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Mario PlebaniUniversity-Hospital
of Padova, Italy
70-80% of clinical decisions requirelaboratory medicine information
(sources: UK Department of Health, Italian Health Minister)
<2%costs
• Actual IVD spend as a part of overall HCE islow, accounting for 2.3% and 1.4% in the USand Germany, respectively
• IVD testing guides approximately 65% ofclinical decisions
• Physicians overrate the costs of IVD as aproportion of HCE
• Physicians demand diagnostic tests that showboth clinical utility and cost-effectiveness
JALM 2017; 1: 410-4
The greater the acuityof a patient population,the more likely thelaboratory was used,which explains whyalmost all inpatientsused laboratory testing
Biomarkersfor early
diagnosis
Risk factorsfor diseaseprevention
“Omics”technologies
More effectivetests (stronglyinfluencing the
clinical decision-making)
Real-timeresults
MODERN LABORATORY-
MEDICINE
• 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
TEST DISEASE
2015 ESC Guidelines for the management of ACS
The liquid biopsy approach
THE GOOD
Analyticalquality
THE BAD
Pre-analytic
THE UGLY
Post-analytic
Plebani CCLM 2006
Analytical Post-analytical
Pre-analytical
Samplecondition
Handlingproblem
IncorrectID
Incorrectsample
Insufficientsample
Reporting or analysis
IncorrectData entry
InadequateTurn aroundSample mix-up
Interference
Equipmentmalfunction
46-68% 7-13% 19-47%
Pre-
pre-
anal
ytic
al e
rror
sPost-post-analytical errors
JAMA 1981
M.Plebani
George D Lundberg
Although the brain-to-brain concept is widelyaccepted by laboratory professionals, there islittle clarity concerning the inter-relationshipbetween the different phases of the cycle,in particular the interdependence betweenthe pre-analytical phase and analyticalquality, and the role of post-analyticalsteps in affecting the quality of theultimate laboratory information provided.
M.Plebani
WHAT COUNTS IS THE CONTINUUM
M Plebani, 2016
M.Plebani
Good samples make good assays
M.Plebani
Good post-analytical quality makesgood laboratory information
The five “rights” in laboratory medicine:
The right patient, the right sample, theright time, the right analytical result, andthe right clinical interpretationBut there is a sixth element that must becorrect – and we believe it’s time to add toeach prescription: the right indication
M.Plebani
Plebani M & Panteghini M, Clinica Chimica Acta 432 (2014) 15.
Therapeuticmonitoring
TherapeuticCycle
Patient Presentation
TherapeuticAction
Diagnosis TestCycle
ClinicalDiagnosis
5
1
2 3 4
Test Selection(Pre-pre-Analytic)
Test Performance(Analytic)
Test Interpretation(Post-post-Analytic)
Differential Tentative FinalWorking
Bedside H&PAre “Tests”
Quality in laboratory medicine should bedefined as the guarantee that each andevery step in the total testing process iscorrectly performed, thus ensuring valuabledecision making and effective patientcare.
Plebani M. Clin Biochem Rev 2012
Management ofresponsibility
Managementof resources
Control, evaluation and improvement
Testing process
CLINICIAN
PATIENT
outputinput
REPORTclinical information
CLINICIAN
PATIENT
REQUESTclinical request
Post-analytical
Pre-analytical
Intra-analytical
No ERROR,No HARM
The International Standard for MedicalLaboratories Accreditation (ISO 15189)requires that “the laboratory establishes,documents, implements and maintains aquality management system” that “shallprovide for the integration of all processesrequired to fulfil its quality policy andobjectives and meet the needs andrequirements of the users (4.2.1)”
• 4.1.2.2 NEEDS OF USERSLaboratory management shall ensure thatlaboratory services, including appropriateadvisory and interpretative services,meet the need of patients and those usingthe laboratory services.
There is no doubt thatthe most critical needof users is the provisionof accurate laboratorytest results that do notharm or increase therisk of diagnosticerrors, particularlyerrors related toadverse events.
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
THE TIME THEY ARE A-CHANGING
The last 50 years have seen substantialchanges in the landscape of laboratorymedicine: its role in modern medicine is inevolution and the concept of quality oflaboratory services is changing