How do we use the National Healthcare Safety Network for Hemovigilance in Massachusetts?

BACKGROUND: Use of the National Healthcare Safety Network (NHSN) has been essential to the success of the Massachusetts Hemovigilance Program and has allowed for the timely identification of signals and trends over a defined population that correlate with national and international hemovigilance (HV) data. Here, we outline how the NHSN system is used for monitoring HV data in Massachusetts and encourage adoption of NHSN for nationwide HV surveillance. STUDY DESIGN AND METHODS: A collaboration that grew over time between local HV stakeholders and the Massachusetts Department of Public Health (MDPH) resulted in the change from a paper-based method of reporting adverse reactions and monthly transfusion activity for compliance with state requirements to replacement with statewide adoption of reporting via NHSN. RESULTS: Over 1.5 million blood products were transfused in Massachusetts between 2017 and 2021, with 3000 adverse reactions among 10 defined types reported. Using NHSN, MDPH has been able to produce numerous reports, publications, and presentations that have made previously non-obtainable HV and blood utilization data available. DISCUSSION: Although limitations to these self-reported data exist, such as lack of external validation, successful statewide implementation of NHSN for hospital blood bank reporting is possible and has benefits beyond those for regulatory oversight. It results in standardized, actionable data at both the hospital and state level, enabling inter-facility comparisons, benchmarking, and opportunities for practice improvement.

Classification of posttransfusion adverse events using a publicly available artificial intelligence system.

BACKGROUND: Correct classification of transfusion reactions is important not only for effective patient care and donor management but also for accurate tracking of events in hemovigilance systems. We compared the ability of a generative artificial intelligence (AI) system to correctly diagnose hypothetical clinical situations as transfusion reactions in comparison to previous studies reporting the accuracy of transfusion medicine (TM) specialists in assessing these cases. METHODS: An AI system was requested to assess 36 case scenarios to provide a diagnosis, severity, and imputability of the transfusion reactions using the CDC National Healthcare Safety Network (NHSN) criteria. Responses were compared to an expert panel's classifications and to the published responses of a panel of TM specialists. Additionally, the AI's responses were compared to the TM specialists' prior attempts to use the TrDDx web-based algorithm for the five most challenging cases. RESULTS: The AI's classification accuracy varied widely depending on the NHSN category. The AI accurately classified all transfusion-associated circulatory overload and transfusion-related acute lung injury cases, exceeding TM specialists' assessments. Conversely, it did not correctly identify any cases in select NHSN categories such as DSTR. Overall accuracy among all diagnostic categories was 48.7% for AI responses versus 72.1% for prior TM specialist responses (p = 0.005). AI-generated responses included non-standard terminology, limited severity assessments, and no imputability determinations. DISCUSSION: A generative AI system may have a role in helping healthcare providers to consider transfusion reaction categories that might be missed, but caution is advised in applying the AI's output to transfusion reaction classification at present.

Transfusion-related errors and associated adverse reactions and blood product wastage as reported to the National Healthcare Safety Network Hemovigilance Module, 2014-2022.

BACKGROUND: Transfusion-related errors are largely preventable but may lead to blood product wastage and adverse reactions, resulting in patient harm. In the United States, the incidence of transfusion-related errors is poorly understood nationally. We used data from the National Healthcare Safety Network (NHSN) Hemovigilance Module to describe and quantify transfusion-related errors, as well as associated transfusion-related adverse reactions and blood product wastage. METHODS: During 2014-2022, data from the NHSN Hemovigilance Module were used to analyze errors, including near misses (errors with no transfusion), incidents (errors with transfusion), and associated serious adverse reactions (severe, life-threatening, or death). RESULTS: During 2014-2022, 80 acute care facilities (75 adult; 5 pediatric) reported 63,900 errors. Most errors occurred during patient blood sample collection (21,761, 34.1%) and blood sample handling (16,277, 25.5%). Less than one-fifth of reported errors (9822, 15.4%) had a completed incident form. Of those, 8780 (89.3%) were near misses and 1042 (10.7%) incidents. More than a third of near misses (3363, 38.3%) were associated with a discarded blood product, resulting in 4862 discarded components. Overall, 87 adverse reactions were associated with errors; six (7%) were serious. CONCLUSIONS: Over half of the transfusion-related errors reported to the Hemovigilance Module occurred during blood sample collection or sample handling. Some serious adverse reactions identified were associated with errors, suggesting that additional safety interventions may be beneficial. Increased participation in the Hemovigilance Module could enhance generalizability and further inform policy development regarding error prevention.

Transfusion safety: Is there a difference between reported reactions in low-to-middle income and high-income countries?

BACKGROUND AND OBJECTIVES: Transfusion safety may be becoming dependent on the financial resources made available for transfusion structures and may vary between high-income countries (HIC) and low-to-middle-income countries (LMIC). To assess whether there is a difference in the reported TR between these two groups of countries, we examined TR reported in Tunis the capital of Tunisia, a LMIC, and compared their frequency with reported TR in HIC. MATERIALS AND METHODS: Data of TR were collected from transfusion incident report (TIR) forms declared by healthcare facilities in Tunis between 2015 and 2019. They were analysed and compared to reported TR in France (ANSM) and UK (SHOT). RESULTS: The incidence of TR was 70.6/100 000 blood components (BP) issued. A third of TR (36.8%) occurred at night. Febrile non-hemolytic transfusion reactions (43.7%) and allergic reactions (35%) were the most reported TR respectively 22.4/100 000 BP and 17.9/100 000 BP. The rate of ABO incompatibilities was 1.96/100 000 red blood cell units (RBC): they were all caused by human error. The rates of TRALI, TACO and bacterial contaminations were respectively 1.26/100 000 BP, 1.4/100 000 RBC and 0.7/100 000 BP. CONCLUSION: While advanced technologies applied to transfusion have improved transfusion safety, this study shows that their impact has been relatively minor, as reported TR in LMIC are still comparable to those in HIC. ABO-incompatibilities are still higher in LMIC: this should be addressed by reinforcing the training of all healthcare personnel involved in transfusion medicine.

Longitudinal analysis of annual national hemovigilance data to assess pathogen reduced platelet transfusion trends during conversion to routine universal clinical use and 7-day storage.

BACKGROUND: France converted to universal pathogen reduced (PR; amotosalen/UVA) platelets in 2017 and extended platelet component (PC) shelf-life from 5- to 7-days in 2018 and 2019. Annual national hemovigilance (HV) reports characterized longitudinal PC utilization and safety over 11 years, including several years prior to PR adoption as the national standard of care. METHODS: Data were extracted from published annual HV reports. Apheresis and pooled buffy coat [BC] PC use was compared. Transfusion reactions (TRs) were stratified by type, severity, and causality. Trends were assessed for three periods: Baseline (2010-14; ~7% PR), Period 1 ([P1] 2015-17; 8%-21% PR), and Period 2 ([P2] 2018-20; 100% PR). RESULTS: PC use increased by 19.1% between 2010 and 2020. Pooled BC PC production increased from 38.8% to 68.2% of total PCs. Annual changes in PCs issued averaged 2.4% per year at baseline, -0.02% (P1) and 2.8% (P2). The increase in P2 coincided with a reduction in the target platelet dose and extension to 7-day storage. Allergic reactions, alloimmunization, febrile non-hemolytic TRs, immunologic incompatibility, and ineffective transfusions accounted for >90% of TRs. Overall, TR incidence per 100,000 PCs issued declined from 527.9 (2010) to 345.7 (2020). Severe TR rates declined 34.8% between P1-P2. Forty-six transfusion-transmitted bacterial infections (TTBI) were associated with conventional PCs during baseline and P1. No TTBI were associated with amotosalen/UVA PCs. Infections with Hepatitis E (HEV) a non-enveloped virus resistant to PR, were reported in all periods. DISCUSSION: Longitudinal HV analysis demonstrated stable PC utilization trends with reduced patient risk during conversion to universal 7-day amotosalen/UVA PCs.

Standardized reporting of pulmonary transfusion complications: Development of a model reporting form and flowchart.

BACKGROUND: Pulmonary complications of blood transfusion, including transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), and transfusion-associated dyspnea, are generally underdiagnosed and under-reported. The international TRALI and TACO definitions have recently been updated. Currently, no standardized pulmonary transfusion reaction reporting form exists and most of the hemovigilance forms have not yet incorporated the updated definitions. We developed a harmonized reporting form, aimed at improved data collection on pulmonary transfusion reactions for hemovigilance and research purposes by developing a standardized model reporting form and flowchart. MATERIALS AND METHODS: Using a modified Delphi method among an international, multidisciplinary panel of 24 hemovigilance experts, detailed recommendations were developed for a standardized model reporting form for pulmonary complications of blood transfusion. Two Delphi rounds, including scoring systems, took place and several subsequent meetings were held to discuss issues and obtain consensus. Additionally, a flowchart was developed incorporating recently published redefinitions of pulmonary transfusion reactions. RESULTS: In total, 17 participants completed the first questionnaire (70.8% response rate) and 14 participants completed the second questionnaire (58.3% response rate). According to the results from the questionnaires, the standardized model reporting form was divided into various subcategories: general information, patient history and transfusion characteristics, reaction details, investigations, treatment and supportive care, narrative, and transfused product. CONCLUSION: In this article, we present the recommendations from a global group of experts in the hemovigilance field. The standardized model reporting form and flowchart provide an initiative that may improve data collected to address pulmonary transfusion reactions.

Investigating the quality of hemovigilance process using the first two steps of Six Sigma model: a cross-sectional study.

BACKGROUND AND PURPOSE: Hemovigilance is a set of monitoring methods that covers the blood transfusion chain, from collecting blood and blood products to monitoring the blood recipients. To this end, any error in this process can have serious and irreparable consequences for patients. The present study aimed to investigate the quality of hemovigilance process in Iran, using the first two steps of Six Sigma model. METHODS: This was a quantitative cross-sectional study that was conducted over 6 months (from August 20, 2021, to February 20, 2022) at Afzalipour Hospital in Iran, using the first two steps of Six Sigma model. The study population comprised of all inpatients who needed blood or blood product transfusion in various departments of Afzalipour Hospital, among whom 477 patients were selected via stratified sampling in three shifts (morning, evening, and night). The datasheet was used to record errors in the three shifts. This research was conducted, using the DMAIC cycle's "define" and "measure" steps. RESULTS: In the define step, the hemovigilance process at Afzalipour Hospital was divided into two categories of normal process and emergency process. Each of these processes consists of several sub-processes, including "phlebotomy," "requesting blood and blood products from the department," "preparation of application by the blood bank," " sending a request from the blood bank to the blood transfusion center," "transfusing blood and blood products," and "returning the blood and blood products to the blood bank and waste disposal." In the measure step, the quality of hemovigilance process was evaluated based on sub-processes and labels at morning, evening and night shifts. The sub-process of sending a request from the blood bank to the blood transfusion center had the highest error rate with a sigma level of 1.5. Also, the evening and night shifts had a sigma level of 1.875, and the clinical and registration labels had a sigma level of 1.875. The overall sigma level of hemovigilance process was calculated to be 2. CONCLUSION: The results of this study showed that the quality of hemovigilance process at Afzalipour Hospital was poor. By employing the first two steps of Six Sigma method, we identified the existing errors in the hemovigilance process of Afzalipour hospital in order to assist hospital managers to take the necessary measures to improve this process.

Strengthening Blood Regulatory Systems to Tackle Africa's Unmet Needs for Blood and Blood Products.

Background: Assuring the quality and safety of blood and blood components is an essential element of health care in all countries and requires government commitment and legal frameworks. Ineffective regulation of blood and blood components has far-reaching consequences that are not limited to the affected countries but also have extensive global implications. Summary: In this review, we summarize the work of the project BloodTrain funded by the German Ministry of Health within the framework of the Global Health Protection Programme to strengthen regulatory structures in Africa that are imperative to guarantee the improved availability, safety, and quality of blood and blood products. Key Messages: Intense interaction with the stakeholders in African partner countries lead to first measurable successes in the strengthening of blood regulation, as shown here for hemovigilance.

Analysis of Transfusion-Transmitted Bacterial Infections according to German Hemovigilance Data (2011-2020).

Introduction: Following the first assessment of the effects of safety measures taken against transfusion-transmitted bacterial infections (TTBI), the Paul-Ehrlich-Institut (PEI) decided to newly analyze risk minimization measures (RMM) using German hemovigilance data from 2011 to 2020, focusing on blood components, recipients, and bacterial strains. Materials and Methods: The PEI assessed the imputability of all reported serious adverse reactions (SAR) relying mainly on microbiological test results. Reporting rates (RR) of suspected, confirmed, and fatal confirmed TTBI were calculated and compared to the previous reporting 10-year period (2001-2010) using Poisson regression to estimate RR ratios (RRR). Furthermore, details on blood component age, patients' medical history, and bacterial pathogenicity were collected. Results: With respect to the previous 10-year period, the number of suspected TTBI increased (n = 403), while fewer cases were confirmed (n = 40); the number of deaths remained more or less unchanged (n = 8). The RR for suspected TTBI were 7.9, 18.7, and 1.6 cases per million units transfused for red blood cells (RBC), platelet concentrates (PC), and fresh frozen plasma (FFP), respectively. RRR showed a statistically significant 2.5-fold increase in the RR for suspected TTBI after RBC administration from 2001-2010 to the period under review (p < 0.0001). The RR for confirmed TTBI were 0.4, 5.0, and 0.0 cases per million units transfused for RBC, PC, and FFP, respectively. Compared to the period 2001-2010, there was a statistically significant decrease in the RR of confirmed TTBI by half for PC (p = 0.0052). The RR for confirmed PC-caused TTBI with fatal outcome was 1.4 cases per million units transfused. Regardless of type of blood product transfused and outcome of SAR, the majority of TTBI occurred after administration of a product at the end of shelf life (40.0%) and to recipients of advanced age (median age: 68.5 years) and/or with severe immunosuppression (72.5%) due to decreased myelopoiesis (62.5%). 72.5% of the involved bacteria had a middle/high human pathogenicity. Conclusion: Despite a significant decrease in confirmed TTBI following PC transfusion in Germany after implementation of RMM, the current manufacture of blood products can still not prevent TTBI with fatal outcomes. As demonstrated in various countries, RMM like bacterial screening or pathogen reduction may measurably improve the safety of blood transfusion.

Transfusion-Transmitted Hepatitis A Virus, France, 2018.

We report a transfusion-transmitted hepatitis A virus infection in an immunocompromised patient in France, detected shortly after a transfusion of pathogen-reduced pooled platelets. This case raises questions about the efficacy of donor screening methods. Additional safety measures, such as routine donation screening, should be considered.

Incidence and characteristics of hypotensive transfusion reaction: 10-year experience in a single center.

BACKGROUND: Hypotensive transfusion reaction (HyTR) is rare. It is characterized by a rapid onset of hypotension during transfusion, which usually resolves quickly upon cessation of transfusion. Information on the incidence and clinical characteristics of HyTR has been reported in only a few studies. STUDY DESIGN AND METHODS: We retrospectively reviewed HyTR cases from 10-year hemovigilance data in a tertiary care hospital in Seoul, Korea. RESULTS: We identified 37 HyTRs in 35 patients, and the overall incidence of HyTR was 0.50 per 10,000 transfused units. Among the blood components, the incidence of HyTR was highest in filtered random donor platelets (0.75 per 10,000 units). About half of the HyTRs occurred within 15 min after the start of transfusion (19/37). Blood pressure returned to the normal range within an hour in 73.0% of the cases (27/37). All HyTR cases recovered without severe complications. Known risk factors for HyTR were not prominent in our cohort of patients, with no patients taking angiotensin-converting enzyme inhibitors and only five patients transfused with bedside filtered platelets. DISCUSSION: HyTR can occur in patients with various conditions and types of blood components. Understanding the clinical characteristics of HyTR facilitates proper management, leading to improved transfusion safety.

Active seeking of post-donation information to minimize a potential threat to transfusion safety: A pilot programme in the context of the COVID-19 pandemic.

BACKGROUND AND OBJECTIVES: Early in the pandemic, the transmissibility of coronavirus disease-19 (COVID-19) by transfusion was unknown. We piloted a systematic, post-donation outreach programme to contact blood donors and inquired about symptoms post-donation. MATERIALS AND METHODS: Persons who donated on on May 1 and 2, 2020 were contacted 3 days post-donation, by phone to assess COVID-19-related symptoms. Half of the donors were administered a short questionnaire, consisting of only three questions. Others were questioned using a longer, more specific questionnaire. If symptoms were reported, products were quarantined until donors were contacted again by a trained nurse who more thoroughly assessed the likelihood of COVID-19. Blood products were withdrawn if symptoms indicative of COVID-19 were identified. RESULTS: Of 654 donors, 609 (93.1%) were successfully contacted. Of 310 donors who answered the short questionnaire and 299 who answered the long questionnaire, 19 (6.1%) and 8 (2.7%) had one or more symptoms, respectively. Based on the nurses' assessment, two donations (0.3%) had to be withdrawn. CONCLUSION: These results suggest that actively seeking post-donation information might be feasible to mitigate emerging, unqualified transfusion risks.

Acute hemolytic reaction by anti-Wra: Case report and review of the hemovigilance database of a tertiary care hospital.

Wra is the most common LIA in white population. The incidence of Wra antigen in Spanish population has been estimated to be 1 in 785 in blood donors, while anti-Wra was found in 2.7 % and 3.6 % of healthy donors and transfused patients respectively. Severe, even fatal hemolytic transfusion reactions and hemolytic disease of the newborn caused by anti-Wra have been reported. Since the reagent red blood cells used for antibody screening usually lack Wra antigen, the anti-Wra is not detected and hemolytic reaction could occur if transfusion is performed by type and screen approach. We report an acute hemolytic reaction due to anti-Wra in a patient with negative antibody screening. We have also reviewed the records of the hospital hemovigilance database in order to collect the previous hemolytic cases due to anti-Wra. During a 21-year period 461,539 red blood cell units have been transfused to 81,614 patients in our hospital. Alloimmnunization was detected in 3840 patients (0.83 %) and anti-Wra was detected in 22 patients (1/3709), 10 of whom had other alloantibodies, and only in 1 occasion (this case) has been implicated in mild hemolytic acute transfusion reaction. In our experience, the risk of fatal hemolytic reaction due to LIA in hospitals with blood services using the type and screen policy is extremely low.

Implementation of measures to reduce vasovagal reactions: Donor participation and results.

BACKGROUND: There are several strategies to reduce donor reactions. We report donor participation and reaction rates before and after implementing multiple measures at Canadian Blood Services. STUDY DESIGN AND METHODS: We introduced a structured program of 500 mL of water and a salty snack pre-donation and applied muscle tension (AMT) during donation. Donors were not deferred for out of range blood pressure (BP); however, BP was measured in first time donors. Time on the donation chair post-donation was decreased from 5 to 2 min for repeat donors. We assessed participation rates using our quarterly survey of 10,000 recent donors. We extracted vasovagal reactions with loss of consciousness (LOC) from our operational database and compared pre-implementation (Oct 12,018-March 31,2019) and post-implementation (Oct 12,019-March 31,2020) periods. RESULTS: Survey response rates varied from 11% to 16%. The percentage of donors who drank the water and ate the salty snack increased from 58% to 82% and 44% to 70% over 4 quarters; those performing AMT increased from 24% to 41%. Reactions decreased from 19.07 per 10,000 (744 reactions in 390,123 donations) to 14.04 per 10,000 (537 in 382,382 donations) (p < .0001). No first-time donors with high BP (n = 684) but 5 with low BP (n = 718) had reactions, CI were very large. CONCLUSIONS: Achieving optimal participation was challenging. After implementation of a donor wellness initiative based on best practice, rates of vasovagal reactions with LOC decreased by 25%. A larger dataset is necessary to assess the safety contribution of BP deferrals when other mitigation measures are in place.

The safety of COVID-19 convalescent plasma donation: A multi-institutional donor hemovigilance study.

BACKGROUND: Although the safety and therapeutic efficacy of COVID-19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi-institutional context. STUDY DESIGN AND METHODS: Nine blood collection organizations (BCOs) participated in a multi-institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity. RESULTS: The overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis-naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5-17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions. CONCLUSION: The safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity.

Transfusion-related adverse reactions: Data from the National Healthcare Safety Network Hemovigilance Module - United States, 2013-2018.

BACKGROUND: Despite current blood safety measures, transfusion recipients can experience transfusion-related adverse reactions. Monitoring these reactions can aid in understanding the effectiveness of current transfusion safety measures. Data from the National Healthcare Safety Network Hemovigilance Module were used to quantify adverse reaction risk. METHODS: Facilities reporting at least one month of transfused blood components and transfusion-related adverse reactions during January 2013-December 2018 were included. Adverse reaction rates (number per 100,000 components transfused) were calculated for transfused components stratified by component type, collection, and modification methods. RESULTS: During 2013-2018, 201 facilities reported 18,308 transfusion-related adverse reactions among 8.34 million blood components transfused (220/100,000). Adverse reactions were higher among apheresis (486/100,000) and pathogen-reduced platelets (579/100,000) than apheresis red blood cells (197/100,000). Allergic reactions (41%) were most common. There were 23 fatalities and 9% of all adverse reactions were serious (severe, life-threatening, or fatal). Reactions involving pulmonary complications (transfusion-associated circulatory overload, transfusion-related acute lung injury and transfusion-associated dyspnea) accounted for 35% of serious reactions but 65% of fatalities. Most (76%) of the 37 transfusion-transmitted infections were serious; none involved pathogen-reduced components. CONCLUSIONS: One in 455 blood components transfused was associated with an adverse reaction although the risk of serious reactions (1 in 6224) or transfusion-transmitted infections (1 in 225,440) was lower. Some serious reactions identified were preventable, suggesting additional safety measures may be beneficial. Higher reaction rates identified among pathogen-reduced platelets require further study. These findings highlight the importance of monitoring reactions through national hemovigilance to inform current safety measures and the need for strategies to increase healthcare facility participation.

Putting the spotlight on donation-related risks and donor safety - are we succeeding in protecting donors?

BACKGROUND AND OBJECTIVE: The European consortium project TRANSPOSE (TRANSfusion and transplantation: PrOtection and SElection of donors) aimed to assess and evaluate the risks to donors of Substances of Human Origin (SoHO), and to identify gaps between current donor vigilance systems and perceived risks. MATERIALS AND METHODS: National and local data from participating organizations on serious and non-serious adverse reactions in donors were collected from 2014 to 2017. Following this, a survey was performed among participants to identify risks not included in the data sets. Finally, participants rated the risks according to severity, level of evidence and prevalence. RESULTS: Significant discrepancies between anticipated donor risks and the collected data were found. Furthermore, many participants reported that national data on adverse reactions in donors of stem cells, gametes, embryos and tissues were not routinely collected and/or available. CONCLUSIONS: These findings indicate that there is a need to further develop and standardize donor vigilance in Europe and to include long-term risks to donors, which are currently underreported, ensuring donor health and securing the future supply of SoHO.

Registration errors among patients receiving blood transfusions: a national analysis from 2008 to 2017.

BACKGROUND AND OBJECTIVES: The key first step for a safe blood transfusion is patient registration for identification and linking to past medical and transfusion history. In Canada, any deviation from standard operating procedures in transfusion is an error voluntarily reportable to a national database (Transfusion Error Surveillance System [TESS]). We used this database to characterize the subset of registration-related errors impacting transfusion care, including where, when and why the errors occurred, and to identify frequent high-risk errors. MATERIALS AND METHODS: A retrospective analysis was conducted on transfusion errors reported to TESS by sentinel reporting sites relating to patient registration and patient armbands, between 2008 and 2017. Free-text comments describing the error were coded to further categorize into common error types. The number of specimens received in the transfusion laboratory was used as the denominator for rates to allow for comparison between hospital sites. RESULTS: Five hundred and fifty-four registration errors were reported from 10 hospitals, for a global error rate of 5·4/10 000 samples (median 5·0 [interquartile range 3·7-7·0]). The potential severity was high in 85·7% of errors (n = 475). The patient experienced a consequence in 10·8% of errors (n = 60), but none resulted in patient harm. Rates varied widely and differed by nature across sites. Errors most commonly occurred in outpatient clinics or procedure units (n = 160, 28·8%) and in emergency departments (n = 130, 23·5%). CONCLUSION: Registration errors affect transfusion at every step and location in the hospital and are commonly high risk. Further research into common root causes is warranted to identify preventative strategies.

Frequency and timing of all-cause deaths in visits involving suspected transfusion reactions, and the significance of cardiopulmonary disturbances.

BACKGROUND/OBJECTIVES: Transfusion reactions (TRs) may cause or contribute to death. Cardiopulmonary TRs are distressing, and collectively account for most transfusion fatalities, though the degree to which they alter survival more broadly is unclear. Deaths (and their timing) after TRs may provide further insights. MATERIALS/METHODS: Adult (tri-hospital network) haemovigilance data (2013-2016) recorded referrals with conclusions ranging from unrelated to transfusion (UTR) to entities such as: septic TRs, serologic/haemolytic reactions, transfusion-associated circulatory overload (TACO), transfusion-associated dyspnoea (TAD), transfusion-related acute lung injury (TRALI), allergic transfusion reaction (ATR), and others. For (in- or out-patient) visits involving suspected TRs (VISTRs), all-cause mortalities (% [95% confidence interval]) and associated time-to-death (TTD) (median days, [interquartile range]) were compared. Diagnoses were defined inclusively (possible-to-definite) or strictly (probable-to-definite). RESULTS: Of 1144 events, rank order VISTR mortality following (possible-to-definite) TRs, and associated TTDs, were led by: DHTR 33% [6-19], 1 death at 123d; TRALI 32% [15-54], 6 deaths: 3d [2-20]; BaCon 21% [14-31], 17 deaths: 10d [3-28]; TACO 18% [12-26], 23 deaths: 16d [6-28]; TAD 17% [11-26]: 18 deaths, 6d [3-12]. Higher-certainty TRs ranked similarly (DHTR 50% [9-91]; BaCon 29% [12-55], 4 deaths: 12d [3-22]; and TACO 25% [16-38], 15 deaths: 21d [6-28]). VISTR mortality after TACO or TRALI significantly exceeded ATR (3·3% [2·4-5·8], P < 0·00001) but was not different from UTR events (P = 0·3). CONCLUSIONS: Only half of cardiopulmonary TRs constituted high certainty diagnoses. Nevertheless, cardiopulmonary TRs and suspected BaCon marked higher VISTR mortality with shorter TTDs. Short (<1 week) TTDs in TAD, BaCon or TRALI imply either contributing roles in death, treatment refractoriness and/or applicable TR susceptibilities in the dying.

Severe Acute Hemolytic Transfusion Reaction Treated with Ruxolitinib and Plasma Exchange.

INTRODUCTION: Acute hemolytic transfusion reaction is a rare but extremely mortal condition. Even small quantities of ABO-incompatible erythrocytes, as much as 50 mL, can lead to fatality. Since there is no successful standard therapy, preventive measures are very important. In this case report, we presented a 29-year-old woman who was transfused with 2 units of AB Rh-positive instead of 0 Rh-positive red blood cells following a cesarean section. As far as we know, this is the first patient in the literature for whom ruxolitinib was used as a part of therapy. CASE REPORT: The patient was referred to our center 22 h after the ABO-mismatched transfusion. On admission, she had severe hemolysis, acute renal failure, and disseminated intravascular coagulation. Massive plasma exchange, hemodialysis, and pulse steroid therapy were commenced. The patient was refractory to first-line therapies. She was intubated on day 2 due to hypoxia, respiratory failure and changes in consciousness. Ruxolitinib, 2 × 10 mg/day, was started on day 3. The patient's clinical status improved on day 6. Ruxolitinib was withdrawn on day 15, and the patient was discharged without any complications or sequels on day 26. CONCLUSION: Ruxolitinib may be life-saving in patients with ABO-incompatible transfusion reaction which follows a severe and catastrophic course.