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South Dakota Newborn Screening Program (SDNSP) From Collection to Follow-Up South Dakota Codified Law 34-24-17. Screening of newborn infants for metabolic disease. All infants born in the State of South Dakota shall be screened for metabolic disease. This screening shall be as prescribed by the State Department of Health. The Advisory Committee on Heritable Disorders in Newborns and Children The Committee is charged with advising the Secretary of the Department of Health and Human Services in areas relevant to heritable conditions in newborns and children including newborn and child screening, counseling, and health care services for newborns and children having or at risk for heritable disorders. recommended panel is 31 core disorders and 26 secondary disorders Current Disorders Screened for in South Dakota PKU (1973) Congenital Hypothyroidism (1982) Galactosemia (1991) Congenital Adrenal Hyperplasia (June 1, 2005) Biotinidase Deficiency (June 1, 2005) Hemoglobinopathies (June 1, 2005) Cystic Fibrosis optional June 1, 2005; mandated June 1, 2007 Amino acid, Organic acid, Fatty acid oxidation disorders (Tandem Mass Spectrometry) mandated June 1, 2005; previously supplemental The Next Newborn Screening Test Coming Severe Combined Immunodeficiency (SCID) screening to begin January 1, 2015 usually causes death in the first year of life if SCID is recognized early and treated by stem cell transplant within the first 3.5 months of life before significant infections, success rates of 95% are reported reported incidence of SCID from states that have already begun screening is around 1:50,000 infants previous estimate of 1:100,000 SCID Screening and Reporting Same specimen card already collected Involves counting by-products of T-cell production known as T-cell Excision Circles (TRECs) Normal results will appear on the newborn screening reports routinely sent to the submitter Physicians caring for an infant with abnormal results will be notified and provided further recommendations SCID Education Multiple education efforts planned for providers in South Dakota submission to South Dakota Medical Journal newborn screening brochure revised to include SCID provided to all birthing hospitals and clinics in the state at no charge Working Together for the Health of Infants State Hygienic Laboratory (SHL)-Newborn Screening Laboratory at University of Iowa centralized contract laboratory since 2007 University of Iowa Children's Hospital South Dakota Department of Health Hospitals and Clinics Healthcare Providers Parents Newborn Screening Programs in other states Why Screen? Collectively about 1 in 700 infants affected Conditions are not apparent at birth Allows infants to be identified and treated before they get sick preventing serious health problems or even death Components of Newborn Screening Application to the blood spot collection form Techniques for collection Filling out the NBS collection form Transport of specimen Specimen Quality/Acceptability Specimen Quality Based on Standards written by the Clinical and Laboratory Standards Institute (formerly NCCLS) NBS01-A6, Volume 33 No. 9, 2013 Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth Edition Available from South Dakota Department of Health Specimen Quality Quality specimen for accurate and timely results Poor Quality (PQ) specimens MUST be recollected as soon as possible TSH result is based upon infants 2 weeks of age or less Recollection Adds trauma to the infant Causes anxiety to parents Burdens the screening laboratory Burdens the collecting facility Delays testing delayed diagnosis delayed treatment Blood Collection Techniques Heel stick preferred for highest quality results Avoid using capillary tubes increases the risk of a clotted/layered specimen increases the risk of scratching the filter paper Avoid venous collections lack of anticoagulant and time delays with syringe can cause clot formation and separation of the specimen Umbilical catheter collection can result in contamination from substances previously infused through the line Capillary Tubes….If They Must be Used Avoid anticoagulants EDTA causes false negatives for TSH & IRT, false positives for 17-OHP Heparin may interfere with PCR analysis for Cystic Fibrosis testing and TREC analysis for SCID testing Capillary Tube Collection Apply the blood to the filter paper from each tube as it is collected Do not draw or swirl with the capillary tube onto the filter paper Avoid pressing capillary tube into the paper causes dents or scratches Unacceptable Collection Sites Arch of the foot Fingers (except for collection on the mother) Earlobes Previously punctured or swollen sites Umbilical cord blood maternal contamination Intravenous lines contaminated with interfering substances Heel Stick Method Prep Check the expiration date on form Fill out the form properly and completely Precautions Confirm infant’s identity take extra precaution with twins/multiple births Wash hands Wear powder free gloves and change between infants Follow safety precautions when handling and disposing of sharps Site Preparation Warm the infant’s heel Use heel warming device or Use soft cloth moistened with warm water (less than 42˚C) for 3-5 minutes Positioning Foot Infant’s leg should be lower than the heart increases venous pressure Wipe heel with 70% isopropyl alcohol Air dry Puncture Site Puncture WITHIN shaded area Plantar surface of the heel Puncture Use sterile lancet or heel incision device 1.0 mm deep by 2.5 mm long No scalpel blades or needles Direct Application Wipe away first drop of blood may be contaminated with tissue fluid and this may interfere with the test Allow a large drop to form (50-75 µL) Touch paper to blood ONCE and let soak through Apply Blood Apply ONE drop on a circle Apply to ONE SIDE only Continue and fill all circles Do not press filter paper against puncture site Take Care of Puncture Site Elevate foot above the body Press sterile gauze or cotton swab against puncture site until bleeding stops Do not apply bandages that may damage infant’s delicate skin Examine Blood Collection Look at both sides of filter paper making sure blood has soaked through If blood is not soaking through try again on another circle Do not re-apply to same circle Air Drying the Specimens Do not touch other blood spots Horizontally Elevate off bench No direct sunlight Keep away from direct heat and humidity false + biotinidase and galactosemia results Dry at least 3 hours at ambient temperature Quality Assurance & You After collection of the specimen take time to look at it determine whether it is acceptable or not if not, recollect it at that time Too Much Blood Over-saturated Insufficient Blood Applying drops that are too small Removing filter paper before blood has soaked through to the other side Uneven Saturation Insufficient quantity so blood did not soak through Spreading the blood drop over the surface of the circle, contributing to uneven absorption Improperly applying blood to the filter paper with a device Layering Multiple drops added to each circle Non-uniform concentrations Analyte concentrations variable by amount of blood Contamination or Dilution Alcohol not dried on infant’s heel other fluid/substances Substances on bench top Not always this noticeable May affect analysis Inadequate Drying Putting in envelope before drying Folding the flap before dry air dry for at least 3 hrs. Sending with the courier before dry Serum Separation Serum rings squeezing or milking the heel causes hemolysis - use gentle pressure RBC have settled in capillary tube Clotting Apply blood from each tube as collected Don’t delay or hold Don’t “draw” blood on circles Filling out the Collection Form All requested information must be provided Missing information may prevent or delay test results Collection Information Age of baby at time of collection birth date and time collection date and time Early collection (<24 hrs. old) affects results false negatives for amino acids are possible due to insufficient levels of certain analytes false positives for hypothyroidism and CAH are possible because of the normal hormone surge after birth Missing Information Early Collection Unknown date or time is missing no results for CAH, TSH or TMS Unknown Weight CAH results not reported Transfusion Status must be marked no not assumed as no if not marked Transfusion Affects Biotinidase-plasma Cystic Fibrosis-plasma Galactosemia-RBC Hemoglobin Disorders-RBC SCID-can result in false + (abnormally low TRECs) no change to transfusion protocol Always collect prior to a transfusion, even if the infant is <24 hours of age results from an early collection can be combined with results post transfusion Submitter Information Submitter receives report hospital clinic Infant’s physician & telephone number needed for follow-up for abnormal results if there will be a different physician following hospital discharge this needs to be included examples: Howard Hansen/Kyle IHS Joe Johnson/EAFB Quality Assurance Daily fax sent from SHL to collecting facility Need secure fax line Need a contact person Fill out info and fax back Monitoring Newborn Screening Forms Storage clean dry place in a vertical position Supply availability of forms and expiration date Filter Paper on Collection Form Should NEVER come into contact with anything other than the infant’s blood Never let the filter paper touch the bench top When filling out the form wear gloves and make sure the flap is closed over the filter paper Do not crush the form; take care when storing in charts the filter paper may not absorb blood if crushed Checking the Form Before Submitting Is the form? Complete Legible Accurate Who Conducts Parent Education? Is newborn screening education started during the prenatal period? Does the nursery or obstetrician provide parents with the NBS pamphlet? Who Performs Heel Sticks? Are they properly trained in the collection procedure on filter paper? Are they able to describe a satisfactory specimen? Are they able to describe a poor quality specimen? Are poor quality specimens tracked back to the individual who collected them and retrained as needed? Are they using correct terminology - “newborn screening test” instead of calling it the “PKU test”? Who Sends the Specimens? Are specimens checked for suitable quality prior to sending with the courier? Are all specimens sent within 24 hours of collection using the courier system? Are steps taken to avoid subjecting the specimens to heat and humidity prior to sending? Does someone review the demographic information prior to sending to make sure the form is complete and legible? Does Your Facility have Adequate and Accurate Newborn Screening Documentation? Is there a log in the nursery or lab documenting each newborn’s date and time of birth and blood collection? SDNSP may need to confirm a specimen was an early collection and not just an incorrect date or time of collection Does your facility track the specimens until the results are received? Is Your Facility Providing Adequate and Accurate Newborn Screening Documentation? Is there someone at your facility to track poor quality specimens? Is there documentation indicating the physician or parents were notified of the need to repeat the newborn screen? Does your facility have a system set up to guarantee that all newborns are screened prior to discharge? Is there a system in place to ensure infants discharged prior to 24 hours of age have an initial specimen collected? Reporting Abnormal Results State Hygienic Laboratory notifies a Case Manager at University of Iowa Children’s Hospital all abnormal results are reported to the healthcare provider listed on the collection card with recommendations for rescreening and/or confirmatory testing SDNSP takes over after the initial notification Medical Consultants review the confirmatory tests and provide additional recommendations Ensuring All Infants are Screened EVRSS (Electronic Vital Records Screening System) statewide electronic birth certificate filing system used since 2002 that incorporates web technology each hospital in the state enters birth certificate information directly into this database Ensuring All Infants are Screened the collection card has peel-off stickers that are placed on the form that Vital Records uses at the hospital level to file the birth certificate this sticker is the metabolic unique identifier number to eventually match the birth certificate to the newborn screening results SHL sends an electronic file with the newborn screening results loaded into the EVRSS system Monday through Friday Ensuring All Infants are Screened A Department of Health staff loads the electronic record received from SHL and performs a match process function with EVRSS match process is designed to match the initial specimen as well repeats Never Tested Report ensures all babies are screened picks up home births, refusals, poor quality, transferred or discharged without a newborn screen, and deceased Ensuring All Infants are Screened in South Dakota, birth certificates are filed within 7 days lab analysis and reporting out of results averages about 5.5 days can pick up a baby as soon as 7 days of age as a possible Never Tested baby Unmatched Report for metabolic results but no birth certificate out-of-state births state program to state program coordination to ensure the follow-up Reporting Test Results Reporting options paper reports delivered by USPS web access and paper report web based only – paperless For Additional Information Call the South Dakota Department of Health Newborn Screening Program at 1-800-738-2301 Visit the South Dakota Department of Health Newborn Screening Program homepage for links to additional resources: doh.sd.gov/family/newborn/metabolic/ Video link http://www.pkulife.tv/ Scroll down to Short Film: For Katy