isber self assessment tool for biorepositories
TRANSCRIPT
What’s it Worth?
Assessing the Contributions of Your
Biorepository:
ISBER Self Assessment Tool
Andy Zaayenga
Karen Pitt, Ph.D.
Annual Biobank China 2013
September 28, 2013
Overview
What makes a biospecimen valuable?
Overview of the ISBER Best Practices
How the ISBER Best Practices offer support for
creating a quality environment for biospecimen
collection, processing, storage and dissemination for
research
Introducing the Self Assessment Tool or SAT
How you can evaluate your own repository to
determine opportunities for improvement
What Makes a Specimen
Valuable?
The goal of effective biospecimen
processing is to increase the likelihood
that the specimens are unchanged from
the time at which they were collected to
when they are used in a particular
research study.
Preserve Specimen Value
Learn from others
Identify from the literature which measures are
optimal for study design and ensure that the
biospecimen available are “fit for purpose” for the
types of testing planned
Understand how pre-analytic variables may
affect testing outcomes
Pilot studies, as appropriate
Plan for the future
ISBER Best Practices for
Repositories The availability of high quality biological and
environmental specimens for research purposes
requires the development of standardized
methods for collection, long-term storage,
retrieval and distribution of specimens that will
enable their future use.
First published in 2005, now in its third edition
Peer developed, peer reviewed
International in scope
Written broadly to consider best practices for
specimens other than those obtained from humans
ISBER Best Practices, 3rd Edition
Repository Planning Considerations
Facilities
Storage Equipment and
Environments
Quality Management
Safety
Training
Records Management
Cost Management
Biological Materials
Tracking
Packaging and Shipping
Specimen Collection,
Processing and
Retrieval
Legal and Ethical Issues
for Biospecimens
Specimen Access, Utilization and Destruction
Self Assessment Tool
Introduced with the 2nd edition of ISBER’s Best
Practices
Web-based assessment that contains 158
questions corresponding to the sections of the
best practices
Participants receive a score based on weighted
value given to each response with some
responses weighted more heavily than others,
depending on the critical nature of the question
Responses are confidential
Self-Assessment Tool
247 surveys have been completed to date
Repeating surveys to assess improvement is
possible
The SAT has been revised to match the
evolution of the ISBER Best Practices
Scoring has been adjusted to provide more
comprehensive feedback
Self-Assessment Tool
Example Questions
Do critical pieces of equipment (e.g. environmental specimen storage units) have a supply of emergency power such as a generator in case commercial power is interrupted for any reason? Yes
No
N/A
Comment:
If an emergency power generator is in place, is there sufficient power to run critical equipment for a minimum of 48 hours? Yes
No
We do not have access to an emergency power generator
Comment:
Example Questions
Does the repository have a Quality Management System (QMS) that describes the repository's commitment to its Quality Assurance (QA) and Quality Control (QC) activities? Yes
No
Comment:
Does the repository maintain a Quality Manual that references all procedures which are required to ensure that the QA/QC objectives are fulfilled? Yes
No
Under Development
Comment:
Possible Outcomes for
Results Allows you to compare how your repository to
ISBER Best Practices Recommendations
Allows you to identify areas of improvement
Allows you to communicate with decision
makers about improvements
Allows you to evaluate progress over time
