Whilst the majority of the patients derive improved health as a consequence of health care systems, United Kingdom published data suggests that up to 1 in 6 patients receiving hospital care suffer harm as an unintended consequence of their care (Department of Health 2006). Adverse patient events cause emotional and physical harm for patients and their families including affected staff. Generally, the overwhelming majority of adverse effects are caused by intelligent and competent individuals working in systems that are not designed to trap human errors before leading to harm. Thus, it can be well recognised that adverse patient events occur most commonly through various combinations of team, individual, organisational and environmental factors. Patient Safety is a new healthcare discipline that emphasizes on analysis, reporting and prevention of medical errors that often lead to adverse healthcare events (Department of Health, 2006). The present report provides an overview on the issues related to Managing Patient Safety by taking in to consideration the incident of Blood Transfusion. It summarises the concept of Patient Safety, System and Human factors including scenarios and recommendations.

Patient Safety

The health sector is a highly pressurised, complex system where in which the potential for error and accidents is ever present. Statistics on International Research suggests that ensuing patient safety is one of the most important challenges faced by the healthcare today, not only in the United Kingdom but also worldwide. It was observed that the root cause of various events and accidents together with a majority of mistakes taking place in medical environment, is the system itself-a system whose flaws eventually lead to a “human error”. The Patient Safety initiative is an innovative, proactive approach that provides basis for eliminating the flaws from the system before they result in to needless tragedies. According to World Health Organisation (2011), Patient safety can be defined as a “fundamental principle of health care” (WHO, 2011). Precisely, the improvements concerning to patient safety demand a complex-system of wide effort, environmental and safety risk management, including infection control, safe and effective use of medicines, clinical practices and care. Nevertheless, this new patient safety perspective was been developed in United Kingdom through an initial study, commissioned by the Department of Health and Design Council, to deliver ideologies and recommendations for a design approach to minimise the risk of medical error and to promote patient safety across the National Health Service (Department of Health, 2006).

On the other hand, Risk an inherent part of health care may lead to severe complications while delaying them might be even more dangerous. At the moment, in NHS assessing risk has become part of the process of supporting patients and controlling safety in hospital setting. Documentation of risk is a key to review and improve patient care and it forms the basis for future investigations. Risk assessments carefully examine the systems to identify the factors that could potentially cause or contribute to patient harm (Department of Health, 2004). These assessments highlight whether adequate precautions are being taken to ensure timely and safer provision of care. Additionally, it indicates further measures needed in future to prevent harm and risk to the patients (Department of Health, 2006). The National Patient Safety Agency (2004) demonstrated the importance of risk assessment when it published seven steps to patient safety. These steps included the need to integrate the activity of risk management, involve patients and implement solutions to prevent potential harm (National Patient Safety Agency, 2004). Within NHS, Risk Assessment is highly essential as it allows practitioners to minimise both the risk itself and the underlying consequences of an adverse effect. Risk Assessment provides an early warning system and thus maximise the probability of positive outcomes. Thus, Risk Assessment as a tool was proved to be more effective and has offered a holistic approach that when used in combination with clinical judgment seems extremely effective and efficient. In essence, the tool is the key to ward-based risk management and patient evaluation (Royal College of Nursing, 2004).

The Scenario

The incident accounted for the present study was on the Blood Transfusion process and this persists within the area of health care. Before exploring the patient safety considerations in relation to this incident, it is very important to discuss the relevant problems and the standards implemented by health organisations. The following paragraphs help us in understanding the process of transfusion with a broader perspective on regulations.

The therapy of Blood Transfusion can save and enhance patient’s lives, but much careful consideration should be given to their associated dangers. The Nurses employed with in a Health Care Service must demonstrate high skills and knowledge in caring patients who receive blood components. As per the statistics of Serious Hazards of Transfusion (SHOT) around 2, 914, 228 blood components were been issued from the United Kingdom blood services in the year of 2006-2007. Nurses and midwives involving in the process of transfusion are therefore required to possess knowledge, skills and competence to ensure a safe practice. Till date, many research studies that were been carried out have shown the presence of statistical errors outside the transfusion laboratory (Brooks, 2005). These errors include mistakes made during collection of blood components, monitoring patients before, during and after the process of transfusion. The Blood Safety and Quality Regulations (2005) specify standards for the safety and quality with regard to collection, testing, processing, storage and distribution of human blood sample and its components. These regulations aim in blood establishments and hospital transfusion laboratories as they play vital role in safe blood component transfusion process (Blood Safety and Quality Regulations, 2005).

It must be understood that, giving a blood component to a specific patient exposes them to potential risk. The most commonly assumed greater risk of transfusion to a patient is that they will contract an infection from a blood component. It is the critical responsibility of the staff and health services to acknowledge and understand these risks. One of the most vital considerations in making sure the right blood gets to the correct patient is the provision of scrupulous attention to identification of a patient. Correct patient monitoring is the crucial part of safe transfusion process in order to be able to recognise and manage the transfusion process.

Current risk from the transfusion process is largely due to non-infectious hazards and overall process defects pertaining to delivery of safe transfusion therapy. Safety in transfusion therapy depends upon integration of varied hospital services together with nursing, anaesthesia, surgery, clinical support and transportation. Dzik and his colleagues (2003) identified new solutions to the process of blood transfusion and patient safety. They identified that safe transfusion therapy depends upon the complex process requiring integration and coordination among multiple hospital services (Dzik et al., 2003). However, several technology-based solutions for ensuring transfusion safety rely on the larger issue of technology for patient identification (Dzik et al., 2003). Thus, the devices for the transfusion safety hold an exciting promise, but they must undergo clinical trials to show effectiveness and ease of use. Technology solutions will likely require an effective combination with delivery of pharmaceuticals to make it financially acceptable to hospitals (Dzik et al., 2003).

Human Factors

Before analysing the role of Human Factors in Transfusion process, it is highly crucial to be aware of difficulties that may arise during the process of transfusion and post transfusion periods. The problems encountered comprise of Non Haemolytic febrile reactions (resulting from donor white cell antigen/antibody reaction), Fluid Overload, Benign Allergic reactions (like rashes, prutitis, urticaria and true anaphylaxis), Transfusion related lung injury (Acute non cardiac pulmonary edema), Infections (owing to viral, bacterial and parasitic contamination) and Post transfusion Purpura (PTP) (which is a severe thrombocytopenia developed at 5-10 days of post transfusion period) (Health and Safety Executive, 1999).

According to the Health and Safety Executive (1999, p. 2), “Human factors refer to the environmental, organisational and job factors together with human and individual characteristics which influence behaviour at work in a way which can affect the health and safety. A simple way to view human factors is to think about three aspects: the job, the individual and the behaviour” (Health and Safety Executive, 1999).

Human factors are found to be closely linked to Ergonomics which is the application of scientific information concerned to humans relative to object design, systems and environment for human use (Carayon 2007). Within the context of Blood Transfusion incident, the definition of human factors explores three prime interrelated aspects: the job, the individual and the organisation (Flin, Mitchell 2009).

The Job

Tasks should be designed for the nurses working in Blood Transfusion department in accordance with the principles of Ergonomics to consider the patient limitations and strengths (Carayon, 2007). This includes correlating the job assigned to physical and mental strengths as well as limitations of the people. This perspective takes in to account the work load of the patient and nurse, working environment, nature of task assigned for the professional or Nurse, design of displays and controls and role of procedures employed in carrying out the transfusion process (Runciman, Merry and Walton 2007).

The Individual

This includes competence, skills, knowledge, personality, attitude, risk perception. The individual characteristics exhibit potential impact on behaviour through various complex ways (Reason, 2008). With the patient safety incident considered for the present study, the perceptions, abilities, education, skills, attitudes and other characteristic features of Nurses or Health Professionals need to be well studied and identified to prevent the problem pertaining to medical errors (Reason, 2008). However, the nurses working in this scenario need to understand that certain personality features are generally fixed, although the skills and attitudes may be changed or enhanced (Reader et al., 2006).

The Organisation

This includes working patterns, work place culture, availability of resources, communications, leadership and others pertaining to the individual Blood Transfusion Unit and therefore to the local health organisations (Reason, 2008). But these factors are generally overlooked during the job design for nurses and other staff, although they exert significant influence on individual and group behaviour (Moray, 2000).

Anecdotally, in the context of Blood Transfusion incident, human factors are generally concerned with what the nurses are asked to do (the task of transfusion and its characteristics), who is going to do (patient, nurse and their competency together with skills) and where the nurse and everyone are working (the Transfusion department and its attributes).

The application of Human Factors is discussed in the following section by describing the intentional and Unintentional errors.

Categorising Human Failure

It is very important to understand that human failures in relation to transfusion process are not random and there occur specific patterns for their implementation (Manser, 2009). It is worth knowing about the different failure types that lead to major accidents in the Healthcare sector:

Unintentional Errors like slips/lapses, mistakes are basically unplanned actions and these must be eliminated during the training process of human factors. Errors usually occur during the accomplishment of a familiar task such as forgetting something or omissions, maintenance, calibration and testing errors. Mistakes, on the other hand are the errors of judgment and decision making and they appear in situations when the nurse behaviour is based on remembered rules or familiar procedures or unfamiliar situations where in which decisions are formed from the first principles and lead to miscalculations. By training the nursing staff and other health professionals in Transfusion department, these types of errors can be avoided (Mc Cormick, Wardrope 2003).

Intentional Errors involve violations and these differ from the above type of errors as these are well-meaning failures such as taking a short cut or non-compliance procedures of Transfusion process. These are rarely wilful (like sabotage) and usually occur from an intention of getting the job done quickly despite of consequences. These Violations cane be Routine (behaviour in opposing to a rule and procedure), Exceptional (that prevail unusual and unpredicted circumstances), Situational (occur as a consequence of factors dictated by workers) and Acts of Sabotage (self explanatory and complex) (Manser 2009).

There are various ways to control and manage these violations in the process of transfusion process including the steps to increase detection, ensuring that rules and procedures and explaining the rationale behind the certain rules. It should be kept in mind that Human factors interventions will not be effective and efficient if the nursing professionals and the department consider them in aspects of isolation (Mc Cormick, Wardrope 2003). The scope of human factors involves Organisational systems and it is considerably a broader perspective than traditional factors or Ergonomics. Thus, to ensure a Safe Transfusion Process, Human Factors must and should be included within a good safety management system and so need to be examined in a similar way to any other risk control system (Manser, 2009).

On the whole, it can be instructed that practitioners and nurses applying human factors for measurement, safety management interventions must themselves undertake a basic introductory course on these concepts to effectively implement them in attaining patient safety.

System Factors

Over the recent years, researchers have documented the extent of errors that occur within the transfusion process and their persistent effect on patient safety. Many adverse effects result from the errors (may be intentional and unintentional) made by a person working in the Transfusion unit (Manser, 2009). As it is not possible to reduce the errors owing to human interventions, designing of specific systems to minimise these errors is significantly needed in future to enable a safe transfusion to the patients. The following sections outline the identification and approach of designing safer systems of care based in the work of human factors and reliability engineers (Morray 2000). Simply, System Factors are the errors that result from the use of automated instruments and other sophisticated techniques. The usage of these instruments and techniques by the nurse to enable a faster process may sometimes result in deliberate errors that are highly impossible to reduce (Reason, 2008).

The System Factors that can be encountered with relation to present incident include, usage of similar injection devices for all the patients, catheter and tubing misconnections, absence of control on the concentration of electrolyte solutions (that can be used to preserve the blood samples), failing to comply with the standards in the techniques used, inaccurate patient identification, not following hand hygiene to prevent health care associated infections and so on (Reason, 2008). Additionally, the problems concerned to medical devices and hi-tech coils implanted in arteries were the other system factors identified in relation to blood transfusion process.

Establishing strategies for the design of safe systems of care and patient safety in blood transfusion process is highly needed to ensure the reduction in the errors in a way by making them visible (Vincent 2003). The design of new innovative system of care involves three different tasks:

Designing the system to prevent errors

In the complex systems, like those delivering health care various distinct factors influence the rate of errors. Vincent (2003) suggested a nested hierarchy of system factors that affect the safety within team health care and these principles can be applied in Blood Transfusion process. These factors include problems encountered with the implementation of contemporary methods and other patient related factors (Vincent 2003). The proximal cause of errors and the adverse effects are closely linked with the underlying factors associated within the system and individuals. Nevertheless, to effectively prevent these errors, factors must be reconsidered in a way to implement the new system of care and in addition the less obvious factors like institutional change, work environment also need to be considered (Reason 2000).

Designing the systems to make errors visible

Though the errors cannot be minimised to zero, the aim of the system designed should be in such a way that the errors can be reduced to zero only for instances in which the errors harms the patient (Manser 2009). A safe system should be designed by employing specific procedures and attributes that make the errors visible to those working within the Transfusion departments, so that they can be corrected before making any potential harm.

Inspection or double checking like inspection of medications and prescriptions pertaining to transfusion process, checking of the nurse’s dose calculations by another nurse or through a computer are some of the examples of making the errors potentially visible. If the patients are educated about the treatment course and their medications in the context of trusting relationship, patients can also identify the errors and thus make them visible for detection and minimisation (Manser 2009).

Designing systems to mitigate the effects of errors

Not all the errors will be intercepted and intervened before reaching the patient. When certain errors go undetected, specific system processes are needed to halt them or reverse them. For instance, antidotes for high hazard drugs when they do exist they should be readily made available through sophisticated technology right at the point of administration. Many tactics can be used to make system changes and to reduce errors and adverse effects resulting from the combination of system and human factors. These include reducing the complexity, optimising the information processes and systems, wise automation techniques, use of constraints and mitigating the unwanted side effects of change (Vincent, 2003).

Thus, improvements to a system with empirical error rates in the parts per thousand will generally necessitate more sophisticated system changes including substantial use of all three types of constraints and substantial automation levels. Much is yet to be learnt about these system errors and how to design health care systems that are effective and safe. However, solid foundation of knowledge and methods exist on which to build the healthcare systems that can be deserving for both clinicians and patients.

Conclusions and Recommendations

To improve a better and safe transfusion process, following recommendations need to be followed by the professionals working within the Transfusion Unit. They include:

Each blood component must be carefully tested for consideration and before the transfusion process. A culture of elevating errors into opportunities for improvement need to be encouraged.

As there is no legal requirement in the United Kingdom, at present to gain formal written from the patient for the transfusion process of blood components, a suggestion pertaining to obtaining ethical consent need to elucidated and recommended. This can seem to be a good clinical practice to discuss the treatment options with the patients and understanding their decisions. Additionally, patients must be provided with a chance of refusing transfusion if they are not interested and should be enabled to explore alternative treatment methods if available.

Staff with in the health care organisations and Transfusion departments should be responsible to acknowledge and understand the potential risks. Besides these, at the critical stages of transfusion process, methods to confirm the identity of the patient need to be developed.

Sampling must be performed in a safe and effective manner and the collected sample must be preserved for future use under aseptic conditions.

To ensure that each blood component is used to its maximum advantage, nurses working within the transfusion unit should follow the hospital local policy standards with regard to handling, administration, storage and transportation.

Conclusively, it must be understood that blood transfusion can be life-saving and life-enhancing treatment when used appropriately and when the patients were cared for safely by knowledgeable and skilled practitioners.

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