Luca Giobelli

BACKGROUND: Validation of digital whole slide images is crucial to ensure that diagnostic performance is at least equivalent to that of glass slides and light microscopy. The College of American Pathologists Pathology and Laboratory Quality Center recently developed recommendations for internal digital pathology system validation. Following these guidelines we sought to validate the performance of a digital approach for routine diagnosis by using an iPad and digital control widescreen-assisted workstation through a pilot study. METHODS: From January 2014, 61 histopathological slides were scanned by ScanScope Digital Slides Scanner (Aperio, Vista, CA). Two independent pathologists performed diagnosis on virtual slides in front of a widescreen by using two computer devices (ImageScope viewing software) located to different Health Institutions (AOUI Verona) connected by local network and a remote image server using an iPad tablet (Aperio, Vista, CA), after uploading the Citrix receiver for iPad. Quality indicators related to image characters and work-flow of the e-health cockpit enterprise system were scored based on subjective (high vs poor) perception. The images were re-evaluated two weeks apart. RESULTS: The whole glass slides encountered 10 liver: hepatocarcinoma, 10 renal carcinoma, 10 gastric carcinoma and 10 prostate biopsies: adenocarcinoma, 5 excisional skin biopsies: melanoma, 5 lymph-nodes: lymphoma. 6 immuno- and 5 special stains were available for intra- and internet remote viewing. Scan times averaged two minutes and 54 seconds per slide (standard deviation 2 minutes 34 seconds). Megabytes ranged from 256 to 680 (mean 390) per slide storage. Reliance on glass slide, image quality (resolution and color fidelity), slide navigation time, simultaneous viewers in geographically remote locations were considered of high performance score. Side by side comparisons between diagnosis performed on tissue glass slides versus widescreen were excellent showing an almost perfect concordance (0.81, kappa index). CONCLUSIONS: We validated our institutional digital pathology system for routine diagnostic facing with whole slide images in a cockpit enterprise digital system or iPad tablet. Computer widescreens are better for diagnosing scanned glass slide that iPad. For urgent requests, iPad may be used. Legal aspects have to be soon faced with to permit the clinical use of this technology in a manner that does not compromise patient care.

BACKGROUND: The verification/validation of laboratory test results is one of the most critical aspects of the total testing process, which may produce conflicts between competencies and duties at the point of professional crossroads. This process has centered for decades on the human component, with positive effects as well as potential adverse consequences (postanalytical errors). Manual validation of data is a time-consuming activity, is inherently subjective and arbitrary, and requires the constant presence of postgraduate physicians or biologists within the laboratory with adverse economical and organizational impacts. To overcome these inherent limitations, we have developed and implemented in our stat department an automatic system for verification, validation and delivery of laboratory results. METHODS: The procedure is based on automatic validation of test results by an expert system, coupled with remote wireless connection, which allows the laboratory professional "on call" to access, visualize, analyze, validate and deliver alert values (suspect, erroneous or critical) using a small laptop. This system also provides five phases where preanalytical and analytical errors can be identified and handled. RESULTS AND CONCLUSIONS: Six months following implementation of this innovative system, which can be customized to facilitate a wide variety of laboratory workflow models, the reporting efficiency of our stat laboratory has greatly improved, reducing manual data entry, and increasing the timeliness and utility of test results.

Implementation of an automatic system for verification and validation of laboratory test results: a personal experience. The manual test validation is a time-consuming process largely influenced by individual skills and knowledge, which would require the constant presence of specialized professionals. To overcome these inherent shortcomings, we developed a new procedure encompassing automatic validation of test results and a system of remote wireless connection, which allows the laboratory professional “on call” to access, visualize and validate data outside the laboratory by using a laptop. This system also provides steps where preanalytical and analytical errors can be identified and dealt with. The procedure implemented, as well as its healthcare and organizational advantages, are described in the present article.