Patient Safety

Competencies

#	Learning outcome	Competency	Action
# 1	Learning outcome 1	Competency Act as Department of Health Central Alerting System responsible officer, including ability to use the national database	Action View
# 2	Learning outcome 1	Competency Act as the Medicines and Healthcare  products Regulatory Agency (MHRA) liaison officer	Action View
# 3	Learning outcome 1	Competency Receive and determine actions associated with a national safety notice	Action View
# 4	Learning outcome 2	Competency Investigate an incident	Action View
# 5	Learning outcome 2,3	Competency Interpret safety alerts and extract key information, such as actions, deadlines and stakeholders	Action View
# 6	Learning outcome 4	Competency Execute root cause analysis on a range of medical device-related incidents	Action View

Assessments

You must complete:

• 2 case-based discussion(s)
• 1 of the following DOPS/ OCEs:

Describe the Institution's approach to the handling of safety alerts. Review current safety alerts on the prevailing national distribution systems	DOPS
Assess technical matters that could impair device efficacy	DOPS
Review a medical device incident & describe the reporting requirements to the Medicine and Healthcare products Regulatory Aency	DOPS
Describe the institutions approach to the handling of safety alerts	DOPS
Execute root cause analysis on a range of medical device related incidents	DOPS
Shadow personnel receiving and determining actions in relation to a number of safety alerts and report to your supervisor the considerations for staff and patient care	OCE
Advise clinical colleagues on policy development to assist clinical governance and patient safety within the organisation	OCE
Discuss with clinical colleagues the circumstances of an incident and attempt to establish the root cause.	OCE

Learning outcomes

1. How to manage and deal with safety alert standards within the organisation
2. Act on notices and identify corrective actions to take
3. Investigate incidents using root cause analysis or equivalent methodologies
4. Advise on policy development to assist clinical governance and patient safety within the organisation
5. Assess technical matters that could impair device efficacy