11. Resources


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
  • (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
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
Anaphylactic reaction Hypotension with one or more of: rash, dyspnoea, stridor, wheezing, angioedema, pruritus, urticaria, during or within 24 hrs of transfusion. SHOT
Anticoagulant solution A substance that prevents or delays blood clotting (coagulation) http://www.transfusionguidelines.org.uk
  • 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
  • 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
  • Systematically developed statement designed to help physicians and patients make appropriate healthcare decisions in specific clinical circumstances
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
  • 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
  • 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
  • (Noun) A computer file containing information input by a computer user and usually created with an application
  • (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/
  • 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
  • Deviation from a standard procedure
  • 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”
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
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
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
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
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
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
  • 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
  • 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
  • Written or electronically captured evidence that an event has occurred or an outcome has been achieved
  • A document that contains objective evidence which shows how well activities are being performed or what kind or results are being achieved
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’
  • 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
  • A set of rules that control how people develop and manage materials, products, services, technologies, processes and systems
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

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
  • Blood collected from a donor, not further separated into components
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