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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
Outline
Principles of Successful Reporting

Purpose
Processes
Implementation
Data highlights
Global initiatives

Incident Management
Purposes of Reporting
learn
improve
prevent recurrence
Incident Occurs
Escalation and submission
Risk Rating & Reporting
providers involved
+ site manager
secure safety of client
daisy smith
Client Safety
Escalation
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
Progress
Shortcomings
System implementation
Increase in global reporting, 2013 - 2015
Increased adherence to deadlines
Initial notification (24hrs)
2014
Investigation & Supporting docs (30 Days)
2014
Q1&2 2015
Global Initiatives
Improve data quality
Version 2.0
CLIENT SAFETY
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
Investigation
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
2014
2015
Data Quality!
Evidence to Action
Safety alerts
Support to programmes
Protocol development
CSM Conference 2015
Full transcript