a) Blood
spot samples received by the Department for newborn screening will be retained
for a minimum of two months.
b) If
all test results obtained from a blood spot sample are determined to be within
normal range, the sample will be retained for a maximum of four
months.
c) If any test result
obtained from a blood spot sample is determined to be abnormal (i.e., out of
normal range), the sample will be retained for a minimum of six
years.
d) Based on need, blood spot
samples with an abnormal result may be referred to other clinical laboratories
for supplemental testing to further characterize the abnormality.
e) Blood spot samples that the Department
retains may be used:
1) Within the Department
for quality control purposes as required under the Clinical Laboratory
Improvement Amendments (CLIA);
2)
Within the Department for the development, validation, and quality assurance of
newborn screening tests; and
3) For
the development, validation, and quality assurance of newborn screening tests
by public health newborn screening systems, newborn screening partners such as
the Centers for Disease Control and Prevention (CDC), and others authorized by
the Department
f) For
purposes of this subsection, the following definitions apply:
"Parent or legal guardian" means the mother or father of a
person under eighteen years of age or one who is legally appointed to the care
and management of a person under eighteen years of age or of a person incapable
of managing his or her own affairs.
"Portion" means a section of the residual blood spot sample
which may be less than, equal to, or greater than, the amount of sample
originally tested by the Department.
With consent from the parent or legal guardian, and
sufficient residual sample, a portion of a residual blood spot sample may be
released:
1) To a health care provider
or designated CLIA certified clinical laboratory for further analysis;
or
2) To the parent or legal
guardian.
A) The Department will charge a
$25.00 fee due to administrative costs related to disposition of residual
sample;
B) The Department will
release a portion of a residual blood spot sample upon receipt of the fee, and
a signed and notarized release form from the parent or legal guardian;
and
C) Following release of a
portion of a residual blood spot by the Department to the parent or legal
guardian, the parent or legal guardian will assume full responsibility,
including ownership, storage, security, integrity, and quality of their child's
residual sample.
3) The
Department will make the determination of blood spot sample sufficiency and
provision of residual specimen consistent with this Section and standard
operating procedures.
g)
After the maximum time period for retention, the Department will destroy all
blood spot samples. Residual blood spot sample destruction will be in
accordance with the Department's laboratory standard operating
procedures.
