LABORATUVARLAR ARASI PERFORMANS DEĞERLEDİRME PROGRAMI VE HEMATOLOJİ ALANINDA ÜLKEMİZDEKİ UYGULAMA

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2 LABORATUVARLAR ARASI PERFORMANS DEĞERLEDİRME PROGRAMI VE HEMATOLOJİ ALANINDA ÜLKEMİZDEKİ UYGULAMA Laboratuvarlararası kalite güvence programı 2000 yılı Ocak ayında Düzen Laboratuvarlar Grubu önderliğinde 40 özel laboratuvarın iştirakiyle başlamıştır ve bu gün ülke çapında 120 den fazla laboratuvarın katılımıyla gerçekleştirilmektedir (bk. slide 11). Dünya Sağlık Örgütü nün yayınlamış olduğu Milenyum Gelişim Programı doğrultusunda ülkelerin sağlık sistemlerinin geliştirilmesi, ekonomik ve siyasal politikaların fert bazında refah düzeyini artıracak şekilde planlanarak sağlık sistemini desteklemesi yönünde ortak kararlar almayı gerekli görmüştür. Bu amaç doğrultusunda uluslararası organizasyonlar ve standardizasyon çalışmaları bu merkezde odaklanmaya başlamıştır (bk. slide 1, 2). Terminoloji PT/EQAS ve kodeks'e göre belirlenmektedir. Bizim çalışmamız bu tanımlar içinde ILEP'in hizmet değerlendirmesi ve bir sertifikasyona yönelik olmadığından EQAS olarak kabul edilebilir. Biz de bu terminolojiyi daha uygun görüyor ve bu tanım çerçevesinde belirlenen hedeflere ulaştığımızı elde ettiğimiz neticelerden görüyoruz. Bundan sonraki hedef laboratuvarlararası farklılığı CLIA kriterlerinden daha dar olan AB hedeflerine çekmektir. (bk. slide 19).

3 Yürütülmekte olan "EQAS" uygulaması 17 ve 18. slide da da belirtilen sebeplerden ötürü THD ve TÜRKAK tarafından da desteklenerek bugüne gelmiştir. AB'nin Türkiye için yayınlamış olduğu 2004 ilerleme raporunda, sağlık araştırması alanında yeterli kalibrasyon standardının ülkemizde mevcut olmadığı dile getirilirken, laboratuvarlararası hiçbir kalite değerlendirme programının bulunmadığı vurgulanmıştır. Akreditasyonun gönüllü bir sertifikasyon uygulaması olması, kalite değerlendirmelerinde kuruluşların yeterliliklerini göstermede zorunlu aranacak belge statüsünde bulunmayı geçersiz kılmaktadır. Bu yüzden ilk etapta ülkemizin tek resmi akreditasyon kurumu olan TÜRKAK'ın AB ile arasında karşılıklı kabul edilme anlaşmasını gerektiren şartları bir an önce sağlaması ve bu köprüyü kurması gerekmektedir. Fertlerin dünya üzerinde eşitliği ilkesinin ülke yönetimleri tarafından benimsenmesi ve sağlık bilgisinin yer aldığı kayıt kartlarının dünya genelinde takibini kolaylaştıracak formata dönüştürülmesi öncelikli planlar ve hedefler arasında yer almaktadır. Hematoloji konusunda ülkemizde sürdürülen laboratuvarlararası kalite değerlendirme programının yıldan yıla katılımcı sayısı ve hedefleri yönünden etkinliğine baktığımızda gözle görülür bir artışa tanık olmaktayız. Bu çalışma ile laboratuvarlararası metot değerlendirmeleri, kalibrasyon kullanımının test sonuçlarında yarattığı etkiler, izlenebilirlik, biyolojik varyasyon, hata kaynakları ve konsensus değere ulaşmadaki uğraşlar açıkça ortaya konmaktadır. Ülke bazın da, daha dinamik buna karşın daha az bürokratik çalışmalar ulusal ve uluslararası alanda bir konsensusa ve dolayısıyla harmonizasyona ulaşmanın adımları olacaktır.

4 Bütün bu terimler ne ifade ediyor? Elazığ daki netice Ankara dakinden en fazla bu belirlenen aralıklarda farklı olacak ve bu neticeler birbirine hatta mutlak değere yine kabul edilebilir hata hudutları içinde yakın olacak, hastalığın takibinde tekrarlanabilirlik yüksek olduğundan tedavinin etkin olup olmadığı daha dar aralıklarda yapılan testlerde belirgin olacaktır. Daha önceden PT ve Dış Kalite Güvence (EQA) kavramları birbiri yerine kullanılabilmekteyken, 2004 yılında CODEX tarafından sunulan yeni terminolojide ILEP bu iki kavramı birleştiren yeni bir yapı ortaya koymuştur. "Proficiency Testing" zorunlu ve EQA eğitim odaklı uygulama iken, ILEP programında terminolojiye yeni kavramlar getirilmiştir. Bu kavramlar aşağıdaki slaytlarda yer almaktadır. Sürdürmekte olduğumuz programda amacımız ülkemizin aktüel durumunu ortaya koymak ve laboratuvarcılık anlayışını uluslararası standartlara oturtmanın uğraşını vermektir. Programa hastanelerden de katılımın etkin ve daha geniş perspektifte sonuçları ortaya koymak açılarından gerekli ve faydalı olacağını düşünüyoruz.

5 DESIGN OF QUALITY ASSESSMENT SYSTEM USING PROFICIENCY TESTING IN HEMATOLOGY AND WHAT WE CAN GAIN FROM OUR APPLICATION IN TURKEY? Dr. Yahya R. LALELİ (Turkish Hematology Society, Laboratory Standardization Subgroup), Dr. Murat ÖKTEM (Duzen Laboratories Group)

6 EVOLUTIONARY The past decade has been a time of significant change in international health. United Nations system aims to make organizations more responsive concerning the needs of nations for the achievement of International development goals; To strengthen health systems and ensure they are equitable. To ensure that health is prioritized within overall development and economic policies. To develop health strategies that respond to the diverse and evolving needs of countries. To mobilize needed resources for health in poor countries. To improve the quality of health data

7 EVOLUTIONARY (cont d) This challenge will require; More emphasis on effectiveness through collective action and partnerships. More dynamic, and less bureaucratic, approaches to management assuming a greater role in establishing wider national and international consensus on health policy.

8 AIM In the quest for laboratory quality, proficiency testing, accreditation and the inter-laboratory quality assessment programs are essential tools to measure harmonization and progress through accuracy.

9 AIM (cont d) For achieving this goal: set by WHO Non profit organizations, such as IFCC, ISH, NCCLS, or national bodies; CMS, set effective performance characteristics for diagnostic tests to ensure reliable, traceable and comparable laboratory test results. (

10 Quality Assessment Scheme Test monitoring system External QC (different from proficiency testing) Internal monitoring Proficiency testing, PT ( ILEP by Codex) Analytical system quality assessment Calibration verification Quality assessment activities Personal competency assessment (ISLH 14th International Symposium, Quality Assurance Workshop. External Quality Assurance Overview. RM Rowan.)

11 TERMINOLOGY It would be interesting to know How different are the EQAS of each nation?. Organisers treat this point, so that in future guidelines the organisers of external quality assessment surveys might give guidance in how to proceed in such cases. The terms quality, integrity and competence must apply equally to both organiser and participant aiming the harmonization at at the assigned value!

12 NATIONAL GEOGRAPHICAL SCOPE OF EXTERNAL QUALITY ASSESSMENT PEER REVIEW STUDY in TURKEY PARTICIPATING CITIES

13 EQAS Each and every nation has different EQAS Differences are determined by international surveys at; Quality Integrity Competance Discrepancies are triedtobe minimized and further dissappeared

14 TERMINOLOGY (Codex) described proficiency testing as Inter Laboratory Exchange Programs (ILEP) and described as a study in which several laboratories measure a quantity in one or more identical portions of stable materials under documented conditions. Major purpose of ILEP is to set method performance studies which include inter laboratory compatibility of results between different methods and instruments. ILEP will be used together with external QC material which gives a clue for evaluation of any new instrument or method.

15 ILEP should include quality issues such as turnaround time, training and education of laboratory staff and appropriateness in test request and the utilization of the test results. Aim is to increase both efficiency and the operational effectiveness. The data can be used for certification and accreditation. Organizational principles of ILEP are well established and clearly presented in guidelines released from IFCC, NCCLS/NCQA has been adapted to hematology from ISLH.

16 ILAC, IFCC, ISO Concerted efforts have been made internationally by laboratory accreditation experts to harmonize assessment activities through the International Laboratory Accreditation Cooperation (ILAC) and the International Organization for Standardization (ISO). Accreditation involves the assessment of the systems and methods used by a laboratory to ensure that it is competent to perform specific tests or calibrations

17 ILAC, IFCC, ISO ILAC, oversaw efforts to harmonize disparate accreditation criteria and these efforts culminated with the ILAC Arrangement, a mutual recognition arrangement. The agreement was signed at meetings held in conjunction with the ILAC 2000 Conference in Washington, D.C., in November. In all, 36 laboratory accreditation bodies from 28 economies worldwide signed the document. The objectives of such laboratory assessment schemes include: Unify laboratory accreditation schemes. Grant formal recognition to laboratories with proven capability and competence in specific fields. Reduce and eventually eliminate the practice of multiple assessments. Upgrade the status and standards of laboratories. Promote the worldwide acceptance of calibration and other tests performed by accredited laboratories. Enhance the quality, safety, acceptability and reputation of goods in domestic and overseas markets. Help protect the product manufac-turer or supplier against potential liability.

18 EQAS by ILAC EQAS have a two essential goals: 1. To monitor the analytical or diagnostic performance of the single laboratory. 2. To observe and monitor the performance of analytical systems in the common market and to inform the single laboratories, the manufacturers and if necessary the competent health authorities about observed deficiences.

19 EQAS, PT PT focus essentially on laboratory performance evaluations for regulatory purposes. EQAS focus essentially also on laboratory performance evaluations but the purpose of the schemes is educational

20 EQAS by ILAC IFCC/EMD/C-AQ Guidelines for the Requirements for the Competence of EQAP organizers External Quality Assurance Programmes (EQAP) is an interlaboratory comparison designed and operated to assure one or more of following aspects: - Participant performance evaluation - Method performance evaluation - Vigilance of IVD s - Continuous education, training and help The primary intention of the activities of an EQAP in laboratory medicine shall be to support quality improvements of the services provided by participating laboratories for the benefits of the patients.

21 EQAS by ILAC EQAP organizer A body (organisation or firm, public or private) that undertakes the design and conduct of one or several External Quality Assurance Programmes. Collaborator (Subcontractor) A body, (organisation or firm (public or private» that undertakes subcontracted activities for an EQA scheme or EQAP organizer. Coordinator The person with responsibility for coordinating all of the activities involved in the operation of one of several EQA schemes or EQAP.

22 EQAS by ILAC The responsibilities of an expert board should include, but are not necessarily be limited to, consideration of the following: a) design of the scheme (e.g. goals, number of samples, frequency of distribution, reply forms, evaluation of results); b) the evaluation of the clinical relevance of the schemes and the involved parameters c) agree on the selected parameters in the surveys d) sample nature of the test item(s) and test(s) selected, as well as a short description of the considerations underlying these choices, where appropriate; e) range of values to be expected for the test items; f) where appropriate, the test methods to be used; g) help in the search for appropriate patient sample material h) any difficulties expected in the preparation and maintenance of homogeneous test items or in providing a stable reference value for a measurement artefact; preliminary sample evaluation studies; i) agree on detailed instructions for participants; j) agree on any standardised reporting formats to be used by participants;

23 EQAS by ILAC k) getting feedback from participants l) number of significant figures to which results are to be reported; m) comments on any remark raised by participants; n) provision of advice for participating laboratories; o) establish acceptance limits and criteria for detecting poor performers; p) comments on the performance both and on individual participants and on participation as a whole; q) commentary on the summary report; r) evaluation of the responses of participants performing poorly (if feedback is required).

24 Conduct of EQAP schemes The EQAP organizer shall give participants early warning of the intention to conduct a scheme to ensure that they are aware of the aims of the scheme and that their staff are available at the required time. The EQAP organizer shall give detailed document instructions to all participants. Such instructions may, for example, be included as an integral part of the scheme protocol. Instructions to participants shall include details of factors which could influence the testing of the test materials, for example, conditions of storage, the nature of the materials or test items, the test procedure employed, and the timing of the testing.

25 Conduct of EQAP schemes Specific instructions on the manner of recording and reporting test results shall include, but are not necessarily limited to, the units of measurement, the number of significant figures, reporting basis, the latest date for receipt of test results and clinical data allowing an interpretation of data. For consistent in the presentation of test results, and for ease of statistical treatment, standardised report sheets are often prepared and distributed to participants. They are sometimes supplemented by asking participants to also submit a test report in their usual format. Scheme participants shall be required to treat EQAP samples in the same manner as routine samples (unless there are particular requirements of an EQAP which require departure from this principle) The target value(s) shall not be disclosed to participants until after the results have been collated.

26 EQA EDUCATIONAL & IMPROVEMENT ASPECTS INTER- LABORATORY COMPARABLITY INTEGRAL PART OF QUALITY ASSURANCE VOLUNTARY PARTİCIPATION OF INDIVIDUAL LABORATORIES SELF-ASSESSMENT TOOL HARMONIZATION ILEP PT POINT-SAMPLING OF LABORATORY OUTPUT ENCOURAGE MORE PARTICIPATION AND TREAT ALL LABORATORIES EQUALLY INDISPENSABLE PREREQUISITE FOR ACCREDITATION MANDATORY

27 Our Application Unfortunately there is no external quality assessment program neither in the area of Clinical Biochemistry nor in that of Hematology in Turkey. As Duzen Laboratories Group, our first study as starting point was peer view methods performance study to build up the compatibility harmonization among the test results between the private laboratories. Turkish Hematology Society and TURKAK support our inter laboratory peer view study because of: Determining the present situation in Turkey, Extending the content and improving to an EQAS program from proficiency testing, Increasing the participation from hospitals to the program.

28 Our Application (cont d) Furthermore, within the last 2 years, TURKAK (Turkish Accreditation Agency) has undertaken the supervision of sample preparation, distribution and evaluation components of the program. The whole program from sample preparation to evaluation is prepared and organized according to EQA program given by IFCC (Fundamentals for External Quality Assessment, IFCC).

29 Participant number Hb Hct RBC WBC Trombocytes * min-max CLIA ISLH European Countries ** min-max Table 1. Annual %CV values of CBC parameters of our programme and comparison with some others. * First two distributions ** JM Jou, Hematology external quality assessment in Europe, 2004 ISLH Congress

30 Figure 1: The distribution of variation described as SDI (z score) for Hb.

31 Figure 2: The distribution of variation described as SDI (z score) for Hct. on instrument base.

32 Figure 3: The distribution of variation described as SDI (z score) for RBC

33 Figure 4: The distribution of variation described as SDI (z score) for WBC.

34 Figure 5: The distribution of variation described as SDI (z score) for trombocyte

35 Analyte Within-subject Variation (%) Between-subject Variation (%) Index of Individuality (II) Hb Hct MCV MCH MCHC RBC WBC Thrombocytes Table 2. Within, between-subject variations and II value of CBC parameters (Biological variation: From principles to practice. CG Fraser, AACC 2005).

36 In order to add an extra value to our programme we make a special study in June The distributed sample is obtained from a single healthy donor and two levels of sample are prepared by taking and adding of plasma and buffy coat from one half to other. With this way we obtain 2 samples with different Hb, Hct, RBC, WBC and thrombocyte values and same RDW, MCH, MCV and MCHC values from the same person (Table 3). In this study our aim was to see the variation between their results and the CV values that they obtain from their internal controls. MCH MCV MCHC RDW Level 1 Level 2 Level 1 Level 2 Level 1 Level 2 Level 1 Level 2 Mean SD CV% Table 3. MCH, MCV, MCHC and RDW values that we obtain from our special study (Participant number=28).

37 Figure 6: The distribution of variation described as SDI (z score) for calibrator using laboratories.

38 What can we gain from our application? Almost 95 % of the participating laboratories were perceived as competent for maintaining reliability, tracebility and comparability in their individual external quality system by suiting to CLIA limits. Further progress in accuracy and traceability could be reached by wider use of control samples. Extented participation might be the case by the enforcement and encouragement of third parties Through the aim of increasing the effectiveness in realizing the principles of GLP rather than management, The application scheme of the study should be converted to a more responsive and organized structure. Reliabilities of the test results could be ensured by the support of TSH and TURKAK. Achieving success in the realization of this system will be the outcome with the continuous support of Non profit organizations and political enforcements.

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