The combined positive impact of Lean methodology and Ventana Symphony autostainer on histology lab workflow

<p>Abstract</p> <p>Background</p> <p>Histologic samples all funnel through the H&E microtomy staining area. Here manual processes intersect with semi-automated processes creating a bottleneck. We compare alternate work processes in anatomic pathology primarily in the H&E staining work cell.</p> <p>Methods</p> <p>We established a baseline measure of H&E process impact on personnel, information management and sample flow from historical workload and production data and direct observation. We compared this to performance after implementing initial Lean process modifications, including workstation reorganization, equipment relocation and workflow levelling, and the Ventana Symphony stainer to assess the impact on productivity in the H&E staining work cell.</p> <p>Results</p> <p>Average time from gross station to assembled case decreased by 2.9 hours (12%). Total process turnaround time (TAT) exclusive of processor schedule changes decreased 48 minutes/case (4%). Mean quarterly productivity increased 8.5% with the new methods. Process redesign reduced the number of manual steps from 219 to 182, a 17% reduction. Specimen travel distance was reduced from 773 ft/case to 395 ft/case (49%) overall, and from 92 to 53 ft/case in the H&E cell (42% improvement).</p> <p>Conclusions</p> <p>Implementation of Lean methods in the H&E work cell of histology can result in improved productivity, improved through-put and case availability parameters including TAT.</p

Validation Protocol: First Step of a Lean-Total Quality Management Principle in a New Laboratory Set-up in a Tertiary Care Hospital in India

Method validation is pursued as the first step in establishing Lean-Total Quality Management in a new clinical laboratory, in order to eliminate error in test results. Validation of all the new tests were done (with particular reference to alkaline phosphatase) by verifying reference intervals, analytical accuracy and precision, inter-assay and intra-assay variations, analytical sensitivity, limit of detection, linearity and reportable range, i.e. (i) Analytical measurement range (AMR) and (ii) Clinically reportable range (CRR). Our obtained reference range was within that of the manufacturer’s and showed high degree of analytical accuracy between two laboratories (r2 = 0.99). Precision was comparable with the manufacturer’s claim with inter-assay variation CV 1.04% and intra-assay variation CV 1.54%. Lowest limit of detection was 1.0324 ± 0.007 with CV 0.34%. AMR was also verified with CV 1.26 and 0.69%, for level 1 and level 2 control sera, respectively. The assay was linear with different dilutions. Lean concept was also verified with high recovery percentage. Validation ensures that accurate and precise results are reported in a clinically relevant turn around time