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External quality assessment scheme for blood coagulation
1Department of Clinical Pathology, Faculty of Medicine, University of Indonesia, Dr Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
Insights
External Quality Assessment Schemes (EQAS) for blood coagulation testing aim to harmonize lab results. In Indonesia, the first EQAS trial showed about two-thirds of labs achieved consensus, but significant variations persist across all tested parameters.
Area of Science:
- Clinical Pathology
- Laboratory Medicine
- Hematology
Background:
- Harmonization of blood coagulation testing is crucial for accurate patient diagnosis and treatment.
- External Quality Assessment Schemes (EQAS) play a vital role in achieving laboratory standardization.
- Limited participation in current Indonesian EQAS for blood coagulation highlights a need for broader engagement.
Purpose of the Study:
- To assess the harmonization of blood coagulation test results among Indonesian laboratories through the first EQAS trial.
- To evaluate the performance of different reagent brands used in coagulation testing.
- To identify areas for improvement in blood coagulation testing quality across participating institutions.
Main Methods:
- An EQAS for blood coagulation was organized in Indonesia, involving 65 laboratories.
- Control materials from Organon Teknika were used for Prothrombin Time (PT), International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT), and fibrinogen testing.
- Participant results were compared against median values, stratified by reagent brand or overall median, with consensus defined as median +/- 15%.
Main Results:
- Overall, 63-68% of participants achieved consensus for PT, INR, APTT, and fibrinogen.
- Coefficient of Variation (CV) for these parameters ranged from 17.89% to 23.96%, indicating wide variations.
- Laboratories using Behring reagents showed higher consensus (54-82%) than Organon users (48-90%) for specific parameters, with notable discrepancies in APTT and INR.
Conclusions:
- Approximately two-thirds of participating laboratories demonstrated harmonization in blood coagulation test results.
- Significant variations in PT, INR, APTT, and fibrinogen testing persist, necessitating further quality improvement initiatives.
- EQAS is essential for enhancing the reliability and comparability of coagulation testing across Indonesian laboratories.
Abstract:
The aim of setting an External Quality Assessment Scheme (EQAS) for Blood Coagulation is to achieve a harmonization among the participating laboratories on blood coagulation testing. In Indonesia EQAS for blood coagulation is organized by the Department of Clinical Pathology, Faculty of Medicine, University of Indonesia which cooperates with the Indonesian Society of Clinical Pathologists, Jakarta Chapter. Currently coagulation tests in Indonesia are only performed in a limited number of laboratories especially in the hospital. Therefore only 65 laboratories participated in the first trial of EQAS. The control material for EQAS was provided by Organon Teknika and parameters involved in the first trial were PT, INR, APTT, and fibrinogen. Currently there are 7 brands of reagents for coagulation tests available in the market, i.e.: Behring, Biomerieux, Biopool, Human, Nycomed, Organon, and Ortho. In the evaluation, the results of each participant were compared to the median of participants who used the same reagent. If the number of participants using a given reagent was less than 10, then the result of each participant was compared to the median of overall participants. The result of a given parameter was classified as within consensus if it fell into the range of median +/- 15%. In the overall evaluation, the percentage of participants which was classified as within consensus for PT, INR, APTT, and fibrinogen were 68%, 64%, 63%, and 67%, respectively, but the CV for PT, INR, APTT, and fibrinogen were 19.84%, 17.89%, 20.21%, and 23.96% respectively. In the evaluation of participating laboratories using Behring's reagent, the percentages of participants classified as within consensus for PT, INR, APTT, and fibrinogen were 72%, 82%, 54%, and 74%, respectively. For Organon's product users, the percentages of those parameters were 84.6%-90%, 48%-75%, 86%, and 67%, respectively. It is concluded that around two-thirds of overall participating laboratories achieved harmonization in the results of coagulation test, but the variation of all parameters is still wide.
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