title: Process evaluation of an open architecture real-time molecular laboratory platform.
abstract: The needs of molecular diagnostic laboratories that perform both Food and Drug Administration-cleared as well as laboratory-developed tests are usually not met on a single analytical platform. Furthermore, little information is available about the direct impact of molecular automation on labor costs and efficiency in clinical laboratories. We performed a process impact analysis from time and motion studies of a novel molecular diagnostic robotic system designed to automate sample preparation, extraction, and analysis. All 27 preanalytical tasks were quantified for the amount of time spent preparing 24 specimens for analysis. These steps were completed in 899 s (14 min, 59 s) followed by 7887 s (131 min, 27 s) of instrument operation independent of operator control (walk-away time). Postanalytical results evaluation required 1 min per specimen. The instrument automatically extracted the nucleic acid from the specimen, added the eluted DNA to the amplification reagents, and performed the analysis. Only 12% of the total instrument operations required relatively unskilled human labor. Thus, the availability of automated molecular diagnostic instruments will facilitate the expansion of molecular testing in the clinical laboratory because they reduce operator costs with respect to time and complexity of the tasks they are asked to perform.
authors.affiliation: Department of Pathology, Charlottesville, The University of Virginia, Charlottesville, VA, USA rfelder@virginia.edu.
authors.forename: Robin A
authors.initials: RA
authors.lastname: Felder
authors.affiliation: BD Diagnostics, Sparks, MD, USA.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Jackson
authors.affiliation: BD Diagnostics, Sparks, MD, USA.
authors.forename: Adam M
authors.initials: AM
authors.lastname: Walter
mesh_terms: D057205:Automation, Laboratory / Q000295:instrumentation / Q000379:methods*; D057166:High-Throughput Screening Assays / Q000295:instrumentation / Q000379:methods; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000295:instrumentation / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D013048:Specimen Handling / Q000295:instrumentation / Q000379:methods*; D013997:Time Factors
keywords: automation; clinical laboratory robotics; molecular diagnostics; process evaluation; process improvement; process optimization