Standard Guide for
Sample Chain-of-Custody Procedures1
This standard is issued under the fixed designation D 4840; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of the last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This guide contains a comprehensive discussion of
potential requirements for a sample chain-of-custody program
and describes the procedures involved in sample chain-of-custody. The purpose of these procedures is to provide accountability for and documentation of sample integrity from the time
samples are collected until sample disposal.
1.2 These procedures are intended to document sample
possession during each stage of a sample’s life cycle, that is,
during collection, shipment, storage, and the process of analysis.
1.3 Sample chain-of-custody is just one aspect of the larger
issue of data defensibility (see 3.2.2 and Appendix X1).
1.4 A sufficient chain-of-custody process, that is, one that
provides sufficient evidence of sample integrity in a legal or
regulatory setting is situationally dependent. The procedures
presented in this guide are generally considered sufficient to
assure the legal defensibility of sample integrity. In a given
situation, less stringent measures may be adequate. It is the
responsibility of the users of this guide to determine their exact
needs. Legal counsel may be needed to make this determination.
1.5 Because there is no definitive program that guarantees
legal defensibility of data integrity in any given situation, this
the guide provides a description and discussion of a comprehensive list of possible elements of a chain-of-custody program, all
of which have been employed in actual programs but are given
as options for the development of a specific chain-of-custody
program. In addition, within particular chain-of-custody elements, this guide proscribes certain activities to assure that if
these options are chosen, they will be implemented properly.
1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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