Cytogenetic Guidelines and Quality Assurance - EuroGentest

9. SUCCESS RATES 25
10. REPORTING TIME 26
10.1 PROVISIONAL RESULTS 26
11. CLINICAL RECORDS AND STORAGE 26
11.1 RECORDS 26
11.1.1 RETENTION OF DOCUMENTATION 26
11.2 SPECIMEN STORAGE 26
11.2.1 STORAGE TIMES 26
QUALITY ASSURANCE
12. GENERAL 27
13. ACCREDITATION 27
13.1 ACCREDITATION 27
13.2 CERTIFICATION 27
14. LABORATORY ORGANISATION AND MANAGEMENT 27
15. QUALITY MANUAL 27
16. DATA PROTECTION AND CONFIDENTIALITY 27
17. DOCUMENT CONTROL OF PROCEDURES AND PROTOCOLS 28
18. HEALTH AND SAFETY (H & S) 28
19. EQUIPMENT, INFORMATION SYSTEMS AND MATERIALS 28
19.1 EQUIPMENT 28
19.2 INFORMATION SYSTEMS (IT) 28
19.3 MATERIALS 28
20. LAB STAFF EDUCATION AND TRAINING 28
21. PRE-EXAMINATION PROCESS - SPECIMEN RECEIPT 29
22. EXAMINATION PROCESS – ANALYSIS 29
23. POST-EXAMINIATION PROCESS – CHECKING AND AUTHORISATION 29
24. INTERNAL AND EXTERNAL QUALITY ASSURANCE (IQA & EQA) 29
24.1 INTERNAL QUALITY ASSESSMENT (IQA) 29
24.2 EXTERNAL QUALITY (EQA) 29
ACKNOWLEDGEMENTS 30
APPENDIX 30
A. INDICATIONS FOR CYTOGENETIC ANALYSIS 30
B. REFERENCES 31
C. NATIONAL GUIDELINES 31
D. INTERNATIONAL/EUROPEAN STANDARDS 32
1. INTRODUCTION
1.1 BACKGROUND
The Permanent Working Group “Cytogenetics and
Society” of the European Cytogeneticists Association
(E.C.A.) prepared these guidelines as a quality
framework for cytogenetic laboratories in Europe in
collaboration with EU sponsored Network of
Excellence, ‘Eurogentest’ workpackage 1.4 (external
quality assessment in cytogenetics). It is hoped that
this document will lead to the establishment of
common guidelines and standards that can be used as
a reference manual in all European countries. This is
particularly applicable to those countries without
GUIDELINES
15
national guidelines, as they aim to achieve and
maintain high standards. The adoption of this
document by E.C.A. will facilitate this process.
These guidelines are intended to assist in the development
of national standards. Cytogenetic practises
and regulations differ throughout Europe so in some
instances these guidelines may not be in accordance
with national/federal laws and regulations. In such
cases, those regulations already form the basis upon
which the national standards operate.
These guidelines take into account the existing quality
assessment (QA) schemes, good laboratory practice
(GLP) documents, accreditation procedures and protocols
from different countries, as well as international