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