Sample Integrity Observation #4 No Chain of Custody

Modified on: Tue, 7 May, 2019 at 12:06 PM


PURPOSE:

The Chain of Custody (COC) provides legal defensibility and is required in order to maintain the chain of custody of samples.  The COC must accompany the samples.


Electronic COC (eCOC):

  • Using the eCOC from Bureau Veritas Laboratories Customer Portal allows the testing instructions to be submitted electronically.  The physical tracking process and chain of custody is maintained by using the Custody Tracking Form which is relinquished by the submitter and accompanies the samples in transit to the lab. 

Manual COC:

  • For multi-cooler shipments, a best practice is to include one COC per cooler.  If one cooler is delayed in transit, all other coolers would have accompanying COCs, and the lab could proceed with the received samples.
  • Remember that multiple COCs can be included in one final Certificate of Analysis.  Pack 1 COC per cooler and indicate Page 1 of X, 2 of X, 3 of X etc. 

PROCESS


Bureau Veritas Laboratories contacts you in cases where samples arrive without a COC.  For eCOC submissions, please record the eCOC number on the Custody Tracking Form (this number is the link to the electronic test instructions). 

If a COC is accidently forgotten from a shipment, a copy can be emailed to Bureau Veritas Laboratories.  Note that the absence of a COC means there is a break in the chain of custody and the submission is no longer legally defensible..


For multi-cooler shipments, multiple COCs can be included in one final Certificate of Analysis.  Pack 1 COC per cooler and indicate Page 1 of X, 2 of X, 3 of X etc.


The lack of COC could have adverse consequences in litigation cases therefore, complete COC must accompany every submission of IOL samples.

Receipt of emailed COCs instead of with the shipment, or COCs shipped within a different shipment will be noted as a deficiency.

For eCOC submissions, the Custody Tracking Form must be included in the shipment of samples along with the eCOC number accurately transcribed, otherwise a deficiency will be noted.

Shipments without a COC will be noted as a single deficiency (#4) and will not be noted for items 5,6,9 or 10.



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