The UK Core Hazard Log is a mechanism for recording and communicating the on-going identification and mitigation of hazards associated with HL7 FHIR® UK Core R4. It is organised so that it enables a systematic approach to the management of hazards and supports the effective collation of safety case evidence. Such on-going revisions will:
The Hazard Log is a living document and continues to be updated during the lifecycle of the UK Core.
Each version of the Hazard Log has to be reviewed and approved by the Clinical Safety Officer to signify that the clinical safety information recorded is accurate and appropriate.
To make software clinically safe, clinical risk management standards must be met which have been established in law through the Health and Social Care Act 2012.
There are two clinical risk management standards:
The standards ensure potential clinical hazards are identified and suitable mitigations are put in place to minimise associated clinical risks.
This UK Core hazard log records generic hazards separated into:
A nominated Clinical Safety Officer (CSO) is responsible for making sure that these clinical risk management requirements are effectively met.
| Likelihood | Very High | 3 | 4 | 4 | 5 | 5 |
| High | 2 | 3 | 3 | 4 | 5 | |
| Medium | 2 | 2 | 3 | 3 | 4 | |
| Low | 1 | 2 | 2 | 3 | 4 | |
| Very Low | 1 | 1 | 2 | 2 | 3 | |
| Minor | Significant | Considerable | Major | Catastrophic | ||
| Consequence |
| Risk Rating | Definition |
|---|---|
| 5 | Unacceptable level of risk. |
| 4 | Mandatory elimination or control to reduce risk to an acceptable level. |
| 3 | Undesirable level of risk. Attempts should be made to eliminate or control to reduce risk to an acceptable level. Shall only be acceptable when further risk reduction is impractical. |
| 2 | Acceptable where cost of further reduction outweighs benefits gained. |
| 1 | Acceptable, no further action required. |
| Likelihood Category | Interpretation |
|---|---|
| Very High | Certain or almost certain; highly likely to occur |
| High | Not certain but very possible; reasonably expected to occur in the majority of cases |
| Medium | Possible |
| Low | Could occur but in the great majority of occasions will not |
| Very Low | Negligible or nearly negligible possibility of occurring |
| Consequence Category | Consequence | Patients Affected |
|---|---|---|
| Catastrophic | Death | Multiple |
| Permanent life-changing incapacity and any condition for which the prognosis is death or permanent life-changing incapacity; severe injury or severe incapacity from which recovery is not expected in the short term | Multiple | |
| Major | Death | Single |
| Permanent life-changing incapacity and any condition for which the prognosis is death or permanent life-changing incapacity; severe injury or severe incapacity from which recovery is not expected in the short term | Single | |
| Severe injury or severe incapacity from which recovery is expected in the short term | Multiple | |
| Severe psychological trauma | Multiple | |
| Considerable | Severe injury or severe incapacity from which recovery is expected in the short term | Single |
| Severe psychological trauma | Single | |
| Minor injury or injuries from which recovery is not expected in the short term. | Multiple | |
| Significant psychological trauma | Multiple | |
| Significant | Minor injury or injuries from which recovery is not expected in the short term | Single |
| Significant psychological trauma | Single | |
| Minor injury from which recovery is expected in the short term | Multiple | |
| Minor psychological upset; inconvenience | Multiple | |
| Minor | Minor injury from which recovery is expected in the short term; minor psychological upset; inconvenience; any negligible consequence | Single |