According to the Rand Corporation, “The number of tissue samples in U.S. banks alone was estimated at more than 300 million at the turn of the century and is increasing by 20 million a year.”1 Given the sheer volume of tissue samples that continues to grow year over year, several countries, including the U.S. have formed regulatory boards that manage specific standards and regulations as relates to their own domestic biobanking industry. While these standards and regulations vary from country to country, most are geared towards:
Protecting the identity of the tissue donor
Protecting the quality and integrity of the biological specimens contained within each facility
Exposing any “weak links in the chain” – processes, controls, etc.
One such method for safeguarding the identity of a tissue donor and the integrity of biological specimens within a biobank is with a chain of custody (CoC) solution - commonly included as a module or function with top-tier Laboratory Information Management Systems (LIMS). A CoC solution typically provides users and auditors of the LIMS with an audit trail that represents:
A date stamp regarding when, in this case, a biological specimen was first entered into the biobank facility, when it left the facility and when it was returned
A listing of individuals that had handled the biological specimen(s) and the processes that they had conducted on it
The location of the biological specimen when processes were conducted on it
Given these aforementioned CoC capabilities, there are at least three ways that biobanking facilities can benefit from a solid LIMS CoC solution:
1. Quality Improvement via Accountability
By instituting a LIMS CoC solution, biobanks can hold accountable those researchers who have been granted access to the biobank’s biological specimen(s). As a result, researchers will exhibit increased caution and better handling to ensure that the quality of the specimen will be upheld for the next researcher.
2. Better Results
As a result of preserving the quality of biological specimens via accountability, researchers have a better probability of solving diseases and safeguarding our environment.
3. Providing Transparency to the Tissue Donor
Tissue samples contain personal information and are collected or donated in an institutional relationship in which the donor entrusts the biobank to protect their donated tissue. A LIMS CoC can provide the necessary transparency to donors as well as various regulatory boards to ensure that the donated tissue samples are being used per the signed and agreed upon terms between the donor and the biobank.
Do you agree with these three high-level benefits? What other benefits would you add?
Eiseman, E. & Haga, S. Handbook of Human Tissue Sources (RAND, 1999).
- Parag H. Matalia, PMP, CSM
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