adenocarcinoma, or other malignant neoplasm) has been identified for a patient for whom the clinical laboratory earlier reported a normal finding, all previous available cytologic slides on that patient shall be reexamined by the clinical laboratory.

(c) Records of the review of previous slides required by subdivision (b) shall be maintained by the clinical laboratory, including the name of the individual performing the earlier examination.

(d) A clinical laboratory shall maintain records of all false positive and false negative cases.

When any errors in the reporting of a smear evaluation are discovered, a corrected report shall be immediately sent, when medically applicable. Copies of corrected reports shall be maintained in the laboratory records for a period of 10 years.

history: (History: Amended by Stats. 2004, Ch. 695, Sec. 4. Effective January 1, 2005.)

article: 4. Licensing


citation: BPC § 1275

text: 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 organizations. On and after January 1, 1994, the department shall require not more than 12 hours of continuing education completed within a 12-month period or not more than 24 hours of continuing education completed within a 24-month period as a condition for renewal of a license issued under this chapter. The department may establish a fee for the implementation of this section, the total fees collected not to exceed the total costs to the program for the implementation of this requirement.

history: (History: Amended by Stats. 2003, Ch. 319, Sec. 4. Effective January 1, 2004.)

article: 4. Licensing


citation: BPC § 1280

text: 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.

article: 5. Offenses Against the Chapter

path: 2. HEALING ARTS > 3. Clinical Laboratory Technology > 5. Offenses Against the Chapter


citation: BPC § 1281

text: 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 not perform clinical laboratory services, but provides laboratory services to its patients under an agreement with another person or entity that holds and is operating under a valid clinical laboratory license, the health facility shall not be required to obtain a clinical laboratory license.

history: (History: Amended by Stats. 1994, Ch. 261, Sec. 1. Effective January 1, 1995.)

article: 5. Offenses Against the Chapter


text: 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 clinical laboratory practice, unless the person is serving as an agent of a clinical laboratory or another facility legally utilizing those specimens only for purposes of research or teaching or for quality assurance purposes, or is an entity licensed under Chapter 4 (commencing with Section 1600) of Division 2 of the Health and Safety Code.

history: (History: Added by Stats. 2000, Ch. 322, Sec. 4. Effective January 1, 2001.)

article: 5. Offenses Against the Chapter


citation: BPC § 1282

text: 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.

history: (History: Amended by Stats. 1990, Ch. 195, Sec. 9. Effective July 9, 1990.)

article: 5. Offenses Against the Chapter


text: 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.

history: (History: Added by Stats. 2000, Ch. 322, Sec. 5. Effective January 1, 2001.)

article: 5. Offenses Against the Chapter


text:
(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 collection, handling, storage, or labeling of the biological specimen or the erroneous transcription or reporting of clinical laboratory test or examination results.

(b) Notwithstanding Section 1287, a violation of this section shall be punished as follows:

(1) A first conviction is punishable by imprisonment in a county jail for a period of not more than one year, or by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code for 16 months, or two or three years, by a fine not exceeding fifty thousand dollars ($50,000), or by both this imprisonment and fine.

(2) A second or subsequent conviction is punishable by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code for two, four, or six years, or by a fine not exceeding fifty thousand dollars ($50,000), or by both this imprisonment and fine.

(c) The enforcement remedies provided under this section are not exclusive, and shall not preclude the use of any other criminal or civil remedy. However, an act or omission punishable in different ways by this section and any other provision of law shall not be punished under more than one provision. Under those circumstances, the penalty to be imposed shall be determined as set forth in Section 654 of the Penal Code.

history: (History: Amended by Stats. 2011, Ch. 15, Sec. 7. (AB 109) Effective April 4, 2011. Operative October 1, 2011, by Sec. 636 of Ch. 15, as amended by Stats. 2011, Ch. 39, Sec. 68.)

article: 5. Offenses Against the Chapter


citation: BPC § 1283

text: 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.

history: (History: Added by renumbering Section 1284 by Stats. 1970, Ch. 1377.)

article: 5. Offenses Against the Chapter


citation: BPC § 1284

text: 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.

history: (History: Added by renumbering Section 1285 by Stats. 1970, Ch. 1377.)

article: 5. Offenses Against the Chapter


citation: BPC § 1285

text: 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.

history: (History: Added by renumbering Section 1286 by Stats. 1970, Ch. 1377.)

article: 5. Offenses Against the Chapter


citation: BPC § 1286

text: 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 provided.

history: (History: Amended by Stats. 1978, Ch. 429.)

article: 5. Offenses Against the Chapter


citation: BPC § 1287

text:
(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 subdivision (a), a violation of Section 1281.1 is a public offense and is punishable upon conviction by imprisonment in the county jail for not more than one year, or by a fine not exceeding ten thousand dollars ($10,000), or by both that imprisonment and fine.

(2) Notwithstanding subdivision (a), a violation of Section 1282.2 is a public offense and is punishable upon conviction by imprisonment in the county jail for not more than one year, or by a fine not exceeding one thousand dollars ($1,000), or by both that imprisonment and fine.

(3) The enforcement remedies provided under this section are not exclusive, and shall not preclude the use of any other criminal or civil remedy. However, an act or omission punishable in different ways by this section and any other provision of law shall not be punished under more than one provision. Under those circumstances, the penalty to be imposed shall be determined as set forth in Section 654 of the Penal Code.

history: (History: Amended by Stats. 2000, Ch. 322, Sec. 7. Effective January 1, 2001.)

article: 5. Offenses Against the Chapter


citation: BPC § 1288

text: 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 evaluation specimens for proficiency testing or referral of specimens or such assignment from one clinical laboratory to another clinical laboratory, either licensed or exempt under this chapter, providing the report indicates clearly the laboratory performing the test. A report of results issuing from a clinical laboratory shall show clearly the name and address of the laboratory and the name of the director.

history: (History: Added by renumbering Section 1292 by Stats. 1970, Ch. 1377.)

article: 5. Offenses Against the Chapter


text:
(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 laboratory employee, agent, or courier, utilizing the form provided by the State Department of Health Services pursuant to Section 1220.5, shall (1) notify the licensee by attaching the appropriate copy of the form to the unlocked storage container, and (2) mail the appropriate copy of the form to the Department of Consumer Affairs. The Department of Consumer Affairs shall forward all forms received to the appropriate licensing entity.

(b) This section shall not apply where the biological specimens have been received by mail in compliance with all applicable laws and regulations.

(c) For purposes of this section: (1) “locked container” means a secure container that is fully enclosed and locked by a padlock, key lock, combination lock, or similar locking device.

(2) “Licensee” means a person licensed pursuant to this division 2 (commencing with Section 500), who collects human biological specimens for clinical testing or examination.

(d) A violation of this section is not subject to Section 1287.

(e) This section shall become operative on January 1, 2001. Nothing in this section shall be construed to require clinical laboratory employees, agents, or couriers to notify licensees or the Department of Consumer Affairs of an unsecured specimen if the State Department of Health Services has not provided the appropriate forms.

history: (History: Added by Stats. 1999, Ch. 748, Sec. 3. Effective January 1, 2000. Section operative January 1, 2001, by its own provisions.)

article: 5. Offenses Against the Chapter


text: 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 the category of test or examination which includes that testing or examination, and the person performing the test or examination is authorized to perform the test or examination under this chapter.

history: (History: Added by Stats. 1995, Ch. 510, Sec. 31. Effective January 1, 1996.)

article: 5. Offenses Against the Chapter


citation: BPC § 1289

text: 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.

history: (History: Added by Stats. 1970, Ch. 1377.)

article: 5. Offenses Against the Chapter


citation: BPC § 1290

text: 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 unprofessional conduct within the meaning of this chapter.

history: (History: Repealed and added by Stats. 1970, Ch. 1377.)

article: 5. Offenses Against the Chapter


citation: BPC § 1291

text: 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.

history: (History: Added by Stats. 1971, Ch. 1070.)

article: 5. Offenses Against the Chapter


citation: BPC § 1300

text:
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 laboratory toxicologist’s, clinical genetic molecular biologist’s, clinical cytogeneticist’s, clinical laboratory geneticist’s, or clinical reproductive biologist’s license, or license for another specialty or subspecialty specified by regulation adopted by the department, is five hundred seventy dollars ($570).

(b) The annual renewal fee for a license listed in subdivision (a) is five hundred seventy dollars ($570).

(c) The application fee for a clinical laboratory scientist’s or limited clinical laboratory scientist’s license is three hundred dollars ($300).

(d) The application and annual renewal fee for a cytotechnologist’s license is two hundred sixty dollars ($260).

(e) The annual renewal fee for a clinical laboratory scientist’s or limited clinical laboratory scientist’s license is three hundred dollars ($300).

(f) The application and annual renewal fee for a phlebotomist’s certification is one hundred fifty dollars ($150).

(g) A clinical laboratory applying for a license to perform tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory applying for certification under subdivision (c) of Section 1223 shall pay an application fee for that license or certification based on the number of tests it performs or expects to perform in a year, as follows:

(1) Less than 2,001 tests: three hundred thirty-five dollars ($335).

(2) Between 2,001 and 10,000, inclusive, tests: one thousand one hundred dollars ($1,100).

(3) Between 10,001 and 25,000, inclusive, tests: one thousand eight hundred dollars ($1,800).

(4) Between 25,001 and 50,000, inclusive, tests: two thousand two hundred dollars ($2,200).

(5) Between 50,001 and 75,000, inclusive, tests: two thousand seven hundred dollars ($2,700).

(6) Between 75,001 and 100,000, inclusive, tests: three thousand three hundred dollars ($3,300).

(7) Between 100,001 and 500,000, inclusive, tests: four thousand dollars ($4,000).

(8) Between 500,001 and 1,000,000, inclusive, tests: seven thousand two hundred dollars ($7,200).

(9) More than 1,000,000 tests: eight thousand six hundred thirty dollars ($8,630) plus four hundred twenty dollars ($420) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.

(h) A clinical laboratory performing tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory with a certificate issued under subdivision (c) of Section 1223 shall pay an annual renewal fee based on the number of tests it performed in the preceding calendar year, as follows:

(1) Less than 2,001 tests: three hundred thirty-five dollars ($335).

(2) Between 2,001 and 10,000, inclusive, tests: one thousand one hundred dollars ($1,100).

(3) Between 10,001 and 25,000, inclusive, tests: one thousand eight hundred dollars ($1,800).

(4) Between 25,001 and 50,000, inclusive, tests: two thousand two hundred dollars ($2,200).

(5) Between 50,001 and 75,000, inclusive, tests: two thousand seven hundred dollars ($2,700).

(6) Between 75,001 and 100,000, inclusive, tests: three hundred three hundred dollars ($3,300).

(7) Between 100,001 and 500,000, inclusive, tests: four thousand dollars ($4,000).

(8) Between 500,001 and 1,000,000, inclusive, tests: seven thousand two hundred dollars ($7,200).

(9) More than 1,000,000 tests per year: eight thousand six hundred thirty dollars ($8,630) plus four hundred twenty dollars ($420) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.

(i) The application fee for a trainee’s license is forty-five dollars ($45).

(j) The annual renewal fee for a trainee’s license is forty-five dollars ($45).

(k) The application fee for a duplicate license is five dollars ($5).

(l) The personnel licensing delinquency fee is equal to the annual renewal fee.

(m) The director may establish a fee for examinations required under this chapter. The fee shall not exceed the total cost to the department in conducting the examination.

(n) A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only those clinical laboratory tests or examinations considered waived under CLIA shall pay an annual fee of one hundred fifty-five dollars ($155). A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only provider-performed microscopy, as defined under CLIA, shall pay an annual fee of two hundred thirty-five dollars ($235). A clinical laboratory performing both waived and provider-performed microscopy shall pay an annual registration fee of two hundred thirty-five dollars ($235).

(o) The costs of the department in conducting a complaint investigation, imposing sanctions, or conducting a hearing under this chapter shall be paid by the clinical laboratory. The fee shall be no greater than the fee the laboratory would pay under CLIA for the same type of activities and shall not be payable if the clinical laboratory would not be required to pay those fees under CLIA.

(p) The state, a district, city, county, city and county, or other political subdivision, or any public officer or body shall be subject to the payment of fees established pursuant to this chapter or regulations adopted thereunder.

(q) In addition to the payment of registration or licensure fees, a clinical laboratory located outside the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections at the clinical laboratory in order to ensure compliance with this chapter.

(r) The department shall establish an application fee and a renewal fee for a medical laboratory technician license, the total fees collected not to exceed the costs of the department for the implementation and operation of the program licensing and regulating medical laboratory technicians pursuant to Section 1260.3.

(s) The costs of the department to conduct any reinspections to ensure compliance of a laboratory applying for initial licensure shall be paid by the laboratory. This additional cost for each visit shall be equal to the initial application fee and shall be paid by the laboratory prior to issuance of a license. The department shall not charge a reinspection fee if the reinspection is due to error or omission on the part of the department.

(t) A fee of twenty-eight dollars ($28) shall be assessed for approval of each additional location authorized by paragraph (2) of subdivision (d) of Section 1265.

(u) On or before July 1, 2013, the department shall report to the Legislature during the annual legislative budget hearing process the extent to which the state oversight program meets or exceeds federal oversight standards and the extent to which the federal Department of Health and Human Services is accepting exemption applications and the potential cost to the state for an exemption.

history: (History: Amended by Stats. 2025, Ch. 105, Sec. 3. (AB 144) Effective September 17, 2025.)

article: 6. Revenue

path: 2. HEALING ARTS > 3. Clinical Laboratory Technology > 6. Revenue


text:
(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 section shall become operative on January 1, 2020.

history: (History: Amended by Stats. 2025, Ch. 105, Sec. 4. (AB 144) Effective September 17, 2025.)

article: 6. Revenue


text: 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 personnel.

history: (History: Added by Stats. 2009, Ch. 201, Sec. 5. (SB 744) Effective October 11, 2009.)

article: 6. Revenue


citation: BPC § 1301

text:
(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 licensee or registrant, as a condition precedent to renewal, shall pay a delinquency fee equal to 25 percent of the annual renewal fee for up to 60 days after the expiration date, in addition to the annual renewal fee in effect on the last preceding regular renewal date. Failure to pay the annual renewal fee in advance during the time the license or registration remains in force shall, ipso facto, work a forfeiture of the license or registration after a period of 60 days from the expiration date of the license or registration.

(b) (1) The department shall give written notice to all persons licensed pursuant to Section 1260, 1260.1, 1261, 1261.5, 1262, 1264, or 1270 30 days in advance of the regular renewal date that a renewal fee has not been paid. In addition, the department shall give written notice to licensed clinical laboratory bioanalysts or doctoral degree specialists and clinical laboratory scientists or limited clinical laboratory scientists by registered or certified mail 90 days in advance of the expiration of the fifth year that a renewal fee has not been paid and if not paid before the expiration of the fifth year of delinquency the licensee may be subject to reexamination.

(2) If the renewal fee is not paid for five or more years, the department may require an examination before reinstating the license, except that no examination shall be required as a condition for reinstatement if the original license was issued without an examination. No examination shall be required for reinstatement if the license was forfeited solely by reason of nonpayment of the renewal fee if the nonpayment was for less than five years.

(3) If the license is not renewed within 60 days after its expiration, the licensee, as a condition precedent to renewal, shall pay the delinquency fee identified in subdivision (k) of Section 1300, in addition to the renewal fee in effect on the last preceding regular renewal date. Payment of the delinquency fee will not be necessary if within 60 days of the license expiration date the licensee files with the department an application for inactive status.

history: (History: Amended by Stats. 2010, Ch. 328, Sec. 7. (SB 1330) Effective January 1, 2011.)

article: 6. Revenue


text: 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 necessary, to permit the most efficient and economical use of the department’s personnel and equipment. To the extent practical, provision shall be made for the proration or other fee adjustments in a manner that no licensee shall be required to pay a greater or lesser fee than he or she would have been required to pay if the change in license periods or renewal dates had not occurred.

history: (History: Added by Stats. 1990, Ch. 195, Sec. 10. Effective July 9, 1990.)

article: 6. Revenue


citation: BPC § 1302

text:
(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, and shall be deposited by the department in the Clinical Laboratory Improvement Fund, along with any other moneys received by the department for the purpose of licensing, certification, inspection, proficiency testing, or other regulation of clinical laboratories, blood banks, or clinical laboratory personnel. Notwithstanding Section 16305.7 of the Government Code, all interest earned on moneys deposited in the fund shall be maintained in the fund.

(c) Moneys deposited in the Clinical Laboratory Improvement Fund that are appropriated in the annual Budget Act, or any other appropriation, for support of, or expenditure by, the state department shall, upon appropriation, be expended by the state department to administer this chapter and Chapter 4 (commencing with Section 1600) of Division 2 of the Health and Safety Code. All fees collected pursuant to this chapter shall, upon appropriation, be expended to administer this chapter and shall not be redirected for any other purpose. All fees collected pursuant to Chapter 4 (commencing with Section 1600) of Division 2 of the Health and Safety Code shall, upon appropriation, be expended to administer that chapter and shall not be redirected for any other purpose.

history: (History: Amended by Stats. 2009, Ch. 201, Sec. 7. (SB 744) Effective October 11, 2009.)

article: 6. Revenue


citation: BPC § 1310

text:
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 regulations adopted thereunder, the department, in lieu of, or in addition to, revocation or suspension of the license or registration under Section 1320 or 1323, may impose any of the following:

(a) Directed plans of correction, as defined under CLIA.

(b) Civil money penalties in an amount ranging from fifty dollars ($50) to three thousand dollars ($3,000) per day of noncompliance, or per violation, for a condition-level deficiency that does not pose immediate jeopardy, to an amount ranging from three thousand fifty dollars ($3,050) to ten thousand dollars ($10,000) per day of noncompliance, or per violation, for a condition-level deficiency that poses immediate jeopardy, but only after notice and an opportunity to respond in accordance with Section 100171 of the Health and Safety Code, and consideration of facts enumerated in CLIA in Section 493.1834 of Title 42 of the Code of Federal Regulations.

(c) Civil money penalties in an amount ranging from fifty dollars ($50) to three thousand dollars ($3,000) per day of noncompliance, or per violation, for a violation of subdivision (t) of Section 1320, for failure to comply with disease reporting requirements, but only after notice and an opportunity to respond in accordance with Section 100171 of the Health and Safety Code.

(d) Onsite monitoring, as defined under CLIA, and payment for the costs of onsite monitoring.

(e) Any combination of the actions described in subdivisions (a), (b), (c), and (d).

history: (History: Amended by Stats. 2005, Ch. 219, Sec. 1. Effective January 1, 2006.)

article: 6.5. Penalties

path: 2. HEALING ARTS > 3. Clinical Laboratory Technology > 6.5. Penalties


citation: BPC § 1311

text: 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.

history: (History: Added by Stats. 2000, Ch. 322, Sec. 9. Effective January 1, 2001.)

article: 6.5. Penalties


citation: BPC § 1320

text:
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 any rule or regulation adopted pursuant thereto.

(c) Aiding, abetting, or permitting the violation of this chapter, the rules or regulations adopted under this chapter or the Medical Practice Act, Chapter 5 (commencing with Section 2000) of Division 2.

(d) Permitting a licensed trainee to perform tests or procure specimens unless under the direct and responsible supervision of a person duly licensed under this chapter or physician and surgeon other than another licensed trainee.

(e) Violation of any provision of this code governing the practice of medicine and surgery.

(f) Proof that an applicant, licensee, or registrant has made false statements in any material regard on the application for a license, registration, or renewal issued under this chapter.

(g) Conduct inimical to the public health, morals, welfare, or safety of the people of the State of California in the maintenance or operation of the premises or services for which a license or registration is issued under this chapter.

(h) Proof that the applicant or licensee has used any degree, or certificate, as a means of qualifying for licensure that has been purchased or procured by barter or by any unlawful means or obtained from any institution that at the time the degree, certificate, or title was obtained was not recognized or accredited by the department of education of the state where the institution is or was located to give training in the field of study in which the degree, certificate, or title is claimed.

(i) Violation of any of the prenatal laws or regulations pertaining thereto in Chapter 2 (commencing with Section 120675) of Part 3 of Division 105 of the Health and Safety Code and Article 1 (commencing with Section 1125) of Group 4 of Subchapter 1 of Chapter 2 of Part 1 of Title 17 of the California Code of Regulations.

(j) Knowingly accepting an assignment for clinical laboratory tests or specimens from and the rendering of a report thereon to persons not authorized by law to submit those specimens or assignments.

(k) Rendering a report on clinical laboratory work actually performed in another clinical laboratory without designating clearly the name and address of the laboratory in which the test was performed.

(l) Conviction of a felony or of any misdemeanor involving moral turpitude under the laws of any state or of the United States arising out of or in connection with the practice of clinical laboratory technology. The record of conviction or a certified copy thereof shall be conclusive evidence of that conviction.

(m) Unprofessional conduct.

(n) The use of drugs or alcoholic beverages to the extent or in a manner as to be dangerous to a person licensed under this chapter, or any other person to the extent that that use impairs the ability of the licensee to conduct with safety to the public the practice of clinical laboratory technology.

(o) Misrepresentation in obtaining a license or registration.

(p) Performance of, or representation of the laboratory as entitled to perform, a clinical laboratory test or examination or other procedure that is not within the specialties or subspecialties, or category of laboratory procedures authorized by the license or registration.

(q) Refusal of a reasonable request of HCFA, a HCFA agent, the department, or any employee, agent, or contractor of the department, for permission to inspect, pursuant to this chapter, the laboratory and its operations and pertinent records during the hours the laboratory is in operation.

(r) Failure to comply with reasonable requests of the department for any information, work, or materials that the department concludes is necessary to determine the laboratory’s continued eligibility for its license or registration, or its continued compliance with this chapter or the regulations adopted under this chapter.

(s) Failure to comply with a sanction imposed under Section 1310.

(t) Failure to comply with the disease reporting requirements adopted pursuant to Section 120130 of the Health and Safety Code. However, when a laboratory is not able to obtain complete information for a patient within the reporting timeframes, it shall document that it made a good faith effort to do so and it shall submit the report with the available information within the required reporting timeframes and, in that case, the laboratory shall not be subject to sanctions for failure to submit complete patient information.

history: (History: Amended by Stats. 2005, Ch. 219, Sec. 2. Effective January 1, 2006.)

path: 2. HEALING ARTS > 3. Clinical Laboratory Technology > 7. Denial, Revocation and Suspension of Licenses


citation: BPC § 1321

text: 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 been affirmed on appeal or when an order granting probation is made suspending the imposition of a sentence, notwithstanding a subsequent order pursuant to Section 1203.4 of the Penal Code permitting withdrawal of a plea of guilty, or setting aside a verdict of guilty or dismissing the accusation, information, or indictment. The director shall take into account all competent evidence or rehabilitation furnished.

history: (History: Amended by Stats. 1995, Ch. 510, Sec. 35. Effective January 1, 1996.)

article: 7. Denial, Revocation and Suspension of Licenses


citation: BPC § 1322

text: 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.

history: (History: Amended by Stats. 1997, Ch. 220, Sec. 7. Effective August 4, 1997.)


citation: BPC § 1323

text: The department may temporarily suspend a license or registration prior to any hearing, when it has determined that the action is necessary to protect the public welfare. The department shall notify the licensee or registrant of the temporary suspension and the effective date thereof and at the same time shall serve the licensee or registrant with an accusation. Upon receipt of a notice of defense by the licensee or registrant, the matter shall, within 15 days, be set for hearing. The hearing shall be held as soon as possible, but not later than 30 days after receipt of that notice. The temporary suspension shall remain in effect until the time the hearing is completed and the department has made a final determination on the merits. However, the temporary suspension shall be deemed vacated if the department fails to make a final decision within 60 days after the hearing has been completed.

history: (History: Amended by Stats. 1995, Ch. 510, Sec. 37. Effective January 1, 1996.)


citation: BPC § 1324

text: Except for a person or entity whose license was revoked automatically under Section 1265, no person or entity who has owned or operated a clinical laboratory that had its license or registration revoked may, within two years of the revocation of the license or registration, own or operate a laboratory for which a license or registration has been issued under this chapter.

history: (History: Amended by Stats. 2000, Ch. 322, Sec. 10. Effective January 1, 2001.)


citation: BPC § 1325

text: Notwithstanding Sections 1267 and 1322, the license or registration of a clinical laboratory that has been excluded from participation under the Medicare program (Title XVIII of the Social Security Act (42 U.S.C. Sec. 1395 et seq.)), under the Medicaid Program (Title XIX of the Social Security Act (42 U.S.C. Sec. 1396 et seq.)), or that had its certificate revoked under CLIA, shall be automatically suspended by the department for the period the laboratory is so excluded or has its certificate revoked.

history: (History: Amended by Stats. 1995, Ch. 510, Sec. 39. Effective January 1, 1996.)


citation: BPC § 1326

text: The department may bring an action to enjoin the violation or threatened violation of this chapter or the regulations adopted pursuant thereto in the superior court in and for the county in which the violation occurred or is about to occur. Any proceeding under this section shall conform to the requirements of Chapter 3 (commencing with Section 525) of Title 7 of Part 2 of the Code of Civil Procedure, except that the department shall not be required to allege facts necessary to show or tending to show lack of adequate remedy at law or irreparable damage or loss. With respect to any action brought pursuant to this action alleging actual violation of this chapter or the regulations adopted pursuant thereto, the court shall, if it finds the allegations to be true, issue its order enjoining the discontinuance of the violation.

history: (History: Added by Stats. 1989, Ch. 927, Sec. 18.)


citation: BPC § 1327

text: The department may enter into agreements with the Secretary of Health and Human Services for the use of the services or facilities of the department for carrying out the provisions of CLIA.

history: (History: Amended by Stats. 1995, Ch. 510, Sec. 40. Effective January 1, 1996.)


citation: BPC § 1600

text:
This chapter constitutes the chapter on dentistry of the Business and Professions Code. It may be known and cited as the Dental Practice Act.

Whenever a reference is made to the Dental Practice Act by the provisions of any statute, it shall be construed as referring to the provisions of this chapter.

history: (History: Added by Stats. 1937, Ch. 415.)

chapter: 4. Dentistry

article: 1. Administration

path: 2. HEALING ARTS > 4. Dentistry > 1. Administration


text:
(a) There shall be in the Department of Consumer Affairs the Dental Board of California in which the administration of this chapter is vested. The board shall consist of eight practicing dentists, two registered dental assistants, and five public members. Of the eight practicing dentists, one shall be a member of a faculty of any California dental college, and one shall be a dentist practicing in a nonprofit community clinic. The appointing powers, described in Section 1603, may appoint to the board a person who was a member of the prior board. The board shall be organized into standing committees dealing with examinations, enforcement, and other subjects as the board deems appropriate.

(b) For purposes of this chapter, any reference in this chapter to the Board of Dental Examiners shall be deemed to refer to the Dental Board of California.

(c) The board shall have all authority previously vested in the existing board under this chapter. The board may enforce all disciplinary actions undertaken by the previous board.

(d) This section shall remain in effect only until January 1, 2029, and as of that date is repealed. Notwithstanding any other law, the repeal of this section renders the board subject to review by the appropriate policy committees of the Legislature.

history: (History: Amended by Stats. 2024, Ch. 483, Sec. 1. (SB 1453) Effective January 1, 2025. Repealed as of January 1, 2029, by its own provisions.)

article: 1. Administration


text: Protection of the public shall be the highest priority for the Dental Board of California in exercising its licensing, regulatory, and disciplinary functions. Whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.

history: (History: Added by Stats. 2002, Ch. 107, Sec. 2. Effective January 1, 2003.)

article: 1. Administration


text:
(a) All committees of the board have the authority to evaluate all suggestions or requests for regulatory changes related to their committee. Committees shall have the authority to hold informational hearings in order to report and make appropriate recommendations to the board, after consultation with departmental legal counsel and the board’s chief executive officer. The committees shall include in any report regarding a proposed regulatory change, at a minimum, the specific language or the proposed change or changes and the reasons therefor and any facts supporting the need for the change.

(b) No part of this section shall restrict the Dental Hygiene Board of California from adopting, amending, or revoking regulations authorized by Article 9 (commencing with Section 1900).

history: (History: Amended by Stats. 2018, Ch. 858, Sec. 3. (SB 1482) Effective January 1, 2019.)

article: 1. Administration


text:
(a) (1) The board shall review both of the following:

(A) Available data on all adverse events related to general anesthesia and deep sedation, moderate sedation, and minimal sedation in dentistry.

(B) Relevant professional guidelines, recommendations, or best practices for the provision of dental anesthesia and sedation care.

(2) By January 1, 2022, the board shall report to the Legislature any findings pursuant to this subdivision that are relevant to inform dental anesthesia and sedation standards.

(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.

(b) The board shall provide a report on pediatric deaths related to general anesthesia and deep sedation in dentistry at the time of its sunset review pursuant to subdivision (d) of Section 1601.1.

(c) The board shall retain available data on all adverse events related to general anesthesia and deep sedation, moderate sedation, and minimal sedation in dentistry for not less than 15 years.

history: (History: Amended by Stats. 2018, Ch. 929, Sec. 1. (SB 501) Effective January 1, 2019.)

article: 1. Administration


text: For purposes of training standards for general anesthesia, deep sedation, and moderate sedation, the board may approve a training standard in lieu of Pediatric Advanced Life Support (PALS) certification if the training standard is an equivalent or higher level of training for pediatric dental anesthesia-related emergencies than PALS certification that includes, but is not limited to, pediatric life support and airway management.

history: (History: Added by Stats. 2018, Ch. 929, Sec. 3. (SB 501) Effective January 1, 2019.)

article: 1. Administration


citation: BPC § 1602

text: All of the members of the board, except the public members, shall have been actively and lawfully engaged in the practice of dentistry in the State of California, for at least five years next preceding the date of their appointment. The registered dental assistant members shall have been a registered dental assistant, in the State of California for at least five years next preceding the date of their appointment. The public members shall not be licensees of the board or of any other board under this division or of any board referred to in Sections 1000 and 3600. No more than one member of the board shall be a member of the faculty of any dental college or dental department of any medical college in the State of California. None of the members, including the public members, shall have any financial interest in any such college.

history: (History: Amended by Stats. 2025, Ch. 592, Sec. 3. (SB 861) Effective January 1, 2026.)

article: 1. Administration


citation: BPC § 1603

text:
(a) Except for the initial appointments, members of the board shall be appointed for a term of four years, and each member shall hold office until the appointment and qualification of the member’s successor or until one year shall have elapsed since the expiration of the term for which the member was appointed, whichever first occurs.

(b) A vacancy occurring during a term shall be filled by appointment for the unexpired term, within 30 days after it occurs.

(c) No person shall serve as a member of the board for more than two terms.

(d) The Governor shall appoint three of the public members, the two registered dental assistant members, and the eight licensed dentist members of the board. The Senate Committee on Rules and the Speaker of the Assembly shall each appoint a public member.

(e) Of the initial appointments, one of the dentist members and one of the public members appointed by the Governor shall serve for a term of one year. Two of the dentist members appointed by the Governor shall each serve for a term of two years. One of the public members and two of the dentist members appointed by the Governor shall each serve a term of three years. The registered dental assistant members and the remaining three dentist members appointed by the Governor shall each serve for a term of four years. The public members appointed by the Senate Committee on Rules and the Speaker of the Assembly shall each serve for a term of four years.

history: (History: Amended by Stats. 2025, Ch. 592, Sec. 4. (SB 861) Effective January 1, 2026.)

article: 1. Administration


text: A member of the Dental Board of California who has served two terms shall not be eligible for reappointment to the board. In computing two terms hereunder, that portion of an unexpired term that a member fills as a result of a vacancy shall be excluded.

history: (History: Added by renumbering Section 1603a by Stats. 2019, Ch. 865, Sec. 8. (AB 1519) Effective January 1, 2020.)

article: 1. Administration


citation: BPC § 1604

text: Each member of the board, upon qualification, shall file with the executive officer the member’s post office address, and thereafter any notice of any change thereof. Any notice mailed to the address so on file, shall be deemed to comply with the requirements of this chapter as to notice to that member of the board.

history: (History: Amended by Stats. 2019, Ch. 865, Sec. 9. (AB 1519) Effective January 1, 2020.)

article: 1. Administration


citation: BPC § 1605

text: Each appointing authority has power to remove from office at any time any member of the board appointed by that authority under Section 1603 pursuant to Section 106.

history: (History: Amended by Stats. 2019, Ch. 865, Sec. 10. (AB 1519) Effective January 1, 2020.)

article: 1. Administration


citation: BPC § 1606

text: The board shall elect a president, a vice president and a secretary from its membership. This section controls over the provisions of section 107 of this code with respect to the selection of officers.

article: 1. Administration


citation: BPC § 1608

text: Special meetings may be held at such times as the board may elect, or on the call of the president of the board, or of not less than four members thereof. A written notice of the time, place, and object of the special meeting shall be mailed by the executive officer to all the members not parties to the call, at least 15 days before the day of the meeting.

history: (History: Amended by Stats. 1984, Ch. 47, Sec. 4. Effective March 21, 1984.)

article: 1. Administration


citation: BPC § 1609

text: Meetings may be held at any time and place by unanimous consent evidenced either by writing or by the presence of any member whose consent is necessary.

history: (History: Amended by Stats. 1983, Ch. 380, Sec. 1.)

article: 1. Administration


citation: BPC § 1610

text: Eight members of the board shall constitute a quorum for the transaction of business at any meeting.

history: (History: Amended by Stats. 1986, Ch. 1092, Sec. 4.)

article: 1. Administration


citation: BPC § 1611

text: The board shall carry out the purposes and enforce the provisions of this chapter. It shall examine all applicants for a license or permit to practice dentistry and dental assisting, according to the provisions of this chapter, and shall issue licenses and permits to practice dentistry and dental assisting in this state to such applicants as successfully pass all applicable licensing and permitting examinations administered by the board, or any regional or national testing entity designated to administer licensing or permitting examinations, and otherwise comply with the provisions of this chapter. The board shall collect and apply all fees as directed by this chapter.

history: (History: Amended by Stats. 2018, Ch. 703, Sec. 7. (SB 1491) Effective January 1, 2019.)

article: 1. Administration


text: The board shall require that the notice required under Section 138 includes a provision that the board is the entity that regulates dentists and dental assistants and provides the telephone number and internet website of the board. The board shall require the notice to be posted in a conspicuous location accessible to public view and accessible electronically for patients receiving dental services through telehealth.

history: (History: Amended by Stats. 2019, Ch. 865, Sec. 12. (AB 1519) Effective January 1, 2020.)

article: 1. Administration


text:
(a) The board may inspect the books, records, and premises of any dentist licensed under this chapter and the licensing documents, records, and premises of any dental assistant permitted under this chapter in response to a complaint that a dentist or dental assistant has violated any law or regulation that constitutes grounds for disciplinary action by the board, and may employ inspectors for this purpose.

(b) Failure to allow an inspection or any part thereof shall be grounds for suspension or revocation of the license or permit in accordance with Section 1670.

history: (History: Amended by Stats. 2018, Ch. 703, Sec. 9. (SB 1491) Effective January 1, 2019.)

article: 1. Administration


citation: BPC § 1612

text: The board shall keep a record of the names of all persons to whom licenses or permits have been granted by it to practice dentistry, dental assisting, or any other function requiring a permit, and such other records as may be necessary to show plainly all of its acts and proceedings.

history: (History: Amended by Stats. 2018, Ch. 703, Sec. 10. (SB 1491) Effective January 1, 2019.)

article: 1. Administration


citation: BPC § 1613

text: The board shall have and use a seal bearing the name “Dental Board of California.”

history: (History: Amended by Stats. 2013, Ch. 473, Sec. 1. (SB 821) Effective January 1, 2014.)

article: 1. Administration


citation: BPC § 1614

text:
The board may adopt regulations pursuant to this chapter concerning:

(a) The holding of meetings.

(b) The holding of examinations.

(c) The manner of issuance and reissuance of licenses.

(d) The establishment of standards for the approval of dental colleges and dental assisting programs and educational courses.

(e) Prescribing subjects in which applicants are to be examined.

(f) The administration and enforcement of this chapter.

Such rules shall be adopted, amended, or repealed in accordance with the provisions of the Administrative Procedure Act.

history: (History: Amended by Stats. 2018, Ch. 703, Sec. 11. (SB 1491) Effective January 1, 2019.)

article: 1. Administration


citation: BPC § 1615

text: Each member of the board shall receive a per diem and expenses as provided in Section 103.

history: (History: Amended by Stats. 2018, Ch. 703, Sec. 12. (SB 1491) Effective January 1, 2019.)

article: 1. Administration


citation: BPC § 1616

text: The board shall have full power to employ all necessary investigators, clerical and other assistants and appoint its own attorney, prescribe his duties and fix his compensation. Members and employees of the board shall be entitled to other necessary traveling expenses. The investigators employed by the board shall be specifically trained to investigate dental practice activities.

history: (History: Amended by Stats. 1979, Ch. 573.)

article: 1. Administration


text: There is hereby established within the board a full-time management level staff position, under the direction of the executive officer, whose responsibilities shall include the management of matters related to dental assisting, including, but not limited to, education, examination, licensure, and enforcement.

history: (History: Amended by Stats. 2019, Ch. 865, Sec. 14. (AB 1519) Effective January 1, 2020.)

article: 1. Administration


citation: BPC § 1617

text: A copy of any part or all of the books of the board duly certified by the executive officer shall be primary evidence in any court of this state.

history: (History: Amended by Stats. 1984, Ch. 47, Sec. 6. Effective March 21, 1984.)

article: 1. Administration


citation: BPC § 1618

text:
(a) The original books, records, and papers of the board shall be kept at the office of the executive officer, which shall be at such place as may be designated by the board.

(b) The executive officer shall furnish to any person making application a copy of any part thereof, certified by the executive officer as executive officer, upon payment of the fee specified in Section 163. The fee shall be deposited in the State Dentistry Fund.

history: (History: Amended by Stats. 2019, Ch. 865, Sec. 15. (AB 1519) Effective January 1, 2020.)

article: 1. Administration


text:
(a) The board shall provide to the Director of the Department of Managed Health Care a copy of any accusation filed with the Office of Administrative Hearings pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code, when the accusation is filed, for a violation of this chapter relating to the quality of care of any dental provider of a health care service plan, as defined in Section 1345 of the Health and Safety Code. There shall be no liability on the part of, and no cause of action shall arise against, the State of California, the Dental Board of California, the Department of Managed Health Care, the director of that department, or any officer, agent, employee, consultant, or contractor of the state or the board or the department for the release of any false or unauthorized information pursuant to this section, unless the release is made with knowledge and malice.

(b) The board and its executive officer and staff shall maintain the confidentiality of any nonpublic reports provided by the Director of the Department of Managed Health Care pursuant to subdivision (i) of Section 1380 of the Health and Safety Code.

history: (History: Amended by Stats. 2015, Ch. 426, Sec. 7. (SB 800) Effective January 1, 2016.)

article: 1. Administration


citation: BPC § 1619

text: All examination documentation of any applicant shall be preserved by the board for a period of no less than one year from the date of final successful examination, after which time the documentation shall be destroyed. Prior to destruction, examination documentation shall be open to inspection only by members of the board, by the applicant or by someone appointed by the latter to inspect them, by a court of competent jurisdiction in a proceeding where the question of the contents of the papers is properly involved, or by the director in accordance with Section 110 or 153.

history: (History: Amended by Stats. 2019, Ch. 865, Sec. 16. (AB 1519) Effective January 1, 2020.)

article: 1. Administration


text: Notwithstanding Section 1619, the board need not retain the National Board of Dental Examiners’ examination papers.

history: (History: Added by Stats. 1975, Ch. 872.)

article: 1. Administration


citation: BPC § 1621

text:
The board shall utilize in the administration of its licensure examinations only examiners whom it has appointed and who meet the following criteria:

(a) Possession of a valid license to practice dentistry in this state or possession of a valid license in one of the registered dental assistant categories licensed under this chapter.

(b) Practice as a licensed dentist or in a licensure category described in subdivision (a) for at least five years preceding the examiner’s appointment.

(c) Hold no position as an officer or faculty member at any college, school, or institution that provides instruction in the same licensure category as that held by the examiner. This subdivision shall not apply to a portfolio examiner.

history: (History: Amended by Stats. 2019, Ch. 865, Sec. 18. (AB 1519) Effective January 1, 2020.)

article: 1. Administration


citation: BPC § 1625

text:
Dentistry is the diagnosis or treatment, by surgery or other method, of diseases and lesions and the correction of malpositions of the human teeth, alveolar process, gums, jaws, or associated structures; and such diagnosis or treatment may include all necessary related procedures as well as the use of drugs, anesthetic agents, and physical evaluation. Without limiting the foregoing, a person practices dentistry within the meaning of this chapter who does any one or more of the following:

(a) By card, circular, pamphlet, newspaper, internet website, social media, or in any other way advertises themselves or represents themselves to be a dentist.

(b) Performs, or offers to perform, an operation or diagnosis of any kind, or treats diseases or lesions of the human teeth, alveolar process, gums, jaws, or associated structures, or corrects malposed positions thereof.

(c) In any way indicates that the person will perform by themselves or their agents or servants any operation upon the human teeth, alveolar process, gums, jaws, or associated structures, or in any way indicates that the person will construct, alter, repair, or sell any bridge, crown, denture, or other prosthetic appliance or orthodontic appliance.

(d) Makes, or offers to make, an examination of, with the intent to perform or cause to be performed any operation on the human teeth, alveolar process, gums, jaws, or associated structures.

(e) Manages or conducts as manager, proprietor, conductor, lessor, or otherwise, a place where dental operations are performed.

history: (History: Amended by Stats. 2019, Ch. 865, Sec. 19. (AB 1519) Effective January 1, 2020.)

article: 2. Admission and Practice

path: 2. HEALING ARTS > 4. Dentistry > 2. Admission and Practice


text:
(a) Any of the following entities may employ licensees and dental assistants and charge for the professional services they render, and shall not be deemed to be practicing dentistry within the meaning of Section 1625:

(1) A primary care clinic that is licensed pursuant to subdivision (a) of Section 1204 of the Health and Safety Code.

(2) A primary care clinic that is exempt from licensure pursuant to subdivision (b), (c), or (h) of Section 1206 of the Health and Safety Code.

(3) A clinic owned or operated by a public hospital or health system.

(4) A clinic owned and operated by a hospital that maintains the primary contract with a county government to fill the county’s role under Section 17000 of the Welfare and Institutions Code.

(b) The entities described in subdivision (a) shall not interfere with, control, or otherwise direct the professional judgment of a licensee or dental assistant lawfully acting within the licensee’s or dental assistant’s scope of practice as defined in this chapter. A requirement that licensees shall constitute all or a percentage of the governing body of the entity shall not be applicable to these entities.

history: (History: Amended by Stats. 2019, Ch. 865, Sec. 20. (AB 1519) Effective January 1, 2020.)

article: 2. Admission and Practice


text:
(a) For purposes of subdivision (e) of Section 1625, the ownership or management, by a tax-exempt nonprofit corporation supported and maintained in whole or in substantial part by donations, bequests, gifts, grants, government funds, or contributions, that may be in the form of money, goods, or services, of a place where dental operations are performed, shall not be construed to be the unlicensed practice of dentistry, as long as all of the following apply:

(1) The entity obtains the board’s approval to offer dental services pursuant to regulations adopted by the board.

(2) The entity does nothing to interfere with, control, or otherwise direct the professional judgment of or provision of dental services by a licensee or dental assistant lawfully acting within the licensee’s or dental assistant’s scope of practice as defined in this chapter.

(3) The licensees and dental assistants of the entity providing services are in compliance with all applicable provisions of this chapter.

(4) The entity is otherwise in compliance with this chapter and all other applicable provisions of state and federal law.

(b) This section does not apply to any of the following entities:

(1) A primary care clinic that is licensed pursuant to subdivision (a) of Section 1204 of the Health and Safety Code.

(2) A primary care clinic that is exempt from licensure pursuant to subdivision (b), (c), or (h) of Section 1206 of the Health and Safety Code.

(3) A clinic owned or operated by a public hospital or health system.

(4) A clinic owned and operated by a hospital that maintains the primary contract with a county government to fill the county’s role under Section 17000 of the Welfare and Institutions Code.

history: (History: Amended by Stats. 2019, Ch. 865, Sec. 21. (AB 1519) Effective January 1, 2020.)

article: 2. Admission and Practice