DRAFT: This module has unpublished changes.

Implementation of Value Stream Mapping (VSM) to Study RNA-Based Testing Workflow and Collect Performance Metrics in the Molecular Pathology Laboratory.


Winner of a 2013 Association for Molecular Pathology (AMP) Technologist Poster Award


Hannah C. Hohendorf, B.A., B.S., Lisa Whiteley, B.A., Joanne Beher, B.S., Milena Cankovic Ph.D, Dhananjay Chitale M.D., Gaurav Sharma, M.D.


Department of Pathology and Laboratory Medicine; Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, Michigan 48202 U.S.A.



The advent of molecular diagnostic testing has revolutionized diagnostics, prognostication and monitoring of treatment in a wide variety of clinical settings. While the role of the molecular laboratory is expanding, the changing healthcare climate is impacting reimbursement models. Successfully adapting to these new conditions requires close inspection of laboratory work processes to distinguish value-added (activity that contributes towards the end product) vs non-value added (activity that does not contribute towards the end product, often defined as waste) steps. Value Stream Mapping (VSM) is a graphical LEAN tool that is used to improve workflow by identifying process delay(s) and studying movement of information and material in a family of related processes. We applied VSM to our laboratory's RNA-based testing menu for hematolymphoid malignancies. The goal was to study our workflow and capture baseline process performance metrics that could be utilized to validate future process improvements to accommodate increased workload.


Material and Methods

VSM of pre-, post- and analytical processes was performed on specimens analyzed over 9 workdays by a team of 3 technologists. Specimens submitted for RNA-based testing for hematolymphoid malignancies (BCR/ABL p210, BCR/ABL p190, PML/RARA, AML1/ETO and CBFB/MYH11 inv(16)) were tracked through each step. VSM metrics such as lead time (time between specimen receipt and result report), cycle time (time from start of a process to its completion), and takt time (pace to meet work demand) were calculated to define the baseline performance.  



Analysis of VSM metrics for 16 specimens (14 peripheral bloods, 1 bone marrow, 1 CSF) yielded a process cycle efficiency of 27%, derived from a lead time of 1224 minutes and a cycle time of 337 minutes. Takt time was 406 minutes/specimen. Seven distinct steps of value-addition were identified and the longest intermediate queue time was between RNA isolation and cDNA synthesis (330 minutes). These metrics demonstrated that the process performance was adequate for the current test volume.



With VSM, baseline performance metrics were successfully captured and points of delay identified. We will now implement VSM for our other test families (example, fragment length analysis). Overall, with this technique we were able to show that our process capacity and workflow are adequate to accommodate the current customer demand and objectively measure any impact due to anticipated increase in future test volume. Furthermore, we can now systematically select, plan and implement future process improvements. We strongly recommend that molecular laboratories utilize VSM to benchmark their performance and design efficient processes.





DRAFT: This module has unpublished changes.