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S outh Dakota Newborn Screening Program (S DNSP ). From Collection to Follow-Up. South Dakota Codified Law 34-24-17. - PowerPoint PPT Presentation
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From Collection to Follow-Up
South Dakota Newborn Screening Program
(SDNSP)
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)-NewbornScreening 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 notsoak through
Spreading the blood drop over the surface of the circle, contributing to uneven absorption
Improperly applying blood to the filterpaper 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 startedduring the prenatal period?
Does the nursery or obstetrician provideparents 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 tosending with the courier?
Are all specimens sent within 24 hours of collectionusing 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/