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