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INSTAND registered society

INSTAND registered society. INSTITUTE FOR STANDARDISATION AND DOCUMENTATION IN MEDICAL LABORATORIES. formerly Haemometer Control Institution, founded 1936. WHO Collaborating Centre for Quality Assurance and Standardization in Laboratory Medicine since 1994. INSTAND Headquarters.

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INSTAND registered society

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  1. INSTAND registered society INSTITUTE FOR STANDARDISATION AND DOCUMENTATION IN MEDICAL LABORATORIES formerly Haemometer Control Institution, founded 1936 WHO Collaborating Centre for Quality Assurance and Standardization in Laboratory Medicine since 1994

  2. INSTAND Headquarters Ubierstr. 20 D-40223 Düsseldorf Germany Phone +49 211 1592 13-0 Fax +49 211 1592 1330 E-mail instand@instand-ev.de Internet www.instand-ev.de

  3. INSTAND Profile Non-profit scientific medical society Member of the Association of the Scientific Medical Societies (AWMF) in Germany • Responsibilities in laboratory medicine: • Organisation of External Quality Assessment Schemes (EQAS; 160 schemes) • Development of guidelines/standards for quality assurance • Determination of reference method values • Scientific publications • Organisation of scientific conferences

  4. Institute for Standardisation and Documentation in Medical Laboratories The Institute for Standardisation and Documentation in Medical Laboratories (INSTAND e.V. [registered society]) is a non-profit organisation dealing with quality assurance in medical laboratories. It is an interdisciplinary scientific-medical society with an appropriate constitution and bylaws and is member of the Association of Scientific Medical Societies (AWMF) of the Federal Republic of Germany.

  5. Aims The aims of INSTAND are the continual improvement of quality of performance in medical diagnostic laboratories by promoting internal quality control and organising inter-laboratory surveys, as well as by means of scientific meetings and publications. The different schemes of external quality assurance are subdivided into several specific programs.

  6. Structure The main organisations of INSTAND are: 1. the General Assembly 2. the Board, consisting of the president and 5 board members 3. the Central Administration in Düsseldorf 4. the departments in Düsseldorf and Berlin 5. the group of reference laboratories 6. the group of assigned value laboratories 7. the external quality assurance managers 8. the advisory project group of the Board

  7. Prof. Dr. Hans Reinauer Dr. Silke Heller Dr. Klaus Janitschke Prof. Dr. Joachim Thiery Dr. Diethard Nies Prof. Dr. Heinz Zeichhardt The Board of INSTAND President Vice President Vice President Secretary Treasurer Board Member

  8. Membership INSTAND has full, corres-ponding, cooperative and honorary members.

  9. Publications In a series of monographs – INSTAND-Schriftenreihe– reviews on quality assessment in medical laboratories are edited and published by INSTAND. Professor Reinauer is Editor in Chief of German Medical Science (GMS), an electronic journal of the AWMF. INSTAND publishes a brochure “instand-informationen”twice a year. INSTAND has founded an electronic GMS-Journal for Quality Assurance in Medical Laboratories.

  10. Awards Two prizes are awarded biennially for excellent applied scientific work dealing with quality assurance in medical laboratories Award for Outstanding Scientific Work Award for Young Scientists

  11. Responsibilities The main activities of INSTAND may be characterized by: 1. Development of guidelines and procedures for quality assurance in medical diagnostic laboratories 2. Development of external quality control schemes in different medically relevant fields 3. Establishing / developing reference method procedures and assigned method values. 4. Organisation and running of quality assurance surveys 5. Evaluation of standards and standard reference materials

  12. 6. Organisation of meetings, expert conferences, symposia 7. Organisation of special postgraduate courses in quality assurance (WHO) 8. Publications in the field of quality assurance in the medical laboratory (structures, procedures, and results) 9. Support of standardisation work at national (DIN) and international (ISO, CEN, COWSA, WASPaLM-SEQUA, IFCC) levels 10. Consultation of government and health authorities

  13. Terms of reference 1. Organisation of international external quality assessment schemes in immunology and other selected topics 2. Training in quality assurance and quality management of laboratory medicine, including organisation of, and/or participation in, training courses and assistance in preparing training materials 3. Standardisation in laboratory medicine including clinical laboratory practice guidelines 4. Assisting WHO in organisation and participation in symposia and conferences on laboratory quality assurance and standardisation 5. Strengthening national capacities in laboratory management in collaboration with WHO through the provision of experts

  14. WHO Collaborating Centre INSTAND was first appointed as a WHO Collaborating Centre for Quality Assurance in Medical Laboratories in 1994 and will be reassessed in 2006. The main activities of INSTAND in this field are:

  15. } } } } 1. Organisation of Training Courses and seminars in Quality Management for developing countries 2. Organisation of voluntary and free EQA programs for the diagnosis of infectious diseases in developing countries 3. Cooperation with WHO in standardisation, terminology, methodology 4. Participation in WHO conferences

  16. INSTAND has 22 full time employees who are concerned with the organisation of external quality assessment schemes. There are special laboratories equipped with gas chromatographs, HPLC, CE, mass spectrometers and routine laboratory analysers.

  17. The interlaboratory surveys are organised on behalf of the Bundesärztekammer (Board of the Federal Medical Council) and in co-operation with the Federal Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung (KBV)) as well as with both national and international scientific societies and organisations which include:

  18. National Co-operation German Society for Haematology and Oncology German Society for Hygiene and Microbiology German Society for Internal Medicine United German Societies for Clinical Chemistry and Laboratory Medicine German Society for Parasitology German Society for Quality Assurance in the Medical Laboratory German Society for Transfusion and Immunohaematology German Society for Urology German Institutes for Standardisation DIN, DKD, PTB

  19. International Co-operation World Association of Societies of Pathology and Laboratory Medicine (WASPaLM) National Committee for Clinical Laboratory Standards (NCCLS) European Committee for External Quality Assurance Programs in Laboratory Medicine (EQALM) International Council for Standardisation in Haematology (ICSH) International Federation of Clinical Chemistry (IFCC) International Organisation for Standardisation (ISO) European Committee for Standardisation (CEN) Institute for Reference Materials and Measurements (IRMM)

  20. The actual quality assurance schemes of INSTAND include: autoimmune diseases bacteriology blood gas analysis cardiac markers chemical pathology / clinical chemistry dry chemistry drug monitoring diabetes care gene defects glycated proteins haematology haemostaseology hormones immunohaematology lipid profiles markers of alcohol abuse osmotic pressure parasitology plasma proteins photometer control POCT devices serology trace elements tumour markers urine analysis vitamins virology

  21. 3. IWTC 15.03. – 31.03.1999 (Düsseldorf) 1. IWTC24.02. – 13.03.1997 (Düsseldorf) 2. IWTC 01.03. – 18.03.1998 (Düsseldorf) INSTAND-WHO Training Course (IWTC)

  22. 4. IWTC 16.02. – 02.03.2003 (Düsseldorf) 5. IWTC 23.10. – 25.10.2005 (Cairo)

  23. INSTAND-WHO Training Course (IWTC) Participants 36 from 27 countries from EMRO, AFRO, SEARO and WPRO Lectures 21 from INSTAND, WHO HQs (Prof. C. Heuck) and EMRO (Dr. El-Nageh) Topics (selected) Quality Management GLP in Health Labs External/Internal QC Accreditation Biosafety

  24. INSTAND: WHO Collaborating Centre INSTAND Meetings with Major INSTAND Contributions Teheran IRAN EMRO Regional Intercountry Workshop in Laboratory Medicine – 10-14 May 1997 Rabat MOROCCO EMRO Regional Meeting of Directors of Health Laboratory Services – 16-20 November 1998 Muscat OMAN EMRO Intercountry Workshop on Quality Assurance in Health Laboratories – 6-10 December 1998 Muscat OMAN EMRO Regional Meeting of Directors of Health Laboratories – 18-22 June 2000

  25. 4-year plan of work of the WHO Collaborating Centre for Quality Assurance Proposed plan of action during 2002 to 2006 1. Organisation of training courses in laboratory quality management, laboratory safety and quality assurance 2. WHO document on Laboratory Screening and Monitoring of Diabetes Mellitus 3. Participation in the activities of the WHO Working Group on Anaemia 4. St. Vincent Declaration: WG Laboratory 5. Seminars in Developing Countries (Cairo)

  26. 6. Continuation and extension of the WHO International External Quality Assessment Scheme for viral immunology for developing countries in collaboration with WHO 7. Assistance to WHO in the establishment of a laboratory quality assessment programme for the surveillance of viral infections 8. Establishment of methods of highest metrological order for the measurement of hormones, drugs substrates and ions 9. Training of students from countries in need in the management of laboratory quality assessment

  27. List of Reference-Measurement Procedures • Enzymes (IFCC 37 °C) - ALT, AST, LDH, CK, -GT • Hormones (GC-IDMS) – Aldosterone, Cortisol, Progesterone, Testosterone, Thyroxine, 17β-Oestradiol • Clin. Chem. (GC-IDMS) – Glucose, Uric Acid, Creatinine, Cholesterol, Total Glycerides • Drugs (LC-IDMS/MS) – Digoxin, Digitoxin, (GC-IDMS) – Theophyllin • Diabetes Care (LC-MS – IFCC Method) – HbA1c • Ions – FES – Na+, K+, AAS – Ca+2, Mg+2, Li+, Coulometrie – Cl-

  28. The Instand Reference Laboratory is at present in the process of being accredited by the DKD according to DIN-EN-ISO/IEC 17025:2005 + DIN-EN-ISO 15195:2003 (with reference to DIN-EN-ISO 15193 and 15194)

  29. Thank you for your attention

  30. INSTAND: WHO Collaborating Centre Activities K.-O. Habermehl Consultant for Virology and Quality Management Qatar (1998) H. Zeichhardt Consultant for Virology, Risk Assessment, Biosafety and Quality Management Bahrain (1999) Oman (1998, 2000) Dubai (1999, 2002) ICBS Consultant for Virus Safety of Blood Indonesia (2002)

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