دورية أكاديمية
أعرض في EDS

The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care.

التفاصيل البيبلوغرافية
العنوان: The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care.
المؤلفون: Kaul KL; Department of Pathology and Laboratory Medicine, NorthShore University HealthSystem, Evanston, IL, USA., Sabatini LM; Department of Pathology and Laboratory Medicine, NorthShore University HealthSystem, Evanston, IL, USA., Tsongalis GJ; Laboratory for Clinical Genomics and Advanced Technology, Department of Pathology, Dartmouth Hitchcock Medical Center and Norris Cotton Cancer Center, Lebanon, NH, USA.; Laboratory Medicine, Dartmouth Hitchcock Medical Center and Norris Cotton Cancer Center, Lebanon, NH, USA., Caliendo AM; Department of Medicine, Alpert Medical School of Brown University, Providence, RI, USA., Olsen RJ; Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, TX, USA., Ashwood ER; GeneDx, Gaithersburg, MD, USA., Bale S; Department of Pathology, University of Colorado, Aurora, CO, USA., Benirschke R; Department of Pathology and Laboratory Medicine, NorthShore University HealthSystem, Evanston, IL, USA., Carlow D; Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Funke BH; Laboratory for Molecular Medicine, Massachusetts General Hospital, Boston, MA, USA., Grody WW; Departments of Pathology and Laboratory Medicine, Pediatrics and Human Genetics, UCLA School of Medicine, Los Angeles, CA, USA., Hayden RT; Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA., Hegde M; Department of Human Genetics, Emory University School of Medicine, Atlanta, GA, USA., Lyon E; Pathology Department, University of Utah School of Medicine/ARUP Laboratories, Salt Lake City, UT, USA., Murata K; Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Pessin M; Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Press RD; Department of Pathology and Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA., Thomson RB; Department of Pathology and Laboratory Medicine, NorthShore University HealthSystem, Evanston, IL, USA.
المصدر: Academic pathology [Acad Pathol] 2017 Jul 16; Vol. 4, pp. 2374289517708309. Date of Electronic Publication: 2017 Jul 16 (Print Publication: 2017).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier Inc Country of Publication: United States NLM ID: 101698648 Publication Model: eCollection Cited Medium: Print ISSN: 2374-2895 (Print) Linking ISSN: 23742895 NLM ISO Abbreviation: Acad Pathol Subsets: PubMed not MEDLINE
أسماء مطبوعة: Publication: 2022- : [Cambridge, MA] : Elsevier Inc.
Original Publication: Thousand Oaks, CA : Sage Publications, [2014]-
مستخلص: 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.
Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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معلومات مُعتمدة: P30 CA023108 United States CA NCI NIH HHS
فهرسة مساهمة: Keywords: Clinical Laboratory Improvement Amendments; Food and Drug Administration; genomics; lab-developed procedures; lab-developed tests; molecular diagnostics; next-generation sequencing
تواريخ الأحداث: Date Created: 20170818 Latest Revision: 20240728
رمز التحديث: 20240728
مُعرف محوري في PubMed: PMC5528950
DOI: 10.1177/2374289517708309
PMID: 28815200
قاعدة البيانات: MEDLINE
الوصف
تدمد:2374-2895
DOI:10.1177/2374289517708309