title: Legal issues in neonatal screening.
abstract: Legal issues arise if some persons or institutions feel wrongfully treated whether or not this feeling is justified. In neonatal screening, the following topics may be causing legal issues: no screening programme where such a programme should be (UN Convention for the right of the child); neonate(s) not screened for conditions within the established programme; no consent when it should have been given; error(s) in sampling, analysis, reporting; no follow-up available, error(s) in confirmatory diagnostics and treatment; irregular storage of dried blood spot specimen. Legal issues can be solved easily when responsibilities of parties concerned have been established and documented. Unfortunately, legal systems vary from country to country and what has become "normal" practice in one jurisdiction may still be battled about in another. The management of a neonatal screening programme should try to define as best as possible the performance criteria and to have the programme assessed and accredited to certain internationally accepted standards. It diminishes the chances for errors and it helps to avoid legal issues.
authors.affiliation: International Society for Neonatal Screening, PO Box 1, 3720 BA Bilthoven, The Netherlands. Gerard.Loeber@rivm.nl
authors.forename: J Gerard
authors.initials: JG
authors.lastname: Loeber
mesh_terms: D006801:Humans; D007231:Infant, Newborn; D015997:Neonatal Screening / Q000331:legislation & jurisprudence*