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Research draft

blood donation

vr.tr.blood-donation · ACT.ACT

Enable an agent to recognise a blood donation episode, assess its documented state, and identify permitted next steps under the responsible blood service's rules.

Thing Registry Activities and processes

Research draft, second pass

A second pass drafted this model: the structure a model of this thing needs, and what is known about it in the world. The line under this one says how the second half was obtained - researched against sources, or recalled without web access, in which case nothing here was read anywhere and every claim is a lead to verify. Unreviewed either way.

recalled by Codex without web access - no source was read

Researched by: Codex

Purpose and description

Enable an agent to recognise a blood donation episode, assess its documented state, and identify permitted next steps under the responsible blood service's rules.

Blood donation is the collection of whole blood or selected blood components from a person for therapeutic use, principally transfusion into another person or subsequent manufacture of blood-derived medicinal products.

It can be Assemble an episode record and identify missing assessment or consent evidence.; Present the applicable eligibility and collection rules to authorised staff without independently granting clearance.; Track planned, completed, and interrupted collection with reasons and observations.; Flag recorded donor reactions for the responsible service's response and follow-up workflow.; Verify the documented linkage and handoff of containers and samples.; Route post-donation information to authorised personnel and record resulting actions..

Distinguishing features

The episode has a declared donation purpose; taking blood solely for a diagnostic test does not qualify.

It records collection or attempted collection from a donor, rather than administration of a blood product to a recipient.

Whole-blood collection and apheresis are distinguished by whether blood is collected as a whole or selected components are retained through a separation process.

Presentation, screening, or consent alone does not establish that a donation was completed.

A completed collection and material suitable for its intended use are separate states requiring separate evidence.

Scope

+ The donation episode, its intended use, participants, and responsible blood service

+ Donor information, consent, eligibility assessment, and deferral decisions

+ Whole-blood and apheresis collection pathways

+ Collection completion, interruption, and immediate donor recovery

+ Traceable handoff of collected material and donation-related follow-up

- Manufacturing, storage, inventory, and distribution of blood products beyond the donation handoff

- Recipient matching, transfusion decisions, and transfusion administration

- Diagnosis and long-term treatment of donor medical conditions

- Diagnostic blood sampling and therapeutic blood removal performed without a donation purpose

- Organ, tissue, and haematopoietic stem-cell donation

- Blood-service governance and population-level recruitment programmes beyond their relationship to an episode

Characteristics

Episode stage
presented | assessment underway | deferred | authorised for collection | collection underway | collection stopped | collection completed | recovery underway | episode closed Identifies what has happened and which transition requires evidence or an authorised decision.
Collection pathway
whole blood | apheresis, with intended component or components specified Determines which collection plan, observations, and completion criteria apply.
Intended use
allogeneic transfusion supply | autologous use | further manufacture | research | other declared use Makes the donation's purpose explicit without assuming every collection goes directly to another person's transfusion.
Responsible service and decision authority
links to collecting service, collection site, responsible personnel, and applicable rule version Locates accountability and prevents an agent from treating context-dependent eligibility rules as universal.
Eligibility decision
not assessed | pending | eligible for specified collection | temporarily deferred | indefinitely deferred under applicable policy Records the decision for this episode without treating eligibility as a permanent personal attribute.
Consent status
not obtained | documented for specified scope | withdrawn, with time and affected activities Separates willingness to donate from documented authority for collection and associated uses.
Donation history
links to relevant previous donations, collection types, dates, and recorded reactions Supports assessment against the responsible service's interval and donor-protection rules.
Collected quantity
mL of collected material, with material type and measurement basis; component yield where applicable Distinguishes the planned collection from the amount actually obtained.
Donor reaction status
none reported or observed | suspected reaction | assessed reaction | resolved | follow-up required Keeps donor outcome visible even when collection is technically complete.
Collection traceability
controlled links among donor record, episode identifier, collection containers, samples, and receiving service Supports identification, investigation, and downstream notification while controlling access to donor identity.

Also called

plasma donationautologous blood donationwhole blood donation

Where this came from

wikidata · CC0 1.0

Drafted structure

Bundle to layer to finding to question, as the second pass will find it: 6 bundles · 11 layers · 19 findings · 31 questions.

Donation purpose and pathway Establishes what episode is being modelled and which donation pathway it follows.

Blood donation must be distinguished from other blood-taking activities, and its intended use must not be inferred from collection alone.

Episode boundary

Identifies the donation attempt and separates it from neighbouring clinical activities.

Declared donation purpose

Record why blood is being offered and whether collection was attempted, completed, or never started.

  1. What declared purpose makes this episode a blood donation rather than diagnostic sampling or therapeutic blood removal? boundary
  2. Which events mark the start and closure of this donation episode, including an unsuccessful attempt? definition

Collection and use pathway

Connects the intended collection method with the declared destination of the material.

Specified donation pathway

Record whole-blood or component collection, intended use, and the responsible service's pathway designation.

  1. Is the planned donation whole blood or apheresis, and which components are intended to be retained? definition
  2. Who specified the intended use, and where is that designation documented? provenance
Donor assessment and consent Captures the evidence and authority needed before collection can proceed.

A donor's willingness, eligibility, and consent are distinct and may change during an episode.

Eligibility and deferral

Records an episode-specific assessment under identifiable rules.

Evidenced eligibility decision

Link the decision to assessment evidence, relevant donation history, assessor, and applicable policy without embedding universal thresholds.

  1. Which donor history, observations, and screening results support the decision for this collection type? provenance
  2. Which service policy and version govern this decision, and who is authorised to make it? provenance
  3. If collection is deferred, what reason, review condition, or reassessment date is recorded? action

Informed and voluntary participation

Records the donor's informed agreement and its limits.

Consent scope and withdrawal

Distinguish consent for collection from permissions for associated testing, information handling, and additional uses.

  1. What information and consent record cover the planned collection and associated activities? provenance
  2. How can the donor communicate withdrawal, and what actions remain possible at the episode's current stage? action
Blood collection execution Tracks the collection plan, actual procedure, and deviations.

An eligible donor may undergo an incomplete or altered collection, and component collection needs pathway-specific observations.

Collection readiness

Records the planned procedure and checks required by the collecting service.

Authorised collection plan

Identify the planned material, quantity, collection system, and documented readiness to begin.

  1. What collection quantity or component yield is planned, and who authorised that plan? measurement
  2. Which required checks link the assessed donor to the collection containers, samples, and selected collection system? action

Collection progress and outcome

Records what was collected and whether the procedure followed its plan.

Actual collection and deviations

Capture actual quantity, completion status, interruptions, and method-specific events, including return-cycle issues where applicable.

  1. What quantity and material were actually collected, using which measurement basis? measurement
  2. Was collection completed, altered, or stopped, and what reason and responsible decision were recorded? provenance
  3. For apheresis, what deviations in separation or return cycles require assessment or follow-up? action
Donor recovery and follow-up Maintains the donor's outcome through immediate recovery and later donation-related reports.

The donor's recovery cannot be inferred from the amount collected or the usability of the donated material.

Immediate recovery

Captures observations, reactions, responses, and departure assessment.

Reaction and recovery record

Separate reported symptoms and observed signs from assessed reactions and document the service's response.

  1. What symptoms or signs were reported or observed, and when did they occur relative to collection? measurement
  2. What response, recovery assessment, and departure instructions were documented by responsible staff? action

Later donor contact

Connects delayed reports and future-donation advice to the episode.

Donation-related follow-up

Record later donor concerns, unresolved reactions, and any authorised reassessment before another donation.

  1. What delayed reaction or concern has the donor reported, and who is responsible for reviewing it? provenance
  2. What follow-up or reassessment must occur before the service considers another donation? action
Traceability and material handoff Links the donation to collected material and downstream safety communications.

The episode must remain traceable without equating successful collection with approval for use.

Identity and custody linkage

Connects donor, episode, containers, samples, and the receiving workflow.

Verified donation linkage

Record identifiers and handoff evidence sufficient to trace the collection while restricting donor-identifying information.

  1. Which identifiers link this episode to every associated container and testing sample? provenance
  2. Who accepted the material at handoff, and what unresolved identification or custody discrepancy requires action? action

Downstream status and notification

References material disposition and routes information that may affect its use.

Collection status versus use status

Keep collection outcome separate from downstream testing and disposition decisions, with links to the records that own those decisions.

  1. Which downstream record owns testing, release, restriction, or discard decisions for this donation's material? boundary
  2. If new donor information or a testing concern arises, which authorised workflow must receive it and how is receipt recorded? action
Evidence and external alignment What the world already says about this thing, gathered so the model can be checked against it.

A model that cannot be lined up against existing standards, identifiers and practice cannot be adopted by anyone who already uses them.

Reported evidence

Findings from the breadth pass, kept separate from the structural claims.

Check these first

Recalled without web access and unsourced; every item is a lead to verify.

  • This describes the collection activity; it does not provide individual donor eligibility advice.
  • The listed kinds use overlapping classifications: component collected and intended recipient.
  • Recalled standards and approximate measurements require verification against current local requirements; no sources were consulted.
  1. Which of these check these first hold for the sense of blood donation this model covers, and on what evidence? provenance

Kinds and varieties

Recalled without web access and unsourced; every item is a lead to verify.

  • Whole-blood donation
  • Platelet donation by apheresis
  • Plasma donation by apheresis
  • Red-cell donation by apheresis
  • Autologous donation for the donor's own later use
  • Directed donation intended for a specified recipient
  1. Which of these kinds and varieties hold for the sense of blood donation this model covers, and on what evidence? provenance

Identifiers and schemes

Recalled without web access and unsourced; every item is a lead to verify.

  • ISBT 128 Donation Identification Number - 13-character identifier incorporating a facility identification number, year and sequence number - Administered by ICCBBA; identifies a donation rather than a donor, and works with product identifiers to support traceability.
  1. Which of these identifiers and schemes hold for the sense of blood donation this model covers, and on what evidence? provenance

Standards and regulation

Recalled without web access and unsourced; every item is a lead to verify.

  • WHO guidance on blood donor selection and screening donated blood for transfusion-transmissible infections
  • AABB Standards for Blood Banks and Transfusion Services
  • Council of Europe/EDQM Guide to the preparation, use and quality assurance of blood components
  • US FDA requirements under 21 CFR Parts 630 and 640 governing donor eligibility and blood and blood components
  • ICCBBA ISBT 128 standard for identification, coding and labelling of medical products of human origin
  1. Which of these standards and regulation hold for the sense of blood donation this model covers, and on what evidence? provenance

Real-world use

Recalled without web access and unsourced; every item is a lead to verify.

  • Providing red cells for patients with major bleeding or clinically significant anaemia
  • Providing platelets for selected patients with low platelet counts or impaired platelet function
  • Providing plasma for selected coagulation-factor deficiencies
  • Supplying plasma for manufacture of immunoglobulins, albumin and coagulation-factor products
  • Maintaining blood-component inventories for routine care and emergencies
  1. Which of these real-world use hold for the sense of blood donation this model covers, and on what evidence? provenance

Typical measurements

Recalled without web access and unsourced; every item is a lead to verify.

  • Whole-blood collection volume, excluding anticoagulant - Approximately 450-500 in many adult collection programmes; smaller collections are used in some settings - mL
  • Iron removed in a whole-blood donation - Approximately 200-250 for a standard adult collection - mg
  1. Which of these typical measurements hold for the sense of blood donation this model covers, and on what evidence? provenance

Failure modes and hazards

Recalled without web access and unsourced; every item is a lead to verify.

  • Vasovagal reactions, including fainting and associated injury
  • Bruising, haematoma or, less commonly, nerve injury at the needle site
  • Iron depletion and possible iron-deficiency anaemia with repeated red-cell loss
  • Citrate-related symptoms during apheresis because citrate temporarily lowers ionised calcium
  • Residual risks to recipients from infectious donations, bacterial contamination or identification and handling errors despite screening and quality controls
  1. Which of these failure modes and hazards hold for the sense of blood donation this model covers, and on what evidence? provenance

Regional variation

Recalled without web access and unsourced; every item is a lead to verify.

  • Eligibility criteria, collection volumes and minimum donation intervals vary by jurisdiction and donation type.
  • Systems differ in their reliance on voluntary unpaid, family/replacement or compensated donation, particularly for plasma collected for manufacture.
  • Required infection testing and donor deferrals vary with local epidemiology and regulatory requirements.
  1. Which of these regional variation hold for the sense of blood donation this model covers, and on what evidence? provenance

Neighbouring kinds and how to tell them apart

Recalled without web access and unsourced; every item is a lead to verify.

  • Blood transfusion - Donation collects blood from a donor; transfusion administers blood components to a recipient.
  • Diagnostic blood sampling - Diagnostic sampling collects blood for testing rather than to supply therapeutic blood products.
  • Therapeutic phlebotomy - Its primary purpose is to treat the person whose blood is removed; whether that blood can enter a donation supply depends on applicable rules.
  • Apheresis - Apheresis is a separation procedure that can collect donated components or treat a patient; it is not necessarily donation.
  1. Which of these neighbouring kinds and how to tell them apart hold for the sense of blood donation this model covers, and on what evidence? provenance

What the second pass must settle

  • Does the registry intend blood donation to include autologous collection, research-only donation, and plasma collection for further manufacture within one model?
  • Which authoritative blood-service sources and jurisdictions should establish the initial eligibility, deferral, consent, and collection rules?
  • Which terminology should distinguish an attempted donation, a completed collection, and a donation counted in service statistics?
  • Which donor-reaction classification and follow-up framework should the model reference across whole-blood and apheresis pathways?
  • Where should responsibility divide between this episode model and neighbouring models for test-result notification, material disposition, and repeat-donor monitoring?