@article{c6e4f24b755b496db91c34a486fc8c64,
title = "The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care",
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.",
keywords = "Clinical Laboratory Improvement Amendments, Food and Drug Administration, genomics, lab-developed procedures, lab-developed tests, molecular diagnostics, next-generation sequencing",
author = "Kaul, {Karen L.} and Sabatini, {Linda M.} and Tsongalis, {Gregory J.} and Caliendo, {Angela M.} and Olsen, {Randall J.} and Ashwood, {Edward R.} and Sherri Bale and Robert Benirschke and Dean Carlow and Funke, {Birgit H.} and Grody, {Wayne W.} and Hayden, {Randall T.} and Madhuri Hegde and Elaine Lyon and Kazunori Murata and Melissa Pessin and Press, {Richard D.} and Thomson, {Richard B.}",
note = "Funding Information: According the Genetic Test Registry, over 50 laboratories in the United States offer testing for FX (https://www.ncbi.nlm. nih.gov/gtr/; accessed 11-01-2016). Currently, all FX testing is performed as LDPs: No FDA-cleared assay is available. PCR primers and Southern blot reagents are available commercially as analyte-specific reagents (ASR) or as investigational use only. Clinical laboratories use these commercial reagents, or design primers or probes, combine them internally to develop the assay and establish performance characteristics. The ACMG has published standards and guidelines for clinical laboratories that perform this test.98 Reference materials to standardize sizing were developed through the Genetic Testing Reference Material program99 sponsored by the Centers for Disease Control and Prevention (CDC), the National Institute of Standards and Technology (https://www.nist.gov/node/ 608501, Accessed November 1, 2016), and the World Health Organization.100 Proficiency testing through the CAP has demonstrated the excellent performance of clinical laboratories of this high-complexity LDP.101 Publisher Copyright: {\textcopyright} The Author(s) 2017.",
year = "2017",
doi = "10.1177/2374289517708309",
language = "English (US)",
volume = "4",
journal = "Academic Pathology",
issn = "2374-2895",
publisher = "SAGE Publications Ltd",
}