A day in the life of a Clinical Safety Officer

- 12 March 2024

Dave Sherwood, Doc-works Director of Clinical Safety and Quality, shares some of his day to day roles and responsibilities.

Clinical Safety Officers (CSOs), particularly where Health Information Technology (HIT) vendors are seeking to sell their products to the NHS in England must satisfy the Digital Technology Assessment Criteria (DTAC) including DCB0129.

The Clinical Safety Officer is accountable for clinical safety ensuring that effective clinical risk management is carried out by organisations that are responsible either for manufacturing or deploying health IT systems. The Clinical Safety Officer is an expert in areas relating to the assurance of Health IT in scope of the two Clinical Safety standards: DCB0129 and DCB0160.

As the CSO for Doc-works I am responsible for maintaining the Clinical Risk Management folders for all the products that Doc-works develop and market as software as a service to customers in the NHS. The main documents in the clinical risk management folder are the Clinical Safety Case Report, Clinical Risk Management Plan, Hazard log and incident log.

The task is to ensure that any changes to the software, including updates are assessed for  risk to patients. If the change or update has new functionality that could potentially cause patients harm or put them at risk then a hazard workshop should be convened to review the processes and identify risks, hazards and any mitigations. There may be existing mitigations and there may be some new ones that can be implemented prior to release. After each risk has been evaluated, mitigations applied and re-evaluated then the final risk score needs to be within the acceptable range agreed in the clinical risk management plan. This is then shared with the customers for consideration in their DCB 0160.

Doc-works recently held a hazard workshop for the new Personal Demographic Service look-up functionality added to the Scribe ePCR product. The workshop was convened following the CSO’s preparation work to create a step by step process flow and use cases that the workshop could use to evaluate the risk to patients at each stage of the process. In attendance at the workshop were three customers, Doc-works staff including the Chief Technical Officer, developers and the Scribe Product Services Manager. One of the customers in attendance was the organisations CSO.

Each process was analysed for risks and each of the identified hazards was then risk rated and any existing mitigations reviewed. If following the review, the new risk score was not within acceptable range then any new mitigations were sought and applied to reduce the risk to within acceptable levels. Three hazards were identified, two reduced to acceptable levels following the review of existing mitigations and the third following a small upgrade to the software prior to release. All documentation, hazard log and clinical safety case reports were updated and sent to all customers.

The clinical risk management folder is available to all Doc-works staff in a green identifiable folder in the companies shared file system. As CSO I attend all the management meetings and update the team on any new or emerging clinical news that may affect our current or future roadmap products so as to ensure that patient safety is always in the Doc-works staffs mind throughout their working day.