Pre-analytical phase: The automated ProTube device supports quality assurance in the phlebotomy process

Background: Most errors in laboratory medicine occur in the pre-analytical phase of the total testing process. Phlebotomy, a crucial step in the pre-analytical phase influencing laboratory results and patient outcome, calls for quality assurance procedures and automation in order to prevent errors and ensure patient safety. Methods: We compared the performance of a new small, automated device, the ProTube Inpeco, designed for use in phlebotomy with a complete traceability of the process, with a centralized automated system, BC ROBO. Results: ProTube was used for 15,010 patients undergoing phlebotomy with 48,776 tubes being labeled. The mean time and standard deviation (SD) for blood sampling was 3:03 (min:sec; SD +/- 1:24) when using ProTube, against 5:40 (min:sec; SD +/- 1:57) when using BC ROBO. The mean number of patients per hour managed at each phlebotomy point was 16 +/- 3 with ProTube, and 10 +/- 2 with BC ROBO. No tubes were labeled erroneously or incorrectly, even if process failure occurred in 2.8% of cases when ProTube was used.