- Owner
- Laboratory Manager
- Effective date
- September 15, 2026
- Review cycle
- Every 12 months
1.Purpose
To maintain a documented, unbroken record of who has held a sample and when, so results can be defended in legal, regulatory or client disputes.
2.Scope
Applies to samples submitted with a chain-of-custody requirement, such as environmental, forensic or regulated testing. Routine samples without this requirement follow the sample receiving SOP only.
Definitions
- Chain of custody (COC) form
- The document that records every person who has held a sample and the date and time each transfer occurred.
- Custody seal
- A tamper-evident label placed across a container or cooler that must be intact when custody transfers.
- Custodian
- The person currently responsible for a sample's security and location.
3.Responsibilities
- Sample Custodian
- Takes custody of samples at receipt and each transfer, and maintains secure storage.
- Lab Analyst
- Signs the COC form when checking out a sample for testing and returns it to the custodian afterward.
- Laboratory Manager
- Audits the custody log and approves any exception, such as a broken seal.
- Client Services Coordinator
- Confirms COC requirements with the client and resolves discrepancies on the submitted form.
RACI matrix
| Activity | Sample Custodian | Lab Analyst | Laboratory Manager | Client Services Coordinator |
|---|---|---|---|---|
| Verify COC form and seals at receipt | R/A | I | I | C |
| Log custody transfer to analyst | R/A | R | - | - |
| Approve exception for broken seal | R | I | A | I |
| Resolve COC discrepancy with client | I | - | A | R |
| Audit custody log | C | - | R/A | - |
R = Responsible, A = Accountable, C = Consulted, I = Informed
4.Materials and PPE
Materials, tools and systems
- โChain-of-custody forms
- โTamper-evident custody seals
- โLocked sample storage cabinet or room
- โCustody transfer log
- โSign-in and sign-out sheet for the storage area
Personal protective equipment
- โDisposable nitrile gloves
5.Procedure
- 5.1
Receive the sample with its COC form
Sample CustodianAccept the sample and its accompanying chain-of-custody form together, and confirm the sample count matches the form.
- 5.2
Verify the custody seal is intact
Sample CustodianInspect the custody seal on the container or cooler for signs of tampering, cutting or re-adhering before accepting the sample.
Warning: Do not accept a sample with a broken or missing seal without the laboratory manager's written approval.
- 5.3
Record the initial custody transfer
Sample CustodianSign and date the COC form as the receiving custodian, recording the exact time of transfer from the submitter or courier.
- 5.4
Open a custody log entry
Sample CustodianCreate an entry in the custody transfer log with the sample ID, submitter, date received and initial storage location.
- 5.5
Store the sample securely
Sample CustodianPlace the sample in the locked storage cabinet or room designated for custody samples, accessible only to authorized staff.
Checkpoint: Custody samples are never left unattended outside locked storage.
- 5.6
Log each checkout to an analyst
Sample CustodianWhen an analyst needs the sample for testing, record the checkout time, analyst name and reason on both the COC form and the custody log.
- 5.7
Verify the seal at each transfer
Lab AnalystBefore taking custody, the analyst checks that the seal or evidence tape applied since the last transfer is intact and reports any concern immediately.
- 5.8
Reapply the seal after handling
Lab AnalystAfter removing an aliquot or completing testing steps, reseal the container with a new tamper-evident seal and initial and date it.
- 5.9
Record the return to storage
Lab AnalystSign the sample back in on the COC form and custody log with the return time when testing steps for the day are complete.
- 5.10
Resolve custody discrepancies
Client Services CoordinatorIf a COC form is incomplete, unsigned or does not match the physical samples, contact the client the same day to resolve the discrepancy in writing.
- 5.11
Close custody after final disposition
Sample CustodianRecord the final transfer, whether to disposal, return to the client, or long-term archive, with signature and date to close the custody chain.
- 5.12
Audit the custody log
Laboratory ManagerPeriodically review a sample of custody logs against physical inventory to confirm every transfer is documented with no gaps.
6.Quality checks
- โEvery custody transfer has a signature, printed name and timestamp.
- โNo gap exists between the time a sample leaves one custodian and is received by the next.
- โCustody seals are verified and documented at every transfer.
- โClosed custody records are retrievable for the full retention period.
7.Records
- โChain-of-custody forms
- โCustody transfer log
- โStorage area sign-in and sign-out sheet
- โDiscrepancy resolution correspondence
8.KPIs
- โPercentage of samples with a complete, unbroken custody record
- โNumber of custody discrepancies per month
- โAverage time to resolve a COC discrepancy
- โNumber of broken-seal exceptions per quarter
9.Common mistakes
- โLeaving a custody sample on the bench between transfers instead of in locked storage.
- โForgetting to record the exact transfer time, not just the date.
- โAccepting a sample with a broken seal without documenting an approved exception.
- โClosing out a COC form before the final disposition is confirmed.
10.Revision history
| Revision | Date | Description | Reviewed by |
|---|---|---|---|
| 1.0 | September 15, 2026 | Initial release | Ilia Pirozhenko |
This is a template. Adapt it to your organization, equipment and local regulations before use.