External quality assessment providers’ services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions

Christoph Buchta; Wim Coucke; Wolfgang Huf; Andrea Griesmacher; Mathias M. Müller; Wolfgang R. Mayr; Øystein Flesland; Constantina Politis; Johanna Wiersum-Osselton; Andrés Aburto; Tony Badrick; Lobna Bouacida; Marek Budina; Joseph A. Duenas; Wolf-Jochen Geilenkeuser; André V.P. Guimarães; Ana Hecimovic; Markus Jutzi; Chang-Keun Lee; Young Ae Lim; Joy Mammen; Petra Magdolna Molnár; Azita Mokhtari; Giuseppa Morabito; Eduardo Muñiz-Diaz; Truscha Niekerk; Anja Pakkanen; Paola Pezzati; Razvan Popa; Erika Sárkány; Jean-Pascal Siest; Dhitiwass Suvagandha; Marc Thelen; Jenny Ullhagen; Dalius Vitkus; Günther F. Körmöczi

doi:10.1515/cclm-2021-1219

Article

External quality assessment providers’ services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions

Christoph Buchta , Wim Coucke , Wolfgang Huf , Andrea Griesmacher , Mathias M. Müller , Wolfgang R. Mayr , Øystein Flesland , Constantina Politis , Johanna Wiersum-Osselton , Andrés Aburto , Tony Badrick , Lobna Bouacida , Marek Budina , Joseph A. Duenas , Wolf-Jochen Geilenkeuser , André V.P. Guimarães , Ana Hecimovic , Markus Jutzi , Chang-Keun Lee , Young Ae Lim , Joy Mammen , Petra Magdolna Molnár , Azita Mokhtari , Giuseppa Morabito , Eduardo Muñiz-Diaz , Truscha Niekerk , Anja Pakkanen , Paola Pezzati , Razvan Popa , Erika Sárkány , Jean-Pascal Siest , Dhitiwass Suvagandha , Marc Thelen , Jenny Ullhagen , Dalius Vitkus and Günther F. Körmöczi

Published/Copyright: January 19, 2022

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 3

Abstract

Objectives

Medical laboratories may, at their own discretion, exceed but not undercut regulatory quality requirements. Available economic resources, however, may drive or hinder eagerness to exceed minimum requirements. Depending on the respective scopes of regulatory and economic framework conditions, differing levels of quality efforts to safeguard laboratory performance can be anticipated. However, this has not yet been investigated.

Methods

Immunohaematology external quality assessment (EQA) results collected by 26 EQA providers from their participant laboratories in 73 countries from 2004 to 2019 were evaluated. Error rates were aggregated in groups according to the respective national regulatory and economic framework conditions, to whether or not expert advice was provided in case of incorrect results, and the frequency of EQA samples.

Results

These representative data indicate no association between national regulatory (mandatory participation in EQA, monitoring of performance of individual laboratories by authorities, financial consequences of incorrect results) and economic (level of national income, share of national health expenditure) conditions to the quality performance of medical laboratories in immunohaematology. However, EQA providers’ support for laboratories in the event of incorrect results appear to be associated with lower error rates, but a high EQA sample frequency with higher error rates.

Conclusions

Further research into the impact of introducing or changing services of EQA providers is needed to confirm the results found in this first of its kind study.

Keywords: economic conditions; external quality assessment (EQA); laboratory performance; legal background

Corresponding authors: Christoph Buchta, Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Hörlgasse 18/5, 1090 Vienna, Austria, Phone: +43 1 3198895, E-mail: christoph.buchta@oequasta.at and Günther F. Körmöczi, Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Hörlgasse 18/5, 1090 Vienna, Austria; and Department of Blood Group Serology and Transfusion Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria, Phone: +43 1 40400 53200, E-mail: guenther.koermoeczi@meduniwien.ac.at

Christoph Buchta and Wim Coucke contributed equally to this work.

Acknowledgments

The authors gratefully acknowledge participating laboratories that were enrolled in the EQA providers’ programs and contributed to this data anonymously. Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), Saint-Denis Cedex, France, is gratefully acknowledged for provision of data without a representative co-authoring this manuscript. The following persons are gratefully acknowledged for data collection: Dolly Daniel MD (Scientific coordinator) and Amal Raj (Technical coordinator) from CMC Vellore; Ulvi-Kaire Kongo, Anastasia Korovesi, Anne Kane collaborating with Labquality at the Estonian Immunohaematology Reference Laboratory (UKK), at Alpha Medical SA (Greece, AK) and IEQAS (Ireland, AK); Imre Ocsovszki, Izabella Hoffer and Katalin Barna from QualiCont; the QC Department and PT Team from SANBS; Roger Palau Capedvila and Neus Boto Ruiz from SETS; Ron Meijer from SKML; Jose Abol Correa and Maria Elizabeth Menezes from PNCQ; Arida Klomkleng from the Division of Proficiency Testing, Department of Medical Sciences, Ministry of Public Health, Thailand.

Research funding: None declared.
Author contributions: CB and WCO devised the study questions and were co-chief investigators responsible for all aspects of the study. They contributed equally to the preparation of this manuscript. CB, AA, TB, LB, MB, JAD, WJG, AVPG, AH, MJ, CKL, YAL, JM, PMM, AM, GM, EMD, TN, AP, PP, RP, ES, JPS, DS, MT, JU and DV provided and discussed results of their affiliated EQA provider organisations and critically reviewed the manuscript. WCO managed study database and performed statistical analysis. WH reviewed data management and statistical analysis. CB, WCO and GFK wrote the manuscript. WH, AG, MMM, WRM and GFK critically reviewed the manuscript. ØF, CP and JWO provided international haemovigilance data and discussed the possible correlations of error rates in immunohaematology EQA and haemovigilance data. All authors reviewed, contributed to and approved the final version of the manuscript.
Competing interests: Authors state no conflict of interest.
Informed consent: Not applicable.
Ethical approval: Not applicable.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2021-1219).

Received: 2021-11-20

Accepted: 2022-01-09

Published Online: 2022-01-19

Published in Print: 2022-02-23

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Articles in the same Issue

https://doi.org/10.1515/cclm-2021-1219

Keywords for this article

economic conditions; external quality assessment (EQA); laboratory performance; legal background