Solution and clinical assurance

Aims:

• clearly defined solution assurance process for the immunisation FHIR® API, with a focus on what will need to be demonstrated
• clearly defined clinical assurance process for the immunisation FHIR API, with a focus on what will need to be demonstrated

Outcomes:

• consumer understanding on WHAT features will need to be demonstrated and HOW the demo will take place for solution assurance sign off
• consumer understanding on WHAT features will need to be demonstrated and HOW the demo will take place for clinical assurance sign off

Following the agreed supplier testing approach we can implement the solution assurance process.

NHS England solution assurance will work with the connecting system team/assurance lead to iteratively review, provide feedback and ultimately approve phases and tasks of the testing approach.

The aim is for the completion of the DOS process which can be completed during the testing lifecycle. It would be expected that the DOS assurance requirements are at least superseded by the supplier testing approach, in which case can contribute as we go to the DOS process.

The clinical assurance activities performed during onboarding aim to ensure that DCB0129 and DCB0160 standards have been complied with, including the existence of the relevant documentation and identified stakeholders from all parties.

NHS England has a Clinical Risk Management Plan (CRMP) and a Clinical Safety Management System implemented. It describes how the Vaccination Digital Services programme conducts clinical risk management to ensure patient safety with respect to services or products provided. Additionally, it ensures that the programme meets the requirements of DCB0129 and DCB0160 where applicable.

Background to clinical safety standards and requirements

Information standards provide the mechanism for introducing requirements to the NHS, those with whom it commissions services and its IT system suppliers. There are two information standards related to patient safety described below. 

These standards can be found at:

• DCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems: This standard sets clinical risk management standards for manufacturers of Health IT systems. It requires the manufacturer to establish a structure within which clinical risks associated with the design and development of a new Health IT system or the modification of an existing system are properly managed. It also ensures that outputs are clearly documented to provide evidence of compliance. Compliance with the standard ensures that the manufacturer has instigated a best practice clinical safety programme during the manufacture of the health IT system

• DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems: This standard requires health organisations deploying and using new or modified health IT systems to have a structure to manage clinical risks associated with that deployment. Many of the requirements in DCB0129 are repeated in DCB0160 for the health organisations.

The Vaccinations Digital Services Programme supports a range of products and services that support the national immunisation initiatives in England. It has articulated with multiple systems and infrastructures public and private in ensuring effective vaccination delivery supporting but not limited to:

• selecting and inviting eligible individuals for multiple vaccination campaigns
• supporting booking capabilities at a national level for selected vaccination campaigns
• accurate capture of immunisation events across multiple systems and platforms
• flow of data for clinical and non clinical purposes to provide up to date accurate information to
• relevant stakeholders
• supporting a national vaccination strategy to improve health outcomes

Whilst the Vaccinations Digital Services programme may not physically be manufacturing the service itself, it may classify as a ‘Manufacturer’ as defined in DCB0129.

Within the safety standard DCB0160 we can also assume partial responsibility in the role of a Health Organisation. This standard is addressed to those persons in Health Organisations who are responsible for ensuring clinical safety in the deployment of Health IT Systems through the application of clinical risk management.

The Vaccinations Digital Services will therefore adhere to all applicable requirements of DCB0129 and DCB0160 in this regard.

The clinical assurance process is integrated with the Digital Onboarding process undertaken by consumers of the API. This is aimed to ensure the onboarding process is made in adherence to the information standards. During the process the relevant information and documentation is shared between parties. Key stakeholders are engaged to ensure accurate reflection of the clinical safety profile.

The risk and hazard profile must be shared between parties with the involvement of the respective Clinical Safety Officers for each organisation. It is the responsibility of each party to perform the clinical risk management activities as defined by the standards in relation to the defined scope and agreed use cases.

For more information, see DCB0129 and DCB0160.