Quality improvement methodologies increase autologous blood product administration.

Whole blood from the heart-lung (bypass) machine may be processed through a cell salvaging device (i.e., cell saver [CS]) and subsequently administered to the patient during cardiac surgery. It was determined at our institution that CS volume was being discarded. A multidisciplinary team consisting of anesthesiologists, perfusionists, intensive care physicians, quality improvement (QI) professionals, and bedside nurses met to determine the challenges surrounding autologous blood delivery in its entirety. A review of cardiac surgery patients' charts (n = 21) was conducted for analysis of CS waste. After identification of practices that were leading to CS waste, interventions were designed and implemented. Fishbone diagram, key driver diagram, Plan-Do-Study-Act (PDSA) cycles, and data collection forms were used throughout this QI process to track and guide progress regarding CS waste. Of patients under 6 kg (n = 5), 80% had wasted CS blood before interventions, whereas those patients larger than 36 kg (n = 8) had 25% wasted CS before interventions. Seventy-five percent of patients under 6 kg who had wasted CS blood received packed red blood cell transfusions in the cardiothoracic intensive care unit within 24 hours of their operation. After data collection and didactic education sessions (PDSA Cycle I), CS blood volume waste was reduced to 5% in all patients. Identification and analysis of the root cause followed by implementation of education, training, and management of change (PDSA Cycle II) resulted in successful use of 100% of all CS blood volume.

A solvent/detergent-treated and 15-nm filtered factor VIII: a new safety standard for plasma-derived coagulation factor concentrates.

BACKGROUND: Since the early 1990 s the Committee for Proprietary Medicinal Products has set the mandatory requirement that all manufacturing processes for blood products include two virus removal/inactivation steps that are complementary in their action. OBJECTIVES: The objective was to develop a manufacturing process for factor VIII (FVIII) including two complementary steps of viral inactivation/elimination. METHODS: A 35-15 nm nanofiltration step was added to a former FVIII manufacturing process that included solvent/detergent (S/D) treatment to generate a new FVIII concentrate called Factane. The impact of nanofiltration on the structural and functional characteristics of FVIII, as well as virus/transmissible spongiform encephalopathy reduction factors were assessed. RESULTS: Using an innovative approach, FVIII was successfully nanofiltered at 35-15 nm, while the biological properties of the active substance were unmodified. FVIII coagulant and antigen content for Factane and previous S/D-treated FVIII (FVIII-LFB, commercialized as Facteur VIII-LFB) were comparable. The FVIII one-stage chromogenic and coagulant/antigen ratios confirmed that nanofiltered FVIII was not activated. After nanofiltration, the copurified von Willebrand factor (vWF) was reduced but vWF/FVIII binding properties were unaffected. Phospholipid binding and thrombin proteolysis studies displayed no differences between Factane and FVIII-LFB. The rate of factor Xa generation was slightly lower for Factane when compared to FVIII-LFB. Viral validation studies with different viruses showed no detectable virus in the filtrate. CONCLUSIONS: Nanofiltration of FVIII at 15 nm is feasible despite the large molecular weight of FVIII and vWF. Nanofiltration has been proven to be highly effective at removing infectious agents while preserving the structural and functional integrity of FVIII.

Current opinions on safer red cell transfusion practice and the appropriate use of alternative strategies.

This report summarizes the need for changes in certain areas of transfusion practice that may have some beneficial effect in improving transfusion safety and reducing the ever increasing demand for the use of red blood cells. These dual objectives can be achieved through a continuous educational and quality awareness program, encouraging the use of other available alternatives, including implementation of transfusion triggers reducing hemoglobin values, increased application of peri-operative/post-operative blood salvage, introduction of improved additive solutions and apheresis double dose RBC with a standardized hemoglobin content per unit; and changes in the clinical/laboratory practices, in particular when preparing patients for surgery. It is only through continuous education integration of better diagnosis/development/research and clinical practices in targeted patients that one can anticipate making a true contribution to the plodding and controversial issue of predicting transfusion safety and the cost benefit value of alternative strategies for transfusion. The current opinions on "safer transfusion" through the use of currently available alternatives are highlighted with the goal of promoting the use of transfusion alternatives in everyday clinical practice.

[Legal aspects of preparation and handling of concentrated red cells derived from placental blood in Germany]. / Juristische Aspekte bei der Herstellung und Verwendung von Plazentablut-Erythrozytenkonzentraten in Deutschland.

Legal aspects of collection, preparation and storage of autologous red cells derived from cord blood according to German law are presented and discussed.

Designing an integrated extracorporeal therapy service quality system.

Reorganization in clinical operations of a national service provider organization, Fresenius Medical Care Extracorporeal Alliance (FMC-EA), provided the opportunity to overhaul and integrate quality systems. Under the new structure, the management of acute dialysis, apheresis, open-heart perfusion, and intraoperative autotransfusion services were combined into an integrated service portfolio supported by a multidisciplinary team of nurses, perfusionists, and technicians. This communication is intended to be a concise review of the literature that establishes the foundation for the new quality system as well as a discussion of the five clinical policies and clinical procedure guidelines that govern clinical behavior in mobile, point of care, acute extracorporeal therapy services. The clinical policy standards are based on recognized essentials and guidelines published by professional organizations, federal and state government agencies, and accreditation groups. The standards list the essential behaviors that clinicians should exhibit during the provision of extracorporeal therapy procedures such as acute therapeutic apheresis. Compliance with the redesigned procedure guidelines and policies will provide the clinical practice platform for continuous quality improvement (CQI) activities, benchmarking, and self-improvement. These practices can lead to improvements in the quality of care, a decrease in medical errors, and a reduction in overall health care costs.

Levels of inflammatory markers in the blood processed by autotransfusion devices during cardiac surgery associated with cardiopulmonary bypass circuit.

Intraoperative blood salvage devices allowing a reinfusion of red blood cells (RBCs) after processing of shed blood and stagnant blood in the mediastinal cavity are more and more used to reduce homologous blood requirements in cardiac surgery with cardiopulmonary bypass (CPB). As the proinflammatory activity of the shed blood also contributes to morbidity during CPB, we conducted a prospective study in order to examine the quality of autologous blood before and after processing with five different devices [BRAT2, Sequestra, Compact Advanced, Cell Saver 5 (CS5), Continuous Autologous Transfusion System (CATS)]. All systems resulted in an excellent haemoconcentration, ranging from 53.7% (Compact) to 68.9% (CATS). The concentrations and elimination rates of several inflammatory markers [IL-1beta, IL-2, IL-8, TNFalpha, myeloperoxidase (MPO), elastase] were examined. Except for the Sequestra, an important increase in concentration of IL-1beta (between 30% and 220%) has been observed after processing with each device. In contrast, the attenuation rate of IL-6 and TNFalpha (95%) was optimal for all investigated blood salvages systems. Regarding IL-8, only the CATS and CS5 systems were able to attenuate this biological parameter with an excellent efficacy. The rate of attenuation in MPO and elastase, as markers of leukocyte activation, was higher than 80% for all devices. In conclusion, the different RBC washing systems tested in this study resulted in a significant attenuation of the inflammatory response. Increased levels of IL-1beta after processing remained, however, unclear. According to the type of protocol, based on inlet haematocrit, fill and wash speeds, and wash volumes, small variations in reducing the inflammatory response have been observed from one device to another.

Adverse reactions associated with mobile therapeutic apheresis: analysis of 17,940 procedures.

In order to evaluate the nature and frequency of adverse reactions associated with Therapeutic Apheresis (TA), database information from two large mobile apheresis services was analyzed. A total of 17,940 procedures performed on 3,583 patients were studied using an Access Database. Seventy percent (12,558) of the procedures were performed on a Fresenius AS104 blood cell separator and 30% (5,382) were performed on a COBE Spectra. The five most commonly treated diseases were Guillain-Barre Syndrome (25%), thrombotic thrombocytopenic purpura (20%), myasthenia gravis (18%), the hyperviscosity syndrome (12%), and chronic inflammatory demyelinating polyneuropathy (9%). All patients received calcium gluconate supplement during the procedures. Cardiac monitoring was used during 80% of the procedures and blood pressure monitoring was used during all procedures. All procedures were supervised by a physician. Both apheresis services fully comply with the ASFA Guidelines for Therapeutic Apheresis Providers. Adverse reactions occurred in 3.9% of all procedures. The following adverse reactions were documented: reactions related to ACD toxicity (3%), vasovagal reactions (0.5%), vascular access related complications (0.15%), reactions related to FFP (0.12%), hepatitis B from FFP (0.06%), arrhythmias (0.01%), hemolysis due to inappropriate dilution of 25% albumin (0.01%), and one death (from underlying disease) during a TA procedure (0.006%). These data demonstrate that therapeutic apheresis is associated with a low rate of side effects when performed by well-trained and certified nurses under the direction of experienced physicians, even in the diverse setting of large mobile therapeutic apheresis programs.

[Labile blood products and their preparation]. / Produits sanguins labiles et leur préparation.

Licensed labile blood components are put down on a regulatory list by the French Health Authority. They are prepared by the French National Blood Service and controlled according to regulatory and validated procedures. Depending on the origin of the blood, labile blood components are either homologous (donors) or autologous (from patients). Blood components (red cell concentrates, platelet concentrates and fresh frozen plasma) are processed within sterile closed disposable systems using either post-donation processing of whole blood or apheresis technology. All homologous blood components are leuco-reduced. Depending on specific settings, blood components could be washed, gamma irradiated or cryopreserved. Fresh frozen plasma is either "donor retested" after quarantine or viro-attenuated by solvent detergent treatment. Release is only allowed after a full conformity control of each blood component unit.

Monitoring universal leucodepletion performance: the current issues within components production and testing.

The UK NBS completed the introduction of universal leucodepletion in November 1999. This involved the implementation of new methods of production, testing and monitoring, the development of which is still ongoing. Whilst important lessons have been learnt, much remains to be achieved in respect of quality improvement through standardisation of procedures, processes and product modifications to improve safety/efficacy of therapeutic blood components. Since the introduction of universal leucodepletion, many changes in component production and testing have occurred. The primary goal of this report is to review the level of standardisation and harmonisation currently achieved for low leucocyte counting within the NBS and discuss remedial actions undertaken to improve the standard of blood component production and quality monitoring and to highlight some of the related issues which are currently being worked on. The following issues are discussed.

Efficacy of autotransfusion in spine surgery: comparison of autotransfusion alone and with hemodilution and apheresis.

STUDY DESIGN: Two prospective groups of patients received intraoperative autologous transfusion during reconstructive spine surgery. Before intraoperative autologous transfusion, one group underwent normovolemic hemodilution and apheresis of blood components in the operating room while being prepared for surgery. The allogeneic blood products needed for transfusion by each group were studied and compared with those of a retrospective group of patients receiving conventional transfusion therapy. OBJECTIVES: To determine if a combination of intraoperative autologous transfusion and hemodilution and apheresis decreases reliance on allogeneic blood products and increases autologous transfusions. SUMMARY OF BACKGROUND DATA: Transfusion rates of allogeneic red blood cells, which were unchanged by intraoperative autologous transfusion alone, were lowered when treatment included transfusion of these cells and preoperative autologous deposit. However, donor exposures from transfusions of allogeneic platelets and fresh frozen plasma have not been addressed. METHOD: Preoperative hemodilution and apheresis of autologous red blood cells, fresh plasma, and platelets, performed during induction of anesthesia for spine surgery was followed by intraoperative autologous transfusion using the same supplies. Intra- and postoperative transfusion of blood products to each group were evaluated and compared; allogeneic transfusions were given to a retrospective cohort of patients who received conventional transfusion therapy. RESULTS: Hemodilution and apheresis followed by intraoperative autologous transfusion reduced exposures to individual blood donor products resulting in fewer transfusions and in transfusion of significantly fewer blood products. Intraoperative autologous transfusion alone decreased the number of red blood cells transfused, but required the same donor exposures for fresh frozen plasma and platelet support as the cohort of patients who received conventional transfusion therapy. CONCLUSIONS: A combination of hemodilution and apheresis and intraoperative autologous transfusion significantly decreased transfusion of allogeneic blood products and reliance on preoperative autologous deposit. Autologous transfusion of all blood products was significantly increased.