| ACD-A Apheresis Frozen Plasma | Apheresis fresh frozen plasma is collected into 70-90 ml anticoagulant citrate dextrose formula A (ACD-A) using automated apheresis techniques. The plasma is frozen within eight hours of collection. |
| Adverse Event/Reaction | An undesirable and unintended occurrence during or after the administration of blood or during or after a blood donation. |
| AITD | Active Inpatient Treatment Days |
| Agglutination | The clumping and sticking together of normally free cells or bacteria or other small particles forming visible aggregates |
| Allogeneic Person | Blood collected from an individual for transfusion to another undesignated person |
| ANH | Acute normovolemic hemodilution: autologous blood collected just prior to surgery (perioperatively). |
| Apheresis | A process where a specific component(s) of blood are harvested, and the rest is returned to the donor (or patient). The procedure is for both blood donation (e.g. plasmapheresis) and therapeutically for certain patient groups. |
| Autologous | Blood is collected from an individual for transfusion back to the same individual at a later time. |
| Blood centre | A facility that collects blood or blood components intended for transfusion, but not perioperative collections. Usually tests, stores and distributes as well. |
| Blood component | A portion of a blood donation intended for transfusion (e.g., RBCs, granulocytes, platelets, plasma; contained in bags) that can be prepared in a blood centre. |
| Blood product | Any therapeutic substance prepared from human blood (I.e. component or PPRP). |
| Biohazard Container | A container approved by the Laboratory Safety Committee that can be used to prevent potential exposure to biohazardous material. |
| Buffy coat | The portion of anticoagulated blood that contains most of the WBCs and platelets after centrifugation. It is pale cream or “buff” coloured. |
| Calibration | Comparison of a measurement system or device of unknown accuracy to a measurement system or device of known accuracy (traceable to national standards). E.g. thermometers, scales, timers, centrifuges. |
| Change control | A formal process that ensures changes to a product or system are introduced in a controlled and coordinated manner to minimize operational impacts. |
| Circular of Information | Blood component labelling that provides directions for storage and use, contraindications and possible adverse effects. This information may also be provided in auxiliary documents. |
| Closed System | A blood collection system for collecting and/or processing blood in containers that have been connected together before sterilization so that there is minimal possibility of bacterial or viral contamination from outside after collection of blood from the donor. |
| Clinically significant antibody | An antibody that is associated with Hemolytic Disease of the Fetus and Newborn (HDFN) and/or hemolytic transfusion reactions (HTR) with decreased RBC survival. |
| Compatibility | Processes performed before transfusion to ensure that a blood component testing will not produce a harmful antibody reaction with the recipient’s blood. Tests may include ABO and Rh grouping, antibody screen and crossmatch. |
| Corrective action | Corrective action is a reactive approach where action is taken in response to an identified problem; the problem has already occurred. It ensures that problems, customer complaints or other nonconformities are identified, documented, analyzed, resolved and that an evaluation of the solution takes place. Modifications to the corrective plan may occur because of the evaluation. |
| Crossmatch | The process used to detect incompatibilities between donor and recipient blood prior to transfusion. |
| Computer (electronic) crossmatch | Computerized procedure that is used in place of a serologic crossmatch to detect ABO incompatibility (applicable only if antibody screen is negative) |
| Serologic crossmatch | In vitro test performed between donor red cells (from a segment removed from the RBC unit) and recipient’s serum or plasma (from the group and screen blood sample) to determine compatibility |
| Cryoprecipitate | A plasma component produced from frozen plasma and containing a specified amount of fibrinogen. |
| Cryosupernatant Plasma (CSP) | The transfusable plasma product resulting from cryoprecipitate production. |
| Designated donation | Donations planned and/or selected for medical reasons for transfusion to a specific recipient. The donor and recipient are unknown to each other (E.g. IgA deficient donor, rare phenotype). |
| Directed donation | The process whereby the blood is collected from a specific donor to a specific recipient. The donor has been selected by or for the recipient. |
| Distribution | a process of sending blood components or blood products from their source or from a storage location to another location hwere they will be stored or used. |
| Issue | Releasing a blood component or blood product from a transfusion service to a specific patient for purposes of transfusion |
| Transfer | Sending a blood component or product from one facility to another or from a transfusion service to a fridge or temperature monitored device within the same facility for purposes of storage |
| Donation Code | The unique group of numbers, letters, symbols or a combination of these that an establishment assigns to a unit of blood at the time of collection |
| Donor | A person who donates blood for transfusion. |
| Donor Identification Code | The unique group of numbers, letters or symbols, or combination of these that an establishment assigns to a donor |
| Error | A deviation from Standard Operating Procedures. |
| Facility | Establishments that collect, process or provide blood and/or blood products for transfusion purposes. E.g. blood centres, transfusion services, storage facilities. |
| Fresh frozen plasma (FFP) | Plasma stored at -18⁰C or colder within 8 hours of donation (the donation start time). |
| Frozen plasma (FP) | Plasma stored at -18⁰C or colder within 24 hours of donation (the donation start time). |
| HDFN | Hemolytic disease of the fetus and newborn. |
| Health Facility | An establishment that provides medical services. E.g. hospitals, clinics, long term care facilities, dental office etc. |
| Hospital | A hospital is a health care institution providing patient treatment by specialized staff and equipment. For ORBCoN’s purposes a ‘hospital’ is defined as an institution with a MAK code. |
| Transfusion Service | An entity that performs pretransfusion serological testing or is involved in the provision of blood components or blood products and their transfusion or administration. |
| Issue | Releasing blood components/products from the transfusion services’-controlled temperature environment to a recipient. |
| Lookback | A procedure that investigates previous donations from any blood donor found to have a transfusion-transmitted infection. All organizations, attending physicians and recipients are notified. |
| Massive Transfusion | A transfusion volume equal or greater to the recipient’s blood volume that was transfused within 24 hours. |
| Medical director | A licensed physician who is responsible for all clinical and laboratory policies for processes and procedures. |
| MAK Code | Number assigned to each hospital by CBS information system (MAK Progesa). |
| NAIT | Neonatal alloimmune thrombocytopenia. |
| Neonate | An infant that is less than 4 months of age. |
| Nonconformance | A deviation from policies, processes or procedures resulting in a noncompliance to the established quality management system. |
| Operating Procedure | A thorough, step by step documentation of a procedure |
| Organization | See facility |
| Packing slip/voucher | The document(s) that accompany blood or blood products during shipping |
| Pasteur Pipette | Also known as droppers; glass or plastic pipettes that are used with a bulb for transfer of small volumes of liquids; the pipet typically tapers to a narrow opening; in various lengths and plugged and unplugged formats |
| Pathogen Reduced Pooled Platelet Component | Platelets that undergo treatment with platelet additive solution (PAS), photoactive compounds and UV illumination to intercalate DNA and RNA from cells and pathogens within a range of concentrations to inactivate pathogens. |
| Perioperative blood collection | Autologous blood collection just prior, during or immediately following trauma or surgery: acute normovolemic hemodilution (ANH), intraoperative and post-operative harvest. |
| Plasma protein products (PPPs) | Plasma protein products that are either derived from pools of human or animal plasma or through a recombinant process. E.g. Albumin, Factor VIII, IVIG contained in boxes, bottles and syringes. |
| Platelets | A transfusable cellular product containing a high proportion of platelets prepared by pooling platelets derived from whole blood donation or collected from apheresis donation. |
| Policy | A document that guides decisions or action. |
| Positive Patient Identification Technology(PPID) | Refers to a computerized system that scans a barcode, radiofrequency identification (RFID) or another electronically readable element on a patient’s identification band to confirm identity |
| Post-donation information (PDI) | Information sent to transfusion facilities concerning a donor or donation acquired by the blood service post donation. (E.g. A donor feeling ill with the flu 2 days post donation). |
| Preventative measures/action | Preventative measures are proactive, rather than reactive is in corrective action. Preventative measures are processes that identify potential problems or nonconformances and eliminates them before they occur. Effective quality management systems identify potential issues. |
| Pretransfusion | See compatibility testing. |
| Procedure | A series of tasks/steps performed to generate a result or product. |
| Process | A series of procedures that take place to produce an outcome/goal. |
| Process control | Establishment of processes and activities that minimize variation to produce a quality output that meets specifications. |
| Proficiency testing | A component of quality assurance that assesses the performance of a laboratory where independently prepared, unknown samples are tested and compared to the known results. |
| Quality assurance | The planned and systematic activities surrounding quality planning, control, assessment, reporting and improvement demonstrate that all activities that affect a product or service meet established quality standards and regulations. |
| Quality control | The routine testing and monitoring of materials, equipment, blood and blood products and activities to ensure continuous specified performance requirements are met and eliminate causes of poor performance. |
| Quality indicators | Metrics or data used to monitor progress towards an organization’s stated quality goals and objectives. |
| Quality management | Application of a quality system in managing the structure, processes and procedures used to direct and control the quality activities of an organization. Includes strategic planning, allocation of resources, quality planning, implementation and evaluation. |
| Quality system | A formalized system that defines and documents the organizational structure, responsibilities, procedures, instructions, processes, and resources involved in the implementation of quality management. |
| Quality system essentials | Key factors that apply to a quality system (e.g. organization and leadership, suppliers and materials management, human resources). |
| Quarantine | Segregation of blood or blood products that are unsuitable for transfusion |
| Record | A document containing recorded information (writing or electronic) that provides evidence an activity has been performed. |
| Red blood cells (RBCs) | Pertains to a blood component containing mostly RBCs with minimal plasma. Some examples of RBC units available are: SAG-M, washed, deglycerolized. |
| Saline | Can be labelled as “Buffered or Normal” Saline. Saline is intended for use in immunohematological procedures or as a general laboratory diluent. The active ingredient is sodium chloride 0.90% w/v, pH 6.0-7.5 at 25°C. It is a non-sterile isotonic solution, 0.90% w/v, not suitable for any in vivo use or patient transfusion. |
| Serious adverse reaction | An extreme adverse event with at least one of the following characteristics: requires hospitalization or extended hospitalization for an in-patient, results in persistent or significant disability, requires surgical or medical intervention, is life-threatening or results in death. |
| Shipping container | A container used to ship blood or blood products. |
| Traceback | A procedure that investigates a report of a suspected transfusion-associated infection in a patient in order to identify a potential implicated donor. A traceback will determine whether any donor who contributed to the transfusion is infected, permit retrieval of all available blood components contributed by that donor and notifies consignees and recipients of components collected from that donor. |
| Validation | Documented assurance that new, changed or challenged processes and procedures are capable of consistently meeting established performance standards and specified requirements before implementation. |