citation: BPC § 1214

text: As used in this chapter, “health fair” means a program of health assessment procedures offered to the general public that may include screening, self-ordered, or diagnostic clinical laboratory tests or examinations performed by a clinical laboratory licensed or registered under subdivision (a) of Section 1265 that meets all the requirements of this chapter.

history: (History: Added by Stats. 2004, Ch. 450, Sec. 2. Effective January 1, 2005.)

article: 1. Definitions


kind: section

code: BPC

citation: BPC § 1220

text:
(a) (1) Each clinical laboratory shall maintain records, equipment, and facilities that are adequate and appropriate for the services rendered.

(2) (A) Except for tests or examinations classified as waived under CLIA, each clinical laboratory shall enroll, and demonstrate successful participation, as defined under CLIA, for each specialty and subspecialty in which it performs clinical laboratory tests or examinations, in a proficiency testing program approved by the department or by HCFA, to the same extent as required by CLIA in Subpart H (commencing with Section 493.801) of Title 42 of the Code of Federal Regulations. This requirement shall not be interpreted to prohibit a clinical laboratory from performing clinical laboratory tests or examinations in a specialty or subspecialty for which there is no department or HCFA approved proficiency testing program.

(B) Each clinical laboratory shall authorize its proficiency test results to be reported to the department in an electronic format that is compatible with the department’s proficiency testing data monitoring system and shall authorize the release of proficiency tests results to the public to the same extent required by CLIA.

(b) Each clinical laboratory shall be conducted, maintained, and operated without injury to the public health.

(c) (1) The department shall conduct inspections of licensed clinical laboratories no less than once every two years. The department shall maintain a record of those inspections and shall ensure that every licensed clinical laboratory in California is inspected at least that often.

(2) Registered clinical laboratories shall not be routinely inspected by the department.

(3) The department shall conduct an investigation of complaints received concerning any clinical laboratory, which may include an inspection of the laboratory.

(4) Each licensed or registered clinical laboratory shall be subject to inspections by HCFA or HCFA agents, as defined by CLIA, as a condition of licensure or registration.

(d) (1) Each clinical laboratory shall perform all clinical laboratory tests or examinations classified as waived under CLIA in conformity with the manufacturer’s instructions.

(2) Except for those clinical laboratories performing only tests or examinations classified as waived under CLIA, each clinical laboratory shall establish and maintain all of the following:

(A) A patient test management system that meets the standards of CLIA in Subpart J (commencing with Section 493.1100) of Title 42 of the Code of Federal Regulations.

(B) A quality control program that meets the requirements of CLIA in Subpart K (commencing with Section 493.1200) of Title 42 of the Code of Federal Regulations as in effect on January 1, 2015, and that may include the clinical laboratory’s use of the following alternative quality control testing procedures recognized by the federal Centers for Medicare and Medicaid Services (CMS):

(i) Until December 31, 2015, equivalent quality control procedures.

(ii) Commencing January 1, 2016, an Individualized Quality Control Plan, as incorporated in Appendix C of the State Operations Manual adopted by CMS.

(C) A comprehensive quality assurance program that meets the standards of CLIA in Subpart P (commencing with Section 493.1701) of Title 42 of the Code of Federal Regulations.

history: (History: Amended by Stats. 2015, Ch. 18, Sec. 2. (SB 75) Effective June 24, 2015.)

division: 2. HEALING ARTS

chapter: 3. Clinical Laboratory Technology

article: 2. Administration and Regulation

path: 2. HEALING ARTS > 3. Clinical Laboratory Technology > 2. Administration and Regulation


text:
(a) The Department of Health Services shall develop, and provide to all licensed clinical laboratories, a form in triplicate to be used by employees, agents, and couriers of licensed clinical laboratories to give notice when a specimen storage container has been improperly secured pursuant to Section 681.

(b) The three copies of the triplicate form shall each contain instructions so that one copy is to be attached to the unlocked specimen storage container, one copy is mailed to the Department of Consumer Affairs to be forwarded to the appropriate licensing entity pursuant to Section 1288.3, and one copy is kept by the licensed clinical laboratory for its records.

(c) This form shall be provided to all licensed clinical laboratories on and after January 1, 2001.

history: (History: Added by Stats. 1999, Ch. 748, Sec. 2. Effective January 1, 2000.)

article: 2. Administration and Regulation


citation: BPC § 1221

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

history: (History: Amended by Stats. 1977, Ch. 579.)

article: 2. Administration and Regulation


citation: BPC § 1222

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

history: (History: Amended by Stats. 1995, Ch. 510, Sec. 15. Effective January 1, 1996.)

article: 2. Administration and Regulation


text:
(a) The department may approve any of the following seeking to provide clinical laboratory scientist programs for instruction in clinical laboratory technique that, in the judgment of the department, will provide instruction adequate to prepare individuals to meet the requirements for licensure or performance of duties under this chapter and regulations of the department:

(1) A California licensed clinical laboratory.

(2) An accredited college or university in the United States of America.

(3) A United States military medical laboratory specialist program of at least 52 weeks duration.

(4) A laboratory owned and operated by the United States government.

(b) Upon approval by the department, clinical laboratory scientist programs approved by the department may use multiple clinical laboratories to provide training in clinical laboratory technique, provided the following conditions are met:

(1) The program may apportion the clinical training among multiple clinical laboratories in any percentage as long as the total training meets the requirements established by the department.

(2) Each clinical laboratory has been approved by the department as part of the program in accordance with regulations. The program shall notify the department in writing within 30 days of a change in clinical laboratories used by the program to provide training.

(3) The director of the approved program shall be responsible for notifying the department in advance of the start and end date of training for each trainee. The program shall coordinate with the department in meeting established requirements.

(4) The director of the approved program shall ensure that all of the department’s requirements for training and affiliation are met.

(5) The program has submitted an application on forms provided by the department for approval.

(c) The department shall establish by regulation the ratio of licensed clinical laboratory scientists to licensed trainees on the staff of the clinical laboratory and the minimum requirements for training in any specialty or in the entire field of clinical laboratory science or practice. Application for approval shall be made on forms provided by the department.

history: (History: Amended by Stats. 2012, Ch. 352, Sec. 2. (SB 289) Effective January 1, 2013.)

article: 2. Administration and Regulation


citation: BPC § 1223

text:
(a) The Legislature finds and declares that it is the public policy of the state to ensure that California’s laboratory standards, including its laboratory personnel standards, be sustained in order to provide accurate, reliable, and necessary test results. The Legislature further finds that inspections are the most effective means of furthering this policy. It is not the intent of the Legislature to reduce in any way the resources available to the department for inspections, but rather to provide the department with the greatest flexibility to concentrate its resources where they can be most effective. It is the intent of the Legislature to provide for an inspection process that includes state-based inspection components and that determines compliance with federal and state requirements for clinical laboratories.

(b) 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 and may incur other expenses as necessary.

(c) Laboratories accredited by a private, nonprofit organization shall be deemed by the department to meet state licensure or registration requirements, and shall be issued a certificate of that deemed status by the department, provided that both of the following conditions are met:

(1) The private, nonprofit organization meets all of the following requirements:

(A) Is approved by the federal Center for Medicare and Medicaid Services as an accreditation body under CLIA and provides the department with the following information:

(i) A detailed comparison of the individual accreditation or approval requirements, with the comparable condition-level requirements.

(ii) A detailed description of its inspection process, including all of the following:

(I) Frequency of inspections.

(II) Copies of inspection forms.

(III) Instructions and guidelines.

(IV) A description of the review and decisionmaking process of inspections.

(V) A statement concerning whether inspections are announced or unannounced.

(VI) A description of the steps taken to monitor the correction of deficiencies.

(iii) A description of the process for monitoring proficiency testing performance, including action to be taken in response to unsuccessful participation.

(iv) A list of all of its current California licensed or registered laboratories and the expiration date of their accreditation, licensure, or registration, as applicable.

(B) Is approved by the department as having accreditation standards that are equal to, or more stringent than, state requirements for licensure and registration.

(C) Conducts inspections of clinical laboratories in a manner that will determine compliance with federal standards and California laws to the extent that California laws provide greater protection to residents, or are more stringent than federal standards, as determined by the department. Notwithstanding any other provision of law, the department may, without taking regulatory action pursuant to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, implement or interpret this section by means of an All Clinical Laboratories Letter (ACLL). The department shall post the ACLL on its Internet Web site so that any person may observe which California laws are more stringent than federal standards, and which accreditation bodies have been approved to conduct inspections. Public comment on the ACLL shall be accepted by the department for 30 days after posting and shall become final 45 days after the posting. Comments received shall be considered by the department. Nothing in this subdivision is intended to change existing statutory or regulatory requirements governing the operation of clinical laboratories or their personnel.

(D) Is approved by the department as meeting the requirements of this paragraph. The department shall begin accepting applications for approval, in a form and manner prescribed by the department, by January 1, 2011. The department shall make a determination on an application submitted pursuant to this subparagraph within 180 days of receiving the application.

(2) The laboratory meets all of the following requirements:

(A) Meets the accreditation standards of the private, nonprofit organization.

(B) Agrees to permit the private, nonprofit organization to provide any records or other information to the department, its agents, or contractors, as the department may require.

(C) Pays the applicable fees required under Section 1300.

(D) Authorizes its proficiency testing organization to furnish to the department and the private, nonprofit organization the results of the laboratory’s participation in an approved proficiency testing program, as defined in 42 C.F.R. 493.2, for the purpose of monitoring the laboratory’s proficiency testing, along with explanatory information needed to interpret the proficiency testing results, upon request of the department.

(E) Authorizes the private, nonprofit organization to release to the department a notification of every violation of condition-level requirements, including the actions taken by the organization as a result of the violation, within 30 days of the initiation of the action.

(F) Authorizes the private, nonprofit organization to give notice to the department of any withdrawal of the laboratory’s accreditation.

(d) If the private, nonprofit organization described in subdivision (c) has withdrawn or revoked its accreditation of a laboratory, the laboratory shall retain its certificate of deemed status issued pursuant to subdivision (c) for 45 days after the laboratory receives notice of the withdrawal or revocation of the accreditation, or the effective date of any action taken by the department, whichever is earlier.

(e) A certificate of deemed status issued pursuant to subdivision (c) shall be renewed annually provided that the conditions for issuance specified in subdivision (c) are still met. Except as authorized under subdivision (f), the department shall not conduct routine inspections of a laboratory issued a certificate of deemed status pursuant to subdivision (c). Each application for a certificate of deemed status issued under subdivision (c) and each request for renewal of that certificate shall be accompanied by the fees set forth in Section 1300. The total of those certificate application and renewal fees collected by the department shall be sufficient to cover the cost of issuing the certificate. If the department determines that those certificate fees do not fully support the costs of these activities, it shall report that determination to the Legislature.

(f) Nothing in this section shall be construed to prohibit the exercise of the department’s authority to conduct complaint investigations, sample validation inspections, or require submission of proficiency testing results to the department to ensure compliance of any clinical laboratory with state standards.

history: (History: Amended by Stats. 2009, Ch. 201, Sec. 2. (SB 744) Effective October 11, 2009.)

article: 2. Administration and Regulation


citation: BPC § 1224

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

history: (History: Amended by Stats. 1995, Ch. 510, Sec. 17. Effective January 1, 1996.)

article: 2. Administration and Regulation


text: The department shall conduct a study to determine whether the persons conducting tests in physician office laboratories under paragraph (12) of subdivision (b) of, and paragraph (10) of subdivision (c) of Section 1206.5, produce accurate, reliable, and necessary test results comparable to those produced by other persons performing moderate complexity or high complexity testing, or both.

history: (History: Added by Stats. 1995, Ch. 510, Sec. 18. Effective January 1, 1996.)

article: 2. Administration and Regulation


citation: BPC § 1225

text:
(a) In order to carry out this chapter, any duly authorized representative of the department may do any of the following:

(1) Enter or inspect on an announced or unannounced basis any building, premise, equipment, materials, records, or information at any reasonable time to secure compliance with, or prevent a violation of this chapter or the regulations adopted pursuant thereto.

(2) Inspect, photograph, or copy any records, reports, test results, test specimens, or other information related to the requirements of this chapter or the regulations adopted pursuant thereto.

(3) Secure any sample, photograph, or other evidence from any building or premise for the purpose of enforcing this chapter or the regulations adopted pursuant thereto.

(b) The department may cooperate with, or assist persons licensed under this chapter, or other qualified persons, in evaluating laboratory procedures and techniques necessary to achieve and maintain high quality performance in clinical laboratories.

history: (History: Amended by Stats. 1989, Ch. 927, Sec. 2.)

article: 2. Administration and Regulation


citation: BPC § 1226

text: Annually the department may compile and may thereafter publish and sell a directory of persons within the state licensed under the provisions of this chapter who hold unsuspended, unforfeited and unrevoked licenses. The directory may also contain a copy of the provisions of this chapter and regulations relating thereto and such other information as the department may determine advisable.

history: (History: Added by renumbering Section 1227 by Stats. 1970, Ch. 1377.)

article: 2. Administration and Regulation


citation: BPC § 1227

text: 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.

history: (History: Amended by Stats. 1995, Ch. 510, Sec. 19. Effective January 1, 1996.)

article: 2. Administration and Regulation


citation: BPC § 1228

text: The department shall appoint a multidisciplinary committee to assist, advise, and make recommendations for the establishment of rules and regulations necessary to insure proper administration and enforcement of the provisions of this chapter and to assist and advise the department in matters concerning examinations for licensees of this chapter. Appointments shall be made from lists of nominees solicited by the department and shall provide adequate and proper representation of all persons affected by this chapter. Subcommittees of the committee may be appointed consisting of committee members and consultants having particular knowledge in a subject area for the purpose of assisting the department on special administrative problems and in making recommendations to the committee for consideration in the establishment of rules and regulations. The terms of office of the members shall be determined by the department.

history: (History: Added by Stats. 1970, Ch. 1125.)

article: 2. Administration and Regulation


citation: BPC § 1240

text: This chapter does not authorize any person to practice medicine and surgery or to furnish the services of physicians for the practice of medicine and surgery. This chapter does not repeal or in any manner affect any provision of this code relating to the practice of medicine. This chapter does not prohibit the performance of tests not covered in Section 1206.

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

article: 3. Application of the Chapter

path: 2. HEALING ARTS > 3. Clinical Laboratory Technology > 3. Application of the Chapter


citation: BPC § 1241

text:
(a) This chapter applies to all clinical laboratories in California or receiving biological specimens originating in California for the purpose of performing a clinical laboratory test or examination, and to all persons performing clinical laboratory tests or examinations or engaging in clinical laboratory practice in California or on biological specimens originating in California, except as provided in subdivision (b).

(b) This chapter shall not apply to any of the following clinical laboratories, or to persons performing clinical laboratory tests or examinations in any of the following clinical laboratories:

(1) Those owned and operated by the United States of America, or any department, agency, or official thereof acting in his or her official capacity to the extent that the Secretary of the federal Department of Health and Human Services has modified the application of CLIA requirements to those laboratories.

(2) Public health laboratories, as defined in Section 1206.

(3) Those that perform clinical laboratory tests or examinations for forensic purposes only.

(4) Those that perform clinical laboratory tests or examinations for research and teaching purposes only and do not report or use patient-specific results for the diagnosis, prevention, or treatment of any disease or impairment of, or for the assessment of the health of, an individual.

(5) Those that perform clinical laboratory tests or examinations certified by the National Institutes on Drug Abuse only for those certified tests or examinations. However, all other clinical laboratory tests or examinations conducted by the laboratory are subject to this chapter.

(6) Those that register with the State Department of Health Care Services pursuant to subdivision (c) to perform blood glucose testing for the purposes of monitoring a minor child diagnosed with diabetes if the person performing the test has been entrusted with the care and control of the child by the child’s parent or legal guardian and provided that all of the following occur:

(A) The blood glucose monitoring test is performed with a blood glucose monitoring instrument that has been approved by the federal Food and Drug Administration for sale over the counter to the public without a prescription.

(B) The person has been provided written instructions by the child’s health care provider or an agent of the child’s health care provider in accordance with the manufacturer’s instructions on the proper use of the monitoring instrument and the handling of any lancets, test strips, cotton balls, or other items used during the process of conducting a blood glucose test.

(C) The person, receiving written authorization from the minor’s parent or legal guardian, complies with written instructions from the child’s health care provider, or an agent of the child’s health care provider, regarding the performance of the test and the operation of the blood glucose monitoring instrument, including how to determine if the results are within the normal or therapeutic range for the child, and any restriction on activities or diet that may be necessary.

(D) The person complies with specific written instructions from the child’s health care provider or an agent of the child’s health care provider regarding the identification of symptoms of hypoglycemia or hyperglycemia, and actions to be taken when results are not within the normal or therapeutic range for the child. The instructions shall also contain the telephone number of the child’s health care provider and the telephone number of the child’s parent or legal guardian.

(E) The person records the results of the blood glucose tests and provides them to the child’s parent or legal guardian on a daily basis.

(F) The person complies with universal precautions when performing the testing and posts a list of the universal precautions in a prominent place within the proximity where the test is conducted.

(7) Those individuals who perform clinical laboratory tests or examinations, approved by the federal Food and Drug Administration for sale to the public without a prescription in the form of an over-the-counter test kit, on their own bodies or on their minor children or legal wards.

(8) Those certified emergency medical technicians and licensed paramedics providing basic life support services or advanced life support services as defined in Section 1797.52 of the Health and Safety Code who perform only blood glucose tests that are classified as waived clinical laboratory tests under CLIA, if the provider of those services obtains a valid certificate of waiver and complies with all other requirements for the performance of waived clinical laboratory tests under applicable federal regulations.

(9) Those doctors of chiropractic listed on the most current federal Department of Transportation National Registry of Certified Medical Examiners that perform urine specific gravity, urine protein, urine blood, and urine sugar tests as those tests relate to the National Registry of Certified Medical Examiners, as adopted by the United States Department of Transportation, as published by the notice in the Federal Register, Volume 77, Number 77, Friday, April 20, 2012, on pages 24104 to 24135, inclusive, and pursuant to Section 391.42 of Title 49 of the Code of Federal Regulations, that are classified as waived clinical laboratory tests under CLIA for the sole purpose of completing the Department of Motor Vehicles Medical Examination Report, if the doctor of chiropractic obtains a valid certificate of waiver and complies with all other requirements for the performance of waived clinical laboratory tests under applicable federal regulations. If a doctor of chiropractic receives an abnormal finding, the doctor of chiropractic shall refer the applicant to the applicant’s primary care physician.

(c) Any place where blood glucose testing is performed pursuant to paragraph (6) of subdivision (b) shall register by notifying the State Department of Health Care Services in writing no later than 30 days after testing has commenced. Registrants pursuant to this subdivision shall not be required to pay any registration or renewal fees nor shall they be subject to routine inspection by the State Department of Health Care Services.

history: (History: Amended by Stats. 2014, Ch. 269, Sec. 1. (AB 2143) Effective August 22, 2014.)

article: 3. Application of the Chapter


text:
(a) A primary care clinic, licensed pursuant to subdivision (a) of Section 1204 of the Health and Safety Code, that is operating within a network of primary care clinics, may be issued a license to operate a clinical laboratory pursuant to Section 1265, which authorizes the conduct of clinical laboratory tests and examinations from its network of primary care clinics, if all of the following conditions are met:

(1) The central laboratory’s sole purpose is performing moderate or high complexity clinical laboratory tests and examinations, or both, for the patients of the clinics in the network.

(2) Prior to performing any tests or examinations, the central laboratory obtains a certificate under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) (CLIA) and a state laboratory license for the appropriate complexity level of clinical laboratory testing pursuant to Section 1265.

(b) For purposes of this section, “network of primary care clinics” means two or more primary care clinics operated by the same nonprofit corporation with the same board of directors and the same corporate officers, and operating under the same procedures and protocols.

history: (History: Added by Stats. 2006, Ch. 795, Sec. 1. Effective January 1, 2007.)

article: 3. Application of the Chapter


citation: BPC § 1242

text: Any person duly licensed under the provisions of this chapter to perform tests called for in a clinical laboratory may perform skin tests for specific diseases, arterial puncture, venipuncture, or skin puncture for purposes of withdrawing blood or for clinical laboratory test purposes as defined by regulations established by the department and upon specific authorization from any person in accordance with the authority granted under any provisions of law relating to the healing arts.

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

article: 3. Application of the Chapter


text: Notwithstanding paragraphs (2) and (3) of subdivision (b) of Section 1241, the department may by regulation authorize laboratory personnel certified pursuant to Section 1246 to perform venipuncture, arterial puncture, or skin puncture for the purposes of withdrawing blood or for clinical laboratory test purposes, as defined by regulations established by the department.

history: (History: Amended by Stats. 1999, Ch. 695, Sec. 2. Effective January 1, 2000.)

article: 3. Application of the Chapter


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

(b) Any licensed vocational nurse licensed under the provisions of Chapter 6.5 (commencing with Section 2840) of Division 2 may perform arterial puncture, venipuncture, or skin puncture for the purposes of withdrawing blood or for test purposes upon authorization from any licensed physician and surgeon, or any licensed dentist if prior thereto the licensed vocational nurse has been instructed by a physician and surgeon and has demonstrated competence to the physician and surgeon in the proper procedure to be employed when withdrawing blood, or has satisfactorily completed a prescribed course of instruction approved by the Board of Vocational Nursing and Psychiatric Technicians or has demonstrated competence to the satisfaction of that board.

(c) Any respiratory care practitioner certified under the provisions of Chapter 8.3 (commencing with Section 3700) of Division 2 may perform arterial puncture, venipuncture, or skin puncture for the purposes of withdrawing blood or for test purposes upon authorization from any licensed physician and surgeon.

history: (History: Amended by Stats. 1997, Ch. 759, Sec. 10. Effective January 1, 1998.)

article: 3. Application of the Chapter


citation: BPC § 1243

text: A student regularly matriculated in any college or university accredited by an accrediting agency acceptable to the department, or in any legally chartered school approved by the department for training purposes may perform arterial puncture, venipuncture, or skin puncture as a part of the necessary training program when done under the direct and responsible supervision of a person licensed to perform tests under the provisions of this chapter or a licensed physician and surgeon.

article: 3. Application of the Chapter


citation: BPC § 1244

text:
(a) Nothing in this chapter shall restrict, limit, or prevent a program of nondiagnostic general health assessment provided that:

(1) The program meets the requirements of Section 1265 and complies with the requirements of CLIA for waived testing.

(2) The purpose of the program is to screen asymptomatic individuals for chronic health disorders and to refer individuals to licensed sources of care as indicated.

(3) The program does not test for human immunodeficiency virus or any reportable disease or condition identified in Section 120130 of the Health and Safety Code or the regulations adopted under that section.

(4) The program utilizes only those devices that comply with all of the following:

(A) Meet all applicable state and federal performance standards pursuant to Section 111245 of the Health and Safety Code.

(B) Are not adulterated as specified in Article 2 (commencing with Section 111250) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.

(C) Are not misbranded as specified in Article 3 (commencing with Section 111330) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.

(D) Are not new devices unless they meet the requirements of Section 111550 of the Health and Safety Code.

(E) Are approved as waived tests and are used according to the manufacturer’s instructions.

(5) Blood collection is performed by skin puncture only.

(6) Testing of a urine specimen is performed by the dipstick method only.

(7) Testing is performed on site and reported directly to the person requesting the test.

(8) The program maintains a supervisory committee consisting of, at a minimum, a licensed physician and surgeon and a clinical laboratory scientist licensed pursuant to this code.

(9) The supervisory committee for the program adopts written protocols that shall be followed in the program and that shall contain all of the following:

(A) Provision of written information to individuals to be assessed that shall include, but not be limited to, the following:

(i) The potential risks and benefits of assessment procedures to be performed in the program.

(ii) The limitations, including the nondiagnostic nature, of assessment examinations of biological specimens performed in the program.

(iii) Information regarding the risk factors or markers targeted by the program.

(iv) The need for followup with licensed sources of care for confirmation, diagnosis, and treatment as appropriate.

(B) Proper use of each device utilized in the program including the operation of analyzers, maintenance of equipment and supplies, and performance of quality control procedures including the determination of both accuracy and reproducibility of measurements in accordance with instructions provided by the manufacturer of the assessment device used.

(C) Proper procedures to be employed when collecting blood, if blood specimens are to be obtained.

(D) Proper procedures to be employed in handling and disposing of all biological specimens to be obtained and material contaminated by those biological specimens. These procedures shall comply with all county and city ordinances for medical waste management and blood-borne pathogen control that apply to the location where the program operates.

(E) Proper procedures to be employed in response to fainting, excessive bleeding, or other medical emergencies.

(F) Documentation that the testing personnel are following the instructions of the instrument’s manufacturer, are trained in the performance of the test, and are competent to perform the testing without supervision.

(G) Reporting of assessment results to the individual being assessed.

(H) Referral and followup to licensed sources of care as indicated.

The written protocols adopted by the supervisory committee shall be maintained for at least one year following completion of the assessment program during which period they shall be subject to review by department personnel and the local health officer or his or her designee, including the public health laboratory director.

(b) If skin puncture to obtain a blood specimen is to be performed in a program of nondiagnostic general health assessment, the individual performing the skin puncture shall be authorized to perform skin puncture under this chapter.

(c) A program of nondiagnostic general health assessment that fails to meet the requirements set forth in subdivisions (a) and (b) shall not operate.

(d) For purposes of this section, “skin puncture” means the collection of a blood specimen by the finger prick method only and does not include venipuncture, arterial puncture, or any other procedure for obtaining a blood specimen.

(e) Nothing in this chapter shall be interpreted as prohibiting a licensed clinical laboratory from operating a program of nondiagnostic general health assessment provided that the clinical laboratory complies with the requirements of this section.

(f) A program for a health fair providing diagnostic or screening tests is not a nondiagnostic general health assessment program if all of the requirements of this chapter are met, and the laboratory performing the testing is licensed or registered under subdivision (a) of Section 1265. For a test that is not authorized for self-ordering pursuant to Section 1246.5 and that is not for a nondiagnostic general health assessment pursuant to this section, the licensed or registered clinical laboratory participating in the health fair shall assure that the test is ordered on-site only by a person licensed under this division who is authorized under his or her scope of practice to order the test or by a person authorized by that licensee. The results of a test performed at a health fair shall be provided to the test subject along with an explanation of the results.

history: (History: Amended by Stats. 2004, Ch. 450, Sec. 3. Effective January 1, 2005.)

article: 3. Application of the Chapter


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

(a) The location of the program, the type and kind of nondiagnostic general health assessments being conducted, the dates and times of operation of programs, and evidence that the program shall be operated in compliance with Section 1244.

(b) The local health officer shall be notified in writing of any changes to occur in locations, dates, or times indicated in the documentation required in subdivision (a). The local health officer shall be notified of any changes at least 24 hours prior to the program operating at the different locations, dates, or times.

history: (History: Added by Stats. 1990, Ch. 195, Sec. 5. Effective July 9, 1990.)

article: 3. Application of the Chapter


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

history: (History: Added by Stats. 1990, Ch. 195, Sec. 6. Effective July 9, 1990.)

article: 3. Application of the Chapter


text: Any fee for the filing of documentation and related enforcement activities pursuant to Section 1244, 1244.1, and 1244.3 shall be determined by the local enforcement agency and shall not exceed one hundred dollars ($100) except that those fees shall be adjusted annually by any annual increase in the California Consumer Price Index as determined pursuant to Section 2212 of the Revenue and Taxation Code. All moneys collected as fees pursuant to this section shall be deposited in the appropriate city, county, or city and county treasury and shall only be expended in carrying out Sections 1244, 1244.1, and 1244.3.

history: (History: Added by Stats. 1990, Ch. 195, Sec. 7. Effective July 9, 1990.)

article: 3. Application of the Chapter


citation: BPC § 1245

text:
(a) Any individual may perform a blood gas analysis if all the following conditions exist:

(1) He or she has earned a high school diploma or equivalent, as determined by HCFA pursuant to CLIA.

(2) He or she performs the blood gas analysis in a clinic or a general acute care hospital, as defined respectively in Sections 1202 and 1250 of the Health and Safety Code.

(3) He or she has been instructed by a physician and surgeon licensed in this state, who is in charge of a department of pulmonary physiology or clinical pathology in licensed clinics or hospitals, as defined respectively in Sections 1202 and 1250 of the Health and Safety Code, in the proper procedure to be employed when performing a blood gas analysis.

(4) He or she performs the blood gas analysis under the direction and supervision of the physician and surgeon.

(5) He or she submits the analysis for interpretation to the physician and surgeon under whose direction and supervision he or she performed the analysis.

(b) After September 1, 1997, any person may perform a blood gas analysis classified as of high complexity under CLIA, if, in addition to the requirements of subdivision (a), he or she has earned an associate degree related to pulmonary function from an accredited institution as determined by HCFA pursuant to CLIA.

(c) Nothing contained in this section shall be construed as authorizing any individual, not otherwise authorized, to withdraw blood.

(d) Nothing contained in this section is applicable to a person licensed as a respiratory care practitioner under Chapter 8.3 (commencing with Section 3700). Those persons are authorized to perform those functions set forth in that chapter.

history: (History: Amended by Stats. 1995, Ch. 510, Sec. 23. Effective January 1, 1996.)

article: 3. Application of the Chapter


citation: BPC § 1246

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

(2) The department shall adopt regulations for certification by January 1, 2001, as a certified phlebotomy technician that shall include all of the following:

(A) The applicant shall hold a valid, current certification as a phlebotomist issued by a national accreditation agency approved by the department, and shall submit proof of that certification when applying for certification pursuant to this section.

(B) An applicant with fewer than 1,040 hours of work experience shall complete education, training, and experience requirements as specified by regulations that shall include, but not be limited to, the following:

(i) At least 40 hours of didactic instruction.

(ii) At least 40 hours of practical instruction.

(iii) At least 50 successful venipunctures.

(C) An applicant who has at least 1,040 hours of work experience that includes at least 50 successful venipunctures shall complete at least 20 hours of didactic instruction, as specified in regulations adopted by the department.

(D) Each certified phlebotomy technician shall complete at least three hours per year or six hours every two years of continuing education or training. The department shall consider a variety of programs in determining the programs that meet the continuing education or training requirement.

(E) The applicant has been found to be competent in phlebotomy by a licensed physician and surgeon or person licensed pursuant to this chapter.

(F) The applicant works under the supervision of a licensed physician and surgeon, licensed registered nurse, or person licensed under this chapter, or the designee of a licensed physician and surgeon or the designee of a person licensed under this chapter.

(3) A certified phlebotomy technician may collect blood through a peripheral venous catheter if all of the following are met:

(A) The blood collection procedure is performed in a facility licensed under Division 2 (commencing with Section 1200) of the Health and Safety Code.

(B) The blood collection procedures or protocols are developed and approved by the facility’s supervising physician and surgeon or licensed clinical laboratory director and approved by the licensed facility.

(C) The certified phlebotomy technician has received a minimum of three hours of training by the supervising physician and surgeon or their delegate in the proper procedures to be employed when collecting blood through a peripheral venous catheter.

(i) Training in the blood collection procedure through a peripheral venous catheter shall be conducted according to standardized training procedures developed and approved by the facility’s supervising physician and surgeon or licensed clinical laboratory director. The facility shall make these standardized procedures available to the department upon request.

(ii) The instructor shall document the certified phlebotomy technician’s successful completion of training. The facility shall maintain and make available to the department, upon request, documentation of training completed by a certified phlebotomy technician pursuant to this paragraph.

(D) The certified phlebotomy technician performs the blood collection procedure under the supervision of a physician and surgeon licensed under Chapter 5 (commencing with Section 2000). Notwithstanding subdivision (b), the physician and surgeon may only delegate the supervision duties in this subparagraph to a registered nurse. A physician and surgeon or a registered nurse may restrict or limit a certified phlebotomy technician’s ability to collect blood from a patient’s peripheral venous catheter.

(E) The certified phlebotomy technician performs the blood collection procedure using a device or devices approved by the licensed facility and the United States Food and Drug Administration.

(F) This paragraph does not authorize the certified phlebotomy technician to manage, stop, or restart a patient’s active intravenous infusion or insert or remove a peripheral intravenous catheter.

(4) Paragraph (3) does not authorize a certified phlebotomy technician to withdraw blood through a peripherally inserted central catheter or central venous catheter.

(5) The department shall adopt regulations establishing standards for approving training programs designed to prepare applicants for certification pursuant to this section. The standards shall ensure that these programs meet the state’s minimum education and training requirements for comparable programs.

(6) The department shall adopt regulations establishing standards for approving national accreditation agencies to administer certification examinations and tests pursuant to this section.

(7) The department shall charge fees for application for and renewal of the certificate authorized by this section pursuant to subdivision (f) of Section 1300.

(b) (1) (A) A certified phlebotomy technician may perform venipuncture or skin puncture to obtain a specimen for nondiagnostic tests assessing the health of an individual, for insurance purposes, provided that the technician works under the general supervision of a physician and surgeon licensed under Chapter 5 (commencing with Section 2000). The physician and surgeon may delegate the general supervision duties to a registered nurse or a person licensed under this chapter, but shall remain responsible for ensuring that all those duties and responsibilities are properly performed. The physician and surgeon shall make available to the department, upon request, records maintained documenting when a certified phlebotomy technician has performed venipuncture or skin puncture pursuant to this paragraph.

(B) As used in this paragraph, general supervision requires the supervisor of the technician to determine that the technician is competent to perform venipuncture or skin puncture, or to collect blood, before the technician’s first blood withdrawal, and on an annual basis thereafter. The supervisor is also required to determine, on a monthly basis, that the technician complies with appropriate venipuncture, skin puncture, and blood collection policies and procedures approved by the medical director and required by state regulations. The supervisor, or another designated licensed physician and surgeon, registered nurse, or person licensed under this chapter, shall be available for consultation with the technician, either in person or through telephonic or electronic means, at the time of blood withdrawal.

(2) (A) Notwithstanding any other law, a person who has been issued a certified phlebotomy technician certificate pursuant to this section may draw blood following policies and procedures approved by a physician and surgeon licensed under Chapter 5 (commencing with Section 2000), appropriate to the location where the blood is being drawn and in accordance with state regulations. The blood collection shall be done at the request and in the presence of a peace officer for forensic purposes in a jail, law enforcement facility, or medical facility, with general supervision.

(B) As used in this paragraph, “general supervision” means that the supervisor of the technician is licensed under this code as a physician and surgeon, physician assistant, clinical laboratory bioanalyst, registered nurse, or clinical laboratory scientist, and reviews the competency of the technician before the technician may perform blood withdrawals without direct supervision, and on an annual basis thereafter. The supervisor is also required to review the work of the technician at least once a month to ensure compliance with venipuncture policies, procedures, and regulations. The supervisor, or another person licensed under this code as a physician and surgeon, physician assistant, clinical laboratory bioanalyst, registered nurse, or clinical laboratory scientist, shall be accessible to the location where the technician is working to provide onsite, telephone, or electronic consultation, within 30 minutes when needed.

(c) The department may adopt regulations providing for the issuance of a certificate to an unlicensed person employed by a clinical laboratory authorizing only the performance of skin punctures for test purposes.

history: (History: Amended by Stats. 2025, Ch. 105, Sec. 2. (AB 144) Effective September 17, 2025.)

article: 3. Application of the Chapter


text:
Notwithstanding any other provision of law, any person may request, and any licensed clinical laboratory or public health laboratory may perform, the laboratory tests specified in this section. A registered clinical laboratory may perform the laboratory tests specified in this section if the test is subject to a certificate of waiver under CLIA and the laboratory has registered with the department under paragraph (2) of subdivision (a) of Section 1265. A program for nondiagnostic general health assessment that includes a laboratory test specified in this section shall comply with the provisions of Section 1244. The results from any test may be provided directly to the person requesting the test if the test is on or for his or her own body. These test results shall be provided in a manner that presents clear information and that identifies results indicating the need for referral to a physician and surgeon.

The tests that may be conducted pursuant to this section are: pregnancy, glucose level, cholesterol, occult blood, and any other test for which there is a test for a particular analyte approved by the federal Food and Drug Administration for sale to the public without a prescription in the form of an over-the-counter test kit. A test approved only as an over-the-counter collection device may not be conducted pursuant to this section.

history: (History: Amended by Stats. 2004, Ch. 450, Sec. 4. Effective January 1, 2005.)

article: 3. Application of the Chapter


text:
(a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection center in this state, if the department, as part of its routine, fee-supported inspection of the licensed plasma collection center, including its review of personnel reports for licensed and unlicensed personnel and job descriptions of all center positions for a licensed plasma collection center, determines that all of the following conditions are met:

(1) (A) The person has earned a high school diploma or equivalent, as determined by the federal Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).

(B) The person has training sufficient to demonstrate that the individual has the skills and abilities described in paragraph (2) of subdivision (a) of Section 1269.

(2) (A) In addition to the education and training requirements specified in paragraph (1), the person has received five hours of training in the proper procedures to be employed when performing a total protein test using a digital refractometer, including evaluation of specimen acceptability and criteria for rejection of inadequate specimens, and the procedures for recording the test results pursuant to paragraph (9).

(B) Their training in the proper procedure to be employed when performing a total protein test using a digital refractometer has been certified by a moderate complexity laboratory technical consultant as specified in Section 1036.2 of Title 17 of the California Code of Regulations, by a physician and surgeon licensed in this state, or by a licensed clinical laboratory director who is in charge of the licensed plasma collection center.

(C) The instructor documents, and the plasma collection center maintains the documentation of, the individual’s successful completion of training in the performance of the total protein test using a digital refractometer. This documentation shall be made available to the department upon request.

(3) The person performs the total protein test using a digital refractometer under the supervision of one of the following individuals:

(A) A moderate complexity laboratory technical consultant as specified in Section 1036.2 of Title 17 of the California Code of Regulations.

(B) A registered nurse licensed pursuant to Chapter 6 of Division 2.

(C) A physician or surgeon licensed pursuant to Chapter 5 of Division 2.

(D) A clinical laboratory director licensed pursuant to this chapter.

(E) A clinical laboratory scientist licensed pursuant to this chapter.

(4) The supervisor is physically onsite in the licensed plasma collection center and available for consultation during the entire time that the person is processing specimens and performing the test.

(5) The licensed plasma collection center’s supervising physician and surgeon or licensed clinical laboratory director provides a written job description for each employee who performs a total protein test using a digital refractometer that specifies the responsibilities and supervision requirements as specified in this section.

(6) The person performs the total protein test using a digital refractometer in accordance with both of the following:

(A) Standardized operating procedures required by the licensed plasma collection center’s license.

(B) Standardized procedures approved by the licensed plasma collection center’s supervising physician and surgeon or licensed clinical laboratory director for administration of the total protein test by the persons authorized to perform the total protein test pursuant to this section. These standardized procedures shall be made available to the department upon request.

(7) The person does not draw the blood sample required for the test using a procedure that requires a registration, certification, or license under state law unless they are properly registered, certified, or licensed to perform the procedure.

(8) The person’s competency in performing total protein tests using a digital refractometer is evaluated before testing on donors, and every six months thereafter, by the CLIA lab director or technical consultant by direct observation. A licensed plasma collection center shall maintain documentation of the competency evaluation, which shall be made available to the department upon request.

(9) The person accurately records the results of the predonation total protein test in a federal FDA 510k-approved blood establishment computer system (BECS).

(10) For each protein refractometer test system in use at the licensed plasma collection center, the center shall perform control procedures using the number and frequency specified by the manufacturer that meet the requirements of Section 493.1256 of Title 42 of the Code of Federal Regulations and this chapter.

(b) The digital refractometer used to perform a total protein test pursuant to this section shall meet all of the following criteria:

(1) Is used within 30 feet of the donor for whom the test is being conducted.

(2) Is used in accordance with the donor test management system, the quality control program, and the comprehensive quality assurance program established and maintained by the laboratory pursuant to paragraph (2) of subdivision (d) of Section 1220, if applicable to the licensed plasma collection center under federal law.

(3) Performs total protein tests classified as waived or of moderate complexity under CLIA.

(4) Performs total protein tests using a digital refractometer on biological specimens that require manual blood collection, centrifugation to separate the blood cells from the plasma, pipetting the plasma from the cells, and application of the plasma into the refractometer.

(5) Provides total protein test results without calculation or discretionary intervention by the testing personnel.

(6) Performs total protein tests without the necessity for testing personnel to perform calibration or maintenance, except basic cleaning, resetting, and daily standardization pursuant to the manufacturer’s instructions.

(c) To assess the competency and performance of persons authorized to perform the total protein test pursuant to this section, a licensed plasma collection center utilizing this section shall make available to the department any information required by statute or regulation to be collected or maintained by the licensed plasma collection center, and the results of any testing required by statute or regulation to be performed by the licensed plasma collection center, related to assessing the competency and performance of persons using a digital refractometer, as determined by the department. Information obtained pursuant to this subdivision shall be confidential and is not a public record. The department may contract for collection and review of the information required by this subdivision. The contract shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code and shall be exempt from review or approval by any division of the Department of General Services.

(d) Records of digital refractometer test results collected pursuant to paragraph (9) of subdivision (a) shall be maintained for three years and made available to the department upon request.

history: (History: Amended by Stats. 2022, Ch. 429, Sec. 1. (AB 392) Effective January 1, 2023.)

article: 3. Application of the Chapter


citation: BPC § 1247

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

history: (History: Amended by Stats. 1995, Ch. 302, Sec. 1. Effective January 1, 1996.)

article: 3.5. Hemodialysis Training

path: 2. HEALING ARTS > 3. Clinical Laboratory Technology > 3.5. Hemodialysis Training


text:
For the purpose of this article, the following terms have the following meaning:

(a) “Immediate supervision” means supervision of dialysis treatment in the same room in which the dialysis treatment is being performed.

(b) “Department” means the State Department of Public Health.

(c) “Hemodialysis technician” means an unlicensed health care provider who is employed by a hemodialysis clinic or unit for the purpose of participating in the direct treatment of patients undergoing hemodialysis. A hemodialysis technician certified by the state as a person meeting the requirements of Section 1247.61 shall be referred to as a Certified Hemodialysis Technician (CHT).

(d) “Standardized test” means an examination certified by faculty of the University of California to validly and reliably measure the knowledge required to demonstrate competency in the areas being tested.

history: (History: Amended by Stats. 2009, Ch. 559, Sec. 2. (SB 112) Effective October 11, 2009.)

article: 3.5. Hemodialysis Training


text: 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 treatment of patients includes the administration of local anesthetics, heparin, and sodium chloride solutions. The administration of these medications shall be pursuant to protocol established by the medical director of the hemodialysis clinic or unit and shall be under the immediate supervision of a licensed physician and surgeon or a licensed registered nurse. The administration of local anesthetics shall be limited to intradermal, subcutaneous, or topical administration. Hemodialysis technicians who treat patients in the home and are certified by the Board of Nephrology Examination for Nurses and Technicians are exempted from the requirements of immediate supervision until January 1, 1991.

history: (History: Amended by Stats. 1989, Ch. 248, Sec. 2. Effective July 31, 1989.)

article: 3.5. Hemodialysis Training


text: The department may adopt regulations it deems necessary to implement this article.

history: (History: Amended by Stats. 2009, Ch. 559, Sec. 3. (SB 112) Effective October 11, 2009.)

article: 3.5. Hemodialysis Training


text: 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 and testing program. A hemodialysis technician training program and competency test, provided under this section, or provided by an accredited college, an accredited university, or a private training program, shall be approved by the department, shall comply with the regulations adopted pursuant to Section 1247.4, and shall include training and testing in the administration of local anesthetics, heparin, and sodium chloride solutions.

history: (History: Amended by Stats. 1997, Ch. 122, Sec. 1. Effective January 1, 1998.)

article: 3.5. Hemodialysis Training


text:
(a) Except during training under immediate supervision, and except as provided in Section 1247.62, no person shall provide services as a hemodialysis technician without being certified by the department as a Certified Hemodialysis Technician (CHT).

(b) This article does not apply to home dialysis patients, or patient helpers not employed by the licensed facility, who have undergone a home dialysis training program operated by a licensed clinic or hospital as defined in Sections 1204 and 1250 of the Health and Safety Code and have been certified by the medical director of the facility as being competent to perform home dialysis treatment.

history: (History: Amended by Stats. 2009, Ch. 559, Sec. 4. (SB 112) Effective October 11, 2009.)

article: 3.5. Hemodialysis Training


text: 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 whenever involved in the treatment of a patient, as described in Section 1247.3.

history: (History: Added by Stats. 1987, Ch. 1297, Sec. 4.)

article: 3.5. Hemodialysis Training


text: Each hemodialysis unit or clinic shall have information available for inspection by the department survey teams which verifies that the hemodialysis technicians employed at the unit or clinic meet the requirements of Section 1247.61.

history: (History: Amended by Stats. 2009, Ch. 559, Sec. 9. (SB 112) Effective October 11, 2009.)

article: 3.5. Hemodialysis Training


text: 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 to Section 1204 of the Health and Safety Code, or a general acute care hospital, licensed pursuant to Section 1250 of the Health and Safety Code.

history: (History: Amended by Stats. 2009, Ch. 39, Sec. 2. (SB 221) Effective January 1, 2010.)

article: 3.5. Hemodialysis Training


text:
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 diploma or equivalency, or have greater than four years of work experience in dialysis as of October 14, 2008.

(b) Have successfully completed a training program that is approved by the medical director and governing body of a hemodialysis clinic or unit, under the direction of a registered nurse. Following approval by the medical director and governing body, the training program shall be submitted to the department for approval. The training program shall be approved by the department prior to implementation. The training program shall focus on the operation of kidney dialysis equipment and machines, providing direct patient care, and communication and interpersonal skills, including patient sensitivity training and care of difficult patients. For purposes of this subdivision, a person “successfully completes a training program” if he or she completes all didactic portions of the program and demonstrates competency in the knowledge and skills provided by the program.

(1) The training program shall include all of the following subjects, at a minimum:

(A) Principles of dialysis.

(B) Care of patients with kidney failure, including interpersonal skills.

(C) Dialysis procedures and documentation, including initiation, proper cannulation techniques, monitoring, and termination of dialysis.

(D) Possible complications of dialysis.

(E) Water treatment and dialysate preparation.

(F) Infection control.

(G) Safety.

(H) Dialyzer reprocessing, if applicable.

(2) A community or corporate-based training program, or a training program offered by an educational institution, is acceptable if the program meets the requirements of this subdivision.

(3) A person employed as a hemodialysis technician by a hemodialysis clinic or unit for more than two years as of October 14, 2008, who does not have documentation of having successfully completed a training program meeting the requirements of this subdivision, shall be deemed to be in compliance with this subdivision by doing both of the following:

(A) Passing a written exam, offered by a hemodialysis clinic or unit, or a community or corporate-based training program that meets the requirements of this chapter, covering the subjects listed in paragraph (1).

(B) Passing a skills checklist through observation by a registered nurse of the skills listed in paragraph (1).

(c) Successfully accomplish either of the following:

(1) Pass a standardized test that is approved by the department and that covers the subjects listed in paragraph (1) of subdivision (b) and in Section 1247.5. This test shall be administered in a proctored environment by an independent examiner. For purposes of this subdivision, independent examiners may include representatives appointed by End-Stage Renal Disease Network 17, End-Stage Renal Disease Network 18, the California Dialysis Council, or any private testing organization approved by the department for that purpose.

(2) Successfully pass an examination offered by a national, commercially available certification program for hemodialysis technicians which is approved for this purpose by the Centers for Medicare and Medicaid Services.

(d) (1) No later than July 1, 2019, the department shall require an applicant to provide either the individual taxpayer identification number or social security number for purposes of applying for or the renewal of a certificate issued under this section or regulations promulgated pursuant thereto.

(2) If the department utilizes a national examination to issue a certificate, and if a reciprocity agreement or comity exists between the State of California and the state requesting release of the individual taxpayer identification number or social security number, any deputy, agent, clerk, officer, or employee of the department may release an individual’s taxpayer identification number or social security number to an examination or certifying entity only for the purpose of verification of certification or examination status.

(3) The individual taxpayer identification number or the social security number shall serve to establish the identification of persons affected by state tax laws and for purposes of establishing compliance with subsection (a) of Section 666 of Title 42 of the United States Code, Section 60.15 of Title 45 of the Code of Federal Regulations, Section 17520 of the Family Code, and Section 11105 of the Penal Code, and to that end, the information furnished pursuant to this section shall be used exclusively for those purposes.

(4) The department shall not do either of the following:

(A) Require an applicant to disclose citizenship status or immigration status for purposes of the application or renewal of a certificate.

(B) Deny certification to an applicant based solely on his or her citizenship status or immigration status.

history: (History: Amended by Stats. 2018, Ch. 838, Sec. 3. (SB 695) Effective January 1, 2019.)

article: 3.5. Hemodialysis Training


text:
(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 certified hemodialysis technician applying for renewal of his or her certification shall submit proof that he or she has obtained 30 hours of in-service training or continuing education in dialysis care or general health care as a requirement for the renewal of his or her certification.

(c) An expired certification may be renewed at any time within two years after its expiration on the filing of an application for renewal and documentation of the required in-service education.

history: (History: Amended by Stats. 2009, Ch. 559, Sec. 7. (SB 112) Effective October 11, 2009.)

article: 3.5. Hemodialysis Training


text:
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 following sources:

(a) Health-related courses offered by accredited postsecondary institutions.

(b) Health-related courses offered by continuing education providers approved by the California Board of Registered Nursing.

(c) Health-related courses offered by recognized health associations if the department determines the courses to be acceptable.

(d) Health-related, employer-sponsored in-service training or continuing education programs.

history: (History: Amended by Stats. 2009, Ch. 559, Sec. 8. (SB 112) Effective October 11, 2009.)

article: 3.5. Hemodialysis Training


text:
(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 regulations adopted by the department to administer this article.

(b) The department may deny, suspend, or revoke the certification of a hemodialysis technician for any of the following causes:

(1) Unprofessional conduct, which includes incompetence or gross negligence in carrying out his or her usual functions.

(2) Procuring a certificate by fraud, misrepresentation, or mistake.

(3) Making or giving any false statement or information in conjunction with the application for issuance or renewal of a certificate.

(4) Conviction of a crime substantially related to the qualifications, functions, and duties of a hemodialysis technician in which event the record of the conviction shall be conclusive evidence thereof.

(c) In addition to other acts constituting unprofessional conduct within the meaning of this article, all of the following constitute unprofessional conduct:

(1) Conviction for, or use of, any narcotic drug, as defined in Division 10 (commencing with Section 11000) of the Health and Safety Code, or any dangerous drug, as defined in Article 7 (commencing with Section 4211) of Chapter 9, or alcoholic beverages, to an extent or in a manner dangerous or injurious to the hemodialysis technician or any other person, or the public, to the extent that this use impairs the ability to conduct, with safety to the public, the practice of a hemodialysis technician.

(2) Abuse, whether verbal, physical, or mental, of a patient in any setting where health care is being rendered.

(d) Proceedings to deny, suspend, or revoke a certification under this article shall be conducted in accordance with Section 100171 of the Health and Safety Code.

history: (History: Amended by Stats. 1999, Ch. 979, Sec. 4. Effective January 1, 2000.)

article: 3.5. Hemodialysis Training


citation: BPC § 1260

text: 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 degree as determined by the department with a major in chemical, physical, biological, or clinical laboratory sciences. This education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the department. The applicant also shall have a minimum of four years’ experience as a clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory certified under CLIA. The quality and variety of this experience shall be satisfactory to the department and shall have been obtained within the six-year period immediately antecedent to admission to the examination. The applicant shall successfully pass a written examination and an oral examination conducted by the department or a committee designated by the department to conduct the examinations, indicating that the applicant is properly qualified. The department may issue a license without conducting a written examination to an applicant who has passed a written examination of a national accrediting board having requirements that are, in the determination of the department, equal to or greater than those required by this chapter and regulations adopted by the department. The department shall establish by regulation the required courses to be included in the college or university training.

history: (History: Amended by Stats. 2015, Ch. 341, Sec. 3. (AB 940) Effective January 1, 2016.)

article: 4. Licensing

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


text: The department shall issue a histocompatibility laboratory director’s license to each person who meets the qualifications specified in Section 1209.1.

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

article: 4. Licensing


text:
(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 any reasonable qualifications established by regulations of the department, including, but not limited to, any of the following:

(A) Lawfully holds an associate degree or an equivalent or higher degree in chemical, physical, biological, or clinical laboratory science, which includes a minimum of 36 semester units of physical or biological sciences.

(B) The completion of 60 semester (90 quarter) units from an accredited college or university, with 36 semester units in physical or biological sciences.

(C) Graduation from a medical laboratory technician training program accredited by the National Accrediting Agency for Clinical Laboratory Sciences or other recognized accrediting program approved by the department.

(D) Graduation from an advanced military medical laboratory specialist program approved by the department.

(2) Has applied for the license on forms provided by the department.

(3) Has paid a license fee established in regulations of the department in accordance with subdivision (q) of Section 1300.

(b) A licensed medical laboratory technician may perform clinical laboratory tests or examinations classified as waived or of moderate complexity under CLIA, but not high complexity, and may report the test results. However, a licensed medical laboratory technician shall not perform microscopic analysis or immunohematology procedures, except for blood smear reviews other than manual leukocyte differentials, microscopic urinalysis, and blood typing of moderate complexity such as automated ABO/Rh testing and antibody screen testing. The medical laboratory technician shall work under the supervision of a licensed physician and surgeon or a baccalaureate, masters, or doctoral level person licensed pursuant to this chapter. The supervision shall be required during the entire time a medical laboratory technician performs clinical laboratory tests or examinations.

history: (History: Amended by Stats. 2018, Ch. 235, Sec. 1. (AB 2281) Effective January 1, 2019.)

article: 4. Licensing


citation: BPC § 1261

text:
(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 of a baccalaureate or an equivalent or higher degree, who has applied for the license on forms provided by the department and has met the requirements of this chapter and any reasonable qualifications established by regulations of the department. However, an exception to the degree requirement may be made by the department for the clinical laboratory scientist’s license only if the applicant for the license has completed a minimum of two years of experience as a licensed trainee or the equivalent thereof, as determined by the department, doing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the department. In addition, the applicant applying under this section must have 90 semester hours or equivalent quarter hours of university or college work or the equivalent thereof, as may be determined by the department, which shall have included at least 23 semester hours or equivalent quarter hours of science courses as specified by regulations of the department. Additional college or university work that includes courses in the fundamental sciences may be substituted for one of the two years of experience in the ratio of 30 semester hours or equivalent quarter hours for each year of experience. This exception shall not apply to the limited clinical laboratory scientist’s license. The department shall hold examinations to aid it in judging the qualifications of applicants. Licenses may be issued in any or all of the sciences applied in a clinical laboratory as determined by regulation established by the department. The department shall establish by regulation the college courses or majors to be included in the college or university training and the amount and kind of training or experience required. Examinations, training, or experience requirements for limited licenses shall cover only the science concerned. The department may identify by regulation the appropriate sciences and shall establish the minimum requirements for training and experience and required courses or major for each.

(2) Prior to the adoption of implementing regulations and notwithstanding subdivision (c) of Section 1261.5, the department shall issue a clinical reproductive biologist scientist license to every applicant for licensure who has applied for the license on forms provided by the department, who holds a baccalaureate or an equivalent or higher degree in a chemical, physical, or biological science or clinical laboratory science, who is certified as an andrology laboratory scientist, an embryology laboratory scientist, or a technical supervisor of andrology or embryology by a certifying board in the specialty of reproductive biology, clinical andrology, or clinical embryology approved by the department, and who meets the qualifications of training, education, and experience specified in Section 1261.5.

(3) Prior to the adoption of implementing regulations and notwithstanding subdivision (c) of Section 1261.5, the department shall issue a clinical laboratory geneticist scientist license to every applicant for licensure who has applied for the license on forms provided by the department, who holds a baccalaureate or an equivalent or higher degree in a chemical, physical, or biological science, clinical laboratory science, or a field related to genetics, who is certified in biochemical genetics or laboratory genetics and genomics by a certifying board in the specialty of genetics approved by the department, and who meets the qualifications of training, education, and experience specified in Section 1261.5.

(4) Experience as a clinical laboratory technician in any branch of the Armed Forces of the United States may be considered equivalent to the experience as a trainee, if the experience is approved by the department. Each year of training and experience as a clinical laboratory technician in the armed forces shall be equivalent to 15 semester hours, which shall be credited to the minimum number of hours required to qualify for licensure as a trainee. The semester hours acquired in this manner shall not consist of the science courses required by the department under this section. The maximum number of hours granted shall not exceed 60 semester hours or its equivalent.

(b) (1) Notwithstanding subdivision (a), the department shall establish an “MLT-to-CLS” pathway program by January 1, 2022, that would authorize a licensed MLT to apply their work experience and training from a department-approved MLT training program towards the completion of a CLS training program. The work experience and training may only be eligible for the pathway program upon approval by the department.

(2) For purposes of this subdivision:

(A) “CLS” means a clinical laboratory scientist.

(B) “MLT” means a medical laboratory technician.

history: (History: Amended by Stats. 2022, Ch. 473, Sec. 7. (SB 1267) Effective January 1, 2023.)

article: 4. Licensing


text:
(a) The department may issue limited clinical laboratory scientist’s licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, genetic molecular biology, cytogenetics, laboratory genetics, reproductive biology, or other areas of laboratory specialty or subspecialty when determined to be necessary by the department in order for licensure categories to keep abreast of changes in laboratory or scientific technology. Whenever the department determines that a new limited clinical laboratory scientist license category is necessary, it shall adopt regulations identifying the category and the areas of specialization included within the category.

(b) To qualify for admission to the examination for a special clinical laboratory scientist’s license, an applicant shall have both the following:

(1) Graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate or higher degree with a major appropriate to the field for which a license is being sought.

(2) One year of full-time postgraduate training or experience in the various areas of analysis in the field for which a license is being sought in a laboratory that has a license issued under this chapter or which the department determines is equivalent thereto.

(c) Whenever a limited clinical laboratory scientist’s license is established for a specific area of specialization, the department may issue the license without examination to applicants who had met standards of education and training, defined by regulations, and to applicants certified by a board approved for that certification by the department, prior to the date of the adoption of implementing regulations.

(d) The department shall adopt regulations to implement this section.

history: (History: Amended by Stats. 2022, Ch. 473, Sec. 8. (SB 1267) Effective January 1, 2023.)

article: 4. Licensing


text: 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 this state as a cytogenetic technologist who provides evidence of satisfactory performance on a written examination administered by the National Credentialing Agency for Laboratory Personnel on or before December 31, 1991, in the specialty of cytogenetics, and who meets the federal regulatory requirements for personnel performing high-complexity testing.

history: (History: Added by Stats. 2004, Ch. 807, Sec. 1. Effective January 1, 2005.)

article: 4. Licensing


citation: BPC § 1262

text: 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 clinical laboratory scientist’s license or a temporary limited clinical laboratory scientist’s license may be issued to an individual who fulfills the requirements for admission to the examination unless the individual has failed a previous examination for the license. The department may issue licenses without examination to applicants who have passed examinations of the national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The department may issue licenses without further examination to applicants who have passed examinations of another state whose laws and regulations are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of national or state accrediting boards for the purposes of this chapter shall be carried out by the department with assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by a national board or another state examination prior to the establishment of requirements that are equal to or exceed those of this chapter or the regulations of the department. The department may, however, make exceptions if individuals are otherwise qualified.

history: (History: Amended by Stats. 2003, Ch. 319, Sec. 3. Effective January 1, 2004.)

article: 4. Licensing


text: Notwithstanding Section 135, an applicant for a clinical laboratory or limited technologist license who fails to pass the written examination two times shall not be eligible to be reexamined a third time until at least one year has elapsed from the date of the second examination. An applicant who fails the third examination shall not be eligible to take the examination a fourth time until two years have elapsed from the date of the third examination. Thereafter, the examination may not be taken more frequently than once in two years.

history: (History: Added by Stats. 1985, Ch. 805, Sec. 1.)

article: 4. Licensing


citation: BPC § 1263

text:
The department shall license as trainees those individuals desiring to train for either a clinical laboratory scientist’s license or a limited clinical laboratory scientist’s license, providing those individuals meet the academic requirements.

No trainee license shall be issued unless the applicant has completed at least 90 semester hours or equivalent quarter hours of university or college work or the essential equivalent as determined by the department which must have included at least 23 semester hours or equivalent quarter hours of courses in the sciences as determined by regulations of the department. Applicants who have completed military training schools may be granted academic credit toward licensure by the department on the basis of recommendations made by the American Council on Education.

Applicants shall apply for the license on forms provided by the department and meet the requirements of this chapter and any standards as are established by regulations of the department.

history: (History: Amended by Stats. 1995, Ch. 510, Sec. 28. Effective January 1, 1996.)

article: 4. Licensing


citation: BPC § 1264

text:
(a) (1) The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical genetic molecular biologist, clinical laboratory geneticist, clinical reproductive biologist, or clinical cytogeneticist license to each person who has applied for the license on forms provided by the department, who is a lawful holder of a master of science or doctoral degree in the specialty for which the applicant is seeking a license, and who has met the additional reasonable qualifications of training, education, and experience as the department may establish by regulations.

(2) The department shall issue a clinical reproductive biologist license to an applicant for licensure who has applied for the license on forms provided by the department, who holds a master of science degree in a chemical, physical, or biological science or clinical laboratory science, who was board certified as a Reproductive Biology Laboratory Director, Andrology Laboratory Director, Embryology Laboratory Director, or High-Complexity Clinical Laboratory Director by the American Board of Bioanalysis before July 1, 2020, who has passed an oral and written examination conducted by the department or a committee designated by the department to conduct the examination, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulations.

(3) Prior to the adoption of implementing regulations and notwithstanding subdivision (c), the department shall issue a clinical reproductive biologist license to an applicant for licensure who meets each of the following:

(A) Has applied for the license on forms provided by the department.

(B) Holds a master of science in a chemical, physical, or biological science or clinical laboratory science, and was board certified as a Reproductive Biology Laboratory Director, Andrology Laboratory Director, Embryology Laboratory Director, or High-Complexity Clinical Laboratory Director by the American Board of Bioanalysis before July 1, 2020, or holds a doctoral degree in a chemical, physical, or biological science or clinical laboratory science and is board certified as a Reproductive Biology Laboratory Director, Embryology Laboratory Director, or High-Complexity Clinical Laboratory Director by the American Board of Bioanalysis or other certifying board in clinical reproductive biology, clinical andrology, or clinical embryology approved by the department.

(C) Has passed an oral and written examination conducted by the department or a committee designated by the department to conduct the examination.

(D) Meets the qualifications of training, education, and experience specified in subdivision (b).

(4) Prior to the adoption of implementing regulations and notwithstanding subdivision (c), the department shall issue a clinical laboratory geneticist license to an applicant who meets each of the following:

(A) Has applied for the license on forms provided by the department.

(B) Holds a doctoral degree in a chemical, physical, or biological science, clinical laboratory science, or a field related to genetics.

(C) Is certified as a diplomate in laboratory genetics and genomics or clinical biochemical genetics by the American Board of Medical Genetics and Genomics or other certifying board in the specialty of genetics approved by the department.

(D) Has passed an oral and written examination conducted by the department or a committee designated by the department to conduct the examination.

(E) Meets the qualifications of training, education, and experience specified in subdivision (b).

(5) The department shall issue an oral and maxillofacial pathologist license to every applicant for licensure who has applied for the license on forms provided by the department, who is a registered Diplomate of the American Board of Oral and Maxillofacial Pathology, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulation.

(b) The graduate education shall have included 30 semester hours of coursework in the applicant’s specialty. Applicants possessing only a master of science degree shall have the equivalent of one year of full-time, directed study or training in procedures and principles involved in the development, modification, or evaluation of laboratory methods, including training in complex methods applicable to diagnostic laboratory work. Each applicant shall have had one year of training in their specialty in a clinical laboratory acceptable to the department and three years of experience in their specialty in a clinical laboratory, two years of which must have been at a supervisory level. The education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by an agency acceptable to the department. The department shall determine by oral and written examination conducted by the department, or a committee designated by the department, that the applicant is properly qualified. Examinations, training, or experience requirements for specialty licenses shall cover only the specialty concerned.

(c) The department may issue licenses without examination to applicants who have passed examinations of other states or national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of other state requirements or requirements of national accrediting boards shall be carried out by the department with the assistance of representatives from the licensed groups. This section does not apply to persons who have passed an examination by another state or national accrediting board before the establishment of requirements that are equal to or exceed those of this chapter or regulations of the department.

(d) The department may issue licenses without examination to applicants who had met standards of education and training, defined by regulations, before the date of the adoption of implementing regulations.

(e) The department shall adopt regulations to conform to this section.

history: (History: Amended by Stats. 2022, Ch. 473, Sec. 9. (SB 1267) Effective January 1, 2023.)

article: 4. Licensing