ISBER Self Assessment Tool for biorepositories

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

Andy [email protected]

Thank You

www.isber.org