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Run: Specimen Chain of Custody Audit

Audit specimen chain-of-custody records for labeling, transfers, signatures, storage, and disposition. Use it to catch documentation gaps and custody breaks ...

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Specimen Receipt and Identification

Confirm the label is legible, affixed to the specimen container, and includes all required identifiers without overwriting or ambiguity.
Verify the specimen identifier, patient/case number, and test request align exactly with the source documentation.
Check for smudging, peeling, partial detachment, or any condition that could compromise identification.
Confirm the seal is present, intact, and consistent with site procedure for forensic or controlled specimens.

Collection and Transfer Documentation

Verify the custody record contains chronological timestamps for each custody event and that times are plausible and consistent.
Confirm every handoff is documented with both parties identified in the chain-of-custody record.
Check that the record states why the specimen was transferred and whether the container/seal was intact at the time of transfer.
Review the chain for continuity; any missing custody period, unsigned handoff, or undocumented possession is a non-conformance.

Signatures, Witnessing, and Authorization

Verify the custody record is signed or initialed by the responsible individuals at each required step.
Check that signatories are authorized to handle specimens and that the role or title aligns with site procedure.
Confirm witness documentation is present for specimens or events that require dual verification.
Review any edits to custody records for proper correction method and preservation of the original record.

Storage Controls and Access Security

Verify the storage location is controlled, locked, or otherwise restricted to authorized personnel only.
Measure and record the current storage temperature and confirm it meets the applicable SOP or manufacturer requirement.
Confirm entries exist for authorized access events and that the log is retained according to policy.
Check that specimens are organized by case, status, or storage requirement and physically separated as needed.

Retention, Disposition, and Non-Conformance Review

Verify the specimen or record retention schedule is defined and being followed for the specimen type.
Confirm final disposition includes date, authorization, and method of release or destruction where applicable.
Document missing signatures, broken seals, storage excursions, or other non-conformances and note the corrective action owner.

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