Critically discuss the hazards associated with transfusion of plasma products. In your answer refer to the role of SHOT for monitoring such hazards.
The use of plasma products during transfusion is not without hazards (Sachs, 2010). Plasma is a fluid compartment of blood and is made of 90% water, 7% colloids/proteins and 3% nutrients and vitamins (Shaz, Abrams, Hillyer & Roshal, 2013). Plasma can be manufactured from whole blood after centrifugation and RBC removal. Plasma transfusions can be prescribed during an emergency situation like in trauma, surgery, excess bleeding, in patients with liver disease, congenital or acquired coagulation defect. Clotting factors are the constituents for which transfusion of plasma is often required (Shaz et al. 2013). The most common plasma based products are fresh frozen plasma (FFP), cryoprecipitate reduced plasma and thawed plasma that are used in hospitals and during emergency situations. Studies have shown that FFP is normally requested for non-bleeding patients with abnormal coagulation results (Pandey & Vyas, 2012). Studies conducted by Suchitra in 2006 have shown that many of the FFP transfusions conducted do not follow any guidelines (Pandey & Vyas, 2012). Plasma transfusions are associated with a number of infectious and non-infectious adverse events. Transfusion transmitted diseases include HIV, hepatitis B and C which are currently rare. Non infectious risks include Transfusion Related Acute Lung Injury (TRALI), Transfusion Associated Circulatory Overload (TACO) and acute transfusion reactions which include hypotensive and allergic reactions (Pandey & Vyas, 2012). Other less common risks include febrile non- haemolytic or haemolytic transfusion reactions and RBC/WBC allo-immunization (Bux & Sachs, 2007). In order to improve and mitigate such hazards the haemovigilance systems have emerged globally. Haemovigilance is the systematic surveillance of transfusion related adverse events or reactions, aiming to improve the safety of the transfusion process (Prinoth, 2008). It is an important part of quality management. In 1996, the Serious Hazards of Transfusion (SHOT) confidential haemovigilance reporting scheme was introduced and since then it has prompted changes in the transfusion processes. The objective of SHOT is to improve standards of transfusion practice, educate users about the different hazards involved in transfusions and inform national policy on transfusion safety (Maggs & Cohen, 2013). All the member states, according to the EU legislation, are required to report serious adverse events and reactions to Medicines and Healthcare products Regulatory Authority (MHRA) using the fully accessible online reporting system known as Serious Adverse Blood Reactions and Events (SABRE) (Maggs & Cohen, 2013). SABRE provides a single starting point for reporting to both the MHRA and SHOT although reporting to SHOT remains voluntary, but it is a standard for the Clinical negligence scheme for Trusts in England. TRALI is known to be one of the causes of transfusion-related mortality, characterised by acute hypoxemia and non-cardiogenic pulmonary oedema within 6 hours of a completed transfusion (Murphy, Pamphilon & Heddle, 2013). The key mechanism of TRALI is the activation of neutrophils within the pulmonary endothelium (Pandey & Vyas, 2012). Multiple strategies have been taken to reduce the risk of TRALI from plasma, such as donors implicated in prior TRALI reactions are deferred from further blood donation, female donors are tested for HLA and HNA antibodies and blood products with high volume plasma are not made from those with high-titre antibodies (Maggs, Poles, Watt, Thomas & Cohen, 2013). Also plasma supplied to hospitals for transfusion can be only from male donors while the female plasma is diverted for fractionation (separating various components of blood plasma). An assessment of data collected from 1996-2006 through SHOT has shown a significant decrease in TRALI following institution of such policies (Shaz et al. 2013). No cases of TRALI involving FFP were observed in the year 2013.
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Acute Transfusion Reactions (ATR) can also occur at any time up to 24 hours aftera transfusion of blood or its components. ATR’s can be classified into different types of reactions namely, febrile, allergic and hypotensive. According to the SHOT reports in 2013, a slight decrease in the number of ATR was observed. Around 320 cases were consistent with ATR’s out of which 31 occurred during the transfusion of FFP (SHOT report 2013). Anaphylactic is one of the most severe forms of an allergic transfusion reaction. They can be rare, but are life-threatening emergencies. Nausea, abdominal cramps, vomiting, diarrhoea, hypotension and shock are some of its symptoms which can occur after the transfusion of only a few millilitres of plasma has taken place. They are associated with antibodies to IgA. Some patients with IgA deficiency develop anti-IgA antibodies, which may then cause anaphylactic transfusion reactions when an IgA containing component is transfused (Murphy et al. 2013). Allergic transfusions can take place when pre-formed recipient antibodies bind to transfused allergens (Shaz et al. 2013). They can occur in approximately 1-3% of plasma transfusions but most of them are mild reactions. Patients that have severe allergic reactions should be tested for IgA deficiency and the presence of anti-IgA. If anti IgA is present, the patient should receive plasma products from IgA deficient donors or washed RBC and platelets products (Shaz et al. 2013). Sometimes these reactions can be detected by routine observations. According to SHOT, stopping the transfusion reaction in this case is very important and checks for obvious contamination should be carried out further. In case of severe reactions, the plasma component should be taken down and further investigation should be carried out.
TACO has been one of the leading causes of transfusion related mortality and morbidity. SHOT reports have shown a steady increase with almost 96 cases in 2013, 2 of which occurred during the transfusion of FFP. TACO is a result of infusion of blood product volume that exceeds the recipient’s circulatory capacity. This could be due to high volume or excessive infusion rate (Shaz et al. 2013). TACO is found to be more common in young or elderly patients with impaired cardiac function or positive fluid balance. Improved recognition of TACO is of key importance as it allows early institution of treatment. Some of the symptoms of TACO could be dyspnea, tachycardia, and increased blood pressure within six hours of a completed transfusion (Pandey & Vyas, 2013). Additional known risk factors for TACO include larger volumes of transfusion, greater plasma transfusion volume and faster transfusion rate. TACO can be prevented by avoiding rapid transfusion unless clinically indicated. Pre and post transfusion assessment and process mapping of the medical errors can to done to prevent TACO (SHOT annual report 2013). SHOT advocates that when an adult patient with increased risk of TACO is transfused, clinical review should be undertaken after the transfusion of each unit to ensure that the patient has not develop any signs of circulatory overload (Maggs et al. 2013). The clinical staff should also be aware of TACO and should be trained in measures to reduce this avoidable complication. Using single unit transfusions for young and elderly patients can help reduce TACO risk.
Haemolytic transfusion reactions (HTR) are defined as signs or symptoms of haemolysis that occur within 24 hours of transfusion (including other parameters like fall in Haemoglobin, positive/negative crossmatch). To prevent this, SHOT highly recommends transfusion services to provide ABO compatible FFP to patients and if not available, the FFP of a different ABO group may be used but with low tier antibodies A or B (Pandey & Vyas, 2013).
The risk of infectious disease transmission has decreased in the last two decades due to infectious disease testing and extensive donor medical screening. To enhance plasma safety donor retested plasma (DRP) or pathogen reduced or inactivated plasma (PRP) is used. PRP provides virus protection. There are about four cases of transfusion transmitted variant (vCJD- Creutzfeld Jacob disease) in the UK which are associated with the transfusion of non leukocyte reduced red cells. To reduce the risk of vCJD and other infectious diseases, children under 15 receive plasma which is imported from places with low bovine encephalopathy incidence (Rudmann, 2005).
Other complications such as leukocyte associated risks including transfusion associated graft versus host disease (TA-GVHD), febrile non-haemolytic transfusion reactions (FNHTR) and transmission of leukotropic viruses are not associated with plasma transfusion since FFP is considered to be non-cellular (Pandey & Vyas, 2013). However the 2010 SHOT reports had shown significant numbers of WBCs contaminating plasma units pre-freeze. Residual RBC fragments within plasma units can also cause RBC allo-immunisation and identification of anti-D, Fya, Jka after plasma transfusion has been reported (Liu, Zhou & Hu, 2009).
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Another possible hazard in plasma transfusion could be the transfusion of an incorrect component i.e. when a patient gets transfused with an incompatible blood component or other than what was prescribed for the patient. 19 such cases were reported to SHOT in 2013 involving the fresh frozen plasma where confusion between platelets and FFP was regarded as the most common mistake. ABO antibodies in donor plasma can cause problems when transfused to a different group. Procedural and testing errors during the transfusion process can be one of the reasons for it. Lack of the component knowledge can also lead to the incorrect component being transfused to the patient. Wrong blood in tube (WBIT) can be another reason, meaning that the blood was taken from the wrong patient and labelled with the intended patient’s details and vice versa. Since the error cannot be detected easily, there can be a high potential risk under such a situation. To prevent these situations, the staff should always check the prescriptions to ensure that the components have been authorised to the right patient. Patient records should be linked, merged and updated whenever necessary. Pre-administration transfusion checks are very important to be carried out since that is the final opportunity to detect a wrong transfusion (SHOT report 2013).
In terms of bacterial contamination, only a few reports have concluded that plasma products get contaminated during water bath with Pseudomonas species, since plasma products are not known to be contaminated (Rudmann, 2005). Special care taken when cleaning the water-baths can help in avoiding in bacterial contamination. SHOT also recommends, using thawed plasma as soon as possible to avoid any contamination during the transfusion.
Other significant errors identified by SHOT involved the hospital and laboratory information technology system. The report states that the main issue with patient administration systems is that the hospitals do not have secure systems in place which therefore is leading to the misidentification of the patient and thereby the incompatible product being given. Storage error, which includes the temperature and proper management of the freezers or storage units, could be some of the reasons too.
To conclude it must be said that haemovigilance systems play an extremely important role in identifying the risks associated with plasma and other blood transfusions. The annual report of SHOT (2010) revealed that TRALI was one of the major risks of transfusion, but thanks to the policy changes TRALI cases have declined. More focus is now being placed on TACO which appears to be of much greater risk followed by allergic reactions. Although it can be said that plasma transfusions are much safer today than in the past, zero risk is not achievable. Unfortunately human error plays a major role in some of the hazards involved in transfusions- taking short cuts, distractions or omission of essential steps are some of them (Prinoth, 2008). More can be done to train and encourage the staff to learn from the incidents that have occurred. Using a transfusion checklist recently has proved to be effective in reducing errors and hopefully in the coming years more measures can be undertaken to reduce the risks of these hazards.
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