1. Abstract Staff members of the Department of Pathology, University of Iowa Hospitals and Clinics set forth to redesign and improve the pre- analytical and post-analytical process phases of the gynecologic cytopathology testing cycle through the utilization of process analysis tools and the application of Lean methodology. The project team developed detailed process maps and why-why tree diagrams of the reasoning for certain steps or constraints within the current process. These process analysis tools effectively served to establish a common understanding of the current process. The team was then able to thoroughly assess the current process for deviations from Lean principles and identified various sources of waste and process defects. Process redesigns were drafted and trialed for feasibility prior to implementation. The redesigns effectively reduced the total number of steps within these processes by 40% versus the number of steps being performed at project inception. The redesigns applied to gynecologic specimen receipt and accessioning processes: 1) effectively transformed the process from a batch-and-queue workflow to single piece flow, 2) eliminated a significant process constraint, and 3) provided a systematic means for reducing specimen labeling errors. The teams assessments also identified inefficiencies in billing processes that were eliminated by process redesign. Overall, the teams improvement project demonstrated that a process- focused analysis governed by the application of Lean principles can effectively improve laboratory operations, reduce the potential for error, and identify many other opportunities for improvements in tangential processes. Background The Cytopathology Laboratory receives and accessions roughly 18,000 gynecologic cytology specimens annually. A lack of a consensus understanding of the current workflows and the relevant history that lead to the current state created frustrations. Consequently, it was difficult to manage this area. Ultimately, management decided the pre and post analytical workflows of this laboratory were prime candidates for a formalized process improvement project. Methods (cont.) Phase 2: As-is process analysis and measurements. Process mapping the current processes. ( Figures 1a,b & 2 ). Process maps were developed by directly observing the primary operators performing the current processes. The process maps established a baseline representation and facilitated a common understanding of the current state. Use of the 5-Whys tool to analyze key features of the process ( Figure 3 ) Enabled thorough analysis and effectively identified the reasoning and root causes behind the current state. Identification of process steps contrary to Lean principles. Conclusions A process-focused, employee-involved approach to operational management can effectively identify and address problems and inefficiencies within a laboratorys workflows. Process analysis tools facilitate a thorough analysis and a mutual understanding of the laboratorys existing processes. The information yielded by the use of these tools is key to the teams success in objectively assessing the current state for opportunities for improvement. Application of Lean principles effectively reduced waste within the laboratorys processes and is proof that manufacturing-based quality improvement methods can be used to effectively improve operational efficiency and effectiveness. These process changes have yielded opportunities for improvements in related processes. The staff involved in this project have produced recommendations for other process improvements in other laboratories and work areas. Improvement projects such as this one create momentum for continuous improvements throughout the laboratory. Kent Becker, Jeanne Myers, Cheryl Lown, Tanika Moreland, Rose Meyer, Chad Hoffman Anatomic Pathology, Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242 References 1.Madison, D. Process Mapping, Process Improvement, and Process Management: A Practical Guide to Enhancing Work and Information Flow. Chico, CA: Paton Press LLC; 2005. 2.Liker JK. The Toyota Way: 14 Management Principles from the Worlds Greatest Manufacturer. New York, NY: McGraw-Hill; 2004 3.Persoon TJ, Zaleski M, Cohen M. Improving pap test turnaround time using external benchmark data and engineering process improvement tools. Anatomic Am J Clin Pathol. 2002; 118:527-533. 4.Zarbo RJ, DAngelo R. Transforming to a quality culture: the Henry Ford Production System. Am J Clin Pathol. 2006;126(suppl 1):S21-29. Contact Information: kent-becker@uiowa.edu Figures 1a,b: As-is process maps under development. Figure 1a was the labs pre- accessioning process; Figure 1b was the accessioning process. These process maps were initially constructed using a combination of self-stick notes, whiteboards, poster paper, etc. These materials made it easy to edit the details and reconfigure the process steps during construction. Figure 4. Avoid keys that force readers to labor through complicated graphs: just label all the lines (or bars) and then delete the silly key altogether (as above). The above figure would also be greatly improved if I had the ability to draw mini rats with and without brains. I would then put these really cute little illustrations next to the lines they represent. Effective Use of Process Analysis and Lean Principles to Improve Processes within the Gynecologic Cytopathology Testing Cycle Objectives Utilize a team approach and process analysis tools to thoroughly investigate the current state of the laboratorys pre- analytical and post-analytical workflows; create a consensus understanding of these workflows. Assess the current state for whether these processes adhere to Lean principles; identify opportunities for process improvements. Streamline the existing processes by removing non-value added process steps, by standardizing the workflows, and by reducing opportunities for error. Methods Phase 1: Getting started. Meeting with management. Defined scope and established project objectives. Formation of the process improvement project team: Quality assurance representative and division manager serving as co-project facilitators; primary operators within the specimen receipt, accessioning, and preparation areas; a cytotechnologist; a financial manager. Communication of the team charter to the team members. Outlined the project objectives and scope. Provided the team with a basic introduction to process analysis, process redesign, and Lean principles. Figure 2: Process map of the as-is pre-accessioning process (Figure 1a) once translated into a Visio diagram (Microsoft, Redmond, WA). This process map detailed the steps involved in specimen receipt, unpackaging, assessment and batching – steps occurring before a subsequent acccessioning process. Process mapping proved to be a key tool as it facilitated a consensus understanding and a thorough assessment of the as-is process. Figure 3: Example of a 5-whys tree-diagram developed during the analysis of the as-is pre-accessing process map (represented in Figure 2). This tool helped the project team to understand the rationale behind certain aspects of the current process – in this case, why the work was batch accessioned and why worklists were being produced at accessioning. It also served to remind the team of key issues to consider when proposing process changes. Methods (cont.) Investigation and measurements of specimens held in waiting because accessioning workstations could not accession concurrently. Defined the customers of these processes and identified their requirements. Phase 3: Process redesign and trials. The team collectively developed first-cut redesigns of the process maps. The information assembled during Phase 2 was crucial in developing proposed process changes. The diverse experience and collective expertise of the project team members facilitated a rapid feasibility assessment of proposed changes. The redesigned processes were trialed for feasibility. Some minor adjustments were necessary to make the redesigned processes operationally feasible, but the Lean principles driving the changes remained. Phase 4: Implementation of redesign. Finalized the redesigns; revised the process maps; revised procedures. Changes to the information system trialed in Phase 3 were moved from the systems test environment to the production environment. Trained affected personnel on procedural changes. Implemented measures to prevent reversion: Information system changes (by rule) prevented reversion. Removed the supplies made obsolete by the process redesigns. Monitored occurrence reports for any problems with the redesigned processes. Figure 4: Examples of some of the steps and decision trees found in the as-is process maps. Each step (or a combination of steps) of the as-is process map could be evaluated for deviation from Lean principles. Chart 1 : Breakdown of a sampling of specimen wait times in Outreach. Elapsed time was measured from time of receipt to time accessioned. (N=49) Table 1: Measurement of the wait effect. Cytopathology could not begin accessioning specimens until outreach had completed their specimens. Results Pre-accessioning process after redesign: Process for pre-analytical technical billing entry: Process for post-analytical professional billing: Figure 5: The final version of the pre-accessioning process map after process redesign and feasibility trial. For comparison, Figure 2 is the corresponding before map. Redesign removed 8 decision steps and 32 action steps – reductions of 73% and 86% respectively. Before: 7 decision steps; 5 different billing codes. After: 2 decision steps; 2 different billing codes. Before: 4 decision steps; Select from 5 billing codes After: 1 decision step; Select from 2 billing codes Results