1. Clinical Utility of EQA Dr. Angela Amayo UON27/11/2008

2. Objectives To give background of quality To give background of quality To define EQA To define EQA Outline Process of EQA Outline Process of EQA Outline usefulness of EQA to the Clinical Laboratory. Outline usefulness of EQA to the Clinical Laboratory.

3. Introduction Clinical laboratories operate in a competitive environment. Clinical laboratories operate in a competitive environment. External pressure to meet customers expectations. External pressure to meet customers expectations. Internal pressure to reduce costs and increase revenues. Internal pressure to reduce costs and increase revenues. Quality management is now a business strategy. Quality management is now a business strategy. Improving quality is necessary for financial success of clinical laboratories. Improving quality is necessary for financial success of clinical laboratories.

4. Definitions of Quality The totality of features and characteristics of a product and service that bear on its ability to satisfy given needs. ( ISO ) The totality of features and characteristics of a product and service that bear on its ability to satisfy given needs. ( ISO ) Quality refers to the satisfaction of the needs and expectations of customers. ( Westgard ) Quality refers to the satisfaction of the needs and expectations of customers. ( Westgard ) On-Target with minimum Variance ( New definition of quality ) On-Target with minimum Variance ( New definition of quality )

5. Quality in clinical laboratories is assured by effective use of: Management, Management, Personnel, Personnel, Equipment and reagents Equipment and reagents A quality control system. A quality control system.

6. Cost of quality Quality is free: it is the lack of Quality that costs. ( Philip B Crosby (1979) costs. ( Philip B Crosby (1979) Cost of conformance Cost of conformance Cost of non-conformance Cost of non-conformance

7. Costs of conformance Prevention costs Prevention costs 1. Skilled personnel 2. Continuing education 3. Collaboration 4. Servicing of equipment Appraisal costs Appraisal costs 1. Internal Quality control 2. External quality assurance 3. Accreditation

8. Costs of non-conformance Internal failure costs: Repeat analysis Repeat analysis Staff time and effort Staff time and effort Staff confidence Staff confidence Staff morale Staff morale External failure costs Complaints/loss of customers ( Dissatisfied customer tells several others) Complaints/loss of customers ( Dissatisfied customer tells several others) Repeat requests Repeat requests Prolonged patient stay Prolonged patient stay Mismanagement/Litig ation. Mismanagement/Litig ation.

9. External Quality Assurance (PT) A program in which multiple samples are periodically sent to members of a group of laboratories for analysis and/or identification; whereby each laboratory’s results are compared with those of other laboratories in the group and/or with an assigned value, and reported to the participating laboratories and others.”

10. EQA process EQA Scheme organizer: sends out challenge specimens for testing. sends out challenge specimens for testing. Participating laboratory: analyses samples, analyses samples, remits results to organizer remits results to organizer EQA Scheme organizer: Laboratories’ results evaluated, Laboratories’ results evaluated, Laboratories sent scores of its perfomance. Laboratories sent scores of its perfomance. All areas of laboratory medicine covered

11. Uses of EQA results Measure of laboratory quality Measure of laboratory quality Early warning-system for problems Early warning-system for problems Indicator of where to direct improvement Indicator of where to direct improvement efforts efforts Valuable benchmarking tool Valuable benchmarking tool (standardization and traceability) (standardization and traceability) Identify training needs of laboratory staff Identify training needs of laboratory staff Monitor of changes in technology and Monitor of changes in technology and Testing practices (evaluation component) Testing practices (evaluation component)

12. EQA as measure of laboratory quality: Is most widely applied use of EQA. Is most widely applied use of EQA. Complements Internal quality control. Complements Internal quality control. Measures accuracy and precision. Measures accuracy and precision. Performance limits set by Scheme provider used as basis of quality. Performance limits set by Scheme provider used as basis of quality. Can assess all phases of laboratory process (pre-analytical, analytical and post) Can assess all phases of laboratory process (pre-analytical, analytical and post)

13. EQA as Early warning-system for problems Requires serial evaluation of EQA data. Requires serial evaluation of EQA data. Simplified by use of statistical control Simplified by use of statistical control Used to depict shifts and drifts. Used to depict shifts and drifts. Bias at different decision making limits can be noted. Bias at different decision making limits can be noted.

14. EQA for Continuous Quality Improvement Performance in EQA identifies weak links in quality chain. Performance in EQA identifies weak links in quality chain. Can be focus of QI initiatives Can be focus of QI initiatives Goal of QI achieved when EQA performance improves. Goal of QI achieved when EQA performance improves. All stages of laboratory process can be targets of QI initiatives. All stages of laboratory process can be targets of QI initiatives. Requires active quality team/circle in laboratory Requires active quality team/circle in laboratory

15. Examples of Quality Improvement targets: Preparation and storage of EQA material, esp. lyophilised Preparation and storage of EQA material, esp. lyophilised Progressive improvement in target values – aim at SDI -1 to +1. Progressive improvement in target values – aim at SDI -1 to +1. Individual technical staff analytical performance improvement. Individual technical staff analytical performance improvement. Minimising post- analytical errors. Minimising post- analytical errors. Timeliness of evaluation of EQA and actions on non-conformances Timeliness of evaluation of EQA and actions on non-conformances

16. EQA provides systematic approach to QI Enhances employee involvement and team effort Enhances employee involvement and team effort Facilitates communication Facilitates communication Ensures effective planning Ensures effective planning Keeps proper focus on important quality determinants Keeps proper focus on important quality determinants

17. EQA provides systematic approach to QI (ctd) Provides efficient path to effective solutions to quality problems Provides efficient path to effective solutions to quality problems Requires documentation, easily transferred. Requires documentation, easily transferred. Fits with Plan-Do-Check-Act Cycle. Fits with Plan-Do-Check-Act Cycle.

18. EQA as an aid to benchmarking Benchmarking is a Continuous Improvement tool. Benchmarking is a Continuous Improvement tool. Involves finding and implementing best practices in laboratory industry. Involves finding and implementing best practices in laboratory industry. Identify with quality leaders. Identify with quality leaders. Requires sharing of EQA results with quality leaders Requires sharing of EQA results with quality leaders

19. Benchmarking ctd.. Learn their quality practices. Learn their quality practices. Adopt practices that are feasible. Adopt practices that are feasible. Monitor effectiveness of interventions. Monitor effectiveness of interventions. Can benchmark with several laboratories Can benchmark with several laboratories Quality leader in Microbiology Quality leader in Microbiology Quality leader in Haematology etc Quality leader in Haematology etc Overall improvement in total quality. Overall improvement in total quality.

20. EQA and standardization EQA results are “field” results. EQA results are “field” results. Give indication of how equipment and reagents are performing in hands of users. Give indication of how equipment and reagents are performing in hands of users. Diversity of equipment/ methods can show where there is lack of harmonization. Diversity of equipment/ methods can show where there is lack of harmonization. This has negative impact in patient care. This has negative impact in patient care. If laboratory results not reproducible across methods, patients can be mis- managed. If laboratory results not reproducible across methods, patients can be mis- managed.

21. EQA and standardization Main concern has been chronic diseases such as diabetes, kidney disease, and coronary artery disease, endocrine. Main concern has been chronic diseases such as diabetes, kidney disease, and coronary artery disease, endocrine. Realisation of lack of reproducibility came from evaluation of EQA reports (e.g HbA1c, Troponin, creatinine, Immunoassays). Realisation of lack of reproducibility came from evaluation of EQA reports (e.g HbA1c, Troponin, creatinine, Immunoassays). Has led to efforts to standardize methods. Has led to efforts to standardize methods. To date HbA1c, troponin standardized. To date HbA1c, troponin standardized.

22. EQA for training Staff proficiency key in attainment of quality. Staff proficiency key in attainment of quality. EQA assessments can identify skills gaps among staff. EQA assessments can identify skills gaps among staff. Very important for manual procedures. Very important for manual procedures. EQA can be used to assess effectiveness of training. EQA can be used to assess effectiveness of training.

23. EQA and technological advances EQA reports valuable for identifying new techniques EQA reports valuable for identifying new techniques Information used in preliminary evaluation of new methods and techniques. Information used in preliminary evaluation of new methods and techniques. Important before major capital investment is made. Important before major capital investment is made. See how many labs are using a particular method. See how many labs are using a particular method. Assess how a particular method is performing. Assess how a particular method is performing.

24. Benefits of EQA - summary Laboratory mistakes are prevented Laboratory mistakes are prevented Significant improvements in testing performance can be achieved. Significant improvements in testing performance can be achieved. (Evidence from research (CAP, CDC) (Evidence from research (CAP, CDC) Increased confidence of staff Increased confidence of staff Reduced number of test repeats Reduced number of test repeats Reduced analytical cost. Reduced analytical cost.

25. Maximize Benefits of EQA (summary) See how well your laboratory is doing. See how well your laboratory is doing. view how your laboratory performance compares to other laboratories. view how your laboratory performance compares to other laboratories. See where your lab can begin to make improvements. See where your lab can begin to make improvements. Plan how to initiate improvements. Plan how to initiate improvements. Monitor effectiveness of initiatives. Monitor effectiveness of initiatives.