Every provision of this chapter shall be liberally construed to protect the interests of all persons affected....
As used in this chapter, person includes firm, association, partnership, individual, limited liability company, and corporation....
As used in this chapter, department means the State Department of Health Services....
(a) For purposes of this chapter CLIA means the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; P.L. 100-578) and the regulations adopted thereunder...
As used in this chapter, clinical laboratory bioanalyst or bioanalyst means a person licensed under Section 1260 to engage in clinical laboratory practice and direction of a...
As used in this chapter, clinical laboratory scientist means any person other than a licensed clinical laboratory bioanalyst or trainee who is licensed under Sections 1261 and 1262 to...
As used in this chapter, trainee means any person licensed under this chapter for the purpose of receiving comprehensive practical experience and instruction in clinical laboratory procedures...
(a) For the purposes of this chapter the following definitions are applicable: (1) Biological specimen means any material that is derived from the human body. (2) Blood electrolyte...
(a) Notwithstanding subdivision (b) of Section 1206 and except as otherwise provided in Section 1241, no person shall perform a clinical laboratory test or examination classified as...
(1) A licensed physician and surgeon holding a M.D. or D.O. degree. (2) A licensed podiatrist or a licensed dentist if the results of the tests can be lawfully utilized within his or...
(a) As used in this chapter, clinical chemist, or clinical microbiologist, or clinical toxicologist, or clinical genetic molecular biologist, or clinical cytogeneticist, or...
(a) For the purposes of this chapter whenever the department determines that a new category of license is necessary, either to direct a laboratory, or to perform clinical laboratory...
(a) As used in this chapter, laboratory director means any person who is a duly licensed physician and surgeon, or is licensed to direct a clinical laboratory under this chapter...
As used in this chapter histocompatibility laboratory director means any person who is (a) a duly licensed physician, (b) a bioanalyst, or (c) a person who has earned a doctoral degree...
(a) As used in this chapter, clinical chemist scientist, clinical microbiologist scientist, clinical toxicologist scientist, clinical immunohematologist scientist,...
(a) As used in this chapter, owner means any person with an ownership or control interest in a clinical laboratory. (b) Person with an ownership or control interest means...
For the purposes of this chapter, cytological slides shall refer to cellular materials submitted for preliminary cytologic examination....
(a) As used in this chapter, unlicensed laboratory personnel means a laboratory aide, histocompatibility technician, cardiopulmonary technician, or other person performing the...
As used in this chapter, school means any place, establishment, or institution organized and operated to offer training for one or more of the personnel classifications included in this...
(a) (1) Each clinical laboratory shall maintain records, equipment, and facilities that are adequate and appropriate for the services rendered. (2) (A) Except for tests or...
(a) The Department of Health Services shall develop, and provide to all licensed clinical laboratories, a form in triplicate to be used by employees, agents, and couriers of...
The department may employ special examiners, and may make regulations for the conduct of examinations under this chapter....
The department may approve schools that are accredited by the National Accrediting Agency for Clinical Laboratory Sciences....
The department may approve schools seeking to provide instruction in clinical laboratory technic which in the judgment of the department will provide instruction adequate to prepare individuals...
(a) The department shall employ, or contract for, inspectors, special agents, and investigators, and provide any clerical and technical assistance as necessary to administer this chapter...
The department may, pursuant to Chapter 3.5 (commencing with Section 11340) of Division 3 of Title 2 of the Government Code, adopt, amend, or repeal any regulations necessary for...
The department shall conduct a study to determine whether the persons conducting tests in physician office laboratories under paragraph (12) of subdivision (b) of, and paragraph...
(a) In order to carry out this chapter, any duly authorized representative of the department may do any of the following: (1) Enter or inspect on an announced or unannounced basis...
Annually the department may compile and may thereafter publish and sell a directory of persons within the state licensed under the provisions of this chapter who hold unsuspended, unforfeited...
Every person or clinical laboratory licensed or registered under this chapter shall report to the department, within 30 days thereof, any change of name or address....
The department shall appoint a multidisciplinary committee to assist, advise, and make recommendations for the establishment of rules and regulations necessary to insure proper...
This chapter does not authorize any person to practice medicine and surgery or to furnish the services of physicians for the practice of medicine and surgery. This chapter does not repeal...
(a) This chapter applies to all clinical laboratories in California or receiving biological specimens originating in California for the purpose of performing a clinical laboratory...
Any person duly licensed under the provisions of this chapter to perform tests called for in a clinical laboratory may perform skin tests for specific diseases, arterial puncture,...
Notwithstanding paragraphs (2) and (3) of subdivision (b) of Section 1241, the department may by regulation authorize laboratory personnel certified pursuant to Section 1246...
(a) Any registered nurse licensed under the provisions of Chapter 6 (commencing with Section 2700) of Division 2 may perform arterial puncture, venipuncture, or skin puncture for the...
A student regularly matriculated in any college or university accredited by an accrediting agency acceptable to the department, or in any legally chartered school approved by the...
(a) Nothing in this chapter shall restrict, limit, or prevent a program of nondiagnostic general health assessment provided that:...
Thirty days prior to operating a program of nondiagnostic general health assessment, the entity or person operating that program shall file the following documentation with the...
Responsibility for enforcement of Sections 1244 and 1244.1 shall be with the local health officer or his or her authorized designee, including public health laboratory directors. Nothing...
Any fee for the filing of documentation and related enforcement activities pursuant to Section 1244, 1244.1, and 1244.3 shall be determined by the local enforcement agency and shall...
(a) Any individual may perform a blood gas analysis if all the following conditions exist: (1) He or she has earned a high school diploma or equivalent, as determined by HCFA pursuant to CLIA. ...
(a) Except as provided in subdivisions (b) and (c), and in Section 23158 of the Vehicle Code, an unlicensed person employed by a licensed clinical laboratory may perform venipuncture...
Notwithstanding any other provision of law, any person may request, and any licensed clinical laboratory or public health laboratory may perform, the laboratory tests specified in this section....
This article shall be known and may be cited as the Hemodialysis Technician Training Act....
For the purpose of this article, the following terms have the following meaning: (a) Immediate supervision means supervision of dialysis treatment in the same room in which the...
The treatment of patients by a hemodialysis technician includes performing venipuncture and arterial puncture for the purpose of providing dialysis treatment for a patient. The...
The department shall adopt rules and regulations, by July 1, 2001, prescribing minimum training standards for hemodialysis technicians who are certified pursuant to paragraphs (2), (3), and (4)...
A hemodialysis clinic or unit within a licensed clinic or hospital, as defined respectively in Sections 1204 and 1250 of the Health and Safety Code, may operate a hemodialysis training...
(a) Except during training under immediate supervision, no person shall provide services as a hemodialysis technician without meeting one or more of the following requirements: (1)...
(a) Certification of a hemodialysis technician issued by the department pursuant to subdivision (a) of Section 1247.6 shall be valid for four years. (b) Those hemodialysis technicians...
A hemodialysis technician may obtain the in-service training or continuing education required by subdivision (c) of Section 1247.63 from one or more of the following sources: (a)...
(a) The department may deny, suspend, or revoke the certification of a hemodialysis technician if it finds that the hemodialysis technician is not in compliance with this article, or any...
An employee in training shall be classified as a hemodialysis technician trainee and shall be under the immediate supervision of a licensed physician and surgeon or licensed registered...
An employee in training shall be classified as a hemodialysis technician trainee and shall be under the immediate supervision of a licensed physician and surgeon or licensed registered nurse...
Each hemodialysis unit or clinic shall have information available for inspection by the department survey teams which shows the local training program and competency test and the names...
No person or entity shall provide chronic dialysis services to patients in this state unless the services are provided under the direction of a chronic dialysis clinic, licensed pursuant...
The department shall issue a clinical laboratory bioanalyst's license to each person who is a lawful holder of a degree of master of arts, master of science, or an equivalent or higher...
The department shall issue a histocompatibility laboratory director's license to each person who meets the qualifications specified in Section 1209.1....
(a) The department shall issue a medical laboratory technician license to each person who meets the following requirements: (1) Has met the requirements of this chapter and...
The department shall issue a clinical laboratory scientist's or a limited clinical laboratory scientist's license to each person who is a lawful holder of a baccalaureate or an equivalent...
The department may issue limited clinical laboratory scientist's licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, genetic molecular biology, cytogenetics,...
No clinical laboratory scientist's or limited clinical laboratory scientist's license shall be issued by the department except after examination; provided, that a temporary...
Notwithstanding Section 135, an applicant for a clinical laboratory or limited technologist license who fails to pass the written examination two times shall not be eligible to be...
The department shall license as trainees those individuals desiring to train for either a clinical laboratory scientist's license or a limited clinical laboratory scientist's license, providing...
The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical molecular biologist, or clinical cytogeneticist license to each person who has...
(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...
The clinical laboratory license and the license or current renewal permit of each person performing tests shall be conspicuously posted in the clinical laboratory....
Any denial, suspension, or revocation of a license under this chapter shall be conducted in compliance with Section 100171 of the Health and Safety Code....
Upon filing application therefor, containing such information as the department may require, and the payment of the license fee, the department shall issue to any person duly licensed...
(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...
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...
(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...
(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...
(a) A cytotechnologist shall not examine more than 80 gynecologic slides in a 24-hour period. (b) The maximum workload limit in subdivision (a) is the maximum number of gynecologic slides...
(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,...
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...
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...
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...
(a) Laboratories shall send to persons submitting cytologic samples for evaluation, on a quarterly basis, informational letters on all cases of dysplasia (Cervical...
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...
It is unlawful for any person to represent himself or act as a licensed individual under this chapter unless he is, in fact, duly licensed under this chapter....
It is unlawful for any person to own, operate, maintain, direct, or engage in the business of operating a clinical laboratory, as defined in this chapter, unless he or she possesses...
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...
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...
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,...
(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...
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...
It is unlawful for a duly licensed physician and surgeon, or any person authorized to serve as director under this chapter, to serve only as a nominal director....
It is unlawful for any person conducting, maintaining, or operating a clinical laboratory to employ any person to perform clinical laboratory procedures unless the person is a...
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...
(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...
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...
(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,...
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...
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...
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...
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...
The amount of application, registration, and license fees under this chapter shall be as follows: (a) The application fee for a histocompatibility laboratory director's, clinical...
The application and renewal fees for clinical laboratory licenses specified in Section 1300 shall be adjusted annually in the manner specified in Section 100450 of the Health and Safety...
(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...
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...
(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)...
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...
The department shall have three years from the date of a violation of this chapter or of a regulation adopted thereunder to file a civil or administrative action....
The department may deny, suspend, or revoke any license or registration issued under this chapter for any of the following reasons: (a) Conduct involving moral turpitude or dishonest...
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...
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....
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...
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...
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 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...
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....