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.

scholarly journals Using Shewhart p control charts of external quality-assurance program data to monitor analytical performance of a clinical chemistry laboratory

1996 ◽  
Vol 42 (9) ◽  
pp. 1478-1482 ◽  
Author(s):  
D Chesher ◽  
L Burnett
Keyword(s):  
Quality Assurance ◽  
Control Charts ◽  
Clinical Chemistry ◽  
Analytical Performance ◽  
External Quality Assurance ◽  
Chemistry Laboratory ◽  
Quality Assurance Program ◽  
External Quality ◽  
Simple Method

Abstract We have investigated the application of Shewhart's p control charts in our external quality-assurance program to monitor the long-term performance of our laboratory's analytical quality. The p control charts have been able to detect long-term changes in our laboratory's analytical performance that would have been difficult to detect by more-conventional techniques. We have explored methods for interpreting these charts as well as some of their limitations, which include minimum subgroup size and dependence on constant specification limits. These charts may be not only a simple method for the long-term monitoring of analytical performance of a laboratory, but also of use to the organizers of external quality-assurance programs.

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.

scholarly journals Analysis of a 6-year pilot external quality assurance survey of free light chain using Sigma metrics

2019 ◽  
Vol 43 (5) ◽  
pp. 235-242
Author(s):  
Hyojin Chae ◽  
Jaeeun Yoo ◽  
Joonhong Park ◽  
Kyoungho Cha ◽  
Jeong Joong Lee ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Light Chain ◽  
Peer Groups ◽  
Free Light Chain ◽  
External Quality Assurance ◽  
External Quality ◽  
Reference Change Value ◽  
Relevant Reference ◽  
Quality Specifications ◽  
Sample Dilution

Abstract Background A pilot external quality assurance (EQA) survey for the free light chain (FLC) assay was developed and implemented in Korea. Methods Survey data over 6 years (2010–2015) were collected retrospectively and Sigma metrics were calculated for method-specific peer groups. Results Nineteen to 29 laboratories participated in the EQA survey, and nephelometric (20%) and turbidimetric (80%) methods were used. Using a previously published clinically relevant reference change value (RCV) of 54.5% as the tolerance limit, the method-specific median Sigma metrics of kappa (κ) and lambda (λ) FLC achieved greater than Three-Sigma for 86–97% of all EQA distributions, and Five-Sigma for 48–72% of all distributions. Conclusions This EQA analysis of FLC assay applied clinically relevant quality specifications using Sigma metrics. During the 6-year EQA survey, we found that most of the results from participating laboratories meet clinically relevant quality specifications. In addition, method-specific differences were noted for λ FLC, at FLC concentrations above the initial measuring range that require a sample dilution.

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.

scholarly journals Informatics External Quality Assurance (IEQA) Down Under: evaluation of a pilot implementation

2018 ◽  
Vol 42 (6) ◽  
pp. 297-304
Author(s):  
Rae-Anne Hardie ◽  
Donna Moore ◽  
Derek Holzhauser ◽  
Michael Legg ◽  
Andrew Georgiou ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Laboratory Medicine ◽  
External Quality Assurance ◽  
Small Scale ◽  
Test Accuracy ◽  
External Quality ◽  
Health Level 7 ◽  
Survey Report ◽  
Compliance Testing ◽  
Pilot Implementation

AbstractExternal quality assurance (EQA) provides ongoing evaluation to verify that laboratory medicine results conform to quality standards expected for patient care. While attention has focused predominantly on test accuracy, the diagnostic phases, consisting of pre- and post-laboratory phases of testing, have thus far lagged in the development of an appropriate diagnostic-phase EQA program. One of the challenges faced by Australian EQA has been a lack of standardisation or “harmonisation” resulting from variations in reporting between different laboratory medicine providers. This may introduce interpretation errors and misunderstanding of results by clinicians, resulting in a threat to patient safety. While initiatives such as the Australian Pathology Information, Terminology and Units Standardisation (PITUS) program have produced Standards for Pathology Informatics in Australia (SPIA), conformity to these requires regular monitoring to maintain integrity of data between sending (laboratory medicine providers) and receiving (physicians, MyHealth Record, registries) organisations’ systems. The PITUS 16 Informatics EQA (IEQA) Project together with the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) has created a system to perform quality assurance on the electronic laboratory message when the laboratory sends a result back to the EQA provider. The purpose of this study was to perform a small scale pilot implementation of an IEQA protocol, which was performed to test the suitability of the system to check compliance of existing Health Level-7 (HL7 v2.4) reporting standards localised and constrained by the RCPA SPIA. Here, we present key milestones from the implementation, including: (1) software development, (2) installation, and verification of the system and communication services, (3) implementation of the IEQA program and compliance testing of the received HL7 v2.4 report messages, (4) compilation of a draft Informatics Program Survey Report for each laboratory and (5) review consisting of presentation of a report showing the compliance checking tool to each participating laboratory.

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