§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 within the Department for quality control purposes as required under the Clinical Laboratory Improvement Amendments (CLIA).

 

f)         With consent from the parent or legal guardian, any remaining sample, that is residual blood spot sample, may be released to a health care provider or designated laboratory for further analysis.

 

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.