Resource library

Blood & Tissue Resources

Blood & tissue resources for accession identity, separate material and test status, custody, processing evidence and accountable human disposition.

Guides: 2 guides
Glossary: 5 glossary entries
Checklist: 9 buyer questions

Donor Evidence & Lookback Reading

Keep interview evidence, eligibility determinations and blood lookback clocks distinct.

GuideDonor Eligibility & Lookback ReadinessWorked blood and HCT/P record exercises, separate use pathways and retention clocks.Read the guide
GlossaryDonor EligibilityBlood and HCT/P determinations, screening versus testing, and pending versus ineligible status.Open
GlossaryLookbackBlood record review, consignee communication and recipient-notification clocks.Open
GlossaryDonor Risk Assessment InterviewThe HCT/P documented dialogue, information sources and its place in screening records.Open

Blood Component Control Chain

Blood-specific procedure, unit-record and reporting duties; tissue framework gaps remain separate.

Glossary21 CFR 606SOP-controlled handoffs, concurrent results and interpretations, retention and separate reporting decisions.Open

HCT/P Record Handoff & Scope

Tissue framework and record retrieval, kept separate from blood-component duties.

Tissue Reference & Scope

This US FDA tissue overview concerns HCT/Ps, not every blood component or clinical use. Your organisation determines the applicable rules and responsibilities.

ReferenceFDA — Tissue & Tissue ProductsOfficial overview of human tissue scope, establishment records and linked guidance.Read the reference

Software Pages

Compare the separate establishment workflows with your actual product, procedures and system boundaries. These pages offer software, not donor or clinical services.

Evaluate the software

Work through these questions with your production and quality teams, then use them to plan an evaluation with your own records.

Product and Establishment ScopeWhich tissue, blood component or processing activity are we evaluating, and which organisation owns regulatory and clinical responsibilities?

Accession Identity and ReconciliationCan we reconcile the received identifier, source records and any derived units without losing the link to the original accession?

Material Status versus Test StatusHow will quarantine, availability and discard status remain separate from pending, entered and reviewed test results?

Custody and Every MoveCan we reconstruct who moved a unit, when, from where and to where, including handovers between organisations?

Storage Evidence and ExcursionsWhich system owns storage-condition records, and who evaluates missing records or excursions under our procedures?

Processing Instructions and EvidenceCan the reviewer identify the procedure revision, performed processing steps, corrections and linked test evidence for a selected unit?

Donor and Clinical ResponsibilitiesWhere are the responsible organisation’s donor-eligibility and clinical-suitability decisions recorded, without asking the software to make them?

Authorised Disposition and DistributionWho reviews the required records, records the disposition and confirms the distribution handover and follow-up trace?

Equipment and System BoundariesWho supplies and approves our equipment qualification, mapping and intended-use testing evidence, and what records must the software reference rather than perform?

The existing establishment guide remains email-gated. Review its product and market scope with your responsible team; printing is available in the reader. Open the existing guide offer.

Explore the workflow

The illustrated five-step workflow follows accession identity, separate statuses, recorded custody moves, processing and test evidence, and authorised review before distribution.

Explore the blood & tissue workflow