What information on quality specifications should be communicated to clinicians, and how?

Clinica Chimica Acta; International Journal of Clinical Chemistry
Mario Plebani

Abstract

Quality specifications, the level of performance required to facilitate clinical decision-making, not only have a central role in quality management in the laboratory but are also essential for assuring the interpretation and utilization of laboratory data by physicians. Consensus has been reached on the hierarchy of criteria for quality specifications. However, the information on quality specifications that should be communicated to clinicians, and the way in which this information should be given, is still widely debated. Laboratory tests have been grouped into four categories including uni-modal, and bi-modal distributions, tests used in patients monitoring and in evaluating the response to therapy (serial measurements), and, finally, tests that require interpretive comments. The most suitable and informative ways to communicate quality specifications to clinicians have been proposed for each category. For tests with a uni-modal distribution, the decision limits should replace traditional reference values in the report. For tests with a bi-modal distribution, in addition to traditional reference values, some flags based on the uncertainty (i.e., analytical and biological variability) of laboratory data, can be included to he...Continue Reading

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Citations

Jun 11, 2005·Clinica Chimica Acta; International Journal of Clinical Chemistry·Jillian R TateDevinder Gill
Sep 10, 2009·Veterinary Clinical Pathology·Anne GeffréJean-Pierre Braun
Sep 24, 2005·Clinical Chemistry and Laboratory Medicine : CCLM·Mario Plebani
Feb 16, 2006·Clinical Chemistry and Laboratory Medicine : CCLM·Mario PlebaniPierangelo Bonini
Nov 20, 2009·Clinical Chemistry and Laboratory Medicine : CCLM·David BurnettJames Westgard
Dec 18, 2009·Clinical Chemistry and Laboratory Medicine : CCLM·Emmanuel J Favaloro, Giuseppe Lippi
Nov 26, 2010·Clinical Chemistry and Laboratory Medicine : CCLM·Gerald J Kost, Kristin N Hale
Oct 15, 2013·Clinica Chimica Acta; International Journal of Clinical Chemistry·Mario Plebani, Mauro Panteghini
Jan 30, 2016·Clinical Chemistry and Laboratory Medicine : CCLM·Michael A Moss
Mar 24, 2009·Clinica Chimica Acta; International Journal of Clinical Chemistry·Mario Plebani
Mar 21, 2009·Clinica Chimica Acta; International Journal of Clinical Chemistry·Mario Plebani
Apr 19, 2007·Clinical Chemistry and Laboratory Medicine : CCLM·Mario Plebani
Jun 21, 2007·Clinical Chemistry and Laboratory Medicine : CCLM·Mario Plebani
Apr 26, 2008·Clinics in Laboratory Medicine·Giuseppe LippiGian Cesare Guidi
Apr 22, 2008·Clinica Chimica Acta; International Journal of Clinical Chemistry·Mario Plebani
Jun 1, 2007·Autoimmunity Reviews·Elio TonuttiNicola Bizzaro
Jan 16, 2009·Electrophoresis·Roberto GuerrantiRoberto Pagani
Mar 31, 2009·Clinical Chemistry and Laboratory Medicine : CCLM·Emilio FloresMaria Salinas
Mar 19, 2013·Clinica Chimica Acta; International Journal of Clinical Chemistry·Mario PlebaniDiego Faggian
Jul 17, 2020·Critical Reviews in Clinical Laboratory Sciences·Neda MilinkovićSvetlana Ignjatović
May 8, 2018·Clinical Chemistry and Laboratory Medicine : CCLM·Andrea PadoanDaniela Basso

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