Designing a diagnostic Total Testing Process as a base for supporting diagnostic stewardship

• Published in: Clinical chemistry and laboratory medicine Vol. 59; no. 3; pp. 473 - 489
• Main Authors: Cobbaert, Christa, Albersen, Arjan, Zwiers, Irna, Schippers, Pascal, Gillis, Judith
• Format: Journal Article
• Language: English
• Published: Germany De Gruyter 23.02.2021; Walter De Gruyter & Company
• Subjects: Automation; Blood; Brain; competitive dialogue variant; Delft Systems Approach; Diagnostic systems; functional design; Laboratories; Laboratory tests; Medical tests; Productivity; Systems engineering; Total Laboratory Automation; Total Testing Process; Vision; Delft Systems Approach; Total Testing Process; Total Laboratory Automation; functional design; competitive dialogue variant
• ISSN: 1434-6621; 1437-4331
• DOI: 10.1515/cclm-2020-1251

To more comprehensively support clinical management of patients in our hospital, we redesigned the diagnostic Total Testing Process (TTP) from request to report. To that end, clinical needs were identified and a vision on Total Laboratory Automation (TLA) of the TTP was developed. The Delft Systems Engineering Approach was used for mapping a desirable laboratory testing process. The desirable “To Be” diagnostic process was tendered and the translation of a functional design into a specific TLA-configuration – compliant with the vision and the predefined functional design – was accomplished using a competitive dialogue tender variant (based on art. 29 of the EU guideline 2014/24). Realization of this high-end TLA-solution enabled a high-quality testing process with numerous improvements such as clear and supportive digital request forms, specimen consolidation, track and trace and non-conformity registration at the specimen level, better blood management (∼40% less blood sampled), lean and in line processing with increased productivity (42% rise in test productivity per capita), and guaranteed turn-around-times of medical tests (95% of TLA-rooted in line tests are reported <120 min). The approach taken for improving the loop of medical testing, as fundament for better diagnostic stewardship, is explained.