Newborn Screening Panel

Laboratory Fee Schedule

Procedure #: N/A
CPT: S3620, 82016, 82128

Synonym(s):	NBS
Requisition Form	Medicaid/CHIP/Uninsured (NBS 3) or Insurance/Self-Pay (NBS 4) Newborn Screening Collection Kits
Test Description	Amino Acid, Fatty Acid Oxidation, and Organic Acid disorders, Classic Galactosemia, Primary Congenital Hypothyroidism, Congenital Adrenal Hyperplasia, Biotinidase Deficiency, Hemoglobinopathies, Cystic Fibrosis, X-linked Adrenoleukodystrophy, Severe Combined Immunodeficiency, Spinal Muscular Atrophy due to homozygous deletion of exon 7 in SMN1, Pompe, Infantile Krabbe, MPS I and MPS II. *Texas does not test for all the disorders listed on the Recommended Uniform Screening Panel (RUSP). The full list of conditions on the Texas Newborn Screening Panel can be found here.
Pre-Approval Needed	N/A
Supplemental Information Required	N/A
Supplemental Form(s)	N/A
Performed on Specimens from (sources)	Human
Sample/Specimen Type for Testing	Capillary blood collected by heelstick puncture applied to the filter paper section of a DSHS approved Newborn Screening Collection Kit. 1^st screen collected 24-48 hours of age. 2^nd screen collected 7-14 days of age, a minimum of 168 hours of age. View a specimen collection training video for collecting on filter paper
Minimum Volume/Size Required	Completely fill all preprinted circles on the filter paper section of the Newborn Screening Collection Kit.
Storage/Preservation Prior to Shipping	Dried blood spot specimen Allow blood spots on the filter paper to dry thoroughly at room temperature in a horizontal position for at least 3 hours. Do NOT allow specimen to touch any surface. Cover dried blood spot specimens with attached flap. Keep specimen away from heat and direct sunlight.
Transport Medium	N/A
Specimen Labeling	Provide all information requested on the Demographic Form attached to the Newborn Screening Collection Kit. Two patient-specific identifiers (e.g., patient full name, date of birth, medical record number) and date of collection are required. If not provided, specimen will be rejected.
Shipping and Specimen Handling Requirements	DRIED BLOOD SPOT SPECIMENS Shipping regulations require Double containment of dried blood spot specimens. Ensure specimens are thoroughly dried prior to placing in envelope. 1st containment: Cover the dried blood spot specimens with the attached wrap-around cover with printed universal biohazard symbol. Do not put biohazard labels on outside of envelope. 2nd containment: Place dried blood spot specimens in an envelope that is not hermetically sealed. Do not put specimens in plastic bags. Ship as soon as possible; national recommendations states that first screen specimens should arrive to the DSHS Laboratory within 24hrs after collection. If placing more than one specimen in an envelope rotate each specimen 180° such that the blood specimens do not touch. Fluctuating temperatures and humidity may damage the dried blood spot specimens placed in mailboxes or specimen lock boxes that are located outside. Shipping address can be found at: https://www.dshs.texas.gov/lab/nbs_collect_reqs.shtm#shipSpec
Method(s)	Tandem Mass Spectrometry, Immunofluorometric, Fluorometric, Colorimetric, Isoelectric Focusing, Multiplex Real-time Polymerase Chain Reaction and DNA Sequencing
Turn-around Time	Results available within 3-5 working days of specimen receipt in the DSHS laboratory.
Interferences/Limitations	Transfusion, Total Parenteral Nutrition (TPN), Hematocrit levels, prematurity, and age of the infant may affect the interpretation of results. Anticoagulants such as EDTA, citrate, and heparin may cause inaccurate test results and must not be used during the collection of the specimen.
Common Causes for Rejection	Use of expired Newborn Screening collection kit No date of collection provided. Missing/invalid patient demographic information Kit serial number on patient demographic form does not match the kit serial number on the specimen filter pape Specimens not received at the DSHS Laboratory within 13 days of collection will be unsatisfactory for testing and require a recollection. Day of collection is equal to day 1. Insufficient blood Incomplete saturation, contamination, or caked, clotted or layered blood. Visit website for complete list.
Additional Information	Additional information: Prior to use Newborn Screening Collection kits should be stored in original wrapping and stacked in a manner (vertically) to avoid compression of the filter paper. The newborn screening may NOT identify all babies with the disorders on the panel. If the baby is showing clinical symptoms or family history of a condition, the newborn screen results alone should not be used to rule out or confirm a condition; diagnostic testing should be pursued. Abnormal screen results will be followed up by Clinical Care Coordination Other useful websites: NBS Laboratory Web Page NBS Clinical Care Coordination Web Page