UK Core Hazard Log

Introduction

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:

  • DCB0129 is for organisations building software
  • DCB0160 is for care organisations that are deploying and using software

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.


Risk Matrix

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

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.




Interpretations

Likelihood Interpretation

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 Interpretation

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
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