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S outh Dakota Newborn Screening Program (S DNSP ). From Collection to Follow-Up. South Dakota Codified Law 34-24-17.
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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 DisordersScreened for in South Dakota • PKU (1973) • CongenitalHypothyroidism (1982) • Galactosemia (1991) • CongenitalAdrenalHyperplasia (June 1, 2005) • BiotinidaseDeficiency (June 1, 2005) • Hemoglobinopathies(June 1, 2005) • Cystic Fibrosis • optional June 1, 2005; mandated June 1, 2007 • Aminoacid,Organicacid, Fattyacidoxidationdisorders(TandemMassSpectrometry) • 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 TogetherfortheHealthofInfants • State HygienicLaboratory (SHL)-Newborn • Screening Laboratory at University of Iowa • centralized contract laboratory since 2007 • Universityof Iowa Children'sHospital • SouthDakotaDepartmentofHealth • Hospitals and Clinics • HealthcareProviders • 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
ComponentsofNewborn Screening • Applicationto thebloodspot collectionform • Techniques forcollection • FillingouttheNBS collection form • Transportof specimen • SpecimenQuality/Acceptability
SpecimenQuality • Basedon Standardswrittenbythe Clinicaland LaboratoryStandards Institute(formerlyNCCLS) • NBS01-A6,Volume33 No.9, 2013 • BloodCollectiononFilterPaperfor NewbornScreeningPrograms;Approved Standard—SixthEdition • AvailablefromSouthDakotaDepartment ofHealth
SpecimenQuality • Quality specimen for accurate and timely results • Poor Quality (PQ) specimens MUSTbe recollected • as soon as possible • TSH result is based upon infants 2 weeks of age or less
Recollection • Addstraumatotheinfant • Causesanxietyto parents • Burdensthescreeninglaboratory • Burdensthecollectingfacility • Delaystesting • delayed diagnosis • delayed treatment
BloodCollectionTechniques • Heelstick preferred for highest quality results • Avoidusingcapillary 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
CapillaryTubes….If They Must be Used • Avoidanticoagulants • EDTAcausesfalse negatives forTSH&IRT, falsepositivesfor17-OHP • Heparinmayinterfere withPCRanalysisfor CysticFibrosis testing and TREC analysis for SCID testing
CapillaryTube Collection • Applythebloodtothe filterpaperfrom eachtubeasitiscollected • Donotdraworswirl withthecapillarytube onto thefilterpaper • Avoidpressingcapillarytubeintothepaper • causesdentsor scratches
UnacceptableCollectionSites • Archof the foot • Fingers (except for collection on the mother) • Earlobes • Previouslypuncturedor swollen sites • Umbilical cord blood • maternal contamination • Intravenouslinescontaminatedwith • interferingsubstances
HeelStickMethodPrep • Check theexpirationdateonform • Fillouttheformproperlyandcompletely
Precautions • Confirm infant’sidentity • take extra precaution with twins/multiple births • Washhands • Wearpowderfree glovesandchangebetweeninfants • Follow safetyprecautionswhenhandlinganddisposing ofsharps
Site Preparation • Warmtheinfant’sheel • Useheelwarmingdeviceor • Use softclothmoistenedwith warmwater • (lessthan42˚C)for3-5 minutes
PositioningFoot • Infant’slegshouldbelowerthanthe heart • increasesvenous pressure • Wipeheelwith70%isopropylalcohol • Airdry
PunctureSite • PunctureWITHINshaded area • Plantarsurfaceoftheheel
Puncture • Use sterilelancetorheelincisiondevice • 1.0mmdeepby2.5 mmlong • Noscalpelbladesorneedles
DirectApplication • Wipe away first dropofblood • may be contaminated with tissue fluid and this may interfere with the test • Allowalargedrop to form(50-75 µL) • Touchpaperto bloodONCE andletsoakthrough
ApplyBlood • ApplyONEdropon acircle • ApplytoONE SIDE only • Continueand fillallcircles • Donotpress filterpaperagainstpuncturesite
TakeCareofPunctureSite • Elevate footabovethebody • Presssterilegauzeorcottonswab againstpuncture site untilbleeding stops • Do notapply bandagesthatmay damageinfant’s delicate skin
ExamineBloodCollection • Lookatboth sidesof filterpapermaking surebloodhassoaked through • If bloodis notsoaking through tryagain onanother circle • Do not re-apply to samecircle
AirDrying theSpecimens • Donottouchotherbloodspots • Horizontally • Elevateoffbench • Nodirectsunlight • Keepawayfromdirect heatandhumidity • false + biotinidase and galactosemia results • Dryatleast3hoursat ambienttemperature
QualityAssurance&You • After collectionofthespecimen • take timetolookatit • determinewhetheritisacceptable or not • ifnot,recollectitatthattime
Too MuchBlood • Over-saturated
InsufficientBlood • Applyingdropsthataretoosmall • Removingfilterpaperbeforebloodhassoakedthroughtotheotherside
UnevenSaturation • Insufficientquantitysoblooddidnot • soakthrough • Spreadingtheblooddropoverthe surfaceofthecircle,contributingto unevenabsorption • Improperlyapplyingbloodtothefilter • paper withadevice
Layering • Multipledropsaddedtoeachcircle • Non-uniformconcentrations • Analyteconcentrationsvariablebyamount ofblood
ContaminationorDilution • Alcohol not dried on infant’sheel • otherfluid/substances • Substancesonbench top • Not alwaysthisnoticeable • Mayaffectanalysis
InadequateDrying • Puttinginenvelopebeforedrying • Foldingtheflapbeforedry • airdryfor atleast3 hrs. • Sending withthecourier beforedry
SerumSeparation • Serum rings • squeezingormilkingtheheelcauses • hemolysis - usegentlepressure • RBChavesettledin capillarytube
Clotting • Applyblood from eachtubeas collected • Don’t delayor hold • Don’t “draw” bloodon circles
Filling out theCollectionForm • Allrequestedinformationmustbeprovided • Missinginformationmaypreventordelaytestresults
CollectionInformation • Ageof babyat timeof collection • birthdateandtime • collectiondateandtime • Early collection(<24 hrs.old) affects results • false negatives for aminoacidsare possible due to insufficient levels of certain analytes • false positives for hypothyroidism and CAH are possible because of the normal hormone surge after birth
MissingInformation • Early CollectionUnknown • dateortimeismissing • noresultsforCAH, TSH or TMS • UnknownWeight • CAHresultsnotreported • TransfusionStatus • mustbemarkedno • not assumed as no if not marked
TransfusionAffects • Biotinidase-plasma • Cystic Fibrosis-plasma • Galactosemia-RBC • HemoglobinDisorders-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
SubmitterInformation • Submitterreceivesreport • hospital • clinic • Infant’sphysician&telephonenumber • needed forfollow-upforabnormal results • if there will be a different physician following hospital discharge this needs to be included • examples: Howard Hansen/Kyle IHS • Joe Johnson/EAFB
QualityAssurance • DailyfaxsentfromSHLtocollecting facility • Needsecurefax line • Need a contact person • Filloutinfoandfaxback
MonitoringNewbornScreening Forms • Storage • cleandryplaceinavertical position • Supply • availabilityof formsand expirationdate
FilterPaperonCollection Form • ShouldNEVERcomeintocontactwith • anythingotherthantheinfant’sblood • Neverletthefilterpapertouchthebenchtop • Whenfillingouttheformwearglovesand makesuretheflapisclosedoverthefilter paper • Donotcrushtheform;takecarewhen storingincharts • thefilterpapermaynot absorbbloodifcrushed
Checking the Form Before Submitting • Istheform? • Complete • Legible • Accurate
WhoConductsParent Education? • Is newbornscreeningeducation started • during theprenatalperiod? • Does thenursery orobstetrician provide • parentswiththeNBS pamphlet?
WhoPerforms HeelSticks? • Aretheyproperlytrainedinthecollectionprocedureonfilterpaper? • Are theyabletodescribeasatisfactoryspecimen? • Are theyabletodescribea poor qualityspecimen? • 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”?
WhoSendstheSpecimens? • Arespecimenscheckedforsuitablequalitypriorto • sending withthe courier? • Areallspecimenssent within24 hoursof collection • usingthe couriersystem? • Aresteps takento avoid subjectingthe specimens to heatandhumiditypriorto sending? • Doessomeonereviewthe demographicinformation priortosending to makesure the formis complete andlegible?
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?