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Incident Management 2015 [CSM]

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Medical Development Team

on 29 February 2016

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Transcript of Incident Management 2015 [CSM]

Unexpected events
Contraceptive products - LARC failures
MA drugs - misoprostol, mifepristone (>2/10)
MSI-branded or procured products
20 programmes have reported ZERO red incidents in 2015

9 programmes have reported ZER0 red incidents since 2012
Principles of Successful Reporting

Data highlights
Global initiatives

Incident Management
Purposes of Reporting
prevent recurrence
Incident Occurs
Escalation and submission
Risk Rating & Reporting
providers involved
+ site manager
secure safety of client
daisy smith
Client Safety
Notification Form
Immediate Response
mdt global response
Red incident occurs. MDT notified w/in 24 hours.
Data analysed & learning disseminated.
Investigation & docs submitted w/in 30 days.
MDT Lead reviews documentation
MDT Incident Panel meeting
MDT submits feedback to CP
System implementation
Increase in global reporting, 2013 - 2015
Increased adherence to deadlines
Initial notification (24hrs)
Investigation & Supporting docs (30 Days)
Q1&2 2015
Global Initiatives
Improve data quality
Version 2.0
2016 updates to policy

QTA & IA checklist indicators
Marie Stopes
Other gaps
no reporting
Channels not reporting (SF)
Product-related incidents
Goals of Reporting at MSI
Incident Reporting process
Increase support
Global training packages
MDT Panel feedback
MA support to CPs

msi root cause analysis
Q1&2 2015
Late Reporting
Initial notification (24hrs)
Investigation & Supporting docs (30 Days)
Q1&Q2 2015
Monthly Incident Data Reports
Quarterly Reporting through Ops
Quarterly Review through Operations

Increase use of available data
Data highlights
MDT Agreement with Programme Investigations
Types of Incidents: Service Type and Incident Causation
Incidents by Region
Q1 & Q2 RCA
Summary of 2014 & 2015 incidents
What is a clinical incident?
Key Principles
Trends in Reporting, 2013-2015
Q1&Q2 2015
the client: at the centre of everything we do
Product-Related Incidents
Work-in-Progress: RAG Flowchart
2014 Roll-out Materials
Excel Tools
Roll-out Guides
Data Quality!
Evidence to Action
Safety alerts
Support to programmes
Protocol development
CSM Conference 2015
Full transcript