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 1 - Definitions › Section 6500.50 - Newborn Screening Specimen

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Newborn Screening Specimen" means a blood sample taken from
						  an infant that is collected on CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM
						  (NBS-TRF) (CDPH-4409).
1. New
						  section filed 4-4-2016 as an emergency; operative 4-4-2016 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
						  (Register 2016, No. 15). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the Department
						  of Public Health.
2. Statement of Compliance pursuant to Health and
						  Safety Code section
						  124977(d)(1)
						  as to 4-4-2016 order filed 4-17-2017. 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 2017, No. 16). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
3. Amendment filed 6-6-2019 as an emergency; operative
						  6-6-2019 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
						  (Register 2019, No. 23). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
4. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 6-6-2019 order filed 9-30-2019. 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 2019, No. 40).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 125000,
							 131050,
							 131051
							 and
							 131052,
							 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 1 - Definitions › Section 6500.51 - Newborn Screening Test

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Newborn Screening Test" means a biochemical or other assay
						  of blood spots collected from an infant for the purpose of determining whether the
						  newborn might be at increased risk for certain genetic and other congenital
						  disorders for which early identification and treatment may prevent disability and/or
						  death.
1. New
						  section filed 4-4-2016 as an emergency; operative 4-4-2016 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
						  (Register 2016, No. 15). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the Department
						  of Public Health.
2. Statement of Compliance pursuant to Health and
						  Safety Code section
						  124977(d)(1)
						  as to 4-4-2016 order filed 4-17-2017. 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 2017, No. 16). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 125000,
							 131050,
							 131051
							 and
							 131052,
							 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 1 - Definitions › Section 6500.55 - Out-of-Hospital Newborn Screening Providers

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Out-of-Hospital Newborn Screening Providers" means:
(a) All healthcare professionals including, but
						not limited to, licensed midwives (LM), certified nurse midwives (CNM), registered
						nurses (RN), physician assistants (PA), pediatric nurse practitioners (PNP),
						physicians/medical doctors (MD), doctors of osteopathy (DO), and naturopathic
						doctors (ND), who are licensed or certified by the State to provide maternal care
						and to deliver pregnant women in alternative settings other than perinatal licensed
						health facilities including, but not limited to, private homes and clinics;
						and
(b) Staff of health care entities,
						such as clinics and free-standing independent laboratories that are authorized by
						the Department to collect newborn screening specimens in alternative settings other
						than perinatal licensed health facilities.
1. New
						  section filed 4-4-2016 as an emergency; operative 4-4-2016 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
						  (Register 2016, No. 15). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the Department
						  of Public Health.
2. Statement of Compliance pursuant to Health and
						  Safety Code section
						  124977(d)(1)
						  as to 4-4-2016 order filed 4-17-2017. 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 2017, No. 16). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 125000,
							 131050,
							 131051
							 and
							 131052,
							 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 1 - Definitions › Section 6500.57 - Perinatal Licensed Health Facility

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Perinatal licensed health facility" means any health
						  facility licensed by the State and approved to provide perinatal, delivery, newborn
						  intensive care, newborn nursery or pediatric services.
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).
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 1 - Definitions › Section 6500.58 - Perinatal Licensed Health Facility Staff

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Perinatal Licensed Health Facility Staff" means the
						  individuals working in the laboratory, maternal, or nursery departments of perinatal
						  licensed health facilities who collect the newborn screening
						  specimens.
1. New
						  section filed 4-4-2016 as an emergency; operative 4-4-2016 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
						  (Register 2016, No. 15). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the Department
						  of Public Health.
2. Statement of Compliance pursuant to Health and
						  Safety Code section
						  124977(d)(1)
						  as to 4-4-2016 order filed 4-17-2017. 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 2017, No. 16). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 125000,
							 131050,
							 131051
							 and
							 131052,
							 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 1 - Definitions › Section 6500.59 - Preventable Heritable or Congenital Disorder

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Preventable heritable or congenital disorder" means any
						  disorder or abnormality present at birth which is detectable by testing a newborn
						  and for which effective means of prevention or amelioration
						  exists.
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).
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 1 - Definitions › Section 6500.65 - Recall Specimen

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 4-4-2016 as an
						  emergency; operative 4-4-2016 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
						  (Register 2016, No. 15). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the Department
						  of Public Health.
3. Statement of Compliance pursuant to Health and
						  Safety Code section
						  124977(d)(1)
						  as to 4-4-2016 order filed 4-17-2017. 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 2017, No. 16). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
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 1 - Definitions › Section 6500.67 - Recall Test

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 4-4-2016 as an
						  emergency; operative 4-4-2016 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
						  (Register 2016, No. 15). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the Department
						  of Public Health.
3. Statement of Compliance pursuant to Health and
						  Safety Code section
						  124977(d)(1)
						  as to 4-4-2016 order filed 4-17-2017. 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 2017, No. 16). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
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 1 - Definitions › Section 6500.69 - Repeat Specimen

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Repeat specimen" means a specimen collected from a newborn
						  following the newborn screening laboratory's report that a previously collected
						  specimen was either inadequate or that test results were
						  inconclusive.
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).
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 1 - Definitions › Section 6500.70 - Repeat Test

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Repeat test" means a test required by this Group to be
						  repeated for a newborn because the previous specimen or test results were inadequate
						  or test results were not complete.
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).
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 1 - Definitions › Section 6500.71 - Screening Information System (SIS)

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Screening Information System (SIS)", in this Group, means
						  the Department Newborn Screening Program's database and associated screens
						  that:
(a) List the newborn screening
						specimens that have been received by the Department for testing; and
(b) Provide for reporting of those specimens that
						are missing.
This system is to be used to verify receipt of specimens and
						  report those that have not been received pursuant to §
												6506.
1. New
						  section filed 4-4-2016 as an emergency; operative 4-4-2016 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
						  (Register 2016, No. 15). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the Department
						  of Public Health.
2. Statement of Compliance pursuant to Health and
						  Safety Code section
						  124977(d)(1)
						  as to 4-4-2016 order filed 4-17-2017. 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 2017, No. 16). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 125000,
							 131050,
							 131051
							 and
							 131052,
							 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 1 - Definitions › Section 6500.74 - Sickle Cell Counselor

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Sickle cell counselor" means a person who:
(a) Is a physician, or has a master's degree in
						genetic counseling and is board eligible or board certified by the American Board of
						Genetic Counseling, or is certified by the Department of Public Health as having
						successfully completed an approved sickle cell counselor training program;
						and
(b) Provides face-to-face
						information on the medical, social, and genetic consequences of sickle cell disease
						and trait.
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. Change without regulatory effect
						  amending subsection (a) and NOTE filed 8-13-2009 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2009, No. 33).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124980,
							 125000,
							 125025,
							 131050,
							 131051
							 and
							 131052,
							 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 1 - Definitions › Section 6500.77 - Sickle Cell Education and Counseling Program

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Sickle cell education and counseling program" means an
						  educational and counseling program in which the disease orientation is, in whole or
						  in major part, sickle cell disease.
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. Change without regulatory effect
						  amending section and NOTE filed 8-13-2009 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2009, No. 33).
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124980,
							 125000,
							 125025,
							 131050,
							 131051
							 and
							 131052,
							 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 1 - Definitions › Section 6500.78 - This Group

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"This Group" means Group 3. Newborn Screening Program in the
						  official California Code of Regulations as follows: 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.
1. New
						  section filed 4-4-2016 as an emergency; operative 4-4-2016 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
						  (Register 2016, No. 15). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the Department
						  of Public Health.
2. Statement of Compliance pursuant to Health and
						  Safety Code section
						  124977(d)(1)
						  as to 4-4-2016 order filed 4-17-2017. 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 2017, No. 16). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
Note: Authority cited: Sections
							 124980,
							 125000
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 125000,
							 131050,
							 131051
							 and
							 131052,
							 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 1 - Definitions › Section 6500.80 - Transfer

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Transfer" means release of the newborn from care and
						  custody of one perinatal licensed health facility to care and custody of another
						  perinatal licensed health facility, or admission to another perinatal licensed
						  health facility of a newborn from an out-of-state facility.
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).
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 2 - Testing and Follow-up Program Requirements › Section 6501 - Scope of Newborn Testing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Except for provisions in §
												6501.2 and §
												6502, each newborn born in California
						  shall be tested for galactosemia, hereditary hemoglobinopathies, phenylketonuria,
						  primary congenital hypothyroidism and disorders authorized for testing in Health and
						  Safety Codes 124977, 124980 and 125001 in accordance with procedures in this
						  Group.
1. New
						  section filed 4-11-80; designated effective 9-1-80 (Register 80, No.
						  15).
2. Amendment filed 11-21-86; effective thirtieth day thereafter
						  (Register 86, No. 47).
3. Amendment of subsections (a) and (c) 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).
4. Change without regulatory effect adding article
						  2 heading and amending section and NOTE filed 10-12-2006 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 2006, No. 41).
5. Amendment of section and NOTE
						  filed 4-4-2016 as an emergency; operative 4-4-2016 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
						  (Register 2016, No. 15). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the Department
						  of Public Health.
6. Statement of Compliance pursuant to Health and
						  Safety Code section
						  124977(d)(1)
						  as to 4-4-2016 order with amendments filed 4-17-2017. 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 2017, No. 16). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
Note: Authority cited: Sections
							 124977,
							 124980,
							 124996,
							 125000,
							 125001
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 125000,
							 125001,
							 125025,
							 131050,
							 131051
							 and
							 131052,
							 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 2 - Testing and Follow-up Program Requirements › Section 6501.2 - Religious Objection

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
						provisions of Section
						6501 shall not apply if a parent or
						legally appointed guardian objects to a test on the ground that it conflicts with
						his or her religious beliefs or practices. If the parent or legal guardian refuses
						to allow the collection of a blood specimen, such refusal shall be:
(1) made in writing,
(2) signed by a parent or legally appointed
						guardian, and
(3) included in the
						newborn's medical or hospital record.
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 6502 - Fatal Condition

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The provisions of Section
						  6501 shall not apply if the newborn has
						  a condition almost certain to be fatal in the first 30 days of life. The prognosis
						  shall be documented in the medical record.
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). For prior history, see Register 87, No.
						  47.
Note: Authority cited: Sections
							 124980
							 and
							 125000,
							 Health and Safety Code. Reference: Section
							 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 2 - Testing and Follow-up Program Requirements › Section 6502.1 - Confidentiality

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All information,
						records of interview, written reports, statements, notes, memoranda, or other data
						procured by an individual, group or research team in the course of any testing under
						this Group shall be confidential and shall be used solely for the purposes of
						medical intervention, counseling, or specific research project approved by the
						Department.
(b) Except as provided by
						law, such information shall not be exhibited nor disclosed in any way, in whole or
						in part, by any individual, group, or research team except with the written consent
						of the person or his/her legally authorized representative unless such data can be
						made available in a manner which preserves anonymity of the persons
						tested.
1. New
						  section filed by the Department of Health Services with the Secretary of State on
						  5-30-90 as an emergency; operative 5-30-90. Submitted to OAL for printing only
						  pursuant to Health and Safety Code section
						  309(g)
						  (Register 90, No. 30).
2. Change without regulatory effect amending
						  subsection (a) 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
							 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 2 - Testing and Follow-up Program Requirements › Section 6504 - Parent Education: Birth Attendants

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
All birth attendants engaged in providing perinatal care
						  shall provide pregnant women, prior to the estimated date of delivery, with a copy
						  of the informational material, entitled "Important Information for Parents,"
						  provided by the Department.
1. New
						  section filed 4-11-80; designated effective 9-1-80 (Register 80, No.
						  15).
2. Amendment of subsection (f) filed 8-29-80 as an emergency
						  (Register 80, No. 35). A certificate of compliance must be filed within 120 days or
						  emergency language will be repealed on 12-28-80.
3. Certificate of
						  Compliance transmitted to OAL 12-15-80 and filed 1-12-81 (Register 81, No.
						  3).
4. Repealer and new section filed 11-21-86; effective thirtieth day
						  thereafter (Register 86, No. 47).
5. 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
							 and
							 125000,
							 Health and Safety Code. Reference: Sections
							 124980,
							 125000
							 and
							 125001,
							 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 2 - Testing and Follow-up Program Requirements › Section 6504.2 - Parent Education: Perinatal Licensed Health Facilities

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Perinatal licensed health facilities shall provide each
						  pregnant woman admitted for delivery with a copy of the informational material
						  provided by the Department, entitled "Important Information for Parents" prior to
						  collection of the blood specimen if such information has not been provided pursuant
						  to Section 6504. If a woman is unable to read such
						  material, it shall be translated or read to her in a language she
						  understands.
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).
Note: Authority cited: Sections
							 124980
							 and
							 125000,
							 Health and Safety Code. Reference: Sections
							 124980,
							 125000
							 and
							 125001,
							 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 2 - Testing and Follow-up Program Requirements › Section 6504.4 - Specimen Collection Forms

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Department
						approved specimen collection forms shall not be copied, printed, reproduced,
						acquired, purchased or distributed other than as provided for in this
						Group.
(b) Such Department approved
						specimen collection forms shall be fully and accurately completed by birth
						attendants, perinatal licensed health facilities and laboratories; and a copy shall
						be filed in each newborn's medical record.
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).
Note: Authority cited: Sections
							 124980
							 and
							 125000,
							 Health and Safety Code. Reference: Sections
							 124980,
							 125000
							 and
							 125001,
							 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 2 - Testing and Follow-up Program Requirements › Section 6504.6 - Record Maintenance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Perinatal licensed health facilities shall maintain such
						  records as are necessary to assure compliance with this Group and provide the
						  Department with such data as may be periodically required including, but not limited
						  to, information on all newborns discharged or transferred from the facility without
						  collection of a blood specimen. All such information and records shall be
						  confidential, but shall be open to examination by the Department personnel or its
						  designated agents for any purpose directly connected with the administration of the
						  newborn screening program.
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).
Note: Authority cited: Sections
							 124980
							 and
							 125000,
							 Health and Safety Code. Reference: Sections
							 124980,
							 125000
							 and
							 125001,
							 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 2 - Testing and Follow-up Program Requirements › Section 6505 - Collection of Newborn Screening Specimens

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) For each newborn born in a perinatal licensed
						health facility, the perinatal licensed health facility staff shall:
(1) Collect the newborn screening specimen, using
						the Instructions for Collecting Adequate Blood Specimens on the CALIFORNIA NEWBORN
						SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to §
													6501.5(a) and §
													6504.4(b). This
						specimen collection shall occur after 12 hours but no later than 48 hours of age
						prior to discharge or transfer of the newborn unless the newborn's condition is
						life-threatening and the collection cannot be done safely. Physicians attending
						critically ill newborns who require special care may postpone collection of a
						newborn screening specimen until the newborn's emergency condition is stabilized.
						The receiving perinatal licensed health facility staff shall then collect the
						newborn screening specimen using the Instructions for Collecting Adequate Blood
						Specimens on the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF)
						(CDPH-4409) pursuant to §
													6501.5(a) and §
													6504.4(b) as soon as
						the newborn's condition is stabilized. Any specimen collected on a newborn prior to
						12 hours of age is an early specimen and another specimen shall be collected after
						12 hours of age pursuant to §
													6505(a)(2) and §
													6506.6.
(2) Collect a newborn screening specimen prior to
						red blood cell transfusion when the newborn is stable, even if the newborn is under
						12 hours of age, using the Instructions for Collecting Adequate Blood Specimens on
						the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to
						§
													6501.5(a) and §
													6504.4(b).
(3) Ensure that specimens are given, on the
						same-day or next business day of the designated carrier, to a carrier contracted
						with the Department or contracted with a newborn screening laboratory or to another
						sameday or overnight delivery service for transport to the assigned newborn
						screening laboratory.
(4) Not collect a
						newborn screening specimen under this section if the parent or legal guardian has
						executed a refusal of the newborn screening test on the CALIFORNIA NEWBORN SCREENING
						TEST REQUEST FORM (NBS-TRF) (CDPH-4409) pursuant to §
													6501.2.
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 6506.2 - Newborns Discharged from a Perinatal Licensed Health Facility Without Testing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Whenever a perinatal
						licensed health facility determines that a discharged newborn has not received the
						mandated tests, the facility shall contact the newborn's physician by telephone to
						inform him/her that a specimen must be obtained and immediately send written
						notification to the newborn's physician and the Department. If the newborn's
						physician cannot be contacted or will not obtain a specimen, the perinatal licensed
						health facility shall notify the Department-approved Newborn Screening Area Service
						Center by telephone and shall send written notification within five days to the
						Newborn Screening Area Service Center and the Department.
(b) When the newborn's physician is notified by
						telephone by the perinatal licensed health facility that a newborn was discharged
						from the perinatal licensed health facility before a specimen was taken, the
						newborn's physician shall make every reasonable effort to have a specimen obtained
						within five days of notification. If the newborn's physician cannot obtain the
						specimen, the Newborn Screening Area Service Center shall be notified by the
						newborn's physician by telephone. Such telephone notification shall be noted in the
						newborn's physician's records, specifying the date of notification, the person
						notified and the information provided.
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).
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 2 - Testing and Follow-up Program Requirements › Section 6506.6 - Follow-Up to Reports of Inadequate and Early Newborn Screening Specimens

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) For those specimens
						identified by the Newborn Screening Area Service Center as early, or where the
						infant's age at time of specimen collection cannot be determined, the Newborn
						Screening Area Service Center shall verify with the collecting person or facility
						the dates and times of birth and specimen collection written on the CALIFORNIA
						NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409 -- (6/16)) NBS-I
						(F).
(b) Upon notification by the
						Newborn Screening Area Service Center that the specimen is verified as an early
						specimen, the perinatal licensed health facility staff, birth attendant,
						out-of-hospital newborn screening provider, or newborn's physician shall:
(1) collect a repeat specimen within 48 hours of
						notification, using the Instructions for Collecting Adequate Blood Specimens on the
						CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409 -- (6/16)) NBS-I
						(F) pursuant to §
													6501.5(a) and §
													6504.4(b).
(2) Ensure the specimen is given, on the same or
						next business day of the designated carrier, to a carrier contracted with the
						Department or contracted with a newborn screening laboratory or is transported by
						another same-day or overnight carrier to the assigned newborn 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 3 - Newborn Screening Program › Article 2 - Testing and Follow-up Program Requirements › Section 6506.8 - Follow-Up to Reports of Initial Positive Result

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) When the newborn's physician is notified by a
						Newborn Screening Area Service Center of a positive test result, the physician
						shall, within 48 hours of notification:
(1)
						Consult with a medical specialist from a California Children's Services (CCS) center
						or a CCS-paneled medical specialist, and upon the specialist's advice, shall refer
						the infant to a CCS center or a CCS paneled medical specialist for confirmatory
						testing and/or evaluation, diagnosis, and treatment; and
(2) Instruct the parents about medically necessary
						recommendations to care for the infant.
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 6506.10 - Repeat and Recall Specimen Collection and Transmittal

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) When repeat or confirmatory tests are
						required, the newborn's physician will ensure that:
(1) Repeat or confirmatory specimens are collected
						within 48 hours;
(2) Specimens are
						placed in containers appropriate for the specified test; and
(3) Specimens are transported, on the same or next
						business day of the designated carrier, by a carrier contracted with the Department
						or contracted with a newborn screening laboratory or by same-day or overnight
						carrier, to the assigned newborn 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 3 - Newborn Screening Program › Article 2 - Testing and Follow-up Program Requirements › Section 6506.12 - Diagnosis Reporting

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
All physicians making an initial diagnosis of a preventable
						  heritable disorder for which testing is required under this Group shall report such
						  diagnosis and provide the information necessary for follow-up and investigation to
						  the Department.
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).
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 2 - Testing and Follow-up Program Requirements › Section 6507 - Failure to Comply

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Willful or repeated failure to comply with this Group shall
						  be referred by any person having knowledge of non-compliance to the appropriate
						  licensing authority. Failure to report may constitute grounds for disciplinary
						  action including revocation of license.
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). For prior history, see Register 90, No.
						  4.
Note: Authority cited: Sections
							 124980
							 and
							 125000,
							 Health and Safety Code. Reference: Sections
							 124980,
							 124985
							 and
							 125000,
							 Health and Safety Code.