SOURCE: Clinical and Laboratory Standards Institute

Clinical and Laboratory Standards Institute

November 02, 2009 14:46 ET

CLSI Publishes Newborn Screening Guidelines for Preterm, Low Birth Weight, and Sick Newborns

WAYNE, PA--(Marketwire - November 2, 2009) - Infants in special care baby units or neonatal intensive care units are at greater risk for missed or incomplete newborn screening than normal newborns. To minimize the risk of missing or delaying a diagnosis, Clinical and Laboratory Standards Institute (CLSI) recently published a new document, "Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns; Approved Guideline" (I/LA31-A). The guideline focuses on best practices for newborn screening of preterm, low birth weight, sick, and other at-risk newborns in special care baby units worldwide to detect treatable conditions before physical damage can occur to the infant.

"Newborn blood spot screening programs have been expanding their screening panels in recent years. At the same time, care for infants who are premature, low birth weight, or sick has become more complex and effective. Many treatments given in special care nurseries, as well as conditions existing in the infant or the mother, can affect the reliability of newborn screening results. This increases the chance that a preterm or ill infant affected with one of the screened conditions may not be diagnosed or may have diagnosis and treatment delayed. It is hoped that the CLSI document will provide guidance to screening programs and special care personnel to ensure that every baby receives reliable and timely screening, and those infants who are affected can start treatment before damage can occur," says Judith Tuerck, RN, MS, Oregon Health & Science University Laboratory, and co-chairholder of the subcommittee that developed the guideline.

Julie Miller, BS, Nebraska Department of Health & Human Services, and co-chairholder of the subcommittee that developed the guideline, agrees, "I/LA31-A is important to helping newborn screening programs implement uniform practices for greater assurance that these newborns will receive reliable screening. There are so many factors associated with preterm, low birth weight, and sick babies that can influence screening results. These guidelines attempt to account for all of the known interferences, and recommend practices that should provide the best screening with a minimum number of specimens and hearing screening tests."

I/LA31-A includes seven tables, which, along with charts supplied in the appendix, refine a large amount of complex data into easy-to-follow instructions.

Goals of this guideline are to

--  Ensure rapid, consistent, and complete blood spot and hearing
    screening, including appropriate follow-up to ensure early diagnosis and
    treatment for preterm, low birth weight, or sick newborns.
--  Minimize the risk of a missed or delayed diagnosis and treatment for
    all screened conditions.
--  Optimize the timing and minimize the number of blood spot specimen
    collections and hearing screening events.
--  Define essential elements of quality assurance relevant to these
--  Provide education on the effects of special care baby unit treatments
    on newborn blood spot and hearing screening.
--  Identify areas needing further research.

The guideline is intended for use by those involved in any aspect of newborn screening specimen collection or hearing screening testing and follow-up including health care providers, parents, public health professionals, and others concerned with the health and welfare of newborns.

CLSI is a volunteer-driven, membership-supported, nonprofit organization dedicated to developing standards and guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, and the health care professions. For additional information on CLSI, visit the CLSI website at or call 610.688.0100.

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