Routine group and save screening prior to emergency laparoscopic surgery.

INTRODUCTION: Two group and save (G&S) samples are routinely collected from patients undergoing diagnostic laparoscopy and/or emergency appendicectomy. We aimed to identify the necessity of this practice by looking at the perioperative transfusion rates. METHODS: Data were obtained from our electronic theatre system for all patients who underwent emergency laparoscopic surgery (specifically diagnostic laparoscopy and/or laparoscopic appendicectomy) between January 2017 and December 2018. Records were reviewed for the number of G&S samples sent and perioperative transfusion rates. RESULTS: A total of 451 patients were included in the study. The numbers of procedures performed in 2017 and 2018 were 202 (44.8%) and 249 (55.2%), respectively. The total number of samples sent was 930. Only 786 (84.5%) samples were processed and the rest were rejected for various reasons. Of the 451 patients included in the study, 308 (68.3%) had two G&S samples sent, whereas 41 patients (9.1%) had only one G&S sample sent. Fifty-six (12.4%) and 20 (4.4%) patients had three and four G&S samples sent, respectively. Only two patients required transfusion perioperatively (0.4%), and the indication in both was irrelevant to the primary operation. CONCLUSIONS: These results demonstrate a near-zero transfusion rate in this patient cohort. Omitting G&S is safe and potentially saves time and resources.

Assessing the Necessity of Routine Crossmatching for Blood Transfusion in Renal Transplantation.

INTRODUCTION: Routine crossmatch of packed red blood cells (pRBCs) is completed preoperatively at many centers despite conflicting evidence on the incidence of blood transfusions with renal transplantation. In the current economic climate, resource adjudication should be judicious and medically appropriate. The objective of this study was to determine the incidence, timing, and predictors of early postoperative pRBC transfusion in patients undergoing renal transplantation. METHODS: A retrospective review of all patients undergoing renal transplantation at our institution from January 2013 to May 2016 was performed. Demographic, biochemical, and clinical parameters were recorded. The primary outcome was early postoperative transfusion, defined as an intraoperative transfusion or within 2 days of surgery. Multivariable logistic regression was performed to identify associations with early postoperative transfusion. RESULTS: We identified 428 patients during the study period (average age 55 years, 60% male, 30% obese, 67% deceased donor, and 43% preoperative antithrombotic use). Forty (9.3%) patients required early postoperative transfusion (mean: 2.8 pRBCs/transfusion) and most did not require blood urgently. Only 20 (4.7%) patients required a transfusion intraoperatively or on the same day of surgery. Lower preoperative hemoglobin (per g/L unit: odds ratio [OR]: 0.943), female gender (OR: 2.752), and preoperative antithrombotic use (OR 2.369) were associated with a need for early postoperative transfusion. CONCLUSION: Transfusion in the early postoperative period following renal transplantation was less than 10%, suggesting that routine crossmatch may not be necessary for all patients. Preoperative hemoglobin, female gender, and preoperative antithrombotic use were associated with increased risk and may be useful to risk-stratify patients who require crossmatch.

A novel approach to bedside pretransfusion identity check of blood and its components: the Sandesh Positive-Negative protocol.

BACKGROUND: Blood component mistransfusion is generally due to preventable clerical errors, specifically pretransfusion misidentification of patient/blood unit at bedside. Hence, electronic devices such as barcode scanners are recommended as the standard instrument used to check the patient's identity. However, several healthcare facilities in underdeveloped countries cannot afford this instrument; hence, they usually perform subjective visual assessment to check the patient's identity. This type of assessment is prone to clinical errors, which precipitates significant level of anxiety in the healthcare personnel transfusing the blood unit. Hence, a novel objective method in performing pretransfusion identity check, the 'Sandesh Positive-Negative (SPON) protocol,' was developed. METHODS: A nonrandomized study on bedside pretransfusion identity check was conducted, and 75 health care personnel performed transfusion. The intervention was performed by matching a custom-made negative label with blood component with the positive label of the same patient available at bedside who was about to receive transfusion. RESULTS: In total, 85.3% of the subjects were anxious while performing pretransfusion identity check based on the existing standard practice. After the implementation of the SPON protocol, only 38.7% experienced either mild, moderate or severe anxiety. The overall level of satisfaction also increased from 8.0% to 38.7% and none were dissatisfied. Although only 9.3% were dissatisfied about the existing practice, approximately 70.7% felt the need for a better/additional protocol. Clerical error was not observed. CONCLUSIONS: The SPON protocol is a cost-effective objective method that reduces anxiety and increases satisfaction levels when performing final bedside identity check of blood components.

Safety profile and impact of low-titer group O whole blood for emergency use in trauma.

PURPOSE: Following US military implementation of a cold-stored whole blood program, several US trauma centers have begun incorporating uncrossmatched, group O cold-stored whole blood into civilian trauma resuscitation. We set out to evaluate the safety profile, transfusion reactions events, and impact of low-titer group O whole blood (LTO-WB) at our center. METHODS: In November 2017, we added LTO-WB to each of our helicopters and to our emergency department (ED) refrigerator, alongside that of existing red blood cells and plasma. We collected information on all patients with trauma receiving prehospital or ED transfusion of uncrossed, emergency release blood products between November 2017 and June 2018. Patients were divided into those receiving any LTO-WB and those receiving only red blood cell and or plasma (COMP). Serial hemolysis panels were obtained at 3 hours, 24 hours, and 48 hours. All data were run using STATA 12.1. Statistical significance was set at p < 0.05. RESULTS: One hundred ninety-eight patients received LTO-WB and 152 patients received COMP. There were no differences in age, sex, or mechanism. The LTO-WB patients had higher chest Abbreviated Injury Scale scores (median, 3 vs. 2; p = 0.027), as well as worse arrival base excess (median, -7 vs. -5; p = 0.014) and lactate (5.1 vs. 3.5; p < 0.001). The LTO-WB patients received less post-ED blood products than the COMP patients (median, 0 vs. 3; p = 0.001). There was no difference in survival (LTO-WB, 73%; COMP, 74%; p = 0.805). There were only two suspected transfusion reactions, both in the COMP group (p = 0.061). There was no difference in hemolysis panel values. Controlling for age, severity of injury, and prehospital physiology, LTO-WB was associated with a 53% reduction in post-ED blood product transfusion (odds ratio, 0.47; 0.23-0.94 95% CI; p = 0.033) and two-fold increase in likelihood of survival (odds ratio, 2.19; 1.01-4.76 95% CI; p = 0.047). CONCLUSION: Low-titer group O whole blood has similar evidence of laboratory hemolysis, similar transfusion reaction rates, and is associated with a reduction in post-ED transfusions and increase likelihood of survival. LEVEL OF EVIDENCE: Therapeutic, Level II.

Impact of Novel Monoclonal Antibody Therapeutics on Blood Bank Pretransfusion Testing.

Novel monoclonal antibody therapies are increasing in number and clinical significance as their role in oncologic formularies expands. Anti-CD38 and anti-CD47/SIRPα agents commonly interfere with pretransfusion compatibility testing. Anti-CD38 interference is mitigated by dithiothreitol, which disrupts CD38 antigen on reagent red cells; however, this modification limits rule-out of all clinically significant antibodies. Several anti-CD47 agents are in clinical trials and demonstrate wide variability in pretransfusion testing interference. Modifications to pretransfusion testing can limit interference by anti-CD47 agents. Rapid dissemination of knowledge of these monoclonal antibody agents to the broader transfusion medicine community is paramount for continued patient transfusion safety.

Impact of Genotyping on Selection of Red Blood Cell Donors for Transfusion.

Red blood cell (RBC) antigen phenotyping is an essential component of transfusion compatibility testing. Serology has been the gold standard method, but its low throughput and risk of diagnostic interference in certain situations limits its applicability. Genotyping is useful for phenotyping in these cases, providing a high-throughput and reliable alternative to serology. Genotyping is indicated in several hematology and oncology patient populations. Because genotyping requires a complex testing environment and bears an additional risk of genotype-phenotype discrepancy, its use is currently limited, but it serves as a useful adjunct and may eventually supplant serology as a new gold standard.

New rules of ABO-compatibility in kidney transplantation.

ABO compatibility rules in kidney transplantation have been deeply modified with the possibility of ABO-incompatible transplantation. The recipient has to be prepared in the days preceding surgery with an objective of ABO antibody titers of 1/8 or less. This is obtained through a procedure including antibody removal, rituximab and IV immunoglobulins alone or in association according to the initial titer. All ABO combinations are possible. Due to the preparation of the recipient, living related transplantation has been first carried out but ABO-incompatible transplantation from a deceased donor is becoming common practice in some countries (A2 or A2B donor to a B recipient). Lower uncensored graft survival has been reported by some studies but not when ABO-incompatible kidney transplantations were compared with matched ABO-compatible ones. The infectious risk in the perioperative period, consequence of higher immunosuppression, raises concern. The interlaboratory variability in hemagglutination anti-A/B assays remains an important question among cohort studies which leads to development of new tests. ABO-incompatible transplantation is associated with a rare process, accommodation, that is well known in xenotransplantation and according to which, the transplant is protected against the consequences of ABO antibody binding. In human kidney ABO-incompatible transplantation, few studies are available but suggest that this protection against the post-transplant antibody rebound might be mediated by the expression of anti-complement molecules by endothelial cells.

Mass-scale red cell genotyping of blood donors: from data visualization to historical antigen labeling and donor recruitment.

Donor red cell genotyping provides efficiencies to identify "in demand" blood donors for transfusion recipients requiring antigen-negative blood. Donor red cell genotype information can be used to label units with historical types and introduced throughout the supply chain from the blood center to the hospital transfusion service and has potential to be used in recruitment strategies.

Transfusion Safety: The Nature and Outcomes of Errors in Patient Registration.

The transfusion chain is susceptible to error at every step. Accurate patient registration is a key first step that links a patient with their historical medical profile, yet patient registration is marked by its own challenges. Registration errors are deviations from standard operating procedures that occur during the process of patient registration. A frequent consequence of registration errors is the obfuscation of historical information and patient misidentification. Through duplicate registrations, patient information can be spread across multiple records and through hybrid registrations information from multiple patients can be combined into a single record. Patients with the same core identifiers, and the misuse of health insurance information also pose a threat to accurate registration. In the context of transfusion, this can lead to ABO discrepancies, failing to match for previously identified alloantibodies, and redundant serological investigations. Other consequences include missed billing opportunities and the inadvertent sharing of medical information. Reducing the occurrence of registration errors can be achieved through a multifaceted approach combining targeted educational efforts with technological improvements to the registration system. A recent development being the use of biometric identifiers. Despite their frequency, published reports on the occurrence and underlying cause of registration errors are rare. Most reports are found within articles on general medical errors or misidentification events and consequently, the true rate of registration errors among health information systems is not known. Here we summarize literature pertaining to how and why registration errors occur and their implications in the context of blood transfusion.

Incomplete Antibodies May Reduce ABO Cross-Match Incompatibility: A Pilot Study.

OBJECTIVE: Any erythrocyte transfusion among humans having type A or B blood groups is impossible due to antibodies causing fatal transfusion complications. A cross-match test is performed to prevent immune transfusion complications before transfusion. Our hypothesis is that the fragment antibody (Fab) part of the antibody (incomplete antibody) may be used to prevent an immune stimulus related to the complete antibody. Therefore, we designed a pilot study to evaluate the effectiveness of these incomplete antibodies using cross-match tests. MATERIALS AND METHODS: Pepsin enzyme and staphylococcal protein A columns were used to cut anti-A and anti-B monoclonal antibodies and purify their Fab (2) fragments, respectively. An Rh-positive erythrocyte suspension with purified anti-A Fab (2) solution and B Rh-positive erythrocyte suspension with purified anti-B Fab (2) solution were combined correspondingly. Cross-match tests were performed by tube and gel centrifugation methods. The agglutination levels due to the anti-A and anti-B Fab (2) antibodies and their effects on the agglutination normally observed with complete antibodies were then measured. RESULTS: No agglutination for the purified incomplete anti-A Fab (2) with A Rh+ erythrocyte and anti-B Fab (2) with B Rh+ erythrocyte combinations was observed in the tube cross-match tests. These agglutination levels were 1+ in two wells in the gel centrifugation cross-match tests. Fab (2)-treated erythrocytes were also resistant to the agglutination that normally occurs with complete antibodies. CONCLUSION: We determined that the Fab (2) fragments of antibodies may not only be used to obtain a mild or negative reaction when compared to complete antibodies, but they might also be used for decreasing ABO incompatibility. Incomplete antibodies might be a therapeutic option in autoimmune hemolytic anemia and they may also be used in solid organ or hematopoietic stem cell transplantation. Therefore, we have planned an in vivo study to prove these in vitro findings.

Preventing Mistransfusions: An Evaluation of Institutional Knowledge and a Response.

BACKGROUND: Blood product mistransfusions occur when a process error causes transfusion of incompatible blood products. These events are known sources of negative patient outcomes. One such event demonstrated an institutional knowledge gap and an opportunity to reduce this source of transfusion errors. The focus of this study was to evaluate the application of point of care cognitive aids to bridge potentially lethal knowledge gaps in blood product to patient compatibility. METHODS: A patient-donor ABO antigen compatibility grid for red blood cells (RBC) and fresh frozen plasma (FFP) was developed for creation of a cognitive aid and a blood product safety quiz. Participants included 117 registered nurses and postgraduate medical interns who were given 2 minutes to complete the quiz for establishing institutional controls. A separate group of 111 registered nurses and interns were given the same timed quiz twice, without and then with a blood product compatibility cognitive aid. An analysis of covariance was used to evaluate without cognitive aid versus with cognitive aid quiz results while taking the specialty (nurse versus interns) and baseline score into consideration. The blood bank adopted the grid as a forcing function to be completed before release of blood products. RESULTS: The correct RBC answer percentage increased from 84.7% to 98.3% without and with cognitive aid (average improvement 13.6%, standard deviation [SD] = 18.3%, 95% confidence interval, 10.1%-17.1%, P < .0001, ); the correct FFP answer percentage increased from 54.2% to 99.6% without and with cognitive aid (average improvement 45.4%, SD = 20.1%, 95% confidence interval, 41.7%-49.2%, P < .0001). Participants with lower baseline RBC and FFP score showed better improvement in the correct answer percentage for RBC and FFP (P < .001), respectively. CONCLUSIONS: The use of a cognitive aid for determining blood product ABO compatibility may improve performance during a time-limited test for matching correct patient and blood product ABO type. The use of the cognitive aid as a "forcing function" before the release of blood from the blood bank and before transfusion at the bedside may reduce transfusion mismatch associated with gaps in ABO compatibility knowledge.

Evaluation of the non-compliance with grouping guidelines which may lead to "wrong blood in tube", an observational study and risk factor analysis.

BACKGROUND: In France, blood group determination requires the completion of two samples collected at two different times to detect identity mistake and "wrong blood in tube". The aims of the present study were: (1) to evaluate the compliance with guidelines and (2) to identify risk factors of non-compliance. MATERIALS AND METHODS: Samples for ABO group determination collected between January 1st and December 15th, 2013 in the University hospital of Nîmes, France were analyzed. An ABO group determination demand was considered non-compliant if more than one tube arrived in the laboratory within ten minutes apart. Between May 1st and June 30th 2014, a self-administered questionnaire was offered to the nurses of the hospital on a random day for each service during this period. The aim was to validate the non-compliance criterion and the identification of risk factors using logistic regression. RESULTS: Among the 16,450 analyzed blood samples, the overall compliance rate was 65.1%. Lower compliance rates were found in the surgical services. Independent risk factors for wrong practice were work overload, surgical service and individual intermediate transfusion frequency. DISCUSSION: More than one third of ABO group determinations did not follow national recommendations, which induces a substantial risk of "wrong blood in tube" and group error. The study revealed major variations among hospital services. Identification of risk factors allows targeted corrective actions.

New mAb therapies in multiple myeloma: interference with blood transfusion compatibility testing.

PURPOSE OF REVIEW: Immunotherapeutic strategies are emerging as novel therapeutic approaches in multiple myeloma, with several mAbs being in advanced stages of clinical development. Of these, CD38 targeting antibodies appear very promising. In trials with anti-CD38 mAb daratumumab, all patients demonstrated panreactivity in red blood cell (RBC) panel testing, complicating the selection of compatible RBCs for transfusion. This review provides an overview of the interferences and solutions to safely transfuse these patients. RECENT FINDINGS: CD38 is weakly expressed on human erythrocytes. Since the first reports on the interference, different solutions have been reported, including the neutralization of anti-CD38 mAbs in plasma by sCD38 or antiidiotype antibodies, CD38 depletion of RBCs using dithiothreitol or cord blood test cells, and transfusion of extensively typed RBCs. SUMMARY: All methods have (dis)advantages, and it depends on the facilities of the immunohematology laboratory what strategy to choose. As the selection of suitable RBC units can be seriously delayed, hospitals should have protocols to communicate this interference with patients, laboratories, and physicians in a timely manner. As CD38 antibodies may also have a role in the treatment of diseases beyond hematological malignancies, chances are high that health professionals will encounter this issue in the nearby future.

When blood transfusion medicine becomes complicated due to interference by monoclonal antibody therapy.

BACKGROUND: Monoclonal antibodies (MoAbs) are increasingly integrated in the standard of care. The notion that therapeutic MoAbs can interfere with clinical laboratory tests is an emerging concern that requires immediate recognition and the development of appropriate solutions. Here, we describe that treatment of multiple myeloma patients with daratumumab, a novel anti-CD38 MoAb, resulted in false-positive indirect antiglobulin tests (IATs) for all patients for 2 to 6 months after infusion. This precluded the correct identification of irregular blood group antibodies for patients requiring blood transfusion. STUDY DESIGN AND METHODS: The IAT was performed using three- and 11-donor-cell panels. Interference of daratumumab and three other anti-CD38 MoAbs was studied using fresh-frozen plasma spiked with different MoAb concentrations. Additionally it was tested whether two potentially neutralizing agents, anti-idiotype antibody and recombinant soluble CD38 (sCD38) extracellular domain, were able to inhibit the interference. RESULTS: The CD38 MoAbs caused agglutination in the IAT in a dose-dependent manner. Addition of an excess of anti-idiotype antibodies or sCD38 protein to the test abrogated CD38 MoAb interference and successfully restored irregular antibody screening and identification. DISCUSSION: CD38 MoAb therapy causes false-positive results in the IAT. The reliability of the test could be restored by adding a neutralizing agent against the CD38 MoAb to the patient's plasma. This study emphasizes that during drug development, targeted therapeutics should be investigated for potential interference with laboratory tests. Clinical laboratories should be informed when patients receive MoAb treatments and matched laboratory tests to prevent interference should be employed.

Rationalising cross-match requests in vascular surgery is safe and cost effective.

This study describes how a vascular centre rationalised their blood transfusion policy. A multidisciplinary panel reviewed data for blood transfusion protocols and implemented improvements that were analysed. The number of units cross-matched fell from 272 to 183 over a six month period. Unused blood reduced from 80% to 61%. The study concluded that rationalisation of cross matching policies is safe and provides cost and resource benefits.

Safety of a liberal policy for extended-date preadmission testing samples.

BACKGROUND: Regulations governing pretransfusion testing allow specimen expiration to be extended past 3 days before the transfusion if a patient has not been transfused or pregnant in the preceding 3 months. Our hospital allows extension of the expiration of a presurgical specimen to 28 days if 1) the patient has neither been transfused nor pregnant in the past 3 months, 2) the patient does not have an antibody history, and 3) the current antibody screen (ABSC) is negative. Patients not meeting Criteria 2 and 3 are required to have specimens redrawn on the day of surgery (DOS). We evaluated the necessity of this policy. STUDY DESIGN AND METHODS: From October 2009 to September 2010, there were 132 patients who did not meet the above criteria for specimen extension. Equivalent tests were performed on preadmission testing (PAT) and DOS specimens, and the results were compared. RESULTS: The majority (113, 86%) of the samples redrawn on the DOS showed no change in antibody serology upon reinvestigation. Of the remaining patients, DOS specimens did not identify any new antibodies or change in blood product choices. CONCLUSION: Of the PAT specimens rejected for antibody history or positive ABSC, none had new significant serologic findings on DOS. Based on these results, requiring a repeat specimen on the DOS may not be clinically necessary. Our facility changed the PAT policy to extend specimen acceptability to patients with red blood cell antibody history or positive ABSC at time of PAT. A 6-month follow-up period showed that this practice is safe.

Hospital-based transfusion error tracking from 2005 to 2010: identifying the key errors threatening patient transfusion safety.

BACKGROUND: This report provides a comprehensive analysis of transfusion errors occurring at a large teaching hospital and aims to determine key errors that are threatening transfusion safety, despite implementation of safety measures. STUDY DESIGN AND METHODS: Errors were prospectively identified from 2005 to 2010. Error data were coded on a secure online database called the Transfusion Error Surveillance System. Errors were defined as any deviation from established standard operating procedures. Errors were identified by clinical and laboratory staff. Denominator data for volume of activity were used to calculate rates. RESULTS: A total of 15,134 errors were reported with a median number of 215 errors per month (range, 85-334). Overall, 9083 (60%) errors occurred on the transfusion service and 6051 (40%) on the clinical services. In total, 23 errors resulted in patient harm: 21 of these errors occurred on the clinical services and two in the transfusion service. Of the 23 harm events, 21 involved inappropriate use of blood. Errors with no harm were 657 times more common than events that caused harm. The most common high-severity clinical errors were sample labeling (37.5%) and inappropriate ordering of blood (28.8%). The most common high-severity error in the transfusion service was sample accepted despite not meeting acceptance criteria (18.3%). The cost of product and component loss due to errors was $593,337. CONCLUSION: Errors occurred at every point in the transfusion process, with the greatest potential risk of patient harm resulting from inappropriate ordering of blood products and errors in sample labeling.

Is type and screen only policy safe for patients undergoing elective lobectomy?

OBJECTIVE: The purpose of this study was to establish the safety and feasibility of a recently adopted policy to type and screen (TS) (group and save) only for selected patients who had low likelihood of transfusion requirement. METHODS: The TS only policy was applied to patients undergoing first-time elective lobectomy with Hb of >11 g/dl, aged <70 years, with no clotting abnormality and no history of neoadjuvant therapy. A retrospective analysis of prospectively collected data was made of 208 consecutive patients undergoing elective lobectomy from November 2009 to October 2010. The patients who were only type and screened (Group TS, n = 87) were compared with those who had preoperative cross matching (XM) (Group XM, n = 121). The perioperative characteristics, transfusion requirements and outcomes were compared between the two groups. RESULTS: Preoperative characteristics of the two groups were similar, except that the XM group were significantly older, with lower mean preoperative haemoglobin levels. Postoperative complications (9 vs 13%, P = 0.24) and hospital mortality (0 vs 0.8%, P = 0.5) were similar between TS and XM, respectively. On the day of operation, 16 patients (13%) required transfusion in the XM group. Six patients in the TS group were cross matched, of whom only 3 (3.4%) actually required transfusion. The mean postoperative Hb levels in XM were also significantly lower (12.96 vs 10.88 gm/dl). In the XM group, 260 units of blood were unnecessarily cross matched and had to be returned to the blood bank compared with zero units in the TS group. There was no delay caused by unavailability of blood at the time of clinical need. CONCLUSION: Our data suggest that it is safe and feasible to adopt a policy of type and screen only in selected patients undergoing elective lobectomy, who have low likelihood of transfusion requirement.

Exponential error reduction in pretransfusion testing with automation.

BACKGROUND: Protecting the safety of blood transfusion is the top priority of transfusion service laboratories. Pretransfusion testing is a critical element of the entire transfusion process to enhance vein-to-vein safety. Human error associated with manual pretransfusion testing is a cause of transfusion-related mortality and morbidity and most human errors can be eliminated by automated systems. However, the uptake of automation in transfusion services has been slow and many transfusion service laboratories around the world still use manual blood group and antibody screen (G&S) methods. STUDY DESIGN AND METHODS: The goal of this study was to compare error potentials of commonly used manual (e.g., tiles and tubes) versus automated (e.g., ID-GelStation and AutoVue Innova) G&S methods. Routine G&S processes in seven transfusion service laboratories (four with manual and three with automated G&S methods) were analyzed using failure modes and effects analysis to evaluate the corresponding error potentials of each method. RESULTS: Manual methods contained a higher number of process steps ranging from 22 to 39, while automated G&S methods only contained six to eight steps. Corresponding to the number of the process steps that required human interactions, the risk priority number (RPN) of the manual methods ranged from 5304 to 10,976. In contrast, the RPN of the automated methods was between 129 and 436 and also demonstrated a 90% to 98% reduction of the defect opportunities in routine G&S testing. CONCLUSION: This study provided quantitative evidence on how automation could transform pretransfusion testing processes by dramatically reducing error potentials and thus would improve the safety of blood transfusion.