The role of EQA in harmonization in laboratory medicine – a global effort

Jones, Graham

doi:10.11613/bm.2017.004

Cited by 22 publications

(13 citation statements)

References 14 publications

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“…Then, evaluations of HBV qualitative testing samples in EQA would be more authentic and accurate in East In the development of EQA schemes, the attention is usually paid to the quality of the samples, the consistency of laboratory test results, the commutability, and traceability in EQA programs, 1 the pre and postlaboratory phase of testing, 2,3 and the harmonization in laboratory medicine. 4,5 These efforts do not only play an important role in the development of EQA but are very important for laboratories to get the best value from the EQA scheme in terms of validating methods and test results. However, there are still some blind areas that are worthy of more attention and tracking in some parts of China, for an example, the authenticity of test results.…”

Section: Discussionmentioning

confidence: 99%

“…In the development of EQA schemes, the attention is usually paid to the quality of the samples, the consistency of laboratory test results, the commutability, and traceability in EQA programs, the pre and postlaboratory phase of testing, and the harmonization in laboratory medicine . These efforts do not only play an important role in the development of EQA but are very important for laboratories to get the best value from the EQA scheme in terms of validating methods and test results.…”

Section: Introductionmentioning

confidence: 99%

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A 3‐year‐long investigation of the authenticity of the return results of hepatitis B virus qualitative testing in external quality assessment in East China

Song

Shan

2019

Journal of Medical Virology

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Background In external quality assessments (EQAs), it is important and necessary for participants to return authentic test results. However, to obtain better evaluation results, some laboratories have lacked confidence that their own and have preferred to rely upon the test results in surrounding laboratories. These violations covered up errors during testing and affected the authenticity of the returned data. The occurrence of violations in EQA launched by different EQA organizers is still unknown because these violations were carried out in private. In this paper, we adjusted the hepatitis B virus (HBV) qualitative EQA schemes to uncover some of the violations by using specially designed sample combinations in four EQA surveys to show the authenticity and accuracy of HBV testing in some prefectures of East China. Methods Four HBV qualitative EQA surveys were selected from 2016 to 2018, which were named 201602, 201701, 201702, and 201801, and a total of 474 laboratories were included. In the first two EQA surveys, the same EQA sample combinations were distributed. In the last two EQA surveys, three kinds of different sample combinations were designed and distributed with specific plans. The result of adding different sample combinations was that each laboratory only had a 33.3% chance of receiving the same sample combinations as those received by the surrounding laboratories. In addition, the laboratories were not aware that those samples with the same serial numbers might have different concentrations and target values. The sample concentrations, mode of delivery, requirements, results reports, and evaluation criteria were all the same as those of the first two EQA surveys. Results The number of laboratories with failed tests increased from fourfold to sevenfold between the first two and the last two EQA surveys. The number of failed tests in 201702 was eight times that in 201701 during the same year. Six (6 of 469, 1.28%) and three (3 of 472, 0.64%) poor performer laboratories (PPLabs) appeared in 201602 and 201701, respectively, while the number of those laboratories increased to 29 (29 of 474, 6.12%) in 201702 and 201801. Failed tests from PPLabs accounted for 70.5% (201702) and 68.7% (201801) of the total failed tests. The increase in the number of PPLabs was not universal but was concentrated in some prefectures. Conclusions The current EQA results for HBV qualitative testing were not as good as originally anticipated. Violations during the EQA surveys caused by exchanging test results with other laboratories and by modifying results before returning still occurred in some prefectures of East China. The laboratories that were in violation can be partly exposed as PPLabs by providing different kinds of sample combinations. Through such an EQA adjustment, the laboratory would have to re‐establish confidence in its own testing results from HBV EQA samples. Then, evaluations of HBV qualitative testing samples in EQA would be more authentic and accurate in East China.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A 3‐year‐long investigation of the authenticity of the return results of hepatitis B virus qualitative testing in external quality assessment in East China

Song

Shan

2019

Journal of Medical Virology

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“…Recognizing the pivotal role of external quality assessment (EQA) in global harmonization [36], the WG-PRE has recently signed a Memorandum of Understanding (MoU) with EQALM (European Organisation for External Quality Assurance Providers in Laboratory Medicine), which represents European EQA providers in laboratory medicine [36,37]. As a result of this MoU, the WG membership was expanded to include two EQALM representatives.…”

Section: Ongoing Projectsmentioning

confidence: 99%

The EFLM strategy for harmonization of the preanalytical phase

Lippi¹,

Šimundić²

2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:The Working Group for the Preanalytical Phase (WG-PRE) was officially established by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in 2013, with the aim of improving harmonization in the preanalytical phase across European member societies. Since its early birth, the WG-PRE has already completed a number of projects, including harmonizing the definition of fasting status, patient and blood tubes identification, color coding of blood collection tubes, sequence of tubes during blood drawing and participation in the development of suitable preanalytical quality indicators. The WG-PRE has also provided guidance on local validation of blood collection tubes, has performed two European surveys on blood sampling procedures and has organized four European meetings to promote the importance of quality in the preanalytical phase. The future activities entail development and validation of an external quality assessment scheme focused on preanalytical variables, development and dissemination of a survey about the local management of unsuitable samples in clinical laboratories, as well as release of EFLM phlebotomy guidelines. This article summarizes all recent achievements of the WG-PRE and illustrates future projects to promote harmonization in the preanalytical phase.

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“…It is visible in external quality proficiency testing results. Certainly, no two methods are exactly the same; the issue is whether the difference is important relative to the clinical question …”

Section: Introductionmentioning

confidence: 99%

“…Certainly, no two methods are exactly the same; the issue is whether the difference is important relative to the clinical question. 4 That is why we decided to establish reference ranges of TSH in the period of first trimester Down's syndrome screening, that is from 11 to 13 + 6 weeks of gestation.…”

Section: Introductionmentioning

confidence: 99%