Screening Donated Blood For Transfusion- Transmissible .
ScreeningDonated Bloodfor TransfusionTransmissibleInfectionsRecommendations
ScreeningDonated Bloodfor TransfusionTransmissibleInfectionsRecommendations
WHO Library Cataloguing-in-Publication DataScreening donated blood for transfusion-transmissible infections: recommendations.1.Blood transfusion - adverse effects. 2.Blood transfusion - standards. 3.Diseasetransmission, Infectious - prevention and control. 4.Donor selection. 5.National healthprograms. I.World Health Organization.ISBN 978 92 4 154788 8(NLM classification: WB 356)Development of this publication was supported by Cooperative Agreement No. U62/PS024044-05from the Department of Health and Human Services/Centers for Disease Controland Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention(NCHHSTP), Global AIDS Program (GAP), United States of America. Its contents aresolely the responsibility of the authors and do not necessarily represent the officialviews of CDC. World Health Organization 2010All rights reserved. Publications of the World Health Organization can be obtained from WHOPress, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: 41 22791 3264; fax: 41 22 791 4857; e-mail: bookorders@who.int). Requests for permission toreproduce or translate WHO publications – whether for sale or for noncommercial distribution– should be addressed to WHO Press, at the above address (fax: 41 22 791 4806; e-mail:permissions@who.int).The designations employed and the presentation of the material in this publication do notimply the expression of any opinion whatsoever on the part of the World Health Organizationconcerning the legal status of any country, territory, city or area or of its authorities, orconcerning the delimitation of its frontiers or boundaries. Dotted lines on maps representapproximate border lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers’ products does not imply thatthey are endorsed or recommended by the World Health Organization in preference to othersof a similar nature that are not mentioned. Errors and omissions excepted, the names ofproprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by the World Health Organization to verify theinformation contained in this publication. However, the published material is being distributedwithout warranty of any kind, either expressed or implied. The responsibility for the interpretationand use of the material lies with the reader. In no event shall the World Health Organizationbe liable for damages arising from its use.Printed in France.
ContentsPrefaceKey recommendationsPolicy recommendationsTechnical recommendations13341 Introduction1.1 Context1.2 Constraints and challenges1.3 Aim and objectives1.4 Target audience1.5 Methodology5556782 National blood screening programme fortransfusion-transmissible infections2.1 Developing a national blood screening programme2.2 National policy on blood screening2.3 National screening strategy2.3.1 Screening algorithms2.4 Organization and management2.4.1 Blood transfusion service(s)2.4.2 Reference laboratory2.5 Financial and human resources2.6 Evaluation, selection and validation of assay systems2.7 Laboratory quality systems2.8 Procurement and supply of assays and reagents2.9 Storage and transportation2.10 Regulatory mechanisms10101011121212131314141415153 Screening assays3.1 Types of assay3.1.1 Immunoassays3.1.2 Nucleic acid amplification technology assays3.2 Selection of assays3.3 Critical assay characteristics3.4 Evaluation of assays3.5 Monitoring assay performance3.6 Use of automation for performing assays3.7 New assays and technologies161616171819202122224 Screening for transfusion-transmissible infections4.1 Transfusion-transmissible infections4.2 Transfusion-transmissible infectious agents for which universalscreening of all donations in all countries is recommended4.2.1 Human immunodeficiency virus24242526
4.2.2 Hepatitis B virus274.2.3 Hepatitis C virus304.2.4 Syphilis314.3 Transfusion-transmissible infections for which universal screeningis recommended in some countries or for which selectivescreening is recommended374.3.1 Malaria384.3.2 Chagas disease404.3.3 Human T-cell lymphotropic viruses I/II414.3.4 Human cytomegalovirus424.4 Emerging and re-emerging infections434.5 Clinically insignificant transfusion-transmissible infections445 Blood screening, quarantine and release5.1 Blood screening process5.2 Approaches to blood screening5.3 Pooling for serological assays5.4 Sequential screening5.5 Blood screening and diagnostic testing5.6 Emergency screening5.7 Screening plasma for fractionation5.8 Pre-donation testing5.9 Quarantine of blood and blood components prior to releaseor discard5.10 Release of blood and blood components5.11 Long-term storage of donation serum/plasma samples4545454747484849496 Confirmatory testing and blood donor management6.1 Confirmatory testing strategies6.2 Interpretation and use of confirmatory results6.3 Managing blood donors6.3.1 Deferral of blood donors6.3.2 Post-donation counselling5151515353537 Quality systems in blood screening7.1 The elements of quality systems7.2 Organizational management7.3 Standards for quality systems7.4 Documentation7.5 Traceability7.6 Training7.7 Assessment7.8 Maintenance and nowledgements606366495050
PrefaceBlood transfusion is a life-saving intervention that has an essential role in patientmanagement within health care systems. All Member States of the World HealthOrganization (WHO) endorsed World Health Assembly resolutions WHA28.72 (1)in 1975 and WHA58.13 (2) in 2005. These commit them to the provision ofadequate supplies of safe blood and blood products that are accessible toall patients who require transfusion either to save their lives or promote theircontinuing or improving health.WHO recommends the following integrated strategy for the provision of safeblood and blood products and safe, efficacious blood transfusion (3).1Establishment of well-organized blood transfusion services that arecoordinated at national level and that can provide sufficient andtimely supplies of safe blood to meet the transfusion needs of thepatient population.2Collection of blood from voluntary non-remunerated blood donorsat low risk of infections that can be transmitted through blood andblood products, the phasing out of family/replacement donationand the elimination of paid donation.3Quality-assured screening of all donated blood for transfusiontransmissible infections, including HIV, hepatitis B, hepatitis C,Treponema pallidum (syphilis) and, where relevant, other infectionsthat pose a risk to the safety of the blood supply, such as Trypanosomacruzi (Chagas disease) and Plasmodium species (malaria); as wellas testing for blood groups and compatibility.4Rational use of blood to reduce unnecessary transfusions andminimize the risks associated with transfusion, the use of alternativesto transfusion, where possible, and safe clinical transfusionprocedures.5Implementation of effective quality systems, including qualitymanagement, the development and implementation of qualitystandards, effective documentation systems, training of all staffand regular quality assessment.The establishment of systems to ensure that all donated blood is screened fortransfusion-transmissible infections is a core component of every national bloodprogramme. Globally, however, there are significant variations in the extent towhich donated blood is screened, the screening strategies adopted and the overallquality and effectiveness of the blood screening process. As a result, in manycountries the recipients of blood and blood products remain at unacceptable riskof acquiring life-threatening infections that could easily be prevented.In 1991, the World Health Organization Global Programme on AIDS and the-thenLeague of Red Cross and Red Crescent Societies published Consensus Statementon Screening Blood Donations for Infectious Agents through Blood Transfusion (4).Since then, there have been major developments in screening for transfusiontransmissible infections, with the identification of new infectious agents andsignificant improvements in the detection of markers of infection in donatedblood. The recommendations contained in this document have therefore been1
developed to update and broaden the scope of the earlier recommendations.This document is specifically designed to guide and support countries with lessdeveloped blood transfusion services in establishing appropriate, effective andreliable blood screening programmes.It should be recognized, however, that all blood screening programmes havelimitations and that absolute safety, in terms of freedom from infection risk,cannot be guaranteed. In addition, each country has to address specific issuesor constraints that influence the safety of its blood supply, including the incidenceand prevalence of bloodborne infections, the structure and level of developmentof the blood transfusion service, the resources available and special transfusionrequirements. The safety of the blood supply also depends on its source, thesafest source being regular voluntary non-remunerated donors from populationsat low risk for transfusion-transmissible infections.These recommendations are designed to support countries in establishing effectivenational programmes to ensure 100% quality-assured screening of donated bloodfor transfusion-transmissible infections. In countries where systems are not yetfully in place, the recommendations will be helpful in instituting a step-wiseprocess to implement them.Dr Neelam DhingraCoordinatorBlood Transfusion SafetyDepartment of Essential Health TechnologiesWorld Health Organization2
Key recommendationsPolicy recommendations1Each country should have a national policy on blood screening thatdefines national requirements for the screening of all whole bloodand apheresis donations for transfusion-transmissible infections.2There should be a national programme for blood screening whichsets out the strategy for screening, with algorithms that define theactual tests to be used in each screening facility.3All whole blood and apheresis donations should be screenedfor evidence of infection prior to the release of blood and bloodcomponents for clinical or manufacturing use.4Screening of all blood donations should be mandatory for thefollowing infections and using the following markers: HIV-1 and HIV-2: screening for either a combination of HIVantigen-antibody or HIV antibodies Hepatitis B: screening for hepatitis B surface antigen (HBsAg) Hepatitis C: screening for either a combination of HCV antigenantibody or HCV antibodies Syphilis (Treponema pallidum): screening for specific treponemalantibodies.5Screening of donations for other infections, such as those causingmalaria, Chagas disease or HTLV, should be based on localepidemiological evidence.6Where feasible, blood screening should be consolidated instrategically located facilities at national and/or regional levels toachieve uniformity of standards, increased safety and economiesof scale.7Adequate resources should be made available for the consistent andreliable screening of blood donations for transfusion-transmissibleinfections.8A sufficient number of qualified and trained staff should be availablefor the blood screening programme.9There should be a national system for the evaluation, selection andvalidation of all assays used for blood screening.10 The minimum evaluated sensitivity and specificity levels of allassays used for blood screening should be as high as possibleand preferably not less than 99.5%.11 Quality-assured screening of all donations using serology should bein place before screening strategies utilizing nucleic acid testing areconsidered.3
12 There should be a national procurement policy and supply systemto ensure the quality and continuity of test kits, reagents and otherconsumables required for the screening of all donated blood.13 Quality systems should be in place for all elements of the bloodscreening programme, including standards, training, documentationand assessment.14 There should be regulatory mechanisms for oversight of the activitiesof blood transfusion services, including blood screening.Technical recommendations1Every facility in which screening is performed should have a suitableinfrastructure and quality system to perform effective blood screeningfor transfusion-transmissible infections.2All staff involved in blood screening should be trained to performtheir functions to nationally required standards.3Specific indicators of performance of all assays should be designatedand monitored continuously to assure the reliability of results.4All test kits and reagents should be stored and transported underappropriate controlled conditions.5All blood screening tests should be performed in a quality-assuredmanner following standardized procedures.6A quarantine system should be in place for the physical segregationof all unscreened donations and their blood components until allrequired tests have been completed and the suitability of donationsfor therapeutic use has been determined.7Only blood and blood components from donations that are nonreactive in all screening tests for all defined markers should bereleased for clinical or manufacturing use.8All reactive units should be removed from the quarantined stockand stored separately and securely until they are disposed of safelyor kept for quality assurance or research purposes, in accordancewith national policies.9Systems should be put in place to maintain the confidentiality oftest results.10 Confirmatory testing of reactive donations should be undertaken fordonor notification, counselling and referral for treatment, deferral orrecall for future donation, and look-back on previous donations.4
1Introduction1.1ContextIt is the responsibility of governments to assure a safe and sufficient supply ofblood and blood products for all patients requiring transfusion (1). Each countryshould formulate a national blood policy and plan, as part of the national healthpolicy, to define how safe blood and blood products will be made available andaccessible to address the transfusion needs of its population, including howblood transfusion services will be organized and managed.The provision of safe and efficacious blood and blood components for transfusionor manufacturing use involves a number of processes, from the selection of blooddonors and the collection, processing and testing of blood donations to the testingof patient samples, the issue of compatible blood and its administration to thepatient. There is a risk of error in each process in this “transfusion chain” and afailure at any of these stages can have serious implications for the recipients ofblood and blood products. Thus, while blood transfusion can be life-saving, thereare associated risks, particularly the transmission of bloodborne infections.Screening for transfusion-transmissible infections (TTIs) to exclude blood donationsat risk of transmitting infection from donors to recipients is a critical part of theprocess of ensuring that transfusion is as safe as possible. Effective screeningfor evidence of the presence of the most common and dangerous TTIs canreduce the risk of transmission to very low levels (5). Blood transfusion servicesshould therefore establish efficient systems to ensure that all donated blood iscorrectly screened for specific TTIs and that only non-reactive blood and bloodcomponents are released for clinical and manufacturing use.The adoption of screening strategies appropriate to the needs, infrastructureand resources of each country can contribute significantly to improvements inblood safety. In countries where effective blood screening programmes have beenimplemented, the risk of transmission of TTIs has been reduced dramaticallyover the last 20 years (6–7).Nevertheless, a significant proportion of donated blood remains unsafe as it is eithernot screened for all the major TTIs or is not screened within a quality system. Dataon blood safety indicators provided in 2007 by ministries of health to the WHO GlobalDatabase on Blood Safety (GDBS) indicate that, of the 155 countries that reportedperforming 100% screening for HIV, only 71 screen in a quality-assured manner (8).Concerted efforts are still required by a substantial number of countries to achieve100% screening of donated blood for TTIs within quality systems.1.2Constraints and challengesVarious assay systems with differing sensitivities and specificities are availablefor blood screening. However, the efficacy of screening depends on their correctuse in laboratories that are appropriately resourced and staffed and that havewell-maintained quality systems.Countries that are still unable to screen all donated blood for TTIs in a qualityassured manner face a variety of constraints. At national level, the main challenges5
are often ineffective policies, lack of national standards or screening strategies, andlimited resources for implementing the national blood screening programme.At the operational level, the effectiveness of blood screening is often constrainedby the fragmentation and lack of coordination of blood transfusion services,inadequate infrastructures, shortages of trained staff and poor quality systems.This may result in: Inefficient screening systems and wastage of resources owing to differinglevels of operation at multiple sites Lack of quality management and quality assurance systems Use of poor quality test kits and reagents Unreliable, inconsistent supplies of test kits and reagents due to poorlogistics Equipment failure Variations in laboratory procedures and practices Incorrect storage or inappropriate use of test kits and reagents Inadequate procedures for identification, leading to the misidentificationof patient or donor blood samples, donations or processed units of bloodand blood components Technical failure in testing Misinterpretation of test results Inaccuracies in the recording or transcription of test results.Leading to: Higher error rates in test results Increased risk of failure to detect TTIs Unnecessary discard of non-reactive blood Blood shortages and use of unscreened blood in urgent situations Incorrect donor notification and stigmatization.Blood donors and blood screeningScreening of donated blood for TTIs represents one element of strategies forblood safety and availability. The first line of defence in providing a safe bloodsupply and minimizing the risk of transfusion-transmitted infection is to collectblood from well-selected, voluntary non-remunerated blood donors from low-riskpopulations, particularly those who donate regularly. The prevalence of TTIs involuntary non-remunerated blood donors is generally much lower than amongfamily/replacement (9–11) and paid donors (12–14). Each country shouldestablish voluntary blood donor programmes which provide donor informationand education and develop stringent national criteria for blood donor selectionand deferral to exclude prospective donors at the risk of TTIs (15).A lower prevalence of TTIs in the donor population also reduces the discard ofdonated blood and hence results in improved efficiency and use of resources.1.3 Aim and objectivesIn 1991, a Consensus Statement on Screening of Blood Donations for InfectiousAgents Transmissible through Blood Transfusion (4) was published by the WHOGlobal Programme on AIDS and the League of Red Cross and Red Crescent6
Societies. Recognizing that these recommendations were long outdated, theWHO Blood Transfusion Safety programme initiated a review process to developnew guidance on strengthening blood screening programmes.AimThe aim of Screening Donated Blood for Transfusion-Transmissible Infections is tosupport countries in es
4.4 Emerging and re-emerging infections 43 4.5 Clinically insignificant transfusion-transmissible infections 44 5 Blood screening, quarantine and release 45 5.1 Blood screening process 45 5.2 Approaches to blood screening 45 5.3 Pooling for serological assays 47 5.4 Sequential screening 47 5.5 Blood screening and diagnostic testing 48 5.6 Emergency screening 48 5.7 Screening plasma for .
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7.1 Guidelines for recognition and management of acute transfusion reactions 28 7.2 Investigating acute transfusion reactions 29 7.3 Haemolytic transfusion reaction 30 7.4 Bacterial contamination and septic shock 31 7.5 Transfusion associated circulatory overload 31
Tissue Donor Selection Guidelines Cord Blood Donors TDSG-CB 203 (Published 01 June 2010) Release 29 (Published 24 April 2018) page 1 of 140 United Kingdom Blood Transfusion Services (UKBTS) . Scottish National Blood Transfusion Service (SNBTS) E-mail marcturner@nhs.net .
9.3. The compatibility label/tag shall remain attached to the blood component or blood product until the transfusion is complete. 10. A policy shall be established for patient monitoring pre, during and post transfusion. 10.1. The recipient shall be observed for changes in status pre, during and post
laboratory practices (GLP), good manufacturing practices (GMP) and moving towards total quality management is vital for organization and management of Blood Transfusion Services. I would like to acknowledge the contribution made by the experts in Transfusion Medicine as membe
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administrim publik pranë fakultetit “Maxwell School of Citizenship and Public Affairs” të Universitetit të Sirakuzës. Dmitri është drejtues i ekipit të pro jektit për nënaktivitetin e kuadrit të raportimit financiar pranë programit PULSAR. FRANS VAN SCHAIK : Profesor i plotë i kontabilitetit, Universiteti i Amsterdamit Dr. Frans Van Schaik është profesor i plotë i .
