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Standards › Standard 33 › Standard operating procedures (SOPs)

Standard operating procedure (SOP) · LBT-SOP-006 · Version 1.0 · Approved by the ASF Expert Committee

Supports: 33.10

At a glance

  • Each forensic or legal specimen has a chain of custody from collection (LBT-FRM-004).
  • Each transfer is signed and dated.
  • The specimen is disposed of only as recorded.
  • Any gap in custody is reported at once.
  • Stop and get help straight away if: a legal specimen is handled with a gap in its chain of custody.

1. Purpose

To make sure forensic and legal specimens can be shown to be the same specimen, handled the same way, from collection to disposal (33.10).

2. Scope

Applies to Clinical and support staff in the hospital
Locations All wards, clinics and departments of the facility
When Whenever the activity described is carried out
Does not apply to Activities covered by another document listed in section 15

3. Definitions

Term Meaning
Clinical lead The doctor or nurse in charge of the area at the time

4. Background

A specimen used as legal evidence must show, at each step, who held it and what happened to it. Without that custody record, the evidence can be challenged.

5. Responsibilities

Role Responsibility Competence
Senior scientist Owns the custody process and the forms Laboratory director
Each person who handles the specimen Signs and dates each transfer Senior scientist

6. Materials and equipment

Item Requirement Condition
Records and forms named in this document Current version Checked before use

7. Safety

8. Before you start

9. Procedure

Step 1. Start the form.

  • Start the chain of custody at collection and record the collector.

Key point: Started.

Step 2. Sign each transfer.

  • Sign and date each transfer of the specimen (LBT-FRM-004).

Key point: Signed.

Step 3. Dispose.

  • Dispose of the specimen only as the form records.

Key point: Disposed.

10. Decision points

11. Special situations

Situation Action
Out of hours Follow the same steps. Use the on-call contact on the wall of the area.

12. Escalation

13. Monitoring

Measure Target Frequency Owner If not met
Forensic specimens with a complete custody form 100% Quarterly Senior scientist Escalate to the laboratory director

14. Records

Record Kept in Retention
Record named in this document Patient record or the area file the period set by the facility’s records policy years

15. Training

16. Related documents

ID Title Use
LBT-FRM-004 Chain of custody form Form

17. Evidence

Reference Note
E-009 Based on ISO 15189:2022 Medical laboratories: requirements for quality and competence, ISO 9001:2015 for supplier control, and the Global Patient Safety Action Plan 2021–2030 for critical results.
E-006 ASF Policy Framework v1.2. Adapted.
E-009 ASF Expert Committee consensus.

18. Change history

Version Date What changed Approval
1.0 the date of approval First version set Expert Committee approval

E-learning for this document

References

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