Transcript Ensuring Safety of CFH PACS Systems

Ensuring Safety of CFH PACS
Systems
Tony Newman-Sanders
National Clincial Advisor, CFH
PACS Programme
Overview
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Some definitions
LSP Contractor Safety
National CFH Safety
Cluster Safety
– National CCN
• Examples
– Clinical Safety Process
Some definitions
• Safety; The process by which an organisation
makes patient care safer.
– It should involve: risk assessment; the identification and
management of patient-related risks; the reporting and analysis
of incidents; and the capacity to learn from and follow-up on
incidents and implement solutions to minimise the risk of them
recurring.
• Hazard; A situation with a potential for human
injury and/or damage to property or the
environment.
• Risk; Combination of frequency or probability
and consequence/impact of a specific
hazardous event.
Hazard Severity
Severity
Category
Qualitative Definition
Catastrophic
This category will also apply to a hazard that causes many occurrences of Major
severity 3 or more fatalities 10 severe 100 Moderate 10000 Negligible
Major/Fatal
Patient fatality. The hazard creates a situation that is inherently and immediately
threatening to a patient’s life. Harm is unlikely to be prevented by Clinician.
This category will also apply to a hazard that causes approx 10 Severe (100
Moderate, 1000 Low etc)
Severe
Permanent or long term harm. The hazard presents a serious and imminent safety
risk to a patient by allowing a life-threatening situation to develop. Harm may
be prevented by Clinician.
This category will also apply to a hazard that causes many occurrences of Minor
severity.
Moderate
The hazard presents a significant risk to a patient, though not one that is
immediately or necessarily life-threatening. Harm is likely to be prevented by
Clinician.
This category will also apply to a hazard that causes many occurrences of Minimal
severity.
Low
Negligible
Extra observation or treatment. Minimal harm.
Minimal extra observation or very minor treatment
Frequency/Probability
>1:10 per patient
year
Frequent
Greater than Once a day
for GP
7
1:10 – 1:100
per patient year
Likely
Once a week to once a
month
6
1:100 – 1:1000
per patient year
Probable
Once a year to one in 10
years
5
1:1000 – 1:10,000 Occasional
per patient year
One in 10 years to 1 in 100 4
years for GP
1:10,000 –
1:100,000
per patient year
Remote
etc
3
1:100,000 –
1:1,000,000 per
patient year
Improbable
etc
2
< 1:1,000,000
Per patient year
Incredible
Less than 1 per 1000 GP
years
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>1:10 per patient year
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1:10 – 1:100
per patient year
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M
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1:100 – 1:1000
per patient year
5
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1:1000 – 1:10,000
per patient year
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1:10,000 – 1:100,000
per patient year
3
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1:100,000 – 1:1,000,000 per patient
year
2
L
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M
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< 1:1,000,000
Per patient year
1
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B
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Very
Low
Low
Moderate
Severe
Major/
Fatal
Catastro
phic
Patient Safety
Risk Matrix
Consequence/Impact
Risk Mitigation
• Terminate
– Avoid or eliminate
– Barriers/Design//training
• Treat
• Tolerate
– Acceptable level of risk
• Transfer
– Insurance
LSP/ Contractors
• Patient Safety predominantly an LSP
responsibility
• CFH main role is Quality Assurance.
• Joint end to end hazard assessment
• Agreeing with LSPs which risks devolve to
Trusts
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Board/Clinical Governance Committee
Risk Management
PACS Project Board
Clinical Director Radiology
Clinical Safety Organisation
NHS CFH Programme Board
Chief Clinical Officer, Prof Michael Thick
Clinical Risk and Safety Board
Chair; NHS Trust Cinical Director
NHS CFH Clinical Risk and Safety Team.
Chair, Maureen Baker National Clinical Safety Officer
Clinical Experts
Project
Safety Officer
Technical Assurance
Test Manager
National CFH Safety Structure
– Chief Clinical Officer - Prof Michael Thick
– National Safety Officer-Dr Maureen Baker
• acts to provide an independent oversight of the NHS CfH
Clinical Safety Management System.
– Clinical Safety Group
• Fortnightly teleconference
– National Integration Centre- Ian Harrison.
• Major technical brief for safety testing
• regularise the testing support process
• facilitates collaboration between the service suppliers
Cluster Structure
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CFH Clinical Lead
PACS Clinical Lead
Clinical Advisory Group
Patient Safety Forum
LSP Safety team
National PACS Safety Lead
Central Change Control Note
(CCN)
• ‘..new policy in relation to Contractors fulfilling
their clinical risk management obligations’
• ‘…to ensure that each Contractor is
implementing a structured and regimented
approach to clinical risk management, and is
regularly monitoring and reviewing its own
activities in this regard.’
• …to set out the Authority's expectations of a
"typical" Clinical Safety Management System,
which is representative of Good Industry
Practice
Clinical Risk Process
Draft Patient Safety
assessment
Scope
Hazard Log (1)
Initial
Design
Patient Safety assessment
Version 1
Regression test as required
Detailed
Design
Module
Test
System
test
Patient Safety assessment +
Relevant measure
Safety
Case
Safety
Closure
report
Integration
test
RFO
Scalability
Go Live
ITERATIVE PRODUCT –
REVIEWED AT EACH STAGE
RISKS REVIEWED ANY NEW
RISKS INTRODUCED
RISKS MITIGATED AT EACH
REVIEW
Model
Communities
test
Initiation
complete
Hazard Log (2)
Clinical
Safety
Certificate
Clinical
Authority
to release
Hazard Log (9)
LOG HANDED OVER TO TRUST SAFETY
OFFICER TO ADDRESS ANY OUTSTANDING
IMPLEMENTATION ISSUES
NHS Connecting for Health is delivering the National Programme for Information Technology
Patient Safety Assessment
Workshop
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The key input to the workshop is the PID.
Attendees typically include:
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Chair: Supplier Clinical Lead
LSP Clinical Safety Manager
NHS CFH Clinical Lead
NHS CFH Release Manager
A representative from NHS CFH Technical
Assurance.
Patient Safety Assessment
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Interviews with appropriate accredited clinicians
Interviews with message analysts
Interviews with technical architects
Comments and observations from the Clinical Safety
Officer at NHS Connecting for Health
• Approved minutes of the ‘Safety workshop’ or overview
of the process which took place to populate the hazard
log
• Names, statements and dates of relevant professional
experience for all participants
• A ‘Hazard Log’ completed using the appropriate template
Patient Safety Assessment
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Hazards in 4 main
categories
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End to End Clinical
Process
Message Risk
Technical Risk
Patient Safety Risk
NHS Connecting for
Health’s ‘Hazard
Checklist’
• Hazard Log
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Raised By (Name / Job Title)
Date Updated
Owner
Type
Functional Area
Summary
Probability (High, Medium,
Low)
Impact (High, Medium, Low)
Rating
Safety Justification
Summary of Actions and
Approvals
Status
Clinical Safety Case
• Inputs
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Patient Safety Assessment
System Specification and Requirements
Systems Design Documentation
Message Implementation Manual
Test Strategy and Plans
Quality Management Documentation
• Structured document
– Risk assessment
– Mitigations
Safety Closure Report
• Input
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Patient Safety Assessment
Clinical System Safety Case
System Specification and Requirements
Systems Design Documentation
Message Implementation Manual
Test Strategy and Plans
• Output- Summarise safety aspects of
– Design and Build
– Subsequent tests
• Not carried out; reasons and mitigations
• Inconclusive tests
Examples
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MPR annotation
Radiation Dose
Southern Cluster Archive
Patient Record merge/misassignment
Plymouth deployment.
Clinical Safety Reporting Procedures