In Focus
Definitions Utilised in the Quality Management of Blood Establishments
Challenges in both Diagnosis and Treatment
A word can have multiple meanings depending on the context. To avoid confusion, it is best to define terms commonly used within a specific field. At their best, definitions act as a compass pointing the reader in the right direction. The Board of the ISBT Quality Management Working Party initiated a project to harmonise the definitions commonly used in blood establishments around the world. A working group was established with the aim of providing simple, unambiguous definitions that can be applied in a standardised way.
Common references available internationally were consulted in drafting a list of definitions relating to quality management. These reference sources are quoted in the document for each definition. Individual references can be accessed via links appearing at the end of the document. Criteria for selection of the optimal definition included clarity, simplicity, comprehensiveness and best applicability. Definitions have been adapted from the original sources in some instances. The resulting list of definitions was published on the ISBT website in July 2023. Blood establishments are encouraged to utilise the document when developing internal documents. The list is not prescriptive but is meant to serve as a recommendation. It is understood, however, that establishments in some countries are obliged to follow national legislation and terminology.
For ease of use, the definitions are listed in alphabetical order, incorporating quality terms used across the transfusion chain. This encompasses the areas of donor management, blood collection, production of components, laboratory testing, storage, distribution and transfusion. However, detailed definitions relating specifically to haemovigilance and adverse events have been excluded as the ISBT Haemovigilance Working Party has produced a separate document covering this.
The following are examples of some of the definitions relating specifically to the quality management system within a blood establishment: • audits, assessments, inspections and accreditation • agreements, sub-contractors, suppliers • calibration, qualification and validation • change control • compliance, non-compliance, non-conformances, deviations and near-miss events • corrective and preventive action • documents, records and standard operating procedures • external quality assessment • good manufacturing practice • process control including statistical process control • proficiency testing • quality control and quality indicators • risk management incorporating risk assessment and risk mitigation • specifications and standards • traceability
It is the intention of the ISBT Quality Management Working Party to periodically review the list of definitions, performing updates when required. Ongoing feedback from interested parties is welcome.
Figure 1: Example page from the list of definitions on the ISBT website.
Acknowledgements to the following experts in the working group for their valuable input: Christian Seidl (Germany), Tomislav Vuk (Croatia), Wade Atkins (USA), Sibel Eldemir (Turkiye), Nigar Ertuğrul Őrüç (Turkiye).
