Transcript JCTLM05-12

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
Ubierstr. 20
D-40223 Düsseldorf
Germany
Phone +49 211 1592 13-0
Fax
+49 211 1592 1330
E-mail [email protected]
Internet www.instand-ev.de
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
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.
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.
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
The Board of INSTAND
President
Vice President
Vice President
Prof. Dr. Hans Reinauer
Dr. Silke Heller
Secretary
Treasurer
Board Member
Prof. Dr. Joachim Thiery
Dr. Diethard Nies
Prof. Dr. Heinz Zeichhardt
Dr. Klaus Janitschke
Membership
INSTAND has full, corresponding,
cooperative
honorary members.
and
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.
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
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
6. Organisation
symposia
of
meetings,
expert
conferences,
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
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
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:
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
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.
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:
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
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)
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
INSTAND-WHO Training Course
(IWTC)
3.
1. IWTC
2.
15.03.
24.02. – 31.03.1999
01.03.
13.03.1997 (Düsseldorf)
18.03.1998
4. IWTC
5. IWTC
16.02. – 02.03.2003 (Düsseldorf)
23.10. – 25.10.2005 (Cairo)
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
INSTAND: WHO Collaborating Centre
INSTAND Meetings with Major INSTAND Contributions
EMROTeheran
Regional Intercountry Workshop in Laboratory
IRAN
Medicine
– 10-14 May 1997
EMRO Rabat
Regional Meeting of Directors of Health
MOROCCO
Laboratory
Services – 16-20 November 1998
Muscat
EMRO Intercountry Workshop on Quality Assurance in
OMAN
Health Laboratories – 6-10 December 1998
EMROMuscat
Regional Meeting of Directors of Health
OMAN
Laboratories – 18-22 June 2000
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)
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
List of Reference-Measurement Procedures
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Enzymes (IFCC 37 °C) - ALT, AST, LDH, CK, -GT
Hormones (GC-IDMS) – Aldosterone, Cortisol,
Progesterone, Testosterone, Thyroxine, 17βOestradiol
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-
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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)
Thank you for your attention
INSTAND: WHO Collaborating Centre
Activities
K.-O. Habermehl
H. Zeichhardt
Consultant for Virology
and Quality Management
Consultant for Virology, Risk Assessment,
Biosafety and Quality Management
Bahrain (1999)
Oman (1998, 2000)
Dubai (1999, 2002)
Qatar (1998)
ICBS Consultant for Virus Safety of Blood
Indonesia (2002)