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The Royal Marsden Hospital Manual of Clinical Nursing Procedures - Lisa Dougherty [284]

By Root 2017 0
with jurisdiction for these regulations is the Medicines and Healthcare Products Regulatory Agency (MHRA).

The principal requirements of these Regulations in relation to transfusion practice are as follows.

Traceability: whereby hospitals must have a system to record and retain information on the fate of each unit of blood/blood component for a period of 30 years.

Haemovigilance: 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 Medical Device Adverse Incident Reporting Centre. This will usually be done by a designated member of laboratory staff and therefore clinical staff must ensure that all incident reporting is conducted in line with hospital policy.

The MHRA defines such events as follows.

A serious adverse event is defined as an unintended occurrence associated with the collection, testing, processing, storage and distribution of blood or blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalization or morbidity.

A serious adverse reaction is defined as an unintended response in a donor or in a patient associated with the collection or transfusion of blood components that is fatal, life-threatening, disabling or incapacitating, or which results in or prolongs hospitalization or morbidity.

(MHRA 2005)

Prior to these regulations, Better Blood Transfusion initiatives 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 2007). 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 product carries with it the potential of reaction and risk (SHOT 2005). All staff involved in the transfusion of blood and/or blood products must have the knowledge and skills to ensure the process is completed safely. Therefore, the nurse caring for those receiving transfusion therapy must do so within his or her sphere of competence, always acting to minimize risk to the patient (NMC 2008a).

Practitioners must understand the theory and reasoning behind the necessity to follow the correct transfusion procedures and practices (Pirie and Gray 2007). In November 2006, the 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 the Safer Practice Notice (SPN) No. 14, Right Patient, Right Blood. 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. The current guideline is for all staff involved in the blood transfusion process to have completed their initial competency assessments by November 2010 (BCSH 2009, Blood Safety and Quality Regulations 2005).

There are three key principles which underpin every stage of the blood component transfusion process:

patient identification

documentation

communication (BCSH 2009).

Consent

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 prescribing it (NMC 2008b). Although blood components may not be prescribed as they are not medicinal products (Green and Pirie 2009), a blood component transfusion must be treated as any prescribed medicine, that is, patients (or guardian) must be informed of the indication for the transfusion,

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