Specimen Chain of Custody Audit

Inspection template for auditing forensic and routine specimen chain-of-custody practices, including labeling, transfer documentation, signatures, and storage controls.

Specimen Receipt and Identification

• Specimen label includes unique identifier, collection date/time, and specimen type
  Confirm the label is legible, affixed to the specimen container, and includes all required identifiers without overwriting or ambiguity.
• Specimen identity matches requisition, case file, or evidence record
  Verify the specimen identifier, patient/case number, and test request align exactly with the source documentation.
• Label is intact, readable, and not obscured by condensation, damage, or residue
  Check for smudging, peeling, partial detachment, or any condition that could compromise identification.
• Specimen container is sealed with tamper-evident closure when required
  Confirm the seal is present, intact, and consistent with site procedure for forensic or controlled specimens.

Collection and Transfer Documentation

• Collection time, transfer time, and receipt time are documented
  Verify the custody record contains chronological timestamps for each custody event and that times are plausible and consistent.
• Each custody transfer includes releasing and receiving person names or IDs
  Confirm every handoff is documented with both parties identified in the chain-of-custody record.
• Transfer reason and specimen condition at handoff are recorded
  Check that the record states why the specimen was transferred and whether the container/seal was intact at the time of transfer.
• Custody form contains no unexplained gaps or missing transfer entries
  Review the chain for continuity; any missing custody period, unsigned handoff, or undocumented possession is a non-conformance.

Signatures, Witnessing, and Authorization

• Required signatures or initials are present for collection and each transfer
  Verify the custody record is signed or initialed by the responsible individuals at each required step.
• Signatures are attributable to authorized personnel and match the documented role
  Check that signatories are authorized to handle specimens and that the role or title aligns with site procedure.
• Witness signature obtained when required by procedure or specimen type
  Confirm witness documentation is present for specimens or events that require dual verification.
• Corrections or amendments are dated, initialed, and do not obscure original entries
  Review any edits to custody records for proper correction method and preservation of the original record.

Storage Controls and Access Security

• Specimens are stored in a designated secure area with restricted access
  Verify the storage location is controlled, locked, or otherwise restricted to authorized personnel only.
• Storage temperature is within the required range for the specimen type
  Measure and record the current storage temperature and confirm it meets the applicable SOP or manufacturer requirement.
• Access log or electronic audit trail is maintained for specimen storage
  Confirm entries exist for authorized access events and that the log is retained according to policy.
• Specimens are segregated to prevent mix-ups, contamination, or unauthorized removal
  Check that specimens are organized by case, status, or storage requirement and physically separated as needed.

Retention, Disposition, and Non-Conformance Review

• Retention period aligns with policy, regulation, or case requirement
  Verify the specimen or record retention schedule is defined and being followed for the specimen type.
• Disposal or release of specimen is documented and authorized
  Confirm final disposition includes date, authorization, and method of release or destruction where applicable.
• Any chain-of-custody deficiency is recorded with corrective action and escalation
  Document missing signatures, broken seals, storage excursions, or other non-conformances and note the corrective action owner.