| Other Laboratory Operations Food and Drug Administration |
| DOCUMENT NO.: III-2 | VERSION NO.:1.2 | Section 2 - Chain of Custody – Sample Handling | EFFECTIVE DATE: 04/17/2004 | REVISED: 06/27/2008 |
2.8 Shipping Samples from the Laboratory
Samples may be shipped from the FDA/ORA laboratory for a variety of reasons:
- Shipment of a split sample to another laboratory for additional analysis;
- Return of a consumer complaint sample to the consumer; and,
- Shipment of a 702(b) potion to a claimant.
The individual circumstance will dictate whether the entire sample or only
a portion of the sample is shipped. The Sample Custodian is generally responsible
for shipment of samples to other facilities. He or she assures that the sample
is packaged in a manner that maintains its integrity. If the Sample Custodian
is uncertain how a sample should be packaged for shipment, the Laboratory
Supervisor or Analyst is consulted.
When a 702(b) portion of a sample is to be shipped to a claimant, an FDA portion
shipped to another laboratory, or a complaint sample is returned to the consumer,
the Sample Custodian proceeds only with electronic or written authorization
from laboratory management.
Samples are shipped from the FDA/ORA laboratory facility by various means,
(e.g. FedEx®, UPS®, Airborne®, FDA personnel, or personal deliveries
such as the Sample Custodian to the local police).
2.8.1 Shipping the Entire Sample
Preparation and shipment of the entire sample depends upon the following:
- sample is stored in the sample storage area, or,
- sample is in the Analyst custody.
2.8.1.1 Sample is stored in the sample storage area
If
the sample to be shipped is in the sample storage area, the Sample Custodian
retrieves the sample from the storage area, packs the sample for shipment,
and ships the sample following the laboratory's local SOP or work instruction(s)
for shipping samples.
2.8.1.2 Sample is in the Analyst custody
If the sample to be shipped is in the custody of the Analyst, the Analyst prepares
the sample for shipment following the procedure described in Section 2.6 Preparing
Reserve Samples for Storage or Shipment.
The Analyst returns the sample to be shipped to the Sample Custodian following
the procedure described in Section 2.7, Returning Samples to Custodial Storage.
The Sample Custodian packs the sample for shipment, and ships the sample following
the laboratory's local Standard Operating Procedure (SOP) or work instruction(s)
for shipping samples. The Sample Custodian documents shipment of the sample
in accordance with federal regulations procedures.
2.8.2 Shipping a Portion of the Sample
For the preparation and shipping a portion of the sample to a claimant or another
laboratory, an analyst will prepare the portions for shipment. Detailed instructions
depend upon the following:
- sample is stored in the sample storage area, or,
- sample is in the Analyst custody.
2.8.2.1 Samples stored in the sample storage area
Samples that are stored in the sample storage area are obtained by the Analyst
from custodial storage following procedures described in Section 2.4 Receiving
Samples from Custodial Storage and Opening the Sample Package. If the sample
had previously been analyzed by the laboratory, the Analyst whose name appears
on the seals(s) of the Reserve Sample (if applicable) obtains the sample,
prepares, and seals the subdivision for shipment.
After receiving custody of the sample, the Analyst breaks the official seal
and opens the sample package following the procedure described in Section 2.4
Receiving Samples from Custodial Storage and Opening the Sample Package. The
Analyst splits the sample into subdivision(s) and documents the split by following
the procedure described in Section 2.5 Intra/Inter Laboratory Splitting and
Transferring of Samples. Additionally, the Analyst documents the process of
breaking seals, preparing samples, and describing the reserve sample on a new
Analyst Worksheet. The worksheet is processed through normal channels to become
an addition to the original worksheet.
The Analyst prepares the subdivision(s) for shipment following the procedure
described in Section 2.6 Preparing Reserve Samples for Storage or Shipment.
The Analyst returns the portion of the sample to be shipped to the Sample Custodian
following the procedure described in section 2.7 Returning Samples to Custodial
Storage.
The Sample Custodian packs the sample portion for shipment, and ships the portion
in accordance with federal regulations. The Sample Custodian documents shipment
of the sample following the procedures described in Section 2.8.3 Documenting
Sample Shipment.
2.8.2.2 Samples in the Analyst custody
The Analyst splits the sample into portions following the procedure described
in Section 2.5 Intra/Inter Laboratory Splitting and Transferring of Samples.
If the sample being prepared for shipment is in process, the Analyst states
the following on the Analyst Worksheet:
- sample description, sample provided, and amount;
- how it was prepared for delivery;
- sample identification (description of seal, if appropriate);
- brief explanation as to why the sample was sent;
- whom the sample was sent; and,
- date of shipment.
If the sample being prepared for shipment is a Reserve Sample that has
not been returned to the Sample Custodian due to special storage (refer to
Section 2.7, Returning Samples to Custodial Storage, a new Analyst Worksheet
is initiated to document the following:
- the process of breaking seals (if applicable),
- preparing the sample portions,
- sample description and amount provided,
- to whom the sample was sent,
- how the sample was sent for delivery,
- short explanation why the sample portion was sent, and
- description of the reserve sample.
The worksheet is processed through normal channels to become an addition
to the original worksheet.
The Analyst prepares the portions for shipment following the procedure described
in Section 2.6, Preparing Reserve Samples for Storage or Shipment. The Analyst
returns both portions of the Reserve Sample to the Sample Custodian following
the procedure described in Section 2.7 Returning Samples to Custodial Storage.
The Sample Custodian packs the sample portion identified for shipment, and
ships the portion in accordance with federal regulations. The Sample Custodian
documents shipment of the sample following the procedures described in Section
2.8.3 Documenting Sample Shipment.
2.8.3 Documenting the Sample Shipment
The Sample Custodian (or designee) documents the shipment of samples or sample
portions by entering the information into FACTS.
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