Previous EU Initiatives

In 1999 the European Commission published the report “Blood safety in the European Community: an initiative for optimal use”, the outcome of a symposium held in Wildbad Kreuth, Germany. (Download from the bottom of this page.) The following paragraphs are from this report, referred to elsewhere in the text as the EU 1999 Optimal Use Initiative:

“…Considerable attention has been given to ensuring that the material collected and the processes adhered to in the preparation and distribution of (blood) products are as safe as possible. While attention has also been given to the therapeutic use … through guidelines, consensus conferences etc, there is increasing evidence that the results have been less than satisfactory and as a consequence over-use, under-use and inappropriate use of blood products persists. This can contribute to increased risks for patients and the waste of resources.”

“Transfusion of blood … involves numerous steps … which need to be strictly controlled to ensure the safety of patients and to prevent (avoidable) adverse events. These steps can be related to:

The patient, including assessment of physical condition and the need for blood under emergency or non emergency conditions; verification of identity; informed consent to the transfusion and taking a blood sample for pretransfusion testing.

The (blood) product, including reserving products in the transfusion service; identification of the assigned unit; delivery to the clinical ward and management of used and unused blood products.

The product and the patient, including identification before transfusion, administration to the patient, and documentation of outcomes.

“…Every effort should be made to establish a quality management system … in the clinical part of the blood transfusion chain.”

These points were reiterated at a second Wildbad Kreuth symposium in May 2009 on “The Optimal Clinical Use of Blood Components: Quality and Best Practices in Haemotherapy”, at which participants noted that despite many developments since 1999, concerns persist about the safety and effectiveness of blood component transfusions.

The European Commission SANGUIS study showed wide variations in surgical blood use in 43 European Hospitals during 1989-90. More recent audits have continued to show variations. Such variations in practice are an indicator of clinical uncertainty in prescribing. There were similar findings in a recent Austrian survey

Funding and participants

European Commission Funding for the project was obtained in spring 2007 with participants from eight countries. Participants from a further ten countries had joined the project by October 2008. In all 18 EU Member States have taken part: Austria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Malta, Netherlands, Poland, Portugal, Romania, Slovenia; and three UK countries: England, Northern Ireland and Scotland. This book and the website that supports it have been developed during a collaborative project that was initiated by the European Blood Alliance and co-funded by the European Commission and the Scottish National Blood Transfusion Service.

Project workshops

At the first project meeting in Edinburgh in May 2007 three working groups were established. The meeting, over three days, included both working group and plenary sessions. All participants, at their first project meeting, gave a short presentation on the key features of their own service and working environment. The decision to work in sequential plenary and small groups was chosen because of the degree of interaction between the topics covered by the working groups. It allowed for ideas to be developed in the small groups and then tested by discussion in the whole group. This arrangement proved successful and was continued for the subsequent workshops in Edinburgh (August 2007), Slovenia (Lake Bled) in March 2008, and Estonia (Tallinn) in October 2008. The final workshop was in Edinburgh in September 2009. Additional participants who had joined during the first year of the project were invited to form a fourth working group that has developed the Glossary for the project.

Evaluation

Participants received the first draft of the manual for the Tallinn workshop, where it was exhaustively discussed. The second draft was distributed in February 2009 with specific questions to participants. Detailed responses were received from a majority of participating countries and these were incorporated into the third draft.

Dissemination

Workshop reports, presentations, and questionnaire reports have been displayed on the project website. However it has been recognised that a website with greater functionality and capacity is essential for effective sharing and discussion of the results of the project. During the course of the project, the Project team and participants have given presentations at numerous meetings of scientific/medical societies and European bodies. An open meeting to launch the manual is planned to coincide with the 31st Meeting of the International Society of Blood Transfusion in Berlin, June 2010.

Although not funded in the EU Grant, external funds have been secured to develop the first phase of a new website that will ensure that the resources of the project are made widely available.

The project group worked in English. Participants recognised the challenges of achieving a shared understanding of precise meanings, especially in the case of words that may have several usages in everyday non technical language, rather than those that are specialist technical terms unique to transfusion.

The glossary is based as far as possible on definitions used in the EU Directives or taken from standard dictionaries. Where other definitions are used, the source is identified. Some key terms and definitions are also mentioned in the text.

For many important aspects of transfusion practice, there is not a firm basis of empirical evidence that identifies the most effective process or treatment. Ideally this would be derived from well conducted, randomised, controlled clinical trials. As a result, many accepted procedures and clinical transfusion guidelines are based on the best available information and evidence, such as observational studies, case reports or professional consensus. The Transfusion section of the site provides an illustration of evidence-based practice recommendations with extracts from the 2009 German haemotherapy guidelines. (Download at the bottom of the page).

In addition, the web version of the manual provides links to the underpinning evidence where there is high quality information as judged by established grading systems. An extensive database of clinical trials and systematic reviews of evidence relating to transfusion can be found at www.transfusionguidelines.org.uk.

Evidence about common procedures in the clinical transfusion process is extremely limited and is reviewed in: PMID 18399846, 19302450 and 18194372.

Quality systems have developed largely in relation to manufacturing processes. The same broad principles apply to the clinical setting. However some of the vocabulary, concepts and methods used by quality experts are unfamiliar to many clinicians and also they may not apply directly to the clinical context.

For this reason we have used simple and non-specialist terms where possible. Relevant extracts from the EU directives are shown throughout the text. One relevant definition of clinical quality assurance is:

“Improving performance and preventing problems, through planned and systematic activities including documentation, training and review.”

Essential elements include:

Leadership

• Management demonstrates commitment to quality
• Responsibility for quality is clearly assigned
• Resources are available
• There is an effective hospital transfusion committee or equivalent

Standards or specifications

• There are explicit statements of what a product should be or a process should achieve

Documentation

• There are written instructions for doing each job
• There are records to show whether the job has been done correctly

Change control

Changes in procedures are introduced in a controlled fashion and proper records are maintained

Evaluation or Audit

• Performance is independently assessed

Staff Training and Assessment

• Staff are taught what to do and why it is important
• Their knowledge and competence is assessed

Quality Improvement

There is a culture of learning from errors and acting on the lessons learned

Professional leadership

A key success factor can be leadership provided by a respected senior clinician who develops an active professional interest in improving transfusion treatment. ‘Clinical Champions’ for good transfusion may emerge from specialties such as anaesthetics/ intensive care, surgery or haematology, where transfusion is frequently utilised. One approach that has been successful is to engage such specialists in collaborative programmes of clinical audit or research on the use of transfusion in their own specialist field.

Effective Hospital Transfusion Committee

An effective and well-led Hospital Transfusion Committee (HTC) or a body with equivalent functions is widely held to be essential for improvement of clinical transfusion practice. The primary aim should be to promote a high standard of care for patients at risk of transfusion (i.e. those who must be transfused, and also those who, with good clinical management, may avoid the need for transfusion). The HTC should have a clear line of accountability to an appropriate post at a senior management level in the institution. The HTC should have the authority to determine hospital policy in relation to blood transfusion and must have an effective means of disseminating it to all relevant staff and to patients where appropriate. (www.transfusionguidelines.org.uk)

Terms of Reference for an HTC

Should include the following:

• Promote the dissemination and the use of national or local guidelines that apply to the clinical transfusion process
• Regularly review and update the hospital’s documentation for blood transfusion
• Carry out audits that evaluate the hospital’s clinical blood transfusion process against the relevant guidelines and benchmark the use of blood components against best practice
• Promote the education and training of clinical, laboratory and support staff involved in the clinical transfusion process
• Report serious adverse reactions and events to the national haemovigilance programme
• Ensure that incidents are analysed and the information is used to help improve practice and prevent a repetition

Membership of HTC

The HTC should include clinicians from specialties in the hospital that utilise transfusion, for example haematology, anaesthetics, intensive care, surgery, or obstetrics, as well as staff from nursing, blood bank and audit or research departments. The committee requires an effective chairperson who has the professional respect of senior medical personnel and can command the attention of hospital management.

Operation of HTC

The HTC should meet regularly, have a formal agenda and keep full records of its decisions. It must have the authority and support to ensure that its decisions are effectively communicated to and followed by staff who contribute to the clinical transfusion process.

Someone who is employed to make things happen

The transfusion committee may make excellent recommendations, but it needs an executive officer, a person who is employed specifically to ensure that the recommendations are converted into actions. Several countries have created a new position for this purpose. The manual uses the term Transfusion Practitioner (TP) (www.betterblood.org.uk) but posts with similar responsibilities have also been given titles such as Transfusion Safety Officer (TSO), Transfusion Nurse Coordinator (TNC) or Haemovigilance Officer (www.transfusionsafety.ca). The TP is concerned with the clinical transfusion process, ”taking quality assurance from the blood bank to the patient”. The transfusion practitioner’s job description would typically specify responsibilities such as these:

• Education and training of nursing and medical staff
• Patient information
• Promote compliance and safety in activities such as specimen collection, administration blood components and products
• Carry out transfusion practice audit
• Investigate and report adverse events and reactions
• Trouble shoot and take preventive and corrective action
• Support development and implementation of transfusion policies and guidelines

In many countries the TP have a background in nursing or the transfusion laboratory; other countries have employed doctors or pharmacists in similar roles. The goal should be for the TP to be part of a wider transfusion team that should develop with the encouragement and motivation of the transfusion committee. In several EU countries, the TP role is now viewed as an essential part of the hospital’s quality improvement programme in transfusion.

The Departments of Health in the UK have recommended that hospitals have a Hospital Transfusion Team (HTT) to manage the day-to-day business of blood transfusion within the hospital. Membership should include a medical transfusion specialist, the head of the blood bank and the transfusion practitioner.

www.transfusionguidelines.org.uk

Success in creating change and improvement depends on factors other than the scientific or technical. It is important to be aware of the many influences on the ability to make change happen. Awareness of pressures such as those illustrated in Figure 3.1 can improve the ability to influence decisions and actions. Research also shows the importance of a better understanding of psychological and behavioural factors that underlie the behaviours of health care professionals.

Figure 3.1 Environmental factors affecting quality

Evaluation of the clinical use of blood products is often done by monitoring or surveying clinical practice against objective indicators of performance. This is perhaps better described as benchmarking than audit. Useful indicators of practice (quality or performance indicators) must be easy to collect and quantifiable.

Quality indicators may be used to monitor and evaluate the quality of the therapeutic transfusion process or compliance with clinical guidelines. There are two types of indicators: internal and external.

Internal indicators are used for quality management and improvement of the clinical transfusion process within an institution. They must be relevant for the critical steps in the process and the professionals involved. They must be specific and detailed, easy to sample, educative and effective in stimulating actions for improvement.

External indicators provide information for external control agencies such as health care inspectorate and/or for comparison between hospitals (benchmarking). These have to provide monitoring or signaling information about the quality of the process, measure global aspects such as global outcome and require good validation. According to what they measure three types of indicators can be described:

Structure indicators: How well have I organised the process?
Process indicators: Am I doing well?
Outcome indicators: Do I reach the result required?

Indicators are only one tool for evaluating practice. In some cases audit may provide better information. However, if used in the right way indicators may be an efficient and tool for improving the quality of the therapeutic transfusion process.

The following list is a practical example from the Leiden University Hospital in the Netherlands, where indicators are sampled annually and reviewed by the Hospital Transfusion Committee. This identifies priorities and sets targets for evaluation.

Management of hospital stock

The number of expired products in the stock of the hospital blood bank divided by the total number of blood products in the stock of the hospital blood bank.

Prescription

The number of units of blood components (red cells, platelets and fresh frozen plasma) that are not prescribed according to the known guidelines, divided by the number of prescriptions for blood products (red cells, FFP, platelets) in the same period.

Ordering and wastage

The number of blood components (red cells, platelets and fresh frozen plasma) returned to the hospital blood bank by a department, divided by the total number of blood components supplied by the blood bank service to that department.

The number of blood components that are not transfused divided by the number obtained from the blood establishment.

Request forms

The number of blood product request forms lacking essential data divided by the total number of orders for blood components in the same period.

Patient and blood sample identification

The number of detected discrepancies in ABO and RhD typing of patients due to identification or labeling errors outside the transfusion laboratory divided by the total number of patient samples tested for ABO and RhD type screenings in the same period.

Compatibility testing

The number of detected discrepancies in ABO and RhD screening of patients due to errors in the transfusion laboratory divided by the total number of ABO and RhD type screenings performed in the same period.

Traceability

The number of units for which there is no record in the hospital blood bank or blood establishment of the final destination (transfused to an identified patient, destroyed or returned to the BE) divided by the number of units issued by the HBB or BE.

Figures 1.2 to 1.7 in the Synopsis section of the site illustrate the causes and consequences of errors that can occur throughout the clinical transfusion process and give an outline of practical actions that can help to minimise risk.

The Netherlands’ haemovigilance scheme has estimated that up to half of all serious transfusion reactions are preventable by methods that are currently available.

Table 4.4 hows a classification of adverse transfusion reactions. This distinguishes (a) reactions that are due to an intrinsic quality defect in the blood component supplied (e.g. undetected hepatitis B infectivity) from (b) reactions that may result from a failure to select the correct product (e.g. irradiated components for patient at risk of GvHD) and (c) reactions, such as anaphylaxis or TRALI that may impossible to predict.

Established national haemovigilance programmes have developed somewhat different definitions and reporting requirements such as the examples that follow.

The Netherlands’ Haemovigilance Organization (TRIP), uses the term:

• Serious Transfusion Reaction – any incident that results in death or is life threatening to a patient, or that requires hospitalisation or prolongs hospital stay or that results in persistent significant disability. www.shotuk.org

A number of schemes including the UK scheme, SHOT use the term:

• Near miss – an error that might have harmed a patient but did not

National haemovigilance schemes do not all collect the same level of information, for example,

• the Netherlands’ scheme requires hospitals to report all incidences of transfusion of an incorrect blood component, but regards reporting of near misses as optional
• UK and Ireland concentrate on ‘serious hazards’ of transfusion, which are defined in their reporting schemes but do not accept reports of transfusion reactions that, although more common are considered to be less serious such as febrile non haemolytic reactions
• in France haemovigilance data is collected on all reactions regardless of severity www.ints.fr

These differences make it important to exercise care when comparing results among the different schemes. This is illustrated by the data from four national Haemovigilance schemes shown in Table 4.3, which shows very different rates of events, due in part to the different reporting requirements.

Table 4.4 Preventable and non preventable adverse events

Type of adverse reaction	Related to the quality and safety of the supplied blood component?	Related to failure in clinical transfusion process?	Means of prevention
Transfusion - transmitted bacterial infection	Yes	Possible due to failure to inspect component before transfusion	Donor skin cleansing Diversion pouch on donation line Pathogen reduction Correct storage conditions
Transfusion-transmitted viral infection HBV HCV HIV-1/2 Other	Yes	No	Correct handling to avoid damage to containers Donor selection Donation testing Pathogen reduction
Transfusion-transmitted parasitic infection Malaria Other	Yes	No	Donor selection Donation testing Pathogen reduction
Haemolysis due to incorrect storage	No	Yes	Quality assured clinical transfusion process
Immunological haemolysis due to ABO incompatibility	No	Yes
Immunological haemolysis due to other alloantibody	No	Yes
Anaphylaxis or hypersensitivity Posttransfusion purpura Transfusion-related acute lung injury	No	No	May be unpredictable and unavoidable TRALI risk may be reduced with FFP from male donors
Graft versus host disease	No	Yes Due to failure to select component or failure to recognise patient at risk	Use of irradiated components for at-risk patients Use of amotosalen treated platelets
Transfusion associated circulatory overload	No	Yes Due to failure to recognise patient at risk	Avoid over-infusion.

Figure 4.1 Types of adverse events and reactions. Serious hazards of transfusion (SHOT) UK.

www.shot.org.uk

Cumulative numbers of cases reviewed 1996-2008 n=5374
*New categories for 2008

Table 4.3 Adverse events and reactions: reported rates in different countries

International Comparison
Country	Status	Captures	Reports/1000 units
France (2005)	Mandatory	all	2.8
UK (2005)	Voluntary	serious	0.20
Ireland (2005)	Voluntary	serious	1.22
Netherlands (2006)	Voluntary	all	2.9

Risk management involves recording information on when errors were made, whether they were detected and how they were detected, and the reason for the error. This is sometimes called “root cause analysis”. Figures 4.2 and 4.3 show how one scheme has used its data to map the site of the first error the step in the clinical transfusion process where it occurred. In this example, the large number of incidents reported and categorised as ‘pretransfusion testing’ is mainly due to errors in collecting the pretransfusion sample rather than to errors in the blood bank laboratory. Nearly all these reports are of near misses. The corrective measure adopted in this case was to require that the blood group is always determined on two independent samples before compatible blood is issued.

Figure 4.2 Where adverse events and reactions occur in the clinical transfusion process: Netherlands haemovigilance scheme (TRIP)

 

Figure 4.3 Site of first error leading to potential ABO incompatibility incident Netherlands haemovigilance scheme (TRIP)

 

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
Haemovigilance

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

Until the late 1970s, most blood was transfused without being further processed to separate plasma or platelets. This was termed ‘whole blood’. Current practice in many EU countries is to process most or all whole blood donations into components – red cells, platelets and plasma.

In a typical blood establishment process, 450-500 ml of the donor’s blood is drawn into a plastic pack containing 63 ml of an anticoagulant-preservative solution such as Citrate Phosphate Dextrose (CPD) or CPD–Adenine. The citrate binds calcium and acts as an anticoagulant, and the glucose and adenine support red cell metabolism during storage. The whole blood unit may be filtered to remove white cells, most of the plasma is removed, and an additive solution, formulated to support erythrocyte metabolism, is added to the remaining red cells.

Platelet concentrate may be prepared either from the white cell and platelet layer (the so-called buffy coat) or from platelet rich plasma. Red cells, platelets, plasma and white cells can also be collected by apheresis.

Directive 2002/98 EC lists names and specifications of red cell, platelet and plasma components. These are summarised in table 6.1 at the end of this chapter. This section of the manual provides information about some of these components that are in common use.

In the manual, the term ‘red cell unit’ is used to denote the red cells from one standard blood donation.

The blood component label should comply with the relevant national legislation and international agreements. Most EU countries use the international labelling system known as ISBT 128 www.iccbba.org (R5 downloadable from end of page).

The pack label contains essential information about the blood component, as illustrated in Figure 6.1 and 6.2. The ISBT system requires that the following information be shown in barcode and eye readable form, in the four quadrants of the label.

• Top left: the unique donation number, containing a 5 digit code for the blood establishment, two digits for the year of collection, and a six digit donation number. The blood establishment name and date of the collection must be in eye readable form, (and in figure 6.1 are also shown as a barcode)
• Top right: ABO and RhD blood group
• Lower left: The identification code for the type of blood component (eg red cells, leucocyte depleted in additive solution)
• Lower right: The expiry date of the component. Additional information (eg irradiated) may be added in this quadrant in eye readable and barcode form (see fig 6.2)

Detailed information about barcoding of blood components can be found at www.iccbba.org

Figure 6.1 International ISBT 128 blood component label as specified in the ICCBBA Standard. www.iccbba.org

Directive 2002/98/EC requires that the following information should be shown on the label:

• Official name of the component
• Volume or weight or number of cells in the component (as appropiate)
• Unique numeric or alphanumeric donatior identification
• Name of producing blood establishment
• ABO Group (not required for plasma intended only for fractionation)

Figure 6.2 Blood component labels from EU countries

Above: Denmark, Below: Portugal

Components issued for an individual patient should also have a label that identifies the patient for whom the blood component has been prepared. This is often referred to as the Compatibility Label. It must be firmly attached to the pack and may be an adhesive label or a tie-on tag. Figure 6.3 shows an example of such a label that has been designed to provide documentary evidence of traceability.

Figure 6.3

Example of a compatibility label. It must be firmly attached to the pack and may be an adhesive label or a tie-on tag. This example can be used to provide documentary evidence of traceability.

This section gives a general overview of the information that clinicians may need about blood components. Other examples are given at www.edqm.eu (Search for Blood Transfusion) Guide to preparation, use and quality control of blood components) and national guides (attached at bottom of this page).

Red Cell Components

Whole blood

Typically this contains 450-500 ml of donor blood that has been collected into a pack containing 63 ml of an anticoagulant solution such as CPD.

Red cells in additive solution

Typically all but 20 ml of plasma is removed from the collected whole blood and replaced with an additive solution designed to optimise red cell preservation, such as saline solution containing added adenine, glucose and mannitol (also called SAGM, SAGMAN, Adsol or optimal additive solution). It should contain at least 45 g of haemoglobin per unit. The EU Directive refers to this as “red cells in additive solution”. Other variants of red cell components include red cells that are leucocyte-depleted, have buffy coat removed, or are collected by apheresis.

Often referred to as “platelet concentrate”.

Recovered or apheresis

Platelets can be prepared by centrifuging a whole blood donation (often called recovered platelets) or collected by apheresis. Platelets prepared by each method have similar efficacy, but use of apheresis platelets exposes the recipient to the blood of fewer donors. The yield of platelets recovered from four to six whole blood donations should be 300x109 to 350x109 platelets in about 300 ml of plasma (the plasma is required to maintain platelet function during storage).

A single apheresis donation of platelets has comparable content of platelets and plasma. The use of a platelet additive solution allows platelets to be stored in reduced amounts of plasma. Platelet function is best maintained by storage at 22°C with agitation. As this temperature favours growth of some bacteria, some centres culture platelet concentrates prior to release from storage with the aim of reducing the risk of bacterial contamination. Platelets are generally stored for up to five days and some countries permit storage for seven days with special precautions.

Fresh frozen plasma (FFP) is separated and frozen, usually within six to eight hours after collection, to preserve factor VIII content. Other plasma components are:

• Cryoprecipitate – this is prepared by controlled thawing of frozen plasma to precipitate high molecular weight proteins, including factor VIIIc, von Willebrand factor and fibrinogen
• Cryoprecipitate depleted plasma – this is FFP from which cryoprecipitate has been prepared, leading to reduced concentration of fibrinogen and factor VIII

Leucocyte depletion

Removal of leucocytes to a level of less than one million per component by filtration or during collection of blood components by apheresis is normal practice in a number of EU countries.
Advantages of leucodepletion include a marked reduction in alloimmunisation to HLA antigens and in the risk of infection by intracellular viruses such as cytomegalovirus. Leucodepletion of red cells may also be associated with improved outcomes in some groups of patients.

Processes that reduce or abolish the infectivity of microrganisms in blood components offer an additional level of security against transfusion transmissible infections, including those for which screening tests are not currently available. (19304113).

Plasma

Several processes are available that have been shown to cause substantial reductions in infectivity while causing only moderate reduction in activity of fibrinogen and other plasma proteins. These processes utilise methylene blue, amotosalen, or riboflavin (single donor units), or a solvent detergent treatment (applied to pool of multiple units). An alternative approach is the use of quarantined plasma (PMID 18583192).

Platelets

Platelets pose a risk of bacterial contamination because they are stored at 22°C. Bacterial culture of platelets during the storage period is used by some organisations to minimise this risk. A process for pathogen inactivation of platelets is now CE marked and in use in several countries. A further large clinical trial of efficacy and safety is due to report its findings.

Red cells

Processes for pathogen reduction of red cell components have not completed clinical trials.

Cellular blood components may result in the transmission of CMV to groups of patients at risk. Practice in many EU countries is to use leucodepleted blood components to avoid this risk. In some countries the use of blood components that test negative for CMV antibody is recommended for patients at special risk of CMV infection (PMID 11149975).

Transfusion can cause Graft Versus Host Disease. TA GvHD causes tissue and organ damage that is usually fatal. There is an intensive immunologic reaction mediated by transfused immunocompetent lymphocytes directed against an immunocompromised recipient, or one who shares an HLA haplotype with the donor.

The risk of TA-GVHD can be avoided by irradiation of cellular blood components or by treating platelet components with amotosalen. This inactivates T lymphocytes remaining in the component so that they are unable to engraft (PMID 18544121, 17655584, 15744235)

Irradiation may employ Gamma irradiation using a Cs137 or Co59 source, or special X-ray equipment that is now available for this purpose.

When a patient has experienced severe allergic reactions associated with transfusion, reactions to subsequent transfusions may be prevented by the use of red cells that have been washed in sterile saline using special equipment.

This should remove residual plasma proteins cytokines or antibodies that may be the cause of the reactions. Saline washed RBCs must be used within 24 hours after washing since the saline contains no red cell nutrients and the original collection bag has been entered with consequent risk of bacterial contamination.

Summary information about the indications for use of blood components is provided in the Transfusion section of the site.

These are summarised in table 6.1

Table 6.1 Summary of specifcations for blood components Directive 2004/33/EC.

This table contains the information given in annex v, para 2.4

Blood Component		Haemoglobin	Haemolysis	Leucocyte Content
RED CELLS: Volume Valid for storage characteristics to maintain product within specifcations or haemoglobin and haemolysis
Red Cells		Not less than 45 g per unit	Haemolysis: Less than 0.8% of red cell mass at the end of the shelf life
Red Cells, buffy coat removed		Not less than 43 g per unit
Red Cells, leucocytedepleted		Not less than 40 g per unit	< 1 × 106 per unit
Red Cells, in additive solution		Not less than 45 g per unit
Red Cells, buffy coatremoved, in additive solution		Not less than 43 g per unit
Red Cells, leucocyte-depleted, in additive solution		Not less than 40 g per unit	<1 × 106 per unit
Red Cells, apheresis		Not less than 40 g per unit
Whole blood Not referenced in annex V, para 2.4 of Directive 202/98 EC
PLATELETS: Volume Valid for storage characteristics to maintain product within specifcations for pH		Platelet content	pH	Leucocyte content
Platelets, apheresis		Variations permitted within limits that comply with validated preparation and preservation conditions	6,4 – 7,4 corrected for 22 °C, at the end of the shelf life
Platelets, apheresis, leucocyte-depleted				< 1 × 106 per unit
Platelets, recovered, pooled platelet-rich plasma method				< 0,2 × 109 per single unit
Platelets, recovered, pooled buffy coat method				< 0,05 × 109 per single
Platelets, recovered, pooled, leucocyte depleted				< 1 × 106 per pool
Platelets, recovered, single unit				< 0,2 × 109 per single unit (platelet-rich plasma method)
Platelets, recovered, single unit, leucocyte depleted				< 1 × 106 per unit
PLASMA Stated volume +/- 10 %	Factor VIIIc Average (after freezing and thawing):	Fibrinogen	Total protein	Residual cellular content
Plasma, fresh-frozen	= / > 70 % value of the freshly collected plasma unit		Not less than 50 g/l	Red cells: < 6,0 × 109 /l Leucocytes: < 0, 1 × 109 /l Platelets: less than 50 × 109 /l
				Red cells: < 6,0 × 109 /l Leucocytes: < 0,1 × 109 /l Platelets: < 50 × 109/l
Cryoprecipitate	= / > 70 international units per unit	= / > 70 140 mg per unit
GRANULOCYTES Volume Less than 500 ml	Granulocyte content
Granulocytes, apheresis	>1 × 1010 granulocytes per unit

The use of blood components per capita, varies widely, even among the populations of countries that have similar levels of health care. This is despite the existence of broadly similar clinic transfusion guidelines in most EU countries. This wide variation may in part be a result of differences in the demographics or patterns of disease in different populations (PMID 7889138, 19210324, 8023386). However a number of studies have shown that, at least for surgical transfusion, much of the variation cannot be explained by these factors. The low blood requirements of some surgical teams may reflect their attention to the many details of patient management that influence the need to transfuse, including the appropriate use of lower haemoglobin thresholds for transfusion, surgical and anaesthetic techniques, avoidance of hypothermia and the use of “blood sparing” technologies.

Studies in several European countries show that although patients undergoing surgery and treatment for malignant disease are major users of transfusion, a substantial proportion of all transfusions are used for patients who do not belong to any simple category, who are in older age groups and who have essentially “medical” conditions, often with multiple diagnoses, interventions and episodes of hospital care (PMID 19500320).

The challenge of making an acute clinical decision about transfusion is to assess the likely benefts for the individual patient (PMID 12076437). One way to aid clinical decision-making is to use a simple checklist (downloadable from end of page>) such as the following to help focus the decision):

• What improvement in the patient’s clinical condition am I aiming to achieve?
• Can it be achieved without transfusing?
• Can I minimize blood loss to avoid the need for transfusion?
• Are there any other treatments I should give before making the decision to transfuse (such as intravenous replacement fuids oxygen, inotropes)?
• What are the specifc clinical or laboratory indications for transfusion for this patient at this time?
• What are the risks of infection or some other severe adverse event?
• Do the benefts of transfusion outweigh the risks for this particular patient?
• Will a trained person respond immediately if an acute transfusion reaction occurs?
• If this blood was for my child, or myself would I accept the transfusion or not?
• Have I recorded on the patient’s chart (and signed) my decision and my reasons for transfusion?

Decision-making can be relatively straightforward when a patient has a life-threatening major haemorrhage, bleeding associated with profound thrombocytopenia, or severe, disabling symptoms of anaemia associated with cancer chemotherapy. Indications for transfusion may also be clear in conditions such as thallasaemia or myelodysplastic disease. The decision can be much less clear – for example in an elderly patient, who has a haemoglobin concentration of 80g/l, has no evident symptoms of anaemia, is haemodynamically stable and is not bleeding.

Figure 7.2 What makes us transfuse red cells

 

A single patient with catastrophic bleeding can be a major challenge for the clinical and blood bank teams. When blood is required very rapidly it is extremely important to have clear communications between clinicians and the blood bank. Clinical and blood bank experience indicates that delays in providing blood in a life-threatening emergency can occur for various reasons and contribute to mortality in critical situations such as obstetric haemorrhage. www.cmace.org.uk

Hospitals should have a Major Haemorrhage Procedure that identifes roles, responsibilities and communication routes. (Example downloadable from end of page)

There should also be a clinical transfusion guideline for management of major bleeding. (example: PMID 17107347, 19135193)

Rehearsals (‘fre practices’) to familarise medical, nursing, laboratory and transport staff and to test the procedure.

Following road traffc accidents and other disasters several unconscious injured patients may arrive at the hospital within a short period, creating risks due to problems in identifying the patients. These are situations when it is vital for all the team to know and use the Major Haemorrhage Procedure (table 7.1).

Table 7.1 Example of a Major Haemorrhage Procedure

There should also be a clinical transfusion guideline for management of major bleeding.

Major Haemorrhage Procedure
Example of a Major Haemorrhage Procedure
If there are several staff working with emergency cases, one person should take charge of ordering blood and communicating with the Blood Bank. This is especially important if several injured patients are involved at the same time.
Insert an intravenous cannula, and take blood sample for crossmatching. Set up the intravenous infusion and get the blood sample and blood request form to the Blood Bank as quickly as possible.
For each patient, the crossmatch sample tube and the blood request form must be clearly labelled. If the patient is unidentifed, some form of emergency identifcation number should be used. Use the patient’s name only if you are sure you have correct information.
Tell the Blood Bank how quickly the blood is needed for each patient. Communicate using words that have been previously agreed with the Blood Bank to explain how urgently blood is needed.
If there is a special stock of ‘emergency O negative’ blood, e.g. in the labour ward, use this frst in an emergency for girls and for women of child bearing age
Do not wait for crossmatched blood if the patient is exsanguinating.
If another request for blood is needed for the same patient within a short period, use the same identifers, as on the frst request form and blood sample, so Blood Bank staff will know it is the same patient.
Do not ask for ‘crossmatched blood’ in an emergency. Ask the Blood Bank to supply what can be provided most quickly with reasonable safety according to the local policy. For girls and women of child bearing age, RhD negative red cells should be used until the RhD type is known.
Make sure that the Blood Bank staff know who is going to take the blood to the clinical area where the blood should be delivered to, for example, if the patient is about to be transferred to another part of the hospital for an X-ray.

Examples are given of procedures where possible and thses are currently used in hospitals in countries participating in the project.

Table 7.2 Clinical situations for which there should be transfusion guidelines

Major Haemorrhage Procedure
Situation	Use this space to note reference to local clinical transfusion guideline or relevant example
Blood ordering and supply in major haemorrhage
The management of major haemorrhage in
Gastrointestinal (variceal non-variceal) acute upper GI bleeds
Obstetrics
Trauma
Critical Illness (transfusion in the intensive therapy unit)
Preoperative assessment and optimisation
Predeposit autologus blood – collection and transfusion
Management of preoperative patients on drugs that affect haemostasis, such as   warfarin, heparin, clopidogrel
Peri-operative blood management and blood saving techniques/drugs
Inherited coagulation disorders
Acquired coagulation disorders
Disseminated intravascular coagulation
Thrombocytopenia and thrombocytopathy, TTP
Prenatal and neonatal transfusion
Haemolytic disease of the newborn: prevention and management
Neonatal: exchange, intrauterine and top-up transfusion
Chronic anaemia due to haematological disorders
Myelodysplasia
Haemoglobinopathies
Autoimmune haemolytic anaemia
Malignant haematological disorders: bone marrow failure
Transplantation of haemopoietic stem cells
Management of patients refusing blood transfusion

Systematic Review

This is a a review of the literature on a topic that

• is based on comprehensive searching of all relevant sources
• uses explicit criteria to assess the eligibility and methodological quality of the studies.
• uses established methods to assess the eligibility and methodological quality of the results
• may involve bringing together the of the results of several comparable studies to increase the strength of the conclusions that can be drawn (sometimes called meta analysis)

Systematic reviews relevant to transfusion can be found at www.transfusionguidelines.org.uk.

The Cochrane Library at http://www3.interscience.wiley.com is a comprehensive source of clinical trial reports and systematic reviews.

Clinical Guideline

Many important aspects of transfusion practice do not have a firm basis of evidence from well conducted randomised controlled clinical trials that have the capability to identify the most effective process or treatment. As a result, clinical guidelines often must be based on the best available information such as observational studies, case reports and properly developed concensus of professional opinion.

Example

The full document can be found at www.arzt.de (English transation downloadable from the bottom of the page). These guidelines were developed over several years on the basis of reviews of the current literature and show.

• How the quality (level) of the evidence was graded
• How the recommendations for practice were constructed.

The following is an extract from the 2009 guidelines of the Bundesaerzekammer (German Medical Association) www.arzt.de

Grading of recommendations

• Level 1: based on available data, the benefits to the patient of complying with the recommendation are judged by experts to outweigh the potential risk
• Level 2: if there are no definite data on the risk-benefit ratio

Grading of level of evidence

• Level A: data from large, prospective, randomised studies
• Level B: data from several prospective studies with conflicting results or with methodological flaws
• Level C: data from case reports and non-randomised studies.
• Level C+: data from case reports and non-randomised studies are unambiguous and confirmed by several investigations

Consequences of the recommendations

Both the level of evidence based on underlying data and the level of recommendation, reflecting the risk-benefit ratio impact on recommendation for medical practice (table 7.3).

Table 7.3 Classification of recommendations for clinical transfusion guidelines

Reproduced from: cross sectional guidelines for therapy with blood components and plasma derivatives, 4th revised edition 2009. Bundesaertztekammer (German Medical Association)

Level of recommendation	Risk-benefit ratio	Level of evidence	Assessment of the methodological validity of the underlying data	Overall assessment, classification	Implications	Key words
1	Unambiguous	A	Randomised, controlled studies without essential methodological flaws with unambiguous results	1 A	Strong recommendation. Valid for most patients	shall
1	Unambiguous	C+	No randomised, controlled studies, but unambiguous data available	1 C+
1	Unambiguous	B	Randomised, controlled study with methodological flaws. Despite unambiguous results of the study, it cannot be safely ruled out that methodical flaws have influenced the results	1 B	Strong recommendation. Probably valid for most patients
1	Unambiguous	C	Observational studies without control group, but with convincing results	1 C	Medium-strong recommendation, seems to be plausible, may be changed once improved data becomes available	Should
2	Ambiguous	A	Randomised, controlled study without methodological reservations, but with conflicting results	2 A	Medium-strong recommendation, depending on the individual case, a different course of action may be indicated. The interpretation of results by the Working Group Guidelines are taken into account in the recommendation
2	Ambiguous	C+	No randomised, controlled studies, but data can be extrapolated from other studies	2 C+	Weak recommendation, depending on the individual case, a different course of action may be indicated. The interpretation of results by the Working Group Guidelines are taken into account in the recommendation	Can
2	Ambiguous	B	Randomised, controlled study with severe flaws	2 B	Weak recommendation, depending on the individual case, a different course of action may be indicated	Can
2	Ambiguous	C	Observational studies, case reports	2 C	Very Weak recommendation, depending on the individual case, a different course of action may be indicated	Could
Cross sectional guidelines for therapy with blood components and plasma derivatives, 4th revised edition 2009. Reproduced with permission from Bundesaertsekammer (German Medical Association).

Red Cells
Major haemorrhage

For patients who are shocked and anaemic red cell transfusion to increase the circulating red cell mass can relieve clinical features that are caused by insufficient oxygen delivery (PMID 14556774, 9504576). Circulating blood volume must be corrected with other fluids (PMID 15163774, 12535407, 11279761). Mortality rates are high in patients who do not receive blood.

Acute anaemia

A randomised trial in ICU patients suggested that transfusion of red cells to achieve a higher haemoglobin concentration target appears to offer no benefit over more conservative transfusion to achieve a lower target Hb concentration. The exception to this may be patients with cardiovascular disease. Table 7.4 shows a recent evidence-based national clinical transfusion guideline for transfusion of red cells in acute anaemia
Germany Haemotherapy Guidelines downloadable from the bottom of the page.

Table 7.4 Evidence based national clincal transfusion guideline for transfusion of red cells in acute anaemia

Reproduced from: cross sectional guidelines for therapy with blood components and plasma derivatives, 4th revised edition 2009. Bundesaertztekammer (German Medical Association)

The decision on transfusion for each patient should take account of that patient’s haemoglobin (Hb) concentration, capacity to compensate for acute anaemia, and risk factors
Hb concentration alone is not an adequate measurement of oxygen supply. If the patient is hypovolaemic the Hb concentration does not correctly reflect the red cell mass in an individual patient and it may be necessary to deviate from the recommendations below
range of haemoglobin concentration	capacity to compensate: risk factors	recommendation on red cell transfusion	strength of recommendation *
< 6 g/dl (3.7mmol/l)		Yes	1C+
> 6-8 g/dl (3.7-5 mmol/l	adequate compensation: no risk factors	No	1C+
	limited compensation: risk factors such as coronary artery disease, cardiac insufficiency, cerebrovascular insufficiency	Yes	1C+
	symptoms of anaemic hypoxia or decompensation (physiologic transfusion trigger) eg tachycardia, hypotension, ECG ischemia, lactic acidosis	Yes	1C+
> 8-10 g/dl (5.0-6.2 mmol/l	symptoms of anaemic hypoxia or decompensation (physiologic transfusion trigger) e.g. tachycardia, hypotension, ECG ischemia, lactic acidosis	Yes	2C
> 10g/dl (6.2 mmol/l)		No	1A

Neonatal ICU patients

Transfusion of red cells to achieve a higher haemoglobin concentration target in patients who require transfusion appears to offer no benefit over more conservative transfusion to achieve a lower target Hb concentration (PMID 19117884). Target haemoglobin levels used in the key randomised controlled clinical trial depended on the age and condition of the infant.

Thalassaemia major

In countries where thalassaemia is still prevalent, it can account for a large proportion of the clinical requirement for red cell transfusion. In many countries, as a result of successful prevention programmes, most cases are now in older individuals. Red cell transfusions are typically given at two to four weekly intervals to maintain a mean Hb around 12g/dl. The aim is to fully relieve the symptoms of anaemia and suppress the patient’s own increased abnormal red cell production in the marrow (ineffective erythropoiesis). This is the cause of the skeletal abnormalities and spleen enlargement seen in under-treated patients. All patients need iron chelation therapy to prevent progressive and ultimately fatal organ damage (PMID 18413891).

Symptomatic anaemia patients with haematological malignancies or solid tumours:

The local clinical management protocol should define the range within which a patient’s haemoglobin should be maintained. A suggested arbitrary guide is to maintain Hb at not less than 9.0g/dl. As a result of complications associated with the use of erythropoetin in patients with cancer, guidelines in a number of countries now discourage or restrict its use in this situation (PMID 16705125).

The normal range for the platelet count in peripheral blood at all ages is 150-400 x 109/l. A platelet count below this level does not in itself indicate a need for platelet transfusion. Isolated thrombocytopenia, in the absence of any other abnormality, is unlikely to be complicated by serious spontaneous haemorrhage if the count remains above 5 -10 x 109/l. Recent studies indicate that the clinically stable patient is unlikely to benefit from prophylactic platelet transfusion if the count is greater than 10 x 109/l. A higher threshold for transfusion is generally advised in the presence of sepsis. However, some experts question the usefulness of the platelet count in the peripheral blood as a guide to the risk of bleeding or as a means for assessing the effect of platelet transfusion.

Clinical transfusion guidelines for platelet transfusion usually cover the management of bleeding during surgery or patients with bone marrow suppression and the prevention of bleeding in patients with low platelet count due to bone marrow suppression or other causes (PMID 19109560, 15495093, 15584985, 16351634). Some guidelines specify target platelet counts. In clinical practice the recommended target platelet counts may not be achieved even with large doses of platelets.

The following is an extract from the 2009 Guidelines of the German Medical Association

Major haemorrhage:

• Transfuse if count <50 × 109/l, or
• In multiple or CNS trauma < 100 × 109/l (recommendation level 2C)

Thrombocytopenia due to chemotherapy

• Transfuse if count <10 × 109/l if not bleeding and no other risk factors (recommendation level 1A)
• Transfuse if count <20 × 109/l if at risk due to sepsis, antibiotics, abnormal clotting (recommendation level 2C)
• Transfuse if there is evident bleeding (recommendation level 1C)

Invasive surgical procedures

• Transfuse if count <50 × 109/l: < 70-100x109 in procedures, such as neurosurgery, where bleeding carries higher risks (recommendation level 1C)

Invasive diagnostic interventions

• Guidance depends on individual procedure, patient risk factors for bleeding, and risk to patient if bleeding occurs

Although FFP is widely used, there are few well-founded indications. A systematic review of all randomised trials of FFP indicates that most clinical indications for FFP that are often recommended by transfusion practice guidelines are not supported by evidence from randomised trials.

Typical clinical guideline for plasma transfusion

Major haemorrhage

Coagulopathy with a prothrombin time prolonged > 50% is likely after replacement of 1-1.5 blood volumes. Initial dose of FFP 15-20 ml/kg. Further doses only if bleeding continues and guided by PT and APTT (1C)

Thrombotic thrombocytopenic purpura (TTP)

Plasma exchange with FFP is effective in many cases (recommendation level 1A).

Other indications

Replacement of coagulation factor deficiency, if the appropiate plasma derivative or recombinant product is not available.

In many EU countries, a fibrinogen product made by plasma fractionation is used for fibrinogen replacement in dysfibrinogenaemia and acquired hypofibrinogenaemia seen in
massive transfusion and DIC. An alternative is cryoprecipitate.

Fresh or stored red cells for transfusion?

A much cited study suggested that transfusion of stored red cells could actually impair regional oxygenation but a recent blinded, randomised, controlled study comparing the effect of fresh versus stored leucocyte-depleted red cells on systemic and regional oxygenation in ICU patients showed no definitive evidence that fresh red cells have better oxygen delivery in critically ill patients (PMID 14758149) (See download at bottom of page). A study of the effect of acute anaemia on cognitive function in healthy subjects detected no difference in the response when haemoglobin concentrations were restored with fresh or stored autologous red cells (PMID 16645441). The TRICC clinical trial (PMID 9971864) suggested that some ICU patients maintained at a lower Hb concentration, and so receiving less transfusion, may have improved outcomes. One interpretation was that this could be associated with some adverse effect of transfusing stored red cells. Randomized trials are in hand to investigate this hypothesis. Large observational studies in cardiac surgery have also suggested poorer outcomes with longer stored red cells. At present, it remains to be conclusively shown in prospective studies whether the use of fresh red cells offers benefits for critically ill patients (PMID 12393351).

Is there a case for single unit transfusion of red cells?

It is often stated that there is no case for giving a single unit transfusion, but in some cases, a single unit may be an appropriate dose. For example in a 40 kg patient with hypoxic signs or symptoms attributed to a Hb concentration of 7g/dl, a single unit of red cells may be quite sufficient to relieve symptoms (and to raise the Hb concentration by 1-2g/dl). Use of a second unit in such a case exposes the patient to additional and unnecessary risks.

Whole blood vs a red cell component?

The concept of blood component therapy (together with the requirement for plasma for fractionation) has encouraged the widespread use of red cell concentrates in most developed countries, although in some other areas of the world, most transfusions are given as red cells (R67). The clinical experience of military surgical teams is that the early administration of plasma with red cells (in approximately equal volumes) appears to be associated with better achievement of haemostasis. Whole blood may be appropriate for a patient with acute bleeding who requires both red cells and expansion of plasma volume. In cases when disseminated intravascular coagulation (DIC) contributes to the blood loss, it may be logical to use whole blood (or leucocytedepleted whole blood) since it contains at least a part of the total dose of fibrinogen and stable clotting factors that the patient requires and could reduce the need for plasma units from other donors.

Is fresh frozen plasma safe?

Worldwide, the largest avoidable risk to patients from transfusion is probably due to the transfusion of fresh frozen plasma (FFP) for unproven clinical indications. Plasma is just as likely as whole blood to transmit viral infections (other than those that are strictly cell associated). In any area where blood safety testing may be unreliable, transfusion of FFP, unless it is pathogen reduced, can be an important source of transmission of these infections.

Is fresh frozen plasma clinically effective?

There is a poor level of evidence to support many of the traditional indications for transfusing FFP (PMID 15198745). This is reflected in the recent clinical guidelines e.g. from Germany and UK. FFP should be used only to replace rare clotting factor deficiencies for which no virus-safe fractionated plasma product is available or when there is a multifactor deficiency due to severe bleeding and DIC. Other indications for FFP are the management of thrombotic thrombocytopenic purpura (TTP) and haemolytic uraemic syndrome (HUS), in which plasma infusion or plasma exchange with FFP is effective (PMID 17266701).

Does Fresh Frozen Plasma have to be used immediately after thawing?

After thawing, the level of factor VIII falls rapidly. Factor V also falls, more slowly, but level of fibrinogen and the other haemostatic proteins is maintained. Guidelines in some countries permit the use of plasma that has been stored in the blood bank for up to 24 hours after thawing. This has the advantage that plasma can be released quickly when required for urgent management of massive bleeding. In some countries, liquid plasma (never frozen) is used.

Table 7.5 Framework for managing the preoperative patient to minimise the need for allogeneic red cell transfusion

For background information try www.nataonline.com

Time period	Manage haemoglobin level	Manage haemostasis	Blood salvage and transfusion
Preoperative Preadmission clinic	Assess for anaemia: diagnose and treat with haematinics and epoetin if indicated	Detect and manage haemostatic defects. Stop anti-coagulants and anti-platelet drugs if safe to do so.	Arrange for intraoperative blood salvage to be available if it is appropriate for the planned operation.
During surgery Surgical and anaesthetic techniques	Monitor haemoglobin, haematocrit or blood loss as a guide to red cell replacement	Keep the patient warm, as cold impairs blood clotting. Rapid haemostasis testing to guide blood component replacement. Consider use of tranexamic acid where large blood loss is expected.	Use intraoperative blood salvage
Post-operative Control Hb concentration, manage blood loss	SOP for post-op check of Hb when haemoglobin should be checked. Minimise blood taken for laboratory samples		SOP specifying blood transfusion thresholds and targets. SOP to trigger surgical re-exploration at specified level of blood loss. Post-operative blood salvage

Table 7.5 provides a simple framework managing the patient waiting planned surgery so as to minimise the need for perioperative transfusion.

The following techniques have all been developed as means of reducing transfusion requirements. While some have been shown to achieve this result there is relatively little knowledge about potential risks. A recent randomised clinical trial comparing three antifibrinolytic agents has demonstrated the importance of obtaining such evidence. (See Aprotinin, below)

Preoperative autologous blood deposit (PABD)

The patient donates one or more units of his own blood which is stored till the time of surgery. May be useful for patients for whom it is very difficult to obtain compatible red cells. May reduce use of allogeneic red cells but does not reduce total red cell use when reinfused units are taken into account.

Acute normovolaemic haemodilution (ANH)

Blood is collected from the patient immediately before surgery and reinfused during or after the procedure. Evidence indicates that the procedure does not reduce transfusion requirements.

Intraoperative blood salvage

Blood lost during surgery is collected, washed to remove plasma and debris, and reinfused.

Postoperative salvage

Blood from wound drains is reinfused with or without washing.

Inhibitors of fibrinolysis

Those currently available are tranexamic acid and in some countries epsilon-aminocaproic acid. Aprotinin, the antifibrinolytic that had been extensively used for many years has recently been withdrawn because in a large randomised trial there was excess mortality in patients receiving this drug compared with those receiving tranexamic acid or EACA (PMID 18480196, 19050037).

Erythropoietin (EPO, epoietin)

EPO is a potent stimulator of red cell production. The drug is made by genetically engineered expression of the human erythropoetin gene. It is highly effective in the anaemia of chronic renal failure. Studies in patients with malignant disease have shown an increase in cancer recurrence and mortality. The risk of hypertension and thrombosis increases if the dose raises the patient’s Hb concentration to near normal levels. Parenteral iron preparations are often used with EPO to deliver the iron required for rapid erythropoiesis (PMID 16999756).

Do these technologies reduce the need for donor blood transfusion?

Clinical trials to answer this question have been subject to systematic reviews with meta-analysis. These methods reduce the use of allogeneic transfusion but may have other consequences. For example, predeposit autologous transfusion usually increases the total amount of red cell units transfused when both autologous and allogeneic units are counted.

In EU member states where data are available the risks associated with receiving a transfusion are small in the context of the totality of risks of hospital care. However, as part of an effective quality system, patients who are able to communicate must be informed in good time about their treatment. Formal consent for transfusion is a requirement in some countries. Regardless of any legal requirement, the clinician has a professional duty to make sure the patient knows if and why a transfusion is required. The discussion should include the reasons why transfusion may be needed and the risks and benefits of receiving blood, (and in some circumstances of not receiving it). There are links to examples of information prepared for patients on the website.

The pre-admission clinic for elective surgery is an ideal opportunity to provide information about transfusion as part of the information given to the patient about the whole process of care. Many EU countries have information leaflets available for patients. Clinical notes should record that the patient has been given information about transfusion.

Questions frequently asked by patients

Figure 7.3 provides some information that may help in responding to questions that patients’ ask about transfusion.

Figure 7.3 Answering patients’ questions about transfusion

(for another example see http://sunnybrook.nextmovelearning.com)

Conducting even a small clinical audit and carrying out a plan of improvement needs resources and the commitment of all participants (management, clinical teams and audit department) to complete the process. Audits that are restricted to a few patients in a single clinical unit and using minimal resources may be valuable in improving practice. Large, multi centre studies require substantial planning and resources. Such large studies may be needed to identify, on a multi centre or national scale, current practices or areas needing improvement.

Research creates new knowledge about best practice that should be used to improve guidelines. Clinical audit examines actual practice, compares it with guidelines, and tests compliance with them (example downloadable below).

Even the best guidelines or SOP’s are only useful if they are followed. Audit is the way to test compliance. Clinical Audit should be part of a continuous improvement process or quality improvement cycle consisting of the following steps:

Choose the target

Plan to audit a topic that is clinically important, with evidence of room for improvement such as errors, adverse events or reactions, large variations in practice or patient complaints (downloadable below)

Define the aim

There should be a clear ‘audit question’ (or questions), just as any research proposal should start with a concise statement of the research question or hypothesis to be tested (downloadable below).

Select the criteria

Local criteria (developed by the hospital’s clinicians) should be used as the basis for audit. Such locally developed guidelines should be based on current national recommendations. These take account of the best available evidence.

Define the methods

Decide what is to be observed or measured, how the data will be collected, quality controlled, analysed, and presented.

Implement an action plan for improvement

Decide what will be done to improve practice if the audit shows that improvement is needed, plan and implement (downloadable below).

Repeat the audit

Test for evidence that practice has improved.

Use an existing design

It may be possible to save time and work by using a pre-existing set of audit questions and tools, modified if necessary. This also makes it easier to compare results between institutions. Even if an existing design is used, a small pilot study should still be performed.

Design a new audit

Build the frame of reference, which should be based on the most recent, available, relevant documentation, including:

• Regulations: European directives, national laws and decrees
• Professional documentation: Clinical guidelines, consensus conferences, scientific literature, expert opinion.
• International (ISO, EN), national or professional standards

Select criteria

A critical step is to reach agreement on the criteria against which practice is to be audited. Although guidelines for many aspects of transfusion process exist, they are frequently based on inadequate evidence. There may be local barriers – such as individual clinicians’ opinions – to general acceptance of a guideline. The process of negotiating an agreed and measurable objective standard of care that can be endorsed by all stakeholders and used in the audit process can be an extremely valuable means of encouraging clinicians to review their practice (R29 document attached below).

Prospective or retrospective?

Prospective audit is based on the collection of information about patients during their process of care. It permits more reliable and complete clinical data collection since the data required is pre-defined and can be validated and errors corrected while the data collection is in progress. A possible disadvantage is that practice could be altered if staff are aware that they are being observed and data is being collected.

Retrospective audit is generally based on review of records of discharged patients. This may provide information that is more representative of day-to-day practice, but it is more difficult to obtain complete data on every subject in the sample. Retrospective audit may make use of computer databases provide the data they contain is of adequate quality.

Develop the audit criteria

A criterion is a principle or standard by which something may be judged. Audit criteria should describe the aspect of care that is being measured. Explicit means SMART:

• Specific: Unambiguous. Relates to a specific area of care and states specific boundaries
• Measurable: There must be objectively measurable aspects to allow comparison
• Achievable: Must be achievable either within available resources, availability of cases, etc.
• Research based: Wherever possible, there should be sound research evidence that shows the best available treatment or method for the aspect of care being audited
• Timely: Criteria should reflect current practice

Each criterion included in the frame of reference should ideally be derived from the reference guidelines or regulations. It should be designed to identify clearly whether practice conforms or does not conform to the guideline or regulation.

Write the protocol

The protocol should include:

Objectives
• Sources of information used to build the frame of reference
• Definition of the audited hospitals, teams or individuals
• Criteria for inclusion and exclusion (when patients’ files are concerned)
• Type of study (prospective, retrospective)
• Type of data collection (observation by external auditor, self-evaluation, interviews, data collection from patients’ files, from hospital blood bank and from blood transfusion establishment.)
• Description of the role of each person involved.
• Any requirements related to consent, confidentiality or ethical issues

Develop or adapt tools for data collection

Data collection must be simple to perform, valid and reliable.
Data collection forms (often called Case Report Forms or CRF) must have a unique identifier, clearly identify the person who completes the document, and show the date of completion. Questions should require a simple unambiguous response (e.g. YES / NO/ Information not available). Responses such as ”not applicable” should not be permitted. The units in which quantitative results are recorded must be stated e.g. “Hb concentration to be recorded as g/l”. Clinical terms must be defined explicitly (e.g. “bleeding”, “cardiovascular disease”). Questions that require free text response should be avoided or strictly limited as they are difficult to analyse (R24 document attached below).

User manual

For a simple audit the user manual should be short and simple, explain exactly how data collectors should obtain the data items for the audit, how they should enter the information in the case report form or equivalent, and how completed CRFs should be submitted to the audit team.

Statistical support

It is strongly advised to engage the help of a statistician right from the planning stage and throughout the audit to provide expert advice on design of the study including aspects such as sample size, power, sampling methods, development of the analysis plan, conduct of the analysis and presentation of findings. If the results of the audit are to change practice, the results and analysis must be robust and also simple enough for everyone in the care process to understand.

The statistician should generally be a co-author in any report prepared for publication (R23 document attached below).

Sample size

Where a research study will need large numbers of subjects to show which intervention is best, clinical audit only needs to determine the extent to which practice complies with standards or criteria. Smaller sample sizes can often provide the information. The information collected from the audit sample should be representative, i.e. should allow 95% confidence that the results will be within 5% of the results that would be obtained from the relevant population. Sample size calculators are useful when determining an appropriate sample size (R31 document attached below).

Sampling

There are several methods of choosing which cases to include in an audit, including:

Random Sampling: Assumes your audit population will remain the same throughout the audit period and that each subject will have an equal chance of being chosen, either by drawing names out of a hat or choosing every nth subject from a list (e.g. choosing every 3rd or 5th patient).

Interval Sampling: Assumes your audit population will change over the period of the audit. In these circumstances, the audit sample is often determined by a period of time e.g. all patients transfused during May and June.

Stratified Sampling: Is a method used to ensure that the proportions of different groups in the population are reflected in the sample. For example, if investigating donor deferrals, and if male blood donors make up 40% of the donor population, you would ensure that 40% of your sample are male.

Rapid Cycle Sampling: Small data sets are audited to improve and monitor care. This approach can make the change cycle quicker and is useful if a problem is suspected and results are needed quickly. Auditing a small sample can show the nature of the problem. After implementing the action plan for improvement, a repeat the audit on another small sample can quickly show if improvement has been achieved.

Because a poorly chosen sample can skew results and give inaccurate information, the advice is repeated to seek advice from statistician or audit department (R31 document attached below).

Pilot testing

The data collection process should always be pilot tested before the full implementation of the audit. This will often lead to improvements in the data collection forms and improve the final result.

The audit team is responsible for:

• Informing all personnel involved in the audit
• Ensuring there is a clear agreement about roles, responsibilities, and authorship of the final report and any publications that result from the audit
• Training data collectors
• Providing the tools for data collection, e.g. paper case report forms with subsequent input of data to computer, PDA or other portable device
• Quality control of the collected data and of the data input process
• Ensuring anonymity of patients, audited staff or institutions when required by protocol
• Being available to respond quickly to questions and problems that arise during the audit
• Ensuring deadlines are met

(R24 downloadable below)

The type of analysis depends on the type of information collected. Quantitative data is concerned with numerical or specific data. E.g. Yes/No, Age, Gender, Blood Pressure, Blood Groups. The analysis of this type of data is performed using simple mathematical techniques. Qualitative data is usually descriptive rather than numerical. E.g. comments on questionnaires, or donor complaints. This data needs to be analyzed differently using specialized techniques (R23 downloadable below)

.

Each team audited must have the opportunity to participate in the analysis and to study and comment on the results, express their opinions on the audit, identify causes for non-compliance and propose improvement actions. The team leader should generously acknowledge the contribution of all participants. At this stage, the team leader should be ready to provide a final validated report at the institution level. If a report is to be submitted for journal publication the active contributors should be properly recognised (R28 downloadable below).

Tables and graphs to present the results should be as simple as possible. Presentation should focus on the quality and completeness of participation and compliance with audit instructions (rate of non evaluable answers, etc.), identification of the major positive points and of the major points of nonconformity that will require improvement. It is important, at this stage, to propose a preliminary root cause analysis, in order to stimulate discussion among the participants; for each nonconforming item:

• Identify the nature of the problem
• Identify the possible causes for non-compliance
• Propose a classification to help build an action plan
• Propose an improvement action plan for consultation and agreement

(R28 downloadable below)

Search for improvement

Analysis of the audit results should define the improvements that can be proposed to the audited teams and to management. The action plan must define the objectives and the approaches to be used.

Examples

The plan may aim to improve deficiencies in the design of process or the resources that are revealed by the audit. This might involve developing or updating an SOP that is (Table 9.1) missing or out of date or correcting deficiencies in resources or training.

Table 9.1 Responding to audit findings. Examples: deficiencies in processes or resources

Responding to audit findings – deficiencies in processes or resources
Criterion	National and local guideline requires that hospitals have a validated procedure for provision of blood to patients in an emergency
Audit finding	Hospital does not have a major haemorrhage procedure
Corrective action	Take steps to ensure that staff who provide this service are supported by written procedures, effective training, and appropriate practises (fire drills) to test the procedures periodically
Criterion	Staff must receive appropriate training for their task(s)
Audit finding	Audits may uncover deficiencies in education and training in any area of practice
Corrective action	Develop and implement training programme
Criterion	National and local guideline requires perioperative monitoring of patients’ haemoglobin levels
Audit finding	Equipment for “near patient” measurement of haemoglobin concentration is not available
Corrective action	Operating departments must be supplied with suitable equipment

 

Alternatively the audit may show that there are non-compliances even though all the appropriate procedures, personnel, training equipment, etc. are in place. (Table 9.2)

Table 9.2 Responding to audit findings. Examples: non-compliance

Responding to audit findings – non-compliance
Criterion	Guidelines require that patient records contain a record of the clinician’s reason for prescribing each red cell transfusion.
Audit finding	A doctor’s record of the reason for transfusing is found in only 20% of patients’ files.
Corrective action	Obtain the agreement of clinical staff to achieve a target of 90% documentation of the reason to transfuse and to participate in education on the importance of clinical accountability for transfusion and to a repeat audit.
Criterion	Guidelines require that all patients undergoing transfusion have observations of pulse, blood pressure, respiration and temperature recorded before and at specified time intervals during the transfusion.
Audit finding	These “routine observations” are performed incompletely or not at all in a substantial proportion of transfusion episodes.
Corrective action	Obtain the agreement of clinical staff to achieve a target of 90% documentation of patient observations according to the guidelines and to a repeat audit. To overcome the problem that nursing staff believe that they do not have time to perform the task, consider action such as: Review the priorities among nursing duties to make more nursing resource available; or A planned change to the Guideline. The clinical responsibility for the decision should be clearly defined, and the Hospital Transfusion Committee should decide if notification to other authority(ies) is required
Criterion	EU Directive requires that the final fate of all blood components issued for recipients is recorded by the hospital blood bank.
Audit finding	Hospital blood bank does not have data on the final fate of all components
Corrective action	Obtain the agreement of clinical staff to achieve an initial target of 98%. Inform staff that monthly reports will be provided to senior nursing managers, identifying the clinical areas not meeting the agreed target. These mangers will be required to identify how non-conformance will be addressed.

Practical proposals for corrective measures must be made to the hospital management. These must be endorsed by all participants in the audit. The presentation should identify both positive and negative findings of the audit, since sharing examples of good practice may contribute as much to improving quality as does the identification of inadequate practice. The improvements expected from carrying out the action plan should be described as accurately as possible. The improvement action plan should be finalised and approved by the project team, the audited team and the hospital management during or shortly after this presentation.

The Audit report

The final report should present the overall project and should include the following sections:

• Objectives
• Participants (Project team, Audited teams)
• Organisation and methodology
• Frame of reference and timeline from planning to report
• Both positive findings and issues requiring improvement
• Agreed action plan for improvement
• Annexes (documents used, e.g. audit protocol, user manual, reference sources)

Publication in the professional literature may add greatly to the value of the audit, for the participants, the hospital and the wider professional community.

Practical examples of audit tools and reports can be found in the resources listing and in the file list below.

An effective training programme requires leadership and commitment from the senior management of the organisation. They need to be aware of the regulatory requirements of the EU Blood directives together with other national standards for safe and appropriate transfusion practice.

It is essential to have an active multidisciplinary Hospital Transfusion Committee (HTC) that takes responsibility for developing and implementing a strategy for the education and training of all clinical, laboratory and support staff involved in blood transfusion. A lead person should be appointed to oversee the day-to-day running of the training programme and must have access to adequate staffing and resources.

Who needs training in what?

Various staff groups have been identified as involved in the process for transfusing blood in hospitals. Undertaking a Training Needs Assessment (TNA) will help to determine:

• The knowledge and skills requirements for each specific task in the clinical transfusion process
• Which staff groups require training
• How many in each specific staff group require training
• What training is currently available and who is responsible for training of each of the staff groups
• A baseline as a basis for later progress reporting

A template for training needs assessment is provided on the website.

Trainers

It is also essential to review the training needs of the trainers to support and develop their ability, confidence and motivation to deliver effective teaching. Trainers need to maintain their knowledge by continuous professional development. They should have access to courses and opportunities for self-learning. In addition, they should have access to training courses to develop and maintain other specific skills in communication, IT, etc.

It is helpful to have data on transfusion practices before the implementation of the education programme. Transfusion practice audits, and reviews of errors and near misses reported to the HTC or the haemovigilance system will provide valuable information on where training and education should be targeted.

The practices that should be audited derive from the activities identified in the essential steps in the clinical transfusion process. (Fig 2.1)

Member States may have different names for similar jobs, and some job titles will not exist in some countries. There are differences among member states and local hospitals as to which staff group undertake particular tasks.

Figure 10.2 identifies the knowledge required for each task. Areas of knowledge and procedures that should be evaluated are:

• Knowledge of blood group serology
• Knowledge of characteristics of blood components
• Procedures for blood sampling and labelling
• Procedures for storage of blood components
• Procedures for collection and delivery of blood components
• Checking and administration procedures for blood components
• Procedures for monitoring the transfused patient
• Understanding of adverse events in transfusion

It is essential to make a realistic assessment of the resources (personnel and financial) required for collecting baseline data and for an ongoing audit programme to ensure standards are being maintained. Each hospital should have a clinical audit department (or a similar function as part of quality management) that should be able to provide advice.

Two methods often used to gather information about existing knowledge and practice are questionnaires and observation of practice.

Questionnaires should reflect the required standards of practice and may differ for each group of staff. While a questionnaire can be a relatively simple way to obtain information, there are known problems. These include poor response rate, deficient completion and the temptation to give the ‘correct’ rather than a ‘true’ response.

Observational audit of transfusion practices can yield very useful information, but is labour intensive and difficult to undertake. Direct observation can make staff alter their practice, however there is evidence to suggest that staff become used to the observer and continue with their usual practice.

Figure 10.2 Essential knowledge and skills for the clinical transfusion process

If you choose to develop your own materials, this will require careful planning and dedicated time. All learning materials should be critically reviewed by subject experts. Due to the large numbers of staff involved in blood transfusion practice, e-Learning education programmes in transfusion have been developed and may be useful in the training programme. However, e-Learning should not be seen as an easy answer, since it requires a comprehensive support strategy.

This must cover the following:

• Access to computers for staff
• Connectivity and bandwidth
• Security of personal information
• IT skills of the learner (consider providing the first e-Learning experience in a facilitated environment)
• Provision of a help line for users and technical support for learners
• Providing step-by-step user guides
• Dedicated time for training.
• Setting up e-learning champions

To access the majority of these e-Learning education programmes, the learner will need an email address and Adobe Flash Player version 8 (or higher). Some English languagelearning sites are given below. See also the list of links at the end of the manual.

Better Blood Transfusion - Continuing Education Programme
www.learnbloodtransfusion.org.uk

Bloody Easy Online Course
http://sunnybrook.nextmovelearning.com

Blood Safe Online Transfusion Course
http://www.bloodsafelearning.org.au/

Learn Cell Salvage
http://www.learncellsalvage.org.uk/

Nursing CE: Blood and Blood Product Administration
www.elearners.com/course/31266.htm

There are several different teaching methods that may be of use in delivering transfusion education. The choice will depend on the target group, the numbers that require transfusion training and the level of training required. Table 10.1 gives a brief description of some of methods.

Table 10.1 Teaching methods

Method	Description	Pros and cons
Large group teaching — lectures	Historically the most widely used teaching technique. Very useful for providing training to large numbers of learners who need the same information. Can be supported by handouts to promote call of information.	Inexpensive approach, however, the quality of lecture is dependent on the knowledge, skill and attitudes of teacher, and learners may feel they have a ‘passive’ role with lack of involvement.
Small group learning	An interactive learning approach using small group, problem based learning. The trainer has the role of facilitating, prompting and providing guidance and prompt feedback. Medical undergraduate education has moved to this approach in may countries.	This method can be used for multidisciplinary education for key staff involved in transfusion. Promotes active participation, sharing of experiences, and learning from each other.
Individual learning	Learning can be self-directed using paper based materials or e-Learning. Should not be used in isolation but integrated into the wider programme. Requires a clear strategy with standardisation of approach.	Learners must have key IT skills and access to IT resources if using e-learning packages. Individual learning is unsuitable for developing practical transfusion skills.
Simulated learning	This technique has been adapted for use in healthcare. Can be used to recreate common errors in transfusion practice e.g. ‘wrong blood’ incidents.	Expensive and only suitable for training small numbers per session.

Directive 2005/62/EC requires that in blood establishments, competence of personnel shall be evaluated regularly (Annex: 2.4). If this principle is to be extended to cover all staff involved in the clinical transfusion process, it will be necessary to consider the points that follow.

The purpose of assessment is to evaluate or measure achievement of learning and competence, and provide information for more effective teaching. There are four stages of development that an individual progresses through from acquiring knowledge to performing a task in clinical practice and these are “knows, knows how, shows how and does”, and each level requires to be assessed differently. See Figure 10.3

Level 1 and 2 theoretical competency

A number of methods can be used to assess the retention of theoretical knowledge following training. These can be paper based or part of the e-Learning programme. The advantage of the e-learning approach is that assessments are scored and recorded online, avoiding time-consuming traditional methods.

Level 3 and 4 practical competence

Formal assessment of clinical competence can be used to integrate theory with practice. Level 3 and 4 are difficult to assess. Issues that have been identified in the UK during the introduction of competency assessment for the clinical transfusion process are:

• The large number of individuals to be assessed.
• Dedicated preparation time is required for the assessor.
• Time must be allocated for the staff to be assessed
• Difficulty in finding clinical situations for assessment
• Cost

Tools for assessing practical competency are available from several organisations: examples of English language versions can be found at the sites below:

http://www.npsa.nhs.uk/patientsafety/alerts-and-directives/notices/blood-transfusions
http://www.skillsforhealth.org.uk

A description of the methods that can be used assess theoretical and practical competency is provided in table 10.2.

Table 10.2 Assessment of knowledge and competency

Method	Description
Background Knowledge Tests	Short, simple questionnaires for use prior to implementing a training programme or introducing an important new topic.
Multiple-choice questions (MCQ)	Measures both simple knowledge and complex concepts. MCQ can be answered quickly and can be easily and reliably scored.
True-false questions	Are less reliable because random guessing may produce the correct answer. However, they provide a method for recall and can be easily and reliably scored.
Matching tests	An effective way to test learners’ recognition of the relationships between words and definitions and categories and examples.
Checklist evaluation	Useful for evaluating any competency that can be broken down into specific behaviours, activities or steps that make up a task or procedure. Can also be used for self-assessment of practice skills.
Objective structured clinical examination (OSCE)	Assessments are administered at a number of separate standardised patient encounter stations. Each station lasting 10-15 minutes.
Live simulated situation	Imitate but do not duplicate real life situations. ‘Actor’ patients or mannequins can be used and scenarios can be administered individually or in groups. They are resource intensive however, and the assistance of technical expertise is required.
Computer simulation	Expensive to create, however, provides an opportunity to assess skills without possible harm to live patients. There is exposure to standardised training content and the ability to provide immediate feedback to the learner.
Direct observation of practice	Assessment takes place in a real practice setting. Desired or proficiency required in specific behaviours in conducting skill have to be demonstrated.
Videotaping a practice session	Seen as a poor assessment technique however, as it captures performance and not competence.

Records of training and assessment of B.E staff are required by Directive 2005/62/EC. Suitable records would show for each person that the required training, assessments and updating had been undertaken. A training record should, as a minimum, contain the following information:

• Name of trainee
• Unique identification number
• Place of work
• Date of training session
• Type of training session
• Length of time of training
• Training method
• Name of the trainer(s)
• Evaluation method
• Attainment achieved
• Record of assessment of competence

These principles would also apply to training records for staff involved in the clinical transfusion process.

The evaluation of the teaching programme against predetermined goals can help determine the overall effectiveness of several components. This includes participant learning, trainer effectiveness, learning environment, use of resources and organisational impact. The main areas of importance are:

• Educational outcomes — has understanding and retention of knowledge following a training session improved?
• Clinical outcomes — has occurrence of transfusion critical incidents or specific aspects of transfusion practice improved (e.g. patient observation during transfusion, documentation of indication for transfusion in case notes etc.)?
• Qualitative and quantitative feedback by trainees and trainers — can be used to evaluate particular teaching sessions. Questionnaires can be paper based or electronic.

Evaluation by trainees

Areas to evaluate:

• Facilities used for training e.g. venue, access to venue for face-to-face teaching
• Access to IT resources for computer based learning
• Did the teaching session cover pre-defined key learning objectives
• Likely impact or anticipated change in clinical practice
• Quality and content of teaching material
• Quality and content of any handout material
• Quality of teaching method
• Clarity of presentation

Evaluation by trainers

Areas to evaluate:

• Facilities available for training e.g. venue etc
• Key learning objectives clearly defined
• Clear information available regarding training needs of target group
• Training provision for teaching and facilitation skills (‘training the trainer’)
• Resources available for teaching
• Quality of teaching material (learner feedback on slides, handouts etc)
• Accessibility to training (e.g. computer based learning)

It is recognised that immediately following training, staff demonstrate higher levels of awareness, motivation and performance, but in time this may decline and bad habits may return to reduce the quality of the work. Suggestions for achieving commitment and maintaining momentum between training sessions are:

• Maintain regular communication with staff
• Be visible
• Use hospital newsletters, hospital intranet, informal teaching/lecturing sessions to promote e-Learning programmes and other learning opportunities
• Set up a network of interested individuals in clinical areas to help disseminate information
• Make sure that protocols and guidelines are available to all the people that should be using them
• Use early feedback to clinical areas of transfusion events or reactions, and lessons learned
• Encourage trainees/learners to provide feedback on training

Implementing a transfusion training and education programme can be very challenging. Finance and facilities may be inadequate to meet the training needs of a large diverse group of staff. Strong and sustained support from management, backed with resources for necessary people and materials is essential.

Table 10.3 Teaching methods

Triangle of knowledge/ clinical skills competence/performance (Adapted from Miller 1980)

Dr Guenther J Wittauer, Head of Blood Services,
Austrian Red Cross Blood Services; Head of Administration,
Austrian Red Cross Blood Donation Centre for Vienna,
Lower Austria and Burgenland, AUSTRIA

Dr Christof Jungbauer, Head of Laboratories,
Austrian Red Cross Blood Donation Centre for Vienna,
Lower Austria and Burgenland, AUSTRIA

Dr Petr Turek, Head of National Blood Transfusion Committee,
Thomayer Teaching Hospital, Prague, CEZCH REPUBLIC

Dr Jiri Masopust, Vice President of the Czech Society for
Transfusion Medicine / Head of Department of Transfusiology,
Masaryk Hospital Usti nad Labem, CEZCH REPUBLIC

Dr Lenka Walterova, Chief, Department of Haematology,
Liberec Regional Hospital, Liberec, CZECH REPUBLIC

Dr Riin Kullaste, Director of Blood Centre, North Estonia Medical Centre, ESTONIA

Dr Georges Andreu, Medical and Scientific Director,
National Institute of Blood Transfusion, FRANCE

Dr Genevieve Gondrexon, Establissement Francais du Sang Lorraine Champagne, FRANCE

Professor Christian Seidl, Vice-Medical Director,
Institute of Transfusion Medicine and Immunohaematology,
German Red Cross, GERMANY

Dr Olga Marantidou, Scientific Director,
Greek National Blood Centre, GREECE

Dr Eleftheria Zervou, Blood Bank Director,
University Hospital of Loannina, GREECE

Dr Eleni Theodori, Blood Bank Director, University Hospital of Patras, GREECE

Dr Vincenzo de Angelis, Director,
Transfusion Medicine Department, Azienda Ospedaliero-
Universitaria, ‘S. Maria della Misericordia’- UDINE (Italy)

Dr Stefan Laspina, Consultant in Transfusion Medicine,
Mater Dei Hospital, MALTA

Dr Magdalena Letowska, Deputy Director for Transfusion
Medicine, Institute of Haematology and Transfusion Medicine,
POLAND

Dr Margarida Amil, Chief of Service of Imunohemoterapia,
Centro Hospitalar do Porto, PORTUGAL

Dr Fatima Nascimento, Chief of Service in Transfusion
Medicine and member of the Board of Portuguese Blood
Institute, Portuguese Blood Institute, PORTUGAL

Dr Laura Castro, Director of the Regional Blood Centre of Lisbon, PORTUGAL

Dr Erika Deak, Assistant Professor,
Department of Physiology and Immunology,
University of Medicine and Pharmacy,
Victor Babes Timisoara, ROMANIA

Dr Alina Debrota, Director, Regional Blood Transfusion Centre
of Constanta, ROMANIA

Dr Andy Rosin, Director of Transfuziology Center, International
Collaborations, ROMANIA

Dr Dragoslav Domanovic, Director of Blood Supply
Department, Blood Transfusion Centre of Slovenia, SLOVENIA

Professor Rene R P de Vries, Head of Blood Transfusion
Service and President of the International Haemovigilance
Network (IHN), Leiden University Medical Centre,
THE NETHERLANDS

Dr Kieran Morris, Acting Medical Director, Northern Ireland
Blood Transfusion Service, NORTHERN IRELAND

Dr Simon Stanworth, Consultant Haematologist, National Blood
Authority and Oxford Radcliff Hospitals NHS Trust, ENGLAND

Dr Shubha Allard, Consultant Haematologist, National Blood
Authority and Barts and the London NHS Trust, ENGLAND

Dr Brian McClelland, Strategy Director, Scottish National Blood
Transfusion Service, SCOTLAND

Professor Ian M Franklin, Medical and Scientific Director,
Scottish National Blood Transfusion Service, SCOTLAND

Liz Pirie, Transfusion Education Specialist, Scottish National
Blood Transfusion Service, SCOTLAND

Advisory Board
Dr Dragoslav Domanic,
Director of the Blood Transfusion Centre of Slovenia

Professor Ian Franklin,
Medical and Scientific Director of the Scottish National Blood
Transfusion Service

Ms Lynda Hamlyn,
Chief Executive of NHS Blood and Transplant, UK

Mr Angus Macmillian, Douglas,
Former National Director of the Scottish National Blood
Transfusion Service

Prof. Dr. med. Dr. h. c. Erhard Seifried,
Ärztlicher Direktor und Medizinischer Geschäftsführer -
Instit für Transfusionsmedizin und Immunhämatologie Frankfurt a. M.

Project Team
Professor Ian Franklin
Medical and Scientific Director

Dr Brian McClelland
Consultant

Mrs Elizabeth Pirie
Transfusion Nurse Specialist, Better Blood Transfusion
Programme

Mrs Shirley Russell
Project Support Officer

General

Schramm WG ed. (1990) Blood safety in the European Community: an initiative for optimal use. ISBN 3-00-005705 European Commission

Schramm WG et al eds (2009) Report of European Symposium on Optimal Clinical Use of Blood Components April 24th-25th 2009, Wildbad Kreuth, Germany. In preparation

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

Council of Europe (2008) Guide to the preparation, use and quality assurance of blood components, 14th edition, ISBN 978-92-871-6330-1. Council of Europe Publishing

Scottish Intercolegiate Guidelines Network (2001) Perioperative Blood Transfusion for Elective Surgery, 54, Edinburgh

National Institute for Health and Clinical Excellence (2006)
‘The Guidelines Manual’, London, www.nice.org.uk

Smith, L.A. (2006) NHS Highland Clinical Governance Strategy and Risk Management, NHS Highland

Systematic reviews

Carless PA, Henry DA, Moxey AJ, O’Connell DL, Brown T, Fergusson DA. (2006) Cell salvage for minimising perioperative allogeneic blood transfusion Cochrane Database of Systematic Reviews Issue 4

Carson JL, Hill S, Carless P, Hebert P, Henry D. (2002) Transfusion triggers: a systematic review of the literature Transfusion Medicine Reviews Jul; 16,3,187-99

Hill SR, Carless PA, Henry DA, Carson JL, Hebert PC, McClelland DB, Henderson KM. (2000) Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion Cochrane Database of Systematic Reviews Issue 1

Stanworth SJ, Hyde C, Brunskill S, Murphy M. (2005) Platelet transfusion prophylaxis for patients with haematological malignancies: where to now? British Journal of Haematology 131, 5, 588-95

Stanworth SJ, Hyde C, Heddle N, Rebulla P, Brunskill S, Murphy MF. (2004) Prophylactic platelet transfusion for haemorrhage after chemotherapy and stem cell transplantation Cochrane Database of Systematic Reviews Issue 4

Stanworth SJ, Brunskill SJ Hyde CJ, McClelland DB, Murphy MF. (2004) Is fresh frozen plasma clinically effective? A systematic review of randomised controlled trials British Journal of Haematology 126, 1,139-52

Stanworth SJ, Brunskill SJ, Hyde CJ, Murphy MF, McClelland DBL. (2006) Appraisal of the evidence for the clinical use of FFP and plasma fractions Best Practice and Research Clinical Haematology, 19, 1, 67-82

Wilson J, Yao GL, Raftery J, Bohlius J, Brunskill S, Sandercock J, Bayliss S, Moss P, Stanworth S, Hyde C (2007) A systematic review and economic evaluation of epoetin alfa, epoetin beta and darbepoetin alfa in anaemia associated with cancer, especially that attributable to cancer treatment Health Technology Assessment Apr, 11, 13,1-220

Original papers

Auroy Y, Lienhart A, Péquignot F, Benhamou D. (2007) Complications related to blood transfusion in surgical patients: data from the French national survey on anesthesia-related deaths Transfusion Aug, 47 (2 Suppl): 184S-189S

Carson JL, Terrin ML, Magaziner J, Chaitman BR, Apple FS, Heck DA, Sanders D. (2006) FOCUS Investigators Transfusion trigger trial for functional outcomes in cardiovascular patients undergoing surgical hip fracture repair (FOCUS) Transfusion 46 (12): 2192-206

Hansen E., Knuechel, R., Altmeppen J., Taeger, K. (1999b) Blood irradiation for intraoperative autotransfusion in cancer surgery: demonstration of efficient elimination of contaminating tumor cells. Transfusion, 39, 608–614

Hébert PC, Wells G, Blajchman MA et al. (1999) With the Transfusion Requirements in Critical Care Investigators for the Canadian Critical Care Trials Group A multicentre, randomized controlled clinical trial of transfusion requirements in critical care New England Journal of Medicine 340: 409–17

Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS. (2006) The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants Journal of Pediatrics Sep; 149, 3, 301-307

Lienhart A, Auroy Y, Péquignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. (2006) Survey of anesthesia-related mortality in France Anesthesiology Dec; 105(6): 1087-97.

Mangano DT, Miao Y, Vuylsteke A, Tudor IC, Juneja R, Filipescu D, Hoeft A, Fontes ML, Hillel Z, Ott E, Titov T, Dietzel C, Levin J; (2007) Investigators of The Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery JAMA Feb 7, 297, 5, 471-9.

McLellan, S.A., Walsh, T.S. and McClelland, D.B.L. (2002) Should we demand fresh red blood cells for perioperative and critically ill patients? British Journal of Anaesthesia, 89, 537-540 (Editorial) Rao SV, Jollis JG, Harrington RA, Granger CB, Newby LK, Armstrong PW, Moliterno DJ, Lindblad L, Pieper K, Topol EJ, Stamler JS, Califf RM. (2004) Relationship of blood transfusion and clinical outcomes in patients with acute coronary syndromes JAMA 292:1555-62.

SAFE Study Investigators (2004) Australian and New Zealand Intensive Care Society Clinical Trials Group; Australian Red Cross Blood Service; George Institute for International Health, Myburgh J, Cooper DJ, Finfer S, Bellomo R, Norton R, Bishop N, Kai Lo S, Vallance S. New England Journal of Medicine 350 2247-2246

Saline or albumin for fluid resuscitation in patients with traumatic brain injury New England Journal of Medicine 2007; 357,874-84

Sirchia, G., Giovanetti, A.M., Mc Clelland, B., Fracchia G.N. (eds.) (1994) Safe and good use of blood in surgery (SANGUIS) Use of blood products and artificial colloids in 43 European hospitals Report No. EUR 15398 EN, Office for Official Publications of the European Communities, Brussels/Luxembourg

Sanguis Study Group 91994) Use of blood products for elective surgery in 43 European hospitals Transfusion Medicine 4: 251–68.

The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. Journal of Pediatrics 2006 Sep; 149(3): 301-307

Thomas MJ. (1999) Infected and malignant fields are an absolute contraindication to intraoperative cell salvage: fact or fiction Transfusion Medicine 9, 269–278

Voak, Chapman and Phillips (2001) Quality of transfusion practice beyond the blood transfusion laboratory is essential to prevent ABO-incompatible death Transfusion 10, 2,95-96

Walsh TS, McArdle F, McLellan SA, Maciver C, Maginnis M, Prescott RJ, McClelland DB. (2004) Does the storage time of transfused red blood cells influence regional or global indexes of tissue oxygenation in anemic critically ill patients? Crit Care Med Feb; 32, 2,364-71.

Weiskopf RB, Feiner J, Hopf H, Lieberman J, Finlay HE, Quah C, Kramer JH, Bostrom A, Toy P. (2006) Fresh blood and aged stored blood are equally efficacious in immediately reversing anemia-induced brain oxygenation deficits in humans Anesthesiology May; 104, 5, 911

International

World Health Organisation

Provides extensive resources on all aspects of transfusion. Resources for clinical transfusion practice improvement include:

• The Clinical Use of Blood in Obstetrics, Paediatrics, Surgery & Anaesthesia, Trauma & Burns. (English, Portuguese, Spanish)

• The Clinical Use of Blood Handbook (English, Portuguese, Spanish)

• Recommendations on Developing a National Policy and Guidelines on the Clinical Use of Blood (English, Portuguese, Spanish, French).

http://www.who.int/bloodsafety/en/

 

International Haemovigilance Network: Resources include haemovigilance definitions, definitions, and downloadable papers on haemovigilance.
http://www.ihn-org.net/Portal.aspx

International committee of commonality in blood banking (ICCBBA) manages the ISBT 128 coding system. This is the global standard for the identification, labeling and information processing of human blood, tissue and organ products.
http://www.iccbba.org/

Europe

European Commission

European Commission Public Health Programme: In addition to the Eu Optimal Use of Blood project, the Commission supports the following projects
http://ec.europa.eu/health/index_en.htm

• EU-Q-Blood SOP Project: Development of a pan-European standard operating procedure (SOP) methodology reflecting European best practice within the area addressing the quality and safety of blood.
  http://www.eu-q-blood-sop.de/

• European Blood Inspection System: Contains publications of this 'sister project', including Manual for Developing Standard Operating Procedures and Inspection Guide.
  www.eubis-europe.eu/

• Domaine:A collaborative project to develop resources for blood donor management in Europe. Includes donor recruitment strategies, donor retention strategies, deferral procedures and blood bank policy regarding patients requiring long-term transfusion
  http://www.domaine-europe.eu/

Council of Europe: European Directorate for Quality of Medicines (EDQM): EDQM now hosts and manages the Council of Europe (programme on blood transfusion, including production of the Guide to the Preparation, Use and Quality Assurance of Blood Components. On the CoE site, search blood transfusion to access relevant pages. The 15the Edition of the Guide should become available on the website during 2010.
http://www.edqm.eu

Report on the collection, testing and use of blood and blood components in Europe in 2004

Haemovigilance Programmes of EU member states

• Denmark http://www.haemovigilance.dk/index_eng.htm
• France http://www.ints.fr
• Netherlands http://www.tripnet.nl/pages/nl/
• Luxembourg http://www.croixrouge.lu/
• Norway http://www.hemovigilans.no/
• Republic of Ireland http://www.giveblood.ie/Clinical_Services/Haemovigilance/
• Spain http://www.msc.es/profesionales/saludPublica/medicinaTransfusional/home.htm
• UK http://www.shotuk.org/

European Blood Alliance: Contributes to safety and security of the blood supply in Europe by developing and maintaining a network of partner blood services across Europe. Co sponsor of this Manual and website.
www.europeanbloodalliance.org

Eurocode (International Blood Labeling Systems): Website is currently uninformative
www.eurocode.org/content/index.html

German medical Association (Bundesaertzekammer): Includes the 2009 cross sectional guidelines for therapy with blood components and plasma derivatives.
http://www.bundesaerztekammer.de/

English language translation of the 2009 cross sectional guidelines for therapy with blood components and plasma derivatives:
http://www.bundesaerztekammer.de/downloads/LeitCrossBloodComponents4ed.pdf

UK Blood Services Professional Advisory Committee: Includes an evidence library with index of systematic reviews and randomised clinical trials relevant to transfusion. Toolkit of resources for quality improvement in transfusion practice and other resources, Handbook of transfusion medicine, Guidelines for the UK blood services.
http://www.transfusionguidelines.org.uk/

British Blood Transfusion Society: Provides information about education, professional development and training activities.
http://www.bbts.org.uk/

British Committee for Standards in Haematology: Displays UK Guidelines for transfusion and other aspects of haematology.
http://www.bcshguidelines.com/

National Institute for Clinical Excellence in the UK: Provides national evidenced based guidance for health professionals. Tools to support service redesign and implementation of NICE guidance.
http://www.nice.org.uk/

National Institute for Health Centre Graduate Medical Education: Training Programs: Has developed a comprehensive portfolio of clinical research training and medical education initiatives.
http://www.cc.nih.gov/index.html

National Patient Safety Agency: Provides a toolkit of resources to assist with improving patient safety. Has information on safe patient identification and competency assessment for blood transfusion.
http://www.npsa.nhs.uk/

NHS Quality Improvement Scotland:An organisation which asists NHS hospitals in Scotland to improve patient care by setting standards. Assesses and measures the performance of hospitals against these standards. Standards for blood transfusion and the peer review inspection reports are available.
http://www.nhshealthquality.org/

Network for the Advancement of Transfusion Alternatives

Provides information about alternatives to transfusion.
http://www.nataonline.com/

Scottish Intercollegiate Guidelines Network (SIGN)

Developed an evidence-based guideline, which aims to maximise patient safety by helping clinicians decide when transfusion is appropriate.
http://www.sign.ac.uk/

Scottish National Blood Transfusion Service

Better Blood Transfusion -continuing education programme
An elearning programme designed at three levels. Targets all practitioners involved in the clinical transfusion process.
http://www.learnbloodtransfusion.org.uk/

Skills for Health

Provides resources to assists the UK health sector develop a skilled workforce e.g. career pathways, competencies.
http://www.skillsforhealth.org.uk/

Centre for Maternal and Child Enquiries

The Centre for Maternal and Child Enquiries' mission is to improve the health of mothers, babies and children by carrying out confidential enquiries on a UK wide basis.

• Maternal death enquiry
• National perinatal and maternal mortality surveillance
• Maternal and perinatal enquiry projects
• Child health enquiry projects

http://www.cmace.org.uk

 

Australia

Australian Blood Services

Gives health professionals access to information about blood and blood products, from donation to transfusion and beyond. It includes a Transfusion Medicine Manual, which contains more detailed information about blood products and clinical practice. Circular of information about blood components (2009), links to e- learning sites and a variety of downloadable resources.
http://www.transfusion.com.au/home.aspx

Canada

Canadian Transfusion Safety Officers

Provides access to clinical and technical guidelines and a variety of downloadable resources.
http://www.transfusionsafety.ca/

Canadian Institutes for Health Research and the Heart and Stroke Foundation of Canada: Offers training in blood transfusion science. http://www.cbr.ubc.ca/STPTS.htm

TraQ Program of the British Columbia Provincial Blood Coordinating Office

Focuses on quality improvement among transfusion medicine professionals through timely sharing of educational resources related to current best practices and guidelines in transfusion medicine. Website offers multiple educational tools, including a resource library, interactive case studies, regulatory information, Canadian, international, industry and government news, job postings, events calendar, patient resources, and more.
http://www.TraQprogram.ca/

Report of the Krever Inquiry into the blood system in Canada.

Provides an extensive account of responses to HIV and Hepatitis C in relation to transfusion in Canada and internationally
www.hc-sc.gc.ca/ahc-asc/activit/com/krever_e.html

USA

Harvard Medical School Fellowship Program in Transfusion Medicine

Offers a core curriculum for blood transfusion. http://www.harvardtransfusion.org/curriculum.pdf

The Joint Commission (Health Care Accreditation)

Accredits and certifies more than 16,000 health care organizations and programs in the United States. 34 www.jointcommission.org/