RESUMEN
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.
Asunto(s)
Sistemas de Información en Laboratorio Clínico/normas , Técnicas de Laboratorio Clínico/normas , Pruebas Diagnósticas de Rutina/normas , Automatización , Sistemas de Información en Laboratorio Clínico/instrumentación , Técnicas de Laboratorio Clínico/instrumentación , Técnicas de Laboratorio Clínico/métodos , Pruebas Diagnósticas de Rutina/instrumentación , Pruebas Diagnósticas de Rutina/métodos , Humanos , Control de Calidad , Reproducibilidad de los Resultados , Proyectos de InvestigaciónRESUMEN
Digital pathology allows networks of "remote" specialist pathologists to report the findings of preimplantation kidney biopsies. We sought to validate the assessment of preimplantation kidney transplant biopsies for diagnostic purposes using whole-slide images according to the recommendations of the College of American Pathologists. Sixty-two consecutive, previously reported, preimplantation kidney biopsies were scanned using the ScanScope Digital Slide Scanner at 0.5 µm/pixel (20× objective). The slides were assessed for percent glomerulosclerosis, tubular atrophy, interstitial fibrosis and vascular narrowing using the Remuzzi criteria by two pathologists, one using glass slides and the other using the whole-slide images viewed on a widescreen computer monitor. After a 2-week washout period, all of the slides were re-assessed by the same pathologists using the opposite mode of reporting to that used in the first evaluation. Very high glass-digital intraobserver concordance was achieved for the overall score and for individual grades by both pathologists (κ range, 0.841-0.973). The overall scores obtained by both pathologists and using both methods were identical. The times needed to assess the biopsies were 14 minutes when using a light microscope and 18 minutes, including scanning time, which averaged 2 minutes 20 seconds per slide, when using digital microscopy. Digital microscopy is a reliable, fast, and safe method for the assessment of preimplantation kidney biopsies.
Asunto(s)
Selección de Donante , Interpretación de Imagen Asistida por Computador , Enfermedades Renales/patología , Trasplante de Riñón/métodos , Riñón/patología , Microscopía , Telepatología/métodos , Donantes de Tejidos , Biopsia , Humanos , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Reproducibilidad de los ResultadosRESUMEN
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.