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Volume III - 2.8 Shipping Samples from the Laboratory

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-2

VERSION NO.:1.9

Section 2 - Chain of Custody – Sample Handling

EFFECTIVE DATE: 04/17/2004REVISED: 05/02/214

Samples or portions of samples thereof are shipped from the FDA/ORA laboratory facility by various means. All shipment information is documented by the Sample Custodian or their designee in FACTS or LIMS.

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, a 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 whether the sample:

  • is stored in the sample storage area under the custody of a Sample Custodian; or
  • is in the custody of an analyst.

2.8.1.1   Sample is Stored in the Custodial 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 Custody of the Analyst

If the sample to be shipped is in the custody of the analyst, the analyst prepares the sample for 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 SOP or work instruction(s) for shipping samples. The Sample Custodian ships the sample in accordance with carrier and federal regulations, i.e., dangerous goods, infectious substances, hazardous materials.

 2.8.2  Shipping a Portion of the Sample

For the preparation and shipping of a portion of the sample to a claimant or another laboratory, an analyst prepares the portion for shipment. Preparation and shipment of the portion depends upon whether the sample:

  • is stored in the sample storage area under the custody of a Sample Custodian, or,
  • is in the custody of the analyst.

2.8.2.1 Samples Stored in the Custodial 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 portion 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 portion(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 portion(s) for 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 Custody of the Analyst

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 or web application:  

  • 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;
  • to 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 or LIMS record 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 or record. 

The analyst prepares the portions for shipment.The analyst returns the now split 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 carrier and federal regulations, i.e., dangerous goods, infectious substances, hazardous substances. 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 or LIMS.