Economic Evaluation of National Patient Blood Management Clinical Guidelines in Cardiac Surgery.

OBJECTIVES: To the best of our knowledge, no published clinical guidelines have ever undergone an economic evaluation to determine whether their implementation represented an efficient allocation of resources. Here, we perform an economic evaluation of national clinical guidelines designed to reduce unnecessary blood transfusions before, during, and after surgery published in 2012 by Australia's sole public blood provider, the National Blood Authority (NBA). METHODS: We performed a cost analysis from the government perspective, comparing the NBA's cost of implementing their perioperative patient blood management guidelines with the estimated resource savings in the years after publication. The impact on blood products, patient outcomes, and medication use were estimated for cardiac surgeries only using a large national registry. We adopted conservative counterfactual positions over a base-case 3-year time horizon with outcomes predicted from an interrupted time-series model controlling for differences in patient characteristics and hospitals. RESULTS: The estimated indexed cost of implementing the guidelines of A$1.5 million (2018-2019 financial year prices) was outweighed by the predicted blood products resource saving alone of A$5.1 million (95% confidence interval A$1.4 million-A$8.8 million) including savings of A$2.4 million, A$1.6 million, and A$1.2 million from reduced red blood cell, platelet, and fresh frozen plasma use, respectively. Estimated differences in patient outcomes were highly uncertain and estimated differences in medication were financially insignificant. CONCLUSIONS: Insofar as they led to a reduction in red blood cell, platelet, and fresh frozen plasma use during cardiac surgery, implementing the perioperative patient blood management guidelines represented an efficient use of the NBA's resources.

London 2017: Lessons learned in transfusion emergency planning.

BACKGROUND AND OBJECTIVES: Hospitals prepare for emergencies, but the impact on transfusion staff is rarely discussed. We describe the transfusion response to four major incidents (MIs) during a 6-month period. Three events were due to terrorist attacks, and the fourth was the Grenfell Tower fire. The aim of this paper was to share the practical lessons identified. METHODS: This was a retrospective review of four MIs in 2017 using patient administration systems, MI documentation and post-incident debriefs. Blood issue, usage and adverse events during the four activation periods were identified using the Laboratory Information Management System (TelePath). RESULTS: Thirty-four patients were admitted (18 P1, 4 P2, 11 P3 and 1 dead). Forty-five blood samples were received: 24 related to nine MI P1 patients. Four P1s received blood components, three with trauma and one with burns, and 35 components were issued. Total components used were six red blood cells (RBC), six fresh frozen plasma (FFP) and two cryoprecipitate pools. Early lessons identified included sample labelling errors (4/24). Errors resolved following the deployment of transfusion staff within the emergency department. Components were over-ordered, leading to time-expiry wastage of platelets. Careful staff management ensured continuity of transfusion services beyond the immediate response period. Debriefing sessions provided staff with support and enabled lessons to be shared. CONCLUSIONS: Transfusion teams were involved in repeated incidents. The demand for blood was minimal. Workload was related to sample handling rather than component issue. A shared situational awareness would improve stock management. A laboratory debriefing system offered valuable feedback for service improvement, staff training and support.

Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019.

During the training workshop on Inspection of Blood Establishments, which was hosted by the PEI GHPP BloodTrain in Harare from the 20th to the 24th of May 2019, participants from the National Regulatory Authorities from seven Sub-Sahara African countries presented their current experiences related to regulation and inspection of blood establishments in their respective countries. While in all seven countries regulation and inspection of conventional medicinal products manufacturer is performed, the regulatory situation of blood and blood components as well as inspection of blood establishments is still heterogeneous.

Status analysis and evaluation of the blood scrap rate from 2015-2017 for a blood center in China.

OBJECTIVES: The objective of this study was to ascertain the current conditions and development in the past three years of clinical transfusion practice in Nanjing, Jiangsu province, China. MATERIALS AND METHODS: Blood quality control practices and the blood production scrap rate from 2015-2017 were monitored and measured using different quality statistics and management tools. RESULTS: The causes of unqualified and scrapped blood during blood collection and supply were analyzed and evaluated. The analysis of the key indices for blood component quality control showed that the qualified rate of FVIII activity (from fresh frozen plasma) was 54.55%, which failed to meet the threshold of 75%. Retrospective analysis of conventional blood scrapping factors showed that laboratory scraps accounted for the majority. The composition ratio of TTI screening results included ALT (31.91%), HBV (21.92%), TP (12.15%), NAT (10.78%), HCV (8.45%), and HIV (7.43%). Retrospective analysis of unconventional blood scrapping factors showed that the total unconventional blood depletion rate was 0.565%. Insufficient or small quantities of collected blood was the most important factor related to unconventional scrapping. The blood donor and blood hospital service satisfaction rates were over 95% and 90%, respectively, which achieved the quality target. CONCLUSIONS: Nonconforming product control was proposed and determined as the urgent theme of the first QCC. It is necessary for blood stations to effectively control blood scrapping, which can reduce the cost of blood collection, protect the blood donation of unpaid blood donors, increase the rate of repeated blood donation, and improve blood safety.

Whole blood transfusion versus component therapy in adult trauma patients with acute major haemorrhage.

OBJECTIVE: In the era of damage control resuscitation of trauma patients with acute major haemorrhage, transfusion practice has evolved to blood component (component therapy) administered in a ratio that closely approximates whole blood (WB). However, there is a paucity of evidence supporting the optimal transfusion strategy in these patients. The primary objective was therefore to establish if there is an improvement in survival at 30 days with the use of WB transfusion compared with blood component therapy in adult trauma patients with acute major haemorrhage. METHODOLOGY: A systematic literature search was performed on 15 December 2019 to identify studies comparing WB transfusion with component therapy in adult trauma patients and mortality at 30 days. Studies which did not report mortality were excluded. Methodological quality of included studies was interpreted using the Cochrane risk of bias tool, and rated using the Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS: Search of the databases identified 1885 records, and six studies met the inclusion criteria involving 3255 patients. Of the three studies reporting 30-day mortality (one randomised controlled trial (moderate evidence) and two retrospective (low and very low evidence, respectively)), only one study demonstrated a statistically significant difference between WB and component therapy, and two found no statistical difference. Two retrospective studies reporting in-hospital mortality found no statistical difference in unadjusted mortality, but both reported statistically significant logistic regression analyses demonstrating that those with a WB transfusion strategy were less likely to die. CONCLUSION: Recognising the limitations of this systematic review relating to the poor-quality evidence and limited number of included trials, it does not provide evidence to support or reject use of WB transfusion compared with component therapy for adult trauma patients with acute major haemorrhage. PROSPERO REGISTRATION NUMBER: CRD42019131406.

Forgot calcium? Admission ionized-calcium in two civilian randomized controlled trials of prehospital plasma for traumatic hemorrhagic shock.

BACKGROUND: Randomized clinical trials (RCTs) support the use of prehospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most prehospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent prehospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that prehospital plasma is associated with hypocalcemia, which in turn is associated with lower survival. METHODS: We studied patients enrolled in two institutions participating in prehospital plasma RCTs (control, standard of care; experimental, plasma), with i-Ca collected before calcium supplementation. Adults with traumatic hemorrhagic shock (systolic blood pressure ≤70 mm Hg or 71-90 mm Hg + heart rate ≥108 bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca of 1.0 mmol/L or less. RESULTS: Of 160 subjects (76% men), 48% received prehospital plasma (median age, 40 years [interquartile range, 28-53 years]) and 71% suffered blunt trauma (median Injury Severity Score [ISS], 22 [interquartile range, 17-34]). Prehospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03). Severe hypocalcemia was significantly associated with decreased survival (adjusted hazard ratio, 1.07; 95% CI, 1.02-1.13; p = 0.01) and massive transfusion (adjusted relative risk, 2.70; 95% CI, 1.13-6.46; p = 0.03), after adjustment for confounders (randomization group, age, ISS, and shock index). CONCLUSION: Prehospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in prehospital hemotherapy. LEVEL OF EVIDENCE: Therapeutic, level II.

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.

Rotational thromboelastometry predicts transfusion and disability in pediatric trauma.

BACKGROUND: Trauma-induced coagulopathy seen on rotational thromboelastometry (ROTEM) is associated with poor outcomes in adults; however, this relationship is poorly understood in the pediatric population. We sought to define thresholds for product-specific transfusion and evaluate the prognostic efficacy of ROTEM in injured children. METHODS: Demographics, ROTEM, and clinical outcomes from severely injured children (age, < 18 years) admitted to a Level I trauma center between 2014 and 2018 were retrospectively analyzed. Receiver operating characteristic curves were plotted and Youden indexes were calculated against the endpoint of packed red blood cell transfusion to identify thresholds for intervention. The ROTEM parameters were compared against the clinical outcomes of mortality or disability at discharge. RESULTS: Ninety subjects were reviewed. Increased tissue factor-triggered extrinsic pathway (EXTEM) clotting time (CT) >84.5 sec (p = 0.049), decreased EXTEM amplitude at 10 minutes (A10) <43.5 mm (p = 0.025), and decreased EXTEM maximal clot firmness (MCF) <64.5 mm (p = 0.026) were associated with need for blood product transfusion. Additionally, EXTEM CT longer than 68.5 seconds was associated with mortality or disability at discharge. CONCLUSION: Coagulation dysregulation on thromboelastometry is associated with disability and mortality in children. Based on our findings, we propose ROTEM thresholds: plasma transfusion for EXTEM CT longer than 84.5 seconds, fibrinogen replacement for EXTEM A10 less than 43.5 mm, and platelet transfusion for EXTEM MCF less than 64.5 mm. LEVEL OF EVIDENCE: Prognostic, Level III; Therapeutic, Level IV.

Pathogen Reduction: The State of the Science in 2019.

In the past 30 years, transfusion safety has increased substantially and blood transfusion is now a safer procedure than at any time in the past. Herein, we provide a comprehensive review of pathogen reduction, which is the new paradigm in transfusion safety. Specifically, we describe the various processes and technologies that are capable of diminishing or neutralizing infectious threats, including those that are not addressed or may not be detected by standard screening techniques. A special emphasis is placed on recent developments that are likely to impact patient care in 2019 and beyond.

Efficacy of a strict surveillance policy towards inappropriateness of plasma transfusion.

BACKGROUND: Plasma transfusion is not without risks. Despite a limited spectrum of indications, plasma is frequently used as prophylaxis in non-bleeding patients, to correct altered coagulation tests. A high rate of inappropriate use of plasma transfusion is frequently reported, as well as underdosage. STUDY DESIGN AND METHODS: Since 2010 we started an education program that occurred in several phases to disseminate the knowledge of plasma transfusion guidelines. Since 2014 a 'zero tolerance' policy was applied: except for massive bleedings, plasma requests were prospectively evaluated, rejecting those without an appropriate indication. When indicated, at least 10 mL/Kg b.w.were issued. The previous five year period (2005-2009) served as control. RESULTS: The number of patients transfused/year decreased by 67.6% vs the control period (149 vs 460), and the liters of plasma issued/year decreased by 70.4% (233 vs 795). The deepest fall was observed in acute care wards (-70.8%). The mean volume transfused per episode raised from 731 mL ±â€¯70 to 879 mL ±â€¯154. The Prothrombin Time ratio at the moment of transfusion request increased from a mean of 1.35 (Interquartile range 1.20-2.64) in the control period to 1.62 (Interquartile range 1.43-1.98) in the last period (p < 0.001). CONCLUSION: With a proactive educational approach a remarkable reduction of plasma order and administration has been obtained, without any consequence on morbidity and mortality and with an estimated saving since 2014 of 750,000 €. A 'zero tolerance' policy can be effectively implemented only with a thorough workup with the local physicians, including repeated rounds of information and refreshing of the updated transfusion practice and knowledge of the established guidelines over the time.

Effect of Pre-Hospital Use of the Assessment of Blood Consumption Score and Pre-Thawed Fresh Frozen Plasma on Resuscitation and Trauma Mortality.

BACKGROUND: Early blood product resuscitation reduces trauma patient mortality from hemorrhage. This mortality benefit depends on a system that can rapidly identify actively bleeding patients, initiate massive transfusion protocol (MTP), and mobilize resources to the bedside. We hypothesized that process improvement efforts that identify patients early and mobilize appropriate blood products to the bedside for immediate use would improve mortality. STUDY DESIGN: Pre-implementation, MTP activation was at the discretion of the trauma surgeon, and only PRBCs were immediately available. In June 2016, the Assessment of Blood Consumption (ABC) score was incorporated in our pre-hospital triage process, and a process for thawed plasma to be available was developed. We performed a retrospective review of patients who were hypotensive on arrival or had MTP activated. We compared mortality and MTP component ratios 15 months pre- vs 15 months post-implementation. RESULTS: Activations of MTP increased 6-fold, while the specificity of the process remained the same. In patients receiving MTP, appropriate blood product transfusion ratios increased 44%. Overall and penetrating trauma mortality improved by 23% and 41%, respectively. When divided by the Injury Severity Score (ISS), penetrating trauma mortality decreased by 65% for the ISS subgroup 15 to 24 and by 38% for ISS subgroup ≥ 25. Length of stay, ICU length of stay, and readmission rates were not significantly different. CONCLUSIONS: Delivery of balanced blood product resuscitation is essential to confer mortality benefits. Process improvement directed at early recognition of the hemorrhagic patient, immediate product availability, and product delivery to the bedside for transfusion allows for mortality reduction without increased resource use.

Blood Component Separation Service: A New Experience in an Institution.

INTRODUCTION: Blood component separation facility began dispatching its blood component units from 21st April 2013 at the new blood component separation service complex at B.P. Koirala Institute of Health Sciences. With the supply of blood components being finite and with the added recognition of a high rate of inappropriate use of blood component services around the world, there is a need to monitor and regulate these services. Our study was conducted to identify blood component utilization pattern in institute and to know about different blood components demand for future preparedness. METHODS: This retrospective study was conducted at B.P. Koirala Institue of Helath Sciences, Dharan, Nepal for blood component dispatched from 21st April, 2013- 12th February, 2014. Blood components requisitions from all clinical department were reviewed regarding the specific component requested, blood group and socio-demographic profile. RESULTS: Among 3054 transfusion units dispatched, 1552 were males, 1498 females and 4 unspecified. Likewise, 1722 were pack cell volume, 808 platelet rich plasma, 523 fresh frozen plasma and 1 cryoprecipitate disptached respectively with majority of A positive blood group demanded from Neonatal and Paediatric Intensive Care Unit ward for Packed Cell Volume was 201 and Fresh Frozen Plasma was 300 followed by emergency ward for Platelet Rich Plasma. About 197 (6.45%) requistions forms lacked the details of requesting department, while some even reveal multiple demands. CONCLUSIONS: Packed Cell Volume of A positive blood group being the predominant blood component requested from Neonatal Intensive Care Unit/Pediatrics Intensive Care Unit ward at the institute making most requests. Finally, these results could be useful for estimating the requirements for our newly establish blood bank to meet the demand in future.

Whole Blood Transfusion.

Whole blood is the preferred product for resuscitation of severe traumatic hemorrhage. It contains all the elements of blood that are necessary for oxygen delivery and hemostasis, in nearly physiologic ratios and concentrations. Group O whole blood that contains low titers of anti-A and anti-B antibodies (low titer group O whole blood) can be safely transfused as a universal blood product to patients of unknown blood group, facilitating rapid treatment of exsanguinating patients. Whole blood can be stored under refrigeration for up to 35 days, during which it retains acceptable hemostatic function, though supplementation with specific blood components, coagulation factors or other adjuncts may be necessary in some patients. Fresh whole blood can be collected from pre-screened donors in a walking blood bank to provide effective resuscitation when fully tested stored whole blood or blood components are unavailable and the need for transfusion is urgent. Available clinical data suggest that whole blood is at least equivalent if not superior to component therapy in the resuscitation of life-threatening hemorrhage. Low titer group O whole blood can be considered the standard of care in resuscitation of major hemorrhage.

Statistical control of the production of blood components by control charts of attribute to improve quality characteristics and to comply with current specifications.

Statistical process control (SPC) is closely related to good quality control practices in the manufacturing process. One of the primary goals is to detect unnatural patterns, allowing the production service to control the conformity of the blood components produced. Despite being recommended by national and international standards, its exercise is not uniform, and sometimes the methodology used is misinterpreted as SPC. When the input data has a Gaussian distribution, control charts for variables are proposed. However, when the data distribution is not normal, control charts for attributes are suggested. This article presents and discusses four statistical procedures for the control of attributes using p-, np-, u-, and c-charts. An empirical demonstration shows these models are reliable for in routine use in the Blood Establishment quality control, as also suggests the use when the control charts for variables are inapplicable.

[The new hemotherapy guideline]. / Die neue Richtlinie Hämotherapie.

The 2017 update of the German guidelines on hemotherapy is highly associated with the drug legislation and guidelines and thus necessitated a new structure of the contents. These guidelines reflect the state of the art for collection and application of blood and blood components corresponding to the Transfusion Act and is therefore the main document in hemotherapy. Topics of high interest in this 2017 update related to application of blood products are clarification and consent of patients, obligation for documentation, information, reporting and notification reports in the case of transfusion reactions and detailed description of quality management and quality assurance, as well as task description of persons responsible for the organization or implementation of transfusion-associated workflows. Surveillance, collating and management of errors are important prerequisites for the continuous optimization of patient safety. Patient blood management (PBM) as a requirement for the efficient use of blood products and the controlled and economical usage of autologous hemotherapy procedures (e. g. mechanical autotransfusion, MAT) are measures to reduce the need for blood products. All medical specialist societies, which carry out hemotherapy and participate in the standing committee of the Federal Medical Council (BÄK) to revise the hemotherapy guidelines have to take care that the guidelines are understandable for medical doctors and the transfusion team. Additionally, the core principles of hemotherapy have to be described in a clear and distinct manner.

Massive transfusions for critical bleeding: is everything old new again?

Massive transfusion or major haemorrhage protocols have been widely adopted in the treatment of critically bleeding patients. Following evidence that higher ratios of transfused plasma and platelets to red blood cells may offer survival benefits in military trauma patients, these ratios are now commonly incorporated into massive transfusion protocols. They more closely resemble the effects of whole blood transfusion, which in the second half of last century was largely replaced by individual blood component transfusion based on laboratory-guided indicators. However, high-quality evidence to guide transfusion support for critically bleeding patients across the range of bleeding contexts is lacking, including for both trauma and non-trauma patients. More data on major haemorrhage support and clinical outcomes are needed to inform guidelines and practice.

Advances in transfusion medicine: gastrointestinal bleeding.

Gastrointestinal bleeding is a common medical and surgical emergency and is the second most common indication for red blood cell (RBC) transfusion in the UK. Most transfusion guidelines recommend the use of restrictive blood transfusion in stable gastrointestinal bleeding. This review explores the evidence supporting this practice, including whether it is safe in lower as well as upper gastrointestinal bleeding, and the risks of restrictive transfusion in patients with cardiovascular disease. There is a lack of evidence supporting the use of platelet and fresh frozen plasma transfusion in gastrointestinal bleeding. The aim of this review is to serve as a practical guide to transfusion in stable gastrointestinal bleeding.

Transfusion of Blood Products in the Neurocritical Care Unit: An Exploration of Rationing and Futility.

Rationing is the allocation of scarce resources, which in healthcare necessarily requires withholding potentially beneficial treatments from some individuals. While it often entails a negative connotation, rationing is unavoidable because need is limitless and resources are not. How rationing occurs is important, because it not only affects individual lives, but also reflects society's most important values. At the core of any rationing, decision is how much a limited resource may benefit a patient, which can be particularly difficult to determine in the practice of neurocritical care, as prognosis is often uncertain. We present a case for the consideration of futility and blood product rationing in neurocritical care.