Clinical governance

Blood safety and quality in the UK

Approximately 2.4 million blood components were administered in the UK in 2017 (Bolton‐Maggs [27]). The transfusion of blood and its components is usually safe and uneventful; however, there are associated risks and there have been significant developments over recent years to improve the quality and safety of transfusion practice in the UK. The Blood Safety and Quality Regulations came into effect in 2005 and cover the collecting, testing, processing, storing and distributing of blood and blood components (BSQR [34]). The official government agency with jurisdiction for these regulations is the MHRA.
The principal requirements of the regulations in relation to transfusion practice are as follows.
  • Traceability: there must be a full audit trail from the donor to the recipient, so hospitals must have a system to record and retain information on the fate of each unit of blood or blood component. These records must be kept for a period of 30 years.
  • Haemovigilance: this is an organized surveillance procedure relating to serious adverse or unexpected events or reactions. The reporting of such events can be done via the online Serious Adverse Blood Reactions and Events (SABRE) system, which is maintained by the MHRA. This will usually be done by a designated member of laboratory staff or transfusion practitioner and therefore clinical staff must ensure that all incident reporting is conducted in line with hospital policy.
The Blood Safety and Quality Regulations ([34]) define serious adverse or unexpected events or reactions as follows:
  • A serious adverse event is defined as an unintended occurrence associated with the collection, testing, processing, storage and/or distribution of blood or blood components that might lead to death or life‐threatening, disabling or incapacitating conditions for patients or that results in, or prolongs, hospitalization or morbidity.
  • A serious adverse reaction is defined as an unintended response in a donor or a patient associated with the collection or transfusion of blood components that is fatal, life‐threatening, disabling or incapacitating, or that results in or prolongs hospitalization or morbidity.
Prior to these regulations, ‘Better Blood Transfusion’ initiatives (still relevant today) aimed to ensure that such guidance became an integral part of NHS care, making blood transfusion safer, ensuring that all blood used in clinical practice is necessary, and improving the information both patients and the public receive about blood transfusion (DH [62]). Therefore, it is a key requirement that all staff involved in the process of transfusion maintain their awareness of all appropriate guidance.

Competencies

The transfusion of any blood component is not without risk and carries with it the potential for reaction (Bolton‐Maggs [27]). All staff involved in the transfusion of blood and/or blood components must have the knowledge and skills to ensure the process is completed safely. Therefore, nurses caring for patients receiving transfusion therapy must do so within their sphere of competence, always acting to minimize risk to patients (NMC [198]).
Practitioners must understand the theory and reasoning behind transfusion procedures and practices (Pirie and Gray [219]). In November 2006, the National Patient Safety Agency (NPSA), the Chief Medical Officer's National Blood Transfusion Committee (NBTC) and SHOT, working in collaboration, developed strategies aimed at ensuring that blood transfusions are carried out safely, and issued Safer Practice Notice No. 14: Right Patient, Right Blood (NPSA [203]). One of the key action points in this notice was for all NHS and independent sector organizations involved in administering blood transfusions to develop and implement an action plan for competency‐based training and assessments for all staff involved in blood transfusions. In 2017, the BSH stated that the evidence for recommending a frequency for training is low (Robinson et al. [236]). Robinson et al. ([236]) highlight that since the SHOT scheme was launched (in 1996), it has continued to report that despite individuals being competency assessed, transfusion errors still occur. Transfusion committees across the UK have reviewed their practices and made their own recommendations, and the BSH (Robinson et al. [236]) has published a summary of training and competency assessments requirements in the UK by country (Table 12.24).
Table 12.24  Summary of training and competency assessment requirements in the UK by country
EnglandWalesScotlandNorthern Ireland
Theory, training and knowledge assessment
All staff involved in the transfusion process should receive training no less frequently than 3‐yearly (2‐yearly for blood collection).
Knowledge and understanding assessment should be performed at least every 3 years (2 years for blood collection).
There should be annual competence‐based educational updates for staff involved in collection of blood from the issue fridge/local storage facility, with assessment of competence as agreed locally in compliance with the Blood Safety and Quality Regulations ([34]).
There should be biennial training for other staff involved in sampling and/or administration of blood.
There should be continued monitoring of the competence of all relevant staff through the appraisal process.
The NHS Quality Improvement Scotland (NHS QIS)c12-note-0009 Clinical Standards: Blood Transfusion ([183]) required 2‐yearly theoretical knowledge training for all staff involved in the transfusion process.
In 2015, NHS Healthcare Improvement Scotland (NHS HIS)c12-note-0009 reviewed these improvement standards against current practice/guidance and archived the standards.
It has been recognized that the 2‐yearly training/updating requirement for all staff involved in the transfusion process is embedded in NHS Scotland's health boards, supported and reported on by Better Blood Transfusion to the Scottish Transfusion Advisory Committee.
Minimum training requirements for clinical and support staff involved in transfusion practice should be 3‐yearly knowledge updates (RCN [227]).
There should be 3‐yearly training in blood components and their indications for use for doctors who authorize (prescribe) blood components.
Healthcare staff should update their knowledge of transfusion that is relevant to their clinical practice and be able to demonstrate evidence of this in their appraisal documentation.
Practical observed competency assessment
Following an individual's initial training, a one‐off practical competency assessment must be undertaken. This practical assessment need not be repeated if there is ongoing satisfactory performance but it should be repeated if there is a period of greater than 1 year out of a workplace where transfusion routinely takes place.
There must be a competency assessment of relevant staff (e.g. newly qualified staff).
Review evidence of competence for new employees assessed elsewhere.
Staff involved in the collection and delivery of blood components should undertake competency‐based assessment for this role at least every 2 years, as agreed locally in compliance with the Blood Safety and Quality Regulations ([34]).
Practical competency assessment in the transfusion roles practised by staff must be done at a minimum of 3‐yearly intervals.
Staff involved in the collection and delivery of blood components should undertake competency‐based assessment for this role at least every 2 years.
Sources   
National Blood Transfusion Committee ([173], [174])Welsh Blood Service (Shreeve, [254])Scottish Clinical Transfusion Advisory Committee (personal communication, 2017)Northern Ireland Transfusion Committee (personal communication, 2016)
* NHS Quality Improvement Scotland (NHS QIS) was replaced by NHS Healthcare Improvement Scotland (NHS HIS) in April 2011.
Source: Adapted from Robinson et al. ([236]).
There are three key principles that underpin every stage of the blood component transfusion process:
  • patient identification
  • documentation
  • communication (Robinson et al. [236]).

Non‐medical written instruction to transfuse

Section 130 of the Medicines Act ([156]) was amended by Regulation 25 of the Blood Safety and Quality Regulations ([34]) and this has resulted in blood components being excluded from the Act (Green and Pirie [93]). In this way, blood components were removed from the legal definition of medicinal products and they can no longer be legally prescribed by any practitioner. Blood components are therefore authorized by a competent practitioner and a written instruction is completed for transfusion. The amendment to the Medicines Act also removed the legal barrier to nurses expanding their role to authorize blood components. This does not mean, however, that all nurses can make the decision to transfuse blood components or authorize their use with a written instruction. Green and Pirie ([93]) developed a document for nurses and midwives who wish to expand their role. This framework contains clear guidance for the implementation of non‐medical authorization of blood components while ensuring patient safety. The guidance includes advice on selecting the patient group, selection criteria for nurses and midwives, education and training required to support role development, clinical governance procedures, safe and appropriate practice, and how to review and monitor improvements to local services (Green and Pirie [93]).

Consent

In 2010 the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) undertook a public consultation on consent for blood transfusion. A total of 14 recommendations were published following the consultation (SaBTO [239]). They recommended that valid consent for transfusion should be obtained and documented in the patient's record by the healthcare professional. SaBTO also recommends that patients who cannot give consent before a transfusion should receive information retrospectively. The Good Practice Guidance (SaBTO [239]) states that retrospective information can be given at any point during the hospital stay but recommends that it is incorporated in the discharge procedure. The retrospective information should include the risk of a transfusion‐transmitted infection and inform the patient that, as they have received a blood component, they can no longer donate blood (SaBTO [239]).
Providing the patient with information before a procedure and ascertaining that the patient understands the procedure and has consented to it is the responsibility of the healthcare professional carrying out the procedure as well as those ordering it (NMC [198]). A blood component transfusion must be treated like any prescribed medicine: that is, patients (or their guardian) must be informed of the indication for the transfusion, advised of the risks and benefits, and told about alternatives to blood transfusion, including autologous transfusion (Robinson et al. [236]). They should also be given the opportunity to ask questions and have the right to refuse to receive the transfusion in accordance with local and national guidance (NMC [198]). One of the key objectives of the Better Blood Transfusion initiative (DH [62]) was to improve information provided to patients and to ensure that those who are likely to receive a blood transfusion will be well informed of their choices. There are a number of information leaflets issued by the NHS Blood and Transplant Service for both patients and healthcare professionals. Guidance is also available from SaBTO ([239]) to ensure that patients receive standardized information prior to a transfusion; this guidance outlines all the key information that should be provided.
Patients with mental capacity have the legal and ethical right to refuse transfusion (RCS [231]), and information regarding alternative treatment must be given. Staff must respect the patient's decision and their autonomy in making the decision; this is a legal duty (RCN [229]).

Jehovah's Witnesses and other patients who may refuse a blood transfusion

Patients may choose to refuse a blood transfusion for a variety of reasons. Principles in caring for patients remain the same regardless of the reason for refusal and there should be a local policy in place to expedite non‐blood management for these patients.
The role of blood in Jehovah's Witnesses’ spiritual belief is based on scripture and followers are usually well informed on both their beliefs and their rights. The need to ensure informed consent is very important. Jehovah's Witnesses’ religious position leads them to refuse red cells, white cells, plasma and platelets. Derivatives of these are seen as a matter of individual patient choice. Staff caring for patients must ensure that they have clearly documented what the patient will accept or refuse and that decisions to consent to or refuse treatment are respected and recorded appropriately (Norfolk [202]). Furthermore, in individual circumstances, practitioners should endeavour to consider non‐blood or autologous methods, as described previously, where appropriate (Norfolk [202]). Jehovah's Witness patients usually carry an advance directive listing which blood products and autologous procedures are acceptable or not acceptable to them (Norfolk [202]). The Jehovah's Witness community has a network of support called Hospital Liaison Committees and they are available at any time, night and day, to assist with communication between hospital teams and patients.

Management of massive blood loss

Massive blood loss has several definitions, such as loss of one blood volume within 24 hours, loss of 50% blood volume within 3 hours, or a loss rate of 150 mL/min. However, the BSH Transfusion Task Force suggests that these definitions are not particularly helpful in acute situations due to their retrospective nature (Hunt et al. [114]). Good patient outcomes are dependent on clinical staff recognizing the blood loss early, taking effective action and ensuring efficient communication between the clinical area and the transfusion laboratory (NPSA [205]). To aid the provision of blood in an emergency situation, the majority of hospitals will have an agreed major haemorrhage protocol in which all processes required in the provision of emergency blood are clearly stated. This includes how to activate the protocol, what blood component availability will be and how the blood components will be transferred from the laboratory to the clinical area.
In emergency situations, where the need for blood is immediate and the patient's blood group is unknown, it may be necessary to transfuse group O un‐cross‐matched red cells (Hunt et al. [114]). In major haemorrhage situations, there is still a need to use group O Rh D‐negative blood judiciously as it is a scarce resource. At the earliest opportunity, a sample should be taken from the patient so that blood group determination can take place. Once the laboratory has received the sample and determined the blood group, it can issue group‐specific blood (Hunt et al. [114]).