The case for laboratory developed procedures: Quality and positive impact on patient care Journal Article

Authors: Kaul, K. L.; Sabatini, L. M.; Tsongalis, G. J.; Caliendo, A. M.; Olsen, R. J.; Ashwood, E. R.; Bale, S.; Benirschke, R.; Carlow, D.; Funke, B. H.; Grody, W. W.; Hayden, R. T.; Hegde, M.; Lyon, E.; Murata, K.; Pessin, M.; Press, R. D.; Thomson, R. B.
Article 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: transplantation; genomics; administration; cell lung-cancer; monoclonal-antibody therapy; tandem mass-spectrometry; chronic myeloid-leukemia; renal-transplant recipients; molecular diagnostics; metastatic colorectal-carcinoma; herpes-simplex encephalitis; next-generation sequencing; solid-organ; clinical laboratory improvement amendments; for-molecular-pathology; of-american-pathologists; food and drug; lab-developed procedures; lab-developed tests
Journal Title: Academic Pathology
Volume: 4
ISSN: 2374-2895
Publisher: Sage Publications  
Date Published: 2017-07-16
Language: English
ACCESSION: WOS:000433777300001
DOI: 10.1177/2374289517708309
PMCID: PMC5528950
PUBMED: 28815200
Notes: Article -- UNSP 2374289517708309 -- Source: Wos
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MSK Authors
  1. Kazunori Murata
    12 Murata
  2. Dean Christian Carlow
    20 Carlow