A Survival Guide for the Rapid Transition to a Fully Digital Workflow: The "Caltagirone Example"

Abstract

Digital pathology for the routine assessment of cases for primary diagnosis has been implemented by few laboratories worldwide. The Gravina Hospital in Caltagirone (Sicily, Italy), which collects cases from 7 different hospitals distributed in the Catania area, converted the entire workflow to digital starting from 2019. Before the transition, the Caltagirone pathology laboratory was characterized by a non-tracked workflow, based on paper requests, hand-written blocks and slides, as well as manual assembling and delivering of the cases and glass slides to the pathologists. Moreover, the arrangement of the spaces and offices in the department was illogical and under-productive for the linearity of the workflow. For these reasons, an adequate 2D barcode system for tracking purposes, the redistribution of the spaces inside the laboratory and the implementation of the whole-slide imaging (WSI) technology based on a laboratory information system (LIS)-centric approach were adopted as a needed prerequisite to switch to a digital workflow. The adoption of a dedicated connection for transfer of clinical and administrative data between different software and interfaces using an internationally recognised standard (Health Level 7, HL7) in the pathology department further facilitated the transition, helping in the integration of the LIS with WSI scanners. As per previous reports, the components and devices chosen for the pathologists' workstations did not significantly impact on the WSI-based reporting phase in primary histological diagnosis. An analysis of all the steps of this transition has been made retrospectively to provide a useful "handy" guide to lead the digital transition of "analog", non-tracked pathology laboratories following the experience of the Caltagirone pathology department. Following the step-by-step instructions, the implementation of a paperless routine with more standardized and safe processes, the possibility to manage the priority of the cases and to implement artificial intelligence (AI) tools are no more an utopia for every "analog" pathology department.

Keywords: 2D-barcode; LIS; WSI; digital pathology; primary diagnosis.

Figure 1

(A), Location of the Catania area in Sicily, south of Italy. (B), the different hospitals in the Catania territory referring to the Caltagirone pathology laboratory at Gravina Hospital.

Figure 2

One of the “home-made” working stations used by pathologists for the off-site sign-out and reporting. The smaller monitor (on the left) has a sufficient size and resolution to run the LIS. The right display allows an adequate visualization of the WSI.

Figure 3

Comparison of some of the principal checkpoints before and after the implementation of DP tools. On the left, during the grossing phase the case identification number was handwritten on every cassette before the introduction of case-specific 2D-barcodes directly generated by the LIS and laser-printed on the cassettes. Similarly, hand-labeled glass slides were randomly returned to the technicians and manually archived (right). The introduction of WSI and scanner next to the staining instrument allowed the direct archiving of physical glass slides using the 2D barcodes.

Figure 4

Digital pictures taken at each step of the life of the specimen and respective cassettes fully document the flow of tissue in the lab, allowing global traceability and high-resolution error tracking. (A) Specimen container as it is received; (B) Cassette at grossing, before closing its lid; (C) Surface of the FFPE block after microtome sectioning; (D) Macro picture of the glass slide after staining.

Figure 5

The reading process of barcodes directly from the rack containing the blocks during the processing phase after the digital transition. In the upper right inset the code extracted from the 2D barcode directly in the LIS.

Figure 6

The BlocDoc at the embedding phase.

Figure 7

An example of a sectioning station. The technician can identify the block through a barcode reader (red arrow), entering the LIS page of the case and printing the related glass slides with a laser printer (yellow arrow). After sectioning, the technician can directly scan the cut surface positioning the block on the dedicated space in the BlocDoc instrument (green arrow), with the possibility to assess the preview of the obtained image (blue arrow).

Figure 8

The importance and relationship of the main points required for the development of a reliable, sustainable and safe digital pathology workflow.