Analytical performance specifications for EQA schemes – need for harmonisation

2015 ◽  
Vol 53 (6) ◽  
Author(s):  
Graham Ross Dallas Jones
Keyword(s):  
State Of The Art ◽  
Analytical Performance ◽  
Analytical Quality ◽  
External Quality ◽  
Individual Laboratory ◽  
Post Market Surveillance ◽  
Post Market ◽  
Performance Specifications ◽  
Clinical Meaning ◽  
Eqa Schemes

AbstractExternal Quality Assurance (EQA) is a vital tool in laboratory medicine to assess individual laboratory analytical performance and also the differences between the results from different laboratories. This information is also useful for professional bodies and manufacturers as part of post-market surveillance. The process involves the measurement of one or more samples by many laboratories and then assessment of the results. Individual results are generally assessed by how far they lie from a target, which may be established using reference methods or a median of some or all of the submitted results. The distance of a result from the target is compared with analytical performance specifications in order to assess the analytical quality. One of the uses of the Stockholm hierarchy of performance goals is to set the performance specifications for analysis of EQA results. Fifteen years after the Stockholm consensus meeting, EQA analytical performance specifications appear to still vary widely between EQA providers. This can be due to a range of factors, including the rationale for setting the criteria, the expected response to a failure to meet the specified performance, the clinical meaning behind meeting the specifications, and the possible need for further analytical improvements. There are also differences in the models chosen to set the criteria, usually either state of the art or biological variation, and then differences in how these are applied. While harmonisation of EQA performance specifications may be some time off, all EQA providers should define the nature of their specifications and the basis for their selection and make this information available to customers.

Analytical performance specifications for external quality assessment – definitions and descriptions

2017 ◽  
Vol 55 (7) ◽  
Author(s):  
Graham R.D. Jones ◽  
Stephanie Albarede ◽  
Dagmar Kesseler ◽  
Finlay MacKenzie ◽  
Joy Mammen ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Analytical Performance ◽  
External Quality Assurance ◽  
European Federation ◽  
Analytical Quality ◽  
External Quality ◽  
Data Set ◽  
Target Value ◽  
Performance Specifications ◽  
Data Points

AbstractExternal Quality Assurance (EQA) is vital to ensure acceptable analytical quality in medical laboratories. A key component of an EQA scheme is an analytical performance specification (APS) for each measurand that a laboratory can use to assess the extent of deviation of the obtained results from the target value. A consensus conference held in Milan in 2014 has proposed three models to set APS and these can be applied to setting APS for EQA. A goal arising from this conference is the harmonisation of EQA APS between different schemes to deliver consistent quality messages to laboratories irrespective of location and the choice of EQA provider. At this time there are wide differences in the APS used in different EQA schemes for the same measurands. Contributing factors to this variation are that the APS in different schemes are established using different criteria, applied to different types of data (e.g. single data points, multiple data points), used for different goals (e.g. improvement of analytical quality; licensing), and with the aim of eliciting different responses from participants. This paper provides recommendations from the European Federation of Laboratory Medicine (EFLM) Task and Finish Group on Performance Specifications for External Quality Assurance Schemes (TFG-APSEQA) and on clear terminology for EQA APS. The recommended terminology covers six elements required to understand APS: 1) a statement on the EQA material matrix and its commutability; 2) the method used to assign the target value; 3) the data set to which APS are applied; 4) the applicable analytical property being assessed (i.e. total error, bias, imprecision, uncertainty); 5) the rationale for the selection of the APS; and 6) the type of the Milan model(s) used to set the APS. The terminology is required for EQA participants and other interested parties to understand the meaning of meeting or not meeting APS.

Analytical performance specifications based on how clinicians use laboratory tests. Experiences from a post-analytical external quality assessment programme

2015 ◽  
Vol 53 (6) ◽  
Author(s):  
Geir Thue ◽  
Sverre Sandberg
Keyword(s):  
Primary Care ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
State Of The Art ◽  
Analytical Performance ◽  
Case Histories ◽  
External Quality ◽  
Assessment Programme ◽  
Erythrocyte Sedimentation ◽  
Performance Specifications

AbstractAnalytical performance specifications can be based on three different models: the effect of analytical performance on clinical outcome, based on components of biological variation of the measurand or based on state-of-the-art. Models 1 and 3 may to some degree be combined by using case histories presented to a large number of clinicians. The Norwegian Quality Improvement of Primary Care Laboratories (Noklus) has integrated vignettes in its external quality assessment programme since 1991, focusing on typical clinical situations in primary care. Haemoglobin, erythrocyte sedimentation rate (ESR), HbA

scholarly journals Spanish society of laboratory medicine external quality assurance programmes: evolution of the analytical performance of clinical laboratories over 30 years and comparison with other programmes

2020 ◽  
Vol 1 (2) ◽  
Author(s):  
Carmen Perich ◽  
Carmen Ricós ◽  
Fernando Marqués ◽  
Joana Minchinela ◽  
Angel Salas ◽  
...  
Keyword(s):  
Quality Assurance ◽  
State Of The Art ◽  
Laboratory Medicine ◽  
Analytical Performance ◽  
External Quality Assurance ◽  
Biological Variability ◽  
External Quality ◽  
Spanish Society ◽  
Clinical Laboratories ◽  
Quality Specifications

AbstractThe purpose of this study is to understand the evolution of the analytical performance of the laboratories participating in the Spanish society of laboratory medicine (SEQCML) external quality assurance (EQA) programmes during its 30 years of operation and to compare it with the performance of other EQA programmes to establish whether the results are similar. The results obtained during this period are evaluated by applying the biological variability (BV) and state of the art-derived quality specifications. In addition, the results are compared with those obtained by other EQA programme organisations. It is noted that the laboratories participating in the EQA–SEQCML programmes have improved their performance over 30 years of experience and that the specifications derived from biological variation are achievable. It is difficult to compare EQA programmes, due to lack of accessibility and the differences in the design of these programmes (control materials, calculations used and analytical specifications established). The data from this study show that for some biological magnitudes the results obtained by the programmes are not yet harmonised, although efforts are being made to achieve this. Organisers of EQA programmes should also join the harmonisation effort by providing information on their results to enable comparison.

Analytical performance specifications based on the state-of-the-art for the newborn screening

2020 ◽  
Vol 510 ◽  
pp. 117-120
Author(s):  
Leonor Guiñón ◽  
Anna Soler ◽  
Angel Molina ◽  
José Luis Marín ◽  
Rosa María López ◽  
...  
Keyword(s):  
Newborn Screening ◽  
State Of The Art ◽  
The State ◽  
Analytical Performance ◽  
Performance Specifications

Performance of Afinion HbA1c measurements in general practice as judged by external quality assurance data

2020 ◽  
Vol 58 (4) ◽  
pp. 588-596
Author(s):  
Anne Stavelin ◽  
Kristine Flesche ◽  
Mette Tollaanes ◽  
Nina Gade Christensen ◽  
Sverre Sandberg
Keyword(s):  
Diabetes Mellitus ◽  
Quality Assurance ◽  
Point Of Care ◽  
Analytical Performance ◽  
External Quality Assurance ◽  
Pass Rates ◽  
Total Quality ◽  
External Quality ◽  
Performance Specification ◽  
Performance Specifications

AbstractBackgroundIt has been debated whether point-of care (POC) glycated hemoglobin (HbA1c) measurements methods can be used for diagnosing persons with diabetes mellitus. The aim of this study was to evaluate the analytical performance of the POC Afinion HbA1c system in the hands of the users, and to investigate which predictors that were associated with good participant performance.MethodsExternal quality assurance (EQA) data from seven surveys in 2017–2018 with a total of 5809 Afinion participants from a POC total quality system in Norway were included in this study (response rate 90%). The control materials were freshly drawn pooled EDTA whole blood. Each participant was evaluated against the analytical performance specification of ±6% from the target value, while the Afinion system was evaluated against the pooled within-laboratory CV <2%, the between-laboratory CV <3.5%, and bias <0.3%HbA1c. Logistic regression analyses were used to investigate which factors were associated with good participant performance.ResultsThe participant pass rates for each survey varied from 98.2% to 99.7%. The pooled within-laboratory CV varied from 1.3% to 1.5%, the between-laboratory CV varied from 1.5% to 2.1%, and bias varied between −0.17 and −0.01 %HbA1c in all surveys. Reagent lot was the only independent factor to predict good participant performance.ConclusionsAfinion HbA1c fulfilled the analytical performance specifications and is robust in the hands of the users. It can therefore be used both in diagnosing and monitoring persons with diabetes mellitus, given that the instrument is monitored by an EQA system.

Harmonising EQA schemes the next frontier: challenging the status quo

2020 ◽  
Vol 58 (11) ◽  
pp. 1795-1797 ◽  
Author(s):  
Tony Badrick ◽  
Anne Stavelin
Keyword(s):  
External Quality Assessment ◽  
Reference Method ◽  
Laboratory Medicine ◽  
Status Quo ◽  
External Quality ◽  
Educational Support ◽  
Laboratory Results ◽  
The Status ◽  
Clinically Significant ◽  
Eqa Schemes

AbstractThere is a focus on standardisation and harmonisation of laboratory results to reduce the risk of misinterpretation of patient results assayed in different laboratories. External quality assessment (EQA) is critical to assess the need for harmonisation and to monitor the success of procedures to achieve harmonisation. However, EQA providers are being stretched to meet the needs of their participants with proven commutable material with reference method targets, a range of clinically significant levels of the materials, detailed and customised data analysis, and educational support. The path ahead for harmonisation of EQA schemes will require leadership from an organisation that has the support and confidence of EQA providers, like the European Organisation for External Qualily Assurance Providers in Laboratory Medicine.

scholarly journals Diagnostic Challenges on the Laboratory Detection of Lupus Anticoagulant

Biomedicines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 844
Author(s):  
Armando Tripodi
Keyword(s):  
Lupus Anticoagulant ◽  
Clinical Laboratory ◽  
External Quality Assessment ◽  
State Of The Art ◽  
Diagnostic Procedures ◽  
External Quality ◽  
Glycoprotein I ◽  
Current State ◽  
Clinical Laboratories

Lupus anticoagulant (LA) is one of the three laboratory parameters (the others being antibodies to either cardiolipin or β2-glycoprotein I) which defines the rare but potentially devastating condition known as antiphospholipid syndrome (APS). Testing for LA is a challenging task for the clinical laboratory because specific tests for its detection are not available. However, proper LA detection is paramount for patients’ management, as its persistent positivity in the presence of (previous or current) thrombotic events, candidate for long term anticoagulation. Guidelines for LA detection have been established and updated over the last two decades. Implementation of these guidelines across laboratories and participation to external quality assessment schemes are required to help standardize the diagnostic procedures and help clinicians for appropriate management of APS. This article aims to review the current state of the art and the challenges that clinical laboratories incur in the detection of LA.

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