11. Resources

Glossary

Term	Definition	Source / Defined in

Additive solution	A solution specifically formulated to maintain beneficial properties of cellular components during storage	Directive 2004/33/EC
Administer	Used in the manual to mean “administer a blood transfusion”, “give a blood transfusion”	EU OBU Project team
Adverse event (serious adverse event)	Any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity	Directive 2002/98/EC
Adverse reaction	A result of drug therapy that is neither intended nor expected in normal therapeutic use and that causes significant, sometimes life-threatening conditions	Steadman’s Medical Dictionary 2002
Adverse reaction	(Serious adverse reaction) An unintended response in donor or in patient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity	Directive 2002/98/EC
Allergic reaction	One or more of: rash, dyspnoea, angioedema, generalized pruritis, urticaria, without hypotension within 24 hours of transfusion	IHN http://www.ehn-net/Portal.aspx
Allogeneic donation	Blood and blood components collected from an individual and intended for transfusion to another individual, for use in medical devices or as starting material/raw material for manufacturing into medicinal products	Directive 2004/33/EC
Alloimmunization (due to transfusion)	Formation of antibodies to RBC, HLA, HPA and HNA antigens which were not detectable pre-transfusion	IHN http://www.ihn-org.net/Portal.aspx
Anaphylactic reaction	Hypotension with one or more of: rash, dyspnoea, stridor, wheezing, angioedema, pruritus, urticaria, during or within 24 hrs of transfusion.	SHOT http://www.shotuk.org/
Anticoagulant solution	A substance that prevents or delays blood clotting (coagulation)	http://www.transfusionguidelines.org.uk
Audit	Documented review of procedures, records, personnel functions, equipment, materials, facilities, and/or vendors in order to evaluate adherence to written SOPs, standards, or government laws and regulations, conducted by professional peers, internal quality system auditors or certification body auditors	www.eubis-europe.eu
Audit	A systematic examination to determine whether actual activities comply with planned activities, are implemented effectively, and achieve objectives. Assessments usually include comparison of actual results to expected results	EU OBU Project team
Audit (prospective)	An audit in which the participants are identified and then followed forward in time	http://www.merriam-webster.com/dictionary
Autologous donation	Blood and blood components collected from an individual and intended solely for subsequent autologous transfusion or other human application to that same individual	Directive 2004/33/EC
Benchmark	Something set up as an example against which others of the same type are compared	www.merriam-webster.com
Blood	Used in this manual as a short form of “blood and blood components	EU OBU Project team
Blood bank (hospital blood bank)	A hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities	Directive 2002/98/EC
Blood establishment	Any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion. This does not include hospital blood banks	Directive 2002/98/EC
Blood component	A therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods intended for transfusion	Directive 2002/98/EC
Blood donation	See “donation”
Blood group	An immunologically distinct, genetically determined class of human blood that is based on the presence or absence of certain red cell antigens and is clinically identified by characteristic agglutination reactions or by nucleic acid testing	EU OBU Project team
Blood product	Any therapeutic product derived from human whole blood or plasma	Directive 2002/98/EC
Blood transfusion chain	The numerous activities that occur from the moment an individual offers to donate blood or plasma until after the blood product has been administered to the patient	www.eubis-europe.eu/
Clinical audit	A quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change	National Institute of Health and Clinical Excellence in the UK www.nice.org.uk
	An evaluation method that enables the comparison of practices to established references, e.g. guidelines, using precise criteria, with the aim of measuring and improving the quality of practice	French Health Authority ‘Haute Autorité de Santé’ www.has-sante.fr
	A method to measure the gap between ideal practice (determined from evidence and guidelines) and actual practice	EU OBU Project team
Clinical Guideline	A document developed through the consensus process describing criteria for a clinical/medical practice.	Scottish Intercollegiate Guidelines network (SIGN)
	A document developed through the consensus process describing criteria for a clinical/medical practice for voluntary use. The guideline may be used as written or modified by the user to fit specific needs.	Canadian Blood Service http://www.bloodservices.ca/s
	Systematically developed statement designed to help physicians and patients make appropriate healthcare decisions in specific clinical circumstances	http://www.transfusion.ca/
Collect, Collection	Usage in this manual: Process in which blood components are collected from the hospital blood bank or from a satellite refrigerator prior to transfusion. This usage should be distinguished from “collection of a donation from the donor”	EU OBU Project team
Compatibility report	Report that accompanies the blood components that are issued by the hospital blood bank for transfusion to a recipient	EU OBU Project team
Compatibility test	Laboratory test performed to ensure immunological compatibility between donor blood and prospective recipient’s blood or blood components prior to transfusion	EU OBU Project team
Competency	Ability of a person to perform a specific task according to procedures	www.eubis-europe.eu/
Consent	To give assent or approval (e.g. consent to being transfused)	http://www.merriam-webster.com/dictionary
Criterion	A principle or standard by which something may be judged or decided	Ask Oxford.com Compact Oxford English dictionary
Deliver, Delivery	Bring or transport to the proper place or recipient	American Heritage Dictionary of the English Language
Deliver, Delivery	Process in which blood components are transferred to the clinical area where they are to be transfused	EU OBU Project team
Distribution	The act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion	Directive 2002/98/EC
Document	Information and the medium that is used to bring it into existence. A document can be digital or physical. ISO identifies five types of documents: specifications, quality manuals, quality plans, records and procedure documents	ISO 9001 www.iso.org
	(Noun) Something written that conveys information	http://www.merriam-webster.com/dictionary/
	(Noun) A computer file containing information input by a computer user and usually created with an application	http://www.merriam-webster.com/dictionary/
	(Verb) Write down, make a record of	EU OBU Project team
Donation	Something that is given to a charity. Used in the manual in the sense “blood donation”	Ask Oxford.com Compact Oxford English Dictionary
Disseminate	Distribute, diffuse, communicate widely	Collins English Dictionary 4th ed 1999 Harper Collins
E-learning	The delivery of a learning, training or education program by electronic means	EU OBU Project team
Educate	Train by formal instruction and supervised practice especially in a skill, trade, or profession. (Similar to: Teach: to impart the knowledge of)	http://www.merriam-webster.com/dictionary/
Efficient	Working productively with minimum wasted effort or expense	http://www.askoxford.com/concise_oed
Elective	Beneficial to the patient but not essential for survival, as in: “elective surgery”	http://www.merriam-webster.com/dictionary/
Emergency	A serious, unexpected, and potentially dangerous situation requiring immediate action	Collins English Dictionary 4th ed 1999 Harper Collins
	Unforseen circumstance especially of a danger demanding immediate action
	Patient requiring urgent treatment
EPO	Abbreviation for: Erythropoietin, epoietin
ERM	Abbreviation for: Electronic Record Management
Error	Deviation from a standard procedure	www.eubis-europe.eu/
Error	Suggests the existence of a standard or guide and a straying from the right course through failure to make effective use of this. As in: “procedural errors”	http://www.merriam-webster.com/dictionary/
European Commission (EC)	The executive organ of the European Union, based in Brussels, which monitors the proper application of the Union treaties and the decisions of the Union institutions	http://www.coe.int/aboutCoe
European Union (EU)	The EU currently has 27 members that have delegated some of their sovereignty so that decisions on specific matters of joint interest can be made democratically at European level. No country has ever joined the EU without first belonging to the Council of Europe	http://www.coe.int/aboutCoe
Evidence-based medicine	The conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research	Health Services Executive, Republic of Ireland http://www.hse.ie
Expire	Come to the end of the period of validility	Ask Oxford.com Compact Oxford English Dictionary
Expiry date (blood components / products)	The last day on which the blood or blood component is considered fit for use for therapeutic transfusion purposes	ESOP Manual Ed 1.0, 2007 www.eubis-europe.eu/
External review	An evaluation of the quality and effectiveness of a system carried out by a team of external evaluators who are specialists in the fields reviewed	EU OBU Project team
Facilities	Hospitals, clinics, manufacturers, and biomedical research institutions to which blood or blood components may be delivered	2005/61/EC,EU-Q-Blood-SOP,
FFP (Fresh Frozen Plasma)	The supernatant plasma separated from a whole blood donation or plasma collected by apheresis, frozen and stored	Directive 2004/33/EC
Graft-versus-host disease (transfusion associated)	A generally fatal immunological complication of transfusion involving the engraftment and clonal expansion of viable donor lymphocytes, contained in blood components in a susceptible host.	Serious hazards of transfusion (SHOT), UK www.shotuk.org
Haematocrit	Ratio of the volume occupied by red cells to the total volume of blood expressed as a percentage	Collins English Dictionary 4th ed 1999 Harper Collins
Haemovigilance	A set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors	Directive 2002/98/EC
Haemolytic transfusion reaction (Acute) (HTR)	Acute: fever and other symptoms/signs of haemolysis within 24 hours of transfusion; confirmed by a fall in Hb, rise in LDH, positive DAT and positive crossmatch. Delayed: fever and other symptoms/ signs of haemolysis more than 24 hours after transfusion; confirmed by one or more of: a fall in Hb or failure of increment, rise in bilirubin, positive DAT and positive crossmatch not detectable pre-transfusion. Simple serological reactions (development of antibody without pos DAT or evidence of	IHN http://www.ehn-org.net/Portal.aspx
Hospital Blood Bank	A hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities	Directive 2002/98/EC
Identification (of a patient)	The documented confirmation of a specified set of patient identifying information as belonging to the respective individual	Modified from ESOP Manual Ed 1.0, 2007 www.eubis-europe.eu/
Imputability	The likelihood that a serious adverse reaction in a recipient can be attributed to the blood or blood component transfused or that a serious adverse reaction in a donor can be attributed to the donation process	Directive 2005/61/EC
Inspection	Formal and objective control according to adopted standards to assess compliance with relevant legislation and to identify problems	Directive 2002/98/EC
Irradiated blood components	Cellular blood component treated with 25 gray (Gy) gamma irradiation to inactivate lymphocytes that could cause graft-versus host disease in a recipient	www.transfusionguidelines.org.uk
Issue (blood component)	The provision of blood or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient Since the word “provision” embraces several different tasks, the Manual uses the term “delivery” to denote the physical movement of the blood component unit from blood bank to the patient’s clinical unit or operating room.	Directive 2005/61/EC,
Labelling	Information that is required/ selected to accompany a product, and may include content, identification, description of processes, storage requirements, expiration date, cautionary statements, or indications for use	Quoted in: AABB (ESOP Manual Ed 1.0, 2007)
Leukoreduction / leukodepletion	A process used to remove white blood cells from blood components before transfusion	www.transfusionguidelines.org.uk
Methods	A way of doing something, especially a systematic way; implies an orderly logical arrangement	Miriam Webster online thesaurus
Monitor	Continuous observation and measurement of a variable, to check on a given condition	EU OBU Project team
Near miss	An error that might have harmed a patient but did not	BMJ 2009
Order (blood)	Request that something be made, supplied or served (used in this manual in the sense) “order blood for a patient”	Ask Oxford.com Compact Oxford English Dictionary
Pack	In the Manual, the term “pack” is used to denote the blood component container and its contents	EU OBU Project team
Parameter	Any of a set of physical properties whose values determine the characteristics or behaviour of something. As in: parameters of the atmosphere such as temperature, pressure, and density	Miriam Webster online thesaurus
Parameter	Framework, variable, limit, boundary, limitation, restriction, criterion, guideline	Ask Oxford.com Oxford Thesaurus
Patient at risk of transfusion	Patient who must be transfused OR who, with good clinical management, may avoid the need for transfusion	EU OBU Project team
Personnel	A body of persons usually employed (as in a factory, office, or organization)	http://www.merriam-webster.com/dictionary
Pilot tests	Preliminary test or study of the program or evaluation activities to try out procedures and make any needed changes or adjustments	http://www.merriam-webster.com/dictionary
Positive patient identification	Process in which patient is asked to give her/his details in order to ensure correct identification and subsequent administration of the right blood component	EU OBU Project team
Prescription Form	A form on which the clinician prescribes a medicine, or a blood component to be transfused to the patient	EU OBU Project team
Pre-transfusion Sampling	Procedure for taking blood samples from the patient requiring a transfusion, for compatibility investigation	EU OBU Project team
Pre-transfusion blood sample	The patient blood sample obtained prior to transfusion in order to assess blood group and compatibility	EU OBU Project team
Procedure	A procedure controls a distinct process or activity, including the associated inputs and outputs. A series of tasks usually performed by one person according to instructions	ISO9001
Process	A set of related tasks and activities that accomplish a work goal AABB (ESOP Manual Ed 1.0, 2007)	www.eubis-europe.eu
Processing	Any step in the preparation of blood component that is carried out between the collection of blood and the issuing of blood component	Directive 2005/62/EC
Protocol	A detailed plan of a medical treatment or procedure Modified from http://www.merriam-webster.com/dictionary	http://www.merriam-webster.com/dictionary
Quality	Manufacture of medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. (according to EN ISO 9000:2005; quality is defined as the ‘degree to which a set of inherent qualities are met’)	EC GMP 2006 Chapter 1 (ESOP Manual Ed 1.0, 2007)www.eubis-europe.eu
Recipient (of blood)	Someone who has been transfused with blood or blood components	Directive 2005/61/EC
Record	Written or electronically captured evidence that an event has occurred or an outcome has been achieved	http://www.bloodservices.ca/
Record	A document that contains objective evidence which shows how well activities are being performed or what kind or results are being achieved	www.iso.org
Release	A process which enables a blood component to be released from a quarantine status by the use of systems and procedures to ensure that the finished product meets its release specification	Directive 2002/98/EC
Reporting establishment	The blood establishment, the hospital blood bank or facilities where the transfusion takes place that reports serious adverse reactions and /or serious adverse events to the competent authority	Directive 2005/61/EC
Requirement	A need, expectation or obligation. Can be stated or implied by an organisation, its customers or other interested parties. There are many types of requirements. Some of these include quality requirements, customer requirements, management requirements and product requirements	www.iso.org
Resources	Include people, money, information, knowledge, skills, energy, facilities, machines, tools, equipment, technologies and techniques	www.iso.org
Satellite refrigerators	Controlled blood storage refrigerators located remote from the main hospital blood bank	EU OBU Project team
Serious adverse event	See: Adverse Event	Directive 2002/98/EC
Specification	A description of the criteria that must be fulfilled in order to achieve the required quality standard	Directive 2005/62/EC
Staff	see ‘personnel’
Standard	The requirements that serve as the basis for comparison	Directive 2005/62/EC
	A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified	http://www.bloodservices.ca/
	A set of rules that control how people develop and manage materials, products, services, technologies, processes and systems	www.iso.org
Sterile	Free from viable micro-organisms	ESOP Manual Ed 1.0, 2007
Systematic review	A review of the literature on a topic that is based on comprehensive searching of all relevant sources and that employs explicit criteria to assess the eligibility and methodological quality of the studies	EU OBU Project Team
Tools	Something that helps you do a particular activity. Used in this manual to mean methods, techniques	Cambridge.com Cambridge dictionary online
TNA	Abbreviation for: Training Needs Assessment
Traceability	The ability to trace each individual unit of blood or blood component derived thereof from the donor to its final destination, whether this is a recipient, a manufacturer of medicinal products or disposal and vice versa	Directive 2005/61/EC
Training	As work in blood transfusion chain is of a specialised nature, specific training of all staff is necessary if they are to perform their duties satisfactorily. Failure to do so will compromise the quality of products	www.eubis-europe.eu
Transfusion-associated autoimmune haemolytic anaemia (TA-AIHA)	Haemolysis-related symptoms (pallor, tachycardia, hyperventilation, etc) in a temporal association with transfusion. TA-AIHA is confirmed by a drop in haemoglobin level, a positive direct antiglobulin test and an eluate revealing an erythrocyte autoantibody which was not present in the recipient’s blood pretransfusion	http://www.ehn-org.net/Portal.aspx
Transfusion-associated circulatory overload (TACO)	Respiratory distress, tachycardia, increased blood pressure, typical signs of cardiogenic lung oedema in the chest x-ray, evidence of a positive fluid balance and / or a known compromised cardiac status during or within 12 hours after transfusion	http://www.ehn-org.net/Portal.aspx
Transfusion-associated dyspnoea (TAD)	Respiratory distress in temporal association with blood transfusion with no evidence of TRALI, allergic dyspnoea or TACO	http://www.ehn-org.net/Portal.aspx
Transfusion (Blood) chain	The numerous activities that occur from the moment an individual offers to donate blood or plasma until after the blood product has been administered to the patient	www.eubis-europe.eu
Transfusion Committee (Hospital transfusion committee)	SEE hospital transfusion committee
Transfusion reaction	Any clinical reaction considered to be related to a blood transfusion event	http://www.bloodservices.ca/
Transfusion related acute lung injury (TRALI)	(TRALI) Acute lung injury following within hours of a transfusion (2) A SHOT incident category and defined as: Acute dyspnoea with hypoxia and bilateral pulmonary infiltrates during or within 6 hrs of transfusion, not due to circulatory overload or other likely cause	www.transfusionguidelies.org.uk
Transfusion transmitted infection	The recipient had evidence of infection post-transfusion and there was no evidence of infection prior to transfusion and no evidence of an alternative source of infection; and, either at least one component received by the infected recipient was donated by a donor who had evidence of the same transmissible infection or at least one component received by the infected recipient was shown to contain the agent of infection	http://www.ehn-org.net/Portal.aspx
Transfusion Safety Officer	TSOs are responsible for the quality and safety of transfusion within their respective institutions, particularly in the transfusion service and in the transfusing units, wards or clinics	http://www.transfusion.ca
Unit (of blood component)	In the Manual, the term ‘red cell unit’ is used to denote the red cells from one standard blood donation	EU OBU Project team
Untoward	Unexpected and inappropriate or adverse	Compact Oxford Dictionary
Validation	The establishment of documented and objective evidence that the pre-defined requirements for a specific procedure or process can be consistently fulfilled. The establishment of documented and objective evidence that the pre-defined requirements for a specific procedure or process can be consistently fulfilled	2005/62/EC
Warming (blood component)	The controlled increase of the temperature of blood components prior to transfusion	EU OBU Project team
Whole blood	A single blood donation	2004/33/EC
Whole blood	Blood collected from a donor, not further separated into components	www.transfusionguidelines.org.uk modified EU Op Lip project team
Wrong blood	Events where a patient received a blood component intended for a different patient or of an incorrect group	www.shot.org.uk

11.1 List of contributors

Dr Guenther J Wittauer, Head of Blood Services,
Austrian Red Cross Blood Services; Head of Administration,
Austrian Red Cross Blood Donation Centre for Vienna,
Lower Austria and Burgenland, AUSTRIA

Dr Christof Jungbauer, Head of Laboratories,
Austrian Red Cross Blood Donation Centre for Vienna,
Lower Austria and Burgenland, AUSTRIA

Dr Petr Turek, Head of National Blood Transfusion Committee,
Thomayer Teaching Hospital, Prague, CEZCH REPUBLIC

Dr Jiri Masopust, Vice President of the Czech Society for
Transfusion Medicine / Head of Department of Transfusiology,
Masaryk Hospital Usti nad Labem, CEZCH REPUBLIC

Dr Lenka Walterova, Chief, Department of Haematology,
Liberec Regional Hospital, Liberec, CZECH REPUBLIC

Dr Riin Kullaste, Director of Blood Centre, North Estonia Medical Centre, ESTONIA

Dr Georges Andreu, Medical and Scientific Director,
National Institute of Blood Transfusion, FRANCE

Dr Genevieve Gondrexon, Establissement Francais du Sang Lorraine Champagne, FRANCE

Professor Christian Seidl, Vice-Medical Director,
Institute of Transfusion Medicine and Immunohaematology,
German Red Cross, GERMANY

Dr Olga Marantidou, Scientific Director,
Greek National Blood Centre, GREECE

Dr Eleftheria Zervou, Blood Bank Director,
University Hospital of Loannina, GREECE

Dr Eleni Theodori, Blood Bank Director, University Hospital of Patras, GREECE

Dr Vincenzo de Angelis, Director,
Transfusion Medicine Department, Azienda Ospedaliero-
Universitaria, ‘S. Maria della Misericordia’- UDINE (Italy)

Dr Stefan Laspina, Consultant in Transfusion Medicine,
Mater Dei Hospital, MALTA

Dr Magdalena Letowska, Deputy Director for Transfusion
Medicine, Institute of Haematology and Transfusion Medicine,
POLAND

Dr Margarida Amil, Chief of Service of Imunohemoterapia,
Centro Hospitalar do Porto, PORTUGAL

Dr Fatima Nascimento, Chief of Service in Transfusion
Medicine and member of the Board of Portuguese Blood
Institute, Portuguese Blood Institute, PORTUGAL

Dr Laura Castro, Director of the Regional Blood Centre of Lisbon, PORTUGAL

Dr Erika Deak, Assistant Professor,
Department of Physiology and Immunology,
University of Medicine and Pharmacy,
Victor Babes Timisoara, ROMANIA

Dr Alina Debrota, Director, Regional Blood Transfusion Centre
of Constanta, ROMANIA

Dr Andy Rosin, Director of Transfuziology Center, International
Collaborations, ROMANIA

Dr Dragoslav Domanovic, Director of Blood Supply
Department, Blood Transfusion Centre of Slovenia, SLOVENIA

Professor Rene R P de Vries, Head of Blood Transfusion
Service and President of the International Haemovigilance
Network (IHN), Leiden University Medical Centre,
THE NETHERLANDS

Dr Kieran Morris, Acting Medical Director, Northern Ireland
Blood Transfusion Service, NORTHERN IRELAND

Dr Simon Stanworth, Consultant Haematologist, National Blood
Authority and Oxford Radcliff Hospitals NHS Trust, ENGLAND

Dr Shubha Allard, Consultant Haematologist, National Blood
Authority and Barts and the London NHS Trust, ENGLAND

Dr Brian McClelland, Strategy Director, Scottish National Blood
Transfusion Service, SCOTLAND

Professor Ian M Franklin, Medical and Scientific Director,
Scottish National Blood Transfusion Service, SCOTLAND

Liz Pirie, Transfusion Education Specialist, Scottish National
Blood Transfusion Service, SCOTLAND

Advisory Board
Dr Dragoslav Domanic,
Director of the Blood Transfusion Centre of Slovenia

Professor Ian Franklin,
Medical and Scientific Director of the Scottish National Blood
Transfusion Service

Ms Lynda Hamlyn,
Chief Executive of NHS Blood and Transplant, UK

Mr Angus Macmillian, Douglas,
Former National Director of the Scottish National Blood
Transfusion Service

Prof. Dr. med. Dr. h. c. Erhard Seifried,
Ärztlicher Direktor und Medizinischer Geschäftsführer -
Instit für Transfusionsmedizin und Immunhämatologie Frankfurt a. M.

Project Team
Professor Ian Franklin
Medical and Scientific Director

Dr Brian McClelland
Consultant

Mrs Elizabeth Pirie
Transfusion Nurse Specialist, Better Blood Transfusion
Programme

Mrs Shirley Russell
Project Support Officer

11.2 References

General

Schramm WG ed. (1990) Blood safety in the European Community: an initiative for optimal use. ISBN 3-00-005705 European Commission

Schramm WG et al eds (2009) Report of European Symposium on Optimal Clinical Use of Blood Components April 24th-25th 2009, Wildbad Kreuth, Germany. In preparation

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

Council of Europe (2008) Guide to the preparation, use and quality assurance of blood components, 14th edition, ISBN 978-92-871-6330-1. Council of Europe Publishing

Scottish Intercolegiate Guidelines Network (2001) Perioperative Blood Transfusion for Elective Surgery, 54, Edinburgh

National Institute for Health and Clinical Excellence (2006)
‘The Guidelines Manual’, London, www.nice.org.uk

Smith, L.A. (2006) NHS Highland Clinical Governance Strategy and Risk Management, NHS Highland

Systematic reviews

Carless PA, Henry DA, Moxey AJ, O’Connell DL, Brown T, Fergusson DA. (2006) Cell salvage for minimising perioperative allogeneic blood transfusion Cochrane Database of Systematic Reviews Issue 4

Carson JL, Hill S, Carless P, Hebert P, Henry D. (2002) Transfusion triggers: a systematic review of the literature Transfusion Medicine Reviews Jul; 16,3,187-99

Hill SR, Carless PA, Henry DA, Carson JL, Hebert PC, McClelland DB, Henderson KM. (2000) Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion Cochrane Database of Systematic Reviews Issue 1

Stanworth SJ, Hyde C, Brunskill S, Murphy M. (2005) Platelet transfusion prophylaxis for patients with haematological malignancies: where to now? British Journal of Haematology 131, 5, 588-95

Stanworth SJ, Hyde C, Heddle N, Rebulla P, Brunskill S, Murphy MF. (2004) Prophylactic platelet transfusion for haemorrhage after chemotherapy and stem cell transplantation Cochrane Database of Systematic Reviews Issue 4

Stanworth SJ, Brunskill SJ Hyde CJ, McClelland DB, Murphy MF. (2004) Is fresh frozen plasma clinically effective? A systematic review of randomised controlled trials British Journal of Haematology 126, 1,139-52

Stanworth SJ, Brunskill SJ, Hyde CJ, Murphy MF, McClelland DBL. (2006) Appraisal of the evidence for the clinical use of FFP and plasma fractions Best Practice and Research Clinical Haematology, 19, 1, 67-82

Wilson J, Yao GL, Raftery J, Bohlius J, Brunskill S, Sandercock J, Bayliss S, Moss P, Stanworth S, Hyde C (2007) A systematic review and economic evaluation of epoetin alfa, epoetin beta and darbepoetin alfa in anaemia associated with cancer, especially that attributable to cancer treatment Health Technology Assessment Apr, 11, 13,1-220

Original papers

Auroy Y, Lienhart A, Péquignot F, Benhamou D. (2007) Complications related to blood transfusion in surgical patients: data from the French national survey on anesthesia-related deaths Transfusion Aug, 47 (2 Suppl): 184S-189S

Carson JL, Terrin ML, Magaziner J, Chaitman BR, Apple FS, Heck DA, Sanders D. (2006) FOCUS Investigators Transfusion trigger trial for functional outcomes in cardiovascular patients undergoing surgical hip fracture repair (FOCUS) Transfusion 46 (12): 2192-206

Hansen E., Knuechel, R., Altmeppen J., Taeger, K. (1999b) Blood irradiation for intraoperative autotransfusion in cancer surgery: demonstration of efficient elimination of contaminating tumor cells. Transfusion, 39, 608–614

Hébert PC, Wells G, Blajchman MA et al. (1999) With the Transfusion Requirements in Critical Care Investigators for the Canadian Critical Care Trials Group A multicentre, randomized controlled clinical trial of transfusion requirements in critical care New England Journal of Medicine 340: 409–17

Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS. (2006) The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants Journal of Pediatrics Sep; 149, 3, 301-307

Lienhart A, Auroy Y, Péquignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. (2006) Survey of anesthesia-related mortality in France Anesthesiology Dec; 105(6): 1087-97.

Mangano DT, Miao Y, Vuylsteke A, Tudor IC, Juneja R, Filipescu D, Hoeft A, Fontes ML, Hillel Z, Ott E, Titov T, Dietzel C, Levin J; (2007) Investigators of The Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery JAMA Feb 7, 297, 5, 471-9.

McLellan, S.A., Walsh, T.S. and McClelland, D.B.L. (2002) Should we demand fresh red blood cells for perioperative and critically ill patients? British Journal of Anaesthesia, 89, 537-540 (Editorial) Rao SV, Jollis JG, Harrington RA, Granger CB, Newby LK, Armstrong PW, Moliterno DJ, Lindblad L, Pieper K, Topol EJ, Stamler JS, Califf RM. (2004) Relationship of blood transfusion and clinical outcomes in patients with acute coronary syndromes JAMA 292:1555-62.

SAFE Study Investigators (2004) Australian and New Zealand Intensive Care Society Clinical Trials Group; Australian Red Cross Blood Service; George Institute for International Health, Myburgh J, Cooper DJ, Finfer S, Bellomo R, Norton R, Bishop N, Kai Lo S, Vallance S. New England Journal of Medicine 350 2247-2246

Saline or albumin for fluid resuscitation in patients with traumatic brain injury New England Journal of Medicine 2007; 357,874-84

Sirchia, G., Giovanetti, A.M., Mc Clelland, B., Fracchia G.N. (eds.) (1994) Safe and good use of blood in surgery (SANGUIS) Use of blood products and artificial colloids in 43 European hospitals Report No. EUR 15398 EN, Office for Official Publications of the European Communities, Brussels/Luxembourg

Sanguis Study Group 91994) Use of blood products for elective surgery in 43 European hospitals Transfusion Medicine 4: 251–68.

The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. Journal of Pediatrics 2006 Sep; 149(3): 301-307

Thomas MJ. (1999) Infected and malignant fields are an absolute contraindication to intraoperative cell salvage: fact or fiction Transfusion Medicine 9, 269–278

Voak, Chapman and Phillips (2001) Quality of transfusion practice beyond the blood transfusion laboratory is essential to prevent ABO-incompatible death Transfusion 10, 2,95-96

Walsh TS, McArdle F, McLellan SA, Maciver C, Maginnis M, Prescott RJ, McClelland DB. (2004) Does the storage time of transfused red blood cells influence regional or global indexes of tissue oxygenation in anemic critically ill patients? Crit Care Med Feb; 32, 2,364-71.

Weiskopf RB, Feiner J, Hopf H, Lieberman J, Finlay HE, Quah C, Kramer JH, Bostrom A, Toy P. (2006) Fresh blood and aged stored blood are equally efficacious in immediately reversing anemia-induced brain oxygenation deficits in humans Anesthesiology May; 104, 5, 911

11.3 Links

International

World Health Organisation

Provides extensive resources on all aspects of transfusion. Resources for clinical transfusion practice improvement include:

The Clinical Use of Blood in Obstetrics, Paediatrics, Surgery & Anaesthesia, Trauma & Burns. (English, Portuguese, Spanish)
The Clinical Use of Blood Handbook (English, Portuguese, Spanish)
Recommendations on Developing a National Policy and Guidelines on the Clinical Use of Blood (English, Portuguese, Spanish, French).

http://www.who.int/bloodsafety/en/

International Haemovigilance Network: Resources include haemovigilance definitions, definitions, and downloadable papers on haemovigilance.
http://www.ihn-org.net/Portal.aspx

International committee of commonality in blood banking (ICCBBA) manages the ISBT 128 coding system. This is the global standard for the identification, labeling and information processing of human blood, tissue and organ products.
http://www.iccbba.org/

Europe

European Commission

European Commission Public Health Programme: In addition to the Eu Optimal Use of Blood project, the Commission supports the following projects
http://ec.europa.eu/health/index_en.htm

EU-Q-Blood SOP Project: Development of a pan-European standard operating procedure (SOP) methodology reflecting European best practice within the area addressing the quality and safety of blood.
http://www.eu-q-blood-sop.de/
European Blood Inspection System: Contains publications of this 'sister project', including Manual for Developing Standard Operating Procedures and Inspection Guide.
www.eubis-europe.eu/
Domaine:A collaborative project to develop resources for blood donor management in Europe. Includes donor recruitment strategies, donor retention strategies, deferral procedures and blood bank policy regarding patients requiring long-term transfusion
http://www.domaine-europe.eu/

Council of Europe: European Directorate for Quality of Medicines (EDQM): EDQM now hosts and manages the Council of Europe (programme on blood transfusion, including production of the Guide to the Preparation, Use and Quality Assurance of Blood Components. On the CoE site, search blood transfusion to access relevant pages. The 15the Edition of the Guide should become available on the website during 2010.
http://www.edqm.eu

Report on the collection, testing and use of blood and blood components in Europe in 2004

Haemovigilance Programmes of EU member states

Denmark http://www.haemovigilance.dk/index_eng.htm
France http://www.ints.fr
Netherlands http://www.tripnet.nl/pages/nl/
Luxembourg http://www.croixrouge.lu/
Norway http://www.hemovigilans.no/
Republic of Ireland http://www.giveblood.ie/Clinical_Services/Haemovigilance/
Spain http://www.msc.es/profesionales/saludPublica/medicinaTransfusional/home.htm
UK http://www.shotuk.org/

European Blood Alliance: Contributes to safety and security of the blood supply in Europe by developing and maintaining a network of partner blood services across Europe. Co sponsor of this Manual and website.
www.europeanbloodalliance.org

Eurocode (International Blood Labeling Systems): Website is currently uninformative
www.eurocode.org/content/index.html

German medical Association (Bundesaertzekammer): Includes the 2009 cross sectional guidelines for therapy with blood components and plasma derivatives.
http://www.bundesaerztekammer.de/

English language translation of the 2009 cross sectional guidelines for therapy with blood components and plasma derivatives:
http://www.bundesaerztekammer.de/downloads/LeitCrossBloodComponents4ed.pdf

UK Blood Services Professional Advisory Committee: Includes an evidence library with index of systematic reviews and randomised clinical trials relevant to transfusion. Toolkit of resources for quality improvement in transfusion practice and other resources, Handbook of transfusion medicine, Guidelines for the UK blood services.
http://www.transfusionguidelines.org.uk/

British Blood Transfusion Society: Provides information about education, professional development and training activities.
http://www.bbts.org.uk/

British Committee for Standards in Haematology: Displays UK Guidelines for transfusion and other aspects of haematology.
http://www.bcshguidelines.com/

National Institute for Clinical Excellence in the UK: Provides national evidenced based guidance for health professionals. Tools to support service redesign and implementation of NICE guidance.
http://www.nice.org.uk/

National Institute for Health Centre Graduate Medical Education: Training Programs: Has developed a comprehensive portfolio of clinical research training and medical education initiatives.
http://www.cc.nih.gov/index.html

National Patient Safety Agency: Provides a toolkit of resources to assist with improving patient safety. Has information on safe patient identification and competency assessment for blood transfusion.
http://www.npsa.nhs.uk/

NHS Quality Improvement Scotland:An organisation which asists NHS hospitals in Scotland to improve patient care by setting standards. Assesses and measures the performance of hospitals against these standards. Standards for blood transfusion and the peer review inspection reports are available.
http://www.nhshealthquality.org/

Network for the Advancement of Transfusion Alternatives

Provides information about alternatives to transfusion.
http://www.nataonline.com/

Scottish Intercollegiate Guidelines Network (SIGN)

Developed an evidence-based guideline, which aims to maximise patient safety by helping clinicians decide when transfusion is appropriate.
http://www.sign.ac.uk/

Scottish National Blood Transfusion Service

Better Blood Transfusion -continuing education programme
An elearning programme designed at three levels. Targets all practitioners involved in the clinical transfusion process.
http://www.learnbloodtransfusion.org.uk/

Skills for Health

Provides resources to assists the UK health sector develop a skilled workforce e.g. career pathways, competencies.
http://www.skillsforhealth.org.uk/

Centre for Maternal and Child Enquiries

The Centre for Maternal and Child Enquiries' mission is to improve the health of mothers, babies and children by carrying out confidential enquiries on a UK wide basis.

Maternal death enquiry
National perinatal and maternal mortality surveillance
Maternal and perinatal enquiry projects
Child health enquiry projects

http://www.cmace.org.uk

Australia

Australian Blood Services

Gives health professionals access to information about blood and blood products, from donation to transfusion and beyond. It includes a Transfusion Medicine Manual, which contains more detailed information about blood products and clinical practice. Circular of information about blood components (2009), links to e- learning sites and a variety of downloadable resources.
http://www.transfusion.com.au/home.aspx

Canada

Canadian Transfusion Safety Officers

Provides access to clinical and technical guidelines and a variety of downloadable resources.
http://www.transfusionsafety.ca/

Canadian Institutes for Health Research and the Heart and Stroke Foundation of Canada: Offers training in blood transfusion science. http://www.cbr.ubc.ca/STPTS.htm

TraQ Program of the British Columbia Provincial Blood Coordinating Office

Focuses on quality improvement among transfusion medicine professionals through timely sharing of educational resources related to current best practices and guidelines in transfusion medicine. Website offers multiple educational tools, including a resource library, interactive case studies, regulatory information, Canadian, international, industry and government news, job postings, events calendar, patient resources, and more.
http://www.TraQprogram.ca/

Report of the Krever Inquiry into the blood system in Canada.

Provides an extensive account of responses to HIV and Hepatitis C in relation to transfusion in Canada and internationally
www.hc-sc.gc.ca/ahc-asc/activit/com/krever_e.html

USA

Harvard Medical School Fellowship Program in Transfusion Medicine

Offers a core curriculum for blood transfusion. http://www.harvardtransfusion.org/curriculum.pdf

The Joint Commission (Health Care Accreditation)

Accredits and certifies more than 16,000 health care organizations and programs in the United States. 34 www.jointcommission.org/