title: Emerging technologies and quality assurance: the United Kingdom National External Quality Assessment Scheme perspective.
abstract: The pattern of tests employed and technologies developed within hemostasis laboratories has changed considerably within the last 10 years. These changes have presented challenges to external quality assessment (EQA) providers, including the United Kingdom National External Quality Assessment Scheme (NEQAS). EQA for point-of-care devices used for monitoring oral anticoagulant therapy has focused on provision of suitable material to assess performance of devices designed for capillary blood testing, and on education of a user group not usually trained in laboratory quality control procedures. Development of novel therapeutic agents for hemophilia has presented challenges regarding standardization of assays for monitoring treatment, whereas advances related to laboratory testing and automation have not always been accompanied by improved accuracy and precision. EQA provision has also been shown to be of value in molecular genetic screening tests for thrombophilia, and in highlighting standardization issues related to D-dimer measurement in the exclusion of deep vein thrombosis. The increasing prevalence of screening tests of global hemostasis, such as thrombin generation tests and thromboelastography, presents additional challenges to EQA providers in the attempt to standardize these new and potentially beneficial technologies.
authors.affiliation: United Kingdom National External Quality Assessment Scheme (UK NEQAS) for Blood Coagulation, Sheffield, United Kingdom. i.jennings@coageqa.org.uk
authors.forename: Ian
authors.initials: I
authors.lastname: Jennings
authors.forename: Dianne P
authors.initials: DP
authors.lastname: Kitchen
authors.forename: Timothy A L
authors.initials: TA
authors.lastname: Woods
authors.forename: Steven
authors.initials: S
authors.lastname: Kitchen
authors.forename: Isobel D
authors.initials: ID
authors.lastname: Walker
mesh_terms: D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage* / Q000627:therapeutic use; D002138:Calibration; D002624:Chemistry, Clinical / Q000379:methods* / Q000592:standards*; D016903:Drug Monitoring; D005169:Factor VIII / Q000096:biosynthesis; D005338:Fibrin Fibrinogen Degradation Products / Q000096:biosynthesis; D006403:Hematologic Tests / Q000379:methods; D006487:Hemostasis; D006801:Humans; D019934:International Normalized Ratio; D011786:Quality Control; D013916:Thrombelastography / Q000379:methods; D006113:United Kingdom; D020246:Venous Thrombosis / Q000175:diagnosis
chemical_list: D000925:Anticoagulants; D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D; C078147:F8 protein, human; D005169:Factor VIII