Abstract
The objective of this study is to evaluate international external quality assessment scheme (IEQAS) program participant laboratories in Ethiopia. Acceptable performance was defined as any proficiency testing (PT) score 80% and above. The retrospective PT database was reviewed and analyzed to assess the testing performance of the participating laboratories and the impact of the program over time. A total of 173, 275 and 334 laboratories participated in the EQA program in 2016, 2017 and 2018 respectively; enrollment increased from 173 laboratories in 2016 to 334 in 2018. As a result, the overall participation rate is 41% whereas failure to participate accounts 52.2% and the rest are due to reagent stock out, equipment down and test suspended during the test event; among the total PT challenges distributed and performed, the rate of scoring ACC were 66.00%, 67.61%, 67.22%, 67.35%, 67.48% and 70.87% in event 2, 3 of 2015, event 1, 2, 3 of 2016 and event 1 of 2017 respectively. Using 95% confidence interval with the hypothesized proportion of ≥ 80% to be acceptable by the ISO standard. One sample proportion test calculation showed the result generated from the laboratory is not significantly meet the standard requirement P value <0.05. The present evaluation conclude that IEQAS program in Ethiopia is not utilized for improvement in the quality of laboratory diagnostic services over time across the six PT events. The laboratory result generated from the Health facilities in Ethiopia is significantly out of the standard.
Highlights
Successful performance in an external quality assessment (EQA) program reflects the effects the effectiveness of laboratorys quality management and allows for recognition of laboratory quality by external body [1]
From the total of 298417 proficiency testing (PT) challenges distributed to participant laboratories throughout of 6 PT events 176442 (51%) of PT challenges were not tested due to different reasons; out of the identified problems the majority of the challenge was failure to participate which account 156935 (52.6%) of the total PT challenges and 3.4%, 2.3% and0.6% of PT challenges were not performed due to Reagent unavailability, Analyzer out of services and Testing suspended during test event respectively
In this study the average PT performance the 6 PT events for 28 PT programs was 67.75% success rate even though significant improvement is not observed through the trend of PT event which among participated facilities those graded as ACC or UNACC which account 97507 (79.9%) among the total PT challenges distributed and the success rate or the rate of scoring ACC were 66.00%, 67.61%, 67.22%, 67.35%, 67.48% and 70.87% which showed relatively good performance compared to the study conducted among 12 government hospitals laboratories in Addis Ababa, who had been participated in proficiency tasting schemes for 20 clinical laboratories test parameters in 6 cycles from 2012 to 2013 G
Summary
Successful performance in an external quality assessment (EQA) program reflects the effects the effectiveness of laboratorys quality management and allows for recognition of laboratory quality by external body [1]. External quality assessment (EQA) is a program and it involves running blind patient-like samples, comparing your results to peer results, in order to retrospectively monitor the accuracy of reporting [2]. The objective of EQA is to ensure that test results are reliable and comparable no matter where they are performed. This involves standardization of procedures and establishment of national level diagnostics centers responsible for developing training modules, training, identifying the materials needed to support PT and improving the performance and maintaining the competence of EQA is essential [3]. The main purpose of External Quality Assessment (EQA) and proficiency testing (PT) preparation is to distribute a stable and consistent sample for participant laboratories to analyze the sample. The target value may be determined by peer group, a reference laboratory, or may be a consensus value for quality improvement process [4]
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