Refresher Training in Safer Design and - Systems

Transcription

Refresher Training in
Safer Design and
Implementation
Training Course Manual
November 2014
Contents
Module 1 - Course Overview and Introductions
Module 2 - Update of New Clinical Safety Developments
Module 3 - Networking and Sharing Best Practice
Module 4 - Using a Safety Case in Health IT—Practical Example
Open Discussion and Close
Evaluation
 Feedback Form
Programme
Time
Subject
10.00 – 10.15
Coffee and Registration
10.15 – 10.45
Module 1 - Course Overview and Introductions
10.45 – 11.30
Module 2 - Update of New Clinical Safety Developments
11.30 – 13.00
Module 3 - Networking and Sharing Best Practice (Attendees are invited to bring examples of
best practice safety work, these can be presented if desired)
13.00 – 13.45
13.45 – 15.15
Lunch
Module 4 – Using a Clinical Safety Case in Health IT—Practical Example
Including Tea and Coffee
15.15 – 16.00
Open Discussion, Evaluation and Close
16.30
Page 2
Close
Refresher Training in Safer Design and Implementation (Version 3)
Copyright for course materials: Health & Social Care Information Centre
Contact Emails
General Enquiries:
Email: clinical.safety@hscic.gov.uk
Course Presenters:
Jane Doris
Clinical Safety Officer
Health & Social Care Information Centre
Email: jane.doris@hscic.gov.uk
Dr Sebastian Alexander CBE
Interim Clinical Director for Patient Safety
Email: sebastian.alexander@hscic.gov.uk
Dr Maureen Baker CBE
Strategic Safety Adviser
Email: maureen.baker@hscic.gov.uk
Dr Ankur Agrawal
Email: ankur.agrawal@hscic.gov.uk
Page 3
1
Course Introductions and
Overview
Introductions
Aims & Objectives

To build on the outcomes of the awareness training

To share clinical safety updates and new developments

To network and learn from each other

To introduce clinical safety requirements based on
published standards

Evaluation, discussion and close
Page 4
2
Update of New Clinical Safety
Developments
Clinical Safety Developments

New updated ISB 0129 and 0160

Governance of clinical safety work with HSCIC

New clinical safety work

On-going clinical safety work

Clinical Safety Networks
New Updated ISB 0129 and 0160
Page 5
Rationale

An assessment on the effectiveness of the
implementation of the initial version of the standard
was carried out during 2011.

Questionnaire had a low response rate, less than
30%.

72% of responding health organisations had either
not start or had just started to implement DSCN
18/2009.

Cumbersome: too lengthy, taking a lot of time to
read with unrelated commentary.

Verbose: very wordy and difficult to distil the
requirements
Approach
Page 6

The new standards maintain the underlying clinical
risk management principles and requirements in the
original standard but has repackaged them to provide
a succinct set of requirements in plain English– “the
what”.

Each standards is supported by Implementation
Guidance which presents possible ways for achieving
the requirements – “the how”.

The succinct requirements facilitate compliance
monitoring. A spread sheet has been developed to
assist in demonstrating compliance.
Key Changes

Widen the scope to cover the health IT system rather
than just health software.

Affirm the scope of the standard applies in a social care
setting in circumstances where this impacts on the provision of healthcare.

Affirm the role of the Clinical Safety Officer.

Introduce the Hazard Log as an appropriate mechanism
to capture the results of the clinical risk management
analysis, estimation and evaluation activities.

Introduce the need for a defined safety incident management process.

Sponsored, owned and mandated by NHS England.
Page 7

MUST be a suitably qualified and experienced
clinician.

MUST hold a current registration with an appropriate
professional body relevant to their training and
experience.

MUST be knowledgeable in risk management and its
application to clinical domains.

MUST make sure that the processes defined by the
clinical management process are followed.
Updated ISB 0129
The Manufacturer MUST define and document a clinical
risk management process shown in ISB 0129.
Top Management MUST:


Make available sufficient resources.

Assign competent personnel from each of the
specialist areas that are involved in developing
and assuring the Health IT System.

Nominate a Clinical Safety Officer.

Ensure the appropriate levels of authorisation
for the Health IT System are defined.
Manufacturers
Page 8

MUST establish at the start of a project a Clinical Risk
Management File for the Health IT System.

MUST produce at the start of a project a Clinical Risk
Management Plan, which will include risk acceptability criteria,
for the new Health IT System.

MUST establish and maintain a Hazard Log.

MUST develop and maintain a Clinical Safety Case for the
Health IT System.

MUST produce a Clinical Safety Case Report at each lifecycle
phase defined in the Clinical Risk Management Plan.

MUST maintain a Safety Incident Management Log.
Updated ISB 0160
The Health Organisation MUST define and document a clinical
risk management process which recognises the risk
management activities shown in ISB 0160.
Health Organisation Top Management MUST:

Make available sufficient resources.

Assign competent personnel from each of the
specialist areas that are involved in developing
and assuring the Health IT System.

Nominate a Clinical Safety Officer.

Authorise the deployment of the Health IT
System accepting any residual clinical risk on
behalf of the Health organisation.
Health Organisations
Page 9

MUST establish at the start of a project a Clinical Risk
Management File for the Health IT System.

MUST produce at the start of a project a Clinical Risk
Management Plan.

MUST establish and maintain a Hazard Log.

MUST develop and maintain a Clinical Safety Case for the
Health IT System.

MUST produce a Clinical Safety Case Report at each lifecycle
phase.

MUST maintain a Safety Incident Management Log.

MUST ensure that the Manufacturer and the Health IT System
complies with ISB 0129 version 2.
Information Standards Board
Link to the standards on the Information Standards Board Website:
 http://www.isb.nhs.uk/documents/isb-0129/amd-39-2012/index_html
 http://www.isb.nhs.uk/documents/isb-0160/amd-38-2012/index_html
Guidance Documents

ISB 029 Compliance Assessment
Able to use this as a checklist to assess compliance with ISB 0129

ISB 0160 Compliance Assessment
Able to use this as a checklist to assess compliance with ISB 0160
Page 10 Copyright for course materials: Health & Social Care Information Centre
Top Level Structure
HSCIC Operations and Assurance Services
and Clinical Safety
HSCIC Clinical Safety Team




Dr Sebastian Alexander - Interim Clinical Director for Patient Safety
Dr Maureen Baker - Strategic Safety Advisor
Jane Doris - Clinical Safety Officer
Ankur Agrawal - Clinical Safety Officer

Stuart Harrison - Head of Safety Engineering
Sean White - Senior Safety Engineer
Mike Anderson - Senior Safety Engineer
Ian Dugdale - Safety Engineer
Frazer Brindley - Safety Engineer
Charles Olowosuko - Safety Engineer

Giash Ahmed—Project Manager





Page
13
New Clinical Safety Work
Spine II
eRS
NHS Mail 2
Public Services Network for Health (N3 to N4)




Spine II Upgrade
Spine currently provides the infrastructure that enables
increased patient safety, improved quality of healthcare,
greater clinical effectiveness and better administrative
efficiency. It is used and supported 24 hours a day, 365
days a year and is highly resilient.


Spine Upgrade - Reason for change the current Spine
contract is approaching its end. To continue to support the
NHS with essential infrastructure and to support the
Government’s Information Strategy, it was agreed that a
Programme, Spine 2, be established.
What we have achieved

Core message moved from BT to HSCIC
- Weekend of August Bank Holiday

CIS (formerly IAM) and SUS
- Due to move and planning in place for those services
What did we want to do?

Deliver a cost effective IT infrastructure
to the NHS

Re-develop core Spine Services using new
technologies (open source) and ‘Agile
Development’ methodology

Provide an infrastructure that is more
flexible to future changes

Deliver an exemplar HSCIC support
model for Spine 2 and other services
Re-cap - Cut Over Approach

Use a strategy that means that the local NHS does not
have to amend their local network configuration

Minimise downtime for EPS Release 2 sites as there is
no local business process workaround

Minimise downtime for PDS retrieve which is the largest
Spine interaction in terms of volume

Minimise impact on SCR viewing as this has a direct
impact on clinical safety

Minimise the impact to the NHS if there was a ‘black
swan’ occurrence that means a full roll back had to be
carried out
How did the cut over go?

Key stakeholders engaged throughout process

Service migrated as per the plan

Service outages as per (or less than) stated plan

No major incidents during the cut over

The majority of the NHS did not notice the cut over
Clinical Safety

0129 Requirements – Ankur Agrawal and Mike Anderson

Safety Case produced on behalf of HSCIC the supplier

0160 Requirements – Jane Doris and Ian Dugdale

Safety Case produced following workshops held with
NHS CSOs

CSG – issued a Clinical Authority to Release
Post Cutover Incidents

EPS
- Data Migration Issues
- Validation failures
- Functional issues with prescription state
Post Cutover Reaction

Noticeable performance improvement in messaging:
- Average seven times faster than before
- Consistency within planned values
- High resilience with service fail over occurring
automatically

User comments re ‘Prescription Tracker’ very positive

DSA tool popular with end users
Spine 2 core - Lessons Learned

Review with Knowledge Management pending
- Covering the entire deployment for core
- All teams and partners involved

Clinical Safety Team to be involved in process
Future Developments

Releases 3 & 4 planned (quarterly)
- Mainly tidy up items and minimal increase in
functionality
- Self Service Portal

CP-IS due to launch this month

New Work Request Process being deployed
- e.g.

EPS Claim Amend & multiple nominated dispensers

SCR 1-click improvements

Historic trace against Spine 1 data

Switching GP2GP messaging constraints
- Regular updates to Spine services webpage
NHS e-Referral Service
Vision:

The new NHS e-Referral Service will improve patient outcomes, user experiences and support the drive to a future paperless NHS referral system.

The new service will build upon the benefits and successes of the Choose and Book system, acknowledging its
failures (both real and perceived) and lessons learned.

There will no longer be a mixed economy of paper and
electronic referrals.

The needs of patients and professionals will be foremost
in designing the new service, which will include support
for enhanced functionality and usability.
Go-Live of the new NHS e-Referral
Service

Noticeable performance improvement in messaging:
- Average seven times faster than before
- Consistency within planned values
- High resilience with service fail over occurring
automatically

User comments re ‘Prescription Tracker’ very positive

DSA tool popular with end users
Spine 2 core - Lessons Learned
Go-live now re-scheduled - aiming for Spring 2015
Why?

There remains a significant test, assurance and defect
resolution activity to complete for us to be able to sign-off the
system as ready

We must be completely confident that there will be minimal
disruption, no degradation of service or negative impact on
patient care in order to allow Go-Live
When will it go-live?

Following completion of more test and assurance activity, we
expect to be able to confirm the revised go-live date by end
December 2014.
What has been achieved?

Successful transition to a replacement supplier for the Telephone Appointment Line

The building of a new NHS e-Referral Service infrastructure to
host the future service

Modern, open-source based software now developed

Transition Plans in place

Communication plans in place

Data Migration plans in place and tested
Testing

External User Experience Testing (UET)

Internal UET (Business Change Team)

Solution Assurance Testing (HSCIC)

Partner Testing (External Suppliers)

Cosmetic Defect analysis (BJSS & e-RS)

External UET planned for November

Final User Assurance before Go-Live
Clinical Safety

0129 Requirements – Michelle Durham CSO

Clinical Safety Case from HSCIC as the supplier

0160 Requirements – Ankur Agrawal and Mike Anderson

Clinical Safety Report on behalf of the NHS
Other Future Work

Public Services Network for Health (N3 to N4).

NHS Mail 2.
On-going Clinical Safety Work
Clinical Safety SharePoint Site
[Home]
Clinical Safety SharePoint Site
For further information or if you have any suggestions or
comments please contact:

Jane Doris (HSCIC Clinical Safety Officer)
jane.doris@hscic.gov.uk
What is the Interoperability Toolkit
(ITK)?

Spine Mini Service Providers (SMSP) is a specification within the Interoperability Toolkit (ITK), it is not a
piece of software.

It allows suppliers to build solutions that connect to
PDS for a limited set of functionality:
- Read only.
- Simple trace.

The suppliers are not under any form of contract with
DH, they build SMSP solutions because they can
subsequently market these to Health and Social Care
Organisations.
Spine Mini Services using
Interoperability Toolkit
Trust Example
Software Development and Clinical
Safety Management

The prevalent Project Management and delivery
approach has been the “waterfall” model.
What is “Waterfall”?
“a sequential design process, often used in software
development processes, in which progress is seen as
flowing steadily downwards {like a waterfall) through phases
of…..”
http://en.wikipedia.org/wiki/Waterfall_model
Common Assurance Process (CAP)
...needs to be followed for all clinical software connected to
PDS.
Common Assurance Process,
Standards and Training
Coming soon to a project near
you…..Agile
Clinical Safety for Agile Projects
Clinical Safety Networks
NHS

National Clinical Safety Officers Group

Accredited Clinicians Page on SharePoint.

Regional Clinical Safety Officers Group.

North East

Yorkshire and The Humber
Suppliers/ Vendors

Intellect (Trade Body)
What This Module Has Covered

New Updated ISB 0129 and 0160.

Governance of Clinical Safety within HSCIC.

New Clinical Safety Work.

On-going Clinical Safety Work.

Clinical Safety Networks.
3
Networking and Sharing Best
Practice
Focus for Session

Implementation of the Safety Standards ISB 0129 and ISB
0160 in your organisations.

Updated standards were issued in February 2013, what are
the challenges and constraints.
Approach:

After action review.

Discuss the implementation of the safety standards and
what has gone well / could have gone better.
Consider:

Whole process (approval to implementation).

Who, what, where, how, etc.…
Networking
Split into teams and discuss your experiences to date related to the
introduction of the safety standards and record:
1.
2.
3.
4.
5.

What has gone well and why?
What could have gone better and why?
Things to maintain, best practices and tools you can
share, etc.
Other learning.
Recommendations and actions.
Share learning between teams.
Network Recording Sheet
What has gone well:
Why:
What could have gone better:
Why:
Things to maintain, best practices and tools you can share, etc.
Other learning
Recommendations for HSCIC:
Team Member Actions:
Compliance with ISB 0129 and 0160
Must define and document a Clinical Risk Management Process.
Top Management MUST make available sufficient resources.
MUST establish a Clinical Risk Management File and Plan.
Compliance with
ISB 0129
MUST establish and maintain a Hazard Log and Clinical Safety Case.
Incident Management Process in place.
Must define and document a Clinical Risk Management Process.
Top Management MUST make available sufficient resources.
MUST establish a Clinical Risk Management File and Plan.
MUST establish and maintain a Hazard Log and Clinical Safety Case.
Integration of clinical safety into business change and work flows.
Incident Management Process in place.
Able to support running the system.
Able to decommission a system safely.
Compliance with
ISB 0160
4
Using a Safety Case in Health
IT— Practical Example
Overview

What is a Safety Case?

Safety Cases in other safety related industries.

Safety Cases and NHS Health IT Safety Standards.

Health IT Systems Safety Cases in the NHS.
What is a Safety Case?
“ Accumulation and organisation of product and business
process documentation and supporting evidence, through the
lifecycle of a system.”

On-going: through out the lifecycle of a system

Organised: to provide understanding of safety
characteristics

Evidence: to provide confirmation of safety
characteristics.

Documented in the Safety Case Report
Clinical Safety Case Report
“Report that presents the arguments and supporting
evidence that provides a compelling, comprehensible and
valid case that a system is safe for a given application in a
given environment at a defined point in a system’s lifecycle.”

Physical artefact that is authored and issued.

Evolves and up-issued at key stages in the health IT
system lifecycle.
Clinical Safety Cases and NHS
Health IT Safety Standards

Recap:
- ISB 0129 (Manufacturer of Health IT Systems)
- ISB 0160 (Deployment and Use of Health IT
Systems
- Simplified, user-friendly text

Requirements 3.4 and 3.5 mandate the need for a
Safety Case and Safety Case Report
Health IT Systems Safety Cases in
the NHS

Health IT System Manufacturer
- Principal safety deliverable to the HSCIC
- Phased submission during national assurance process
- Reviewed and accepted by HSCIC
- Pre-requisite to live deployment within the NHS
- Shared with Health Organisation
- New and modified Health IT Systems
Health IT Systems Safety Cases in
the NHS

Health Organisations
- Need to deliver to the HSCIC
HSCIC require assurance before approving deployment
- Support key activities: deployment, use, upgrade,
decommission
Workshop Instructions
Instruction

Your groups are responsible for clinical safety for the
electronic prescribing service.

Nominate a Clinical Safety Officer (CSO) and select roles for
all others.

Develop a Clinical Risk Management Plan (CRMP) for the
release.

Read the information and follow the instructions in the provided
material to develop a Clinical Safety Case Report and Hazard
Log for the hazard Incorrect Medication Prescribed to the
Patient

Present your recommendations to the Clinical Safety Group

Refresher Training in Safer Design and - Systems

Transcription

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