Professional Practice, Training and Competency

This module is based on The RCPA Guidelines for Digital Microscopy in Anatomical Pathology and Cytology October 2015.

Pathologists undertake a variety of professional development activities, including training, participation in Internal Quality Assurance (IQA) and External Quality Assurance (EQA), and Continuing Professional Development (CPD).

There should be a double-up of conventional and digital processes initially to ensure each pathologist acquires competency in digital microscopy. Many aspects of professional practice, training and competency in digital microscopy relate to existing policies and guidelines in anatomical pathology practice. This demonstrates the importance of double-up between techniques and importance of gradual integration.

When implementing a digital microscopy system for diagnostic use consider professional practice issues such as:

  • Human resourcing, which includes:
  • Handling of peer reviews or second opinions for cases. It is recommended to have a policy for the use of digital microscopy for professional second opinions, that considers situations such as cases from:
    • same organisation but different locations / time zones / disciplines,
    • different organisations,
    • cross border (NOTE: there should be a separate policy for cross-border pathology).
    • the sending/receiving organisations should comply with this guideline with respect to all elements of digital microscopy.

Medicolegal and registration issues need to be considered in drafting these policies.

43. Ranson, D. (2007). Medical Issues: Telemedicine and the Law. J Law Med, 15(3), 356-359;

Also refer to Royal College of Pathologists of Australasia Position Statement Telepathology May 2016

Before using digital microscopy for diagnostic purposes each pathologist must:

  1. Undertake appropriate training from the vendor;

  2. Be proficient in using WSI and be able to:

    1. assess the quality of WSI;

    2. understand the system limitations, including situations where turnaround times are longer or accuracy is lower using the digital system;

    3. understand the system features such as how to navigate WSI, add annotations, etc.

    4. understand patient confidentiality pertaining to digital pathology;

    5. remove metadata from WSI file to copy for teaching sets and educational purposes.

  3. 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:

  1. Pre-analytic, analytic and post-analytic aspects of laboratory testing.

  2. Clinical Governance and Laboratory Management

  3. 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  

Reference: RCPA Policy: Supervision of Diagnostic Laboratories in Australia. August 2015

Validation studies have demonstrated that when too few cases are used the diagnostic accuracy of digital microscopy deteriorates. A meta-analysis of the literature indicates that when an average of 20 cases are employed the concordance between digital microscopy ad conventional microscopy is 75% versus 95% when 60 cases are used.

44. Cucoranu IC et al. Letter to the Editor. Arch Pathol Lab Med. March 2014. 138: 300.

There are numerous validation studies in the literature and the designs of these studies show considerable variations in sample size, case selection, diagnostic setting, type of imaging hardware and software and study outcomes.

45. Pekmezci M et al. Pitfalls in the use of whole slide imaging for the diagnosis of central nervous system tumours: A pilot study in surgical neuropathology. J Pathol Inform. 2016. 7: 25.

Snead and colleagues presented the largest study to date of a pathologist’s ability to assess histopathology cases on digital microscopy as opposed to conventional light microscopy. In line with previous guidelines the group instigated a small pilot study prior to validation composed of 284 cases over a 6-week period.

47. Hartman D. Lecture: Early Adoption and Implementation of Digital Pathology. Digital Pathology Congress: Asia. Global Engage. Kuala Lumpur Malaysia. 2016: 22-23 August.

An incremental adoption of the technology and systems should be considered versus an accelerated rollout. Incremental adoption was the process for University of Pittsburgh Medical Centre where 20-30% of the cases of a certain type of specimen were used, which happened to be gastrointestinal endoscopic biopsies.

20. Thorstenson S et al. Implementation of large-scale routine diagnostics using whole slide imaging in Sweden: Digital pathology experiences 2006-2013. J Pathol Inform. 2014. 5: 15

Recent validation studies and CAP recommendations (Refer to Module Quality and Compliance - Verification and validation) suggest diagnostic concordance should be established between digital and glass slides for the same observer.

45. Pekmezci M et al. Pitfalls in the use of whole slide imaging for the diagnosis of central nervous system tumours: A pilot study in surgical neuropathology. J Pathol Inform. 2016. 7: 25.

A tendency has been observed that in general the digital system is more favourable for low magnification tasks rather than for high magnification work. Experienced pathologists would have an easier transition to digital work since they are generally able to diagnose cases at a lower magnification level.

20. Thorstenson S et al. Implementation of large-scale routine diagnostics using whole slide imaging in Sweden: Digital pathology experiences 2006-2013. J Pathol Inform. 2014. 5: 15

Situations have been identified that have raised concern regarding digital microscopy and intraobserver discordance rates and these include:

  1. difficulties in identifying mitotic figures in WSI and under-grading in primary diagnosis of surgical neuropathology cases

    45. Pekmezci M et al. Pitfalls in the use of whole slide imaging for the diagnosis of central nervous system tumours: A pilot study in surgical neuropathology. J Pathol Inform. 2016. 7: 25.

  2. loss of nuclear details and distortion of the chromatin pattern with erroneous impression of dysplasia in Barrett oesophagus and cervical squamous dysplasia

    45. Pekmezci M et al. Pitfalls in the use of whole slide imaging for the diagnosis of central nervous system tumours: A pilot study in surgical neuropathology. J Pathol Inform. 2016. 7: 25.

    46. Snead et al. Validation of digital pathology imaging for primary histopathological diagnosis. Histopathology. 2016. 68: 1063-1072.

  3. helicobacter-positive gastritis was missed because the organisms were only visible when scanned at x60 magnification or require z-plane focusing

    45. Pekmezci M et al. Pitfalls in the use of whole slide imaging for the diagnosis of central nervous system tumours: A pilot study in surgical neuropathology. J Pathol Inform. 2016. 7: 25.

    48. Kalinski T et al. Virtua; 3D microscopy using multipane whole slide images in diagnostic pathology. Am J Clin Pathol. 2008. 130: 259-264

  4. intensity of red colour not as strong in periodic acid Schiff-diastase stain for fungi, and Ziehl-Neelsen stain in mycobacteria

    46. Snead et al. Validation of digital pathology imaging for primary histopathological diagnosis. Histopathology. 2016. 68: 1063-1072.

  5. identifying bacteria, small cell carcinoma and granulocytic inflammatory cells best performed by scanning slides at x60 magnification

    46. Snead et al. Validation of digital pathology imaging for primary histopathological diagnosis. Histopathology. 2016. 68: 1063-1072.

    41. Bauer TW et al. Validation of whole slide imaging for primary diagnosis in surgical pathology. Arch Pathol Lab Med. 2013. 137: 518-524

  6. examination of ulcer bed

    49. Ito T. Lecture: Validation of whole slide imaging. Digital Pathology Congress: Asia. Global Engage. Kuala Lumpur Malaysia. 2016: 22-23 August

  7. 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

  8. renal biopsies even when scanned at x60 can be difficult to interpret subtle features of membranous change

    46. Snead et al. Validation of digital pathology imaging for primary histopathological diagnosis. Histopathology. 2016. 68: 1063-1072.

  9. such specific situations from the literature, relating to digital diagnostic error need to be tabulated and addressed.

    46. Snead et al. Validation of digital pathology imaging for primary histopathological diagnosis. Histopathology. 2016. 68: 1063-1072.

  1. Objective

    To understand the principles for professional practice, training and competency to consider when implementing digital microscopy in the workplace for diagnostic use in histopathology and cytology.

  2. Knowledge

    Section 1: Professional Development Activities

    Outcomes: Understand the principles and importance of professional development activities to consider when implementing digital microscopy for diagnostic use, such as:

    1. Pathologist participation in Internal Quality Assurance (IQA) and External Quality Assurance (EQA), and Continuing Professional Development (CPD);

    2. The initial double-up of conventional and digital processes.

    Section 2: Professional Practice

    Outcomes: Understand the principles of professional practice to consider when implementing digital microscopy for diagnostic use, such as:

    1. Human resourcing;

    2. Handling of peer reviews or second opinions.

    Section 3: Training and Competency

    Outcomes: Understand the principles and importance of training and competency to consider when implementing digital microscopy for diagnostic use, including:

    1. Appropriate training from vendor;

    2. Proficiency in using digital slides;

    3. Credentialing of pathologists;

    4. Certifications of scientists and technicians;

    5. CPDP and IQA activities;

    6. Adherence to supervision and accreditation requirements.

  3. Behaviours

    Practices the fundamental principles of digital microscopy.

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