Mario Plebani University-Hospital of Padova, Italy

Transcription

1 Mario Plebani University-Hospital of Padova, Italy

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3 70-80% of clinical decisions require laboratory medicine information (sources: UK Department of Health, Italian Health Minister) <2% costs

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5 Actual IVD spend as a part of overall HCE is low, accounting for 2.3% and 1.4% in the US and Germany, respectively IVD testing guides approximately 65% of clinical decisions Physicians overrate the costs of IVD as a proportion of HCE Physicians demand diagnostic tests that show both clinical utility and cost-effectiveness

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7 JALM 2017; 1: 410-4

8 The greater the acuity of a patient population, the more likely the laboratory was used, which explains why almost all inpatients used laboratory testing

9 Real-time results Biomarkers for early diagnosis MODERN LABORATORY- MEDICINE More effective tests (strongly influencing the clinical decisionmaking) Risk factors for disease prevention Omics technologies

10 TEST DISEASE Cardiac troponins (I&T) Anti-Transglutaminase Ab Plasma metanephrins Glycated ferritin Anti-Aquaporin 4 BCR-ABL (quantitative) Jak 2 HFE gene MEFV gene Acute coronary syndrome Celiac disease Pheochromocytoma Adult Onset Stll Disease Neuromyelitis Optica Chronic Myelogenous l. Primary myelofibrosis Hemochromatosis Familial Mediterranean Fever

11 2015 ESC Guidelines for the management of ACS

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15 The liquid biopsy approach

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19 THE GOOD THE BAD THE UGLY Pre-analytic Analytical quality Post-analytic

20 Pre-pre-analytical errors Insufficient sample Incorrect sample Incorrect ID Sample condition Postanalytical Preanalytical Handling problem Equipment malfunction Analytical 46-68% 7-13% 19-47% Sample mix-up Interference Reporting or analysis Incorrect Data entry Inadequate Turn around Post-post-analytical errors Plebani CCLM 2006

21 George D Lundberg JAMA 1981 M.Plebani

22 WHAT COUNTS IS THE CONTINUUM Although the brain-to-brain concept is widely accepted by laboratory professionals, there is little clarity concerning the inter-relationship between the different phases of the cycle, in particular the interdependence between the pre-analytical phase and analytical quality, and the role of post-analytical steps in affecting the quality of the ultimate laboratory information provided. M Plebani, 2016 M.Plebani

23 Good samples make good assays M.Plebani

24 Good post-analytical quality makes good laboratory information M.Plebani

25 The five rights in laboratory medicine: The right patient, the right sample, the right time, the right analytical result, and the right clinical interpretation But there is a sixth element that must be correct and we believe it s time to add to each prescription: the right indication M.Plebani

26 Plebani M & Panteghini M, Clinica Chimica Acta 432 (2014) 15.

27 Therapeutic monitoring 5 Patient Presentation Therapeutic Cycle Therapeutic Action 1 Differential Tentative Clinical Diagnosis Working Final Bedside H&P Are Tests Test Selection (Pre-pre-Analytic) Diagnosis Test Cycle Test Performance (Analytic) Test Interpretation (Post-post-Analytic)

28 Quality in laboratory medicine should be defined as the guarantee that each and every step in the total testing process is correctly performed, thus ensuring valuable decision making and effective patient care. Plebani M. Clin Biochem Rev 2012

29 CLINICIAN Management of responsibility CLINICIAN PATIENT Management of resources Control, evaluation and improvement PATIENT REQUEST clinical request input Testing process Pre-analytical Intra-analytical Post-analytical REPORT clinical information output No ERROR, No HARM

30 The International Standard for Medical Laboratories Accreditation (ISO 15189) requires that the laboratory establishes, documents, implements and maintains a quality management system that shall provide for the integration of all processes required to fulfil its quality policy and objectives and meet the needs and requirements of the users (4.2.1)

31 NEEDS OF USERS Laboratory management shall ensure that laboratory services, including appropriate advisory and interpretative services, meet the need of patients and those using the laboratory services.

32 There is no doubt that the most critical need of users is the provision of accurate laboratory test results that do not harm or increase the risk of diagnostic errors, particularly errors related to adverse events.

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34 THE MAIN DRIVERS OF THE PARADIGMATIC CHANGE OF THE LANDSCAPE OF LABORATORY MEDICINE the evidence of the vulnerability of the extra-analytical phases, the increased recognition of the need for a focus on the added value of laboratory information in improving the decision making process and clinical outcomes

35 THE TIME THEY ARE A- CHANGING The last 50 years have seen substantial changes in the landscape of laboratory medicine: its role in modern medicine is in evolution and the concept of quality of laboratory services is changing