Table 1

Key aspects to consider for digital pathology accreditation change control

ProposalA proposal must be discussed and agreed by management, including the clinical lead
A person should be identified to act as ‘change lead’
The implementation must be fully costed and agreed with the service manager
All stakeholders should agree on a date on which the proposed change will become routine
Health and safetyAll relevant health and safety checks should be completed before implementing digital pathology
The scanner installation site in the laboratory needs to be identified, and adequately assessed
A display screen equipment risk assessment must be completed before users begin their training/validation
Validation and verificationAn in-house evaluation of real-world scanner performance should be completed and can be compared against manufacturer’s data
A suitable electronic location needs to be identified to store all in-house evaluation data
EQAThe quality manager must be informed of any changes that are to be made
Any EQA schemes should be identified and registered for, with an exchange agreement set up
If there are no EQA schemes available, then an internal alternative can be used
IQAThe process for internal quality control should be identified including justification and frequency of performing IQA
Any calibration materials used for example, slides or software should be documented
Laboratory ITFull end-to-end user acceptance testing should be completed on any new software introduced as part of the digital pathology implementation
Any changes to existing laboratory software, for example, Laboratory Information Management System should be completed before digital pathology becomes routine
SOPsAll SOPs should be written and uploaded to a quality management system
A training and competency record should be created based on the SOPs and uploaded to a quality management system
TrainingAll staff members should receive training on how the new digital pathology process will work in the laboratory
Super-users should be identified and given in-depth training in order to troubleshoot and deal with problems
CommunicationThe department must be updated on any changes to current processes, and briefed on anticipated user impact and implementation timelines, including timelines of implementation and impact to users
  • EQA, external quality assurance; IQA, internal quality assurance; SPOs, standard operating procedures.