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U.S. Department of Health and Human Services

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Volume III - 2.9 Disposition of Samples

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-2

VERSION NO.:1.8

Section 2 - Chain of Custody – Sample Handling

EFFECTIVE DATE: 04-17-2004REVISED: 01-29-13

Once all legal action requiring the sample is concluded, the sample custodian receives notification for disposition of the sample. Sample disposition notification is initiated through FACTS. Additional sample disposition notification may be provided through written authorization from the laboratory supervision. Upon receipt of the sample disposition notification, the sample is removed from its place of storage and destroyed within thirty (30) days.

The sample custodian or other personnel as directed by the laboratory management perform sample destruction. When any portion or the entire reserve sample is stored in a location other than the custodial storage area, the analyst may be assigned to destroy the sample.

 2.9.1 Sample Destruction

Sample destruction entails destroying and denaturing the entire reserve sample to the point the material is rendered unusable. The manner of destruction will depend on the individual sample.  Destruction processes that minimally impact the environment are considered. Methods such as incineration, de-characterization, chemical destruction, landfill disposal, and autoclaving can be used. Immediate sample containers are empty when placed in a waste receptacle. Sample destruction is conducted in accordance with the laboratory hazardous waste management plan, applicable biosafety guidelines, and general safety precautions.

Controlled drugs (CRx/DEA) regulations require the destruction of CRx/DEA controlled drugs must be witnessed by a designated Supervisor. The person assigned to perform the sample disposition must contact the laboratory management if there is any question to the method.

Destruction or other authorized disposition is the last step in accountability for the physical sample. FACTS documents sample destruction; only the sample custodian, or those designated with this role within FACTS, may complete and document the disposition of the sample through the FACTS "Sample Disposition" record.

 2.9.2 In-House Disposition of Reserve Samples

In certain instances, the Analyst may destroy the Reserve Sample prior to receiving official notification through FACTS authorizing sample disposition. Conditions where no Reserve Sample remains are usually confined to NAI import and NAI perishable samples where the laboratory supervisor has concurred in immediate destruction. The Analyst documents the In-House destruction on the Analyst Worksheet, Reserve Sample and in the FACTS "In-House Sample Disposition" record.

With the approval of the Laboratory or Compliance Branch Director, the Reserve Sample may be used for FDA purposes rather than destroyed (e.g., research, working standard, exhibit). In these instances, sample numbers are removed or obliterated to avoid potential confusion with samples that are in-progress.