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New Born Metabolic Screening- Program Design ,Planning and Implementation. Dr S Sunija M D (Path) Director State Public Health and Clinical Lab Trivandrum. New Born Metabolic Screening Program of Kerala. Program completed Five Years 4.6 Lakhs Babies Screened
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New Born Metabolic Screening- Program Design ,Planning and Implementation Dr S Sunija M D (Path) Director State Public Health and Clinical Lab Trivandrum
New Born Metabolic Screening Program of Kerala • Program completed Five Years • 4.6 Lakhs Babies Screened • First ever New Born screening in a Program Mode • Early detection of inborn errors of metabolism and early intervention. • First phase expanded pilot program- 3 years • Second Phase – Expansion to all Govt Hospitals(nearly 100 hospital)
General Policy of State • There is benefit for the individual from Early Diagnosis, Early intervention and treatment • Reliable Screening Test facility • Suitable system for testing, treatment , counseling and follow up • No Out of pocket expenditure for beneficiary • Financial Viability
Principle of the Program To ensure that the excellent work is in pace with the best international Practices for early detection and intervention of selected disorders to prevent serious consequences like mental retardation.
Selection of Diseases Screened Considering the serious consequences associated with, • Congenital Hypothyroidism • Congenital Adrenal Hyperplasia • Phenyl Ketonuria • Glucose- 6 Phosphate Dehydrogenase deficiency • Phenyl Ketonuria was replaced after four years by Galactosemia
Stake Holders • Testing Laboratories(4 Public Health Labs) • Delivery Conducting Govt Hospital • Parents of the New Borns • Officials- Health Department, RBSK • KMSCL etc…
Process • Program Started in April 2013 • The Following aspects were considered before starting NBS programme. • Overall Management structure of screening programme • Equipping the Labs • Funding for the program • Technology to support quality service • Mechanism for proper report delivery • Training of those involved • Storage and transportation of sample collection forms.
Selection of Hospital • Pilot Study Phase Hospitals having 100 or more deliveries were selected and ensured that all babies born in these hospital were screened • Expanded phase (after three years) All delivery conducting Hospital are included under this Program despite of number of deliveries • Screening Protocol developed by SPHCL approved by DHS & NHM
Selection of Lab • Region wise labs designated for testing
Trainings • State level sensitization workshop for selected hospital Superintendents, Nursing superintendents and District Programme Managers • Training for blood spot collection conducted in the selected District/General hospitals for the nursing staff involved in blood collection. • Hands on training for laboratory personnel including Specialist Doctors, Scientific Officers and Lab technicians in PH lab. • Periodical quality improvement training for Hospital and Laboratory staff concerned • Sensitization Training for newly added hospital and Staff
Funding • State plan fund • National Health Mission fund • Procurement of Equipments, Sample card Lancet , Test kit and Reagents through Kerala Medical Services Corporation
Sample Collection • Sufficient number of Blood collection forms and lancets were supplied to the hospitals • Heel prick samples collected after 48 hrs of birth is send to the designated testing Laboratory • Verbal Consent from the parents
Blood Collection Card • S& S 903 filter paper is attached to Blood Spot Collection card. • After filling up the card sample has to be collected • After blood Collection it is dried and stored at 2-80C before being couriered to the lab
Transportation of sample Sample transported under cold chain maintenance Various transporting methods are used • By Courier • By Hand Delivery(Near by institutions) • Field Vehicles
Invalid Specimen • Quantity of Blood not sufficient • Blood spot appear wet or discolored(not properly dried) • Blood spot appear clotted( Excess blood applied / repeated application)
Methods Used for testing • Immunofluroscence • ELISA • 2 Methods – to prevent lack of test kit at any given time • Result Delivery – By email, telephone and also updated in JATAKSEVA portal • Follow up is done through the District Early intervention Centre
Prevalance • Congenital Hypothyroidism- 1 in 1947 • G6PD-1 in 10035 • Congenital Adrenal Hyperplasia - 1 in 23083 • PKU-0 • Galactosemia – 1in 76880
Award Winning Poster – NBS Innovative and Replicable Program
Impact • By early detection and early intervention, the programme could help to nip in the bud the most important preventable causes of mental retardation (CH) and serious consequences associated with the other selected inborn errors of metabolism. • Strong NBS testing Laboratory Network with close cooperation of hospitals • Proper system for reporting
CAH Positive Baby After Treatement