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Public Health Nurse Training. Maternal and Child Health Genomics and Newborn Screening Program. Introduction to Indiana’s Newborn Screening Program. Why Do Newborn Screening?. Required by Indiana law (Indiana Code 16-41-17) Early detection & early treatment of newborn screening disorders:

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Public health nurse training

Public Health Nurse Training

Maternal and Child Health

Genomics and Newborn Screening Program


Introduction to indiana s newborn screening program

Introduction to Indiana’s Newborn Screening Program


Why do newborn screening

Why Do Newborn Screening?

  • Required by Indiana law (Indiana Code 16-41-17)

  • Early detection & early treatment of newborn screening disorders:

    • Lessens severity of complications

    • Improves quality of life

  • Lack of early detection & treatment can lead to:

    • Severe mental retardation

    • Inadequate growth & development

    • Death


Mission of isdh newborn screening program

Mission of ISDH Newborn Screening Program

  • Ensure that every newborn in Indiana receives state-mandated screening for all 46 designated conditions

  • Maintain a centralized program to ensure that infants who test positive for screened condition(s) receive appropriate diagnosis and treatment and that their parents receive genetic counseling

  • Promote genetic services, public awareness, and education concerning genetic conditions


History of newborn screening in indiana

History of Newborn Screeningin Indiana

  • 1965: PKU only condition included in newborn screen

  • 1978: Hypothyroidism added

  • 1985: Galactosemia, homocystinuria, maple syrup urine disease (MSUD), and hemoglobinopathies added

  • 1999: Biotinidase deficiency and congenital adrenal hyperplasia added

  • 2003: Screening further expanded to include disorders detected by tandem mass spectrometry (MS/MS)

  • 2007: Cystic fibrosis was added to the panel

  • Currently, all infants born in Indiana are screened for 46 conditions (including hearing loss)


Indiana s newborn screen

Indiana’s Newborn Screen

  • Two parts:

    • Heel Stick Screening

      • Includes Sickle Cell Program & Cystic Fibrosis Program

      • Also includes follow-up for metabolic and endocrine conditions on newborn screening panel

    • Early Hearing Detection and Intervention (EHDI)

      • Includes Universal Newborn Hearing Screen


Part i

Part I

Heel Stick Screening


Heel stick screening

Heel Stick Screening

  • Performed on a blood specimen taken from the heel of an infant shortly after birth

  • Used to screen for certain genetic conditions

    • Metabolic conditions

    • Endocrine conditions

    • Cystic fibrosis


Tandem mass spectrometry ms ms

Tandem Mass Spectrometry (MS/MS)

  • Analytical technique that separates & detects protein ions

  • Enables newborn screening labs to quickly & efficiently detect many conditions in a single process through use of dried blood spot specimens

  • Disorders detected by MS/MS:

    • Fatty acid oxidation disorders

      • Interfere with body’s ability to turn fat into energy

    • Organic acid disorders

      • Inability to break down certain amino acids & their metabolites

    • Other amino acid disorders (including tyrosinemia & urea cycle disorders)


Phn request for assistance form

PHN Request for Assistance Form


Request for assistance form

Request for Assistance Form

  • PHNs are responsible for documenting all follow-up activities on the “Request for Assistance” form

  • Form should be returned to ISDH within 8 days and should document:

    • Follow-up activities are completed

    • Parents fail to bring child in for initial or repeat NBS

    • PHN is unable to contact parents

    • Identified changes to demographic information

  • The “Request for Assistance” Form should be returned to:

    • Iris Stone, ISDH Heel Stick Program Director via:

      • Fax: (317) 234-2995

      • Certified (secure) e-mail only ([email protected])

        • Note: PHNs who need to set up a certified e-mail account should notify ISDH for assistance.


Public health nurse training

REQUEST FOR ASSISTANCE Form (example)

Date:July 26, 2014County:Everywhere

Please advise the parent(s) of the infant named below that a repeat test or initial test for newborn screening is necessary. This can be done at the hospital of birth or any other facility that has the heel-stick test kit.   The hospital of birth is preferable as generally there is no additional charge for a rescreen. If the parents have any questions regarding this request, they may contact the Newborn Screening Program at the Indiana State Department of Health, (317) 233-1379.

Reason: Early Discharge ______<24 Hours Protein Intake ______

Poor Sample ______ Transferred before Screen ______

Abnormal Result ___X___ Other: Decreased T4

Infant's Name:Dahl, KenD.O.B:2/14/2007SEX:M

Birthing Institution:Meridian Hospital

Hospital Number:123456

Mother's Name:Dahl, MaryDoctor’s Name: Marcus Welby

Address:234 Center DriveDoctor’s Address: ABC Street

Anytown, IN 46302Anytown, IN 46302

Telephone:517-789-1011Doctor’s Phone: 517-245-6789


Public health nurse training

REQUEST FOR ASSISTANCE Form (example)

Need Follow-up report returned by: 5/9/2007

PHN Contacts:

TelephoneCall: Yes ___X__ No _____ HomeVisit: Yes _____ No _____

DateRemarks

1) 05 / 01 / 2007 Phone call to Mary: will take baby to hospital for repeat screen___________

2) _____/_____/_____ ______________________________________________________________

3) _____/_____/_____ ______________________________________________________________

4) _____/_____/_____ ______________________________________________________________

5) _____/_____/_____ ______________________________________________________________

NoSuch Address: __________

Will Obtain Screen At: __________________________________________________

Public Health Nurse: _Vickie Nurse, R NTelephone: 517-456-2345

USE BACK OF FORM FOR ADDITIONAL REMARKS

PLEASE RETURN THIS FORM TO:

INDIANA STATE DEPARTMENT OF HEALTH

NEWBORN SCREENING PROGRAM / MCH

2 NORTH MERIDIAN

SUITE 700

INDIANAPOLIS, IN 46204

INCOMPLETE– PHN did not record date/location of repeat NBS. This form should not be returned to ISDH until missing documentation is added.


Public health nurse training

REQUEST FOR ASSISTANCE Form (example)

Need Follow-up report returned by: 5/9/2007

PHN Contacts:

TelephoneCall: Yes ___X__ No _____ HomeVisit: Yes _X___ No _____

DateRemarks

1) 05/01/2007Phone call to mom: got voicemail; left message to call Vickie, PHN at EverywhereHealth Department, phone #-_456-2345

2) 05/02/2007 No return call from mom: made 2nd call to mom; left message for mom to call Vickie, PHN

3) 05/04/2007 No return call from mom: sent letter to mom re: the need for baby to have a repeat newborn screen

4) 05/07/2007 Still no response from mom: made home visit; spoke with mom and explained the importance of the baby having a repeat NBS for further evaluation. Mom said she will take baby back to birthing hospital tomorrow.

5) 05/08/2007 Received call from mom who said she took baby back for re-screen today at 9:00 am.

NoSuch Address: ____________________________________________

Will Obtain Screen At: Meridian Hospital on 05/08/07 at 9:00am

Public Health Nurse: _Vickie Nurse, R NTelephone: 517-456-2345

USE BACK OF FORM FOR ADDITIONAL REMARKS

PLEASE RETURN THIS FORM TO:

INDIANA STATE DEPARTMENT OF HEALTH

NEWBORN SCREENING PROGRAM / MCH

2 NORTH MERIDIAN

SUITE 700

INDIANAPOLIS, IN 46204

COMPLETE – Includes documentation of all PHN activities, as well as date & location of repeat NBS.


Heel stick procedure

Heel Stick Procedure

  • NOTE:The following procedures are modified from the heel stick procedures slides provided by the New York State Department of Health


Collecting heel stick specimen

Collecting Heel Stick Specimen

  • If parent(s) / guardian(s) are unable to get the baby back to the hospital for the repeat screen, PHNs can collect NBS specimen, if trained and certified

  • Trained & certified PHNs are responsible for:

    • Proper collection of heel stick blood sample

    • Proper handling & transport of blood spot specimen to the IU NBS lab


Heel stick procedure step 1

Heel Stick ProcedureStep 1

  • Equipment:

    • Sterile lancet with tip appropriately 2.0 mm - sterile alcohol prep

    • Sterile gauze pads

    • Soft cloth

    • Blood spot card

    • Gloves


Blood spot card front

Blood Spot Card (front)


Blood spot card back

Blood Spot Card (back)


Heel stick procedure step 2

Heel Stick ProcedureStep 2

  • Complete ALL information on blood spot card.

    • Do not contaminate filter paper circles by allowing the circles to come into contact with spillage or by touching before or after blood collection.


Heel stick procedure step 3

Heel Stick ProcedureStep 3

  • Hatched areas (arrows) indicate safe areas for puncture site.


Heel stick procedure step 4

Heel Stick ProcedureStep 4

  • Warm site with soft cloth moistened with warm water (up to 41o C) for 3 – 5 minutes.


Heel stick procedure step 5

Heel Stick ProcedureStep 5

  • Cleanse site with alcohol prep.

  • Wipe DRY with sterile gauze pad.


Heel stick procedure step 6

Heel Stick Procedure Step 6

  • Puncture heel.

    • Wipe away first blood drop with sterile gauze pad.

    • Allow another LARGE blood drop to form.


Heel stick procedure step 7

Heel Stick Procedure Step 7

  • Lightly touch filter paper to LARGE blood drop.

  • Allow blood to soak through and completely fill circle with SINGLE application of LARGE blood drop.

  • To enhance blood flow, VERY GENTLY apply intermittent pressure to area surrounding the puncture site).

  • Apply blood to one side of filter paper only.


Heel stick procedure step 8

Heel Stick Procedure Step 8

  • Fill remaining circles in the same manner as step 7, with successive blood drops.

  • If blood flow is diminished, repeat steps 5 through 7.

  • Provide care to the skin puncture site.


Heel stick procedure step 9

Heel Stick ProcedureStep 9

  • Dry blood spots on a dry, clean, flat, non-absorbent surface for a minimum of four (4) hours.


Heel stick procedure step 10

Heel Stick Procedure Step 10

  • Mail completed blood spot card to IU Newborn Screening Lab within 24 hours of collection.


Heel stick procedure1

Heel Stick Procedure

NOTE:

  • Use of capillary tubes to collect heel stick specimens is NOT recommended or included as part of Indiana’s protocols


Valid vs invalid blood spot specimens

Valid vs. Invalid Blood Spot Specimens


Public health nurse training

Valid Heel Stick Specimens

  • A newborn screen is valid when:

    • The child is at least 48 hours of age

    • The child has been on protein feeding for at least 24 hours

    • The NBS blood specimen is received by the NBS laboratory within 10 days of collection


Valid specimens

Valid Specimens

  • Fill all required circles.

  • Allow blood to soak through to other side of filter paper.

  • Do not layer successive drops of blood.

  • Avoid touching or smearing spots.


Invalid specimens

Invalid Specimens


Specimen quantity insufficient for testing

Specimen Quantity Insufficient for Testing

Possible causes

  • Removing filter paper before blood has completely filled circle or before blood has soaked through to second side.

  • Applying blood to filter paper with a capillary tube.

  • Touching filter paper before/after blood specimen collection (with gloved/ungloved hands, lotion, powder, etc.)


Specimen appears scratched abraded

Specimen Appears Scratched/Abraded

Possible cause

  • Applying blood with capillary tube or other device.


Specimen not dry before mailing

Specimen Not Dry Before Mailing

Possible cause

  • Mailing specimen without drying for at least four (4) hours.


Specimen appears clotted or layered

Specimen Appears Clotted or Layered

Possible causes

  • Touching same circle on filter paper to blood drop numerous times.

  • Filling circle on both sides (front & back) of filter paper.


Possible results of newborn screening

Possible Results of Newborn Screening


Results of nbs

Results of NBS

  • Normal

    • All values fall within normal range

  • Invalid screen

    • Child does not meet criteria for valid screen

    • Specimen > 10 days old

    • QNS (quantity not sufficient)

  • Abnormal result(s)

    • Result(s) fall outside of normal range

    • Additional testing may be required to confirm result(s)

  • Presumptive positive result(s)

    • Suggests abnormal result(s)

    • Additional testing may be required to confirm result(s)


Confirmatory testing

Confirmatory Testing


Public health nurse training

Confirmatory Testing - PHN Responsibilities

  • If confirmatory testing for NBS conditions is required:

    • PHN will receive requisition and name of lab that will perform the test

      • NOTE: Blood specimen can be drawn at birthing facility

    • PHN should provide the following information to ISDH NBS Program:

      • Name of hospital/birthing facility that will collect the specimen

      • Approximate date of collection

      • Name of laboratory performing confirmatory testing


Cost of newborn screening

Cost of Newborn Screening


Cost initial repeat nbs

Cost – Initial & Repeat NBS

  • Parents are billed for the initial newborn screen

    • Cost of initial NBS: $85.00 (effective July 1, 2008)

  • There is no charge for re-screens if baby receives repeat NBS at same hospital where baby born


Cost of confirmatory testing

Cost of Confirmatory Testing

  • Most insurance plans will pay for confirmatory testing

  • Medicaid will pay for confirmatory testing, if mother had Medicaid during pregnancy

  • If mother has no insurance coverage:

    • She should immediately apply for Medicaid and take baby back for testing

      • Medicaid will pay retroactively


Cost of confirmatory testing cont

Cost of Confirmatory Testing (cont.)

  • Check with local hospitals or birthing facilities regarding payment options available to help family

  • If assistance is still needed, contact:

    • Barb Lesko at IU Newborn Screening Laboratory

      • (800) 245-9137

    • Bob Bowman at ISDH

      • (888) 815-0006


Refusal of newborn screening

Refusal of Newborn Screening


Refusal of nbs

Refusal of NBS

  • NOTE: Parents can legally refuse newborn screening (NBS) only due to religious reasons.

  • If parents refuse NBS, PHN should:

    • Have parents complete religious waiver

    • Document refusal of NBS on “Request for Assistance” form

    • Send signed religious waiver & completed “Request for Assistance” form to ISDH NBS Program


Early hearing detection intervention ehdi

Early Hearing Detection & Intervention(EHDI)

Part II


Early hearing detection and intervention ehdi

Early Hearing Detection and Intervention (EHDI)

  • Three main components to the EHDI process:

    • Universal Newborn Hearing Screening (UNHS)

    • Diagnostic audiology assessment

      • For those infants who did not pass UNHS or have risk factors for hearing loss

    • Enrollment in early intervention services (First Steps and/or private intervention)

      • For those infants identified with permanent hearing loss


Why is hearing screening mandated

Why is Hearing Screening Mandated?

* Hearing loss is the condition most commonly detected at or shortly after birth *


Why is hearing screening mandated cont

Why is Hearing Screening Mandated? (cont.)

  • Early identification & intervention help improve speech, language, social, & academic development

  • Early intervention enables parents to make timely & informed decisions


Goals of isdh ehdi program

Goals of ISDH EHDI Program

  • Increase the number of babies receiving UNHS

  • Reduce number of infants for whom no screening data is received at ISDH

  • Remember...

    • UNHS before 1 month of age

    • Diagnosis before 3 months of age

    • Early intervention before 6 months of age


Unhs screening techniques

UNHS Screening Techniques


Screening techniques unhs

Screening Techniques – UNHS

  • Automated auditory brainstem response (AABR)

  • Oto-acoustic emissions (OAE)

** Note: Parents want confident, knowledgeable screeners. Some parents may wish to be with their child when UNHS is performed – this should be offered when possible.


Screening techniques auditory brainstem response abr

Screening Techniques – Auditory Brainstem Response (ABR)

  • Sounds are presented through earphones

  • Surface electrodes measure brainstem activity in response to sound

  • Average test time: 20 min/baby


Screening techniques oto acoustic emissions oae

Screening Techniques – Oto-acoustic Emissions (OAE)

  • Sounds are presented to the ear canal

  • Small microphone measures the cochlear response in the ear canal

  • Average test time: 5 – 15 min/baby


Possible results of unhs

Possible Results of UNHS


Possible results pass

Possible Results - PASS

  • Screeners should tell parents:

    • “Your baby’s hearing is adequate for the development of normal speech & language skills.”

    • “You should continue to monitor your child’s speech & language development.”

    • “Talk to your baby’s doctor if you are worried about your baby’s hearing or speech development.”


Possible results did not pass in one or both ears

Possible Results – DID NOT PASS (in one or both ears)

  • Screeners should tell parents:

    • “Your baby did not pass his/her hearing screen in one/both ears.”

    • “This might have happened for several reasons.”

    • “This does not mean that your baby has permanent hearing loss.”

    • “Your baby needs a diagnostic hearing test, done by an audiologist, in order to determine how your baby hears.”

  • Screeners should give parents a copy of “What If Your Baby Needs More Hearing Tests?”

  • Words matter-Do not use words like “failed”

  • Babies who do not pass UNHS should be:

    • Reported to ISDH EHDI Program

    • Scheduled for diagnostic testing at a Level 1 Audiology

    • Referred/Reported to the PCP


Possible results pass but has risk factors

Possible Results – PASS, but has RISK FACTORS

  • Screeners should tell parents:

    • “Your baby passed his/her hearing screen in both ears, but has a risk factor.”

    • “Your baby’s risk factor is _____________.”

    • “This does not mean that your baby has permanent hearing loss.”

    • “Your baby should have diagnostic testing between 9 and 12 months of age, or sooner if there are concerns

  • Screeners should give parents a copy of “What If Your Baby Needs More Hearing Tests?”

  • Babies who have risk factors for hearing loss should be:

    • Reported to ISDH EHDI Program

    • Reported to their PCP for referral to a pediatric audiologist at 9-12 months of age (earlier if there are immediate concerns)


Risk factors for hearing loss

Risk Factors for Hearing Loss


Family history of congenital childhood hearing loss

Family History of Congenital / Childhood Hearing Loss

  • Includes family members with hearing loss in one/both ears since childhood

    • Can be due to known genetic cause or unknown cause

  • Excludes history of middle ear infections and/or tubes

  • Excludes family members with known, non-genetic causes of hearing loss

    • Exposure to rubella

    • Meningitis

    • Exposure to loud noise

    • Trauma


In utero infection

In Utero Infection

  • Includes conditions from TORCH screen

    • Toxoplasmosis

      • Most commonly affects babies whose mothers were exposed during 1st trimester

    • Other

      • Group beta strep (GBS)

      • Syphilis

        • Baby can be treated prior to delivery

    • Rubella

      • Most commonly affects babies when exposure occurs during 1st trimester

    • Cytomegalovirus (CMV)

      • Can be transmitted during pregnancy (placenta), during delivery (birth canal), or postnatally (breast milk)

    • Herpes Simplex Virus (HSV)

      • Most commonly affects babies whose mothers have active infection during delivery


Hyperbilirubinemia

Hyperbilirubinemia

  • Risk factor for hearing loss when bilirubin levels exceed indication for exchange transfusion


Cranio facial ear malformations

Cranio-facial/Ear Malformations

  • Babies who cannot be screened at the hospital due to no ear, partial ear, or no ear canal opening should be immediately referred to audiology and their physician for diagnostic testing

  • Babies with craniofacial anomalies who pass the screen should be referred for follow-up at 9-12 months of age


Referrals for infants with risk factors

Referrals for Infants with Risk Factors

  • Babies with any of the previous 4 risk factors must be reported to the ISDH EHDI Program

    • These children should receive follow-up testing from an audiologist around 9-12 months of age

  • Families should be:

    • Informed about which risk factor(s) was/were identified

    • Be provided with hearing & language developmental milestones

      • Told to monitor their child’s progress

    • Referred to ISDH & their PCP

    • Be informed of the importance of follow-up testing


Other risk factors

Other Risk Factors

  • Infants who have one of the following risk factors should be referred to their PCP:

    • Spent > 5 days in the Neonatal Intensive Care Unit (NICU)

    • Have a genetic condition or syndrome known to be associated with an increased risk for hearing loss

    • Have or had bacterial meningitis (infection around brain & spinal cord caused by bacteria)

    • Have a parent or caregiver who is concerned about the baby’s hearing and/or language development


Follow up services

Follow-up Services


Services provided for referred infants

Services Provided for Referred Infants

  • Diagnostic audiologic testing to confirm hearing status

    • Should be performed at Level 1 Audiology Center

      • These locations have pediatric experience & equipment necessary to perform diagnostic testing

      • List of locations available on ISDH EHDI website

  • Enrollment in early intervention services

    • For infants with confirmed hearing loss

  • Appropriate follow-up

    • Includes appropriate amplification or treatment and follow-up intervention services


Financial coverage of ehdi follow up services

Financial Coverage of EHDI Follow-up Services

  • Medicaid & Children’s Special Health Care Services: Funding for diagnostic services can be obtained for families who qualify financially

  • Private insurance: Some insurance companies will cover diagnostic audiology services. Families should contact their insurance carrier to determine covered services & identify providers.


Ehdi regional consultants

EHDI Regional Consultants


Phn responsibilities ehdi follow up services

PHN Responsibilities – EHDI Follow-Up Services


Request for assistance form1

Request for Assistance Form

  • PHNs are responsible for documenting all EHDI follow-up activities on the “Request for Assistance” form

  • Form should be returned to ISDH within 8 days, or when:

    • Follow-up activities are completed

    • Parents fail to bring child in for initial or repeat UNHS

    • PHN is unable to contact parents

    • Changes to demographic information are identified

  • The “Request for Assistance” Form should be returned to Gayla Hutsell Guignard, ISDH EHDI Program Director via:

    • Fax: (317) 234-2995

    • Certified (secure) e-mail only ([email protected])

      • Note: PHNs who need to set up a certified e-mail account should notify ISDH for assistance.


How is indiana doing 2009 outcome statistics for heel stick hearing screening

How is Indiana Doing?2009 Outcome Statistics for Heel Stick & Hearing Screening


2009 heel stick screening statistics

2009 Heel Stick Screening Statistics

  • Approximately 89,000 births in Indiana

    • 98.2% of infants received initial newborn screens

    • 81 infants were confirmed to have a metabolic disorder

    • 47 infants were confirmed to have an endocrine disorder

    • 26 infants were confirmed to have a hemoglobinopathy

    • 26 infants were confirmed to have cystic fibrosis

    • 100% of infants with confirmed cases received treatment and follow-up


2009 indiana hearing screening statistics

2009 Indiana Hearing Screening Statistics

Approximately 89,000 births

103 birthing facilities reported

98.7% of babies were screened

2.3% were referred for diagnostic audiology evaluations

81.3% had normal hearing results

6.2% (124 children) were diagnosed with permanent hearing loss

7.4% were lost to follow-up/documentation

Additional 30 babies who were born in 2009 were identified with hearing loss in 2009

Additional 67 babies who were born before 2009 were identified with hearing loss in 2009


2009 indiana diagnostic statistics

2009 Indiana Diagnostic Statistics

87.6% of children born in 2009 received follow-up

0.6% of these children have been evaluated but need additional testing

1.4% moved out of state

0.5% are deceased

2.5% had families who declined follow-up

7.4% LTF/D

Mean age of first evaluation: ~ 3 months (88.2 days)

Median age of first evaluation: ~ 2 months (56 days)

Mean age of diagnosis: ~ 3 months (93.7 days)

Median age of diagnosis: ~ 2 months (58 days)


Contact information for isdh newborn screening program

Contact Information for ISDH Newborn Screening Program

  • Director of Genomics and Newborn Screening

    • Bob Bowman

  • Heel-Stick Program

    • INSTEP Director – Courtney Eddy

    • Heel Stick Program Director – Iris Stone

    • Sickle Cell Program Director – Lisa Mani

    • Genomics & Cystic Fibrosis Programs Director – Malorie Hensley

  • Early Hearing Detection and Intervention (EHDI) Program

    • State EHDI Director – Gayla Hutsell Guignard

    • EHDI Follow-Up Coordinator- Julie Schulte

    • UNHS Nurse Consultant – Bess Godard

    • Lead Audiology Regional Consultant – Molly Pope

    • Guide By Your Side Program Coordinator- Lisa Kovacs

    • EHDI Parent Consultant – Julie Swaim

  • To contact the ISDH Newborn Screening Program:

    • Call (888) 815-0006

    • Visit the ISDH Newborn Screening website at http://www.NBS.IN.gov


Newborn screening it takes a team

Primary care physicians & other health care providers

Public health nurses

IU Newborn Screening Laboratory

ISDH

Early intervention providers (First Steps)

Hospitals & hospital personnel

Newborn Screening: It takes a team!


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