3/31/2011
Lessons from NHS Connecting for
Health
Dr. Maureen Baker CBE DM FRCGP
Clinical Director for Patient Safety
NHS Connecting for Health
Stuart Harrison, Senior Safety Engineer
NHS Connecting for Health
Overview
• History / Background
• NPSA Report, Report Findings & Conclusion
• Action Taken & Second NPSA Report (2006)
• Clinical Safety Management System (CSMS)
• Organisation, Operational Layout, Requirements &
Content
• NHS & IEC Standards for Clinical Safety
• Lessons Learnt
• Conclusion & Key Metrics
• Q&A
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NPSA Report
• Commissioned 2004 by Deputy Chief Medical Officer
(DCMO)
• Conducted by NPSA Risk Advisor
Report Findings
• Not identifying safety as a benefit to drive the
programme
• No formal risk assessment
• No formal clinical safety management system
• Reliance on clinicians to instinctively address patient
safety problems
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Report Conclusion
• NPfIT not addressing safety in structured, pro-active
manner and other safety critical industries would
Action Taken
•
Appointment of National Clinical Safety Officer (seconded from
NPSA)
•
Implementation of Clinical Safety Management System (CSMS)
•
Adoption of principles of IEC 61508
• Patient Safety Assessment
• Safety Case
• Safety Closure Report
•
Accredited clinician training
•
Governance Structure
• Clinical Safety Group
• Clinical Risk and Safety Board (quarterly)
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Second NPSA Report (2006)
Major findings: • Pro-active actions and progress made by NHS CFH to
put in place systems and processes to address patient
safety in the NPfIT in an explicit, proactive, structured
and robust manner
• Gaps (opportunities for further improvement) where
further development will enhance the effectiveness and
efficiency of the NPfIT helping the NHS realise patient
safety benefits
• Recommendations for NHS CFH’s consideration,
aimed at realising the opportunities for improvement
identified
• On-going improvement opportunities
Standards for Clinical Safety in IT
Systems
•
DSCN14/2009
• NHS ISB Health approved (hence link to the common
assurance process)
• Applies to the NHS in England and Wales (may be taken up by
the other countries)
•
•
ISB 0160 Health Informatics — Application of clinical risk management to the manufacture of health software (formerly ISO/TS
29321:2008(E)) – DSCN14/2009
DSCN18/2009
• Guidance for health organisations ‘how to’ monitor the
manufacturer’s DSCN
• Advises on how health organisations set up a Clinical Risk and
Safety Management system
•
ISB 0129 Health informatics - Guidance on the management of clinical risk relating to the deployment and use of health
software (formerly ISO/TR 29322:2008(E)) - DSCN18/2009
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IEC 80001
• Joint IEC/ISO standard on integration, strongly
supported by FDA
• Increasingly the case that medical devices not standalone
• Standard is on safety, security and effectiveness of
integration of medical devices with health IT
• Standard published September 2010
• Sub-group writing guidance for Healthcare Delivery
Organisations - chaired by Dr. Maureen Baker
Organisation Chart
Paul Jones
NHS Chief Technology officer
Dr. Charles Gutteridge
National Clinical Director for
Informatics
Rob Shaw
Director - NICA
Dr. Maureen Baker
Clinical Director, Patient
Safety
S. Harrison
Senior Safety Engineer
N. Young
NICA Help Desk Supervis or &
Defect Manager
N. Watts
Clinical Safety Analyst
L. Young
Help Desk Analyst
M. Anderson
Senior Safety Engineer
(North)
F. Brindley
Safety Engineer
Clinical Safety
Officers
J. Taylor
Programme Manager
C. Ranger
Partnership Manager
Project Lead
(CFH/NPSA)
S. Alexander
CSO
G. Ahmed
Project Manager
K. Tow nsend
Business Manager
J. Doris
CSO
R. Addams
PSO
A. Ellis
Safety Engineer
B. Scott
CSO
N. Oughtibridge
Technical Content Manager
Data Standards
S. White
Safety Engineer
J. Fox
Quality & Safety
Engineer
L. Olow osuko
Clinical Safety Analyst
Tbc (vacant)
CSO
D. Hay
Senior Standards Consultant
Data Standards
SHA CSOs
(10 Nationally)
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CSMS Business Overview
CCN61
CFH
Draft SHA Manual
Supplier
SHA
Policy and
Objectives
DSCN14
CSMS
DSCN18
CSMS
Process / Procedures
Training
Work Instructions / Templates / Forms / Guides
NAO
International Stds
CSMS
Trust
NPSA
Sub-contractor
CSMS
Documentation / information flow
Software Lifecycle
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Clinical Safety Management
•
•
•
•
•
•
All assurance activities require 3 deliverables during the project
lifecycle:
• Patient Safety Assessment [end-to-end]
• Safety Case
• Safety Closure Report
Guidance provided, but no set format
All valid risk management methodologies accepted
Documents are signed off by suitably trained and experienced
clinicians
Review of documents by NHS CFH Clinical Safety Group
[Clinicians and Engineers]
Certificate of Authority to Release [CATR] provided if
documentation approved
Lessons Learnt
• The use of a safety case is appropriate
• Endorsed by no serious incidents to date
• Proactive approach using safety incident management
process as a reactive element
• Not an onerous process
• Implementation and take up from Manufacturers has
its problems
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Metrics
•
Over 250 CATR’s issued
•
755 Safety Incidents reported
•
Choose & Book
• To date 24 million patient referrals, approx 500,000 referrals a
month from GP practices
• 140,000 additional patient referrals being booked per month
to other services, such as those run by Allied Health
Professionals, Community Services and Diagnostic Services
•
Electronic Prescription Service - EPS Release 2 will be
implemented at different times over a considerable period in the
19,000 GP practices, community pharmacies and dispensing
appliance contractors throughout England
Metrics
• GP2GP - Latest deployment statistics
• 5,046 GP practices have had technical upgrades to
connect to the new system
• 60% of these GP practices are now actively
operating GP2GP
• 428, 570 electronic health records have been
transferred to date
• 152 PCTs with eligible GP practices are currently
involved in the roll-out
• On average, 10,000 GP2GP transfers are being
completed every week
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Q&A
Any questions?
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