Quality and Compliance

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

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.

Final approval of validation must be documented and signed by the supervising pathologist.

The record of validation method, test results and final approval must be documented and comply with accreditation standards (including NATA).

Component Processes
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

(NOTE: CAP recommends a washout period of 2 weeks)

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.

Tests themselves are said to be validated after all the individual performance claims appropriate for the clinical application are validated. These performance claims include analytical bias, reproducibility, suitability of specimen types and turnaround times. Performance claims also include accuracy of individual measurements (tumour size) and the accuracy of the diagnosis itself.

Reporting outside the laboratory is particularly relevant regarding the use of portable devices. The College recognises that there are occasions when Fellows may wish to report on anatomical pathology specimens from outside the main laboratory. This includes, but is not limited to, pathologists reporting from home..

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:

  1. Off-site reporting must not be greater than 50% of a pathologist’s practice.

  2. 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:

    1. infrastructure (suitable microscope and adequate lighting),

    2. resource materials (books and internet references), and

    3. access to the laboratory database for checking previous pathology patient data.

  3. The off-site work set-up must comply with Workplace, Health and Safety requirements.

  4. The off-site work area and the pathologist must be accessible to NATA/RCPA assessors performing accreditation visits.

  5. Confidentiality of all patient related materials such as slides, request forms and other health record documents must be maintained at all times.

  6. 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.

  7. The pathologist reporting off-site must be available to the requestor for consultation about cases on which they have reported.

Whilst this policy relates to Australian circumstances, it is considered that the same principles should apply in other jurisdictions.

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.

Bauer et al developed a validation study to support the intention to use WSI for primary diagnosis in both specialty and general surgical pathology practices. The study was to test the hypothesis that interpreting with WSI was not inferior to interpreting with light microscopic slides.

The intended use and procedures for the digital microscopy system must be clearly defined and documented for:

  1. workflow and equipment operation.

  2. quality control activities, including:

    1. image quality standards for image resolution, colour depth, scan rate, barcode read rate and display response time,

    2. use of system tests and calibration tools to measure image quality (if applicable).

  3. business continuity during mechanical or communication downtime. This may include steps to revert to conventional diagnostic microscopy in the event of equipment failure.

  4. the backup and archive of data.

The procedures should be evaluated and updated as required when:

  1. new major releases of software and/or hardware are released,

  2. changes are made to associated standards such as DICOM and HL7,

  3. changes are made to compliance regulations such as NPAAC, national or state Privacy legislations, TGA medical device regulations or NATA.


Equipment:
  1. Vendors should provide information and training on the supplied system tests and calibration tools.

  2. The manufacturer must provide adequate labelling, including on equipment warning labels/instructions, and operation and maintenance manuals.

  3. The laboratory should have an understanding of the technical support requirements for the operation of the digital microscopy system including networking, interfaces and operating systems.

  4. The laboratory should have a service agreement in place with the manufacturer or designated support agent, which will cover routine maintenance and breakdown of equipment.

  5. There should be a documented routine maintenance plan for the equipment.

  6. There should be a log to document all maintenance performed for the life of the equipment.

An ongoing audit, issues and root cause analysis framework must be part of the laboratory quality control program. Examples of issues that need to be documented include:

  • data integrity issues (such as incorrect or incomplete patient metadata in digital microscopy system, and incorrect or incomplete report data in LIS after transmission),
  • quality issues (such as poor/inconsistent staining, slide damages, and incorrect/incomplete transmission errors),
  • Performance issues (such as high barcode error rates, scan rates, poor display response times, and network performance issues),
  • mechanical malfunctions and unanticipated errors, and
  • system and software crashes and unanticipated errors messages.

When implementing digital microscopy systems for diagnostic use, the laboratory must ensure they comply with all national / state regulatory and governing bodies (for examples NPAAC, NATA, and TGA), and Commonwealth, State and Territory privacy legislations, especially in regard to:
- storage and retention of digital slides and associated metadata,
- security,
- privacy,
- communication messaging,
- audit trail.

The manufacturer of the digital microscopy system must comply with all relevant national / state regulatory and governing bodies for a medical device; and Commonwealth, State and Territory privacy legislations.

Useful websites
The following websites may provide helpful information regarding legislation and accreditation requirements:
1. Australian Government Legislation

2. State Based Legislation:

3. Other

  1. Objective
    To understand the best practice principles of quality and compliance when implementing digital microscopy in the workplace for diagnostic use in histopathology and cytology.

  2. Knowledge
    Section 1: Verification and Validation
    Outcomes: Understand the principles and importance of verification and validation when implementing digital microscopy for diagnostic use, such as:

    1. Verify performance in accordance with the manufacturer’s specification;

    2. Validated performance meets the intended use and process;

    3. The record of validation method, test results and final approval must be documented and comply with accreditation standards;

    4. Final approval of validation must be documented and signed by the supervising pathologist.

    5. Each pathologist must be given an adequate transition period between using conventional and changing to digital microscopy for diagnostic use with sufficient time for doubling up.

    Section 2: Quality Management
    Outcomes: Understand the principles and importance of quality management when implementing digital microscopy for diagnostic use, such as:

    1. Intended use and procedures clearly defined;

    2. Vendor and manufacturer information, training and support provided;

    3. Service agreement;

    4. Maintenance plan and log;

    5. Ongoing audit, issues and root cause analysis framework.

    Section 3: Regulations and Compliance
    Outcomes: Understand the principles and importance of regulations and compliance when implementing digital microscopy for diagnostic use, including:

    1. Laboratory compliance with national and state regulatory and governing bodies;

    2. Laboratory and manufacturer compliance with Commonwealth, State and Territory privacy legislation.

  3. Behaviours
    Practices the fundamental principles of digital microscopy.

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