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Volume III - 2.5 Intra/Inter Laboratory Splitting and Transferring of Samples

 

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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: 04-17-2004 REVISED: 05-02-14

 2.5.1 Splitting and Transferring Samples within the Laboratory

A split/transfer of a sample occurs when a sample requires an additional analysis to that performed by the original analyst. If the sample will be analyzed in its entirety at the designated servicing laboratory, an intralaboratory split/transfer is performed in FACTS or LIMS.

If the original analysis is complete, the entire sample may be transferred/change custodianship to the next analyst for the additional analysis. If the original analysis is not complete, the sample may be split into smaller portions. Of these smaller portions, one portion will be analyzed by the original analyst and the “split” portion will be transferred to the next analyst who will perform the additional analysis.

2.5.1.1 Recording the Sample Transfer on the Analytical Worksheet 

To ensure sample integrity, information regarding delivery and receipt of samples or sample portions is recorded on the analyst worksheet, FDA 431, as follows:

  • Sample description and amount delivered (Blocks 7 and 8);
  • Sample identification (Block 2);
  • Date (Block 4);
  • Name of analyst(s) involved in the sample exchange (Block 5), and;
  • Brief explanation of the reason for transfer (on 431 or 431a).

2.5.1.2 Recording Sample Transfer through FACTS

The FACTS or LIMS “Sample Transfer” “In-House Split” operation documents intralaboratory sample splits. The “In-House Split” is initiated by the original Analyst. A unique identification will be added for each sample portion assigned to Analysts within the same laboratory. The “In-House Split” allows each analyst to independently return the reserve portion to the Sample Custodian, or dispose of appropriately. These individual transactions are documented in FACTS or LIMS.

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

If additional analysis of a sample will be performed at a facility other than the designated servicing laboratory, an interlaboratory split/transfer is performed in FACTS or LIMS.

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

For samples that are split between FDA/ORA laboratories, each examining laboratory handles and describes its portion of the sample as an original analysis. The original servicing laboratory retains an intact 702(b) portion, when required.  The receiving laboratory is informed of the amount retained as the 702(b) portion.

2.5.2.1 Recording the Sample Transfer on the Analytical Worksheet

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.

2.5.2.2 Recording Sample Transfer through FACTS or LIMS

The FACTS or LIMS "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 or LIMS "Sample Transfer "Split" operation documents sample splits. This operation is performed by the original servicing laboratory and documents the sample splitting between the original servicing laboratory and another ORA facility or an external entity.