Horace Gumba KEMRI-Wellcome Trust Research Programme The role of the External Quality Assessment in evaluating laboratory’s staff competency Horace Gumba KEMRI-Wellcome Trust Research Programme

Background EQA : An external assessment of a laboratory performance in comparison to its peer and/or to accuracy based reference system. EQAs are blinded samples EQAs are analysed as routine patient samples EQA can be used for: Educational purposes Assessment of laboratory performance against set standards Comparing laboratory performance against peers Provides evidence that a laboratory is competent to produce reliable and accurate results. EQA interprets best practice standards into a numerical score.

Objective of the study To assess staff competency and performance of KEMRI-Wellcome Trust STAT laboratory using past EQA material

Methodology Past EQA materials were used in evaluating staff competency. The existing standard operating procedure (SOP) for training and competency of laboratory staff was used as a guidance. Previous EQA reports of RCPA and UKNEQAS from 2010-2013 were reviewed. Three lab sections (STAT lab, Haematology lab section and Clinical Chemistry lab section) were reviewed for performance comparison. Competency assessments for 6 STAT lab staff, 7 Haematology lab section staff and 3 Clinical Chemistry lab staff were done to compare the three lab sections EQA performance

Table 1: STAT Lab against Clinical Chemistry lab section RCPA EQA chem RCPA EQA passed % pass RCPA EQA UKNEQAS chem Passed % pass UKNEQAS Average performance STAT Lab 48 35 72.9 41 85.4 79.2 Clinical Chem 30 62.5 67.7 TOTAL 96 75 78.1 76 78.6

Table 2: STAT Lab against Hematology lab section RCPA Haem RCPA EQA passed % pass RCPA EQA UKNEQAS Haem UKNEQAS Haem passed % pass UKNEQAS Haem Average performance STAT Lab 48 40 83.3 44 91.7 87.5 Hematology 37 77.1 41 85.4 81.3 TOTAL 96 77 80.2 86 89.6 84.9

Fig 1: Performance Comparison between STAT Lab and Clinical Chemistry sections STAT Lab ( 72.9%, 85.4%) had better performance when compared to Clinical Chemistry lab section (62.5%, 72.9%) STAT had an average of 79.2% and Clinical Chemistry 67.7%

Fig 2: Performance comparison between STAT Lab and Haematology Lab sections STAT Lab still had better performance (83.3%, 91.7%) when compared to Hematology lab section (77.1%, 85.4%). STAT Lab had an average of 87.5% while Hematology had 81.3%

Comparison of staff competency levels of the three lab sections STAT Lab 87% Haematology lab section 57% Clinical Chemistry lab 33%

Recommendations The QA communicated to laboratory supervisors to implement the use of past EQA materials in assessing competency. The training and competency Standard Operating Procedure to capture the use of EQA in assessing staff competency

Conclusion STAT laboratory section had excellent performance in the EQA schemes than the other 3 laboratory sections. STAT laboratory performed 87% on both reports, clinical chemistry laboratory section scored 81% while Hematology laboratory section scoring 80% . STAT Laboratory better EQA performance due to its high number of competent staffs . More confidence by KEMRI-Wellcome Trust users on STAT Laboratory EQA can be used to assess staff competency as well as earning international recognition in relation to quality standards.(STAT Lab is GCLP accredited)

Acknowledgements The STAT Lab, Hematology and Clinical Chemistry laboratory supervisors. The staffs of KEMRI-Wellcome Trust Clinical Trials Laboratory. The Laboratory manager for clinical trials laboratory.

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