Before using digital microscopy for diagnostic purposes each pathologist must:
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Undertake appropriate training from the vendor;
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Be proficient in using WSI and be able to:
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assess the quality of WSI;
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understand the system limitations, including situations where turnaround times are longer or accuracy is lower using the digital system;
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understand the system features such as how to navigate WSI, add annotations, etc.
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understand patient confidentiality pertaining to digital pathology;
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remove metadata from WSI file to copy for teaching sets and educational purposes.
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Credentialing of pathologists and certification of technicians is recommended.
The pathologist should decide the best method for diagnosing each case, i.e. digital or conventional microscopy or a combination of both according to their clinical judgement.
Pathologists should incorporate digital microscopy to their continuing professional development (CPD). This development could include training from the RCPA, industry or in-house training, especially in informatics or bioinformatics. RCPA IQA activities can also be incorporated. Section 1 activities, or Diagnostic Measures (the analytic phase) relates to peer review activities, participation in 10 hours per annum is required. This can involve internal random case review of digital microscopy cases or internal targeted case reviews of digital microscopy cases. Documentation of case/patient number and any type of discordance you may have reviewed.
Activity |
Quality activity monitor related |
Suggested document
requirements |
Case Reviews
Using clinical
audit techniques |
• Internal random case review
- Defined % of cases |
Document the review type
- Who performed the review
- What was reviewed
- What cases were reviewed
- Time it took
Structure discordance as
- None (agreement)
- Minor/ typo error
- Minor discordance/ no
effect on patient care
- Major discordance
/potential impact on patient
care |
• Internal target case review
- Specific case types |
Reference: RCPA. IQA Framework in Morphological & Interpretative Disciplines 2015 – Anatomical Pathology
Templates for IQA Case Reviews can be found on the RCPA Website.
The new digital microscopy system should create no additional medico-legal liability issues for the reporting pathologist. Pathologists must adhere to all existing supervision and accreditation requirements when using digital microscopy for diagnostic purposes and be cognisant of any additional obligations incurred by electronic transmission and storage of patient information (see Modules 4 and Module 5).
It is the College’s position that satisfactory supervision of a laboratory occurs when medical and scientific supervisors ensure that all elements of the following three areas have been executed:
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Pre-analytic, analytic and post-analytic aspects of laboratory testing.
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Clinical Governance and Laboratory Management
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Operational Requirements
All areas of testing in a laboratory must be able to be mapped to a medical or scientific supervisor with relevant qualifications and competency. Nominated supervisors must demonstrate that they have provided sufficient time to execute their duties including review of methods and assay performance. Supervisors must demonstrate that they have implemented systems to monitor quality measures including review of QC and QA. Relevance to anatomical pathology and digital microscopy the table below has been developed from the RCPA Policy: Supervision of Diagnostic Laboratories in Australia.
Category of Laboratory |
Required Supervision |
Category B laboratories |
Specialist pathologist or clinical scientist (as defined in the NPAAC supervision document) in the relevant area must monitor the tests that are performed in that laboratory in the area of their competence |
Pathologists working in the area of anatomical pathology are competent to supervise this area of the laboratory as well as provide clinical and medical governance for the laboratory generally.
They do not have the appropriate qualifications or competency to supervise
other areas of testing outside the discipline of anatomical pathology |
Category GX
Laboratory |
With full-time clinical pathologists and/or clinical scientists as appropriate in all
the areas of testing throughout the whole network |
Supervisory responsibility for their area of testing both in the category GX laboratory and those dependent category B laboratories in the network |
Category G laboratories |
Specialist pathologist or clinical scientist (as defined in the NPAAC supervision document) in the relevant area must monitor the tests that are performed in that laboratory in the area of their competence |
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Reference: RCPA Policy: Supervision of Diagnostic Laboratories in Australia. August 2015
Situations have been identified that have raised concern regarding digital microscopy and intraobserver discordance rates and these include:
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it is not possible to examine digital slides with polarized filters unless the scanner has a polarising lens attached and the glass slide is scanned with a polarised lens
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