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Incident Management 2015 [Lunchtime Talk]

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Medical Development Team

on 29 February 2016

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Transcript of Incident Management 2015 [Lunchtime Talk]

Outline
Principles of Successful Reporting

Purpose
Processes
Implementation
Data highlights
Evidence to action

Incident Management 2015
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
Red incidents: reported to MDT London.

Green & Amber incidents: investigated through local procedures.
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
Evidence to Action
gLOBAL aNALYSIS & ACTION
Next Steps
CLIENT SAFETY
Version 2.0 of Incident Management System
Training packages
Marie Stopes
Other gaps
Safety alerts
Support to programmes
Protocol development
Identified need for quality data (Ops review)
Increase in Countries Reporting
no reporting
Channels not reporting (SF)
Product-related incidents
Goals of Reporting at MSI
Investigation
Incident Reporting process
Opportunities for Improvement
Leadership buy-in
Increase MA support to CPs
Increase use of available data
Attitudes & accountability

msi root cause analysis
Q1&2 2015
Late Reporting
Initial notification (24hrs)
Investigation & Supporting docs (30 Days)
Q1&Q2 2015
2015 updates
QTA Checklist indicators
Tools
Monthly Incident Data Reports
What do we look for?
When is a case "closed?"
What have we noticed?
What actions have we taken?
Data Availability
Quarterly Reporting through Ops
Data highlights
MDT Agreement with Programme Investigations
Types of Incidents: Service Type and Incident Causation
Incidents by Programme
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
Inside the Panel Meetings
PRIF
Internal Processing Form
Product-Related Incidents
unanticipated event
contraceptive products
Misoprostol, mifepristone, MSI-branded products
MSI GP&L procured
Full transcript