title: Quality management in European screening laboratories in blood establishments: A view of current approaches and trends.
abstract: The screening laboratory has a critical role in the post-transfusion safety. The success of its targets and efficiency depends on the management system used. Even though the European Union directive 2002/98/EC requires a quality management system in blood establishments, its requirements for screening laboratories are generic. Complementary approaches are needed to implement a quality management system focused on screening laboratories. This article briefly discusses the current good manufacturing practices and good laboratory practices, as well as the trends in quality management system standards. ISO 9001 is widely accepted in some European Union blood establishments as the quality management standard, however this is not synonymous of its successful application. The ISO "risk-based thinking" is interrelated with the quality risk-management process of the EuBIS "Standards and criteria for the inspection of blood establishments". ISO 15189 should be the next step on the quality assurance of a screening laboratory, since it is focused on medical laboratory. To standardize the quality management systems in blood establishments' screening laboratories, new national and European claims focused on technical requirements following ISO 15189 is needed.
authors.affiliation: Department of Quality Assurance, Portuguese Institute of Blood and Transplantation, Avenida Miguel Bombarda 6, 1000-208 Lisboa, Portugal. Electronic address: paulo.pereira@ipst.min-saude.pt.
authors.forename: Paulo
authors.initials: P
authors.lastname: Pereira
authors.affiliation: Department of Pathology and Laboratory Medicine, University of Wisconsin Medical School, Madison, WI, USA.
authors.forename: James O
authors.initials: JO
authors.lastname: Westgard
authors.affiliation: Católica Lisbon School of Business and Economics, Catholic University of Portugal, Lisbon, Portugal.
authors.forename: Pedro
authors.initials: P
authors.lastname: Encarnação
authors.affiliation: International Consultancy in Blood Components Quality/Safety Improvement, Audit/Inspection and DDR Strategy, London, UK. Electronic address: jseghatchian@btopenworld.com.
authors.forename: Jerard
authors.initials: J
authors.lastname: Seghatchian
authors.affiliation: Directive Board, Portuguese Institute of Blood and Transplantation, Avenida Miguel Bombarda 6, 1000-208 Lisboa, Portugal.
authors.forename: Gracinda
authors.initials: G
authors.lastname: de Sousa
mesh_terms: D001771:Blood Banks / Q000592:standards*; D058731:Blood Safety / Q000379:methods*; D001803:Blood Transfusion / Q000379:methods* / Q000592:standards*; D005060:Europe; D006801:Humans; D007753:Laboratories / Q000592:standards; D061214:Patient Safety / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards; D011786:Quality Control; D012308:Risk Management
keywords: PDCA; Post-transfusion safety; Quality management; Screening test