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 2 - Training › Section 1035 - Phlebotomy Training Program Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) In order to be eligible for approval by the
						department to provide didactic and/or practical phlebotomy instruction leading to
						certification of phlebotomists, a phlebotomy training program shall meet the
						requirements of this section and be offered by either a:
(1) National Accrediting Agency for Clinical
						Laboratory Sciences (NAACLS) approved program for training phlebotomists;
						or
(2) Accredited college or university;
						or
(3) Private, post-secondary program
						or occupational program registered or approved by the Bureau for Private
						Postsecondary and Vocational Education; or
(4) California Adult Education or Regional
						Occupational Program (ROP); or
(5)
						United States of America military medical laboratory specialist program;
						or
(6) California licensed clinical
						laboratory.
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 2 - Training › Section 1035.1 - Medical Laboratory Technician Training Program Standards

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) In order to be eligible for approval by the
						department, a medical laboratory technician training program shall be offered by
						either a:
(1) California licensed clinical
						laboratory; or
(2) Accredited college or
						university in the United States of America; or
(3) United States of America military medical
						laboratory specialist program of at least 26 weeks duration; or
(4) Laboratory owned and operated by the United
						States of America.
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 2 - Training › Section 1035.3 - Medical Laboratory Technician Training Program Standards. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register 2005, No. 2).
						  A Certificate of Compliance must be transmitted to OAL by 5-13-2005 or emergency
						  language will be repealed by operation of law on the following day.
2.
						  New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Register 2005,
						  No. 19). A Certificate of Compliance must be transmitted to OAL by 9-12-2005 or
						  emergency language will be repealed by operation of law on the following
						  day.
3. Certificate of Compliance as to 5-12-2005 order, including
						  amendment of subsection (b)(4)(E), transmitted to OAL 8-3-2005 and filed 9-12-2005
						  (Register 2005, No. 37).
4. Change without regulatory effect renumbering
						  former section 1035.3 to section
						  1035.1 filed 10-6-2022 pursuant to
						  section 100, title 1, California Code of
						  Regulations (Register 2022, No. 40).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Sections
							 1206.5,
							 1208,
							 1209,
							 1222,
							 1222.5,
							 1242,
							 1246,
							 1260.3,
							 1269,
							 1286
							 and
							 1300,
							 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 2 - Training › Section 1035.4 - Timeframes for Approval of Training Programs. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register 2005, No. 2).
						  A Certificate of Compliance must be transmitted to OAL by 5-13-2005 or emergency
						  language will be repealed by operation of law on the following day.
2.
						  New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Register 2005,
						  No. 19). A Certificate of Compliance must be transmitted to OAL by 9-12-2005 or
						  emergency language will be repealed by operation of law on the following
						  day.
3. Certificate of Compliance as to 5-12-2005 order, including
						  subsection (b)(2), transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005,
						  No. 37).
4. Change without regulatory effect renumbering former section
						  1035.4 to section
						  1035.10 filed 10-6-2022 pursuant to
						  section 100, title 1, California Code of
						  Regulations (Register 2022, No. 40).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Sections
							 1261.5,
							 1263,
							 1264,
							 1286
							 and
							 1302,
							 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 2 - Training › Section 1035.10 - Timeframes for Approval of Training Programs

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Timeframes for approval of training programs
						to train clinical laboratory personnel for licensure pursuant to Chapter 3 shall be
						as follows:
(1) Submission of an application for
						approval shall be deemed to occur on the date the application is received by the
						department.
(2) Written notification by
						the department to the applicant program shall be considered to occur on the date the
						documents are postmarked.
(3) The
						department shall notify the applicant within 60 days of submission of an application
						for training program approval, of one of the following:
(A) That the application is complete and
						acceptable for processing by the department; or
(B) That the application is incomplete and not
						accepted for processing. This notification shall include the specific information or
						documentation that the applicant shall submit within 30 days in order for the
						department to consider the application acceptable; or
(C) That the application has been reviewed and
						does not meet the requirements of this section and that approval is
						denied.
(4) The department
						shall consider an application to have been abandoned by any applicant program which
						fails to respond to the department's request to submit specific information or
						documentation within 30 days of notification pursuant to Section
						1035.10(a)(3)(B).
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 2.3 - CLINICAL LABORATORY SUPERVISORS › Section 1036 - Clinical Consultant

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Every
						clinical laboratory director, under whom moderate or high complexity tests or
						examinations are performed, shall either perform the duties of a clinical consultant
						or employ a clinical consultant who can provide consultation about the
						appropriateness of testing ordered and interpretation of test results, as specified
						in Section 1209, chapter 3 of the Business and
						Professions Code.
(b) The clinical
						consultant shall possess a current, valid license issued by the State to direct a
						clinical laboratory pursuant to chapter 3, Business and Professions Code, or to
						practice medicine, osteopathy or podiatry pursuant to chapter 5, Business and
						Professions Code appropriate to the specialties and subspecialties for which he or
						she is consulting.
(c) The clinical
						consultant shall:
(1) Provide clinical
						consultation to the clients of the laboratory; and
(2) Assist in ordering tests appropriate to meet
						clinical expectations; and
(3) Ensure
						that test results include pertinent information required for interpretation;
						and
(4) Communicate matters about
						quality of test results reported and interpretation in relation to specific patient
						conditions.
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 2.3 - CLINICAL LABORATORY SUPERVISORS › Section 1036.1 - General Supervisor

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Every
						clinical laboratory director, under whom high complexity tests or examinations are
						performed, shall either perform the duties of a general supervisor or employ a
						general supervisor who shall be responsible for day-to-day supervision of laboratory
						operation and personnel performing and reporting high complexity tests, pursuant to
						Section 1209, chapter 3 of Business and
						Professions Code.
(b) A general
						supervisor shall:
(1) Possess an active, valid
						license issued by the State to perform high complexity testing pursuant to chapter 3
						of Business and Professions Code or to practice medicine, osteopathy or podiatry
						pursuant to chapter 5 of Business and Professions Code appropriate to the specialty
						or specialties they are supervising; and
(2) Have a minimum of two years' experience in
						high complexity testing in the specialty or specialties they are
						supervising.
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 2.3 - CLINICAL LABORATORY SUPERVISORS › Section 1036.2 - Moderate Complexity Laboratory Technical Consultant

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Every laboratory director, under whom moderate
						complexity tests or examinations are performed, shall either perform the duties of a
						moderate complexity laboratory technical consultant or employ a moderate complexity
						laboratory technical consultant who is responsible for providing technical and
						scientific consultation for each of the specialties and subspecialties
						performed.
(b) A moderate complexity
						laboratory technical consultant of a laboratory performing moderate complexity
						testing shall:
(1) Possess an active, valid license
						issued by the State pursuant to chapter 3 of the Business and Professions Code to
						perform high complexity testing, or to practice medicine, osteopathy or podiatry
						pursuant to chapter 5 of Business and Professions Code appropriate to the specialty
						or specialties for which he or she is consulting; and
(2) Have a minimum of two years' experience in
						moderate or high complexity testing in the specialty or specialties for which he or
						she is consulting.
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 2.3 - CLINICAL LABORATORY SUPERVISORS › Section 1036.3 - Waived Laboratory Supervisor

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
						laboratory director of a clinical laboratory performing waived tests may delegate or
						reapportion his or her responsibilities, as allowed by Section
						1209
						of the Business and Professions Code, by utilizing a waived laboratory supervisor.
						Except for a waived laboratory supervisor of a laboratory performing blood glucose
						testing by a person certified as an Emergency Medical Technician II or Paramedic
						pursuant to Division 2.5 (commencing with section
						1797) of the Health and Safety Code and
						pursuant to subsection (c) and (d), a waived laboratory supervisor shall:
(1) Be listed in Section
						1206.5
						of the Business and Professions Code; and
(2) Possess at least a baccalaureate degree from
						an accredited college or university; and
(3) Have at least one year of training or
						experience in clinical laboratory testing in those tests or examinations that he or
						she will be supervising; and
(4)
						Document competency in those tests he or she will be supervising to the laboratory
						director at least semiannually during the first year and annually, or whenever new
						instrumentation is added, thereafter.
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 2.3 - CLINICAL LABORATORY SUPERVISORS › Section 1036.4 - Technical Supervisor

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Every
						laboratory director, under whom high complexity tests or examinations are performed,
						shall either perform the duties of a technical supervisor or employ a technical
						supervisor who is responsible for the technical and scientific oversight of the
						laboratory.
(b) A technical supervisor
						of a laboratory performing high complexity testing shall:
(1) Possess an active, valid, license issued by
						the state to perform high complexity testing pursuant to chapter 3 of Business and
						Professions Code or to practice medicine, osteopathy or podiatry, pursuant to
						chapter 5 of Business and Professions Code appropriate to the specialty or
						specialties for which they are consulting; and
(2) Meet the experience requirements in Section
						493.1449 of Title 42 of the Code of
						Federal Regulations, as published October 1, 1994.
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 2.5 - Continuing Education › Section 1038 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The definitions set
						forth in subsections b through j inclusive shall govern the interpretation of this
						article.
(b) "Contact Hour" means the
						actual time a licensee participates in continuing education offered by an approved
						provider, utilizing the following conversion standards:
50-60 minutes = 1 contact hour
0.1 continuing education unit (CEU) = 1 contact hour
1 quarter unit = 10 contact hours
1 semester unit = 15 contact hours
(c) "Accredited Academic Institution" means an
						academic institution accredited by the Western Association of Schools and Colleges
						or an accrediting organization recognized by the Council of Post Secondary
						Education.
(d) "Accrediting Agency"
						means an organization approved by the Department pursuant to Section
						1038.5 which evaluates and grants
						approval to providers of continuing education who comply with the standards of that
						agency, and who are other than those identified in (c) above.
(e) "Approved Provider" means an accredited
						academic institution or any person or entity offering continuing education who has
						been approved by an accrediting agency.
(f) "Licensee" means those persons other than
						clinical laboratory technologist trainees licensed pursuant to Chapter 3 (commencing
						with section 1200) of Division 2 of the Business and
						Professions Code.
(g) "Quarter Unit" and
						"Semester Unit" means the hours of instruction offered by an accredited academic
						institution which are credited by that institution as a quarter unit and semester
						unit respectively.
(h) "Active Status"
						means a current license in good standing which authorizes the licensee to perform
						the functions described in this chapter.
(i) "Inactive Status" means a license which is not
						in good standing because the holder has not completed the continuing education
						requirements of this article or has voluntarily requested that the license be made
						inactive.
(j) "Continuing Education
						Program" means a presentation given by an approved provider at a scheduled time or
						times which conforms to the requirements of section
						1038.6.
1. New
						  Article 2.5 (sections
						  1038-1038.7) and section filed 1-28-94;
						  operative 1-28-94 pursuant to Government Code section
						  11346.2(d)
						  (Register 94, No. 4).
2. Change without regulatory effect amending
						  subsections (d) and (j) filed 10-10-2022 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2022, No. 41).
Note: Authority cited: Sections
							 1224
							 and
							 1275,
							 Business and Professions Code; and Section
							 208,
							 Health and Safety Code. Reference: Section
							 1275,
							 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 2.5 - Continuing Education › Section 1038.1 - Continuing Education Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All
						persons licensed under Division 2, Chapter 3 of the Business and Professions Code,
						commencing with Section
						1200, whose license is in active status
						shall complete 12 contact hours of continuing education each calendar year. All
						persons licensed with more than one active license type pursuant to Division 2,
						Chapter 3 of the Business and Professions Code shall be able to renew all license
						types after completion of a total of 12 contact hours of continuing education each
						calendar year.
(b) At the time of
						renewal, each licensee shall provide the Department with the date, name and number
						of contact hours received for each continuing education program successfully
						completed by the licensee in the previous calendar year.
(c) The licensee shall retain continuing education
						documents received from approved providers under Section
						1038.7 for a minimum of four
						years.
(d) A random sample of licensees
						shall be audited by the Department to determine compliance with the continuing
						education requirement. Those licensees selected for audit shall submit to the
						Department, within 30 calendar days of notification of selection, a copy of each
						document provided the licensee under section
						1038.7(c) since the
						date of last license renewal.
(e) Any
						licensee who is found to have not successfully completed the continuing education
						requirement of this article will be placed in inactive status. The licensee shall
						have the right to appeal such findings to the Department. An appeal shall be
						conducted in compliance with chapter 5 (commencing with section
						11500) of Part 1 of Division 3 of Title
						2 of the Government Code.
1. New
						  section filed 1-28-94; operative 1-28-94 pursuant to Government Code section
						  11346.2(d)
						  (Register 94, No. 4).
2. Change without regulatory effect amending
						  subsections (c) and (d) filed 10-10-2022 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2022, No. 41).
Note: Authority cited: Sections
							 1224
							 and
							 1275,
							 Business and Professions Code; and Section
							 208,
							 Health and Safety Code. Reference: Section
							 1275,
							 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 2.5 - Continuing Education › Section 1038.2 - Waiver of Requirement

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) At the
						time of making application for renewal of a license issued pursuant to Division 2,
						Chapter 3 of the Business and Professions Code (BPC), a licensee may request a
						waiver of all or part of the continuing education requirement. To be eligible for a
						waiver, a license holder shall verify in writing that he or she:
(1) Was residing in another country for at least
						half the license period since the license was issued or, if the license was
						previously renewed, since it was last renewed, and that this reasonably prevented
						completion of the continuing education requirements; or
(2) Was absent from California for at least half
						the license period since the license was issued or, if previously renewed, since it
						was last renewed, because of military service, and that this reasonably prevented
						completion of the continuing education requirements; or
(3) Was prevented from completing the continuing
						education requirements for reasons of ill health or other good cause, including, but
						not limited, to:
(A) Total physical and/or mental
						disability of the licensee for at least half of the period since the license was
						issued or, if previously renewed, since it was last renewed; or
(B) Total physical and/or mental disability of an
						immediate family member for at least half of the period since the license was issued
						or, if previously renewed, since it was last renewed, where the licensee has total
						responsibility for the care of that family member.
(4) Verification of a disability under paragraph
						(3) shall include a corroborating statement by a licensed
						physician.
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 2.5 - Continuing Education › Section 1038.3 - Inactive Status

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A licensee whose license issued pursuant to Division 2,
						  Chapter 3 of the Business and Professions Code is in inactive status shall document
						  12 hours of continuing education for the year prior to reinstatement or pass the
						  examination for licensure prior to reinstatement to active status.
1. New
						  section filed 1-28-94; operative 1-28-94 pursuant to Government Code section
						  11346.2(d)
						  (Register 94, No. 4).
2. Change without regulatory effect renumbering
						  former section 1038.3 to section
						  1038.6 and renumbering former section
						  1038.6 to section
						  1038.3 filed 10-10-2022 pursuant to
						  section 100, title 1, California Code of
						  Regulations (Register 2022, No. 41).
Note: Authority cited: Sections
							 1224
							 and
							 1275,
							 Business and Professions Code; and Section
							 208,
							 Health and Safety Code. Reference: Section
							 1275,
							 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 2.5 - Continuing Education › Section 1038.4 - Fees

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A fee of $250.00
						shall accompany an application for approval or renewal as an accrediting
						agency.
(b) At the time of initial
						application or renewal of a clinical laboratory personnel license, an additional fee
						of $8.00 shall be paid by each licensee to support the costs of administering and
						enforcing the continuing education requirements of this article.
1. New
						  section filed 1-28-94; operative 1-28-94 pursuant to Government Code section
						  11346.2(d)
						  (Register 94, No. 4).
2. Change without regulatory effect renumbering
						  former section 1038.4 to section
						  1038.7 and renumbering former section
						  1038.7 to section
						  1038.4 filed 10-10-2022 pursuant to
						  section 100, title 1, California Code of
						  Regulations (Register 2022, No. 41).
Note: Authority cited: Sections
							 1224
							 and
							 1275,
							 Business and Professions Code; and Section
							 208,
							 Health and Safety Code. Reference: Section
							 1275,
							 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 2.5 - Continuing Education › Section 1038.5 - Accrediting Agencies

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Any
						organization seeking approval as an accrediting agency 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
						structure, function, and philosophy for monitoring the content, quality, and faculty
						of approved programs; and,
(3) The
						person designated by the organization to be responsible for overseeing the
						administration and coordination of all continuing education providers approved by
						the organization.
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 2.5 - Continuing Education › Section 1038.6 - Approval of Providers

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) An
						accrediting agency shall approve only providers who offer continuing education
						programs that meet all of the following criteria:
(1) Use instructors who are competent in subject
						matter by education, training or experience;
(2) Are a minimum of 50 minutes in duration
						excluding evaluation by participants of the continuing education program;
(3) Are relevant to the scope of practice of
						clinical laboratory science and may include education, supervision, and
						management;
(4) Have clearly stated,
						measurable, education objectives; and,
(5) Use teaching methods which are consistent with
						the objectives of the continuing education program.
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 2.5 - Continuing Education › Section 1038.7 - Approved Providers

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) No person
						or entity shall represent itself as an approved provider unless approved by an
						accrediting agency or unless it is an accredited academic institution.
(b) Approved providers shall issue certificates to
						participants which include:
(A) The participant's
						name;
(B) Contact hours;
(C) Date of continuing education
						provided;
(D) Name and address of both
						program provider and accrediting agency; and,
(E) Signature of instructor and/or provider or
						provider designee.
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 2.8 - CLIA CERTIFICATION/STATE LICENSURE › Section 1039.1 - Recognition of CLIA Certification for Limited Purpose and Period

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Except for a certificate of accreditation
						issued by HHS, a CLIA certificate issued to a clinical laboratory that on December
						31, 1995 was not required to obtain a state license pursuant to Section
						1241 of Chapter 3, shall be considered
						to be a state license or registration issued pursuant to Chapter 3 until such time
						as CLIA exempt status is obtained, provided that the CLIA certificate is for the
						type and complexity of clinical laboratory tests or examinations performed and that
						it remains in effect, unsuspended and unrevoked during the entire period covering
						January 1, 1996 to when CLIA exempt status is granted by HHS.
(b) A certificate of accreditation issued by HHS
						to a clinical laboratory that on December 31, 1995 was not required to obtain a
						state license pursuant to Section
						1241 of Chapter 3, shall be considered
						a state license or registration issued pursuant to Chapter 3 until such time as the
						accreditation body, upon whose accreditation the certificate of accreditation was
						issued by HHS, fails to be approved by the department as having accreditation
						standards that are equal to, or more stringent than, state requirements for
						licensure; and, provided that:
(1) The certificate
						of accreditation issued by HHS is for the type and complexity of clinical laboratory
						tests or examinations performed and that it remains in effect, unsuspended and
						unrevoked; and
(2) After exempt status
						is obtained, the accredited laboratory pays the department the $100 annual
						certificate of accreditation renewal fee.
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 2.8 - CLIA CERTIFICATION/STATE LICENSURE › Section 1039.2 - Clinical Laboratory Personnel Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All persons performing, supervising,
						consulting on, or directing clinical laboratory tests or examinations in California
						shall meet the requirements for performing, supervising, consulting on, or directing
						laboratory tests or examinations as set forth in Chapter 3 for the type and
						complexity of tests performed and irrespective of whether the clinical laboratory is
						operated under a CLIA certificate or under a state license or
						registration.
(b) All persons
						performing, supervising, consulting on, or directing clinical laboratory tests or
						examinations outside California on biological specimens originating in California,
						and irrespective of whether the clinical laboratory where the tests or examinations
						are performed is operated under a CLIA certificate or under a state license or
						registration, shall meet all personnel requirements set forth in Chapter 3 for the
						type and complexity of testing performed, or shall provide evidence to the
						department that they substantially meet those requirements by documenting inclusion,
						licensure or certification in a class of personnel similar to those required in
						Chapter 3 or requiring equivalent standards.
1. New
						  section 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.
2.
						  New 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.
3.
						  Certificate of Compliance as to 10-7-96 order, including amendment 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,
							 1206.5,
							 1209,
							 1241,
							 1244,
							 1265,
							 1281
							 and
							 1288.5,
							 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 2.8 - CLIA CERTIFICATION/STATE LICENSURE › Section 1039.3 - State Licensure or Approval Required During CLIA Exemption

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
All clinical laboratories except those identified in
						  subdivision (b) of Section
						  1241, or in Section
						  1244
						  of the Business and Professions Code, shall have in effect a state license or state
						  registration, and all public health laboratories shall be approved public health
						  laboratories during any period for which HHS grants CLIA exempt status for clinical
						  laboratories or public health laboratories licensed, registered or approved by the
						  department.
1. New
						  section 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.
2.
						  New 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.
3.
						  Certificate of Compliance as to 10-7-96 order 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,
							 1241,
							 1244,
							 1265,
							 1281
							 and
							 1288.5,
							 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 3 - LICENSE › Section 1040 - Forfeited Licenses

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) No license
						which has been forfeited for failure to pay the required fee shall be reinstated
						until a written request for reinstatement and all unpaid fees have been received by
						the department.
(b) If the renewal fee
						is not paid for five or more years, an examination will be required in addition to
						the requirements of subsection (a) above before the license may be reinstated,
						except as otherwise provided in Division 2, Chapter 3, Section
						1301
						of the Business and Professions Code.
1. Amendment
						  filed 2-18-58; effective thirtieth day thereafter (Register 58, No.
						  3).
2. Amendment filed 11-25-70 as procedural and organizational;
						  designated effective 11-24-70 (Register 70, No. 48).
3. Certificate of
						  Compliance--Sec.
						  11422.1, Gov. Code, filed 1-20-71
						  (Register 71, No. 4).
Note: Authority cited: Sections
							 102 and
							 208,
							 Health and Safety Code. Reference: Section
							 1303,
							 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 3 - LICENSE › Section 1041 - Fee Credits

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Each clinical laboratory that pays a fee subject to
						  reduction under subdivision (u) of Section
						  1300
						  of the Business and Professions Code shall have any reduction credited against the
						  clinical laboratory's future license, registration or other fees payable under
						  Chapter 3.
1. New
						  section filed 11-25-70 as procedural and organizational; designated effective
						  11-24-70 (Register 70, No. 48).
2. Certificate of Compliance--Sec.
						  11422.1, Gov. Code, filed 1-20-71
						  (Register 71, No. 4).
3. Amendment of subsection (a) filed 6-5-78;
						  effective thirtieth day thereafter (Register 78, No. 23).
4. Repealer
						  filed 4-22-82; effective thirtieth day thereafter (Register 82, No.
						  17).
5. New 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 section heading, section and NOTE
						  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 amendment 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: Section
							 1300,
							 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 3 - LICENSE › Section 1042 - Substantial Relationship Criteria

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Four purposes of denial, suspension or revocation of a
						  license, certificate or permit pursuant to Division 1.5 (commencing with Section
						  475) of the Business and Professions
						  Code, a crime or act shall be considered to be substantially related to the
						  qualifications, functions, or duties of a person who is an applicant or holder of a
						  license, certificate or permit under Chapter 3, Division 2, of the Business and
						  Professions Code if to a substantial degree it evidences present unfitness of a
						  person holding a license, certificate or permit to perform the functions authorized
						  by such license, certificate or permit in a manner consistent with the public
						  health, safety or welfare. Such crimes or acts shall include but not be limited to
						  the following:
(a) Violating or attempting
						to violate, directly or indirectly, or assisting in or abetting the violation of, or
						conspiring to violate, any provision of Chapter 3, Division 2 of the Business and
						Professions Code.
(b) Acts of
						dishonesty, fraud or deceit with intent to substantially benefit himself or another,
						or substantially injure another.
(c)
						Acts of gross negligence in the performance of functions authorized by the license,
						certificate or permit under Chapter 3, Division 2, of the Business and Professions
						Code.
A license, certificate or permit shall not be denied,
						  suspended or revoked because of a lack of good moral character or any similar ground
						  relating to a person's character, reputation, personality or
						  habits.
1. New
						  section filed 12-12-75; effective thirtieth day thereafter (Register 75, No. 50).
						  For former history, see Register 71, No. 4.
Note: Authority cited: sections
							 208,
							 3901,
							 15020
							 and
							 25800-
							 25870,
							 Health and Safety Code; section
							 1224,
							 Business and Professions Code. Reference: Sections
							 3901,
							 15000-
							 15023
							 and
							 25811,
							 Health and Safety Code; Sections
							 475,
							 480,
							 481,
							 482,
							 and
							 1242.5,
							 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 3 - LICENSE › Section 1042.1 - Criteria for Evaluating Rehabilitation

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) When considering the denial of a license,
						permit or certificate under Section
						480
						of the Business and Professions Code, for which application has been made under
						Chapter 3, Division 2, of the Business and Professions Code, the Department, in
						evaluating the rehabilitation of the applicant and his present eligibility for a
						license, permit or certificate, shall consider the following criteria:
(1) The nature and severity of the act(s) or
						crime(s) under consideration as grounds for denial.
(2) Evidence of any act(s) committed subsequent to
						the act(s) or crime(s) under consideration as grounds for denial which also could be
						considered as grounds for denial under Section
						480
						of the Business and Professions Code.
(3) The time that has elapsed since commission of
						the act(s) or crime(s) referred to in subsection (a) (1) or (a) (2).
(4) The extent to which the applicant has complied
						with any terms of parole, probation, restitution or any other sanctions lawfully
						imposed upon the applicant.
(5)
						Evidence, if any, of rehabilitation submitted by the applicant.
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 4 - PERSONNEL REPORT › Section 1045 - Personnel Report

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
All clinical laboratory directors shall on or before
						  December 15th of each calendar year transmit to the department, on forms provided by
						  the department, the names of all persons performing clinical laboratory procedures
						  including, but not limited to biochemical, bacteriological, parasitological,
						  hematological, or serological procedures. All clinical laboratory directors shall
						  keep the department advised of current changes in employment of such technical
						  personnel giving employment and/or separation dates of personnel.
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 - Clinical Laboratory Operations › Section 1050 - Clinical Laboratory Standards. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  subsection (h) filed 2-17-77; effective thirtieth day thereafter (Register 77, No.
						  8). For prior history, see Register 76, No. 51.
2. Amendment of
						  subsections (c), (f)(2)(A) and (B), (f)(3)(A), (g)(2)(A) and (B)3, (g)(2)(C)2,
						  (g)(3) filed 10-13-78; effective thirtieth day thereafter (Register 78, No.
						  41).
3. Change without regulatory effect repealing subsections (a)-(c)(9)
						  and (e)-(h), redesignating former subsection (d) as first paragraph and former
						  subsections (d)(1)-(5) as subsections (a)-(e) and amending NOTE filed 5-25-2016
						  pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2016, No. 22).
4. Change without regulatory effect
						  repealing section filed 7-24-2017 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2017, No. 30).
5. Amendment of article heading
						  filed 6-11-2020; operative 10-1-2020 (Register 2020, No.
						  24).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code. Reference: Sections
							 1220
							 and
							 1224,
							 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 - Clinical Laboratory Operations › Section 1051 - Proficiency Testing Services

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A service may be approved by the department for proficiency
						  testing laboratories providing the service:
(a) Makes available to each participating
						laboratory
(1) Materials not less than four times
						during each calendar year for testing those procedures which have been designated by
						the department for evaluation,
(2)
						Acceptable forms for reporting results of proficiency testing,
(3) An evaluation of test results reported by the
						participating laboratory showing acceptable results based on a reference system
						approved by the department, and
(4) A
						summary of results reported by all participating laboratories prepared at least
						annually.
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 - Clinical Laboratory Operations › Section 1052 - Satisfactory Performance in Proficiency Testing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The standards for satisfactory performance for laboratories
						  operating in accordance with Subsections (b) and (g), Sections
						  1241, Division 2, Chapter 3, Business
						  and Professions Code shall be those outlined in Section
						  1050(b) of this
						  Title.
1. New
						  section filed 12-28-71; effective thirtieth day thereafter (Register 72, No.
						  1).
2. Amendment filed 2-17-77; effective thirtieth day thereafter
						  (Register 77, No. 8).
Note: Authority cited: Sections
							 1224
							 and
							 1241.1,
							 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 5.2 - TEST KITS APPROVED FOR OVER-THE-COUNTER SALE TO THE PUBLIC BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION › Section 1053.5 - HIV Tests

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The Department hereby adds to the tests that may be
						  requested and reported pursuant to Business and Professions Code section
						  1246.5
						  any laboratory test or examination to identify HIV, a component of HIV, or
						  antibodies or antigens to HIV when the test or examination has been approved by the
						  United States Food and Drug Administration for sale to the public without a
						  prescription in the form of an over-the-counter test kit.
1. New
						  article 5.2 (section
						  1053.5) and section filed 11-6-96 as an
						  emergency; operative 11-6-96 (Register 96, No. 45). A Certificate of Compliance must
						  be transmitted to OAL by 3-5-97 or emergency language will be repealed by operation
						  of law on the following day.
2. Certificate of Compliance as to 11-6-96
						  order transmitted to OAL 3-4-97 and filed 4-15-97 (Register 97, No.
						  16).
Note: Authority cited: Sections
							 1224
							 and
							 1246.5,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Section
							 1246.5,
							 Business and Professions Code; and Section
							 120775,
							 Health and Safety Code.