This is a ready-to-use log for verifying and recording a single patient’s chain of identity at every handoff of an autologous cell therapy process: collection, receipt into manufacturing, in-process handoffs between operators or systems, final product labeling, and release for infusion. It exists because an autologous batch has no next lot to fall back on; a chain-of-identity gap is not a paperwork finding to close later, it is a patient safety control that has to be verified in real time, at the moment of each handoff, not reconstructed afterward from a batch record. Replace every <<FILL: ...>> placeholder with your own specifics and route the completed log per your document retention procedure. A worked filled sample row follows.
Purpose
This log records, for every real patient’s <<FILL: product / process name>>, a positive identity verification at each defined handoff point, so that a mismatch is caught and stopped at the handoff where it occurred rather than discovered during a later record review or, worse, after infusion.
Scope
Applies to every patient lot of <<FILL: product(s)>> manufactured at <<FILL: site(s)>>, from collection through release for infusion. Out of scope: donor eligibility determination for allogeneic starting material, covered under its own procedure.
Field table
| Field | Format | Required | Who records it | When |
|---|---|---|---|---|
| Unique patient identifier (per site coding / privacy procedure) | <<FILL: format>> | Yes | Collection site staff | At collection |
| Starting material / apheresis unique identifier | <<FILL: format>> | Yes | Collection site staff | At collection |
| Two-identifier verification method used at collection (e.g. patient ID plus date of birth, cross-checked against the collection order) | Text | Yes | Collection site staff, with a second, independent verifier | At collection |
| Courier dispatch identifier check: identifiers verified against the collection record before the shipper leaves the collection site | Yes/No, verification method (barcode scan preferred over a visual label read alone) | Yes | Collection site staff | At courier dispatch |
| Manufacturing receipt: identifier match confirmed against collection record | Yes/No, verified by two individuals | Yes | Receiving manufacturing staff | At receipt into manufacturing |
| In-process handoff identifier checks (one row per handoff: vessel-to-vessel, system-to-system, shift-to-shift) | Text, handoff description plus Yes/No match confirmation | Yes, one entry per handoff | Manufacturing staff at each handoff, with a second verifier | At each in-process handoff |
| Final product label identifier match confirmed against starting material identifier | Yes/No, verified by two individuals | Yes | Manufacturing / packaging staff | At final labeling |
| Quality Assurance identity reconciliation across the full record, collection to final label | Yes/No, reference to reconciliation record | Yes | Quality Assurance | Before release for infusion |
| Discrepancy identified (if any) | Text, cross-referenced to deviation number | As occurs | Whoever identifies it | At the point identified |
| Release disposition | <<FILL: released for infusion / held / rejected>> | Yes | Quality Assurance | Before infusion |
| Receiving clinical site final bedside identity check confirmed | Yes/No | Yes | Clinical site staff | At infusion |
Instructions
Every handoff listed above requires a positive, two-person identifier match at the moment it occurs; a check performed retrospectively from the batch record after the fact does not satisfy this log’s purpose, because its entire function is catching a mismatch before the next step happens, not documenting one after the process has moved on. Do not proceed past a handoff with an unresolved identifier mismatch; stop and initiate a deviation immediately. The courier dispatch check should use a method that does not rely on a single visual read of a printed label, a barcode scan against the collection record is preferable, because two patients collected on the same day with visually similar labels can otherwise be swapped in a way a label-only glance will not catch. Quality Assurance’s end-to-end reconciliation in the second-to-last row is not a repeat of the individual handoff checks, it is an independent, full-record review confirming every recorded check is present, complete, and consistent before the release decision is made. For the cold chain shipping controls that run alongside this identity check on the same shipment, chain of custody, dispatch conditions, temperature qualification, see cold chain qualification for cryoshippers and dry-vapor shippers and the paired cryoshipper dispatch and chain-of-custody log; the two logs run together at dispatch, one for custody and one for identity, and neither substitutes for the other.
Retention
Retain this log per <<FILL: site document retention procedure and retention period, tied to the product's patient medical record retention requirement>>, retrievable alongside the batch record and the release decision for the specific patient lot it documents.
Filled sample row
| Field | Entry |
|---|---|
| Patient identifier | Per site coding procedure, cross-referenced to clinical record |
| Starting material identifier | APH-2026-0341 |
| Collection verification | Two-identifier check (patient ID plus date of birth) against the collection order, confirmed by collection nurse and an independent second verifier |
| Courier dispatch check | Yes, barcode scan of the shipper label against the collection record, confirmed before the courier left the collection site |
| Manufacturing receipt match | Yes, confirmed by receiving technician and a second technician against APH-2026-0341 |
| In-process handoffs | Handoff 1, isolation vessel to formulation vessel: Yes, confirmed by two operators. Handoff 2, formulation to fill: Yes, confirmed by two operators |
| Final label match | Yes, confirmed by packaging technician and a second verifier against APH-2026-0341 |
| QA reconciliation | Yes, reconciliation record REC-2026-0341, reviewed by Quality Assurance, full record consistent from collection through final label |
| Discrepancy | None identified |
| Release disposition | Released for infusion |
| Bedside identity check | Yes, confirmed by clinical site staff at infusion |
Common findings this log prevents
- An identity check described in the batch record narrative with no independent second verifier named, so the check cannot be confirmed as a true two-person verification.
- An in-process handoff with no identity check recorded at all, discovered only when Quality Assurance’s end-to-end reconciliation is performed, by which point the product has already moved past that step.
- A discrepancy identified but not cross-referenced to a deviation number, so its resolution cannot be traced.
- Release for infusion documented with no explicit Quality Assurance reconciliation step distinct from the individual handoff checks.
- A courier dispatch check performed by a single visual read of a printed label, with no barcode or independent cross-check, on a day with more than one similarly labeled patient collection in process.
How to adapt this log
- Map every real handoff your process actually has, vessel changes, system changes, shift changes, site-to-site transfers, and add one row per handoff; a handoff omitted from this log is a handoff this control cannot protect.
- Define the two-identifier method explicitly for your process (patient ID plus date of birth, or your own site standard) and use it consistently at every check, not a different method at each step.
- Tie the retention period to your product’s actual patient medical record retention requirement, not a generic default.
- Route any discrepancy immediately into your deviation process; do not let this log’s own “Discrepancy” field become the only record of an identity mismatch.