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.
Notes
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).
