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Center for Congenital and Inherited Disorders

Iowa Neonatal Metabolic Screening Program (INMSP)

Storage and Use of Residual Newborn Screening Dried Blood Specimens

How is newborn dried blood spot (DBS) screening done?

Birthing providers collect a small sample of blood from the baby (usually by doing a "heel stick"), and put the drops of blood on a special filter paper. The paper is then dried and sent to the state designated central testing laboratory - the State Hygienic Laboratory at the University of Iowa (SHL). Iowa enlists a courier service to pick up the filter paper collection forms and deliver to the SHL on the same day. The SHL screens the DBS specimen for over 50 disorders that can cause serious health problems like illness, physical disability, mental retardation, or even death if left untreated.

Is all of the dried blood spot used?

After the screening tests are done, there is a very small amount of DBS left on the cards. Iowa law authorizes the SHL to store these residual, or leftover, DBS for a period of five years in a locked secure, facility at the SHL newborn screening lab in Ankeny, Iowa. The residual DBS specimens are stored for the first year at sub-zero temperatures, and then the remaining four years at room temperature in a locked, secure storage area. The specimens are destroyed after this time. All identifying information is stored separately from the residual DBS in an access protected data system. A unique identification number is used to link the identifying information to the DBS form if necessary.

Why does Iowa store the residual DBS specimens?

Iowa stores leftover DBS for several reasons. To make sure the SHL maintains the highest quality of operations, samples of the residual specimens are used for quality control testing. Quality control testing is a process to monitor the quality of testing and the accuracy of results. This is a common and even required practice in most laboratories. The baby's name and date of birth are not revealed when doing quality control testing. Quality testing ensures that test results are reliable and consistent. The SHL wants to be sure that the testing done one month gives the same result as the testing done the next month.

When testing begins for a new disease or when an improved testing method starts in the lab, professional staff needs to make sure the new test is running properly. This practice needs to be done on the same type of specimens that the testing will be done on, so all practice testing must be done on dried blood spots from newborns. The babies' names and dates of birth are not revealed when the dried blood spots are used for this testing.

In cases where a child later develops health problems, a parent or healthcare provider might request a repeat or other health-related testing on the residual specimen.

In some cases, results or samples are requested by the family or the baby's healthcare team:

  • The baby's results can be repeated if needed without getting another blood sample from the baby
  • The baby's sample is available to parents for other health-related testing
  • The baby's sample is available to parents to help identify a missing or deceased child.
  • Storage provides a permanent record that the IDPH completed the screening

Dried blood spots can help Iowa babies in other ways unrelated to newborn screening. If an infant dies without a cause of death being confirmed, and treatment prior to death (for example, blood transfusion) precludes evaluation, the infant's dried blood spots may be requested. For the purpose of closure in explaining the cause of the infant's death and providing risk information to the family for future pregnancies, a physician or genetic counselor may request a newborn specimen for diagnostic testing.

Throughout the world, dried blood spots are used to examine public health issues like childhood cancer, type I diabetes, lead poisoning, cytomegalovirus infection, and HIV/AIDS and other disorders affecting children.

Are the residual DBS specimens ever used for research?

Public health studies and research may be done only if the researchers follow these guidelines:

  • The project must be done to help develop a new newborn screening test or to better understand diseases for the benefit of the general public.
  • The baby's name and any identifying details about the baby are removed before the sample is provided.
  • The project must be approved by the Institutional Review Board (IRB) where the researcher works to make sure it meets high ethical standards and to ensure that the privacy and safety of the babies is fully protected.
  • The project must be approved by the Congenital and Inherited Disorders Advisory Committee to make sure it meets high ethical standards and to ensure that the privacy and safety of the babies is fully protected.
  • The project must be approved by the Iowa Department of Public Health to make sure all privacy and confidentiality laws are being followed.
  • Any researchers requesting residual DBS specimens with identifying information must go through the above channels, and in addition must first obtain informed, written consent from the individual, parent or guardian before the SHL will release any specimens.

NBS Research Proposals

What about my baby's DNA?

DNA is the hereditary material in humans; it can be found in all parts of the body including blood, hair, skin, and saliva. It contains the genetic instructions used in the development and functioning of all organisms. Changes or mutations in DNA can cause diseases, such as cystic fibrosis. DNA cannot be used to accurately predict personal traits like intelligence, athletic ability, or violent tendencies. Without another sample for comparison, DNA cannot be used to identify an individual person. For example, a person would have to provide another blood sample to the SHL to compare to the dried blood spot before any identification could be made.

The SHL does not store DNA. The Iowa Neonatal Metabolic Screening Program does not have the capacity to conduct routine DNA analysis on all newborn screening DBS specimens. DNA analysis may be done as needed to identify a specific genetic mutation; for example, if a newborn has a positive screening result indicating a risk for cystic fibrosis, DNA analysis may be conducted to identify the specific genetic mutation (some mutations are "harmless," others can be life-threatening) in order to proceed with an appropriate plan of care for the infant. The baby's primary health care provider is made aware of the recommendation for DNA analysis.

What information is available to prospective parents?

Iowa law requires birthing providers to provide information to parents about the Iowa Neonatal Metabolic Screening Program prior to any screening procedure. The Iowa Department of Public Health and the SHL provide the brochure "One Simple Screening Could Save Your Baby's Life," which has information regarding the screening procedure, conditions included in the screening panel, and information about the use and storage of residual specimens.

Parents/guardians have the option to waive the newborn metabolic screening for their infant. The pros and cons of this decision should be discussed with the health care provider. The provider will then document the request to waive the screening in the infant's medical record, and notify the SHL or Iowa Department of Public Health of this waiver.

The bottom line is that newborn screening saves lives. Every baby should be screened.

Update to Neonatal Metabolic Screening Waiver Process

Iowa Administrative Code (641 IAC 4) now allows birthing providers to document a parent's waiver for the neonatal metabolic screening in the infant's medical record without sending a waiver form to the Iowa Department of Public Health or the State Hygienic Laboratory at the University of Iowa.

Health care providers must provide documentation in the newborn's medical record regarding the parent's decision to waive the metabolic screening. The health care provider must then notify the State Hygienic Laboratory at the University of Iowa of the waiver; providing the mother's name, baby's date of birth, and baby's name and gender. Providers can call 515-725-1600 and leave a message, or may call the Iowa Department of Public Health toll-free at 1-800-383-3826.

Please contact Kimberly Noble Piper, State Genetics Coordinator, with any questions.

Newborn Screening for Severe Combined Immunodeficiency (SCID)

Parent Page --This page is for individuals wanting to know the basics of the Iowa Neonatal Metabolic Screening Program. It includes frequently asked questions, disorders screened for in Iowa, and contact information.

INMSP Healthcare Practitioner's Manual --This is a guide created to help the healthcare practitioner comply with Iowa rules and to better understand the Iowa Neonatal Metabolic Screening Program. 

Special Medical Formula Program --This program is for individuals with inherited diseases of amino acids and organic acids who are identified through the Iowa Neonatal Metabolic Screening Program. The State of Iowa provides the service.

INMSP Contact Information -- A listing of staff to answer your questions regarding INMSP.

Annual Reports

Other Information