12 Summary Safety Statement (page 41 of 18) in Clinical Safety Case Report (chapter 3 of 5) within Core Information Standard: Reports

Thirty-seven potential hazards were identified. All hazards were identified through the consultation processes carried out to assure the PRSB Core Information Standard or the Digital Social Care Information products that form part of the updated CIS; developed to underpin and support the implementation and use of LCRs. The original and subsequent consultation processes are described in detail in the Core Information Standard and Digital Social Care Information final project reports respectively and section 6 of this document. The consultations included patient and carer representatives as well as professionals from Royal Colleges, specialist societies, allied health professions, health informatics professionals, pharmacists, local authority and care home representatives and vendors.

During the consultations, hazards were identified, reviewed and mitigations/actions considered. Nevertheless, some risks are inherent in the standard, but most have been:

(A) mitigated by the development of the standard (B) or the residual risk has been transferred (with guidance) to the implementers.

It is worth drawing attention to two groups of hazards. Issues with the data generally and issues with specific sections of the data. In terms of the first of these, data may be absent, incorrect, conflicting, or present but not found. These hazards are all dependent on the design of the shared record system.

Allergies, Medications, Problems and Diagnoses, Care plans and Alerts are all sections where it was felt to be worth highlighting the hazards specifically. In some cases, further work needs to be done to define the content or ensure the different way in which the data is represented in different systems is fully understood and correctly mapped to the CIS. For instance, Primary Care systems do not specifically define a diagnosis in their information models and Diagnoses tend to be used rather differently in primary and secondary care. The alerts section has been designed to hold a limited range of specific alerts and exactly how it is designed to work in particular systems will need to be conveyed in training.

The section Pregnancy status is designed to alert users to whether a patient is currently pregnant. It seems unlikely that this information can be reliably imported from a single system and so, is likely, to be a calculated field. This is unique in this model and may be defined as a medical device, for which separate safety assessment and registration will be required. System manufacturers will need to consider this.

The hazard log (a separate document) provides guidance for system developers and implementers. It is important that this guidance in relation to those hazards, regarded as system issues, become requirements for implementation.

Most hazards are rated as a risk acceptability level of 2. This level is tolerable where cost of further reduction outweighs benefits gained. But should nevertheless be considered by those deploying the standard. The six with a residual risk at level 3 have been described in section 9. The mitigations for the level 3 risks are outside the control of PRSB and these risks are therefore transferred to the system developers and deployers of this standard. Level 3 risks are defined as “An Undesirable level of risk. Attempts should be made to eliminate the hazard or implement control measures to reduce risk to an acceptable level. Shall only be acceptable when further risk reduction is impractical”.