This is a ready-to-use donor eligibility determination form for allogeneic cell and gene therapy starting material, aligned to the US framework (21 CFR 1271 Subpart C). If you operate under the EU Tissues and Cells Directive 2004/23/EC or another jurisdiction, adapt the testing panel and questionnaire references to your governing framework. Replace every <<FILL: ...>> placeholder. A worked filled specimen follows. This is general guidance to adapt, not legal or regulatory advice.
Donor and material identification
| Field | Entry |
|---|---|
| Donor identifier (pseudonymized) | <<FILL>> |
| Material / cell type collected | <<FILL>> |
| Collection date | <<FILL>> |
| Collection site | <<FILL>> |
Screening
| Item | Result |
|---|---|
| Donor screening questionnaire / medical history review completed | Yes / No |
| Physical assessment (where applicable) completed | Yes / No |
| Relevant risk factors identified per questionnaire | <<FILL: none, or list>> |
Required communicable disease testing (21 CFR 1271.85 base panel, all donors)
| Agent | Result | Non-reactive / negative? |
|---|---|---|
| HIV-1 | <<FILL>> | <<FILL>> |
| HIV-2 | <<FILL>> | <<FILL>> |
| Hepatitis B virus | <<FILL>> | <<FILL>> |
| Hepatitis C virus | <<FILL>> | <<FILL>> |
| Treponema pallidum (syphilis) | <<FILL>> | <<FILL>> |
Additional panel for viable, leukocyte-rich cells or tissue
| Agent | Result | Non-reactive / negative? |
|---|---|---|
| Human T-lymphotropic virus type I | <<FILL>> | <<FILL>> |
| Human T-lymphotropic virus type II | <<FILL>> | <<FILL>> |
| Cytomegalovirus (CMV) | <<FILL>> | <<FILL: if reactive, apply the CMV-reactive donor release procedure, SOP-ID>> |
Eligibility determination
| Question | Answer |
|---|---|
| All required testing complete? | Yes / No |
| Any reactive/positive result (other than CMV under the site’s CMV-reactive-donor procedure)? | Yes / No |
| If Yes, is the donor ineligible per this result? | <<FILL>> |
| Screening history consistent with eligibility? | Yes / No |
| Overall determination | Eligible / Ineligible / Eligible under urgent-medical-need exception (state basis) |
Labeling
- Product labeled per the eligibility determination, including biohazard labeling if any required marker is reactive and the material is used under an applicable exception.
- Ineligible-donor material is not released for allogeneic use except under a documented, regulation-permitted exception with the basis recorded here:
<<FILL>>.
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Screening/testing reviewed by | <<FILL>> | ||
| Eligibility determination made by (Responsible Person / Medical Director) | <<FILL>> | ||
| QA approval | <<FILL>> |
Filled specimen (excerpt)
| Agent | Result | Non-reactive? |
|---|---|---|
| HIV-1 | Non-reactive | Yes |
| HIV-2 | Non-reactive | Yes |
| Hepatitis B virus | Non-reactive | Yes |
| Hepatitis C virus | Non-reactive | Yes |
| Treponema pallidum | Non-reactive | Yes |
| HTLV-I | Non-reactive | Yes |
| HTLV-II | Non-reactive | Yes |
| CMV | Reactive | CMV-reactive-donor release procedure SOP-QA-041 applied |
Determination: Eligible. CMV-reactive result does not disqualify the donor; disposition follows the site’s CMV-reactive-donor release procedure, which was applied and documented.
Common inspection findings this form prevents
- A donor determination made before all required testing is complete.
- CMV reactivity treated as an automatic disqualification with no reference to the site’s CMV-reactive-donor procedure, or treated as irrelevant with no procedure at all.
- Ineligible-donor material used with no documented exception basis.
- No named Responsible Person or Medical Director signature on the eligibility determination itself.
How to adapt this form
- Confirm your governing framework (21 CFR 1271 Subpart C for the US, or your local equivalent) and adjust the testing panel to match exactly.
- Build or reference your CMV-reactive-donor release procedure before using this form; do not leave that disposition undefined.
- If you operate under an exception pathway (e.g., urgent medical need), state the regulatory basis explicitly each time it is invoked.