|Year : 2019 | Volume
| Issue : 2 | Page : 132-139
Risk mitigation in blood transfusion services – A practical approach at the blood center level
Shivaram Chandrashekar, Ambuja Kantharaj
Department of Transfusion Medicine, Manipal Hospital, Bengaluru, Karnataka, India
|Date of Submission||19-Sep-2019|
|Date of Acceptance||26-Sep-2019|
|Date of Web Publication||17-Oct-2019|
Dr. Shivaram Chandrashekar
Department of Transfusion Medicine, Manipal Hospital, Bengaluru, Karnataka
Source of Support: None, Conflict of Interest: None
Hemovigilance is a set of surveillance procedures starting from the donor vein and ending with the patient vein, aimed at reducing the risks associated with transfusion which could be donor related, recipient related, or process related. Donor-related risks include local and systemic complications which need a variety of interventions to ensure safe blood donation and are mainly aimed at preventing local trauma and fall or injury after a blood donation resulting from a vasovagal reaction. Recipient-related risks are hemolytic and nonhemolytic in nature and may present with fever, rash, or dyspnea besides other features. Appropriate mitigation measures are needed for each of them, especially the more ominous ones like transfusion-related acute lung injury/transfusion-associated circulatory overload. Process-related risks are the leading cause of risks associated with transfusion. Human errors can be mitigated by the use of technology such as barcoding, radio-frequency identification, digital transporter boxes, and having effective protocols and checklists in place.
Keywords: Assessment, blood donation, blood transfusion, mitigation, risk
|How to cite this article:|
Chandrashekar S, Kantharaj A. Risk mitigation in blood transfusion services – A practical approach at the blood center level. Glob J Transfus Med 2019;4:132-9
|How to cite this URL:|
Chandrashekar S, Kantharaj A. Risk mitigation in blood transfusion services – A practical approach at the blood center level. Glob J Transfus Med [serial online] 2019 [cited 2021 Jan 24];4:132-9. Available from: https://www.gjtmonline.com/text.asp?2019/4/2/132/269400
| Introduction|| |
Hemovigilance has been defined as “a set of surveillance procedures, from the collection of blood and its components to the follow-up of recipients to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products and to prevent their occurrence or recurrence.” The aim of hemovigilance is to assess the risks of transfusion and take corrective measures aimed at mitigating the same. The spectrum of adverse reactions to blood transfusion ranges from a benign clinical course to serious morbidity and mortality.
Technological advances in transfusion medicine such as leukoreduction, pathogen reduction, bacterial risk reduction, and Nucleic acid Amplification Testing (NAT) all seek to reduce the risks associated with the transfusion process.
Risk is a probability or threat of damage caused by vulnerabilities that may be avoided by preventive actions. Risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs. Risk mitigation is the process of planning for disasters and having a way to lessen the negative impact. Risk mitigation can also be defined as a systematic reduction in the extent of exposure to a risk and/or the likelihood of its occurrence.
| Data Source|| |
This review of risks related to transfusion was performed by searching for the keyword risk, mitigation, adverse reactions, transfusion, blood donor, transfusion-related acute lung injury (TRALI), and transfusion-associated circulatory overload (TACO) in PubMed and Google databases. Reference lists were cross-checked for relevant citations, and more searches were undertaken till the desired information was obtained.
Risk mitigation in transfusion has been classified as donor related, recipient related, or process related in this manuscript.
| Donor -Related Risks and Their Mitigation|| |
Blood donors normally tolerate blood donation very well, but, occasionally, adverse reactions of variable severity may occur before, during, or after collection. The adverse reactions that occur in donors can be divided into local reactions and systemic reactions. Local reactions are primarily related to venous access. Systemic reactions may be classified as mild or severe.
The commonly identified risks of blood donation along with their possible attributes and mitigation measures are discussed below.
The classification of donor complications is as per the ISBT criteria and is shown in [Figure 1].
|Figure 1: ISBT classification of blood donor complications. LOC = Loss of consciousness; DVT: Deep vein thrombosis; AV: Arterio-venous|
Click here to view
| Local Complications of Blood Donation|| |
A hematoma is an accumulation of blood in the tissues outside the vessels characterized by bruising, discoloration, swelling, and local pain. Large hematomas, particularly those in deeper layers of the forearm, put pressure on surrounding tissues and may cause other complications such as nerve irritation and injury and rarely compartment syndrome.
Arterial puncture is commonly seen in the brachial artery or of one of its branches and is the result of bleeding during blood donation and is characterized by fast filling of bag (<4 min always present), bright red blood (usually present), and pulsating tube (rare).
Delayed bleeding or rebleeding is leakage of blood from the venipuncture site after the initial bleeding has stopped. This is caused by pressure applied to wrong site, inadequate pressure for an inadequate duration or by premature removal of the bandage. This is more likely to happen in autologous donors on anticoagulants.
Nerve injury or irritation
Damage to nerve may occur during insertion or withdrawal leading to injury or irritation. Nerve irritation may also be the result of pressure caused by an overlying hematoma. Donors present with a radiating, often “electrical” sharp pain moving away from the venipuncture site and/or paresthesias such as tingling and burning sensations in the hand, wrist, or shoulder area but away from the venepuncture site. Delayed symptoms may be seen in cases associated with hematoma formation. The distinction of injuries to nerves from those to veins and perivascular tissues is at times difficult and is based strictly on clinical grounds.
This may be seen at sight of application of bandage at the phlebotomy site and is caused by allergy to the antiseptic constituents. Alternatives such as applying only pressure bandage will need to be explored once this happens.
Other major complications, include superficial and deep venous thrombosis, arteriovenous fistula, compartment syndrome, and brachial artery pseudoaneurysm. These rare complications need intervention by radiologists and vascular surgeons.
Mitigation measures for local complications
These can be mitigated by the use of good phlebotomy technique, the use of vein detector to identify veins, and applying adequate pressure for adequate time (10–20 min). Effect of arterial punctures can be mitigated by pressure bandage to prevent hematoma and cold compress to reduce hemorrhage/hematoma. Hematoma once formed must be treated by anti-inflammatory measures (cold compress and drugs) to prevent nerve compression and nerve irritation. Donors with local complications should be counseled to avoid vigorous use of arm for 2–3 hours and desist from removing the bandage for 5 hours.
| Systemic Complications Of Blood Donation|| |
Vasovagal reactions (VVR) manifest as dizziness, sweating, pallor, and anxiety. VVRs are mainly physiologic reactions that relate to blood volume loss and therefore occur toward the end of the phlebotomy or after the phlebotomy. VVRs have been shown to be induced by several factors, such as fear of needle, pain during insertion/removal of needle, sight of blood, first time donations, low body weight, and phlebotomy duration. Women donors, young donors, and donors with lower weight are more likely to experience VVRs. Therapeutic intervention must be swift, to avoid complications such as syncope and tonic–clonic muscle spasms (convulsive syncope), accompanied by vomiting and loss of sphincter control.
VVRs may be accompanied by loss of consciousness (LOC), and when this happens, the time duration of LOC, <60 s or >60 s, should be documented. VVR can also be classified as those occurring in the blood donation area and those occurring outside after the donor has left the donation area. Donors can occasionally fall and injure themselves which gives rise to another classification of VVR as those accompanied by injury or not.
| Mitigation of Vasovagal Reaction|| |
This includes reassurance to donors, especially first time donors, woman donors, and those in the younger age group. Another simple, yet effective technique is use of good phlebotomy technique that leads to minimal pain. Factors such as avoiding display of blood or blood bag to donor postdonation to avoid the sight of blood may be useful. Predonation hydration is an adequate measure to mitigate VVR. It has been shown that adequate hydration with half a liter of water or isotonic fluids close to the donation can mitigate this risk. Giving IV fluids is a therapeutic measure once the donor has developed hypotension as a component of VVR. Ensuring adequate rest postdonation is also an important measure.
The local and systemic complications of blood transfusion and their mitigation measures are summarized in [Table 1].
| Process Related Risks and Their Mitigation|| |
Noninfectious complications are now more common and account for the more severe transfusion-related morbidities. Incorrect blood component transfusion resulting in hemolytic transfusion reactions (HTRs) and TRALI remain major sources of morbidity and mortality. Except in the United States, clerical errors are the leading cause of death following blood transfusions worldwide. The findings from studies, on medical errors occurring in blood transfusion practices disclose that 3.7% of patients in the US are vulnerable to adverse events during hospital stay. Another study by Najafpour et al. has shown that transfusion-associated risks were highest with process failures some of them being incorrect blood sample labeling, incorrect order for blood or component, errors in patient identification (ID), and sampling. According to the UK SHOT report, human errors accounted for 87.3% of the adverse transfusion reaction including 20 deaths of which 14 were preventable.
Incorrect identification of patient
This can occur during sampling for compatibility testing or again at the time of transfusion. The use of nonremovable wrist band, the use of two unique identifiers (example full name and unique ID [Hospital Number]/social security number/AADHAR number [a unique Government ID used in India]) and capturing name of phlebotomist drawing the sample are some mitigation measures.
Incorrect blood grouping
Risk attributes include wrong patient sample, wrong blood in tube, incorrect technique, incompetent technologist, or inadequate supervision/checks in place. To mitigate this risk, both cell and serum grouping must be done by a validated method. Repeat blood grouping by an abbreviated method (example-slide method) will help to check the correct identity of the patient and correlate it with the results obtained by a more accurate method.
The use of two sets of anti-D is essential for accurate Rh (D) typing. It is important to have trained competent staff for testing and verification, as blood grouping forms the core activity of the blood bank. All grouping records must be validated by a second or preferably a third person to avoid clerical or transcriptional errors.
| Incompatibility during Cross Match|| |
Incompatibility (IC) detected during crossmatching leads to delay in issue of blood. Reasons for this could be the presence of allo- or autoantibody, wrong preliminary grouping, or samples older than 48 h. To mitigate the risks associated with emergency transfusion, it is essential to have a good pretransfusion testing protocol consisting of antibody screening and grouping done well before the emergency cross match is undertaken. Hospital policies should make pretransfusion type and screen mandatory for all patients scheduled for invasive procedures.
Incorrect labeling of blood bag/samples
This can occur at the time of blood donation/sample collection, at the time of component separation, or at the time of testing.
Mitigation measures include labeling of blood bag and pilot tubes by the same phlebotomist drawing blood from the donor and labeling of samples at bedside soon after collection. Advanced technology like barcoding and radio-frequency ID helps reduce errors.
| Incorrect Blood Transfusion|| |
This is a consequence of failure to check hospital number and failure to check BG and Rh at time of issue. Further, failing to check the date of expiry and transfusion transmissible infection results can be disastrous for the patient. At times, the patient and the blood are correctly identified but not the component leading to wrong component transfusions. Checking the volume prior to transfusion is important in newborn and also in older children and adults prone to transfusion-associated cardiac overload.
To mitigate this risk, it is important to train people to check name/hospital no./blood group/Rh/date of expiry at the time of issue and also identify a process to co-relate the right bag with the right patient using the right documents. Comparing data on blood bag label with the patient data on the wrist band is the only sure way to mitigate this risk. It is thus important to have a protocol in place for blood transfusion to reduce errors.
The process-related complications and their mitigation measures are summarized in [Table 2].
| Recipient-Related Adverse Reactions and Their Isbt Classification|| |
Based on ISBT nomenclature, recipient risks of transfusion are classified, as shown in [Figure 2].
|Figure 2: ISBT classification of recipient adverse transfusion reactions|
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| Hemolytic Transfusion Reaction|| |
HTRs may be acute or delayed. Acute HTR (AHTR) has its onset within 24 h of a transfusion and presents with clinical and laboratory features of hemolysis. AHTR could be due to immunological causes such as ABO IC, allo- or autoantibody-mediated IC to red cells, or nonimmunological (mechanical) hemolysis.
Common signs and symptoms of AHTR are fever, chills/rigors, facial flushing, chest pain, abdominal pain, back/flank pain, dark urine, and gastrointestinal (GI) symptoms such as nausea/vomiting and diarrhea, besides others such as hypotension, pallor, jaundice, and oligoanuria. One or more of the following laboratiory findings maybe present – hemoglobinemia, hemoglobinuria, decreased serum haptoglobin, unconjugated hyperbilirubinemia, increased lactate dehydrogenase and aspartate transaminase levels, and decreased hemoglobin levels.
Delayed HTR usually manifests between 24 h and 28 days after a transfusion. Clinical or laboratory features of hemolysis are present. Signs and symptoms are similar to AHTR but are usually less severe. DHTR may manifest as an inadequate rise of posttransfusion hemoglobin level or unexplained fall in hemoglobin after a transfusion. Blood group serology usually shows abnormal results (example Direct Antiglobulin Test (DAT) positivity).
Delayed serological transfusion reaction or alloimmunization is a demonstration of clinically significant antibodies against red blood cells (RBCs) which were previously absent without obvious features of clinical or laboratory hemolytic. Universal leukoreduction could be a preventive measure.
Mitigation of HTR involves proper pretransfusion workup, ID of compatible blood, proper blood storage, issue, and transfusion using the right devices to prevent mechanical hemolysis.
| Nonhemolytic Transfusion Reactions|| |
For the sake of better understanding, these are classified as those associated with fever, rash, or dyspnea, besides other miscellaneous ones in this manuscript.
| Reactions Associated With Fever Following Blood Transfusion|| |
Febrile non-HTR (FNHTR) is the most common causes of fever following transfusion. Other reasons for fever include HTR, bacterial infection, TRALI, or underlying pathology. Fever >=38 degree C and a change of ≥1C) occurring during or within 4 h of transfusion without other causes such as HTR, bacterial contamination, or underlying condition is called FNHTR. FNHTR may present with only chills/rigors with or without fever. Headache and nausea may also be seen. To label a reaction as FNHTR, it is important to rule out HTR by screening for auto- and alloantibodies and by looking for evidence of hemolysis. DAT positivity favors HTR. All cases presenting with fever must be cultured to exclude bacterial infection of the donor. Underlying pathology like septicemia, dengue may also be the reason for fever, distinct from blood transfusion. It is important to look for evidence of acute lung injury and breathlessness to rule out the more ominous TRALI as the cause of fever.
| Mitigation Measures for Reactions Associated With Fever|| |
FNHTR is caused by cytokines and interleukins. Important cytokines such as interleukin-6 (IL-6), IL-8, and tumor necrosis factor-alpha play a major role. Storage of blood leads to release and accumulation of cytokines causing adverse transfusion reactions. Studies comparing whole blood and buffy coat-depleted red cells have shown significantly low levels of cytokines in buffy coat-depleted red cell concentrate. Cytokines and chemokines accumulate during storage of cellular blood products and are responsible for residual FNHTRs. Hence, prestorage leukoreduction is the only way to mitigate FNHTR.
Studies have shown that bacterial infections of blood bag can be reduced through a combined action consisting of better skin disinfection (example use of dual antiseptics and sterile gauze as opposed to unsterile cotton), improved personal hygiene of blood donation staff, use of blood bags with diversion pouches, and active reporting of changes in health status by donor following the donation. Storage of blood at appropriate temperature, leukoreduction, and separation of components within the stipulated time are all useful in reducing bacterial infection.
Consider premedication with antipyretics to prevent recurrence. It is important to have a policy for transfusion in the presence of fever. Fever per se is not a contraindication for transfusion, and transfusions may be deemed necessary even in the presence of fever.
The treatment of underlying cause
Patients receiving transfusions often have underlying pathology such as septicemia, bacterial, parasitic, or viral fevers which could be the reason for fever independent of transfusions.
| Reactions Associated With Breathlessness (Dyspnea) Following Transfusion|| |
Breathlessness following transfusion could be the result of TRALI, TACO, or transfusion-associated dyspnea (TAD). TRALI and TACO are characterized by acute pulmonary edema within 6 h of blood transfusion.
TRALI is mediated by antileukocyte antibodies leading to leukopenia and fever in the patient. In contrast, TACO is caused by fluid overload and presents with raised jugular venous pressure along with tachycardia and hypertension. White cell counts are not affected by TACO. The pulse and BP are normal or low in TRALI. Raised levels of BNP favor a diagnosis of TACO over TRALI. When the clinical condition does not meet either of these nor is there an underlying pathology to explain the breathlessness, then the condition is called TAD, a benign self-limiting condition presenting within 6 h of transfusion.
TRALI is caused by plasma and plasma-containing products such as plasma and platelets. Despite mitigation strategies that include the exclusion of females from plasma donation or the exclusion of females with a history of pregnancy or known antileukocyte antibody, TRALI remains a leading cause of transfusion-related morbidity and mortality.
American association of blood bank (AABB) suggests a collection of plasma from male donors only and the use of platelets suspended in additive solutions as mitigation measures.
To mitigate TACO, hospitals must identify patients at risk of fluid overload. Newborn babies and elderly cardiac patients are prone to develop TACO. The use of diuretics may be helpful in the mitigation of TACO.
| Reactions Associated With Rash Following Blood Transfusion|| |
A rash following blood transfusion can be a simple allergy, posttransfusion purpura (PTP), or transfusion-associated graft-versus-host disease (TA-GVHD) depending on the time of development and associated features.
Rash following blood transfusion may the result of plasma protein allergy which presents within hours of transfusion. The rash due to PTP appears late 5–12 days after transfusion of cellular products and is mediated by the development of antiplatelet (anti-HPA1) antibodies. TA-GVHD is another condition that appears 1–6 weeks after transfusion and is characterized by symptoms of fever, rash, liver dysfunction, diarrhea, and pancytopenia. Skin biopsy shows characteristic histological appearances.
| Mitigation Measures for Allergy, Posttransfusion Purpura, and Transfusion-Associated Graft-Versus-Host Disease|| |
Allergic reactions are mediated by histamines, cytokines, and leukotrienes and are treated with antihistamines and steroids. The use of washed cells or platelets suspended in additive solutions are some mitigation measures. Giving intravenous immunoglobulins at 1 g/kg single dose to increase platelet count may be helpful in PTP. Transfusion of antigen-negative cellular products (platelets) may be indicated for subsequent transfusion. Preventing transfusions from first-degree relatives and irradiation of blood with 25 Gy are other measures for preventing TA-GVHD.
Anaphylaxis may be considered a severe form of allergic reaction that manifests with cardiopulmonary symptoms within minutes of transfusion. Patients with antibodies to other plasma proteins such as haptoglobin, C3, and C4 alpha-1 antitrypsin can have anaphylactic transfusion reactions. Patients with congenital immunoglobulin A (IgA) deficiency may develop anti-IgA antibodies causing anaphylaxis when exposed to IgA. One in 500 donors is IgA deficient and one in 1200 has been shown to have anti-IgA antibodies., Preventing further donations by donors whose blood has been implicated in anaphylaxis is important.
Hypotensive transfusion reaction is another type characterized by hypotension defined as a drop in systolic blood pressure of ≥30 mmHg occurring during or within 1 h of completing transfusion and a systolic blood pressure ≤80 mmHg. Most reactions occur very rapidly, within minutes of transfusion and respond rapidly to cessation of transfusion and supportive treatment. This type of reaction appears to occur more frequently in patients on angiotensin converting enzyme inhibitors (ACE) inhibitors. Hypotension may be accompanied by facial flushing or GI symptoms. It may be necessary to change the hypertensive drugs.
| Other Transfusion Reactions|| |
Transfusion-associated hemosiderosis is being defined as a blood ferritin level of over 1000 μg/l, with or without organ dysfunction in the setting of repeated RBC transfusions, and can only be treated with chelating agents.
Transfusion-associated hyperkalemia is marked by abnormally high potassium level (>5 mmol/l, or 1.5 mmol/l net increase) within an hour of transfusion. The use of red cells <5 days old or the use of washed red cells may help prevent this complication.
Unclassifiable complication of transfusion
The occurrence of an adverse effect or reaction temporally related to transfusion, which cannot be classified according to an already defined adverse transfusion event and with no risk factor other than transfusion and no other explaining cause.
Recipient-related adverse transfusion reactions along with their mitigation measures are summarized in [Table 3].
| Conclusion|| |
Risk mitigation in blood transfusion services is a key to blood safety. Risk can occur during blood donation, blood processing, or during its transfusion. Risk mitigation is aimed at eliminating or reducing the impact of a disaster such as a severe injury to donor following a blood donation, process-related errors either technical or clerical during blood testing, and also transfusion-related errors at the bedside. It is important for every blood center to identify the risks related to the donor, the recipient, or the transfusion process and take corrective and preventive measures to prevent their occurrence or at least mitigate the level of risk to an acceptable level. Risk mitigation is an ongoing process, and every blood center needs to participate in a hemovigilance program for its own benefit as well as the benefit of the country.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]