Newborn screening is mandated by law in Minnesota for the early identification of disorders that can affect a baby’s health and life. Newborn screening is done by a small heel stick between 24 and 48 hours of birth. Parents may refuse screening by opting out in writing. The Parental Refusal of Newborn Screening (opt-out) form (PDF: 52KB/1 page) is available on the Newborn Screening web site. Without screening, your baby could die or have permanent and severe health problems, such as physical disability and developmental delays. Each year, the Newborn Screening Program finds about 150 babies whose lives are improved or saved by newborn screening. Additionally, over 150 babies a year are found to have a hearing loss through Newborn Hearing Screening.

The drops of blood are collected on special filter paper, dried, and sent to the Minnesota Department of Health (MDH) laboratory where they are tested for over 50 disorders that can cause serious health problems like illness, physical disability, mental retardation, or even death if left untreated. MDH securely stores these samples for 71 days, at which point they are destroyed. The newborn screening results are securely stored for two years.

Yes, the Mayo Clinic is under contract with MDH to perform some of the newborn screening tests. Biochemical Genetics Laboratory staff at the Mayo Clinic are experts in testing for disorders of amino acids, organic acids, and fatty acids. Rather than duplicating the work and equipment available at the Mayo Clinic, MDH sends part of each specimen to the Mayo Clinic for testing.

Newborn screening requires a very small amount of blood and most of this blood is used up in the testing. The amount remaining depends on how much blood is collected on the cards at the hospital and whether the results of the tests require further testing for confirmation of the result. The amount of dried blood left on the filter paper is smaller than a dime.

A dried blood spot is the tiny amount of dried blood that is placed on the special filter paper used to do newborn screening. This is the only type of specimen MDH has; MDH does not have tubes of blood.

MDH and the Mayo Clinic currently store the leftover specimens for 71 days, at which point they are destroyed. Prior to November 16, 2011, MDH and the Mayo Clinic stored leftover bloodspots for several reasons. To make sure MDH has the best newborn screening program operations, samples of the leftover blood are used for quality control testing. Quality control is a process to monitor the quality of testing and accuracy of results. Using leftover samples for quality control purposes is a common practice in all clinical and hospital labs. The babies’ names and date of birth are not revealed when the dried blood spots are used for quality testing. Quality testing ensures that test results are reliable and consistent. Like all clinical labs, MDH and the Mayo Clinic want to make sure that the testing done one month gives the same results as the testing done the next month.

Currently MDH and the Mayo Clinic do not use the specimens for any other reason other than to test your baby. Prior to Novembe 16, 2011, MDH or the Mayo Clinic used some specimens when testing begins for a new disease or when an improved testing method starts in the lab, professional staff need 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 quality testing.

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

Currently no Minnesota stored blood spots are being used for any public health studies or research. Prior to November 16, 2011 public health studies or research may have been done only if researches followed these guidelines: Public health studies and research may be done only if the researchers follow these guidelines:

• The project must have been 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 were removed before the sample is provided.
• The project must have been approved by the Institutional Review Board (IRB) where the researcher worked to make sure it met high ethical standards and to ensure that the privacy and safety of the babies was fully protected.
• The project must have been approved by the Institutional Review Board (IRB) at MDH to make sure it met high ethical standards and to ensure that the privacy and safety of the babies was fully protected.

Currently the cards are securely stored in a freezer for 71 days at which point they are destroyed. Prior to November 16, 2011, the cards containing the very small bit of leftover blood are securely stored. MDH takes the utmost care to ensure that all stored blood samples are secure. Specimens received by MDH between July 1, 1997 and September 7, 2005 are securely stored in an offsite protected record center. MDH employees do not have direct access to these specimens. Requests for specimens housed at the offsite record center go through both a trained Records Coordinator and the outside record management and document storage facility. Specimens received by MDH beginning September 8, 2005 are stored onsite in a locked storage room. Only MDH employees who have received thorough data privacy training are allowed access to this area.

Specimens collected since July 1, 1997 are still stored by MDH. Since the Mayo Clinic does some of the testing for all Minnesota babies, samples are stored there as well. The blood specimens sent to the Mayo Clinic are destroyed two years after they arrive. Like MDH, the Mayo Clinic also securely stores specimens in a secure storage area.

Yes, parents who do not want their child's sample being stored by MDH or the Mayo Clinic can complete the "Directive to Destroy" form (PDF: 57KB/1 page).

MDH maintains the highest commitment to respecting parents' rights and privacy in newborn screening. A letter confirming that the destruction has taken place will be sent to the address provided on the "Directive to Destroy" form (PDF: 57KB/1 page).

No, MDH does not release blood or test results from newborn screening to insurance companies. Further, it is against federal law to use test results to discriminate against people with genetic conditions.

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. 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 MDH to compare to the dried blood spot before any identification could be made.

No, it is not true. The only specimen stored is the tiny bits of leftover blood on the cards. We do not store extracted DNA. No “DNA profile” or unique DNA sequence is ever created.

No, all 5 dried blood spots are collected in order to ensure newborn screening can be completed. A spot is NOT collected for the sole purpose of storage.

There are several ways you can get more information about storage and use of dried blood spots in Minnesota. The Newborn Screening website has additional information about newborn screening in general, as well as storage and use. You can also contact the Newborn Screening Program at health.newbornscreening@state.mn.us or call 651-201-5466 or (800) 664-7772 and ask to speak to one of the genetic counselors on staff. We encourage you to contact us with any questions or concerns you might have.