The Safety Management Approach in NHS Connecting for Health

1
The Safety Management Approach in NHS Connecting
for Health

• Dr. Maureen Baker CBE DM FRCGP
• Special Clinical Adviser NPSA
• Clinical Safety Officer CfH

2
Background June 2004

• NPfIT currently not
• Formally incorporating safety as a benefit to
  drive the programme
• Formally risk assessing systems and processes
• Formally risk assessing solutions to ensure no
  new risks introduced
• Relying on those involved to instinctively
  address patient safety

3
The conclusion

• NPfIT not addressing safety in an explicit,
  proactive, structured and robust manner and.
• Other industries would!

4
NPfIT Action

• Work in partnership with NPSA to address safety
  concerns
• Safety Management Approach evolved in workshops
  Autumn 2004
• Agreed with and supported by NPSA
• Presented to National Programme Board Dec 2004
• Implemented January 2005

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Aims of Safety Management Approach

• To deliver IT systems which improve clinical
  safety.
• To provide suppliers with an easy to use and
  robust safety management system.
• To provide Trusts with assurance and clear
  guidance on the actions they need to take to
  ensure systems are deployed in an effective and
  safe manner.

6
IEC 61508

• HSE standard for safety integrity of electronic
  safety related systems
• Voluntary standard (but ignoring standard might
  be seen as not doing all that is reasonably
  practical and a failure to show due diligence
• Safety management approach built round IEC 61508
• CfH and NPSA in discussion with ISB re
  interpreting IEC 61508 for health sector

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Requirements

• All CfH products and every request to connect
  with spine must have
• End-to-end hazard assessment
• Safety case
• Safety closure report
• Must have clinical authority to deploy (issued
  by Maureen Baker or Sir Muir Gray) before
  products can be accepted into integration testing
  and deployment

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NHS Connecting for HealthSafety Management
Approach

• Weekly safety group
• Clinical Risk and Safety Team - monthly
• NPSA secondment as NHS Connecting for Health
  Clinical Safety Officer
• NPSA input to both weekly and monthly meetings
• Clinical Safety Officer employed by and
  accountable to NPSA

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Clinical Safety Organisation
NHS CfH Programme Board
10
Clinical Safety Lifecycle

• Software focused
• 7 phases
• Hazard assessment, Safety Justification, Design
  Development
• Integration Test, Assurance (ITB)
• Deployment, Operations (ITIL Service
  Management)
• Safety - Embedded in processes and endemic in
  culture

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Accredited Clinicians Programme

• Aimed clinicians involved in developing and
  testing of NHS Connecting for Health
• Clinicians must be registered professionals
• Clinicians must have minimum 5 years clinical
  experience
• Clinicians must have legitimate relationship with
  NHS Connecting for Health or contractor
• System of provisional/full accreditation
• Training provided by NHS Connecting for Health in
  association with the NPSA

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Key Messages

• Patient safety requires an integrated approach
• Safety is embedded in processes from
  specification to implementation
• All staff have a role to play
• Safest organisations self-reflect on their
  progress