Science & Research
Volume III - 2.3 Custodial Receipt and Storage of Samples
Section 2 - Chain of Custody – Sample Handling
|EFFECTIVE DATE: 04-17-2004||REVISED: 01-29-13|
Samples are delivered to the FDA laboratory receiving area, (e.g. FedEx®, UPS®, Airborne®, FDA or state personnel, and other private courier).
Any chain of custody form (e.g. from the Office of Criminal Investigations) received with the sample follows the sample records throughout the laboratory.
It is the responsibility of the person receiving physical custody of the sample to initiate the original record of sample receipt. The sample custodian receives the majority of samples delivered to the laboratory. Occasionally, an analyst or supervisor may receive a sample into the laboratory. Only those designated with the FACTS sample custodial role may electronically receive and sign for the laboratory receipt of the sample within FACTS. If the sample is received in the laboratory by someone who does not possess the role of Sample Custodian, the receipt of the sample must be documented.
If FACTS is unavailable (e.g. computer server is down) at the time of laboratory receipt of the sample, the laboratory uses its Computer Contingency Plan in order to document sample receipt and handling operations.
All samples should be kept in their original shipping container until ready to be entered into FACTS by the Sample Custodian. Frozen samples should be priority to avoid thawing. Sample packages are inspected during laboratory receipt processing to assure the following:
- physical condition is satisfactory,
- official seal (if present) is unbroken, and
- identification on the sample package matches that described in the accompanying records and/or in the FACTS "Collection Report" record.
Immediate action is taken to document and reconcile any discernible abnormalities and/or discrepancies such as the following:
- conflicting sample numbers,
- broken seals,
- breakage, and
- leakage or thawing.
Abnormalities and/or discrepancies are documented using the Laboratory's Complaint/Corrective Action procedures. The sample is placed on hold pending resolution of the non-conformance.
The sample custodian (or designee) completes laboratory receipt and custodial storage of the sample by recording the relevant information in the FACTS "Lab Receipt of Sample" record.
Stored samples are provided the physical security measures as described in the Section 18.104.22.168 Controlled Area and Section 2.2.3 Environmental Storage Conditions for Samples.