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After the Screen

Storage and use of Residual Newborn Screening Specimens

In the screening process, there may be a leftover specimen. The use and storage of this residual newborn screening specimen should be disclosed to the patient.

The following are questions that they may have throughout the process:

Key information for your patients:

  • The State Hygienic Lab tests for over 50 different disorders
  • Iowa law allows residual newborn screening specimens to be stored for five years in a locked, secure facility at the SHL lab in Ankeny, Iowa.
  • All identifying information is protected by being stored separately and given a unique identification number.
  • They can find more information here on our website.

What are they used for?

  • To monitor quality of testing and accuracy of results
  • To make sure that improved testing methods are running properly
  • To be accessed later on if a health problem develops
 
Per Iowa Administrative Code 641 IAC 4:
Retention, use and disposition of residual newborn screening specimens.
a. A newborn screening specimen collection form consists of a filter paper containing the dried blood spots (DBS) specimen and the attached requisition that contains information about the infant and birthing facility or drawing laboratory. The DBS specimen can be separated from the information contained in the requisition form. The INSP is the custodian of the specimens and related data for purposes of newborn screening, quality improvement and quality assurance activities.
(1) The residual DBS specimen shall be held for five years in a locked area at the SHL.
(2) The residual DBS specimen shall be stored for the first year at –75 to –80 degrees C.
(3) After one year, the residual DBS specimen shall be archived for four additional years at room temperature.
(4) The residual DBS specimen shall be incinerated after completion of the retention period.
b. The program shall not release a residual newborn screening specimen except to the following persons and entities:
(1) The parent or guardian of the infant or the individual adult upon whom the screening was performed.
(2) A health care provider acting on behalf of the patient.
(3) A medical examiner authorized to conduct an autopsy on a child or an investigation into the death of a child.
(4) A researcher, upon documentation of parental consent obtained by the researcher, and only to the extent that the information is necessary to perform research authorized by the department.
(5) The newborn screening program, for operations as provided in this rule. 
c. 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.
d. 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.
e. 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.
f. Return or destruction of specimens. A parent or guardian may request return or destruction of the parent’s or guardian’s newborn’s residual newborn screening specimen by contacting the executive officer of the center for congenital and inherited disorders by calling 1-800-383-3826, or by mail to Executive Officer, Center for Congenital and Inherited Disorders, Iowa Department of Public Health, 321 E. 12th Street, Lucas State Office Building, Des Moines, Iowa 50319-0075.
 
If the parent does not want their newborn's residual blood spot specimens stored

If the parents do not want their baby's left over blood spots stored at the State Hygienic Laboratory, they should contact the Iowa Newborn Screening Program Executive Officer at 1-800-383-3826 to discuss options. They may chose to have the left over blood spots destroyed or returned to them. 

Below are the forms they 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