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

作者: Karen L. Kaul , Linda M. Sabatini , Gregory J. Tsongalis , Angela M. Caliendo , Randall J. Olsen

DOI: 10.1177/2374289517708309

关键词: Patient careMedical physicsService (systems architecture)Quality (business)BiotechnologyMolecular diagnosticsQuality managementFood and drug administrationMedicine

摘要: An explosion of knowledge and technology is revolutionizing medicine patient care. Novel testing must be brought to the clinic with safety accuracy, but also in a timely cost-effective manner, so that patients can benefit laboratories offer consistent current guidelines. Under oversight provided by Clinical Laboratory Improvement Amendments, have been able develop optimize laboratory procedures for use in-house. Quality improvement programs, interlaboratory comparisons, ability adjust assays as needed improve results, utilize new sample types, or incorporate mutations, information, technologies are positive aspects Amendments laboratory-developed procedures. Laboratories long history successful service operating under Amendments. A series detailed clinical examples illustrating quality impact on care provided. These demonstrate how ensures accurate, reliable, reproducible laboratories.

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