Section 661.220  Retention of Specimens

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.

(Source:  Amended at 49 Ill. Reg. 4706, effective March 25, 2025)