Section 6550 - California Biobank Program DefinitionsFor 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.Cal. Code Regs. Tit. 17, § 6550
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.
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. 21). The department must comply with Health and Safety Code section 124977(d)by 11-17-2014 or the regulation will be repealed by operation of law.
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).