Evaluation of quality control viral load HIV results from two laboratories in Maputo, after the 3rd Congress of Laboratory Quality Control for Portuguese-Speaking Countries, Mozambique

The Project of Laboratory Quality Improvement for Portuguese Speaking Countries (ProMeQuaLab) is based on three major work tools: education, training and monitoring of quality control measures, in order to build capacity to implement and sustain good laboratory practices. Since 2015, a biennial congress on quality control is organised which includes also courses in this field. The third edition of the Congress was held in Mozambique in May 2019. Theoretical and practical courses concerning internal (CQI) and external quality control (EQA), calculation of Total Error (TE) and Measurement Uncertainty (MU) were held. Two practical work sessions were organized, with the trainers of the quality control courses and trainees from two laboratories, Centro Criança Dream (Dream) and Laboratório de Virologia Molecular (INS) in Maputo (Mozambique), to applied the statistical tools to evaluate their quality control results of viral load HIV from 2018. Evaluation of viral load is strongly recommended by WHO for monitoring response to retroviral treatment. The objective of this work was the implementation of the concepts and tools of the assessment of bias and uncertainty presented in the quality control courses and their application on the quantitative quality control results from 2018 of RNA viral load HIV-1 from two laboratories from Maputo. The concepts and tools presented in quality control courses were applied to quality control results of two laboratories in Maputo (Mozambique) for the measure of imprecision, bias and measurement uncertainty. The courses and the work sessions have proved to be very effective in transferring knowledge and skills and therefore should be continued with other laboratories. The results of the bias and measurement uncertainty show that the INS laboratory (Cobas Ampliprep TaqMan96) had a better performance in comparison to the Dream laboratory (Abbott m2000). Effort must be made to continue the education program, namely the interpretation of the quality control results to achieve an improvement of the evaluation of patient results.N/

Special issue on External Quality Assessment in Laboratory Medicine – current challenges and future trends

Quality assurance in the modern clinical laboratory is evidenced through the complementary process-es of internal quality control and external quality assessment, also known as proficiency testing. By these processes and the achievement of accreditation to international (e.g. ISO) standards, the labor-atory is able to demonstrate its competence to the users of its services, i.e. the clinicians and the pa-tients they care for, who have an expectation that the results of diagnostic testing and monitoring of treatment are correct, comparable and fit-for-purpose within the scope of the service, wherever they are performed

Interpretation of EQA results and EQA-based trouble shooting

Important objectives of External Quality Assessment (EQA) is to detect analytical errors and make corrective actions. The aim of this paper is to describe knowledge required to interpret EQA results and present a structured approach on how to handle deviating EQA results. The value of EQA and how the EQA result should be interpreted depends on five key points: the control material, the target value, the number of replicates, the acceptance limits and between lot variations in reagents used in measurement procedures. This will also affect the process of finding the sources of errors when they appear. The ideal EQA sample has two important properties: it behaves as a native patient sample in all methods (is commutable) and has a target value established with a reference method. If either of these two criteria is not entirely fulfilled, results not related to the performance of the laboratory may arise. To help and guide the laboratories in handling a deviating EQA result, the Norwegian Clinical Chemistry EQA Program (NKK) has developed a flowchart with additional comments that could be used by the laboratories e.g. in their quality system, to document action against deviations in EQA. This EQA-based trouble-shooting tool has been developed further in cooperation with the External quality Control for Assays and Tests (ECAT) Foundation. This flowchart will become available in a public domain, i.e. the website of the European organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM)

EQA quantification HbA1c Diabetes– Long-term and SIGMA analytical performance for Twenty one Portuguese Laboratories

Este poster ganhou o prémio de melhor poster apresentado.Glycated hemoglobin (HbA1c) plays a crucial role in the monitoring and diagnosis of diabetes. In Portugal 9,8% of the population has diabetes (HbA1c ≥ 6,5% or treatment with glucose-lowering medications). Six sigma metrics combine bias, precision, and allowable total error (Tea), and can be used for assessing the quality of the analytic phase. The main objective of this study was to apply a linear regression model for long-term evaluation of the precision and inaccuracy, and apply the sigma metric to evaluate the performance of laboratories in HbA1c quantification.N/

Avaliação Externa da Qualidade da HBA1C- Desempenho Analítico a Longo Termo e Métrica Sigma de Vinte e Um Laboratórios Portugueses

A hemoglobina glicada (HbA1c) tem um papel crucial na monitorização e diagnóstico da diabetes. Em Portugal 9,8% da população tem diabetes (HbA1c ≥ 6,5% ou faz terapêutica para diminuição dos níveis de glicémia). A métrica Seis Sigma combina o bias, a precisão e o erro total admissível (Eta), e pode ser utilizada para avaliar a qualidade da fase analítica. O principal objetivo deste estudo foi aplicar um modelo de regressão linear para avaliar a exatidão e a precisão a longo termo e aplicar a métrica Sigma na avaliação do desempenho dos laboratórios relativamente à quantificação da HbA1c2.N/

Projeto de Melhoria da Qualidade Laboratorial para Países de Língua Portuguesa (2015-2019)

A Lei de Bases da Saúde incentiva a cooperação internacional com Países de Língua Portuguesa na melhoria dos cuidados de saúde, educação, investigação e pesquisa em saúde, a fim de garantir o direito à proteção da saúde humana. A qualidade dos serviços prestados pelos laboratórios clínicos é crucial na prestação de cuidados de saúde, fornecendo informações para as melhores decisões médicas. O Projeto de Melhoria da Qualidade Laboratorial para Países de Língua Portuguesa (ProMeQuaLab), lançado em 2015, é um projeto de colaboração no âmbito da melhoria da Qualidade Laboratorial entre representantes dos diferentes países onde o Português é o idioma oficial. O objetivo do projeto é desenvolver capacidade para implementar e sustentar boas práticas laboratoriais, a fim de melhorar a qualidade dos laboratórios médicos, visando o diagnóstico e tratamento adequados dos doentes. Necessidade da manutenção da realização das visitas aos laboratórios nos diferentes países permitindo a constatação da realidade reportada nas respostas dos questionários. Grande disparidade ao nível dos equipamentos, reagentes e na implementação do controlo da qualidade. Falta significativa de conhecimento sobre controlo interno da qualidade e avaliação externa da qualidade. A metodologia do projeto revelou-se eficaz, uma vez que no último congresso verificámos a aplicação pelos participantes das ferramentas de CQ propostas. É necessário incentivar outros países de língua portuguesa a integrarem o grupo executivo e motivá-los a assumir o cargo de supervisor do projeto. A submissão de pedido para apoio financeiro é essencial para permitir a continuação da implementação contínua desta estratégia educacional e desenvolvimento de ferramentas eficazes de formação. Organização do 4º Congresso em Cabo Verde em 2021N/

EQA total haemoglobine quantification: long-term analytical performance for thirty Portuguese Laboratories

Total haemoglobin is one of the most frequently ordered laboratory tests, both in the hospital and ambulatory. Haemoglobin concentration provides information about the status of anaemia in the population and guides many clinical diagnoses and therapeutic interventions. Portuguese External Quality Evaluation Program (PNAEQ) provides 4 survey per year with 2 samples each since it is important for medical laboratories to know about the stability and performance of their methods over the time. The main objective of this study was to apply a linear regression model for long-term evaluation of the performance of laboratories in haemoglobin quantification by comparing the laboratory individual results with the consensus mean of each round, after outliers exclusion. To evaluate the performance of the laboratory, the long-term analytical CV (LCVa) and the total analytical bias were established.N/

International Normalized Ratio (INR): Performance of External Quality Assessment 2016 results - PNAEQ and ECAT Foundation

The International Normalized Ration (INR) is derived from the measurement of the Prothrombin Time (PT) and the International Sensitivity Index (ISI), and is a quantitative measure of the responsiveness of individual thromboplastin reagents to the different clotting factors involved in the PT measurement. Under the INR system, all results are standardized. For example, a person taking an oral anticoagulant (ex. Coumadin) would need regularly to have a blood test to measure the INR. The INR permits patients on anticoagulants to travel and obtain comparable test results wherever they are. So it is very important to verify the laboratories performance over this test. In 2014 the Portuguese National External Quality Assessment Program (PNAEQ) has established a consortium with ECAT Foundation for INR measurement where Portuguese laboratories are included in the statistical analysis. The main objective of this study was to evaluate the performance for INR of PNAEQ participants that used two different thromboplastin reagents during 2016 and compared those with the results of ECAT participants.N/

Impact of COVID-19 pandemic on the quality of test output in haemostasis laboratories

Introduction: The high incidence of thrombotic events in patients with COVID-19 affects health care worldwide and results in an increased workload in haemostasis laboratories due to more frequent testing of D-dimer, haemostatic parameters and anti-Xa tests. However, the impact of this increase in assay requests on the quality of performance in haemostasis laboratories remains unclear. In this study, the impact of the COVID-19 pandemic on the quality of performance and management of haemostasis laboratories was evaluated. Methods: The impact on the quality of performance was studied using external quality assessment data from 2019 to 2020 derived from ECAT surveys. A questionnaire was sent to Dutch haemostasis laboratories to identify challenges and management strategies. Furthermore, the number of assays performed in 2019 and 2020 was supplied by four Dutch hospitals, located in regions with different disease incidence. Results: No differences in response rate nor the quality of the measurements were observed between the EQA surveys in 2019 and 2020. The questionnaire results showed a large increase of >25% in the number of test requests for anti-Xa, D-dimer and fibrinogen assays in 2020 compared to 2019. Extreme peaks in test requests were also observed in the four evaluated hospitals. Additionally, 84% of the respondents indicated that they had experienced increased work pressure, and increased sick leave was observed in 71% of the participating laboratories. Conclusions: The enormous increase in test requests, especially for D-dimer assays and anti-Xa activity, did not affect the quality of performance within haemostatic laboratories during the COVID-19 pandemic

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)

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.publishedVersio