reglab/statecodes huggingface dataset:
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Group 2 - Clinical Laboratory Regulations › Article 5.3 - Blood Electrolyte Analysis by Respiratory Care Practitioners [Repealed] › Section 1054.1 - Conditions for Performance. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  Article 5.3 (sections
						  1054.1-1054.2) and section filed
						  12-27-94 as an emergency; operative 12-27-94 (Register 94, No. 52). A Certificate of
						  Compliance must be transmitted to OAL 4-26-95 or emergency language will be repealed
						  by operation of law on the following day.
2. New article 5.3 (sections
						  1054.1-1054.2) and section refiled
						  5-5-95 as an emergency; operative 5-5-95 (Register 95, No. 18). A Certificate of
						  Compliance must be transmitted to OAL by 9-4-95 or emergency language will be
						  repealed by operation of law on the following day.
3. New article 5.3 and
						  section refiled 9-15-95 as an emergency; operative 9-15-95 (Register 95, No. 37). A
						  Certificate of Compliance must be transmitted to OAL by 1-15-96 or emergency
						  language will be repealed by operation of law on the following day.
4.
						  Repealed by operation of Government Code section
						  11346.1(g)
						  (Register 96, No. 4).
5. New section filed 1-22-96 as an emergency;
						  operative 1-22-96 (Register 96, No. 4). A Certificate of Compliance must be
						  transmitted to OAL by 5-21-96 or emergency language will be repealed by operation of
						  law on the following day.
6. Editorial correction of subsection (a)(2)
						  (Register 96, No. 25).
7. Certificate of Compliance as to 1-22-96 order
						  including amendment of NOTE transmitted to OAL 5-21-96 and filed 6-18-96 (Register
						  96, No. 25).
8. Repealer of article 5.3 (sections
						  1054.1 and
						  1054.2) and repealer of section filed
						  11-12-2020; operative 1-1-2021 (Register 2020, No.
						  46).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code. Reference: Sections
							 1206,
							 1209,
							 1220,
							 1265,
							 1282
							 and
							 1285,
							 Business and Professions Code.
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 5.3 - Blood Electrolyte Analysis by Respiratory Care Practitioners [Repealed] › Section 1054.2 - Training. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 12-27-94 as an emergency; operative 12-27-94 (Register 94, No. 52). A
						  Certificate of Compliance must be transmitted to OAL 4-26-95 or emergency language
						  will be repealed by operation of law on the following day.
2. New section
						  refiled 5-5-95 as an emergency; operative 5-5-95 (Register 95, No. 18). A
						  Certificate of Compliance must be transmitted to OAL by 9-4-95 or emergency language
						  will be repealed by operation of law on the following day.
3. New section
						  refiled 9-15-95 as an emergency; operative 9-15-95 (Register 95, No. 37). A
						  Certificate of Compliance must be transmitted to OAL by 1-15-96 or emergency
						  language will be repealed by operation of law on the following day.
4.
						  Repealed by operation of Government Code section
						  11346.1(g)
						  (Register 96, No. 4).
5. New section filed 1-22-96 as an emergency;
						  operative 1-22-96 (Register 96, No. 4). A Certificate of Compliance must be
						  transmitted to OAL by 5-21-96 or emergency language will be repealed by operation of
						  law on the following day.
6. Certificate of Compliance as to 1-22-96
						  order including amendment of NOTE transmitted to OAL 5-21-96 and filed 6-18-96
						  (Register 96, No. 25).
7. Repealer of section filed 11-12-2020; operative
						  1-1-2021 (Register 2020, No. 46).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code. Reference: Sections
							 1209,
							 1220
							 and
							 1265,
							 Business and Professions Code.
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 5.5 - USE OF POINT-OF-CARE LABORATORY TESTING DEVICES BY REGISTERED NURSES › Section 1054.5 - Conditions for Performance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  Article 5.5 (sections
						  1054.5-1054.6) and section filed
						  12-27-94 as an emergency; operative 12-27-94 (Register 94, No. 52). A Certificate of
						  Compliance must be transmitted to OAL 4-26-95 or emergency language will be repealed
						  by operation of law on the following day.
2. New article 5.5 (sections
						  1054.5-1054.6) and section refiled
						  5-5-95 as an emergency; operative 5-5-95 (Register 95, No. 18). A Certificate of
						  Compliance must be transmitted to OAL by 9-4-95 or emergency language will be
						  repealed by operation of law on the following day.
3. New article 5.5 and
						  section refiled 9-15-95 as an emergency; operative 9-15-95 (Register 95, No. 37). A
						  Certificate of Compliance must be transmitted to OAL by 1-15-96 or emergency
						  language will be repealed by operation of law on the following day.
4.
						  Repealed by operation of Government Code section
						  11346.1(g)
						  (Register 96, No. 4).
Note: Authority cited: Sections
							 1220(a)
							 and
							 1224,
							 Business and Professions Code. Reference: Sections
							 1206,
							 1209,
							 1220(a),
							 1265,
							 1282
							 and
							 1285,
							 Business and Professions Code.
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 5.6 - MODERATELY COMPLEX LABORATORY TESTING BY LICENSED PSYCHIATRIC TECHNICIANS, LICENSED VOCATIONAL NURSES, LICENSED MIDWIVES, CERTIFIED NURSE ASSISTANTS, AND CERTIFIED HOME HEALTH AIDES › Section 1054.6 - Testing Authority for Licensed Psychiatric Technicians, Licensed Vocational Nurses, Licensed Midwives, Certified Nurse Assistants, and Certified Home Health Aides [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 12-27-94 as an emergency; operative 12-27-94 (Register 94, No. 52). A
						  Certificate of Compliance must be transmitted to OAL 4-26-95 or emergency language
						  will be repealed by operation of law on the following day.
2. New section
						  refiled 5-5-95 as an emergency; operative 5-5-95 (Register 95, No. 18). A
						  Certificate of Compliance must be transmitted to OAL by 9-4-95 or emergency language
						  will be repealed by operation of law on the following day.
3. New section
						  refiled 9-15-95 as an emergency; operative 9-15-95 (Register 95, No. 37). A
						  Certificate of Compliance must be transmitted to OAL by 1-15-96 or emergency
						  language will be repealed by operation of law on the following day.
4.
						  Repealed by operation of Government Code section
						  11346.1(g)
						  (Register 96, No. 4).
5. New article 5.6 (sections
						  1054.6-1054.7), section heading,
						  section, and NOTE filed 5-28-96 as an emergency; operative 5-28-96 (Register 96, No.
						  22). A Certificate of Compliance must be transmitted to OAL by 9-25-96 or emergency
						  language will be repealed by operation of law on the following day.
6.
						  New article 5.6 (sections
						  1054.6-1054.7) and section refiled
						  10-7-96 as an emergency; operative 10-7-96 (Register 96, No. 41). A Certificate of
						  Compliance must be transmitted to OAL by 2-4-97 or emergency language will be
						  repealed by operation of law on the following day.
7. Certificate of
						  Compliance as to 10-7-96 order, including repealer of section, transmitted to OAL
						  2-3-97 and filed 3-19-97 (Register 97, No. 12).
Note: Authority cited: Section
							 1224 Business and Professions Code; and
							 Section
							 100275,
							 Health and Safety Code. Reference: Sections
							 1206.5,
							 and
							 1209,
							 Business and Professions Code.
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 5.6 - MODERATELY COMPLEX LABORATORY TESTING BY LICENSED PSYCHIATRIC TECHNICIANS, LICENSED VOCATIONAL NURSES, LICENSED MIDWIVES, CERTIFIED NURSE ASSISTANTS, AND CERTIFIED HOME HEALTH AIDES › Section 1054.7 - Preceptor Program Requirements for Licensed Psychiatric Technicians, Licensed Vocational Nurses, Licensed Midwives, Certified Emergency Medical Technicians II, Paramedics, Certified Nurse Assistants, and Certified Home Health Aides Performing Moderate Complexity Testing on Point-of-Care Laboratory Testing Devices

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Prior to the performance of any clinical
						laboratory test or examination authorized in Business and Professions Code Section
						1206.5(b)(11),
						a licensed psychiatric technician, licensed vocational nurse, licensed midwife,
						certified emergency medical technician II, paramedic, certified nurse assistant or
						certified home health aide shall have been trained by a preceptor in:
(1) The operation of each instrument to be used by
						the licensed psychiatric technician, licensed vocation nurse, licensed midwife,
						certified emergency medical technician II, paramedic, certified nurse assistant or
						certified home health aide including:
(A) Each
						instrument's requirements for maintenance and calibration which shall include
						training regarding all manufacturer's instructions;
(B) Each instrument's performance criteria
						including the reference ranges, critical values for each test method, and actions to
						be taken for values outside the analytical range; and
(C) Each instrument's quality control and quality
						assurance protocols, including remedial action and reagent and specimen handling and
						integrity; and,
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 6 - LABORATORY REPORTS › Section 1055 - Reports

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Any report of results issuing from a clinical laboratory
						  operating under the provisions of Chapter 3, Division 2, Business and Professions
						  Code shall show clearly the name of a director of said laboratory.
1. New
						  section filed 9-30-60; effective thirtieth day thereafter (Register 60, No.
						  21).
Note: Authority cited: Sections
							 102 and
							 208,
							 Health and Safety Code. Reference: Sections
							 1220,
							 1225,
							 1284 and
							 1285,
							 Health and Safety Code.
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 6 - LABORATORY REPORTS › Section 1056 - Prenatal and Neonatal Blood Typing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
For purposes of compliance with Sections
						  291 and
						  304 of
						  the California Health and Safety Code, rhesus (Rh) blood typing (as defined in Title
						  17, California Administrative Code, Chapter 2, Subchapter 1, Group 1, Section
						  1002, Number 3, [Determination of Rh
						  type]) shall consist of D and if this is negative, Du
						  typing.
1. New
						  Sections 1056 and
						  1057 filed 3-16-70; effective thirtieth
						  day thereafter (Register 70, No. 12).
2. Amendment filed 2-2-71;
						  effective thirtieth day thereafter (Register 71, No. 6).
3. Editorial
						  correction (Register 72, No. 31).
Note: Additional authority cited: Sections
							 290-
							 293 and
							 304-
							 305,
							 Health and Safety Code.
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 6 - LABORATORY REPORTS › Section 1057 - Prenatal Blood Typing Reports

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Licensed clinical laboratories or approved public health
						  laboratories performing tests on pregnant women as required by Sections
						  290 and
						  291 of
						  the California Health and Safety Code shall provide the requesting physician with a
						  copy of the report to be stamped or imprinted as follows: "State law requires that
						  the woman tested be informed as to the rhesus (Rh) typing test results."
Every licensed physician and surgeon or other person engaged
						  in the prenatal care of a pregnant woman, or attending such woman at time of
						  delivery after receiving such report, shall be responsible for notifying the woman
						  tested of the results of the test.
1. Amendment
						  filed 2-2-71; effective thirtieth day thereafter (Register 71, No.
						  6).
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 7 - CYTOTECHNOLOGY › Section 1060 - Definitions: Cytotechnologist License

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The definitions in subsections (b) though (i)
						shall govern the interpretation of this article.
(b) "Competency testing service or program" means
						an organization that has been approved by the Department pursuant to section
						1270
						of the California Business and Professions Code to administer a cytotechnology
						competency examination.
(c)
						"Cytotechnologist competency examination" means an examination which evaluates a
						person's entry level skills and abilities in cytotechnology, including his or her
						understanding of:
(1) the underlying scientific
						principles, technical and procedural aspects of cytotechnology;
(2) the identification of cellular changes in
						gynecological and non-gynecological specimens through both a written and visual
						component;
(3) cytopreparatory
						techniques; and
(4) cytology laboratory
						operations; and which include the following subject areas in the following ratios:
						48% to 52% female reproductive system (to include both the genital system and
						breast); 13% to 17% respiratory system; 9% to 12% male and female genitourinary
						systems; 6% to 10% alimentary system; and 13% to 17% body cavity fluids and other
						body sites.
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 7 - CYTOTECHNOLOGY › Section 1061 - Cytotechnology Licensure

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
						cytotechnologist license shall be issued to an individual who submits the following
						to the Department:
(1) A verified and complete
						application as described in subsection (b);
(2) Evidence of satisfactory
						performance;
(3) The application fee
						required under Business and Professions Code Section
						1300
						and Health and Safety Code Section
						116.
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 7 - CYTOTECHNOLOGY › Section 1062 - Cytotechnologist Competency Testing Services Or Programs

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Any organization seeking approval by the
						Department as a cytotechnologist competency testing service or program shall submit
						an application to the Department which shall include documentation of the following:
(1) The organization's name, address, and
						owner(s);
(2) The organization's
						mechanism for assuring that each individual for whom a cytotechnologist competency
						testing examination is administered meets the criteria as an examinee;
(3) The organization's mechanism for assuring that
						each cytotechnologist competency examination administered by the organization shall
						test each examinee on his or her entry level skills and understanding of:
(A) The underlying scientific principles and the
						technical and procedural aspects of cytology;
(B) The identification of cellular changes in
						gynecologic and non-gynecologic specimens through both a written and visual
						component;
(C) Cytopreparatory
						techniques; and
(D) Cytology laboratory
						operations, and that each test shall include the following subject areas in the
						following ratios: 48% to 52% female reproductive system (to include both genital
						system and breast); 13%-17% respiratory system; 9%-12% male and/or female
						genitourinary system; 6%-10% alimentary system; and 13%-17% body cavity fluids and
						other body sites;
(4) The
						organization's mechanism for determining the validity and passing score for each
						cytotechnologist competency examination administered by the organization in order
						that there is a consistency between and among all testing events as to entry level
						skills that must be demonstrated in order for an examinee to pass the examination;
						and,
(5) The organization's mechanism
						for assuring the security of each cytotechnologist competency examination
						administered by it.
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 8 - ENFORCEMENT › Section 1065 - Imposition of Sanctions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
						department may impose, as applicable, one or more of the following sanctions on a
						clinical laboratory, a public health laboratory or a provider of service:
(1) Principal sanctions.
(2) Intermediate sanctions.
(3) Alternative sanctions.
(4) Automatic suspension of a license or
						registration based on federal exclusion from the Medicare or Medicaid program or
						revocation of CLIA certificate.
(5)
						State-initiated exclusions from the Medicaid and Medi-Cal programs.
(6) Exclusion from ownership or operation for two
						years following license or registration revocation.
(7) Civil suit to enjoin statutory or regulatory
						violations.
(8) Criminal sanctions for
						unlawful activity.
(9) Automatic
						revocation of license/registration or other approval based on intentional referral
						of proficiency testing samples for analysis.
(10) Suspension of Medi-Cal and Medicaid payments
						for failure to permit an inspection.
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 8 - ENFORCEMENT › Section 1065.15 - Alternative Sanctions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
						department may impose on a clinical laboratory one or more of the following
						alternative sanctions in lieu of or in addition to imposing a principal sanction:
(1) Directed plans of correction, as set forth in
						section 1067.
(2) Onsite monitoring, as set forth in section
						1067.10.
(3) Civil money penalties, as set forth in section
						1067.5.
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 8 - ENFORCEMENT › Section 1065.20 - Automatic Suspension

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The department shall automatically suspend a clinical
						  laboratory license or registration based on federal exclusion from the Medicare or
						  Medicaid program or revocation of CLIA certificate. A clinical laboratory that is
						  dissatisfied with the imposition of an automatic suspension may seek judicial review
						  by filing a petition for writ of mandate in accordance with the provisions of the
						  Code of Civil Procedure.
1. New
						  section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A
						  Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency
						  language will be repealed by operation of law on the following day.
2.
						  Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed
						  2-9-98 (Register 98, No. 7).
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; Section
							 101160,
							 Health and Safety Code; Sections
							 1265,
							 1267,
							 1280,
							 1281,
							 1282,
							 1283,
							 1284,
							 1285,
							 1286,
							 1287,
							 1288.5,
							 1289,
							 1310,
							 1320,
							 1323,
							 1324
							 and
							 1326,
							 Business and Professions Code; Sections
							 11503,
							 11504,
							 11506 and
							 11523,
							 Government Code; 42 USC, Section
							 1395x(s) [Section
							 1861(s) of the Social
							 Security Act]; 42 United States
							 Code, Section 1395w-2 [Section
							 1846 of the federal Social Security
							 Act]; 42 United States Code,
							 Section 1396a(a)(9)(C) [Section
							 1902(a)(9)(C) of the
							 federal Social Security Act]; 42
							 United States Code, Section
							 1396a(a)(30) [Section
							 1902(a)(30) of the
							 federal Social Security Act]; 42
							 USC Section 1396a(p) [Section
							 1902(p) of the Social
							 Security Act]; 42 CFR Section
							 1002.2;
							 42 CFR Sections
							 1001.201 through
							 1001.1701; Section
							 14123, Welfare and Institutions Code;
							 and 42 CFR Section
							 493.1840.
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 8 - ENFORCEMENT › Section 1065.25 - State-Initiated Exclusions from Medicaid and Medi-Cal

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The department may initiate exclusions from Medicaid and
						  Medi-Cal when the grounds for taking a permissive exclusion under 42 CFR part 1002
						  exist. The department shall initiate exclusions from Medicaid and Medi-Cal when the
						  grounds for taking a mandatory exclusion under 42 CFR part 1002 exist. Before
						  imposing an exclusion, the department shall give a provider of service an
						  opportunity to submit documents and written argument against the exclusion. A
						  provider of service that is dissatisfied with the imposition of an exclusion may
						  seek judicial review by filing a petition for writ of mandate in accordance with the
						  provisions of the Code of Civil Procedure.
1. New
						  section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A
						  Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency
						  language will be repealed by operation of law on the following day.
2.
						  Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed
						  2-9-98 (Register 98, No. 7).
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; Section
							 101160,
							 Health and Safety Code; Sections
							 1265,
							 1267,
							 1280,
							 1281,
							 1282,
							 1283,
							 1284,
							 1285,
							 1286,
							 1287,
							 1288.5,
							 1289,
							 1310,
							 1320,
							 1323,
							 1324
							 and
							 1326,
							 Business and Professions Code; Sections
							 11503,
							 11504,
							 11506 and
							 11523,
							 Government Code; 42 USC, Section
							 1395x(s) [Section
							 1861(s) of the Social
							 Security Act]; 42 United States
							 Code, Section 1395w-2 [Section
							 1846 of the federal Social Security
							 Act]; 42 United States Code,
							 Section 1396a(a)(9)(C) [Section
							 1902(a)(9)(C) of the
							 federal Social Security Act]; 42
							 United States Code, Section
							 1396a(a)(30) [Section
							 1902(a)(30) of the
							 federal Social Security Act]; 42
							 USC Section 1396a(p) [Section
							 1902(p) of the Social
							 Security Act]; 42 CFR Section
							 1002.2;
							 42 CFR Sections
							 1001.201 through
							 1001.1701; Section
							 14123, Welfare and Institutions Code;
							 and 42 CFR Section
							 493.1840.
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 8 - ENFORCEMENT › Section 1065.30 - Exclusion from Ownership or Operation

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The department shall exclude for a period of two years
						  following revocation any person or entity from owning, operating, or directing a
						  laboratory, whenever the person or entity has been the owner, operator or laboratory
						  director of a clinical laboratory that has had its clinical laboratory license or
						  registration revoked. A person or entity that is dissatisfied with the imposition of
						  an exclusion from owning or operating a clinical laboratory may seek judicial review
						  by filing a petition for writ of mandate in accordance with the provisions of the
						  Code of Civil Procedure.
1. New
						  section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A
						  Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency
						  language will be repealed by operation of law on the following day.
2.
						  Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed
						  2-9-98 (Register 98, No. 7).
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; Section
							 101160,
							 Health and Safety Code; Sections
							 1265,
							 1267,
							 1280,
							 1281,
							 1282,
							 1283,
							 1284,
							 1285,
							 1286,
							 1287,
							 1288.5,
							 1289,
							 1310,
							 1320,
							 1323,
							 1324
							 and
							 1326,
							 Business and Professions Code; Sections
							 11503,
							 11504,
							 11506 and
							 11523,
							 Government Code; 42 USC, Section
							 1395x(s) [Section
							 1861(s) of the Social
							 Security Act]; 42 United States
							 Code, Section 1395w-2 [Section
							 1846 of the federal Social Security
							 Act]; 42 United States Code,
							 Section 1396a(a)(9)(C) [Section
							 1902(a)(9)(C) of the
							 federal Social Security Act]; 42
							 United States Code, Section
							 1396a(a)(30) [Section
							 1902(a)(30) of the
							 federal Social Security Act]; 42
							 USC Section 1396a(p) [Section
							 1902(p) of the Social
							 Security Act]; 42 CFR Section
							 1002.2;
							 42 CFR Sections
							 1001.201 through
							 1001.1701; Section
							 14123, Welfare and Institutions Code;
							 and 42 CFR Section
							 493.1840.
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 8 - ENFORCEMENT › Section 1065.35 - Civil Suit to Enjoin Violations

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The department shall initiate a civil suit whenever such
						  suit is necessary to enjoin the violation or threatened violation of chapter 3
						  (commencing with section
						  1200) of the Business and Professions
						  Code or the regulations adopted thereunder. A person or entity against whom a civil
						  suit is filed shall have all the rights of defense afforded by California civil
						  law.
1. New
						  section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A
						  Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency
						  language will be repealed by operation of law on the following day.
2.
						  Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed
						  2-9-98 (Register 98, No. 7).
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; Section
							 101160,
							 Health and Safety Code; Sections
							 1265,
							 1267,
							 1280,
							 1281,
							 1282,
							 1283,
							 1284,
							 1285,
							 1286,
							 1287,
							 1288.5,
							 1289,
							 1310,
							 1320,
							 1323,
							 1324
							 and
							 1326,
							 Business and Professions Code; Sections
							 11503,
							 11504,
							 11506 and
							 11523,
							 Government Code; 42 USC, Section
							 1395x(s) [Section
							 1861(s) of the Social
							 Security Act]; 42 United States
							 Code, Section 1395w-2 [Section
							 1846 of the federal Social Security
							 Act]; 42 United States Code,
							 Section 1396a(a)(9)(C) [Section
							 1902(a)(9)(C) of the
							 federal Social Security Act]; 42
							 United States Code, Section
							 1396a(a)(30) [Section
							 1902(a)(30) of the
							 federal Social Security Act]; 42
							 USC Section 1396a(p) [Section
							 1902(p) of the Social
							 Security Act]; 42 CFR Section
							 1002.2;
							 42 CFR Sections
							 1001.201 through
							 1001.1701; Section
							 14123, Welfare and Institutions Code;
							 and 42 CFR Section
							 493.1840.
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 8 - ENFORCEMENT › Section 1065.40 - Criminal Sanctions for Unlawful Activity

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The department may refer for prosecution to the Attorney
						  General's office or a District Attorney's office, when appropriate, any person or
						  entity it has reason to believe has engaged in any of the unlawful activities
						  identified in sections
						  1280 through
						  1287, inclusive of the Business and
						  Professions Code. A person or entity against whom a criminal action is filed shall
						  have all the rights of defense afforded by California criminal
						  law.
1. New
						  section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A
						  Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency
						  language will be repealed by operation of law on the following day.
2.
						  Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed
						  2-9-98 (Register 98, No. 7).
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; Section
							 101160,
							 Health and Safety Code; Sections
							 1265,
							 1267,
							 1280,
							 1281,
							 1282,
							 1283,
							 1284,
							 1285,
							 1286,
							 1287,
							 1288.5,
							 1289,
							 1310,
							 1320,
							 1323,
							 1324
							 and
							 1326,
							 Business and Professions Code; Sections
							 11503,
							 11504,
							 11506 and
							 11523,
							 Government Code; 42 USC , Section
							 1395x(s) [Section
							 1861(s) of the Social
							 Security Act]; 42 United States
							 Code, Section 1395w-2 [Section
							 1846 of the federal Social Security
							 Act]; 42 United States Code,
							 Section 1396a(a)(9)(C) [Section
							 1902(a)(9)(C) of the
							 federal Social Security Act]; 42
							 United States Code, Section
							 1396a(a)(30) [Section
							 1902(a)(30) of the
							 federal Social Security Act]; 42
							 USC Section 1396a(p) [Section
							 1902(p) of the Social
							 Security Act]; 42 CFR Section
							 1002.2;
							 42 CFR Sections
							 1001.201 through
							 1001.1701; Section
							 14123, Welfare and Institutions Code;
							 and 42 CFR Section
							 493.1840.
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 8 - ENFORCEMENT › Section 1065.45 - Revocation for Referral of Proficiency Testing Samples

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
If the department determines that a laboratory has
						  intentionally referred proficiency testing samples to another laboratory for
						  analysis, it shall take action to revoke the license/registration or other approval
						  for at least one year and may take action to impose any other available
						  sanction.
1. New
						  section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A
						  Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency
						  language will be repealed by operation of law on the following day.
2.
						  Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed
						  2-9-98 (Register 98, No. 7).
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; Section
							 101160,
							 Health and Safety Code; Sections
							 1265,
							 1267,
							 1280,
							 1281,
							 1282,
							 1283,
							 1284,
							 1285,
							 1286,
							 1287,
							 1288.5,
							 1289,
							 1310,
							 1320,
							 1323,
							 1324
							 and
							 1326,
							 Business and Professions Code; Sections
							 11503,
							 11504,
							 11506 and
							 11523,
							 Government Code; 42 USC, Section
							 1395x(s) [Section
							 1861(s) of the Social
							 Security Act]; 42 United States
							 Code, Section 1395w-2 [Section
							 1846 of the federal Social Security
							 Act]; 42 United States Code,
							 Section 1396a(a)(9)(C) [Section
							 1902(a)(9)(C) of the
							 federal Social Security Act]; 42
							 United States Code, Section
							 1396a(a)(30) [Section
							 1902(a)(30) of the
							 federal Social Security Act]; 42
							 USC Section 1396a(p) [Section
							 1902(p) of the Social
							 Security Act]; 42 CFR Section
							 1002.2;
							 42 CFR Sections
							 1001.201 through
							 1001.1701; Section
							 14123, Welfare and Institutions Code;
							 and 42 CFR Section
							 493.1840.
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 8 - ENFORCEMENT › Section 1066 - Condition Level Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Any
						requirement specified in subsections (b) through (i) shall constitute a condition
						level requirement.
(b) Each clinical
						laboratory performing clinical laboratory tests or examinations classified as of
						moderate or of high complexity under CLIA shall obtain and maintain a valid clinical
						laboratory license issued pursuant to section
						1265
						of the Business and Professions Code.
(c) Each clinical laboratory shall employ:
(1) A sufficient number of laboratory personnel
						with the appropriate education and either experience or training to:
(A) Provide appropriate direction, supervision and
						consultation;
(B) Accurately perform
						tests; and
(C) Report test
						results.
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 8 - ENFORCEMENT › Section 1067 - Procedures for the Imposition of Directed Plans of Correction

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The department may impose a directed plan of
						correction as an alternative sanction for any clinical laboratory that has condition
						level deficiencies.
(b) If the
						department is imposing a directed plan of correction, the following procedures shall
						apply:
(1) The department shall give the laboratory
						a written Notice of Intent to impose a directed plan of correction. The Notice of
						Intent shall include the following:
(A) The
						condition level deficiency that has been identified,
(B) The sanction or sanctions that the department
						proposes to impose against the laboratory,
(C) The rationale for the proposed sanction or
						sanctions,
(D) The projected effective
						date and duration of the proposed sanction or sanctions,
(E) The authority for the proposed sanction or
						sanctions, and
(F) The time allowed for
						the laboratory to respond to the notice. (During the period specified, the
						laboratory may submit to the department written evidence or other information
						against the imposition of the proposed sanction or sanctions.)
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 8 - ENFORCEMENT › Section 1067.5 - Procedures for the Imposition of Civil Money Penalties

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The department may impose civil money
						penalties as an alternative sanction for any clinical laboratory that has condition
						level deficiencies.
(b) If the
						department is imposing civil money penalties, the following procedures apply:
(1) In determining the amount of the penalty, the
						department shall take into account the following factors:
(A) The nature, scope, severity, and duration of
						the deficiency or noncompliance.
(B)
						Whether the same condition level deficiencies have been identified during prior
						inspections.
(C) The laboratory's intent
						or reason for noncompliance.
(D) The
						accuracy and extent of laboratory records and their availability to the department
						or its contractors or agents.
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 8 - ENFORCEMENT › Section 1067.10 - Procedures for the Imposition of On-site Monitoring

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The department may require continuous or
						intermittent monitoring of a plan of correction to ensure that the laboratory makes
						the improvements necessary to bring it into compliance with the condition level
						requirements.
(b) The laboratory shall
						pay the costs of on-site monitoring by the department.
(c) If the department imposes on-site monitoring,
						the following procedures apply:
(1) The department
						shall provide written notice of the following:
(A)
						The condition level noncompliance that it has identified,
(B) The sanction or sanctions that the department
						proposes to impose against the laboratory,
(C) The rationale for the proposed sanction or
						sanctions,
(D) The projected effective
						date and duration of the proposed sanction or sanctions,
(E) The authority for the proposed sanction or
						sanctions, and
(F) The time allowed for
						the laboratory to respond to the notice. [During the period specified, the
						laboratory may submit to the department written evidence or other information
						against the imposition of the proposed sanction or sanctions.]
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 8 - ENFORCEMENT › Section 1067.15 - Procedures for the Imposition of a Temporary Suspension of a Laboratory or Clinical Laboratory under the Medi-Cal Program

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The department may impose a Temporary
						Suspension on a provider of laboratory services prior to hearing if the laboratory
						has condition level deficiencies or there is immediate jeopardy and in the
						director's opinion such action is necessary to protect the public welfare or the
						interests of the Medi-Cal program.
(b)
						If the department is imposing a Temporary Suspension on a provider of service, the
						following procedures apply:
(1) The department
						shall serve the laboratory with a Notice of Sanction which includes the following
						information:
(A) The sanction or sanctions to be
						imposed against the laboratory, and
(B)
						The effective date and duration of sanction.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 3 - COUNTY AND MUNICIPAL LABORATORIES › Article 1 - OFFICIAL PUBLIC HEALTH LABORATORY SERVICE REQUIRED › Section 1075 - Local Health Departments

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Each local health department shall have available the
						  services of an official public health laboratory. The laboratory of the State
						  Department of Health is hereby designated as the official laboratory for all local
						  health department jurisdictions not covered by local laboratory
						  service.
1. Article 1
						  (§§
													1075 to
						  1085, inclusive) originally published
						  8-15-45 (Title 17).
2. Revised Article 1 (§§
													1075 to
						  1084, inclusive) filed 10-26-49
						  (Register 18, No. 4).
3. Amendment filed 1-21-77; effective thirtieth day
						  thereafter (Register 77, No. 4).
Note: Authority cited for Article 1: Sections
							 208,
							 1000,
							 and
							 1002 of
							 the Health and Safety Code. Reference: Sections
							 1000 and
							 1002,
							 Health and Safety Code. Issuing agency: State Department of Public
							 Health.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 3 - COUNTY AND MUNICIPAL LABORATORIES › Article 1 - OFFICIAL PUBLIC HEALTH LABORATORY SERVICE REQUIRED › Section 1076 - Certificates of Approval Required

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A certificate of approval issued after inspection by the
						  Department shall be required to be in the possession of and be on display in every
						  principal and branch public health laboratory and no such laboratory shall continue
						  to operate following receipt of notice of cancellation of any existing certificate,
						  or of refusal of the Department to issue a certificate.
1. Amendment
						  filed 8-16-71; effective thirtieth day thereafter (Register 71, No.
						  34).
2. Amendment filed 1-21-77; effective thirtieth day thereafter
						  (Register 77, No. 4).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 3 - COUNTY AND MUNICIPAL LABORATORIES › Article 1 - OFFICIAL PUBLIC HEALTH LABORATORY SERVICE REQUIRED › Section 1076.1 - Public Health Laboratory

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The official public health laboratory shall consist of a
						  principal public health laboratory and may include branch public health
						  laboratories.
(a) The principal public
						health laboratory is the laboratory facility that provides the major or total
						laboratory services to a public health department.
(b) A branch public health laboratory is any
						laboratory facility that provides minor or auxiliary laboratory services.
1. New
						  section filed 1-21-77; effective thirtieth day thereafter (Register 77, No.
						  4).
Note: Authority cited: Sections
							 208,
							 1000 and
							 1002,
							 Health and Safety Code. Reference: Sections
							 1000 and
							 1002,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 3 - COUNTY AND MUNICIPAL LABORATORIES › Article 1 - OFFICIAL PUBLIC HEALTH LABORATORY SERVICE REQUIRED › Section 1077 - Reports Required

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The following reports shall be transmitted to the Department
						  by all laboratories approved under Section
						  1076. Standard forms shall be used if
						  provided by the Department.
(a) A report
						shall be made semiannually during the months of January and July, of work load data
						and personnel information as requested by the Department.
(b) A report shall be given within 30 days:
(1) Of any change in the directorship of the
						laboratory.
(2) Of any proposed
						expansion, reduction or shift in laboratory services.
(3) Of any change in the location of the
						laboratory.