Key aspects to consider for digital pathology accreditation change control
| Proposal | A 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 safety | All 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 verification | An 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 | |
| EQA | The 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 | |
| IQA | The 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 IT | Full 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 | |
| SOPs | All 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 | |
| Training | All 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 | |
| Communication | The 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.