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3 Ways a Chain of Custody Solution can Enhance Biobanking Operations

Posted on Tue, Nov 12, 2013 @ 06:00 AM

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.


Paper Clip

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? 

       

      Sources

      1. Eiseman, E. & Haga, S. Handbook of Human Tissue Sources (RAND, 1999).

       

      - Parag H. Matalia, PMP, CSM
      Parag

       

       

       

       


      - 5AM Solutions offers innovative custom software solutions, analytics and consulting services to heath care and life sciences organizations. 5AM Solutions has 10 years of specialized experience partnering with, and guiding organizations with critical IT projects through their full life-cycle. Need support on an upcoming IT project? schedule a free consultation


      -Are you looking to publish and share your biospecimens on the web? Learn how here

       

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      Tags: biobanking, Chain of Custody, LIMS

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