The use of error and uncertainty methods in the medical laboratory

Oosterhuis, Wytze P.; Bayat, Hassan; Armbruster, David; Coşkun, Abdurrahman; Freeman, Kathleen; Kallner, Anders; Koch, David D.; MacKenzie, Finlay; Migliarino, Gabriel Alejandro; Orth, Matthias; Sandberg, Sverre; Sylte, Marit Sverresdotter; Westgard, Sten A.; Theodorsson, Elvar

doi:10.1515/cclm-2017-0341

Cited by 73 publications

(41 citation statements)

References 56 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Two major impacts on measurement uncertainty in routine medical laboratories are random and systemic effects (14). These two types of effects can be presented within the intra-laboratory precision and the residual bias of measurement, and are part of the analytical error in the medical laboratory.…”

Section: Top-down Modelmentioning

confidence: 99%

Uncertainty of Measurement in Laboratory Medicine

Milinković¹,

Ignjatović²,

Šumarac³

et al. 2018

Journal of Medical Biochemistry

View full text Add to dashboard Cite

SummaryAn adequate assessment of the measurement uncertainty in a laboratory medicine is one of the most important factors for a reliable interpretation of the results. A large number of standards and guidelines indicate the need for a proper assessment of the uncertainty of measurement re sults in routine laboratory practice. The available docu ments ge nerally recommend participation in the proficiency schemes/ external quality control, as well as the internal quality control, in order to primarily verify the quality performance of the method. Although all documents meet the re quirements of the International Standard, ISO 15189, the standard itself does not clearly define the method by which the measurement results need to be assessed and there is no harmonization in practice regarding to this. Also, the uncertainty of measurement results is the data relating to the measured result itself, but all factors that influence the interpretation of the measured value, which is ultimately used for diagnosis and monitoring of the patient's treat ment, should be taken into account. So in laboratory medicine, an appropriate assessment of the uncertainty of the measurement results should have the ultimate goal of reducing diagnostic uncertainty. However, good profes sional laboratory practice and understanding analytical aspects of the test for each individual laboratory is ne ces sary to adequately define the uncertainty of measurement results for specific laboratory tests, which helps to imple ment good clinical practice. Also, setting diagnoses in medicine is a decision with a certain degree of uncertainty, rather than statistically and mathematically calculated conclusion.Keywords: ISO 15189, laboratory medicine, measurement uncertainty Kratak sadr`ajAdekvatna procena nesigurnosti rezultata merenja u biohemijskoj laboratoriji je jedan od najzna~ajnijih faktora za pouzdanu interpretaciju rezultata. Veliki broj standarda i vodi~a ukazuju na neophodnost pravilne procene nesigurnosti rezultata merenja u rutinskoj laboratorijskoj praksi. Dostupni dokumenti uglavnom preporu~uju u~e{}e u {e -mama osposobljenosti/spolja{njoj kontroli kvaliteta, kao i svakodnevno merenje unutra{njih kontrola kvaliteta, kako bi se primarno proverilo izvo|enje metode. Mada svi dokumenti zadovoljavaju zahteve internacionalnog standarda ISO 15189, sam standard ne defini{e jasno metodu kojom treba procenjivati nesigurnost rezultata merenja i ne postoji harmonizacija u praksi. Tako|e, nesigurnost rezultata merenja je podatak koji se odnosi na sam izmereni rezultat, ali treba uzeti u obzir sve faktore koji uti~u i na interpretaciju izmerene vrednosti, koja se u krajnjem koristi za dijagnozu i pra}enje le~enja pacijenta. Tako da u laboratorijskoj medicini odgovaraju}a procena nesigurnosti rezultata merenja treba da ima za krajnji cilj smanjenje dijagnosti~ke ne sigurnosti. Ipak, dobra profesionalna laboratorijska praksa i razumevanje analiti~kih aspekata testa za svaku poje dina~nu laboratoriju je neophodno da bi se adekvatno definisala procena nesig...

show abstract

Section: Top-down Modelmentioning

confidence: 99%

Uncertainty of Measurement in Laboratory Medicine

Milinković¹,

Ignjatović²,

Šumarac³

et al. 2018

Journal of Medical Biochemistry

View full text Add to dashboard Cite

show abstract

“…These concepts were taken forward by the TFG on Total Error (TFG-TE) established after the conference, commissioned with exploring, developing and coming up with a proposal for how to correctly use the TE concept and how to possibly combine PS for bias and imprecision in a more scientifically sound way. The TFG-TE has recalled criticisms to the conventional biological variability model for deriving allowable TE to be used in assessing quality of laboratory measurements [29]. Using this approach that includes summing of mutual exclusive terms, an overestimation of the permissible TE was demonstrated [30].…”

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)

Self Cite

View full text Add to dashboard Cite

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.

show abstract

“…Measurement errors can be divided into two main aspects: systematic error and random error . Systematic errors involve errors NOT determined by chance but are introduced by a deviation of any part of the assay process . Systematic errors are more predictable and are typically proportional to the true value.…”

Section: Concept Of Error Of Results In Coagulationmentioning

confidence: 99%

Sources and solutions for spurious test results in coagulation

Marlar

Rollins‐Raval

2019

Int J Lab Hematology

View full text Add to dashboard Cite

In the coagulation laboratory, much emphasis has been placed on rapid and accurate testing; however, spurious results that are inaccurate and do not reflect the actual status of the patient can potentially lead to an incorrect diagnosis and altered intervention. Errors in coagulation results and interpretation can occur at any point of the process from obtaining the specimen to interpretation and use of the result by the clinician. The main sources of error include the patient's biological and preanalytical variation, analytical testing, and postanalytical use of the reported result(s). This article reviews various sources of error leading to spurious results, providing methods to recognize these aberrant results and presenting solutions for minimizing their occurrence.

show abstract

The use of error and uncertainty methods in the medical laboratory

Cited by 73 publications

References 56 publications

Uncertainty of Measurement in Laboratory Medicine

Uncertainty of Measurement in Laboratory Medicine

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

Sources and solutions for spurious test results in coagulation

Contact Info

Product

Resources

About