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Reflections and proposals to assure quality in molecular diagnostics
M Raymaekers1, M Bakkus, E Boone
1Laboratorium voor Moleculaire Biologie, Klinisch Laboratorium, Jessa Ziekenhuis, campus Virga Jesse, Hasselt, België. marijke.raymaekers@jessazh.be
Acta Clinica Belgica
|April 14, 2011
Summary
Molecular diagnostic testing requires ISO15189:2007 accreditation for Belgian reimbursement. This consensus interpretation details technical requirements for molecular labs, aiding audit preparation.
Area of Science:
- Clinical Laboratory Science
- Molecular Diagnostics
- Quality Management Systems
Background:
- Molecular diagnostic testing is crucial in modern clinical laboratories.
- ISO15189:2007 accreditation is mandated in Belgium for reimbursement of molecular tests.
- The general ISO15189:2007 standard lacks specificity for molecular biology testing nuances.
Purpose of the Study:
- To provide a consensus interpretation of ISO15189:2007, Chapter 5 (Technical Requirements).
- To tailor quality and competence requirements for molecular diagnostic laboratories.
- To facilitate preparation for internal and external audits specific to molecular diagnostics.
Main Methods:
- A working group, "MolecularDiagnostics.be," developed a consensus interpretation.
- Focus on Chapter 5 of the ISO15189:2007 standard.
- Application of the interpretation within molecular diagnostic laboratory settings.
Main Results:
- A detailed interpretation of ISO15189:2007, Chapter 5, is established.
- The interpretation addresses the specific technical requirements for molecular diagnostics.
- The document serves as a guide for audit preparation.
Conclusions:
- The consensus interpretation bridges the gap between general lab standards and molecular diagnostics.
- This resource aids molecular diagnostic laboratories in meeting ISO15189:2007 criteria.
- Effective audit preparation is supported, ensuring compliance and quality.
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