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Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1241 and 1288.5, Business and Professions Code.
s 1029.31. Arterial Puncture.
"Arterial puncture" means the penetration of an artery with a needle to withdraw blood for clinical laboratory test or examination purposes.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1242, 1242.5, 1242.6, 1243, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.
s 1029.32. Certified Phlebotomy Technician I.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.
s 1029.33. Certified Phlebotomy Technician II.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.
s 1029.34. Certifying Organization.
"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 an individual in a profession, occupation or discipline.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1246, 1262, 1264 and 1270, Business and Professions Code; and Section 120580, Health and Safety Code.
s 1029.35. Chapter 3.
"Chapter 3" means chapter 3 (commencing with section 1200) of division 2 of the Business and Professions Code.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1224, Business and Professions Code.
s 1029.37. Instrument.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209 and 1269, Business and Professions Code.
s 1029.39. Licensed General Acute Care Hospital.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business and Professions Code.
s 1029.40. Civil Money Penalties.
"Civil money penalties" means the civil money penalties imposed by the department under the procedures identified in section 1067.5.
Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Section 1310, Business and Professions Code.
s 1029.43. Patient.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241 and 1269, Business and Professions Code.
s 1029.44. Preceptor.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220 and 1265, Business and Professions Code.
s 1029.45. CLIA Certificate.
"CLIA certificate" means an unsuspended and unrevoked certificate of compliance, certificate for provider-performed microscopy procedures, certificate of accreditation, certificate of registration or a certificate of waiver, as defined in 42 Code of Federal Regulations section 493.2.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224, 1265, 1281 and 1288.5, Business and Professions Code.
s 1029.47. Respiratory Care Practitioner.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5 and 1265, Business and Professions Code.
s 1029.49. Specimen.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1209, 1225, 1241, 1244, 1269, 1288, 1288.5 and 1320, Business and Professions Code.
s 1029.50. CLIA Exempt Status.
"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 263a of title 42 of the United States Code and section 493.513 of title 42 of the Code of Federal Regulations.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Stats. 1995, c. 510 (SB 113) Section 1(a)(6).
s 1029.51. Clinical Consultant.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code.
s 1029.52. Clinical Cytogenetics.
"Clinical cytogenetics" means the techniques used to isolate, replicate and identify whole or parts of human chromosomes including culturing, manipulation, banding, staining and hybridizing, and analysis with respect to genotype and phenotype.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1210, 1261.5 and 1264, Business and Professions Code.
s 1029.53. Clinical Genetic Molecular Biology.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1210, 1261.5 and 1264, Business and Professions Code.
s 1029.55. Condition Level Deficiency.
"Condition level deficiency" means noncompliance with one or more condition level requirements.
Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code.
s 1029.57. Test Purposes.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6 and 1246, Business and Professions Code.
s 1029.59. Unprofessional Conduct.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1320, Business and Professions Code.
s 1029.60. Condition Level Requirement.
"Condition level requirement" means any of the requirements specified in section 1066.
Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code.
s 1029.65. Deficiency.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: Stats. 1995, c. 510, Section 1; and Sections 1310, 1320, 1323 and 1326, Business and Professions Code.
s 1029.70. Direct Patient Care.
"Direct patient care" means medical, psychiatric, nursing or other health care which is legally provided by a care giver or healthcare provider directly to a patient, and which 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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1206.5, Business and Professions Code.
s 1029.75. Directed Plans of Correction.
"Directed plans of correction" means the directed plans of correction imposed by the department under the procedures identified in section 1067.
Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code.
s 1029.80. Electrolytes.
"Electrolytes" means ionized calcium, sodium, potassium and/or chloride.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1206, Business and Professions Code.
s 1029.81. Evidence of Satisfactory Performance.
"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 written examination, or by a certifying board or organization indicating satisfactory performance by the examinee on a written certifying examination.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1260, 1261, 1261.5, 1262 and 1264, Business and Professions Code.
s 1029.82. Field Related to Genetics.
"Field related to genetics" means a major in molecular biology, reproductive biology, biochemistry, clinical genetics, medical genetics, clinical cytogenetics, biochemical genetics, human genetics, clinical laboratory science, or clinical molecular genetics.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206 and 1210, Business and Professions Code.
s 1029.83. General Supervisor.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code.
s 1029.85. HHS.
"HHS" means the federal Department of Health and Human Services, or its designee.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5 and 1224, Business and Professions Code.
s 1029.86. High Complexity Tests or Examinations.
"High complexity tests or examinations" mean those clinical laboratory tests or examinations classified as high complexity under CLIA.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5, 1203, 1204, 1206, 1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code.
s 1029.90. Human Immunodeficiency Virus.
"Human Immunodeficiency Virus" or "HIV" means the etiologic virus of Acquired Immune Deficiency Syndrome, or AIDS.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code.
s 1029.95. Immediate Jeopardy.
"Immediate jeopardy" means a situation in which immediate corrective action is necessary because the laboratory's noncompliance with one or more conditions has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health or safety of the general public. This term is synonymous with imminent and serious risk to human health and significant hazard to the public health.
Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c. 510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; and Sections 1310, 1320, 1323 and 1326, Business and Professions Code; and Section 14123, Welfare and Institutions Code.
s 1029.100. Instrument.
"Instrument" means a device, apparatus, implement, machine or contrivance that is used for the performance of a clinical laboratory test or examination,
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209 and 1269, Business and Professions Code.
s 1029.105. Intermediate Sanction.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; and Section 1323, Business and Professions Code; Section 1002, Health and Safety Code; Section 14123, Welfare and Institutions Code; 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).
s 1029.108. License.
For the purposes of this chapter, "license" means license, certificate, registration or other means to engage in a business or profession regulated by Chapter 3.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 23.7, 1203, 1204, 1205, 1206.5, 1207, 1208, 1209, 1210, 1220, 1227, 1242, 1246, 1246.5, 1260, 1260.1, 1261, 1261.5, 1262, 1263, 1264, 1265, 1267, 1269.5, 1270, 1275, 1280, 1281, 1285, 1288.5, 1300, 1301, 1301.1, 1310, 1320, 1322, 1323, 1324 and 1325, Business and Professions Code; and Section 120580, Health and Safety Code.
s 1029.110. Licensed General Acute Care Hospital.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business and Professions Code.
s 1029.111. Licensed Healthcare Professional.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5 and 1208, Business and Professions Code.
s 1029.115. Licensed Surgical Clinic.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business and Professions Code.
s 1029.116. Limited Phlebotomy Technician.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.
s 1029.117. Medical Laboratory Technician.
"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).
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1210, 1242, 1260.3, 1264 and 1300, Business and Professions Code.
s 1029.118. Moderate Complexity Laboratory Technical Consultant.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code.
s 1029.119. Moderate Complexity Tests or Examinations.
"Moderate complexity tests or examinations" mean those clinical laboratory tests or examinations classified as moderate complexity under CLIA.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5, 1203, 1204, 1206, 1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code.
s 1029.120. Notice of Defense.
"Notice of Defense" means a writing signed by or on behalf of the person, entity or laboratory, stating 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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1267, 1320, 1322 and 1326, Business and Professions Code; Sections 11503 and 11504, Government Code; and Section 14123, Welfare and Institutions Code.
s 1029.124. On-the-Job Experience in Phlebotomy.
"On-the-job experience in phlebotomy" means employment as a phlebotomist in a clinical laboratory performing the techniques pursuant to Section 1035.1(f).
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6, 1243, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.
s 1029.125. Onsite Monitoring.
"Onsite monitoring" means the onsite monitoring imposed by the department under the procedures identified in section 1067.10.
Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code.
s 1029.126. Oral and Maxillofacial Pathology Laboratory Director.
"Oral and maxillofacial pathology laboratory director" means a dentist who possesses a valid, unexpired license to direct an oral pathology laboratory in all areas of anatomic and clinical pathology related to the oral and maxillofacial region.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1207, 1208 and 1209, Business and Professions Code.
s 1029.127. Oral Pathology.
"Oral pathology" means the subspecialty of pathology that deals with the nature, identification and management of diseases affecting the oral and maxillofacial regions, which investigates the causes, processes and effects of these diseases, and includes research and diagnosis of diseases using clinical, radiographic, microscopic, biochemical or other examinations.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206 and 1207, Business and Professions Code.
s 1029.130. Patient.
"Patient" means a person who is an inpatient or outpatient of a licensed health facility, licensed clinic or a clinic that is exempt from licensure, licensed home health agency, or who is a patient of a licensed physician and surgeon or osteopath, licensed dentist, or licensed podiatrist.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241 and 1269, Business and Professions Code.
s 1029.132. Phlebotomist.
"Phlebotomist" means a person who collects blood for clinical laboratory test or examination purposes.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.
s 1029.133. Phlebotomy.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.
s 1029.134. Practical Experience.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1222.5, 1242, 1242.5, 1243, 1246, 1260, 1260.3, 1261, 1261.5, 1264, 1269 and 1286, Business and Professions Code.
s 1029.135. Preceptor.
"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 of 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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220 and 1265, Business and Professions Code.
s 1029.140. Principal Sanction.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c. 510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; Sections 1320 and 1322, Business and Professions Code; Section 1002, Health and Safety Code; and Section 14123, Welfare and Institutions Code.
s 1029.145. Provider of Service.
"Provider of service" has the same meaning as given in 22 CCR 51051.
Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c. 510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; and Section 14123, Welfare and Institutions Code.
s 1029.150. Respiratory Care Practitioner.
"Respiratory care practitioner" means an individual licensed pursuant to chapter 8.3 (commencing with section 3700) of division 2 of the Business and Professions Code.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5 and 1265, Business and Professions Code.
s 1029.153. Satisfactory Performance.
"Satisfactory performance" means achieving at least the minimum grade that an examinee must obtain to get a passing score on a written or oral examination.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1260, 1261, 1261.5, 1262 and 1264, Business and Professions Code.
s 1029.154. Skin Puncture.
"Skin puncture" means penetration of the skin for the purpose of collecting capillary blood for clinical laboratory test or examination purposes.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.
s 1029.155. Specimen.
"Specimen" has the same meaning as given for "biological specimen" in section 1206(a)(1) of the Business and Professions Code.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1209, 1225, 1241, 1244, 1269, 1288, 1288.5 and 1320, Business and Professions Code.
s 1029.160. State License.
"State license" or "license" means the license identified in section 1265(a)(1) of the Business and Professions Code.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1281 and 1288.5, Business and Professions Code.
s 1029.165. State Registration.
"State registration" or "registration" means the registration identified in section 1265(a)(2) of the Business and Professions Code.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1281 and 1288.5, Business and Professions Code.
s 1029.168. Statement of Issues.
"Statement of issues" means a written statement served on the person, entity or laboratory which:
(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 which have come to the attention of the department that could form the basis for a denial of the departmental action sought.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1267, 1320, 1322 and 1326, Business and Professions Code; Sections 11503 and 11504, Government Code; and Section 14123, Welfare and Institutions Code.
s 1029.169. Subspecialty of Histocompatibility.
"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 493.1265 of Title 42, Code of Federal Regulations, as published October 1, 1994.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1209.1 and 1210, Business and Professions Code.
s 1029.170. Temporary Suspension of a License, Registration or Approval.
Note: Authority cited: Section 1224, Business and Professions Code; and Sections 1002 and 100275, Health and Safety Code. Reference: Stats. 1995, c. 510, Section 1; Section 1323, Business and Professions Code; and Section 1002, Health and Safety Code.
s 1029.171. Technical Supervisor.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code.
s 1029.173. Temporary Suspension of a License, Registration or Approval.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Sections 1002 and 100275, Health and Safety Code. Reference: Stats. 1995, c. 510, Section 1; Section 1323, Business and Professions Code; and Section 1002, Health and Safety Code.
s 1029.175. Temporary Suspension of a Provider of Service Under the Medi-Cal Program.
"Temporary suspension of a provider of service under the Medi-Cal program" means the immediate suspension imposed by the department pursuant to 22 CCR 51529(g) under the procedures identified in section 1067.15.
Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; Section 14123, Welfare and Institutions Code; 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).
s 1029.180. Test Purposes.
"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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6 and 1246, Business and Professions Code.
s 1029.185. Testing Event.
"Testing event" means the performance of the preanalytical, analytical, and postanalytical activities related to performing a clinical laboratory test or examination on a biological specimen.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241, 1244, 1265, 1281, 1288.5 and 1300, Business and Professions Code.
s 1029.190. Unprofessional Conduct.
"Unprofessional conduct," pursuant to the provisions of Section 1320(m), 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.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1320, Business and Professions Code.
s 1029.195. Venipuncture.
"Venipuncture" means the penetration of a vein with a needle to withdraw blood for clinical laboratory test or examination purposes.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.
s 1029.196. Waived Laboratory Supervisor.
"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 only performing waived tests.
Note: Authority cited: Sections 1208 and 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.
s 1029.197. Waived Tests.
"Waived tests" mean those clinical laboratory tests or examinations classified as waived under CLIA.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5, 1203, 1204, 1206, 1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code.
s 1030. Examination for Bioanalysts' Licenses.
(a) The examination for license as a clinical laboratory bioanalyst shall consist of three sections; namely, written, oral, and practical. The subjects covered in this examination shall have to do with the technical procedures performed in clinical laboratories for the purpose of obtaining scientific data which may be used to ascertain the presence, progress, and source of disease.
(b) An official transcript of college or university training shall be furnished by each applicant. The college or university training shall include as a minimum the indicated number of semester or equivalent quarter units of standard resident courses or their subject equivalent as follows:
General inorganic chemistry.... 8
Quantitative analysis.......... 3
Organic chemistry.............. 3
Biochemistry................... 8
Bacteriology................... 8
Physics........................ 3
Biology or zoology............. 4
Physiology..................... 3
Parasitology................... 3
Hematology..................... 2
Note: Authority cited for Group 2: Section 208, Health and Safety Code, and Sections 1220 through 1223, Business and Professions Code. Additional authority cited: Section 102, Health and Safety Code.
s 1030.5. Licensure of Clinical Chemists, Clinical Microbiologists, Clinical Toxicologists, Clinical Genetic Molecular Biologists and Clinical Cytogeneticists.
A written and oral examination shall be given to each applicant for licensure as a clinical chemist, clinical microbiologist, clinical toxicologist, clinical genetic molecular biologist or clinical cytogeneticist. In addition to the requirements for licensure as specified in Section 1264 of the Business and Professions Code, an applicant shall have completed one year of training as a licensed trainee or equivalent in his or her specialty or subspecialty pursuant to Section 1207 of the Business and Professions Code. Also, each applicant shall have completed three years of experience in his or her specialty pursuant to Section 1210 of the Business and Professions Code in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in that specialty, two years of which shall have been at a supervisory level.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1204, 1205, 1207, 1210, 1264 and 1265, Business and Professions Code.
s 1030.6. Licensure of Clinical Cytogeneticists.
(a) Except for a clinical laboratory bioanalyst licensed by the department who meets the laboratory director qualifications for high complexity testing in Section 493.1443 of Title 42, Code of Federal Regulations, as published October, 1994, or a pathologist who meets the laboratory director qualifications in Section 493.1443(b)(1) of Title 42, Code of Federal Regulations, as published October 1, 1994, a laboratory director of a clinical laboratory that performs tests or examinations in the subspecialty of clinical cytogenetics within the specialty of genetics shall possess a valid clinical cytogeneticist license issued by the department.
(b) In order to be eligible for licensure as a clinical cytogeneticist, an applicant shall:
(1) Be a physician and surgeon licensed by the State to practice medicine pursuant to Chapter 5 of the Business and Professions Code, and have:
(A) Two years' training in clinical cytogenetics in a training program approved by the American Board of Medical Genetics (ABMG) or the Canadian Council of Medical Genetics (CCMG), and approved by the department pursuant to Section 1286, Business and Professions Code, Chapter 3, and
(B) Two years' experience directing or supervising high complexity testing in the specialty of genetics in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and
(C) Evidence of satisfactory performance on a written examination in clinical cytogenetics administered by the ABMG, CCMG or the department; and
(D) Demonstrated satisfactory performance on an oral examination regarding Business and Professions Code, Chapter 3, and Title 42, CFR, Part 493, as published October 1, 1994; or
(2) Hold an earned doctoral degree in a biological science or field related to genetics from an accredited university with thirty semester or equivalent quarter hours of post-baccalaureate course credit in genetics posted on an official transcript from the university registrar; and
(A) Have two years' training in clinical cytogenetics in a training program approved by the ABMG or the CCMG, and approved by the department pursuant to Section 1286, Chapter 3, of Business and Professions Code; and
(B) Have two years' experience supervising or performing clinical laboratory tests or examinations in clinical cytogenetics in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and
(C) Provide evidence of satisfactory performance on a written examination in clinical cytogenetics administered by the ABMG, CCMG or the department; and
(D) Have demonstrated satisfactory performance on the oral examination administered by the Department regarding Business and Professions Code, Chapter 3, and Title 42 Code of Federal Regulations, Part 493, as published October 1, 1994; or
(3) Have served as a laboratory director of a clinical laboratory performing laboratory tests limited to the subspecialty of cytogenetics on or before December 31, 1997 and either;
(A) Meet the laboratory director qualifications of Section 493.1443(b)(2) or (b)(3) of Title 42, Code of Federal Regulations, as published October 1, 1994; or
(B) Hold an earned doctoral degree, have four years' clinical cytogenetics training or experience in a clinical laboratory certified by HCFA in clinical cytogenetics, and provide evidence of satisfactory performance on a written certifying examination in cytogenetics administered by the ABMG or the CCMG.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1207, 1209, 1264, 1265 and 1282, Business and Professions Code.
s 1030.7. Licensure of Clinical Genetic Molecular Biologists.
(a) Except for a clinical laboratory bioanalyst licensed by the department pursuant to Business and Professions Code, Chapter 3, who meets the laboratory director qualifications for high complexity testing in Section 493.1443 of Title 42, Code of Federal Regulations, as published October, 1994, and a pathologist who meets the laboratory director qualifications in Section 493.1443 of Title 42, Code of Federal Regulations, as published October 1, 1994, a laboratory director of a clinical laboratory that performs tests or examinations in the subspecialty of molecular biology related to the diagnosis of abnormalities related to human genetic disorders shall possess a valid clinical genetic molecular biologist license issued by the department.
(b) In order to be eligible for licensure as a clinical genetic molecular biologist, an applicant shall:
(1) Be a physician and surgeon licensed by the State, pursuant to Chapter 5 of the Business and Professions Code, to practice medicine and have:
(A) Two years of training in clinical genetic molecular biology in a training program approved by the American Board of Medical Genetics (ABMG) or the Canadian Council of Medical Genetics (CCMG), and approved by the department pursuant to Section 1286, Chapter 3 of the Business and Professions Code; and
(B) Two years' experience directing or supervising high complexity testing in the specialty of genetics in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and
(C) Evidence of satisfactory performance on a written examination in genetic molecular biology administered by the ABMG or CCMG or the department; and
(D) Demonstrated satisfactory performance on an oral examination administered by the department regarding Chapter 3 of the Business and Professions Code and Part 493 of Title 42, Code of Federal Regulations, as published October 1, 1994; or
(2) Hold an earned doctoral degree in a biological science or field related to genetics from an accredited university with 30 semester or equivalent quarter hours of post-baccalaureate course credit in genetics posted on an official transcript from the university registrar; and
(A) Have two years' training in clinical genetic molecular biology in a training program approved by the ABMG or the CCMG, and approved by the department pursuant to Section 1286, Chapter 3 of Business and Professions Code; and
(B) Have two years' experience supervising or performing clinical laboratory tests or examinations in clinical genetic molecular biology in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and
(C) Provide evidence of satisfactory performance on a written certifying examination in genetic molecular biology administered by the ABMG or CCMG or the department; and
(D) Have demonstrated satisfactory performance in the oral examination regarding Chapter 3 of Business and Professions Code and Part 493 of Title 42 Code of Federal Regulations as published October 1, 1994; or
(3) Have served as a laboratory director of a clinical laboratory performing laboratory tests limited to the subspecialty of molecular biology related to the diagnosis of human genetic abnormalities on or before December 31, 1997, and either:
(A) Meet the qualifications of Section 493.1443(a), (b)(2), or (b)(3) of Title 42, Code of Federal Regulations, as published October 1, 1994; or
(B) Hold an earned doctoral degree, have four years' clinical genetic molecular biology training or experience in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the subspecialty of molecular biology, and provide evidence of satisfactory performance on a written certifying examination in genetic molecular biology administered by the ABMG or CCMG.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1207, 1209, 1264, 1265 and 1282, Business and Professions Code.
s 1030.8. Licensure of Oral Pathology Laboratory Directors.
(a) Except for a pathologist who meets the laboratory director qualifications of Section 493.1443(b)(1) of Title 42, Code of Federal Regulations, as published October 1, 1994, a laboratory director of an oral pathology laboratory shall possess a valid oral pathology laboratory director license issued by the department.
(b) In order to be eligible for licensure as an oral pathology laboratory director, an applicant shall:
(1) Be a doctor of dental surgery licensed by the State pursuant to Chapter 4 of the Business and Professions Code to practice dentistry, and have:
(A) Advanced training in oral and maxillofacial pathology in a training program approved by the American Dental Association (ADA) Committee on Accreditation of Dental and Dental Auxiliary Education Programs in an educational institution; and
(B) Full time experience in oral pathology which, together with advanced training approved by the ADA, shall total a minimum of four years; and
(C) Evidence of satisfactory performance on the oral pathologist certification examination administered by the American Board of Oral Pathology (ABOP); and
(D) Demonstrated satisfactory performance on an oral (verbal) examination administered by the department regarding Chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 as published October 1,1994; or
(2) Have served as a laboratory director of an oral pathology laboratory on or before January 1, 1996, and be a doctor of dental surgery licensed by the State pursuant to Chapter 4 of the Business and Professions Code to practice dentistry, and provide evidence of satisfactory performance on a certifying examination in oral and maxillofacial pathology administered by the ABOP.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1207, 1208, 1209 and 1264, Business and Professions Code.
s 1031. Licensure of Clinical Laboratory Specialists.
(a) The minimum requirements for admission to the limited scientist examinations shall be as follows:
(1) An applicant for admission to the examination for a clinical chemist scientist license shall meet both of the following requirements:
(A) Hold a baccalaureate or higher degree in chemistry or equivalent major which shall include at least 25 semester or 38 quarter units in chemistry including courses in analytical chemistry and instrumentation. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and
(B) Have completed one year of post-baccalaureate training or experience in all areas of the specialty of chemistry, as listed in (b)(1) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of chemistry.
(2) An applicant for admission to the examination for a clinical microbiologist scientist shall meet both of the following requirements:
(A) Hold a baccalaureate or higher degree in microbiology or an equivalent major which shall include at least 25 semester or 38 quarter units in microbiology including courses in medical or pathogenic microbiology or bacteriology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and
(B) Have completed one year of post-baccalaureate training or experience in allareas of the specialty of microbiology, as listed in (b)(2) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of microbiology. (continued)