Was betrifft es? Warum ist das wichtig?

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

 

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)

Was muss ich befolgen?

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.

Wo kann ich Hilfe anfordern?

Your local CTU can support you with experienced staff regarding this topic

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
Abkürzungen
  • BIMS – Biobank Information Management System
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • PMID – PubMed ID
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
  • WI – Working Instruction
Development ↦ Biobanking ↦ Handling of Biological Material ↦ Sample Reception
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Biobanking ↦ Handling of Biological Material ↦ Sample Reception

Please note: the Easy-GCS tool is currently under construction.