In the screening process, there may be some of the dried blood spot left over. Learn more below about the protocols in place in handling the remaining sample.
Is all of the dried blood spot used?
Frequently, a very small amount of sample is left after the screening is complete. Iowa law allows these to be stored for a period of five years in a locked, secure facility at the State Hygienic Laboratory in Ankeny, Iowa. After this time the blood spots are destroyed. All identifying information is protected by being stored separately and given a unique identification number.
Why does Iowa store the residual dried blood spot specimens?
The leftover dried blood spot is used for several different purposes. The babies’ names and dates of birth are kept confidential.
First, they are used to monitor the quality of testing and accuracy of results, a common practice in most laboratories. The same test done a month apart should yield the same result.
Second, they are used to make sure that improved testing methods are running properly.
Finally, they can be used for the benefit of your child and family later on. A child’s sample may be accessed if other health problems develop, the results need to be repeated, a missing or deceased child needs to be identified or investigated or parents request risk information for future pregnancies.
Are the specimens used for research?
Per Iowa Administrative Code 641 IAC 4:
Retention, use and disposition of residual newborn screening specimens.
Research. A residual newborn screening specimen may be released for research purposes only if written consent has been received by the researcher from a parent or guardian of the child, or the individual adult upon whom the screening was performed, and each of the following conditions is satisfied:
(1) Investigators shall submit proposals to use residual newborn screening specimens to the center. Any intended use of the requested specimens as part of the research study must be clearly delineated in the proposal.
(2) Before research can commence, proposals shall be approved by the researcher’s institutional review board, the congenital and inherited disorders advisory committee, and the department.
(3) Research on residual newborn screening specimens shall be allowed only in instances where research would further: newborn screening activities; the health of an infant or child for whom no other specimens are available or readily attainable; general medical knowledge for existing public health surveillance activities; public health purposes; or medical knowledge to advance the public health.
(4) For specimens collected prior to January 1, 2016, a parent or guardian may send a letter stating that the newborn’s specimen is not to be released for research purposes. This letter shall include the parent’s or guardian’s name, the newborn’s name at birth, and the newborn’s date of birth. The letter of notice shall be sent to the State Hygienic Laboratory at Newborn Screening Program, State Hygienic Laboratory, 2220 S. Ankeny Blvd., Ankeny, Iowa 50023-9093.
Newborn screening program operations. Residual newborn screening specimens may be used for activities, testing, and procedures directly related to the operation of the newborn screening program, including confirmatory testing, laboratory quality control assurance and improvement, calibration of equipment, evaluation and improvement of the accuracy of newborn screening tests, and validation of equipment and screening methods, and the use of linked specimens in feasibility studies approved by the Congenital and Inherited Disorders Advisory Committee for the purpose of incorporating new tests or evaluating new test methodologies.
Prohibited uses. A residual newborn screening specimen shall not be released to any person or entity for commercial purposes or law enforcement purposes or to establish a database for forensic identification.
What about my baby’s DNA?
The State Hygienic Laboratory does not routinely conduct DNA analysis on newborn screening specimens. It may be done as needed to identify a particular genetic mutation in order to create a plan of care for the baby. The recommendation for DNA analysis is typically given to the baby’s primary care provider. DNA within the blood samples does not breach confidentiality of the owner, as another sample must be provided for comparison to make identification.
What if I don't want my baby's specimen stored after the newborn screening is completed?
If you do not want your baby's left over blood spots stored at the State Hygienic Laboratory, please contact the Iowa Newborn Screening Program Executive Officer at 1-800-383-3826 to discuss options. You may chose to have the left over blood spots destroyed or returned to you.
Below are the forms you would need to fill out and send to the newborn screening program executive officer:
Request to Destroy Left Over Blood Spots
Request for Return of Left Over Blood Spots