reglab/statecodes huggingface dataset:
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 3 - Newborn Screening Program › Article 2 - Testing and Follow-up Program Requirements › Section 6507.1 - Local Agency Responsibilities

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
						The county registrar of births shall provide a copy of the informational material
						prepared and provided by the Department to each person registering the birth of a
						newborn that occurred outside of a perinatal licensed health facility when the said
						newborn was not admitted to a perinatal licensed health facility within the first 30
						days of age. The local health officer and the Department shall be notified of each
						such registration by the county registrar.
(b) Each local health department in the county
						where a newborn resides shall be responsible for making every reasonable effort to
						obtain specimens when requested by the Department-approved Newborn Screening Area
						Service Center or the Department. If after every reasonable effort a specimen cannot
						be obtained, the local health department may, after 30 days, with approval from the
						Department, terminate efforts.
1.
						  Renumbering of former Section
						  6507 to Section
						  6507.1 filed by the Department of
						  Health Services with the Secretary of State on 12-22-89 as an emergency; operative
						  12-22-89. Submitted to OAL for printing only pursuant to Health and Safety Code
						  Section
						  309(g)
						  (Register 90, No. 4). For prior history, see Register 86, No. 47.
2.
						  Change without regulatory effect amending section heading, section and NOTE filed
						  10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
3. Editorial correction of section
						  heading (Register 2006, No. 44).
Note: Authority cited: Sections
							 124980
							 and
							 125000,
							 Health and Safety Code. Reference: Sections
							 124980
							 and
							 125000,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 3 - Newborn Screening Program › Article 3 - SICKLE CELL PROGRAMS › Section 6507.2 - Sickle Cell Education and Counseling Program Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Each sickle cell education and counseling
						program shall apply for and obtain written approval from the Department of Health
						Services. Such approval shall be contingent upon compliance with all sections of
						this Group.
(b) Each sickle cell
						education and counseling program shall:
(1)
						Provide counseling services to the clients.
(2) Employ State-approved sickle cell counselors
						to perform all of the counseling following, or relating to, any abnormal
						hemoglobinopathy finding.
(3)
						Demonstrate, upon request by the Department of Health Services, that each of its
						counselors successfully participates in State-approved educational programs which
						serve to update the knowledge and enhance the proficiency of such
						counselors.
(4) Have a physician with
						special training and experience in pediatric hematology to serve as medical director
						or consultant to order and interpret laboratory tests used in counseling.
(5) Have written protocols to protect the
						confidentiality and security of all records containing personal
						information.
(6) Use only State-approved
						educational materials.
(7) Use any
						laboratory that meets the Department's standards for sickle cell hemoglobin
						testing.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 3 - Newborn Screening Program › Article 3 - SICKLE CELL PROGRAMS › Section 6507.3 - Certification of a Sickle Cell Counselor

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A sickle cell counselor shall obtain a
						certificate of approval from the Department of Health Services upon presentation of
						written evidence that he or she has:
(1) Completed
						a course at a sickle cell counselor training center approved by the Department with
						such center's endorsement of his or her ability to function as a sickle cell
						counselor, and/or
(2) Successfully
						completed an examination or examinations which demonstrate his or her knowledge or
						expertise in the field, and one or more personal interviews to demonstrate an
						understanding of, and ability to communicate with persons who have sickle cell
						disease or sickle cell trait.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 3 - Newborn Screening Program › Article 3 - SICKLE CELL PROGRAMS › Section 6507.4 - Voluntary Participation

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Participation by any person in a sickle cell education and
						  counseling program in which medical information is obtained through interview, test
						  or other ascertainment procedure shall be wholly voluntary and shall not be a
						  prerequisite to eligibility for, or receipt of, any other services or assistance
						  from, or to participation in any other program.
1. New
						  section filed by the Department of Health Services with the Secretary of State on
						  12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only
						  pursuant to Health and Safety Code section
						  309(g)
						  (Register 90, No. 4).
2. Renumbering of section
						  6507.4 to section
						  6507.3 and renumbering of section
						  6507.5 to section
						  6507.4 filed 4-20-92 as an emergency;
						  operative 4-20-92 (Register 92, No. 18). A Certificate of Compliance must be
						  transmitted to OAL 8-18-92 or emergency language will be repealed by operation of
						  law on the following day.
3. Certificate of Compliance as to 4-20-92
						  order transmitted to OAL 8-17-92 and filed 9-28-92 (Register 92, No.
						  40).
4. Change without regulatory effect amending NOTE filed 10-12-2006
						  pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125025,
							 Health and Safety Code. Reference: Sections
							 124980,
							 125000,
							 125025
							 and
							 125030,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 3 - Newborn Screening Program › Article 3 - SICKLE CELL PROGRAMS › Section 6507.5 - Informed Consent

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A sickle
						cell education and counseling program shall obtain informed consent from each adult
						upon whom testing or any other screening procedure is to be performed. If the person
						is a minor other than a newborn, informed consent shall be obtained from such
						child's parent or guardian. An informed consent shall be obtained from an
						emancipated minor without the need for parent or guardian consent.
(b) The informed consent shall be in writing in
						format approved by the Department and shall be signed by the person, by his or her
						guardian or, except in the case of an emancipated minor, by his or her
						parent.
1. New
						  section filed by the Department of Health Services with the Secretary of State on
						  12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only
						  pursuant to Health and Safety Code section
						  309(g)
						  (Register 90, No. 4).
2. Renumbering of section
						  6507.5 to section
						  6507.4 and renumbering of section
						  6507.6 to section
						  6507.5 filed 4-20-92 as an emergency;
						  operative 4-20-92 (Register 92, No. 18). A Certificate of Compliance must be
						  transmitted to OAL 8-18-92 or emergency language will be repealed by operation of
						  law on the following day.
3. Certificate of Compliance as to 4-20-92
						  order transmitted to OAL 8-17-92 and filed 9-28-92 (Register 92, No.
						  40).
4. Editorial correction of HISTORY 2 (Register 95, No.
						  18).
5. Change without regulatory effect amending NOTE filed 10-12-2006
						  pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
Note: Authority cited: Section
							 124980,
							 125000
							 and
							 125025,
							 Health and Safety Code. Reference: Sections
							 124980,
							 125000,
							 125025
							 and
							 125030,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 3 - Newborn Screening Program › Article 3 - SICKLE CELL PROGRAMS › Section 6507.6 - Approval of Hemoglobin Testing Laboratories

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All laboratories that accept specimens from an
						approved sickle cell counseling program shall be in compliance with the Business and
						Professions Code governing licensed clinical laboratory operations and personnel
						(commencing with Section
						1200
						of the Business and Professions Code) or be an approved public health laboratory
						operated in accordance with the California Health and Safety Code, Section
						101150
						et seq.
(b) All laboratories involved in
						sickle cell screening as specified in this Article shall use a test or combination
						of tests with demonstrated ability to distinguish hemoglobins including F, A, S, C,
						D, and E, as well as the thalassemias.
(c) The State Department of Health Services shall
						have the responsibility of monitoring sickle cell screening laboratories coming
						under the scope of this Article. Such monitoring may be accomplished by on-site
						inspections and proficiency testing, or any other effective method. The Department
						may deny, revoke, or suspend the approval of any laboratory which does not comply or
						continue to comply with the above qualifications.
1. New
						  section filed by the Department of Health Services with the Secretary of State on
						  12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only
						  pursuant to Health and Safety Code section
						  309(g)
						  (Register 90, No. 4).
2. Renumbering of section
						  6507.6 to section
						  6507.5 and renumbering of section
						  6507.7 to section
						  6507.6 filed 4-20-92 as an emergency;
						  operative 4-20-92 (Register 92, No. 18). A Certificate of Compliance must be
						  transmitted to OAL 8-18-92 or emergency language will be repealed by operation of
						  law on the following day.
3. Certificate of Compliance as to 4-20-92
						  order transmitted to OAL 8-17-92 and filed 9-28-92 (Register 92, No.
						  40).
4. Change without regulatory effect amending section heading,
						  section and NOTE filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125025,
							 Health and Safety Code. Reference: Sections
							 124980,
							 125000,
							 125025
							 and
							 125030,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 3 - Newborn Screening Program › Article 3 - SICKLE CELL PROGRAMS › Section 6507.7 - Sickle Cell Trait Carrier Follow-Up Vendor

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A sickle cell trait follow-up vendor shall
						mean any sickle cell education and counseling program that:
(1) Is approved under this Group, and
(2) Signs a vendor agreement to provide services
						in accordance with Department policies, including a fee schedule provided by the
						Department. The Department may obtain and provide reimbursements for any or all
						follow-up services authorized as a result of newborn sickle cell screening from such
						approved vendors.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 3 - Newborn Screening Program › Article 4 - Newborn Screening Participation Fee › Section 6510 - Rhesus (Rh) Hemolytic Disease of the Newborn. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 3-16-70; effective thirtieth day thereafter (Register 70, No.
						  12).
2. Amendment of subsection (a)(1) filed 2-2-71; effective thirtieth
						  day thereafter (Register 71, No. 6).
3. Editorial correction filed
						  11-5-84 (Register 84, No. 45).
4. Change without regulatory effect
						  renumbering former section
						  6510 to section
						  6529 filed 10-12-2006 pursuant to
						  section 100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
Note: Authority cited: Sections
							 151,
							 208 and
							 306(b),
							 Health and Safety Code. Reference: Sections
							 304,
							 305 and
							 306,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.3 - Analyte. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.5 - Birth Defect. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.7 - Clinician. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.9 - Differential Diagnostic Screening Tests and Procedures. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125065
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.11 - Expanded AFP Follow-Up Vendor. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125065
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.13 - Expanded AFP Prenatal Birth Defects Screening Laboratory. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125065
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.15 - Expanded AFP Prenatal Screening for Birth Defects. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125065
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.17 - Gestational Age. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.19 - Inadequate Specimen. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125065
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.21 - Initial Screening Positive Test. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125065
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.23 - Initial Specimen. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125065
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.25 - Method. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125065
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.27 - Neural Tube Defect. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125065
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.29 - Prenatal Diagnosis Center. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125065
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 1 - Definitions › Section 6521.31 - Repeat Specimen. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect adopting section filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
2. Repealer filed 12-20-2019 as an
						  emergency; operative 12-20-2019 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this repeal shall remain in effect until revised or repealed by the
						  department.
3. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 125070,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125065
							 and
							 125070,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 3 - Testing and Follow up Program Requirements › Section 6523 - Prenatal Birth Defects Screening Laboratories and Analytical Methods

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Only
						prenatal birth defects screening laboratories certified as clinical laboratories in
						compliance with the federal and state regulations under Division 2, Chapter 3
						(commencing with Section
						1200)
						of the Business and Professions Code in contract with the Department may participate
						in the California Prenatal Screening Program.
(b) Prenatal birth defects screening laboratories
						that choose to participate in the California Prenatal Screening Program shall be
						limited to the following:
(1) A laboratory shall
						have obtained a contract from the Department under applicable laws and regulations
						to provide laboratory services in sufficient volume to provide prenatal screening
						for fetal autosomal trisomies, sex chromosome aneuploidies, fetal sex if requested,
						and other genetic conditions detectable by cfDNA screening as determined by the
						Department, or prenatal screening for neural tube defects to pregnant individuals,
						in a quantity specified in their contract, plus an emergency testing capacity that
						will be specified by contract.
(2) A
						laboratory exclusively serving a comprehensive prepaid group practice or health care
						service plan with 20,000 or more births in the last completed calendar year for
						which complete statistics are available may be approved for testing consistent with
						the terms of a mutually acceptable contract for services with the
						Department.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 3 - Testing and Follow up Program Requirements › Section 6527 - Clinician Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Clinicians
						shall provide or cause to be provided to all pregnant individuals in their care
						before 21 weeks 0 days (147 days) of gestation, or before 19 weeks 0 days (133 days)
						from conception, as estimated by medical history or clinical testing, information
						regarding the California Prenatal Screening Program. This information shall be in a
						format provided by the Department and shall be given at the first prenatal visit and
						discussed with each pregnant individual.
(b) The provisions of subsection (a) shall not
						apply if the pregnant individual has completed more than 21 weeks 0 days (147 days)
						of gestation or 19 weeks 0 days (133 days) post conception, as estimated by medical
						history or clinical testing, and this fact is entered in the medical
						record.
(c) Clinicians shall cause to be
						provided to all pregnant individuals who, after being provided with the information
						pursuant to subsection (a), voluntarily request to participate in the California
						Prenatal Screening Program and receive prenatal screening for fetal autosomal
						trisomies, sex chromosome aneuploidies, and other genetic conditions as determined
						by the Department, and/or prenatal screening for neural tube defects, the
						opportunity, to complete consent documentation in a format provided by the
						Department, the circumstances of which are to be documented in the medical record.
						Maternal plasma and serum specimens must be accompanied by the pregnant individual's
						completed Department-designated consent form to be analyzed for screening.
(d) Clinicians must offer patients the opportunity
						to accept or reject screening for fetal sex detection and must record the patient's
						choice on the test requisition form.
(e)
						If the pregnant individual consents to testing, the clinician shall arrange for
						prenatal screening directly or by referral to another clinician by:
(1) Fully and accurately completing all required
						specimen collection forms (physical or electronic copy) provided by the Department
						for this purpose;
(2) Collecting or
						arranging for the collection of specimens following state directions for collection
						provided;
(3) As soon as possible, but
						within 24 hours of collection, place or cause to be placed all specimens in the
						channel of transmittal to the designated prenatal birth defects screening
						laboratory.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 3 - Testing and Follow up Program Requirements › Section 6531 - Reporting of Neural Tube Defects

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All
						cases of neural tube defect in a fetus or an infant under one year of age shall be
						reported to the Department.
(b) This
						report shall be made:
(1) By the health facility
						in which the case is initially diagnosed;
(2) By the physician making the initial diagnosis
						if the case is not diagnosed in a health facility;
(3) Within 30 calendar days of the initial
						diagnosis;
(4) On the form provided by
						the Department for this purpose, CDPH 4427 (11/2015), incorporated by
						reference.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 3 - Testing and Follow up Program Requirements › Section 6532 - Reporting of Chromosomal Disorders

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All cases of chromosomal defects in a fetus or
						an infant under one year of age shall be reported to the Department. Chromosomal
						defects shall mean any abnormality in structure or number of chromosomes.
(b) This report shall be made:
(1) by the laboratory performing the chromosomal
						analysis or by the physician making the diagnosis;
(2) within 30 calendar days of the initial
						diagnosis;
(3) on a form provided by the
						Department for this purpose, CDPH 4427 (11/2015), incorporated by
						reference.