CHAPTER 3. Clinical Laboratory Technology [1200. - 1327.]

Chapter 3 repealed and added by Stats. 1951, Ch. 1727.

§§ 1200–1327 · 124 sections

ARTICLE 1. Definitions §§ 1200–1214 · 22 sections
- § 1200 Every provision of this chapter shall be liberally construed to protect the interests of all persons affected.
- § 1201 As used in this chapter, “person” includes firm, association, partnership, individual, limited liability company, and corporation.
- § 1202 As used in this chapter, “department” means the State Department of Public Health.
- § 1202.5 (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…
- § 1203 As used in this chapter, “clinical laboratory bioanalyst” or “bioanalyst” means a person licensed under Section 1260 to engage in clinical laboratory practice…
- § 1204 As used in this chapter, “clinical laboratory scientist” means a person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed under…
- § 1205 As used in this chapter, “trainee” means a person licensed under this chapter for the purpose of receiving comprehensive practical experience and instruction…
- § 1206 (a) For the purposes of this chapter the following definitions are applicable: (1) “Analyte” means the substance or constituent being measured, including, but…
- § 1206.5 (a) Notwithstanding subdivision (b) of Section 1206 and except as otherwise provided in Sections 1206.6 and 1241, no person shall perform a clinical laboratory…
- § 1206.6 Subdivision (a) of Section 1206.5 shall not apply to a pharmacist at a community pharmacy who, upon customer request, performs only blood glucose, hemoglobin…
- § 1206.7 (a) Notwithstanding Section 1206.5, a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical…
- § 1207 (a) As used in this chapter, “clinical chemist,” “clinical microbiologist,” “clinical toxicologist,” “clinical genetic molecular biologist,” “clinical…
- § 1208 (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…
- § 1209 (a) As used in this chapter, “laboratory director” means any person who is any of the following: (1) A duly licensed physician and surgeon. (2) Only for…
- § 1209.1 (a) As used in this chapter, “histocompatibility laboratory director” means a physician and surgeon licensed to practice medicine pursuant to Chapter 5…
- § 1209.5 (a) “Autoverification” means the use of a computer algorithm in conjunction with automated clinical laboratory instrumentation to review and verify the results…
- § 1210 (a) As used in this chapter, “clinical chemist scientist,” “clinical microbiologist scientist,” “clinical toxicologist scientist,” “clinical immunohematologist…
- § 1211 (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…
- § 1211.5 For the purposes of this chapter, “cytological slides” shall refer to cellular materials submitted for preliminary cytologic examination.
- § 1212 (a) As used in this chapter, “unlicensed laboratory personnel” means a laboratory aide, histocompatibility technician, cardiopulmonary technician, or other…
- § 1213 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…
- § 1214 As used in this chapter, “health fair” means a program of health assessment procedures offered to the general public that may include screening, self-ordered,…
ARTICLE 2. Administration and Regulation §§ 1220–1228 · 12 sections
- § 1220 (a) (1) Each clinical laboratory shall maintain records, equipment, and facilities that are adequate and appropriate for the services rendered. (2) (A) Except…
- § 1220.5 (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,…
- § 1221 The department may employ special examiners, and may make regulations for the conduct of examinations under this chapter.
- § 1222 The department may approve schools that are accredited by the National Accrediting Agency for Clinical Laboratory Sciences.
- § 1222.5 (a) The department may approve any of the following seeking to provide clinical laboratory scientist programs for instruction in clinical laboratory technique…
- § 1223 (a) The Legislature finds and declares that it is the public policy of the state to ensure that California’s laboratory standards, including its laboratory…
- § 1224 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…
- § 1224.5 The department shall conduct a study to determine whether the persons conducting tests in physician office laboratories under paragraph (12) of subdivision (b)…
- § 1225 (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…
- § 1226 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…
- § 1227 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…
- § 1228 The department shall appoint a multidisciplinary committee to assist, advise, and make recommendations for the establishment of rules and regulations necessary…
ARTICLE 3. Application of the Chapter §§ 1240–1246.7 · 15 sections
- § 1240 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.…
- § 1241 (a) This chapter applies to all clinical laboratories in California or receiving biological specimens originating in California for the purpose of performing a…
- § 1241.1 (a) A primary care clinic, licensed pursuant to subdivision (a) of Section 1204 of the Health and Safety Code, that is operating within a network of primary…
- § 1242 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…
- § 1242.5 Notwithstanding paragraphs (2) and (3) of subdivision (b) of Section 1241, the department may by regulation authorize laboratory personnel certified pursuant…
- § 1242.6 (a) Any registered nurse licensed under the provisions of Chapter 6 (commencing with Section 2700) of Division 2 may perform arterial puncture, venipuncture,…
- § 1243 A student regularly matriculated in any college or university accredited by an accrediting agency acceptable to the department, or in any legally chartered…
- § 1244 (a) Nothing in this chapter shall restrict, limit, or prevent a program of nondiagnostic general health assessment provided that: (1) The program meets the…
- § 1244.1 Thirty days prior to operating a program of nondiagnostic general health assessment, the entity or person operating that program shall file the following…
- § 1244.3 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…
- § 1244.4 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…
- § 1245 (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…
- § 1246 (a) (1) On and after the effective date of the regulations specified in paragraph (2), any unlicensed person employed by a clinical laboratory performing the…
- § 1246.5 Notwithstanding any other provision of law, any person may request, and any licensed clinical laboratory or public health laboratory may perform, the…
- § 1246.7 (a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection center in this…
ARTICLE 3.5. Hemodialysis Training §§ 1247–1247.9 · 13 sections
- § 1247 This article shall be known and may be cited as the Hemodialysis Technician Training Act.
- § 1247.2 For the purpose of this article, the following terms have the following meaning: (a) “Immediate supervision” means supervision of dialysis treatment in the…
- § 1247.3 The treatment of patients by a hemodialysis technician includes performing venipuncture and arterial puncture for the purpose of providing dialysis treatment…
- § 1247.4 The department may adopt regulations it deems necessary to implement this article.
- § 1247.5 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…
- § 1247.6 (a) Except during training under immediate supervision, and except as provided in Section 1247.62, no person shall provide services as a hemodialysis…
- § 1247.61 To be certified by the department as a Certified Hemodialysis Technician (CHT), a person shall meet all of the following requirements: (a) Have a high school…
- § 1247.63 (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) A…
- § 1247.64 A hemodialysis technician may obtain the in-service training or continuing education required by subdivision (b) of Section 1247.63 from one or more of the…
- § 1247.66 (a) The department may deny, suspend, or revoke the certification of a hemodialysis technician if it finds that the hemodialysis technician is not in…
- § 1247.7 An employee in training shall be classified as a hemodialysis technician trainee and shall be under the immediate supervision of a licensed physician and…
- § 1247.8 Each hemodialysis unit or clinic shall have information available for inspection by the department survey teams which verifies that the hemodialysis…
- § 1247.9 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…
ARTICLE 4. Licensing §§ 1260–1275 · 29 sections
- § 1260 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,…
- § 1260.1 The department shall issue a histocompatibility laboratory director’s license to each person who meets the qualifications specified in Section 1209.1.
- § 1260.3 (a) The department shall issue a medical laboratory technician license to each person who meets the following requirements: (1) Has met the requirements of…
- § 1261 (a) (1) 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…
- § 1261.5 (a) The department may issue limited clinical laboratory scientist’s licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology,…
- § 1261.6 The department may issue a limited clinical laboratory scientist’s license in cytogenetics to any person with a minimum of seven years of work experience in…
- § 1262 No clinical laboratory scientist’s or limited clinical laboratory scientist’s license shall be issued by the department except after examination; provided,…
- § 1262.5 Notwithstanding Section 135, an applicant for a clinical laboratory or limited technologist license who fails to pass the written examination two times shall…
- § 1263 The department shall license as trainees those individuals desiring to train for either a clinical laboratory scientist’s license or a limited clinical…
- § 1264 (a) (1) The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical genetic molecular biologist, clinical…
- § 1265 (a) (1) A clinical laboratory performing clinical laboratory tests or examinations classified as of moderate or of high complexity under CLIA shall obtain a…
- § 1265.1 (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…
- § 1265.2 (a) For purposes of this section, “digital materials” means digital laboratory data, digital results, and digital images that do not require a microscope or…
- § 1265.3 (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…
- § 1266 The clinical laboratory license and the license or current renewal permit of each person performing tests shall be conspicuously posted in the clinical…
- § 1267 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.
- § 1268 Upon filing application therefor, containing such information as the department may require, and the payment of the license fee, the department shall issue to…
- § 1269 (a) Unlicensed laboratory personnel may perform any of the activities identified in subdivision (b), in a licensed clinical laboratory, under the direct and…
- § 1269.3 (a) Notwithstanding Sections 1206.5 and 1269, within the specialty of pathology, a person certified as a pathologists’ assistant by the American Association of…
- § 1269.5 The department may deny, suspend, or revoke any license, registration, or certificate issued under this chapter for performance by unlicensed laboratory…
- § 1270 (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…
- § 1270.5 (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…
- § 1271 (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…
- § 1271.1 (a) Clinical laboratories which are licensed pursuant to this chapter and provide cytology services shall, if the licensee ceases operation, preserve records,…
- § 1272 A clinical laboratory shall participate in a state-approved proficiency testing program and demonstrate satisfactory performance in all of the laboratory…
- § 1272.4 The department shall establish standards for the evaluation of cytologic slides, for reporting the adequacy of cytologic slides, for a cytotechnologist…
- § 1272.6 The department shall, on or before January 1, 1992, develop or adopt a proficiency testing program for laboratories providing cytology services which may be…
- § 1274 (a) A laboratory shall document to persons submitting cytologic samples for evaluation, on a quarterly basis, informational letters on all cases of HSIL…
- § 1275 The department shall develop and implement regulations for continuing education for persons licensed pursuant to this chapter on or before January 1, 1992,…
ARTICLE 5. Offenses Against the Chapter §§ 1280–1291 · 17 sections
- § 1280 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.
- § 1281 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,…
- § 1281.1 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…
- § 1282 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…
- § 1282.2 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…
- § 1282.3 (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…
- § 1283 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…
- § 1284 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.
- § 1285 It is unlawful for any person conducting, maintaining, or operating a clinical laboratory to employ any person to perform clinical laboratory procedures unless…
- § 1286 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…
- § 1287 (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…
- § 1288 Any person conducting or operating a clinical laboratory may accept assignments for tests only from and make reports only to persons licensed under the…
- § 1288.3 (a) If a clinical laboratory employee, agent, or courier retrieves biological specimens located in a public place outside of the custodial control of a…
- § 1288.5 No person may solicit or accept any biological specimen for clinical laboratory testing or examination unless there is in effect for the clinical laboratory…
- § 1289 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…
- § 1290 With the exception of narcotics and dangerous drugs stored on the licensed clinical laboratory premises for use exclusively as standards for the purpose of…
- § 1291 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…
ARTICLE 6. Revenue §§ 1300–1302 · 6 sections
- § 1300 The amount of application, registration, certification, and license fees under this chapter shall be as follows: (a) The application fee for a…
- § 1300.1 (a) The application, registration, certification, and license fees specified in Section 1300 shall be adjusted annually in the manner specified in Section…
- § 1300.2 Notwithstanding any other provision of this article, the total fees collected under this chapter shall not exceed the costs incurred by the department for…
- § 1301 (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…
- § 1301.1 Notwithstanding any other provision of this chapter, the department may establish such license periods and renewal dates for all licenses issued under this…
- § 1302 (a) There is hereby established in the State Treasury, the Clinical Laboratory Improvement Fund. (b) All fees established under this chapter and Chapter 4…
ARTICLE 6.5. Penalties §§ 1310–1311 · 2 sections
- § 1310 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…
- § 1311 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…
ARTICLE 7. Denial, Revocation and Suspension of Licenses §§ 1320–1327 · 8 sections
- § 1320 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…
- § 1321 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…
- § 1322 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…
- § 1323 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…
- § 1324 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…
- § 1325 Notwithstanding Sections 1267 and 1322, the license or registration of a clinical laboratory that has been excluded from participation under the Medicare…
- § 1326 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…
- § 1327 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…