An overview of the European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM)

Stavelin, Anne; Albe, X; Meijer, Piet; Sarkany, Erika; MacKenzie, Finlay

doi:10.11613/bm.2017.005

Cited by 17 publications

(4 citation statements)

References 10 publications

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“…This study was performed by the Haemostasis Working Group within the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM). A questionnaire on pre-analytical practices for routine coagulation testing was offered to European medical laboratories from their national external quality assurance (EQA) organiser through EQALM [15]. Each EQA organiser distributed the questionnaire either by email or via a web-link at the website of the EQA provider.…”

Section: Methodsmentioning

confidence: 99%

Pre-analytical practices for routine coagulation tests in European laboratories. A collaborative study from the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM)

Kristoffersen

Stavelin

Ajzner³

et al. 2019

Clinical Chemistry and Laboratory Medicine (CCLM)

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Background Correct handling and storage of blood samples for coagulation tests are important to assure correct diagnosis and monitoring. The aim of this study was to assess the pre-analytical practices for routine coagulation testing in European laboratories. Methods In 2013–2014, European laboratories were invited to fill in a questionnaire addressing pre-analytical requirements regarding tube fill volume, citrate concentration, sample stability, centrifugation and storage conditions for routine coagulation testing (activated partial thromboplastin time [APTT], prothrombin time in seconds [PT-sec] and as international normalised ratio [PT-INR] and fibrinogen). Results A total of 662 laboratories from 28 different countries responded. The recommended 3.2% (105–109 mmol/L) citrate tubes are used by 74% of the laboratories. Tube fill volumes ≥90% were required by 73%–76% of the laboratories, depending upon the coagulation test and tube size. The variation in centrifugation force and duration was large (median 2500 g [10- and 90-percentiles 1500 and 4000] and 10 min [5 and 15], respectively). Large variations were also seen in the accepted storage time for different tests and sample materials, for example, for citrated blood at room temperature the accepted storage time ranged from 0.5–72 h and 0.5–189 h for PT-INR and fibrinogen, respectively. If the storage time or the tube fill requirements are not fulfilled, 72% and 84% of the respondents, respectively, would reject the samples. Conclusions There was a large variation in pre-analytical practices for routine coagulation testing in European laboratories, especially for centrifugation conditions and storage time requirements.

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Section: Methodsmentioning

confidence: 99%

Pre-analytical practices for routine coagulation tests in European laboratories. A collaborative study from the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM)

Kristoffersen

Stavelin

Ajzner³

et al. 2019

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…All of this gels perfectly with the design of proficiency or inter-laboratory testing programs; proficiency testing programs successfully used in other areas include biological analysis laboratories and laboratory diagnostics, radio-toxicology [ 44 , 45 ], laboratory or analytical medicine [ 46 , 47 , 48 , 49 ], and therapeutic drug monitoring [ 50 , 51 , 52 ].…”

Section: Proposal Of a Strategy For Overall Improvement In The Person...mentioning

confidence: 99%

An Adequate Pharmaceutical Quality System for Personalized Preparation

2023

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The pharmacy compounding of personalized preparations has evolved a great deal, and with it, the way of working and the legal requirements have also evolved. An adequate pharmaceutical quality system for personalized preparations presents fundamental differences with respect to the system designed for industrial medicines since the size, complexity, and characteristics of the activity of the manufacturing laboratory and the applications and uses of the manufactured medicines must be taken into account. Legislation must advance and adapt to the needs of personalized preparations, filling the deficiencies currently found in this field. The limitations of personalized preparation in its pharmaceutical quality system are analysed and a method based on a proficiency testing program specially designed to overcome these limitations is proposed: the Personalized Preparation Quality Assurance Program (PACMI). This method makes it possible to expand the samples and destructive tests, and dedicate more resources, facilities, and equipment. It allows for more in-depth knowledge of the product and the processes used, and for proposed improvements that increase the overall quality for improved patient health. PACMI introduces tools used in risk management in order to guarantee the quality of an essentially heterogeneous service: personalized preparation.

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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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An overview of the European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM)

Cited by 17 publications

References 10 publications

Pre-analytical practices for routine coagulation tests in European laboratories. A collaborative study from the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM)

Pre-analytical practices for routine coagulation tests in European laboratories. A collaborative study from the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM)

An Adequate Pharmaceutical Quality System for Personalized Preparation

The EFLM strategy for harmonization of the preanalytical phase

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