The Institute for Infectious Diseases at the Free University of Berlin, Germany.
Prof. Dr. Heinz Zeichhardt  Institut für Infektionsmedizin, Universitätsklinikum Benjamin Franklin,  Freie Universität Berlin,  Hindenburgdamm 27,  12203 Berlin, Germany

The German Institute for Standardization and Documentation in Laboratory Medicine in Duesseldorf, Germany.
Prof. Dr. Hans Reinauer Institut für Standardisierung und Dokumentation im Medizinischen Laboratorium (INSTAND), WHO Collaborating Center for Quality Assurance and Standardization in Laboratory Medicine,  Ubierstrasse 2,  40223 Düsseldorf, Germany

SPECIFIC ACTIVITIES OF THE CENTRE



The Institute for Diagnostics Biotechnology in Berlin, Germany.
Prof. em. Dr. Karl-Otto Habermehl,  Institut für Biotechnologische Diagnostik, Potsdamer Chaussee 80,  14129 Berlin, Germany

Introduction
The above three collaborating centers are closely interlinked in their common efforts in the field of laboratory management. This includes quality assurance in external quality assessment and the regular execution of training courses in quality management in laboratory medicine for laboratory personnel from developing countries such as INSTAND-WHO Training Courses (IWTC).

In the context of virus safety testing of blood, a national and international network was established
in 1988 for External Quality Assessment Schemes (EQAS) in Virology on behalf of these three institutions and WHO. So far more than 365,000 samples have been tested in more than 950 laboratories in Germany, 17 cooperating countries and 42 countries appointed by WHO in the regions AFR, AMR, EMR, EUR, SEAR, and WPR. These EQASs are authorized by the German Medical Association and WHO and are the scientific responsibility of three scientific societies (The German Association against Virus Diseases, The Society of Virology and The German Society of Hygiene and Microbiology).  21 EQA programs have already been set up for the detection of virus antibodies and antigens, 9 programs for the detection of virus genomes and in May 2002  one program for the detection of BSE antigen.

The main emphasis of the EQASs lies in the quality control of diagnostic procedures for virus safety testing of blood and blood products. Control programs have been established for the serology and NAT of HIV-1/2, hepatitis A, B, C, D and E viruses, parvo virus B19, cytomegalo
virus, herpes simplex viruses 1 and 2, varicella zoster virus, Epstein Barr virus, rubella virus,
mumps virus, measles virus, tick born encephalitis virus, respiraroty syncytial virus and influenza viruses (A and B).

The three institutions cooperate with other national and international governmental and non-governmental institutions and reference laboratories  e.g Paul Ehrlich Institut, Robert Koch Institut, German AIDS Center, National Institute for Biological Standards and Control (NIBSC, Potters Bar, UK), Centers for Disease Control (CDC, Atlanta) and WHO.  INSTAND is the WHO Collaborating Center for Quality Assurance and Standardization in Laboratory Medicine. Prof. Habermehl is Chairman of the Council of the Bloodbank of the German Red Cross, Berlin. Prof. Zeichhardt is the Vice President of the German Association against Virus Diseases (DVV) and Chairman of the Diagnostic Council of DVV.

Based on the EQAS experiences, samples for daily run controls and national reference samples were established, which for the first time have allowed a direct interconnection between external and internal quality control on the one hand and test standardization on the other.  These samples are well characterized by a broad spectrum of users (institutes of basic science, universities, hospitals, blood banks, governmental institutions, private laboratories and even industries.)

Terms of reference

The terms of reference of the above-mentioned three collaborating centers are:

  • Contribution to the efforts of the ICBS to improve quality assurance and install quality systems in the blood testing facilities of blood banks in the developing countries as well as monitoring performance through external quality assessment.

  • Introduction of internal quality control (methods, control samples and evaluation).

  • Training of personnel of blood transfusion centers from the developing world on
laboratory testing procedures,

quality assurance principles and applications including help for setting up their own quality control programs
biosafety,

waste disposal.