For each Clinical Safety Case (CSC) that we produce, the approach we take can vary depending on the size and complexity of the digital solution.
AutoGrader CSC
The AutoGrader was developed over 10 years ago as a ‘black box’ piece of medical device software as part of the Diabetic Eye Screening (DES) Programme. This CSC is required as part of the meeting regulatory requirements as it qualifies as software as a medical device (SaMD). Aspects on post market surveillance addresses both clinical risk and part of compliance with ISO 13485.
It was scoped as small clinical safety case encompassing the discreet product and addressed basic interfaces with the DES System. It highlights the opportunity to assess the clinical risk profile of a smaller product as part of a larger system, as well as, the desire to clinically assure the other aspects of the system.
New CHI and GPPRS CSC
NHS Scotland implemented a new Community Health Index (CHI) & General Practice Patient Registration System (GPPRS) digital solution in 2023. This was to replace a solution that had served NHS Scotland well for over 30 years. This was a large CSC due to the number of systems that integrated directly with CHI or received updates via Daily Broadcast Files (DBFs). A number of well attended hazard workshops and numerous SME sessions allowed the CSC project team to develop a in-depth understanding of the solution resulting in a comprehensive CSC being developed.
Since handing over the CSC to the CHI Programme there have been several revisits of the CSC prior to go-live and post go-live. This allowed us to reassess each of the hazards as more controls were implemented and supporting evidence provided.
General Practice IT system (GPIT) CSC
The scope for this large CSC covered a number of areas, with particular attention focused on the migration from the EMIS PCS solution to the centrally hosted Cegedim Vision 3 solution. This is a complex migration with a number of third-party tools being utilised to assist with the data mapping and migration of data.
Overall this CSC was delivered in three stages; data migration, Vision 3 hosted solution, ongoing use of EMIS PCS.
SNOMED CT CSC
The SNOMED CT Implementation Programme has been tasked with implementing SNOMED CT as the national clinical coding system across NHS Scotland. SNOMED CT will replace the deprecated READ codes that are still in use within Primary Care in Scotland.
The large CSC covers a number of areas where hazards, associated causes and controls have been identified including the implementation of a new national Terminology Server for Scotland, the service management wrapper for the service and efficient and safe roll out of SNOMED CT within health boards.
As this is a 10+ year programme of work, the CSC will be regularly reviewed to re-assess hazards and identify potential new hazards throughout the implementation and ongoing use of SNOMED CT.