Quality indicators to detect pre-analytical errors in laboratory testing

Plebani, Mario; Sciacovelli, Laura; Aita, Ada; Padoan, Andrea; Chiozza, Maria Laura

doi:10.1016/j.cca.2013.07.033

Cited by 160 publications

(170 citation statements)

References 35 publications

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“…In fact, a wide consensus has been achieved in the last few years on the need to assure quality and safety in the so-called "brain-to-brain loop", in view of the fact that the quality of laboratory information is strongly affected by the coordinated and correlated management of all procedures and processes of the total testing process (TTP). Under this perspective, quality in laboratory medicine should be defined as "the guarantee that each and every step in the TTP is correctly performed, thus ensuring valuable decision making and effective patient care" [4]. Achieving consensus for the comprehensive definition of errors in laboratory testing has been a milestone in the effort to reduce errors and improve patient safety in laboratory medicine [5].…”

Section: Introductionmentioning

confidence: 99%

Performance criteria and quality indicators for the pre-analytical phase

Plebani

Sciacovelli

Aita

et al. 2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:The definition, implementation and monitoring of valuable analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-analytical phases, namely the pre-analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-analytical phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for analytical quality specifications.

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Section: Introductionmentioning

confidence: 99%

Performance criteria and quality indicators for the pre-analytical phase

Plebani

Sciacovelli

Aita

et al. 2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…Clinical quality indicators (QIs) are intended to measure the extent to which set targets are achieved, and also provide a quantitative basis to achieve improvement in care and, in particular, in laboratory services [65][66][67]. QIs are hence essential requirements for medical laboratory accreditation according to the International Standard (ISO 15189: 2012).…”

Section: Preanalytical Quality Indicatorsmentioning

confidence: 99%

Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE)

Lippi¹,

Banfi²,

Church³

et al. 2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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Laboratory diagnostics develop through different phases that span from test ordering (pre-preanalytical phase), collection of diagnostic specimens (preanalytical phase), sample analysis (analytical phase), results reporting (postanalytical phase) and interpretation (post-postanalytical phase). Although laboratory medicine seems less vulnerable than other clinical and diagnostic areas, the chance of errors is not negligible and may adversely impact on quality of testing and patient safety. This article, which continues a biennial tradition of collective papers on preanalytical quality improvement, is aimed to provide further contributions for pursuing quality and harmony in the preanalytical phase, and is a synopsis of lectures of the third European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)-Becton Dickinson (BD) European Conference on Preanalytical Phase meeting entitled 'Preanalytical quality improvement. In pursuit of harmony' (Porto, 20-21 March 2015). The leading topics that will be discussed include unnecessary laboratory testing, management of test request, implementation of the European Union (EU) Directive on needlestick injury prevention, harmonization of fasting requirements for blood sampling, influence of physical activity and medical contrast media on in vitro diagnostic testing, recent evidence about the possible lack of necessity of the order of draw, the best practice for monitoring conditions of time and temperature during sample transportation, along with description of problems emerging from inappropriate sample centrifugation. In the final part, the article includes recent updates about preanalytical quality indicators, the feasibility of an External Quality Assessment Scheme (EQAS) for the preanalytical phase, the results of the 2nd EFLM WG-PRE survey, as well as specific notions about the evidence-based quality management of the preanalytical phase.

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“…It should be highlighted that the different steps required to develop and test QIs previously described [16][17][18] have been carefully followed.…”

Section: The Conference Organization: Background and Preliminary Workmentioning

confidence: 99%

Harmonization of quality indicators in laboratory medicine. A preliminary consensus

Plebani

Astion

Barth

et al. 2014

Clinical Chemistry and Laboratory Medicine (CCLM)

111

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Quality indicators (QIs) are fundamental tools for enabling users to quantify the quality of all operational processes by comparing it against a defined criterion. QIs data should be collected over time to identify, correct, and continuously monitor defects and improve performance and patient safety by identifying and implementing effective interventions. According to the international standard for medical laboratories accreditation, the laboratory shall establish and periodically review QIs to monitor and evaluate performance throughout critical aspects of pre-, intra-, and post-analytical processes. However, while some interesting programs on indicators in the total testing process have been developed in some countries, there is no consensus for the production of joint recommendations focusing on the adoption of universal QIs and common terminology in the total testing process. A preliminary agreement has been achieved in a Consensus Conference organized in Padua in 2013, after revising the model of quality indicators (MQI) developed by the Working Group on "Laboratory Errors and Patient Safety" of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The consensually accepted list of QIs, which takes into consideration both their importance and applicability, should be tested by all potentially interested clinical laboratories to identify further steps in the harmonization project.

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Quality indicators to detect pre-analytical errors in laboratory testing

Cited by 160 publications

References 35 publications

Performance criteria and quality indicators for the pre-analytical phase

Performance criteria and quality indicators for the pre-analytical phase

Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE)

Harmonization of quality indicators in laboratory medicine. A preliminary consensus

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