Pathology Informatics and Digital Pathology
Overview
This domain tests the informatics backbone of pathology practice: laboratory information systems, image standards, whole-slide imaging validation, structured reporting, and the governance of computational tools.
Core rules
- Standards: HL7 carries orders and results between LIS and hospital systems; DICOM, including the whole-slide imaging supplement, governs image storage and transfer; LOINC codes observations; SNOMED CT codes diagnoses.
- Whole-slide imaging validation: before primary diagnosis, a laboratory must validate its scanner and display system against glass, using an adequate case set that includes challenging specimens, with intraobserver concordance and a washout period, and document it.
- Structured reporting: synoptic templates derived from cancer staging standards improve completeness and are required for accreditation in many tumor settings.
- AI and machine learning: algorithms require clinical validation in the local population, defined intended use, monitoring for drift, and version control. A locked algorithm should not change without revalidation.
- Cybersecurity and downtime: laboratories need a documented downtime procedure, since LIS unavailability must not halt urgent reporting.
Worked example
A department wants to replace glass review with whole-slide images for primary diagnosis. Reasoning: the correct path is a formal validation comparing digital and glass diagnoses on a representative case set that includes small biopsies, frozen sections and challenging entities, with a washout period and documented concordance. Installing scanners and switching immediately would breach accreditation requirements regardless of image quality.
Traps
Assuming high-resolution images remove the need for validation. Confusing HL7 with DICOM. Deploying an algorithm whose intended use differs from the local task. Neglecting a downtime plan.