User Tools

Site Tools


capability_6

CA 6: Specimen and Sample Tracking/Chain of Custody

This capability area addresses informatics capabilities related to the laboratory’s ability to create accurate and timely specimen and sample tracking and chain of custody documentation.

Guidance Statement

Purpose: A key aspect of ensuring quality testing and management of samples in any laboratory is the ability to know the status of a sample at any point in time, track the chain of custody, and determine the impact of the state of the sample on quality.

What: Informatics tools can provide a laboratory with the ability to readily and seamlessly determine the state and location of a sample, its disposition, who handled the sample, and any results associated with the sample.

How: A laboratory that has the desired informatics capabilities to ensure that samples are tracked efficiently and accurately and that chain of custody is appropriately documented can:

  • Track the sample and its associated aliquots, their locations, and all steps in the sample’s lifecycle2. This includes sample storage, the duration for which a sample was removed for testing, and sample disposition.
  • Track aliquot hierarchy, including what tests were performed on which aliquot.
  • Track and document custody of the sample from sample receipt to disposal, storage, or return to submitter.
  • Record digital signatures of all staff that handled the sample.
  • Link demographic data on samples with data on chain of custody, sample integrity, sample handling and defined storage parameters.
  • Route the sample to a laboratory section.
  • Track creation of aliquots.
  • Assign an identifier (batch number, worksheet number) to a group of samples that were analyzed together, and assign associated identifiers for the instruments used for these analyses.

Capability Statement #6.1

Capability Statement Level Description of Level
Capability Statement #6.1 The laboratory is able to uniquely identify and track the location and associated dates of a sample and its aliquots at any step in the sample lifecycle2 (including storage, time out for testing, and sample disposition) electronically. Level 3 The laboratory is able to perform these functions electronically
Level 2 The laboratory is able to track some of these attributes electronically
Level 1 The laboratory is only able to track these attributes manually (i.e., external to LIMS).
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #6.2

Capability Statement Level Description of Level
Capability Statement #6.2 The laboratory is able to demonstrate chain of custody by electronically documenting custody of the sample from receipt to disposal or return to submitter, including recording of digital signatures of sample custodians and analysts. Level 3 The laboratory is able to perform these functions electronically.
Level 2 The laboratory is able to partly demonstrate chain of custody and partly track the sample, analyst, location, and time.
Level 1 The laboratory only tracks sample, analyst, location, and time manually.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #6.3

Capability Statement Level Description of Level
Capability Statement #6.3 The laboratory is able to link data on samples with data on chain of custody, sample integrity, sample handling, and defined storage parameters including date range and temperature. Level 3 The laboratory is able perform this sample tracking electronically.
Level 2 The laboratory is able to perform some of this sample tracking electronically
Level 1 The laboratory can only track manually
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #6.4

Capability Statement Level Description of Level
Capability Statement #6.4 The laboratory is able to associate and track the sample (e.g., Sample Identification) with one or more test requests, route the sample to a laboratory section. Level 3 The laboratory is able to perform this sample tracking electronically
Level 2 The laboratory is able to perform some of this sample tracking electronically.
Level 1 The laboratory can only track manually
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #6.5

Capability Statement Level Description of Level
Capability Statement #6.5 The laboratory is able to create, track, and maintain a sample aliquot hierarchy through the LIMS throughout all sections of the laboratory. Level 3 The laboratory is able to perform this aliquot tracking through the LIMS.
Level 2 The laboratory is able to perform some of this aliquot tracking electronically.
Level 1 The laboratory uses a paper-based system to perform this tracking.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules
capability_6.txt · Last modified: 2016/12/30 23:31 by awake