1. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ1 EQAS Organization and Management l Bibliography Fundamentals for External Quality Assessment, IFCC/EMD/C-AQ, 1996 Uldall, A.; Wilding., P; Hill, P. External Quality Assessment in Clinical Laboratories, J. C. Libeer, 1993 Quality Assurance in Clinical Chemistry, Scand. J. Clin. Lab. Invest. 47 (Suppl. 187), 1989 Uldall, A.

2. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ2 ¿What is an External Quality Assessment Scheme (EQAS) ? System designed to objectively assess the quality of results obtained by laboratories, by means of an external agency

3. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ3 Functions of an EQAS Measures inter-laboratory variability Allows comparison and evaluation of methods, reagents, instruments, etc Show laboratory performance Allows determinations of consensus values Investigate factors affecting quality, e.g. interferences Educational stimulus Element of third-part evaluation of laboratories for licensing and accreditation Source for uncertainty calculation

4. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ4 Position of EQA Quality Management Quality Policy Quality Assurance GLP Quality Control Internal Quality Control External Quality Assessment Other aspects of GLP

5. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ5 General cycle of an EQAS Initial survey Laboratory analyze samples and send results Input and validation of data results. Statistical data processing General and individually report EQAS send report to participants laboratories Laboratory analyze samples and send results Laboratory analyze samples and send results

6. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ6 Education l EQA role in motivating through interpretation of reports general individuals discovering factors affecting quality complementing internal quality control calibration preparation of quality control materials quality assurance

7. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ7 Types of EQA l Type 1 Designed to document laboratory performance to a third part: authorities, accreditation bodies, social security, etc. l Type 2 Designed to report analytical performance to individual laboratories l Type 3 Designed to support troubleshooting in laboratory. l Type 4 Designed to evaluate methods of measurement and IVD’s

8. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ8 Important items in planning EQAS How many laboratories are expected to participate Budget Specialties to work on Geographic and climate characteristics Type of control materials Initial analytes to be investigated How long the complete cycle will be Forms design How response of laboratory will be registered and processed Availability of hardware and software Acceptability performance criteria

9. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ9 International EQAS l Advantages Already planned Large number of participants Allow more method groups l Disadvantages Low influence in the EQAS design or content Does not favor development of local experts Harder communications Difficult to arrange peer groups Often expensive

10. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ10 National EQAS l Advantages System developed according own needs Participants communicate with organizers more directly Participants could suggest modification of the scheme Local expert development Employment creation l Disadvantages More management work Greater budget Time consuming

11. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ11 Assume the responsibility in front of the community Transmit a clear image of the EEC Not to influence on the development of the program Sponsor Institution

12. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ12 Organizer: Desirable Profile High reputation among colleagues Commitment to a long term work Knowledge of the real situation were the EQAS is intended to apply Deep knowledge of statistics Vision and diplomacy Independent of IVD-market supplier

13. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ13 Logistics Adequate human resources Adequate resources to data processing Preparation, acquisition and distribution of control materials Print-shop service

14. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ14 Types of EQAS according activity l External assessment only l Combination External assessment/Internal Quality Control

15. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ15 External Assessment only l Advantages Resources concentration to laboratory standardization Freedom of laboratories to select their IQC materials l Disadvantages Very high cost of individuals laboratories to get their IQC materials Slow quality improvement

16. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ16 Combination EQA/IQC l Advantages All needs of laboratories covered. Maximal utilization of EQA reports Unique code system Integration of EQA and IQC data l Disadvantage More work for the organizer Greater widespread of resources and energy Huge administrative work

17. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ17 Financing l Free Advantages Facilitate participation of all laboratories Simpler administration Central financing more stable Disadvantages Seems that EQAS cost nothing If central financing from government, continuity is tied to political changes Possible interference from the financier l Fee Advantages Participants realize the real cost of the service they receive Sense of belonging Allows programmed expansion of the scheme Disadvantages If participation is not mandatory, financing could be unstable Greater administrative work (invoicing) Discourage participation

18. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ18 Participation l Mandatory Advantages The assessment comprises all laboratories More reliable data All patients receive the benefits Disadvantages Does not guarantee improvement Some participants does not use the reports l Voluntary Advantages System based in professional responsibility Participants are interested in their performance and read/use reports Disadvantages The scheme get competitors Only concerned laboratories are assessed

19. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ19 Type of control materials Lyophilized animal serum cheaper, good long term stability important matrix effects for some constituents, reconstitution errors, not appropriate for inmunologic tests Lyophilized human serum More similar to patients specimens, good long term stability Expensive, reconstitution errors, denaturation of proteins/lipoproteins Stabilized liquid serum Ready to use, easy to prepare Great matrix effects, less long term stability Freezed human serum ideal Very expensive, difficult to obtain different level of concentration, more unstable, storing and transport very expensive, danger of contamination.

20. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ20 Source of Control Materials Self prepared Commercial Custom problems

21. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ21 Frequency of distributions l Low frequency Advantages Lower costs Less processing work Less requirement to the participants Disadvantages Less statistical power Harder assessment Lower error detection probability l High frequency Advantages Better data-base Reliable assessment Better error detection probability Disadvantages Greater expedition costs Greater costs in control materials Greater costs to the participant (reagents, time, communications)

22. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ22 Distribution: other factors Postal requirements for delivery of biological materials Type, number and volume of materials to be distributed Containers Labeling of samples Instructions

23. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ23 Reports l Concise Advantages Fast reading Fast and cheaper production Disadvantages Limited information Abridged reports require expertise to be interpreted l Detailed Advantages Much useful information Participants receive all information they need Disadvantages Reading takes more time Greater logistics problems for design and print

24. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ24 Forms l Easy to understand l Need to have Laboratory code Reception of samples date Analysis date Duplicate for the laboratory Design with the help of programmers and operators l Use Description of analytical characteristics (codes) Changes in analytical characteristics Report of results

25. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ25 Instructions to the participants Scope of the scheme Needs of regular participation How the results are assessed Follow instructions to fill forms (units, method info, etc) Adequately answer questions from the organizer How and to whom ask for help

26. 1998 EQAS Organization and Management - IFCC/EMD/C- AQ26 Optimal criteria for EQAS design Scientific validity reliable control materials valid assigned values valid statistical treatment Reliability confidentiality frequent distributions short cycle intelligible reports strictly execution of the schedule scoring system