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U.S. Department of Health and Human Services

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Volume I - 4.5 Subcontracting of Tests

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ORA Laboratory Policies

Food and Drug Administration

DOCUMENT NO.:
ORA-LAB.QM

VERSION NO.:2.0

ORA Laboratory Manual of Quality Policies

EFFECTIVE DATE:
10-01-03
REVISED:
05-02-14

ORA laboratories do not subcontract routine analyses within their scope of accreditation. Collaborative activities conducted with external laboratories, such as universities, are research in nature and do not involve the routine analysis of FDA samples.

4.5.1 Subcontracting Laboratories

Based on workload fluctuations and resource needs, ORA laboratories may request samples assigned to other FDA laboratories for analysis. Samples are administratively transferred after arrangements are made to ensure that the receiving laboratory has the capacity and capability to complete it in a timely manner.

Samples are shipped according to Department of Transportation (DOT), United States Post Office (USPS), and carrier regulations. ORA Laboratory Manual (LM), Volume III, Section 2, Chain of Custody describes the procedure for documenting administratively transferred samples (ATS).

4.5.2 Notification of Customer

FACTS, which is accessible to the customer, serves as a notice of the transfer.

4.5.3 Laboratory Responsibility

The FDA laboratory to which the sample has been transferred assumes responsibility to the collector for the work. 

Related Procedures

  • ORA LM Volume III, Section 2, Chain of Custody