1 Scope
Transfusion of blood [3.7] and blood components [3.9] (blood products) to subjects of care [3.48] is a medical activity that is subject to many legal regulations and constraints. Many problems may be encountered during treatment due to immunological conditions, transmitted diseases, sustainability and other difficulties. Mistakes and failures may have serious or even fatal consequences. Minimising human activity through the increased use of data processing and automated messaging will introduce an additional safety mechanism.
This ENV specifies general messages [3.41] for electronic information interchange between computer systems used by healthcare [3.29] parties [3.33] in the blood transfusion [3.16] domain. The content and structure of the messages specified in this ENV have been developed with the aim of optimising the safety of blood transfusion activity and to facilitate compliance monitoring and secure audit trails [3.2].
This ENV is applicable to blood transfusion related messages including those for:
the collection of blood/blood components [3.22] from blood donor
manufacturing [3.40] and processing [3.44] of blood components
classification [3.19] of blood donations
issue of blood components to the blood components dispenser
Within the blood transfusion process there are a number of actors:
The blood components dispenser [3.10] obtains blood components and blood products from one or more providers, then stores and dispenses them to the user, in some countries this function is known as the Hospital Blood Bank. This actor may appear as a separate entity, or as subdivision, within either the class producer or user. In certain circumstances communication may be required with a different blood components dispenser or with all dispensers within another region or a country.
The blood components manufacturer [3.11] prepares blood components for transfusion from donor blood and issues blood components to the blood components dispenser [3.10] a blood components processor or to another blood components manufacturer. In many countries the production process utilises a special blood transfusion data system providing internal communications between the subdivisions (blood collection, collected blood classification [3.17],manufacturing of blood components [3.40],processing of blood components [3.52]), and issues blood components to a blood components dispenser.
The blood components processor [3.12] receives blood components from a blood components manufacturer [3.11] for processing into blood products.
The Laboratory service provider [3.39] provides a laboratory service (serological, biochemical, bacteriological and virological analyses), to classify a sample of donor blood received from the blood/blood components collector. The laboratory can be an integral part of the healthcare organisation.
The blood /blood components collector [3.8] provides the service of collecting blood from a blood donor, to be delivered to the manufacturer, and to forward a sample of the blood to the Laboratory service provider [3.46] for the classification of blood donation [3.17].
The messages identified within scope are :
The messages used in :
collection,
classification
production activities
They communicate messages between separately organised units within blood collection and production.
Communication between the following parties should be exchanged according to ENV 1613 :
the blood/blood components collector and the laboratory service provider
the laboratory service provider and the blood/blood components manufacturer
Production related messages:
The use of the messages are dependent on the administrative procedures of the transfusion service provider and are concerned with:
Blood/blood component collection request
Blood/blood component classification request
Blood/blood component classification report
Blood/blood component collected delivery note
Blood component request
Blood component manufactured delivery note
Blood component processing request
Blood component processed delivery note
Messages for the transmission of Requests for blood components, covered by the scope of this ENV, shall enable electronic interchange of the semantic content defined in the General Message Descriptions (GMDs) for Request for blood components in clause 6.
Messages for transmission of blood collection requests, covered by the scope of this ENV, shall enable electronic interchange of the semantic content defined in the GMDs for blood collection requests in clause 6.
Messages for transmission of blood component classification requests/reports, covered by the scope of this ENV, shall enable electronic interchange of the semantic content defined in the GMDs for blood component classification request/reports in clause 6.
Messages for transmission of blood component processing requests, covered by the scope of this ENV, shall enable electronic interchange of the semantic content defined in the GMDs for blood component processing requests in clause 6.
Messages for transmission of blood component manufacturing delivery note and blood component processing delivery note, covered by the scope of this ENV, shall enable electronic interchange of the semantic content defined in the GMDs for blood component manufactured delivery notes in clause 6.
Messages for transmission of blood component processed delivery notes, covered by the scope of this ENV, shall enable electronic interchange of the semantic content defined in the GMDs for blood component processed delivery notes in clause 6.
Messages for transmission of applicative acknowledgement of the above messages covered by the scope of this ENV are defined at an application level (ISO 9735‑6:1999). They do not interfere with similar messages at lower levels. These messages are reports that the target applicant has received the message, and whether or not the message can be processed normally.
Implementable message specifications (IMS) [3.37] shall conform to the GMDs defined in this ENV. They shall support both mandatory and optional objects, attribute [3.1] groups and attributes as defined in the GMDs of this ENV. They shall also support the relationships between objects as defined by the GMDs.
Implementable message specifications should be expressed in terms of a syntax that is an International Standard [3.55] except where the healthcare user requirements cannot be met by using such a standard syntax.
When implementing information exchange based upon this ENV, all generated messages must be acknowledged by the receiver.
When implementing information exchange based upon this ENV, data protection and confidentiality principles have to be guaranteed according to the laws actually in force in the different CEN member countries. The mechanisms needed to secure data integrity [3.24], data protection and confidentiality, authentication [3.3] of communicating parties and subjects of care are outside the scope of this ENV.
While the messages specified in this ENV may convey clinical and administrative information concerning subjects of care, the way in which this information is treated in this ENV does not constrain the development of future standards for the electronic healthcare record [3.27] or for other clinical and administrative messages.
The provisions of this ENV have been validated for the purposes described above. However, since the messages described in this ENV are designed for general application in the blood transfusion domain, the users are required to decide for themselves whether or not these messages meet their particular requirements. A requirement for using other messages, e.g. generic messages for cancellation or acknowledgement, in addition to or instead of messages specified in this ENV, does not invalidate the use of this ENV.