2.5 Intra/Inter Laboratory Splitting and Transferring of Samples

• 2.5.1 Splitting and Transferring Samples within the Laboratory
• 2.5.2 Splitting and Transferring Samples between FDA/ORA Laboratories or External (Non-ORA) Entities

2.5.1 Splitting and Transferring Samples within the Laboratory

An intra/inter laboratory splitting and transferring of sample occurs when the sample needing an analysis in addition to that performed by the original analyst is transferred to another analyst within the laboratory. If the original analyst has completed his or her part of the analysis, the entire sample can be transferred. Otherwise, the sample may be split into smaller portions and delivered to another analyst within the laboratory.

There are two methods to record splitting and transferring samples within the laboratory:

• Recording the sample transfer on the analytical worksheet, and
• Recording sample transfer through FACTS "Sample Transfer" record.

2.5.1.1 Recording the sample transfer on the analytical worksheet 

Sample integrity and handling (delivery and receipt of samples or sample portions) information is recorded on the analyst worksheet:

• Sample description and amount delivered;
• Sample identification;
• Date; 
• Name of analyst(s) involved in the sample exchange, and;
• Brief explanation of the reason for transfer.

2.5.1.2 Recording sample transfer through FACTs

The FACTS "Sample Transfer" "In-House Split" operation documents this operation. See the FACTS manual and Section 2.10 Reference for details. The "In-House Split," initiated by the Analyst performing the intra/interlaboratory split or transfer, will add a unique alphanumeric identification after the sample number for each sample portion that is split or transferred to the Analyst within the laboratory. The "In-House Split" allows each analyst to independently return or dispose his or her reserve portion to the sample custodian; these individual transactions are documented in FACTS.

2.5.2 Splitting and Transferring Samples between FDA/ORA Laboratories or External (Non-ORA) Entities

A sample that needs an additional analysis performed by a second ORA/FDA laboratory or external entity (e.g. non ORA contract laboratory for specialized testing, return of a claimants return) may be split into smaller portions and shipped.

There are two methods to record splitting and transferring samples within the laboratory:

• Recording sample transfer on the analytical worksheet, and
• Recording sample transfer through FACTS "Sample Transfer" "record.

Documentation on the analyst worksheet includes the following:

• description of sample and amount delivered,
• how it was prepared for delivery, 
• how it was identified and sealed,
• brief explanation as to why the sample was sent, 
• to whom the sample was sent and, 
• date of shipment.

The FACTS "Sample Transfer" "Split" operation documents this operation. The "Split" will add a unique alphanumeric identification after the sample number for each sample portion that is split or transferred within the laboratory.

The FACTS "Sample Transfer" "Split" operation, performed by the initial laboratory; documents splitting the sample between laboratory facilities or external entities. See FACTS Manual, Section 2.5.1 Splitting and Transferring Samples within the Laboratory and Section 2.10 References for details.

For samples that are split between FDA/ORA laboratories, each examining laboratory handles and describes its portion of the sample as an original analysis. When feasible, each examining laboratory retains a reserve portion for FDA use. The originating or forwarding laboratory retains an intact 702(b) (claimant's) portion when required by the FD&C Act, (see Section 2.12 Definitions) and informs the additional examining laboratory.