AMedP-1.1 minimum requirements for blood, blood donors and associated equipment

What it is

What AMedP-1.1 covers

AMedP-1.1 is the NATO Allied Medical Publication that sets minimum requirements for blood, blood donors and associated equipment, so that blood and blood components collected, tested, processed, labelled, transported and stored to its terms can be exchanged between NATO Forces. Its own aim is "a regulatory framework to enable the provision of blood and blood components as near to the point of need as practicable," letting blood move between nations by fixing minimum requirements the whole alliance can rely on. The scope covers whole blood, red blood cells, plasma, cryoprecipitate and platelets, stored fresh, refrigerated, frozen or dried.

How it comes to bind

Participating Nations agree, in the document's own words, "that blood and blood components used for transfusion by or in support of NATO will be collected, tested, processed, labelled, transported, stored, and tracked in compliance with the requirements described in this agreement." That agreement is recorded in STANAG 2939: AMedP-1.1 is the technical content, STANAG 2939 is what commits a nation to it, and a nation can ratify with reservations, as several have here against specific clauses reflecting their own national legislation on blood donation, collection and cross-border transport. For an organisation, the practical route in is rarely the STANAG directly: it is a national licence to operate as a registered blood establishment, or a contract or tender that names AMedP-1.1's companion standards-related document, SRD-1, for transfusion equipment.

The three blood categories, at subject level

AMedP-1.1 sorts blood and blood components into three categories by where they come from, and each carries its own risk profile that a medical planner has to weigh alongside infection risk, clinical effectiveness, logistic constraints and the estimated operational requirement.

• Category 1 is blood manufactured by a NATO or PIAG nation's licensed or registered blood

establishment, to standards that "meet or exceed those laid down by competent authorities of the respective NATO and PIAG Nations."

• Category 2 is blood collected on operations, outside a licensed establishment, either as an

emergency blood collection for immediate transfusion to a known casualty or as a contingency collection for storage and later issue. The document requires that individuals responsible for authorising, managing, collecting or transfusing this blood "must be assessed by their Nation as competent," and that procedures exist to address documentation, traceability and haemovigilance.

• Category 3 is blood not collected or processed by a NATO or PIAG nation at all. NATO states

plainly that it "cannot assure the quality of blood and blood components in this category," and requires a risk assessment wherever it is used.

This page does not set out the donor-screening, testing or storage detail underneath Categories 2 and 3: that is exactly the kind of clinical and procedural material the document itself reserves to national protocols and a nation's appropriately qualified personnel, not something a reader should take from a summary.

Equipment, administrative typing, and chain of responsibility

Two further provisions matter to a supplier or a nation planning around this document. First, on equipment: "blood transfusion equipment and consumables used on operations must be in accordance with applicable form, fit and function and the specifications in standards-related document (SRD)-1 to AMedP-1.1" - the testable detail lives in SRD-1, not in AMedP-1.1's own text. Second, on responsibility once blood changes hands between nations: the supplying nation carries "overall assurance of blood and blood components from donation to final disposition," the receiving nation has to show it can demonstrate compliance with the supplying nation's own traceability processes, and whichever nation holds custody is responsible for compliance during transport and storage. The document also covers administrative ABO blood group identification of personnel, on identity discs or cards, for planning and emergency use, but is explicit that this is an administrative aid and "should not be routinely accepted as a substitute for blood typing of the donor or recipient."

Where it points beyond itself

Annex A lists other blood-labelling systems and blood-safety frameworks the document sits alongside, without stating that meeting AMedP-1.1 satisfies any of them or the reverse: ISBT code 128 and the MONARCH and Eurocode IBLS labelling systems; the US Code of Federal Regulations Title 21; AABB's Standards for Blood Banks and Transfusion Services; the UK's Blood Standards and Quality Regulations; Health Canada's blood regulations guidance; two Council of Europe/EDQM documents (a Blood Supply Contingency and Emergency Plan, and a Guide to the Preparation, Use and Quality Assurance of Blood Components); EU Directive 2002/98/CE on the quality and safety of human blood and blood components; and the EU's regulation on substances of human origin. None of these is a NATO relation in our catalogue, so none is linked here.