minnesota newborn screening program
Frequently Asked Questions (Providers)
Who is responsible for collecting the newborn screening specimen?
Newborn blood spot screening is mandated by Minnesota Statutes 144.125-144.128; the statute establishes that the hospital caring for a newborn is responsible for collecting the newborn screening specimen.
How should the specimen be collected?
Because normal values and cutoffs for the newborn screening assays are determined from samples collected by heel-stick, national standards require that all newborn screening specimens be collected in this manner. For individual cases in which heel-stick collection is problematic (e.g., baby’s feet are bruised or injured, the baby is in the NICU), the MDH Newborn Screening Program recommends referring to the Specimen Collection page for the alternative methods of venipuncture or capillary tube collection:
Specimen Collection page
When should the specimen be collected?
Specimens must be collected between 24 and 48 hours of age. All normal values and reference ranges for newborn screening tests are based on specimens drawn from infants during this age window. Specimens drawn early or late may increase the chance of false positive or false negative results.
Under special circumstances, specimens may be drawn when an infant is less than 24 hours of age. For example, specimens are required on all babies prior to transfusion or early hospital discharge, even if this means collecting the specimen before 24 hours of age.
If parents ask for hospital discharge before 24 hours of age, a specimen should be collected prior to the infant going home. In addition, arrangements should be made for either a clinic appointment or a return to the hospital close to 48 hours of age for another screening specimen.
For babies less than 24 hours of age at the time of collection, results for some disorders cannot be classified as negative because normal values are not established for this age window. Therefore, if the values are normal for a specimen drawn at less than 24 hours of age, the results will be reported as “Unsatisfactory,” and a repeat specimen will be required to ensure accurate screening results.
Hemoglobinopathy, galactosemia, and biotinidase deficiency results are not impacted by the baby’s age at the time of collection; therefore, results for these disorders will be reported as usual. If an infant is “missed,” and a newborn screening specimen is not collected from an infant during the 24 to 48 hours timeframe, a specimen should still be sent immediately even if the baby is older than 48 hours of age.
Minnesota state law (MN Statute 144.966) requires all newborns to be screened for hearing loss before they are discharged from the hospital. There are two accepted technologies for performing newborn hearing screening: Automated Auditory Brainstem Response (AABR) and otoacoustic emissions (DPOAEs or TOAEs). National standards require that all newborn hearing screens be done using at least one of these technologies. Non-automated ABR testing is not recommended for nursery newborn hearing screening due to issues of potential operator error and significant time/cost effectiveness issues.
Information on proper use of newborn hearing screening technologies and recommended hearing screening protocols can be found on the Hearing Screening Information page.
When should newborn hearing screening occur?
The initial hearing screening should be performed at least 12 hours after birth. Hearing screening may be performed earlier if needed; however, a higher referral rate may occur due to residual birthing debris in the ear canal. For infants who fail the initial screen, rescreening the infant prior to hospital discharge is recommended.
What if a baby is born at home or out of the hospital?
The newborn screening statute applies to all births in Minnesota. The birth attendant is responsible for collecting a blood sample from a baby born outside of a hospital. If no screen is collected at birth, medical professionals caring for the baby in infancy should arrange to collect a screening specimen as soon as possible. The birth attendant should also make arrangements for the baby to have its hearing screened.
Does transfusion impact newborn screening results?
Whenever possible, a newborn screening specimen should be collected prior to a transfusion, even if the infant is less than 24 hours of age. Hemoglobinopathy, galactosemia, biotinidase deficiency, and cystic fibrosis results are impacted by transfusions; therefore, collecting a blood specimen prior to transfusion is critical to determining whether an infant is at risk for these disorders. Cases of these disorders have been missed because screening samples were collected after transfusion. Baby's age at time of collection is not used to interpret screening results for these 4 disorders. If an initial newborn screening specimen is collected prior to transfusion, and the infant is less than 24 hours of age, a second specimen should be collected. This second specimen is necessary because for some assays, normal values are not established for infants less than 24 hours of age.
If the initial specimen is drawn after a transfusion has taken place (and there is no pretransfusion specimen), a second specimen must be collected at 90 days after the last transfusion. The 90-day specimen allows the MDH Newborn Screening Program to accurately interpret those results which are impacted by transfusion. If an infant has a transfusion, hospital staff should check the “transfusion” field on the newborn screening card.
What if an infant is transferred?
Within Minnesota, the birth hospital is legally responsible for ensuring that newborn screening specimens are collected and sent to MDH for every baby born at their facility. Ideally, specimens should be collected before transfer even if the infant is less than 24 hours of age. If the infant is too unstable for collection or time does not permit collection of a screening specimen, the birth hospital should notify the receiving facility of the newborn's unscreened status. The birth hospital should transfer its responsibility for screening to the receiving hospital.
If an infant is transferred to your facility, please verify that a newborn screening specimen was collected and sent to MDH in the transport paperwork completed for each baby. If you cannot verify that a baby has been screened, it is better to rescreen the baby than to miss the opportunity. If a baby accepted for transfer is less than 24 hours old upon arrival, a screening specimen should be obtained by the receiving hospital.
It is especially easy for hearing screens to be missed when babies are transferred from one facility to another. In Minnesota, newborn hearing screening is the legal responsibility of the hospital that discharges the baby to home. MDH has created a special form to help ensure that all Minnesota babies receive the benefit of early hearing screening.
What about infants in the NICU?
Newborn screening is more complex for infants in the neonatal intensive care unit (NICU).
What about infants who cross state lines?
If you admit a baby born in another state, you should try to learn the baby’s screening status from the birth facility. If you are unsure that the baby has been screened it is appropriate to collect a sample for screening by MDH.
If you transfer an infant to another state, you should screen the baby before transfer. A baby born in Minnesota, but who resides in another state should have a newborn screening specimen collected on an MDH newborn screening card and sent to MDH. Special care should be taken to correctly fill out the demographic field entitled “Physician responsible for infant follow-up after discharge.” Birth hospitals should forward the newborn screening results to the infant’s health care provider, even if the clinic is located in a different state.
What if an infant has a family history of a disorder detected by newborn screening?
Please contact the MDH Newborn Screening Program before submitting a sample, if a family has a history of a disorder on the newborn screening panel.
In addition to newborn screening, infants who have a family history of a disorder detected by newborn screening should have definitive diagnostic testing for that particular disorder. This additional diagnostic testing after birth is necessary even if prenatal testing was performed. If a pregnant family has an older affected child, please contact a medical specialist prior to the delivery to plan for immediate evaluation of the baby.
What if an infant is adopted?
If a baby will not be going home with the birth mother, the demographic section of the newborn screening card should contain the contact information for the adoptive parent(s). The MDH Newborn Screening Program must be able to locate a baby with an abnormal result after hospital discharge. If an older infant is adopted and newborn screening was not done shortly after birth, a specimen should be collected and sent to MDH even if the child is older than one week of age. The screening program's normal ranges are set based on the neonatal period. Clinical testing is more appropriate than newborn screening for adopted children older than one year of age and for children whose medical history suggests they may be affected by one of the disorders on the screening panel.
Who informs parents about newborn screening?
Although the birth hospital is ultimately responsible for informing parents about newborn screening the Minnesota Newborn Screening Program encourages prenatal care providers to inform expectant parents about newborn screening sometime in the 3rd trimester. The Prenatal Brochure is a free resource that we encourage all prenatal providers to use.
Many parents are unaware that newborn screening happens amidst all of the activities following labor and delivery. Prenatal care providers are in a unique position to inform parents about this safe and easy way to ensure a healthy start for their babies.
Communicating to Parents About Newborn Screening
Is there newborn screening information for parents?
A fact sheet for parents is available from the MDH Newborn Screening Program and you can obtain free copies by contacting the program directly at (800) 664-7772. For babies with positive results, the MDH Newborn Screening Program has developed parent fact sheets for specific disorders.
What if the family doesn't speak English?
Prenatal Education Brochures and Newborn Screening Fact Sheets are presently available in English, Spanish, and Russian. These materials will be available electronically in additional languages soon (Hmong, Somali, and Karen).
Newborn hearing screening PASS and REFER sheets have been translated into Spanish, Hmong, and Somali.
Fact sheets about newborn screening in a variety of languages are found at the following sites:
Currently, newborn screening refusal forms are not available in any language other than English. In the event that a non-English speaking family refuses newborn screening, MDH recommends you have a translator available to both read the form to the family and answer any questions the family may have about newborn screening.
Can parents refuse newborn screening for their infant?
Parents and legal guardians have the option to refuse screening of their child. Parents must indicate their refusal in writing, and a copy must be submitted to the MDH Newborn Screening Program. The original form must be retained in the child’s medical chart with a copy provided to the parent(s) or legal guardian(s). The refusal form serves as documentation that the parents were informed about the possible adverse outcomes of not performing newborn screening and that they accept legal responsibility for the consequences of their decision.
How do I obtain a copy of newborn screening results?
MDH mails a paper copy of the newborn screening results back to the infant’s birth hospital, and the birth hospital is responsible for forwarding the results to the infant’s health care provider. If screening results are not forwarded to you by the birth hospital, contact the hospital first. If results are not available from the birth hospital, call the MDH Newborn Screening Program at (800) 664-7772.
When do newborn screens need to be repeated?
Occasionally, the baby’s health care provider will be asked to collect a repeat newborn screen after the baby has already been discharged from the hospital. Repeat newborn screen results are typically required after the initial screen has come back with borderline results for a specific disorder or when an initial specimen is unsatisfactory. If the results are borderline, staff from the Newborn Screening Program will call the baby’s health care provider to request a repeat specimen. If the specimen is unsatisfactory, staff from the Newborn Screening Program will call the hospital to request a repeat specimen. Blood collection can be accomplished through the hospital laboratory or the primary care provider clinic. Repeat screening requires the full fee. Contact the Newborn Screening Program at (800) 664-7772 if financial circumstances may prohibit a family from having a repeat newborn screen.Borderline Newborn Screen (PDF: 130KB/1 page)
What if a baby in my care has a positive newborn screening result?
For positive results, MDH immediately notifies the infant’s health care provider by phone or fax. At the same time, the MDH notifies an appropriate specialist. Together with the specialist’s guidance, the health care provider should promptly contact the family and arrange for evaluation and diagnostic tests.
What about false positive results?
Any screening methodology is subject to some false positive results. False positive results may be caused by the stress of birth; the specimen being collected prior to 24 hours after birth; poor specimen collection techniques; or the way the specimen was dried, stored, or transported. The MDH Newborn Screening Program establishes screening cutoff values to keep the number of false positives at a minimum while ensuring that affected infants are not missed.
What is the chance that an infant will have one of the disorders found by newborn screening?
The chance that a baby will have one of the disorders detected by newborn screening is small. Each year, approximately 150 infants are diagnosed with one of the disorders. Additionally, it is estimated that 1 in 300 babies will be found to have a congenital hearing loss in Minnesota. In these cases, early diagnosis, treatment, or intervention may prevent many adverse outcomes associated with these conditions. Health care providers should treat all abnormal or refer screening results urgently and should complete recommended follow-up testing or evaluations without delay.
What is the Newborn Screening Program’s specimen storage policy?
After all of the newborn screening tests are complete, there is a small amount of blood (less than half of one milliliter) left on the specimen card. For babies born after the Bearder, et al., v. State of Minnesota decision on November 16, 2011, MDH routinely destroys remaining leftover blood samples from negative newborn screens after 71 days. The remaining leftover blood samples from positive newborn screens and all test results will be destroyed after two years.
For babies that were born between July 1, 1997 and November 15, 2011, MDH has securely stored these residual screening specimens. Due to the ongoing litigation hold regarding the Bearder, et al., v. State of Minnesota lawsuit, these specimens may not currently be destroyed unless specifically requested by the parent.
Who decides which disorders are included on the newborn screening panel?
Based on nationally accepted criteria, the Minnesota Department of Health Newborn Screening Advisory Committee makes recommendations on disorder inclusion to the Commissioner of Health. The Newborn Screening Advisory Committee meets two times each year to talk about newborn screening issues. Members include parents of affected children, advocacy groups, health care providers, hospital representatives, and other medical and educational experts. The Commissioner has final approval for the addition of new disorders to the screening panel.Updated Friday, 27-Dec-2013 15:18:32 CST