Quality Of Blood Components Research Articles

SampLink: a new system for the collection of donor blood samples.

Increasing demands for screening tests on blood donors, which require a large number of undiluted samples, and the rising concern for the safety of the phlebotomists have led to the development of a new blood sampling system. The new device was evaluated during the collection of 60 blood units, and compared with 50 control units collected using the "cut and drip' method. The time required for both blood donation and donor samples collection, blood component quality, coagulation factors activation and haemolysis were studied. In addition, reports and recommendations of Magen David Adom phlebotomists were evaluated after collecting 75000 units using the new device. Donor sample collection with the new device was comparable and somewhat shorter than with the "cut and drip' method, while the blood unit collection time remained unchanged. There were no differences in plasma haemoglobin, factor VIII and platelet yields and morphology scores in blood units and donor samples collected by the two methods. There were no reported instances of needle-sticks among phlebotomists using either method. The new device was simple to operate, improved blood donor samples collection practice and enabled the collection of as many undiluted donor samples as required for routine testing. In addition, the use of vacuum tubes ensured sterility, safety and standardization of samples. The components provided were comparable in quality to those prepared from units collected by other methods.

Quality of blood components filtered before storage and at the beside: Implications for transfusion practice

TransfusionVolume 36, Issue 5 p. 470-474 Quality of blood components filtered before storage and at the beside: Implications for transfusion practice M. A. Popovsky MD, Corresponding Author M. A. Popovsky MD Adjunct Clinical Professor, Department of Pathology and Laboratory Medicine, Boston University School of Medicine, Boston, MAChief Medical Officer and Acting Principal Officer, American Red Cross Blood Services, New England Region, 180 Rustcraft Road, Dedham, MA 02026.Search for more papers by this author M. A. Popovsky MD, Corresponding Author M. A. Popovsky MD Adjunct Clinical Professor, Department of Pathology and Laboratory Medicine, Boston University School of Medicine, Boston, MAChief Medical Officer and Acting Principal Officer, American Red Cross Blood Services, New England Region, 180 Rustcraft Road, Dedham, MA 02026.Search for more papers by this author First published: May 1996 https://doi.org/10.1046/j.1537-2995.1996.36596282594.xCitations: 31Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Citing Literature Volume36, Issue5May 1996Pages 470-474 RelatedInformation

Practical guidelines for process validation and process control of white cell-reduced blood components: report of the Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT).

The increased use of white (WBC)-reduced blood components has prompted many institutions to develop quality assurance programs directed to such component preparation processes. For consistent preparation of WBC-reduced blood components that meet clinical needs as well as national standards, a program of process validation and control should be instituted. This involves controlling key factors that affect WBC reduction as well as periodic monitoring of the residual cellular content of components. Practical guidelines for the implementation of such a program are provided. A program involving three phases of monitoring was developed by individuals belonging to an international working party of the International Society of Blood Transfusion. The first phase, process validation, evaluates a minimum of 20 consecutive units (a minimum of 60 units when nonparametric measurements are used) to document the successful local implementation of a new or substantially modified process. Ongoing process control employing Levey-Jennings type control charts is used to demonstrate that the process remains stable over time. Process capability assessment and conformance with standards are evaluated once residual WBCs are counted in a sufficient number of units. This enables a facility to claim with a specified degree of confidence that a stated proportion of WBC-reduced units will meet national standards. Two approaches to determine the number of units that should be selected for counting are presented. The first approach considers units as either acceptable or not acceptable and assumes that the distribution of failed (or nonconforming) units approximates the Poisson distribution. The second approach takes into consideration the observed WBC content of the tested units, with the assumption that the residual WBC content in WBC-reduced components follows a lognormal distribution. A method to assess the lognormal distribution of residual WBCs is presented. Specific tables based on each of these approaches are provided to guide the reader in the design of a program that will verify conformance with any national standard at specific confidence levels. The approach can be generalized to other process control applications. Guidelines are presented for process validation, process control, and assessment of conformance in the production of WBC-reduced blood components. Policy makers retain the responsibility to establish, on the basis of the expected use of WBC-reduced components, requirements for the frequency of testing and for the proportion of prepared units that are expected with a stated degree of confidence to meet the standards. Facilities preparing WBC-reduced components can monitor key factors that influence the preparation of WBC-reduced blood, can periodically assess their conformance with the standards, and can intervene to correct adverse changes in the process. This approach can be used to ensure the consistent quality of WBC-reduced blood components.

The BEST Working Party of the International Society of Blood Transfusion: an international effort to improve the quality of blood components

The Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion was formed with the aim of improving the quality and safety of blood components. An outline of the aims, working methodology, and results after the first 4 years of activity of the BEST Working Party is presented. Seven studies have been performed, evaluating techniques for counting residual white cells in white cell-reduced red cells, platelet quality control, and cellular harvests in blood components prepared with different methods. Areas of possible interest in the near future include stem cells, platelet crossmatching, and virus inactivation of blood components. An important BEST feature is the sharing of information gathered through collections of large sets of data from routine settings, so as to produce a reliable picture of the "real world." Such information could prove useful to those in charge of developing recommendations and guidelines.

The impact of polymorphonuclear neutrophils on the quality of stored cellular blood products.

Storage of blood affects all blood components. Polymorphonuclear neutrophils (PMNs) are considered the main culprits of the storage lesion. Their prestorage removal improves the quality of blood components. Therefore, they are considered of no use in blood transfusion. However, their reduction may remove important antibacterial defense mechanisms. The phagocytic activity of PMNs in whole blood was therefore determined together with additional, sequential changes of granula-specific and cytosolic constituents which they release. Blood from 12 volunteer donors was analyzed for plasma Na+ and K+, pH, LDH, lysozyme, PMN elastase, leukocytes, neutrophils, and neutrophil phagocytosis with Phagotest. Leukocytes decreased from (5.0 +/- 1.4) x 10(3) to (3.3 +/- 1.3) x 10(3) cells/microliter (mean +/- SD), most of them being PMNs. Their phagocytic capacity when rewarmed did not change significantly during the first 24 h of storage, after 3 days it came to a halt. At the same time an increasing fall in plasma sodium and pH became apparent, while plasma potassium, LDH, lysozyme, and elastase all rose by 427%, 235%, 87% respectively 1,479% at day 11. Together with these marker enzymes an armamentarium of antibiotic proteins, other proteolytic enzymes, and immunoregulatory molecules is released. At present, it seems that the bactericidal activity in blood, due to the removal of phagocytic PMNs, does not outweight the clinical benefits of an improved component preparation where storage lesions are minimized and a number of transfusion-associated adverse reactions are avoided.

The use of blood products in paediatrics

Transfusing children with blood and blood products requires special consideration of the patient's size, disease status and immunocompetence. Despite improved quality and safety of blood components the continuing risk of viral transmission dictates that every attempt should be made to reduce exposure to homologous blood. While many guidelines apply to all paediatric patients there are specific requirements for neonates, children with bone marrow failure and haemoglobinopathies, and children receiving large volume transfusions during surgery. These will therefore be discussed separately.

Effect of Donation Time on Platelet Concentrates and Fresh‐Frozen Plasma. An in vitro Study

To investigate the effect of donation time on the quality of blood components, we measured the platelet count and pH on platelet concentrates, and the factor V and VIII:C levels and fibrinopeptide A concentration on fresh-frozen plasma by duration of donation time. Platelet concentrates and fresh-frozen plasma were classified into three groups according to donation time: group 1, less than 10 min; group 2, 10-15 min, and group 3, longer than 15 min. Mean platelet counts of platelet concentrate were: group 1, 8.6 +/- 2.5 (in x 10(10], group 2, 8.1 +/- 2.6, and group 3, 6.5 +/- 3.2 (p less than 0.05). The same pH was maintained in all three groups. The fibrinopeptide A concentrations in groups 1 and 2 were 24 +/- 53 and 169 +/- 64 ng/ml, respectively, while in group 3 all were greater than 200 ng/ml, indicating correlation of a higher fibrinopeptide A level with longer donation time. Although a higher fibrinopeptide A level indicated a greater degree of thrombin generation, assays of factors V and VII:C did not show decreased activity in groups 2 and 3.

Effect of Donation Time on Platelet Concentrates and Fresh-Frozen Plasma

To investigate the effect of donation time on the quality of blood components, we measured the platelet count and pH on platelet concentrates, and the factor V and VIII :C levels and fibrinopeptide A concentration on fresh-frozen plasma by duration of donation time. Platelet concentrates and fresh-frozen plasma were classified into three groups according to donation time: group 1, less than 10min;group 2, 10-15min, and group 3, longer than 15 min. Mean platelet counts of platelet concentrate were: group 1, 8.6 ± 2.5 (in x 10^10), group 2, 8.1 ±2.6, and group 3, 6.5 ± 3.2 (p<0.05). The same pH was maintained in all three groups. The fibrinopeptide A concentrations in groups 1 and 2 were 24 ± 53 and 169 ± 64 ng/ml, respectively, while in group 3 all were >200 ng/ml, indicating correlation of a higher fibrinopeptide A level with longer donation time. Although a higher fibrinopeptide A level indicated a greater degree of thrombin generation, assays of factors V and VIII :C did not show decreased activity in groups 2 and 3.

Du contrôle à la gestion de qualité. Application à la production des produits sanguins labiles

The quality controls of blood components, realised in Transfusion Centres, are necessary to check the true conformity of products in accordance with official standards. This controls are insufficient to enhance blood components quality. The practical application of the quality management allows us to reach this aim easier. After the quality display, after it efficiency and regulatory measurement and after a quality objectives selection, we consider that the professional training and the data presentation contribute to the necessary confidence for a better quality management. Finally, standardization and automatization of production processes constitute the only ways to improve the real quality, to decrease waste products and, of course, to increase the productivity.

Improvement of blood component quality--automatic separation of blood components in a new bag system.

We report here on a new multiple bag system with top and bottom drainage of the primary bag which allows automatic separation of blood components on a routine basis. 100 units of 450 ml fresh whole blood (CPD) were centrifuged by hard spin centrifugation and then separated into leukocyte-poor red cell concentrates in additive solution (volume 284 +/- 22 ml, Hct 63.5 +/- 3.2%, platelets 3.1 +/- 1.4 X 10(9)/unit [3.1 +/- 1.2%], leukocytes 1.9 +/- 1.2 X 10(8) [8.3 +/- 5.0%]) and plasma (FFP) with acceptably low cell contamination (volume 262 +/- 33 ml, platelets 14.6 +/- 5.6 X 10(3)/microliter, leukocytes 0.04 +/- 0.03 X 10(3)/microliter). The residual buffy coat of whole blood stored for 16-20 h at room temperature was suitable for the preparation of leukocyte-poor platelet concentrates (n = 20; platelets 0.67 +/- 0.17 X 10(11) (69.8 +/- 15.0%); leukocytes 0.1 +/- 0.1 X 10(8] which showed quite good platelet function in vitro. The removal of leukocytes and platelets caused significantly less in vitro hemolysis during storage when compared to conventionally prepared red cell concentrates with and without buffy coat. Further advantages of the reduction of the cell contamination in red cell concentrates before storage are discussed. From this it can be concluded that leukocyte-poor red cell concentrates with less than 20% residual leukocytes should become the regular red cell preparation also for surgery, especially as the recommended separation technique can easily be performed on a routine basis. Red cell concentrates still containing the whole buffy coat are no longer acceptable.

Effects of environmental warming on blood components dispensed in syringes for neonatal transfusions

We examined the quality of blood components dispensed in syringes for transfusion into neonates, including the effects on quality of environmental conditions to which blood is exposed when it is transfused into neonates nursed in warm-air incubators or under radiant warmers. Syringes of blood placed in incubators rapidly warmed to 36 degrees C. Blood placed under radiant warmers operated at full power was heated rapidly to temperatures approaching 45 degrees C, and all blood components exhibited evidence of falling pH and cellular damage after 6 hours exposure to radiant energy. Erythrocyte damage was suggested by an increase in plasma hemoglobin, potassium, and lactic dehydrogenase. Platelets lost the ability to recover from hypotonic shock. Granulocytes exhibited a marked defect in the ability to produce superoxide anion after stimulation. The excessive warming and functional abnormalities exhibited by all blood components exposed to infrared energy were abrogated when syringes were shielded by covering them with aluminum foil. The clinical importance of these experimental findings remains to be established. Meanwhile, it would seem prudent either to shield syringes of blood placed under radiant warmers by covering them with aluminum foil or to limit the volume of a single transfusion to a quantity that can be infused within a relatively brief period.

The Blood Bank's Role in Transfusion Therapy: A System for Monitoring the Need for and Response to Blood Products

A system for assessing the quality of blood components by following the in vivo response of patients to platelet transfusions is described. Platelet transfusion increments are recorded by the blood bank laboratory technologist on a transfusion flow sheet. Serial information about each platelet transfusion is recorded. The flow sheet includes the name of the donor, the number of units transfused, the ABO group, Rh type, and stored age of each platelet concentrate unit. This system provides a means of measuring the posttransfusion increment in the patient's platelet count, determining patient blood component needs, identifying patients who become refractory to platelet transfusion, and preventing overuse of platelet concentrate. Staff awareness of optimal blood component therapy, as well as communication between the physician and blood bank personnel, have been improved by implementation of this system.