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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.
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