Cal. Code Regs. Tit. 17, § 1029 - General Definitions

"Accreditation body" means an approved accreditation organization for laboratories, as defined in section 493.2 of title 42, Code of Federal Regulations.

"Accredited college or university" means an educational institution accredited by the Middle States Commission on Higher Education, the New England Association of Schools and Colleges Commission on Institutions of Higher Education, the North Central Association of Colleges and Schools Higher Learning Commission, the Northwest Commission on Colleges and Universities, the Southern Association of Colleges and Schools Commission on Colleges, the Western Association of Schools and Colleges Accrediting Commission for Community and Junior Colleges, or the Western Association of Schools and Colleges Senior Colleges and University Commission. A degree from a non-United States college or university that is not accredited by one of these accreditation associations shall be evaluated for comparability by a current member of the National Association of Credential Evaluation Services or endorsed member of the Association of International Credential Evaluators, Inc., or another organization approved by the Department.

"Accredited institution" has the same meaning as given in section 493.2 of title 42, Code of Federal Regulations.

"Accusation" means a written statement filed in order to initiate a hearing to determine whether a right, authority, license, or privilege should be revoked, suspended, limited, or conditioned, and which:

(a) Sets forth in ordinary and concise language the acts or omissions with which a person, entity, or laboratory and its owners or directors are charged with committing to the end that the person, entity, or laboratory and its owners or directors will be able to prepare a defense; and

(b) Specifies the statutes and regulations alleged to have been violated.

"Alternative sanction" means one or more of the following sanctions:

(a) Directed plan of correction;

(b) Civil money penalty; or

(c) On-site monitoring.

"Antibody" means an immunoglobulin molecule that, due to its specific amino acid sequence, reacts to the antigen that induced its synthesis in the cells of the lymphoid series.

"Antigen" means any viral component including, but not limited to, proteins and nucleic acids.

"Approved public health laboratory" means a laboratory that has been issued a certificate of approval by the Department after its determination that the public health laboratory, as defined in Business and Professions Code section 1206(a)(11), is in conformity with chapter 7 (commencing with section 1000) of part 2 of division 1 of the Health and Safety Code and the regulations adopted thereunder.

"Arterial puncture" means the penetration of an artery with a needle to withdraw blood for clinical laboratory test or examination purposes.

"Certified phlebotomy technician I" means a person who has completed the education, training, experience and examination requirements pursuant to Section 1034 and is certified by the department to perform skin punctures and venipunctures.

"Certified phlebotomy technician II" means a person who has completed education, training, experience and examination requirements pursuant to Section 1034 and is certified by the department to perform skin punctures, venipunctures and arterial punctures.

"Certifying organization," also called a national accreditation or accrediting board or agency, means an organization, agency, or body that creates competency examinations that measure the skill, knowledge, and aptitude required of a person in a profession, occupation, or discipline.

Chapter 3 " means chapter 3 (commencing with section 1200) of division 2 of the Business and Professions Code.

"Civil money penalties" means the civil money penalties imposed by the Department under the procedures identified in section 1067.5.

"CLIA" or "Clinical Laboratory Improvements Amendments" shall have the meaning as specified in section 1202.5 of the Business and Professions Code.

"CLIA certificate" means an unsuspended and unrevoked certificate of compliance, certificate for provider-performed microscopy procedures, certificate of accreditation, certificate of registration, or certificate of waiver, as defined in section 493.2 of title 42, Code of Federal Regulations.

"CLIA exempt status" means that the United States Department of Health and Human Services (HHS) has exempted clinical laboratories licensed, registered, or otherwise approved by the Department from the requirements of CLIA pursuant to subsection (p) of section 263 a of title 42, United States Code and section 493.513 of title 42, Code of Federal Regulations.

"Clinical consultant" means a person who meets the requirements of section 493.1455 of title 42, Code of Federal Regulations, as published October 1, 1994, and who provides clinical consultation of a laboratory in accordance with section 1036 of this title and section 493.1457 of title 42, Code of Federal Regulations, as published October 1, 1994.

"Clinical cytogenetics" means the techniques used to isolate, replicate, and identify whole or parts of human chromosomes including culturing, manipulation, banding, staining, hybridizing, and analysis with respect to genotype and phenotype.

"Clinical genetic molecular biology" means the determination of all the aspects of molecular organizations of the nucleic acids of the human genome with respect to genotype and phenotype.

"Clinical laboratory practice" has the meaning set forth in section 1206(a)(7) of the Business and Professions Code. It shall include all activities that support clinical laboratory science, such as collecting and processing biological specimens, solving technical or instrument problems, providing general and technical supervision and consultation, reviewing quality control data, developing test methods, performing and reporting tests, and other activities defined in the work scope of the license category.

"Condition level deficiency" means noncompliance with one or more condition level requirements.

"Condition level requirement" means any of the requirements specified in section 1066.

"Department" means the California Department of Public Health.

"Deficiency" or "Violation" means noncompliance with one or more of the requirements in chapter 3, division 2 of the Business and Professions Code (commencing with section 1200) or any rule or regulation adopted thereunder.

"Direct and constant supervision," as defined in section 1206 of the Business and Professions Code, means personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the unlicensed laboratory personnel are engaged in the duties specified in section 1269.

"Direct and responsible supervision," as defined in section 1206 of the Business and Professions Code, means both:

(a) Personal observation and critical evaluation of the activity of a trainee by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the trainee is performing clinical laboratory tests or examinations; and

(b) Personal review by the physician and surgeon or the licensed person of all results of clinical laboratory testing or examination performed by the trainee for accuracy, reliability, and validity before the results are reported from the laboratory.

"Direct patient care" means medical, psychiatric, nursing, or other health care that is legally provided by a care giver or healthcare provider directly to a patient, and that includes observation of the patient's physical or mental condition to enable the care giver or healthcare provider to report changes in the patient's condition.

"Direct supervision," as defined in section 1269.3 of the Business and Professions Code, means that, for the purposes of section 1269.3, subdivision (b), a qualified pathologist shall be physically present on-site in the vicinity of the clinical laboratory where the specialty of pathology is performed and shall be available for consultation and direction during the time the personnel specified in subdivision (b) are engaged in the processing of specimens that involve dissection. For tissue processing that does not involve dissection, a qualified pathologist may be available by telephone or other electronic means.

"Directed plans of correction" means the directed plans of correction imposed by the Department under the procedures identified in section 1067.

"Electrolytes" means ionized calcium, sodium, potassium, and/or chloride.

"Evidence of satisfactory performance" means a copy of a document issued to an examinee by the Department for satisfactory performance on a Department-administered licensing examination, or by a certifying board or organization indicating satisfactory performance by the examinee on a written certifying examination approved by the Department for a license or certificate category.

"Field related to genetics" means a field of study such as biochemical genetics, biochemistry, biology, biomedical engineering, biotechnology, clinical cytogenetics and genomics, clinical genetics and genomics, clinical laboratory science, clinical molecular genetics and genomics, human genetics and genomics, medical genetics, molecular biology, molecular and cellular biology, molecular genetics and genomics, and reproductive biology; coursework may include such courses as biochemistry, bioinformatics, biology, cell biology, developmental biology, developmental genetics, evolutionary genetics, gene expression, gene mapping, genetic analysis, human genetics, inherited disease, inorganic chemistry, molecular genetics, organic chemistry, or population genetics.

"General supervisor" means a person who meets the requirements of section 493.1461 of title 42, Code of Federal Regulations, as published October 1, 1994, and who provides general supervision of a laboratory in accordance with section 1036.1 of this title and section 493.1463 of title 42, Code of Federal Regulations, as published October 1, 1994.

"HHS" means the federal Department of Health and Human Services, or its designee.

"High complexity tests or examinations" mean those clinical laboratory tests or examinations classified as high complexity under CLIA.

"Human Immunodeficiency Virus" or "HIV" means the etiologic virus of Acquired Immune Deficiency Syndrome, or AIDS.

"Immediate jeopardy" means a situation in which immediate corrective action is necessary because the laboratory's noncompliance with one or more conditions has caused, or is likely to cause, serious injury or death to a person served by the laboratory or to the health or safety of the general public.

"Instrument" means a device, apparatus, implement, machine, or contrivance that is used for the performance of a clinical laboratory test or examination.

"Intermediate sanction" means either or both:

(a) Temporary suspension of a license, registration, or approval; or

(b) Temporary suspension of a provider of service under the Medi-Cal program.

"License," for the purposes of this chapter, means license, certificate, registration, or other means to engage in a business or profession regulated by Chapter 3.

"Licensed general acute care hospital" means a facility as defined in section 1250(a) of the Health and Safety Code that has been licensed pursuant to chapter 2 (commencing with section 1250) of division 2 of the Health and Safety Code.

"Licensed surgical clinic" means a facility as defined in section 1204(b)(1) of the Health and Safety Code that has been licensed pursuant to chapter 1 (commencing with section 1200) of division 2 of the Health and Safety Code.

"Limited phlebotomy technician" means a person who has completed the education, training and experience requirements pursuant to Section 1034 and is certified by the department to perform skin punctures.

"Medical laboratory technician" means a person who has completed education, training or experience, and examination requirements pursuant to Section 1032.5(a), and who is authorized to perform clinical laboratory tests and examinations specified in Section 1032.5(b).

"Moderate complexity laboratory technical consultant" means a person who meets the qualifications of section 493.1411 of title 42, Code of Federal Regulations, as published October 1, 1994, and who provides technical oversight in accordance with section 1036.2 of this title and section 493.1413 of title 42, Code of Federal Regulations, as published October 1, 1994.

"Moderate complexity tests or examinations" mean those clinical laboratory tests or examinations classified as moderate complexity under CLIA.

"Notice of Defense" means a document signed by or on behalf of the person, entity, or laboratory, that states the mailing address of the person, entity, or laboratory, and may:

(a) Request a hearing.

(b) Object to the accusation upon the ground that it does not state acts or omissions upon which the agency may proceed.

(c) Object to the form of the accusation on the ground that it is so indefinite or uncertain that the person, entity, or laboratory cannot identify the transaction or prepare a defense.

(d) Admit the accusation in whole or in part.

(e) Present new matter by way of defense.

(f) Object to the accusation upon the ground that, under the circumstances, compliance with the requirements of a regulation would result in material violation of another regulation enacted by another department affecting substantive rights.

"Official school transcript" means a copy of a student's permanent academic record issued by a school, college, or university identifying the student and attesting to the student's completion of specific courses with grades, credit hours, dates of attendance, academic major(s), degree or diploma granted, if any, including date of graduation, and any awards or honors. The hard copy official school transcript shall bear an official seal, unique identifier of the school, or signature of the registrar, dean, or other authorized official. An official transcript shall be received by the Department

(a) Directly from the school, college, or university registrar, dean, or other person responsible for issuing transcripts in a sealed envelope that bears a tamper-proof mark or seal attached by the school; or

(b) By secure electronic submission directly from the school, college, or university registrar, dean, or other person responsible for issuing transcripts.

"On-site monitoring" means the on-site monitoring imposed by the Department under the procedures identified in section 1067.10.

"On-the-job experience in phlebotomy" means employment as a phlebotomist in a clinical laboratory performing the techniques pursuant to Section 1035.1(f).

"Oral and maxillofacial pathology laboratory director" means a dentist who possesses a valid, unexpired California license to direct an oral pathology laboratory in all areas of anatomic and clinical pathology related to the oral and maxillofacial region.

"Oral pathology" means the subspecialty of pathology that deals with the nature, identification, and management of diseases affecting the oral and maxillofacial regions, investigates the causes, processes, and effects of these diseases, and includes research and diagnosis of diseases using clinical, radiographic, microscopic, biochemical, or other examinations.

"Patient" means a person who is an inpatient or outpatient of a licensed health facility, licensed clinic, clinic that is exempt from licensure, or licensed home health agency, or a person who is under the care of a licensed physician and surgeon or osteopath, licensed dentist, or licensed podiatrist.

"Phlebotomist" means a person who collects blood for clinical laboratory tests or examination purposes.

"Phlebotomy" means the process of collecting blood by venipuncture, arterial puncture, or skin puncture for the purpose of obtaining blood for clinical laboratory test or examination purposes.

"Practical experience" means hands-on, direct work experience in clinical laboratory science and phlebotomy techniques on real patients in a clinical laboratory certified by CLIA, using equipment, instruments, kits, and materials routinely found in clinical laboratories performing moderate or high complexity tests or examinations, and does not include work done in academic, research, forensic, pharmaceutical, or veterinary laboratories.

"Preceptor" means:

(a) The laboratory director or the technical consultant of the laboratory, as that term is defined under CLIA; or

(b) A person who:

(1) Meets the qualifications of a technical consultant under CLIA and of Chapter 3 to perform clinical laboratory tests or examinations classified as moderate complexity; and

(2) Is assigned by the laboratory director or the technical consultant of the laboratory to act as a preceptor; or

(c) Any person listed in subdivision (b) of section 1206.5 of the Business and Professions Code, except for those persons listed in subsections (10), (11), or (12) of subdivision (b), and who:

(1) Has two years of experience performing moderate complexity tests upon the instrument(s) for which she or he will act as a preceptor; and

(2) Meets any CLIA requirements necessary to perform his or her duties and responsibilities in a preceptor program; and

(3) Is assigned by the laboratory director or the technical consultant of the laboratory to act as a preceptor.

"Principal sanction" means:

(a) Suspension or revocation of a registration or license issued under chapter 3 of division 2 of the Business and Professions Code; or

(b) Suspension or revocation of the approval to operate a public health laboratory granted under chapter 7 (commencing with section 1000) of the Health and Safety Code; or

(c) Suspension of a provider of service from further participation in, including reimbursement from, the Medi-Cal and Medicaid programs.

"Provider of service" has the same meaning as given in section of title 2251051 of title 22 of the California Code of Regulations.

"Respiratory care practitioner" means a person licensed pursuant to chapter 8.3 (commencing with section 3700) of division 2 of the Business and Professions Code.

"Satisfactory performance" means achieving at least the minimum grade an examinee must obtain to receive a passing score on a written or oral examination.

"Skin puncture" means penetration of the skin for the purpose of collecting capillary blood for a clinical laboratory test or examination purposes.

"Specimen" has the same meaning as given for "biological specimen" in section 1206(a)(1) of the Business and Professions Code.

"State license" means the license identified in section 1265(a)(1) of the Business and Professions Code.

"State registration" or "registration" means the registration identified in section 1265(a)(2) of the Business and Professions Code.

"Statement of issues" means a written statement served on a person, entity, or laboratory that:

(a) Specifies the statutes and regulations with which the person, entity, or laboratory must show compliance by producing proof at the hearing, and

(b) Includes any particular matters that have come to the attention of the Department that could form the basis for a denial of the departmental action sought.

"Subspecialty of histocompatibility" means those clinical laboratory analyses of factors that determine the acceptance or rejection of grafted tissues or organs and that are performed in a histocompatibility laboratory as specified in section 493.1278 of title 42, Code of Federal Regulations, as published October 1, 1994.

"Technical supervisor" means a person who meets the qualifications of section 493.1449 of title 42, Code of Federal Regulations, as published October 1, 1994, and who provides technical supervision in accordance with section 1036.4 of this title and section 493.1451 of title 42, Code of Federal Regulations, as published October 1, 1994.

"Temporary suspension of a license, registration, or approval" means immediate suspension or limitation of a public health laboratory's approval to perform testing or a clinical laboratory's license or registration to perform tests or examinations in one or more, or all, specialties or subspecialties, prior to a hearing, based on a departmental finding of immediate jeopardy.

"Temporary suspension of a provider of service under the Medi-Cal program" means the immediate suspension imposed by the Department pursuant to section of title 2251529(g) of title 22 of the California Code of Regulations under the procedures identified in section 1067.15.

"Test purposes," as it relates to arterial puncture, venipuncture, and skin puncture, means withdrawal or injection of any test materials specifically required for a clinical laboratory test, provided that appropriate instructions relative to injection technique have been given and that a licensed physician and surgeon is immediately available when test materials are injected. Unlicensed personnel may not inject test material for any purpose.

"Testing event" means the performance of the pre-analytical, analytical, and post-analytical activities related to performing a clinical laboratory test or examination on a biological specimen.

"Unprofessional conduct," pursuant to the provisions of section 1320(m) of the Business and Professions Code, means:

(a) Acts of gross negligence in the performance of duties authorized by the license under chapter 3, division 2, Business and Professions Code;

(b) Acts of gross incompetence in the performance of duties authorized by the license under chapter 3, division 2, Business and Professions Code.

"Venipuncture" means the penetration of a vein with a needle to withdraw blood for clinical laboratory test or examination purposes.

"Waived laboratory technical supervisor," also called "waived laboratory technical consultant," means a person who meets the qualifications specified in section 1036.3(a) or (c) and provides technical oversight of a laboratory that performs only waived tests.

"Waived tests" mean those clinical laboratory tests or examinations classified as waived under CLIA.

Notes

Cal. Code Regs. Tit. 17, § 1029

1. Renumbering of former sections 1029-5 - 1029.197 to new section 1029 filed 11-12-2020; operative 1-1-2021 (Register 2020, No. 46). For prior history, see Register 97, No. 16.
2. Change without regulatory effect renumbering former sections 1029.32, 1029.33, 1029.53, 1029.116, 1029.117 and 1029.124 into section 1029 and changing "on site" to "on-site" throughout filed 9-16-2022 pursuant to section 100, title 1, California Code of Regulations (Register 2022, No. 37).

Note: Authority cited: Sections 1208 and 1224, Business and Professions Code; Sections 100275 and 131200, Health and Safety Code; Stats. 1995, c. 510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Sections 23.7, 1202.5, 1203, 1204, 1205, 1206, 1206.5, 1207, 1208, 1209, 1209.1, 1210, 1212, 1213, 1220, 1222, 1222.5, 1223, 1224, 1225, 1227, 1241, 1242, 1242.5, 1242.6, 1243, 1244, 1246, 1246.5, 1260, 1260.1, 1260.3, 1261, 1261.5, 1262, 1263, 1264, 1265, 1267, 1269, 1269.3, 1269.5, 1270, 1275, 1280, 1281, 1282, 1285, 1286, 1288, 1288.5, 1289, 1300, 1301, 1301.1, 1310, 1320, 1322, 1323, 1324, 1325 and 1326, Business and Professions Code; Sections 1002, 120580, 120775, 131050, 131051 and 131052, Health and Safety Code; Section 14123, Welfare and Institutions Code; Sections 11503 and 11504, Government Code; Stats. 1995, c.510, Section 1; Stats. 1995, c. 510 (SB 113) Section 1(a)(6); 42 United States Code, Section 1395w-2 (Section 1846 of the federal Social Security Act); and 42 United States Code, Section 1396a(a)(9) (Section 1902(a)(9)(C) of the federal Social Security Act).

1. Renumbering of former sections 1029.5-1029.197 to new section 1029 filed 11-12-2020; operative 1/1/2021 (Register 2020, No. 46). For prior history, see Register 97, No. 16.
2. Change without regulatory effect renumbering former sections 1029.32, 1029.33, 1029.53, 1029.116, 1029.117 and 1029.124 into section 1029 and changing "on site" to "on-site" throughout filed 9-16-2022 pursuant to section 100, title 1, California Code of Regulations (Register 2022, No. 37).