California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029 - General Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"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