5. Documentation

This section provides guidance on documents that form an important part of the quality system. These should show how to carry out and record specific steps in the clinical transfusion process and should include guidelines on the indications for blood component transfusion. These are referred to in the manual as Standard Operating Procedures (SOPs) and Clinical Transfusion Guidelines (CTGs). Such documents are an important component of quality management. They provide guidance for the supporting processes and clinical practice of patient care and they are an essential part of the criteria against which practice can be assessed.

Because of the diversity in the ways that transfusion is organised in EU countries, this chapter is intended as a guide to what may be required but not to be prescriptive. Important areas of practice, notably the secure identification of patients, may need to be covered in several documents. It is therefore essential to ensure that information is kept consistent across documents. Documents must also be periodically reviewed and updated. This requires that there is some form of document control system. Hospital managements should ensure that as part of their quality system for transfusion, the documents listed in tables 5.1, 5.2 and 5.3 are in place and in use.

The blood establishment and hospital blood bank should have a written agreement for the provision of service, including ordering procedures, stock levels and delivery1 arrangements

Both the blood establishment and hospital blood bank should be involved in preparing and updating guidelines or procedures relating to logistics of blood components. This should include or refer to agreed procedures for the following. (tables 5.1, 5.2, 5.3)

Guidance on standard operating procedures can be found at www.eu-q-blood-sop.de

5.1 Clinical Transfusion Guidelines

Guidelines on the clinical indications for blood component transfusion should generally be available for clinical situations relevant to the hospital’s clinical activities, see the Transfusion section of this site.

Table 5.1 Hospital blood banks should have SOPs for:

Procedure or process Use this space to note reference to local procedure or relevant example
Stock inventory management
Receipt of blood samples
Pretransfusion testing
Issue of blood components
Emergency supply of blood components
Adverse reaction/event reporting
Traceability of blood components
Blood components: essential information for clinicians

Table 5.2 Agreement between blood establishment and hospital blood bank should include

Procedure or process Use this space to note reference to local procedure or relevant example
Ordering blood components from the Blood Establishment
Storage and transport of blood components
Checking the quality of blood components at receipt
Stock Management
Traceability of blood components

Table 5.3 Hospital blood banks and clinical units should have SOPs for these aspects of the clinical transfusion process:

Procedure or process Use this space to note reference to local procedure or relevant example
Assessing the need for blood component therapy
Patient information and documenting consent from the patient
Taking blood samples for pretransfusion testing
Making the request for blood components
Surgical Blood Ordering Schedule
Ordering, pretransfusion testing, issue and delivery of blood components
  • non urgent
  • urgent and emergency
Transportation of blood samples to the Hospital Blood Bank
Acceptance criteria for samples received in the laboratory
Thawing of FFP
Transportation of blood components
Pre-administration checks and bedside tests
Selection and use of infusion devices (e.g. rapid infusion, neonatal transfusion)
Setting up the transfusion, administering, transfusion rates
Warming infusion fluids including blood
Baseline observation and monitoring of the patient
Management of adverse reactions
Traceability of blood components