Functional verification of the digital microscopy system must be performed to assess the performance and ensure it is operating in accordance with the manufacturer’s specification as documented in accompanying user and technical manuals.
Verification results must be documented and kept for the life of the equipment.
Validation must be performed on the digital microscopy system to assess the performance and ensure it meets the intended use and process:
If the digital microscopy system is intended for diagnostic use then validation must include demonstrating the equivalent diagnosis can be made on WSI compared to glass slides. Validation testing must be supervised by an adequately trained pathologist and involve all relevant stakeholders (such as pathologists, laboratory staff, IT and vendor technicians).
The validation method (see below) should be appropriate for the intended use or uses which may include one or more of diagnostic, teaching or research purposes.
The supervising pathologist must assess whether re-validation of the digital microscopy system is required when there is a significant change of IT infrastructure, hardware or software for either the LIS or digital microscopy systems.
The record of validation method, test results and final approval must be documented and comply with accreditation standards (including NATA).
|Testing must simulate the intended operation and process
||Documented use case scenarios and test plans should be written to test the entire digital microscopy system and intended process.
NOTE: This includes testing on all intended viewing devices such as tablets and smartphones * See below.
|A sufficient sample set is used when testing
||A reasonable coverage of different scan magnifications, stains, specimen types and histological features.
|Consideration is given to repeatability/reproducibility parameters
||Agreement of diagnosis between different pathologists for a select number of digital microscopy slides,
Consistency of diagnosis when viewing cases through conventional and digital microscopy.
To reduce bias consider: sufficient washout period between viewing slides through conventional and digital microscopy
Viewing slides in random order.
|Assessment of performance goals by assessing potential failure points/function
||Review of barcode read errors, slide scan errors, transmission errors to/from LIS and time studies on viewing images on viewer
|Monitor mechanical functions
||Luminance or light intensity and chromaticity or colour temperature
* Please refer to RCPA policy: Reporting of Histopathology and Non-Gynaecological Cytopathology Specimens outside the Laboratory. September 2015.
Table: A validation method should be appropriate for the intended use.
Source: RCPA Guidelines for Digital Microscopy in Anatomical Pathology and Cytology October 2015.
Any testing or reporting, including off-site activities must be NATA/RCPA or IANZ accredited. (REF 40)The list below summarises important aspects of this policy regarding portable device use outside the laboratory. However, please refer to the complete RCPA policy: Reporting of Histopathology and Non-Gynaecological Cytopathology Specimens outside the Laboratory:
Off-site reporting must not be greater than 50% of a pathologist’s practice.
The off-site work set-up must comply with Quality Assurance Program requirements and be subject to Internal Audit process and management reviews. This includes:
infrastructure (suitable microscope and adequate lighting),
resource materials (books and internet references), and
access to the laboratory database for checking previous pathology patient data.
The off-site work set-up must comply with Workplace, Health and Safety requirements.
The off-site work area and the pathologist must be accessible to NATA/RCPA assessors performing accreditation visits.
Confidentiality of all patient related materials such as slides, request forms and other health record documents must be maintained at all times.
There must be adequate computer password protection, fire walls and/or other information technology security measures in place to prevent unauthorised access to patient results.
Each pathologist must be given an adequate transition period between using conventional and changing to digital microscopy for diagnostic use. Allow a sufficient time for doubling up conventional and digital microscopy workflows.