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Laboratory Sample Handoffs: Reconcile Custody and Data

Sample handling fails most often at boundaries between collection, courier, receipt and analysis. A handoff record should explain what moved, when, under.

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Photo: U.S. Air Force photo by Airman 1st Class Madeline Herzog · License: Public domain · Cropped and resized.
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Sample handling fails most often at boundaries between collection, courier, receipt and analysis. A handoff record should explain what moved, when, under which conditions and who accepted the next responsibility.

Map the sample pathway

Use a sample pathway map linked to the protocol and laboratory manual. Identify labels, collection windows, processing steps, packaging and agreed receipt checks. Keep direct patient identifiers out of transfer documents unless a justified, authorised arrangement requires them.

Resolve an unmatched tube

When a tube arrives without a matching manifest entry, quarantine the discrepancy in the laboratory process and contact the named study role. Do not invent an identifier from convenience. Record resolution and any effect on analysis, repeat collection or usability decisions.

Laboratory handoff checks

  • Confirm sample identifier and required timestamps at transfer.
  • Reconcile dispatched, received, rejected and missing samples.
  • Connect corrected laboratory results to the relevant data delivery.

Accept custody and suitability evidence

Accept a handoff when sample status and custody can be reconstructed and discrepancies have a documented disposition. Evaluate sample suitability through the qualified laboratory and study process. A courier delivery signature does not by itself establish that every tube was suitable for analysis. Where tubes within one parcel have different handling requirements, connect specimen-specific acceptance decisions with the information needed for subsequent interpretation.

Frequently asked questions

Does parcel delivery confirm sample acceptance?
No. The laboratory must complete the agreed receipt and suitability checks.
Can a missing label be corrected informally?
Use the documented discrepancy process and authorised verification; retain the original issue trail.

Sources

  1. EMA — Laboratories analysing clinical trial samples
  2. EMA — Computerised systems and electronic data in clinical trials