Programs
This information is intended for use by healthcare professionals. The following includes where to find key pieces of information on:
Types of results
Normal/Within Limits
If the screened condition is within the range of expected values, a text will be visible on the report to the right of the corresponding condition which says “Normal.”
Abnormal/Out-of-Range
If the screened condition is out-of-range of expected values (which is confirmed within the laboratory before reporting), a text will be visible on the report to the right of the corresponding condition which says “Abnormal.” In addition, a comment will be visible below the “Abnormal” result which provides additional information. These values were screened as out-of-range and confirmed within the laboratory.
Borderline/Low-Risk
If the screened condition is out-of-range of expected values, a text will be visible on the report to the right of the corresponding condition which says “Abnormal.” In addition, a comment will be visible below the “Abnormal” result which provides more information. A borderline/low risk result designation is when the values are slightly out-of-range. The state of Kansas recommends another screen be submitted as soon as possible to verify if the values have normalized or remain out-of-range. As babies gain weight and start eating, their values can change.
Hemoglobin Trait
Hemoglobin trait is when the baby has been screened as a carrier for a hemoglobin condition. An example of carrier status is if the baby has been screened as a carrier for sickle cell. Carrier status is important if the baby becomes a parent in the future.
High-Risk
If the screened condition is out-of-range of expected values, a text will be visible on the report to the right of the corresponding condition which says “Abnormal.” In addition, a comment will be visible below the “Abnormal” result which provides information regarding the designation. A high-risk result designation is when the values are significantly out-of-range. The state of Kansas recommends diagnostic testing to determine whether the baby has the condition. A diagnostic test consists of sending a new blood sample from the baby to a hospital laboratory or private laboratory. The baby’s provider can speak with a specialist to confirm that diagnostic testing is needed. The baby’s provider can order this diagnostic testing and/or refer the family to see a specialist. Diagnostic testing needs to be done promptly.
Unsatisfactory
An unsatisfactory specimen is a specimen that the lab scientists review and determine to be of poor quality. Examples of poor quality may include poor saturation of spots, insufficient quantity of blood, multiple spots, discolored spots, rough or wrinkled spots, or any other visible issue which could alter results. The facility that submitted the specimen will be notified to obtain another specimen from the baby as soon as possible. While full analysis cannot be performed on unsatisfactory specimens, the lab may find there is increased concern for one or more time-critical conditions. When this happens, the Newborn Screening Follow-Up Team will notify the primary care physician or submitting provider to expedite the collection of a second specimen and monitor the baby for symptoms.
Invalid
Some conditions require specific data about the baby to be able to determine if the results are within limits or out-of-range. Age, weight, gestational age, and transfusion status are used to determine the validity of results for certain conditions. For example, a baby older than 90 days cannot be screened for cystic fibrosis. Another example is a baby who has received a blood transfusion cannot be accurately screened for a hemoglobinopathy such as sickle cell disease. Most invalid results are due to collecting the sample before a baby reaches 24 hours of age. For NICU babies, most facilities require collection before 24 hours of age for an initial screen. NICU babies should then have a second screen at 48-72 hours after birth. The Kansas Newborn Screening Program recommends collecting between 24-48 hours of age for all well babies.
Indeterminate
An indeterminate specimen designation means results are inconclusive and another specimen should be submitted for analysis. This designation can occur when the specimen is of poor quality (despite being visibly satisfactory) or due to several other factors. These factors include but are not limited to age, weight, gestational age, and red blood cell transfusion status. One example is that a baby younger than 34 weeks gestational age will be indeterminate for Pompe or Mucopolysaccharidosis type I due to age.
What to do next
If a notification of borderline/low risk is received, please submit another specimen as soon as possible.
If a notification of a high risk out-of-range result is received, the Case Management team will contact the baby’s provider of record with next steps.