External quality assurance and quality control

external quality assurance is required for better results and quality product in lab

1. EQAS Dr Arun Sinha

2. Introduction EQA can be called by different names = external quality assurance = external quality assessment = proficiency testing scheme

3. Definition process designed to objectively assess the quality of results obtained by laboratories, by means of an external agency

4. Objectives of EQA Programs Assess the laboratory’s analytical quality and reliability in reported results Enhance worldwide standardization efforts in clinical testing Aid in identifying potential corrective actions and evaluate their effectiveness Build confidence amongst the users towards lab performance

5. To demonstrate a commitment for continuous improvement and quality

6. Difference Between IQC &EQA IQC/QC EQA/PT Frequency Everyday/more frequently Periodically (once in a month) Target value Known Unknown Result availability Immediately Later Can assess Precision only Accuracy and precision Comparison Within lab With other labs

7. Iso 15189 Mandate For Eqas 5.6.4 The laboratory shall participate in organized inter laboratory comparisons, as external quality assessment schemes, that encompass the extent and complexity of examination procedures used by the laboratory. The laboratory management shall monitor the results of external quality assessment and participate in the implementation of corrective actions when control criteria are not fulfilled.

8. The Process

9. Different EQA providers Accredited under ISO 17043 Worldwide: RIQAS( Randox Quality Assessment Scheme), Biorad EQAS programme FCC EQAS CAP EQAS In India: CMC (Vellore, TN) RML (Lucknow, UP) • Metropolis Healthcare Ltd. EQAS (Mumbai, MH) • Neu-QAP(Neuberg Anand Academy of Laboratory Medicine Pvt LTD Quality Assessment Program).

10. Choosing An Eqas Programme important questions to be answered Choosing the parameters which the lab wants to put for external assessment. E.g

11. How closely does the EQA/PT material match typical patient samples in terms of Commutability * , Homogeneity, Concentrations How is the target value established? What is the number of participants in the scheme and in a particular method group?

12. Commutability

13. Sample Matrix

14. Schematic For Eqas In Laboratories

15. Parameter Settings

16. Result Reporting

17. Some key definitions Peer : other labs which are identical in method, instrument, reagent combinations for peer comparison there must be at least 9 reportable results Method group : labs which use the same analyte and method combinations but use other instruments and reagent combinations

18. Mode: all labs who perform the same analyte but use different instrument, reagents and method combinations

19. Interpretation Of EQAS Report

20. Interpretation Of EQAS Report

21. Take Home Message Eqas is an essential part of the total quality assurance programme Even though it may appear cumbersome but it ensures accuracy and precision of the reports generated by the labs Should be evaluated along with the IQC Documentation of the corrective action is must for quality improvement

22. Thank you