Solid Tumor Molecular Diagnostics: Workflow Challenges for Anatomic Pathology and Molecular Testing.
Rachel Ochs, Charuhas Deshpande, Christopher Watt, Kathleen Montone, Vivianna VanDeerlin, Antonia Sepulveda. Hospital of the University of Pennsylvania, Philadelphia
Background: With recent clinical evidence guiding treatment decisions, demand for molecular characterization of solid tumors is increasing, presenting distinct challenges to molecular and surgical pathology laboratories. Testing is frequently requested on outside submitted specimens (OSS) that require review by an anatomic pathologist. Submitted material is often a small surgical biopsy or cytopathology cell block and this material may be exhausted during initial diagnosis. Communicating with clinicians regarding receipt of outside slides and/or paraffin blocks and specimen adequacy can be complex. Here we report our experience with solid tumor molecular diagnostics following transition to a laboratory information system (LIS) based specimen tracking system handled by a dedicated Molecular Anatomic Pathology service.
Design: Solid tumor testing requested on paraffin-embedded tissue was tracked using an internally generated report in the LIS during a three month period (July to September 2010) following transition from a manual tracking system. Comparison of overall turn-around time (TAT), specimen type received and specimen adequacy was performed on OSS and our institutional specimens (OIS). TAT comparison with our prior manual system was also performed.
Results: Analysis performed for melanoma, lung and colon cancer specimens (n=115) revealed 68 OIS and 47 (41%) OSS requests. Significantly shorter average TAT for OIS-11.8 workdays compared to 15.4 workdays for OSS (p<0.05) was noted. Specimens submitted for molecular testing included 73 KRAS, 67 EGFR, 33 BRAF, and 21 CKIT requests. Thirteen tests were cancelled for inadequacy due to low tumor volume (12.8% for OSS, 10.2% for OIS) including 6 fine needle aspiration (FNA) specimens (43% of FNA's) and 7 surgical pathology biopsy specimens (15% of biopsies). Three tests were cancelled because adequate outside materials were not received within two weeks of the initial request (6.4% of OSS). Average TAT in a prior manual system for a representative molecular assay was 18.4 workdays.
Conclusions: Solid tumor testing at an academic referral center results in requests for testing on same institution specimens as well as a high proportion of outside specimens. This leads to challenges for laboratory personnel, including issues with efficient communication and difficulties that arise from processing test requests unaccompanied by adequate or appropriate specimens. Our experience supports the role of a dedicated Molecular Anatomic Pathology service with an integrated LIS solution for efficient workflow.
Category: Quality Assurance
Monday, February 28, 2011 1:00 PM
Poster Session II # 231, Monday Afternoon