Total error vs. measurement uncertainty: the match continues

Panteghini, Mauro; Sandberg, Sverre

doi:10.1515/cclm-2015-1036

Cited by 21 publications

(15 citation statements)

References 8 publications

(14 reference statements)

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“…Importantly, it should be noted that these three models use different principles and do not necessarily constitute a hierarchy. An important innovative aspect of the new consensus is the recognition that some models are better suited for certain measurands than for others; the attention is therefore primarily directed towards the measurand and its biological and clinical characteristics [9]. Another novel aspect is the focus on the quality of the information.…”

Section: The Milan Strategic Conferencementioning

confidence: 99%

“…The Milan conference revitalized the TE vs. measurement uncertainty discussion [9,27]. If TE is still useful in evaluating single EQAS results, there is also a need to look carefully to the measurement uncertainty as this helps very much in the identification of important sources of bias [1,28].…”

Section: The Strategic Conference Heritage Eflm Initiated Task and Fimentioning

confidence: 99%

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Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

Panteghini

Ceriotti

Jones

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:Measurements in clinical laboratories produce results needed in the diagnosis and monitoring of patients. These results are always characterized by some uncertainty. What quality is needed and what measurement errors can be tolerated without jeopardizing patient safety should therefore be defined and specified for each analyte having clinical use. When these specifications are defined, the total examination process will be "fit for purpose" and the laboratory professionals should then set up rules to control the measuring systems to ensure they perform within specifications. The laboratory community has used different models to set performance specifications (PS). Recently, it was felt that there was a need to revisit different models and, at the same time, to emphasize the presuppositions for using the different models. Therefore, in 2014 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) organized a Strategic Conference in Milan. It was felt that there was a need for more detailed discussions on, for instance, PS for EQAS, which measurands should use which models to set PS and how to set PS for the extra-analytical phases. There was also a need to critically evaluate the quality of data on biological variation studies and further discussing the use of the total error (TE) concept. Consequently, EFLM established five Task Finish Groups (TFGs) to address each of these topics. The TFGs are finishing their activity on 2017 and the content of this paper includes deliverables from these groups.

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Section: The Milan Strategic Conferencementioning

confidence: 99%

Section: The Strategic Conference Heritage Eflm Initiated Task and Fimentioning

confidence: 99%

Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

Panteghini

Ceriotti

Jones

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…La proposta non è stata accettata da CLIA (Clinical Laboratory Improvement Amendments) ed è stata criticata, dando origine a un serrato dibattito sulla rivista Clinical Chemistry and Laboratory Medicine [11][12][13].…”

Section: Sicurezza Del Risultato Analiticounclassified

Patient Safety in Laboratory Medicine. The Big Picture ten years later

Cappelletti

2018

Riv Ital Med Lab

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Riassunto Dieci anni fa fu presentata una Grande Visione (the Big Picture) intorno alla sicurezza del paziente (Patient Safety) in Medicina di Laboratorio, costituita dai cerchi concentrici della sicurezza dei risultati (qualità analitica), del processo (Total Testing Process, TTP), degli esiti (efficacia clinica e appropriatezza) e della sicurezza del cittadino. Da allora le innovazioni più importanti al livello della sicurezza dei risultati sono state l'introduzione di nuovi strumenti di controllo analitico (Individualized Quality Control Plan, IQCP) e di accreditamento (ISO 15189:2012) e la ripresa della discussione teorica (criteri di definizione della prestazione analitica; dibattito tra Total Analytical Error-TAE e Measurement Uncertainty-MU come misure dell'accuratezza) soprattutto grazie a EFLM (European Federation of Clinical Chemistry and laboratory Medicine). Tuttavia i dati riportati da Westgard et al nel 2017 mostrano ancora livelli di accuratezza analitica inferiori a 3 sigma, un uso non corretto dei controlli di qualità interni in oltre il 50% dei casi, uno scarso utilizzo di IQCP in termini di laboratori (< 20%) e di test (<5%), un impatto clinico pressoché nullo di MU (<5%). Il tema dell'affidabilità analitica dei risultati di laboratorio, dunque, è ancora essenziale in Medicina di Laboratorio. Per quanto riguarda il TTP, tre sono i percorsi più rilevanti che in questi anni ne hanno potenziato il significato: lo studio e l'identificazione di indicatori di qualità (Quality Indicators, QI) per le fasi extra-analitiche, in assonanza con i requisiti ISO 15189:2012 e inseriti in un quadro di risk management che ne consente benchmark, analisi delle cause di fallimento e azioni correttive; la pubblicazione da parte di The National Academy of Science del documento Impro-B P. Cappelletti pie.cappelletti@gmail.com 1 SIPMeL, Castelfranco Veneto, TV, Italia ving Diagnosis in Health Care che rappresenta un cambio di paradigma, perché si passa dall'attenzione alla riduzione degli errori all'impegno per il miglioramento della diagnosi, con definizione dell'errore diagnostico dal punto di vista del paziente e del processo diagnostico come un lavoro dinamico e collaborativo di gruppo; la revisione del brain-tobrain loop di Lundberg, con la fusione con il concetto di interfaccia clinica-laboratorio amplificata, la definizione delle fasi pre-pre e post-post analitiche come momenti di condivisione clinici-laboratoristi, il concetto di colloquio tra reti di cervelli e la centralità del paziente e dei suoi esiti. Dal punto di vista degli esiti, le tesi più interessanti poggiano sul concetto di "utilità clinica" dei test di laboratorio che esprime il passaggio da una visione "essenzialista" a una "consequenzialista" della Medicina di Laboratorio. Tuttavia restano i problemi della complessità degli esiti clinici in senso lato, la sovrapposizione tra efficacia clinica e appropriatezza e la difficoltà di evidenze che correlino esplicitamente test ed esito clinico. Le evidenze vengono sintetizzate in linee guida che div...

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“…Thus -in its original form -the TE model does not include biological variation and other additional causes of variation into the model, except in the calculation of pTAE [1]. Biological variation, although not relevant when monitoring variation in control samples, is certainly relevant when dealing with patient samples [10]. Biological variation can be taken into account by including biological variation in the model transforming the relationship between imprecision and bias into a curve (see Figure 2 Larsen et al [32]).…”

Section: Considerations Regarding the Te Modelmentioning

confidence: 99%

“…TAE methods are commonly intertwined with quality assurance, analytical performance specifications and Six Sigma methods [2,[6][7][8][9], which are only partially included in this paper [9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

The use of error and uncertainty methods in the medical laboratory

Oosterhuis

Bayat²,

Armbruster

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Error methods -compared with uncertainty methods -offer simpler, more intuitive and practical procedures for calculating measurement uncertainty and conducting quality assurance in laboratory medicine. However, uncertainty methods are preferred in other fields of science as reflected by the guide to the expression of uncertainty in measurement. When laboratory results are used for supporting medical diagnoses, the total uncertainty consists only partially of analytical variation. Biological variation, pre-and postanalytical variation all need to be included. Furthermore, all components of the measuring procedure need to be taken into account. Performance specifications for diagnostic tests should include the diagnostic uncertainty of the entire testing process. Uncertainty methods may be particularly useful for this purpose but have yet to show their strength in laboratory medicine. The purpose of this paper is to elucidate the pros and cons of error and uncertainty methods as groundwork for future consensus on their use in practical performance specifications. Error and uncertainty methods are complementary when evaluating measurement data.

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Total error vs. measurement uncertainty: the match continues

Cited by 21 publications

References 8 publications

Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

Patient Safety in Laboratory Medicine. The Big Picture ten years later

The use of error and uncertainty methods in the medical laboratory

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