Newborn Screening made mandatory in Sindh, ordinance promulgatedJune 14, 2013
Karachi: Sindh Governor has promulgated the ‘Newborn Screening (Sindh) Ordinance 2013’ providing for mandatory screening of a newborn baby under ‘Comprehensive Newborn Screening System’ within three days of delivery.
The Ordinance envisages that newborn screening shall be performed after 24 hours of life but not later than three days from complete delivery of the newborn. A newborn placed in intensive care to ensure his or her survival shall be exempted from the condition of three days but shall be tested by seven days of age and it shall be the joint responsibility of the parents and practitioner or other person delivering the newborn.
The ordinance is aimed to establish and integrate a sustainable newborn screening system within public health delivery system and to provide a description of recommended procedures to audiologists performing follow up hearing screening or audio-logical assessment of infants identified during universal newborn hearing screening.
It also aims to provide a comprehensive and coordinated interdisciplinary program of early hearing screening and follow up care for newborns identified as referring from the hearing screening process. The goal is to screen all newborns for hearing impairment in order to alleviate the adverse effects of hearing loss to speech and language development, academic performance and cognitive development.
The Comprehensive Newborn Screening System means a screening system which includes but not limited to education of relevant stakeholders, collection and biochemical screening of blood samples taken from newborns, tracking and confirmatory testing to ensure the accuracy of screening results, clinical evaluation and biochemical and medical confirmation of test results, drugs and medical or surgical management and dietary supplementation to address the heritable conditions and evaluation activities to assess long term outcome, patient compliance and quality assurance.
The screening with regard to heritable condition shall be carried out to ascertain mental retardation, physical deformity or may cause death if left undetected and untraced and is usually inherited from the genes of either or both biological parents of the newborn.
According to the Ordinance, the newborn shall be examined by paediatrician, ophthalmologist, ear, nose and throat specialist and orthopaedic surgeon to exclude congenital abnormalities and performing biochemical testing for determining whether newborn has suspected heritable condition.
A health practitioner who delivers or assists in delivery of a newborn shall, prior to delivery, inform the parents or legal guardian of the newborn of the availability, nature and benefits of newborn screening. The government shall with assistance of National Institute of Child Health and other government agencies, NGOs and professional societies arrange the informational material.
The health institutions shall have the protocols, policies and procedures available for inspection including staff training, referral and follow up procedures. A parent or legal guardian may refuse testing on the grounds of religious beliefs, but shall acknowledge in writing their understanding that such refusal places the newborn at risk for undiagnosed heritable conditions. A copy of refusal documentation shall be made part of the newborn’s medical record. The health department of Sindh shall require the health institutes to provide newborn screening services as condition for licensure or accreditation. For the purpose of achieving the objectives, the health department shall constitute the Advisory Committee on newborn screening.