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
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.
| 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 | |
| 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 | |
| Haemovigilance | |
| 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
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| 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 | |