Ensuring Safety of CFH PACS Systems

Tony Newman-Sanders

National Clincial Advisor, CFH PACS Programme

Overview

• 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 andmanagement of patient-related risks; the reporting and analysisof incidents; and the capacity to learn from and follow-up onincidents and implement solutions to minimise the risk of themrecurring.

• 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 SeveritySeverity

CategoryQualitative 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 Extra observation or treatment. Minimal harm.

Negligible 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

per patient year

Occasional One in 10 years to 1 in 100 years for GP

4

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

1

L

I

K

E

L

I

H

O

O

D

>1:10 per patient year 7 M H H H H H1:10 – 1:100

per patient year6 M M H H H H

1:100 – 1:1000

per patient year5 L M M H H H

1:1000 – 1:10,000

per patient year4 L L M M H H

1:10,000 – 1:100,000

per patient year3 L L L M M H

1:100,000 – 1:1,000,000 per patient year

2 L L L L M M

< 1:1,000,000

Per patient year1 L L L L L M

Patient Safety

Risk Matrix

A B C D E F

Very Low

Low Moderate Severe Major/

Fatal

Catastrophic

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 – Board/Clinical Governance Committee– Risk Management– PACS Project Board– Clinical Director Radiology

Clinical Safety Organisation

NHS CFH Programme BoardChief Clinical Officer, Prof Michael Thick

NHS CFH Clinical Risk and Safety Team.Chair, Maureen Baker National Clinical Safety Officer

Clinical ExpertsProject

Safety OfficerTechnical Assurance

Test Manager

Clinical Risk and Safety BoardChair; NHS Trust Cinical Director

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

• 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

NHS Connecting for Health is delivering the National Programme for Information TechnologyNHS Connecting for Health is delivering the National Programme for Information Technology

Clinical Risk Process

Go Live

Initiation complete

Model Communities

test

Scalability

RFO

Integrationtest

Systemtest

ModuleTest

Detailed DesignR

eg

ression

test as re

quire

d

Draft Patient Safety assessment

Hazard Log (1)

Patient Safety assessment Version 1

Patient Safety assessment +Relevant measure

Hazard Log (2)

ITERATIVE PRODUCT –REVIEWED AT EACH STAGE

RISKS REVIEWED ANY NEW RISKS INTRODUCED

RISKS MITIGATED AT EACH REVIEW

Hazard Log (9)

LOG HANDED OVER TO TRUST SAFETY OFFICER TO ADDRESS ANY OUTSTANDING

IMPLEMENTATION ISSUES

SafetyClosure

report

Clinical Authority to release

InitialDesign

Scope

SafetyCase

Clinical Safety Certificate

Patient Safety Assessment Workshop

• The key input to the workshop is the PID.

• Attendees typically include: • 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

• 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

• Hazards in 4 main categories

– End to End Clinical Process

– Message Risk– Technical Risk– Patient Safety Risk

• NHS Connecting for Health’s ‘Hazard Checklist’

• Hazard Log• 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• 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• 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

• MPR annotation

• Radiation Dose

• Southern Cluster Archive

• Patient Record merge/misassignment

• Plymouth deployment.

• Clinical Safety Reporting Procedures