Your Easy Guide to Clinical Studies

Sample reception is the sample-workflow step where Biological Material (BM) is received for:

• Sample processing (e.g. BM handling prior to long or short-term storage)
• Sample storage, where BM is kept until analysis (e.g. storage at -80°C)

 

The aim is to document the reception of BM, which includes:

• Reception time = duration of sample transport (e.g. time-laps between the collection and reception of BM)
• A quality check documenting:
  • BM received (e.g. type, volume or amount)
  • Packaging (e.g. condition of transport container, temperature, broken collection tubes / spillage)
  • Labelling (e.g. correct coding, matching and identification of BM, collection tube(s) and paper document(s))
  • Non-conformities (e.g. BM is damaged, missing, or additional material is included)
  • Measures taken in the event of quality concerns upon arrival of BM (maintain or destroy)
• The registration of BM-related information in BIMS (e.g. includes all information collected from collection until reception)

Define sample reception processes. Aspects to consider include:

• Quality checks: Create a list of standardised questions to be answered upon BM reception:
  • Define sample acceptance criteria (e.g. minimal volume, maximum acceptable delay between collection and reception).
  • If criteria are not met define how to proceed (e.g. BM destruction, adaptations to processing procedures, report non-conformity)
• Follow-up procedures: Upon reception, BM is either forwarded for additional processing, or directly stored in a storage unit. Include relevant information regarding laboratory or storage conditions (e.g. on ice, current freezer temperature during storage time)
• Documentation in BIMS: Include all required information needed for:
  • The tracking of BM (e.g. BM identifier for subsequent retrieval, ongoing surveillance of BM inventory)
  • BM quality evaluation during downstream analysis

 

Write a SOP and/or WI that explains the BM reception process. Ensure staff is trained on the reception and documentation of BM.

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

SBP Documents

SOPs, Forms and Templates – see in particular

• Biological Material SOP

References

ISO 20387:2018 Biotechnology - Biobanking (access liable to cost)- General Requirements for Biobanking – see in particular section

• 7.3 Reception and distribution of biological material and associated data

Publications PubMed

PMID: 28242283

• Giavarina, et al. “Blood venous sample collection: Recommendations overview and a checklist to improve quality”

PMID: 23072858

• Lippi et al. "Preanalytical quality improvement: in quality we trust"

PMID: 25979952

• Ellervik et al. “Preanalytical variables affecting the integrity of human biospecimens in biobanking”

PMID: 29377712

• Betsou et al. “Standard PREanalytical Code Version 3.0