Author/Authors :
Kaul, Karen L. Department of Pathology and Laboratory Medicine - NorthShore University HealthSystem, Evanston, IL, USA , Sabatini, Linda M. Department of Pathology and Laboratory Medicine - NorthShore University HealthSystem, Evanston, IL, USA , Tsongalis, Gregory J. Laboratory for Clinical Genomics and Advanced Technology - Department of Pathology - Dartmouth Hitchcock Medical Center and Norris Cotton Cancer Center, Lebanon, NH, USA , Caliendo, Angela M. Department of Medicine - Alpert Medical School of Brown University, Providence, RI, USA , Olsen, Randall J. Department of Pathology and Genomic Medicine - Houston Methodist Hospital, Houston, TX, USA , Ashwood, Edward R. Department of Pathology - University of Colorado, Aurora, CO, USA , Bale, Sherri GeneDx, Gaithersburg, MD, USA , Benirschke, Robert Department of Pathology and Laboratory Medicine - NorthShore University HealthSystem, Evanston, IL, USA , Carlow, Dean Department of Laboratory Medicine - Memorial Sloan Kettering Cancer Center, New York, NY, USA , Funke, Birgit H. Laboratory for Molecular Medicine - Massachusetts General Hospital, Boston, MA, USA , Grody, Wayne W. Departments of Pathology and Laboratory Medicine - Pediatrics and Human Genetics - UCLA School of Medicine, Los Angeles, CA, USA , Hayden, Randall T. Department of Pathology - St. Jude Children’s Research Hospital, Memphis, TN, USA , Hegde, Madhuri Department of Human Genetics - Emory University School of Medicine, Atlanta, GA, USA , Lyon, Elaine Pathology Department - University of Utah School of Medicine/ARUP Laboratories, Salt Lake City, UT, USA , Murata, Kazunori Department of Laboratory Medicine - Memorial Sloan Kettering Cancer Center, New York, NY, USA , Pessin, Melissa Department of Laboratory Medicine - Memorial Sloan Kettering Cancer Center, New York, NY, USA , Press, Richard D. Department of Pathology and Knight Cancer Institute - Oregon Health & Science University, Portland, OR, USA , Thomson, Richard B. Department of Pathology and Laboratory Medicine - NorthShore University HealthSystem, Evanston, IL, USA
Abstract :
An explosion of knowledge and technology is revolutionizing medicine and patient care. Novel testing must be brought to the clinic with safety and accuracy, but also in a timely and cost-effective manner, so that patients can benefit and laboratories can offer testing consistent with current guidelines. Under the oversight provided by the Clinical Laboratory Improvement Amendments, laboratories have been able to develop and optimize laboratory procedures for use in-house. Quality improvement programs, interlaboratory comparisons, and the ability of laboratories to adjust assays as needed to improve results, utilize new sample types, or incorporate new mutations, information, or technologies are positive aspects of Clinical Laboratory Improvement Amendments oversight of laboratory-developed procedures. Laboratories have a long history of successful service to patients operating under Clinical Laboratory Improvement Amendments. A series of detailed clinical examples illustrating the quality and positive impact of laboratory-developed procedures on patient care is provided. These examples also demonstrate how Clinical Laboratory Improvement Amendments oversight ensures accurate, reliable, and reproducible testing in clinical laboratories.
