Genetic Testing and the Clinical Laboratory Improvement Amendments of 1988: Present and Future

摘要: CLIA '88 superseded '67. set standards designed to improve quality and expanded federal oversight virtually all clinical laboratories in the United States. Presumably because genetics testing was then its infancy, did not devote a special section testing. Biochemical immunochemical tests used evaluate inborn errors of metabolism other genetic entities were categorized as analytes Clinical Chemistry section, DNA probes primarily infectious disease included Microbiology. The legal, social, economic, ethical implications rapid commercialization these led recommendations that be defined laboratory specialty with subsection CLIA. advisory committee created under assigned review recommendations. agreed sufficiently different from areas already warrant separate section. Two definitions adopted. more clear-cut one is for molecular cytogenic tests. This includes analysis human DNA/RNA evaluating diseases. second definition proteins metabolites predominantly detect metabolism. Many are according their uses purposes. include detailed specific proposals concerning personnel, confidentiality informed consent, control, contamination, proficiency testing, validation tests, reporting, retention records, reuse tested specimens.