Newborn Screening Program (NBS) Community and Family Health Services Commission Indiana State Department of Health
NBS § A blood test (by heel-stick) that is done on all infants shortly after birth to test for certain genetic conditions. All infants born in Indiana must be tested for: - Phenylketonuria (PKU) - Galactosemia - Homocystinuria (Classic) - Maple Syrup Urine Disease (MSUD) - Hypothyroidism - Hemoglobinopathies / Sickle Cell Disease - Congenital Adrenal Hyperplasia (CAH) § - Biotinidase Deficiency -Disorders Detected by MS/MS
MS/MS: Tandem Mass Spectrometry n n n In 2001 the IN State Legislature amended the requirements of the NBS Law to include additional disorders detected by this process Tandem Mass Spectrometry is an analytical technique that separates and detects protein ions Expanded testing for 17 additional conditions was initiated in January 2003
Disorders Detected by Tandem Mass Spectrometry n n n Fatty Acid Oxidation Disorders: Interfere with the body’s ability to turn fat into energy Organic Acid Disorders: Inability to break down amino acids and other metabolites Other Amino Acid Disorders: Include Tryrosinemia & disorders of Urea Cycle
Mission Statement n n n Ensure that all newborns receive state-mandated screening for genetic disorders. Follow-up to ensure that infants who test positive for a screened condition receive appropriate treatment, and that their parents receive appropriate genetic counseling. Promote public awareness concerning genetic conditions.
NBS Law It is legislatively mandated (IC 16 -41 -17) IC 16 -41 -17 -8 states that “Each hospital and physician shall ~ take or cause to be taken a blood sample from every infant born under the hospital’s and physician’s care” §
NBS Law 410 IAC 3 -3 -3 Sec. 3 (d) states that; “If the infant is discharged from the hospital before forty-eight (48) hours after birth or before being on a protein diet for twenty-four (24) hours, a blood specimen shall be collected regardless. ”
Newborn Screening Process Protocols n n n Initial screening Normal result Invalid screen Abnormal Result Presumptive positive Positive cases
Newborn Screening Process n n WHAT IS A VALID SCREEN? A valid screen is one which is drawn after the child is 48 hours of age and has been on protein feeding for at least 24 hours. The blood specimen must be received at the laboratory within 10 days of collection.
Newborn Screening Process Why may a screen be invalid / incomplete? n n n If a screen is drawn prior to 48 hours of age and/or 24 hours protein feeding. Missing or erroneous information on card. Rejection due to QNS, or specimens
Newborn Screening Process Video - How to conduct valid NBS test
Newborn Screening Process Centralized follow-up system n n Invalid screen Abnormal Result Presumptive positive Confirmed Positive
ISDH Responsibilities § Ensure mandated newborn screening tests are properly conducted. § Ensure appropriate diagnosis & management of affected newborns. § Administer the Newborn Screening Program Fund. § Designate / contract with a Newborn Screening Laboratory. § Conduct an educational program for health care providers, local health officials, and the public.
Hospital Responsibilities n n Screen all the newborns prior to discharge Notify/educate parents of needed tests (<24, <48, <24 & < 48, abnormal, presumptive positive) n Notify ISDH: 1. Non-compliant 2. Unable to contact
Reporting - MSR Due by the 15 th of each month n MSR Report consists of 2 pages Data page Reason code page n Printed instructions available n
Reporting - MSR n n n Use information gathered from NBS Log Attach with MSR a copy of religious waiver if parents refuse screening Completeness
MSR: Common Errors n n Reason code errors MSR data errors Missing data or incomplete data Wrong form completed
Assurance More than 99% of infants receive initial screen n More than 98% of newborns receive complete / valid screens n 100% of infants with positive test condition received treatment and follow-ups n
Indiana Newborn Hearing Screening Children and Family Health Services Commission Indiana State Department of Health
UNHS Indiana’s Universal Newborn Hearing Screening Program is designed to identify infants, assure appropriate intervention, and collect information on the incidence of hearing loss in infants born in Indiana.
UNHS Legislative mandated program IC 16 -41 -17 -2 “… every infant shall be given a physiologic hearing screening examination at the earliest feasible time for the detection of hearing impairments. ”
Why Is UNHS Mandated § Hearing loss occurs more frequently than any other problems screened for at birth § 1 to 3 out of every 1000 babies are born with permanent hearing loss § Simple, inexpensive and safe tests are available
Expected Outcomes of UNHS § Across the nation, 2 -10% of babies do not pass the screen § The expected referral rate for UNHS is <4% § Less than 1% will have a hearing loss
Why Is Detection of Hearing Loss Important § Most common congenital anomaly § Evidence suggests that early identification and intervention results in significantly better language ability § UNHS increases the chance that intervention will occur before 6
Goals of UNHS § Physically screen all infants born in Indiana prior to discharge § Perform diagnostic evaluation before three months of age § Enroll in early intervention before six months of age
Hospital Responsibilities § Screen all the infants prior to discharge § Provide second screen to those who do not pass initial screen § Notify parents of results § Report all that do not pass two screens to ISDH § Report all that do not pass two screens and all that are at risk for delayed onset hearing loss to the First Steps for 1. Diagnostic evaluation 2. Early intervention
Hospital Responsibilities § Notify ISDH of 1. Non-compliance 2. Inability to contact families 3. Change of information
Basic Protocol Provide UNHS brochure to all parents n Explain how, when, where, duration of the screening process to all parents n
Basic Protocol Reassure all parents that screen is safe, non-invasive and painless n Complete religious waiver and attach a copy to MSR if parents refuse screening due to religious reasons n Best Practice: Complete rescreens prior to discharge n
When the Baby Passes Explain screening process n Give family the certificate n Recommend parents keep records of screening results n Provide parents with local resources if concerns arise regarding speech/language/development n
When the Initial Screen Is Not Passed Complete re-screen prior to discharge
When the Baby Does Not Pass Inform parents of screening results and the need for referral n Give parents referral brochure and certificate n Report the findings to the PCP and First Steps n Complete MSR follow-up report n
What Are Risk Factors Family history of congenital hearing loss n Congenital infection (Herpes, Cytomegalovirus, Rubella, Syphilis, Toxoplasmosis) n Hyperbilirubinemia/Transfusi on n
When a Baby Has A Risk Factor And Passes the Screening n Explain the results n Inform the parents about PMP and First Steps referral n Discuss the importance of monitoring speech/language process n Complete MSR/Follow-up Report
When a Baby Has A Risk Factor And Does not Pass Screening Treat as a baby who does not pass
What to Say to Parents When Referral Is Indicated n n Keep it simple Do not say “failed” or “deaf” or “this happens a lot” Indicate the infant did not pass the hearing screen Reassure the family that there are many reasons why this can happen
What to Say to Parents When Referral Is Indicated n n n Reassure the family that further diagnostic testing will clarify the hearing status Stress that it is important for this to be completed in a timely manner (before the age 3 months) Provide the family with the referral brochure and inform them about First Steps Early Intervention
MSR Report MSR Data: Due Date 15 th Each Month n MSR Report Consists of 3 Pages: Data Page Reason Code Page Follow-up Page n Printed Instructions Available n Attach with MSR A Copy of Religious Waiver if Parents Refuse Screening n
MSR: Common Errors § § § § § Reason Code Errors Follow-Up Code Errors Referral Errors MSR Data Errors Missing Data or Incomplete Data Re-screens Errors Date of Newborn Screen Not Completed Wrong Form Completed No Data on High Risk Infants
Other Barriers § Parents not receiving brochures, materials and explanations § Transfers to other facilities § Insufficient documentation § Failure to link with local resources upon hospital discharge § Out of county/out of state births § Out of county/out of state referrals
First Steps Program n Early Intervention Program (Administered by FSSA, Part C/IDEA) n n n Provide testing and follow-up to families for a minimal cost Audiologist must be enrolled provider for reimbursement Waiver of informed consent
First Steps Responsibilities l l l Ensure appropriate diagnostic evaluation for all babies in need Assist ISDH with tracking of babies identified with hearing loss Provide follow-up for children at risk of delayed onset hearing loss
Medical Homes n n n The primary medical physician is responsible for overall medical well being of the child Need to be informed about screening results/risk factors, and follow up issues Important member of the team for the best long term outcomes
Regional Consultants Six Consultants n Provide technical assistance, training, and consultation to hospitals, families and community agencies n Resource to ensure appropriate and timely care for children with hearing loss n
Lake ·Comm Hosp of Munster ·Methodist Hosp Gary ·Methodist Hosp Merrillville ·Saint Anthony Med Cen of Map of Indiana - Crown Point ·Saint Catherine Hosp of East Chicago ·Saint Margaret Mercy – Hammond ·Saint Margaret Mercy –Dyer ·Saint Mary's Med Cen Hobart Steuben La. Grange ·Cameron ·Elkhart St. Porter ·La. Porte Hosp Joseph ·La. Grange ·Gen Hosp Lake ·Portage ·St Anthony ·Goshen Comm Hosp Mich ·Gen Hosp Noble Hosp City Marshall ·Parkview ·Porter ·Comm. Hos Kosciusko Starke ·St Joe Hos ·Kosciusko Noble Hosp Mem Hosp ·Starke Mem Marshall Co Comm Hosp Whitley Jasper Hosp ·Pulaski Fulton ·Jasper Co Pulaski New ton Howard ·Howard Comm Hosp ·St Joe Hosp/Health Care Ctr Elkhart La. Porte ·Woodlawn Mem Hosp White ·White Co Mem Hosp De. Kalb • De. Kalb Mem Hosp St. Joseph ·Ancilla Health Care ·Mem Hosp – South Bend ·St Joseph Med Cen – South Bend Allen ·Whitley ·Lutheran Hosp Mem Hosp·Parkview Mem ·St Joe Med Wells Miami Wabash Hunt- Cen – Ft Wayne ·Bluffton Med Center ·Dukes Wabash ington Cass Wells Adams ·Caylor-Nickel Hosp Mem Co Hosp ·Parkview ·Logansport • Adams Hosp Health Mem Hosp Co Mem Center Hosp Blackford Black Jay - Kokomo ·Blackford Co Hosp Howard Marion Gen ford Hosp Warren ·Jay Co Tipton Vermillion Clinton Delaware Hosp ·Tipton Co M ·St Vincent a Madison ·West Central Community Mem Hosp ·Ball Mem Randolph ·Community Hosp of Anderson d Fountain Montgomery Franklin Hosp ·St Vincent Hosp ·St John Med Center Hamilton i ·St Clares V Randolph ·St Vincent Mercy Hosp – Elwood ·Riverview s Med Center Boone Morgan e o Hosp Henry n r ·Henry Co Wayne m ·Morgan Co Mem Hosp Hendricks Marion Hancock Mem Hosp ·Reid Hosp i ·St Francis Hosp & Health Parke Marion ll ·Hendricks ·Hancock Mooresville Putnam Comm Care Ctr i Mem Hosp ·Columbia Women's Hosp of Indpls o Fayette ·Putnam Co Hosp n Rush Fayette Union ·Community Hosp of Indpls Hosp Vigo Shelby Johnson 1 -East, 2 -North, 3 -South Mem Hosp Clay Morgan ·Johnson • Major Vigo ·St ·Methodist Hosp Indpls ·Columbia Terre Haute Hosp Mem Franklin ·Nurse Midwives ·Vincent Decatur ·Union Hosp – Terre Hosp Clay ·Riley Hosp - Data Management Off. Haute Barthol ·Decatur Owen Monroe Co ·St Francis Hosp. Center omew Mem Hosp Dearborn Dubois Sullivan ·Bloom Brown·Columbus ·St Vincent Hosp & Health Care Center Ripley ington Reg Hosp ·Wishard Mem Hosp ·Sullivan Co Greene ·Margaret ·Memorial Hosp Jennings Mary Comm Hosp ·Greene Co ·University Hospital & Health Care – Jackson Gen Hosp Lawrence Hosp Jasper Ohio ·Memorial ·Bedford Jefferson ·St Joseph Hosp Switzerland Medical Ctr Hosp Seymour Knox Dearborn ·King’s – Deaconess – ·Dunn Mem Daviess Daughters Hosp Good ·Daviess Martin Hosp Washington ·Dearborn Hosp Huntingburg Orange ·Wash. Co Scott Samaritan Co Hosp Scott ·Bloomington Mem Hosp Clark Hosp of ·Scott Co Mem Hosp ·Clark Mem Vanderburgh Pike Orange Co Hosp Gibson Dubois ·Deaconess Hosp ·Gibson Crawford Floyd Gen Hosp ·St Mary’s Med Center Harrison Floyd Evansville Perry ·Harrison Warrick ·St Mary’s Riverside ·Perry Co ·Floyd Mem Hosp Co Hosp Posey Vander Hosp burgh Spencer Mem Outreach Benton Carroll Tippecanoe ·Lafayette Home Hosp Grant
Meconium Screening Program Community and Family Health Services Commission Indiana State Department of Health
Meconium Screening Program Meconium Testing Newborn Screening Program • Pilot Program • Permanent Law • Universal Screening • Selected Screening • Invasive Procedure • Non-invasive Procedure • Parents May Refuse • Refusal Not Allowed • IU Newborn Screening • AIT Laboratory Lab • Funded by State If • Funded by Criteria Met Hospital/patient • Follow-up by Physician • Centralized Patient – No Individual
Why Meconium Testing § It is legislatively mandated (PL-291/2001) § Drug abuse during pregnancy is a major health problem. Early recognition, proper treatment, and follow-up to maximize the child’s development is imperative since intrauterine drug exposure is associated with mild to severe developmental delay, central nervous system damage, and behavioral dysfunction.
Mission Statement § To identify drug afflicted infants for referral to appropriate intervention and protection programs. § To collect information on the incidence of drug abuse during pregnancy.
State Criteria 1. The newborn’s weight is less than 2500 grams and the head is smaller than the 10 th percentile for the infant’s gestational age when there is no other medical explanation for these conditions. OR
State Criteria 2. When any two of the following conditions exist: • history of current or past drug use • unexpected abruptio placentae • no or inconsistent prenatal care; and • infant shows signs/symptoms suggestive of drug effects
Drug for Testing CLASS Amphetamines Methamphetamine Cannabinoids Cocaine Opiates SPECIFIC DRUG Amphetamine, Marijuana Cocaine Heroine, Morphine, Codeine, Hydrocodone
Positive Screening Result § Refer Child to First Steps § Refer Mom to a Treatment Program § Refer to Division of Family Services – Child in Need of Services
Negative Screening Result § No drugs/controlled substances were used, or §Use of drug not detected by the test, or § Use of drug that is detected by the test but, – did not take large enough dose – did not take it frequently enough to be detected – drug was taken in early pregnancy, during the First Trimester
Benefit • Reduction of post-delivery drug exposure (breast feeding) • Maternal drug treatment • Pediatric follow-up • Programs for improvement of parenting skills • Home assistance
AIT Laboratories State designated labs for the drug testing program 317 -243 -3894 n
Meconium Collection Procedures Groups Associated and Responsible for Testing § Attending Physician / Birthing Institution § Courier § Laboratory
Meconium Collection Procedures Collection Supplies: . ISDH Instruction Package. Requisition Form (317 -243 -3894). Collection Kit (317 -243 -3894)
Meconium Collection Procedures. Proper completion of the Requisition Form. Proper collection of specimen. Proper sealing & shipping of the specimen. Shipping of the specimen to AIT Laboratories timely
Reporting - MSR § Mandated by law (PL 291/2001) § Forms are provided by ISDH § Report must be submitted to ISDH by 15 th of each month § Reason code sheet must be completed § Report card is issued to hospital biannually
Evaluation 2003 program report
Questions? THANK YOU!
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