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 6 - California Biobank Program › Article 1 - Definitions › Section 6550 - California Biobank Program Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
For the purposes of this group the following definitions
						  under authority of the California Hereditary Disorders Act (Sections
						  124975
						  through
						  124996
						  of the California Health and Safety Code (HSC), Newborn Screening (Sections
						  125000 through
						  125002 of the HSC), and Prenatal
						  Testing (Sections
						  125050 through
						  125119.5 of the HSC) apply.
(a) "Batch" means biospecimens that are located in
						the same box, bag, bin or other container in the California Biobank Program's
						storage facilities.
(b) "Biospecimen"
						means a blood sample collected from a person for the purposes of newborn or prenatal
						testing and which may be subsequently stored for program development or research
						purposes.
(c) "California Biobank
						Program" or "CBP" means the administrative activities performed by the Department in
						connection with the storage and distribution of biospecimens, including assessment
						of research requests for biospecimens, and the establishment of fees related to
						biospecimens.
(d) "California Birth
						Defects Monitoring Program" or "CBDMP" is part of Maternal Child and Adolescent
						Health or MCAH and is one of the programs that makes up the CBP and which is
						administered by the California Department of Public Health.
(e) "Case biospecimen" means one specific
						biospecimen requested by a researcher that is defined according to criteria provided
						by the researcher and is from an individual known to have a specific
						condition.
(f) "Control biospecimen"
						means one specific biospecimen that is defined by the researcher and is from an
						individual that is not thought to have a specific condition.
(g) "Department" means the California Department
						of Public Health, Center for Family Health.
(h) "Genetic Disease Screening Program" or "GDSP"
						is one of the programs that makes up the CBP and which is administered by the
						California Department of Public Health.
(i) "Newborn Biospecimen" means a sample of blood
						that was collected and screened for specific disorders by the Department's Newborn
						Screening Program and stored by the CBP after testing is completed.
(j) "Newborn Screening Program" or "NBS" means the
						program within GDSP that screens newborns in California for genetic or congenital
						disorders. Screening takes place in Department approved screening
						laboratories.
(k) "Newborn Screening
						Specimen Collection Filter Paper Card" means the Department filter paper that
						biospecimens are collected on.
(l)
						"Prenatal Biospecimen" means a sample of blood collected from a pregnant woman for
						the Department's Prenatal Screening Program. The biospecimens are screened by the
						Department and those biospecimens that are stored, are processed and separated into
						two components, serum aliquot and cell pellet.
(m) "Prenatal Screening Program" or "PNS" means
						the program within GDSP that screens pregnant women for prenatal birth defects.
						Screening takes place in Department approved screening laboratories.
(n) "Screening Information System" or "SIS" means
						the CBP's databases and associated data entry screens. Researchers will be granted
						access to designated SIS screens that they will use to request biospecimens and/or
						data and upload research request documents.
1. New group
						  6 (articles 1-5, sections
						  6550-6557.3), article 1 (section
						  6550) and section filed 5-20-2014 as an
						  emergency; operative 5-20-2014. Submitted to OAL for filing and printing only
						  pursuant to Health and Safety Code section
						  124977
						  (Register 2014, No. 20). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  this regulation shall not be repealed by OAL and shall remain in effect until
						  revised or repealed by the department.
2. Editorial correction of HISTORY
						  1 (Register 2014, No. 45).
3. Statement of compliance pursuant to Health
						  and Safety Code section
						  124977(d)(1)
						  as to 5-20-2014 order filed 1-21-2015. Exempt from OAL review pursuant to Health and
						  Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing pursuant to Government Code section
						  11343.8
						  (Register 2015, No. 4).
Note: Authority cited: Sections
							 124977,
							 124991,
							 125002,
							 131050,
							 131051,
							 131052
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124975-
							 124996,
							 125000,
							 125001,
							 125002
							 and
							 125050-
							 125119.5,
							 Health and Safety Code.