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SBP offers to biobanks a compliance review through SBP Biobank SQAN, its online assessment tool of biobanks’ practices. After completion of the compliance review, three labels can be awarded. They reflect the biobank compliance level with:
the applicable ethical/legal framework
the standardization of the multiple biobanking processes from consent presentation to sample shipment, including personnel and equipment management
the optimization of the overall biobanking management system with focus on the implementation of quality assurance measures
Below are listed the domains that are evaluated within the compliance review:
Compliance with legal and ethical standards
Consent information process
Return of results
COLLECTION PROCESS TRANSPORT PROCESS RECEPTION PROCESS PROCESSING PROCESS STORAGE PROCESS DISTRIBUTION PROCESS METHODS
Quality control methods
Quality control results
Validation of methods
Implementation of quality assurance measures of the overall biobanking system
Quality Assurance Management
Service Level Agreement
Internal communication DOCUMENTATION MANAGEMENT SYSTEM
Document list PROFESSIONAL DEVELOPMENT
Internal audit reports
Management of nonconformities
List of non-conformities RISK MANAGEMENT
Business model and cost recovery (sustainability)
SBP recommends its biobank partners to aim for at least for the NORMA label which will guarantee the quality of the biobanking processes and the harmonization of the biobanks’ practices at the national level. Efficient sample management is indeed a prerequisite to enable researchers to perform reliable and high-quality research.