how to learn lessons from concerns - patient safety wales · 2016-02-02 · appendix 1 – ptr...

Guidance: How to Learn Lessons from Concerns

J.Rix.V9. of 43

How to Learn Lessons from Concerns:

All Wales Document


J.Rix.V9. of 43

CONTENTS

1 Introduction

2 Grading Concerns

3 Investigation and Concerns Management Tools

4 Investigators

- Table 1: The WHEN, HOW & WHO to investigate

5 Key Stages in the investigation and management of concerns

6 Quality Improvement

7 Sources of help and support

8 Acknowledgements

Annex 1a – Completed examples of Concerns Report Writing

Template, Plans and Investigation Tools

Annex 1b – Templates for Concerns Report, Plans and Investigation

Tools

Appendix 1 – PTR Grading and Risk Ratings

Appendix 2 – Flow Chart: Key Stages in the Investigation and

Management of Concerns


J.Rix.V9. of 43

1 Introduction

This guide has been written to support the Welsh Government’s Putting Things Right Guidance (PTR) on dealing with concerns about the NHS, which details the arrangements for handling complaints, claims or reported patient safety incidents and learning from what has gone wrong.

What is a “concern?”

The term “concern” is used throughout this document and should be taken to mean any complaint, claim or reported patient safety incident (about NHS treatment or services) to be handled under the PTR arrangements.

The PTR arrangements represent a significant culture change for the NHS in Wales. It provides an integrated and consistent approach to the raising, investigation and learning from concerns. In line with this approach it is important that investigations are effectively conducted to identify the root causes of a concern. The intention is that a standardised and well established approach to the investigation process will support organisations to

“investigate once, investigate well”. This will enable them to achieve long term solutions

in order to prevent or reduce the likelihood of the concern recurring, thereby improving patient safety.

Purpose of this document

This document has been produced to enable healthcare organisations and their teams

determine:

When and how to undertake an investigation so that it is proportional to the level

of the concern

Which investigation and reporting tools to use at the various stages of an

investigation and grade of concern

How to manage the investigation of a concern through to its final closure to

ensure that lessons are learnt and patient safety is improved

This guide provides a toolkit to help establish a standardised approach to the

investigation and general management of concerns.


J.Rix.V9. of 43

The value of using a standardised approach to the investigation of concerns

Using a standardised approach to the investigation and management of concerns will

help demonstrate that investigations have been conducted to a satisfactory level. This in

turn will be the basis for the development and implementation of effective solutions

which address the root causes of concerns to ultimately prevent or reduce the likelihood

of concerns recurring.

Seeking and Providing Assurance

NHS organisations and stakeholders need to be assured that concerns are being

managed effectively and appropriately. It is essential that robust systems are in place

for the reporting and management of concerns to ensure that when concerns are closed

by the relevant group or committee that solutions have been implemented across the

various healthcare organisations involved and that lessons have been learnt.

“Investigate once investigate well”

In order to improve the quality of investigations the recommended approach is to focus

efforts on the simplest and most effective investigation tools to avoid confusion and

misapplication. This standardised approach will enable a consistent and appropriate use

of tools at the different stages of the investigation process as detailed below.

The Incident Management Process and Key Investigation Tools

WHAThappened

HOW ithappened

SolutionDevelopment

Chronology Unsafe Act (Key problems)

Fix WhatIs Broken

WHY ithappened

Contributory Factors

•TabularTimeline

•TabularTimeline

•Brainstorming•ChangeAnalysis

•Barrier Analysis

•PDSA Cycle•Report

Template

•Classification Framework &

Fishbone •Five Why’s

•Brainstorming

The RCA Tools selected are based on consultation with key investigation leads in organisations that have been responsible for

conducting investigations, overseeing the quality of investigations and for cascade training over the past 7 years. This feedback is

also concurrent with existing Investigation/PTR Leads and the RCA Task and Finish Working Group.


J.Rix.V9. of 43

2 Grading Concerns

Concerns are graded to help determine how they are to be managed within the

organisation. Grading should be considered a dynamic process that may change as the

investigation progresses. The initial grading may be subjective, and there may be a

need to take further advice from relevant people who would be able to advise on the

concern (Ref Table 1).

The grading of concerns in this document includes the following processes:

Risk Rating Matrix 5x5 Likelihood and Severity (Appendix 1)

PTR Grading Framework 1-5 in severity (Appendix 1)

3 Investigation and Concerns Management Tools

Table 1 below outlines the investigation tools which it is suggested should be used with

the various grades of concerns and by whom. However, it is important to note that

overall judgement on which tools to use and when, is on a case by case basis and will

depend on professional experience. The level of detail gathered will normally reflect the

complexity of the concern and grading assigned. The effectiveness of some tools will

be dependent on the nature of the incident e.g. Change Analysis is particularly effective

for well defined processes; 5 Whys is generally suitable for simpler problems which tend

to have a lower grading.

The standardised investigation tools which are referred to in this document are all

included and completed in Annex 1 of this document to provide examples and

explanations of how they should look. Annex 2 includes templates of these investigation

tools. They can also be downloaded from the Wales Patient Safety Website -

www.patientsafetywales.org.uk.

4 Investigators

It is strongly recommended, that investigations should not be undertaken by one person

alone, unless considered reasonable. This ensures that bias and assumption is

minimised and that a more objective approach is achieved throughout the investigation

process. Table 1 below suggests who should be involved in the investigation process.

An investigating officer should be identified for all serious concerns and will need to be

trained and have experience in the principles of investigating and managing Concerns.

NHS organisations are advised to hold a register of investigators who have received

training, which should include the level of experience they have gained. A system of

http://www.patientsafetywales.org.uk/


J.Rix.V9. of 43

mentorship is also recommended as a highly effective approach to enable individuals to

gain familiarity and practice in the investigation process.

Table 1: The WHEN, HOW & WHO to investigate

This table outlines the recommended, standardised tools which should be used for

different grades of concerns and who should investigate.

Grading Investigation Tools and

plans (Ref Annex 1a)

Undertaken by

PTR Grading of 4 and 5

(Possibly 3 where

considered appropriate by

the organisation)

Risk Rating of : 9-15 high risk (Amber), 16-25 extreme risk

(Red & therefore

reportable to Welsh

Govt Improving Patient

Safety Team)

Tabular Timeline

(& brainstorming)

with

Classification

Framework (&

fishbone)

and/or

5 Why’s

and/or

Change Analysis

Barrier Analysis

Action Plan

Report Writing

Template

Investigation Team

E.g. Patient Safety

Lead, SIM (Senior

Investigation

Manager), lay

person, Senior

Nursing/medical or

Divisional staff

external to the

location and specialty

of the concern.

Expert in the specialty

or location and of the

concern.

PTR Grading of 1 and 2

(Possibly 3 where

considered appropriate by

the organisation)

Risk Rating of :

1-4 negligible risk

(Green)

5-8 minor risk

(Yellow)

Tabular Timeline

(&brainstorming)

5 Whys

Action Plan

Report Writing

Template

Ward Manager &

member of the local

team


J.Rix.V9. of 43

It is essential that the investigation is proportionate to the grade of concern. Whilst

Table 1 above provides guidance its use will be dependent on the nature of the concern

and organisational arrangements which may already be in place.

Important Note

Not all concerns will require an investigation and some can be managed and closed

immediately at source e.g. an explanation and/or an apology given to the patient for a

waiting room being cold, car parking deficiencies. This is where the patient is satisfied

with the explanation and actions taken. These concerns are defined as “on the spot”,

1.12 of the PTR Guidance. These concerns are not dealt with under the Regulations and

thus will not be graded. In these cases this document does not apply. When

managed in a timely and effective manner, it is possible to avoid the concern progressing

to a more serious level.


J.Rix.V9. of 43

5 Key Stages in the Investigation and Management of Concerns

Key Stages

The stages listed below will enable an organisation to provide a standardised and

comprehensive approach to the investigation and management of concerns, including

the assurances required within the organisation and with key stakeholders that lessons

have been learnt.

Relevant organisational policies and procedures regarding the handling and

management of concerns will already be in place, however, it is recommended that they

include the following:

1. When a concern occurs, where appropriate, the patient should be assessed and the

immediate situation made safe. The concern should be reported to the appropriate

manager. Defined arrangements for managing concerns out of hours should be

established. In the case of any serious concerns e.g. all PTR grades 4/5, or all red risks

16-25 the Senior Investigation Manager (SIM) will also need to be alerted.

2. The appropriate manager will ensure that any action required to make the situation

safer is taken immediately and that any other relevant managers are informed.

3. Where appropriate the Being Open process is initiated by those with identified

authority as soon as feasibly possible. Those identified with responsibility by the

organisation for leading on Being Open conversations with patients/carers/relatives will

initiate this process as soon as considered feasibly possible and in line with the needs

of the patient/relatives/carers. Please note this is an ongoing process.

4. The concern will need to be reported using the local incident reporting system and

graded using the PTR and local Risk Rating process. It is important to note that the

concern grading is dynamic in nature throughout the investigation.

5. Those with responsibility for the line management of staff involved in the incident may

wish to initiate the Incident Decision Tree (IDT) (footnote) to establish if there has been

any intended harm. It is a tool which can be used to encourage an open and fair culture

and to avoid inappropriate suspensions. Please note that use of the IDT is not a one off

occurrence and can continue throughout the investigation.


J.Rix.V9. of 43

6. Those with responsibility for staff involved in the incident will also be responsible for

assessing the impact of the concern on staff and to provide de-briefing and support

where considered appropriate. Please note this is an ongoing process.

7. Some moderate and all low harm concerns (i.e. grade 2 and 3s) will be investigated

by the Ward/Departmental Manager in conjunction with a local member of staff using:

a) The Tabular Timeline, 5 Why’s (Please ref to Table1) will be used for this

level of incident,

b) Action plans to address the root causes will be developed and shared

locally and recorded on datix.

c) The investigation will be reported at the Local Safety Group and decisions

taken to share on a wider basis as considered appropriate.

8. Serious concerns (i.e. grade 4 and 5) will be investigated by an Investigation Team

that will be identified by the SIM or as per organisational arrangements. An executive

lead will also be identified to regularly track progress on the incident to final closure and

at least one member of the team will be trained and experienced in the RCA process.

9. The decision to escalate the concern to the organisation’s Board will be taken by the

Investigation Team. The decision to include the concern on the Risk Register will be

taken at the Board meeting.

10. Concerns, particularly serious and moderate concerns (i.e. grade 4 and 5) should be

investigated using all stages of the investigation process. Appropriate investigation tools

for both the level and nature of concern should be considered (Ref Table 1).

a) What happened – Tabular Timeline (& brainstorming)

b) How it happened – Tabular Timeline (& brainstorming), Change Analysis

c) Why it happened – Classification framework (& fishbone), 5 Whys

d) Solutions Development – Barrier Analysis, Plan, Do, Study, Act (PDSA) Cycle &

Report Writing Template (which includes the lessons that need to be learnt)

11. Solutions will be developed to address the root causes identified during the

investigation process, using the Barrier Analysis and a summary of control measures

included in the Action Plan. It is essential that the solutions are developed in conjunction

with local managers to ensure ownership and that there is a thorough consultation with

teams who will be required to adhere to any solutions. The PDSA cycle can also be

used at this stage to test solutions prior to spreading the solution to other areas.


J.Rix.V9. of 43

12. The local manager will ensure solutions are implemented and monitored to achieve

compliance with the new procedures wherever relevant.

13. The Concern will be closed via local organisational arrangements. If it is a Serious

Incident i.e. PTR 4/5 or Red (16-25) then the Welsh Government Closure form must be

approved and signed by an Executive Director.

A flow chart of this process is available in Appendix 2


J.Rix.V9. of 43

6 Quality Improvement

Using the Concerns Investigation Report Template (Annex 1 and 2) can be a powerful

way of increasing focus and engagement with quality and safety issues. It allows

organisations to examine the quality of their investigations following the adoption of a

systematic and reliable approach as described in this document. Organisations will be

able to demonstrate how problems in the process of care have been identified; where

and which actions have been introduced to address these problems and to prevent the

likely recurrence of the concern. The PDSA cycle can be used to test the solution prior

to implementation etc.

Consultation with key staff and stakeholders is a key element in the development of

solutions and will directly affect the effectiveness of the solution and the likelihood of it

being adopted as a long term solution.

Where concerns recur organisations should consider the audit of new procedures to

identify gaps in implementation and reasons for non-compliance, so that further actions

can be focused on these specific areas.

7 Sources of help and support Wales Patient Safety Website www.patientsafetywales.org.uk:

- NPSA. (2004). Root cause analysis toolkit. - NPSA. (2008). RCA investigation tools: Guide to investigation report writing.

Document 0769B V1. - Incident Decision Tool (IDT) - Being Open - Investigation and Management of Concerns Training Programme

Putting Things Right – Guidance on dealing with concerns about the NHS from 1 April 2011 Version 2 – April 2012 Australian/New Zealand Risk management standards AS/NZS 4360:1999 now replaced by ISO 31000:2009 The Quality Improvement Guide – A method for improving public services in Wales 2011

Further guides are available from the 1000 Lives Plus office, or online at

www.1000livesplus.wales.nhs.uk to support you in your improvement work:

■ A Guide to Measuring Mortality

■ Improving Clinical Communication using SBAR

■ Learning to use Patient Stories

■ Using Trigger Tools

■ Reducing Patient Identification Errors


http://www.wales.nhs.uk/sites3/docopen.cfm?orgid=932&id=170588&544E1E51-DD70-E12B-CDE323F40D389301

http://www.wales.nhs.uk/sites3/docopen.cfm?orgid=932&id=170588&544E1E51-DD70-E12B-CDE323F40D389301

http://www.1000livesplus.wales.nhs.uk/


J.Rix.V9. of 43

8 Acknowledgements

This guide has been produced by Patient Safety Wales in conjunction with the

Concerns Task and Finish Working Group; and following extensive consultation with

NHS organisations and lead individuals in the field of incident management.

We would particularly like to thank those who have fed back lessons and experiences

relating to their years in the area of incident management.


J.Rix.V9. of 43

Annex 1a - Completed examples of Concerns Report Writing

Template, Plans and Investigation tools

The following section, Annex 1a, provides examples and explanations of what should be

included in the completed templates for the investigation and management of Concerns.

Annex 1b contains all the templates for the investigation and management of Concerns.

There are over 40 different RCA tools available. However, it is suggested that the

limited number of tools below are used to simplify the investigation process and ensure

that they are used properly and systematically and at the appropriate stages of the

investigation process.

The recommended investigation tools for the key stages of the concerns management

process are as detailed below and need to be selected so that they are proportionate to

the grade of concern.

Wherever possible, investigations should not be conducted in isolation in order to avoid

potential bias and assumption (Ref: Table1)

The Incident Management Process and Key Investigation Tools

WHAThappened

HOW ithappened

SolutionDevelopment

ChronologyUnsafe Act

(Key problems))Fix WhatIs Broken

WHY ithappened

Contributory Factors

•TabularTimeline

•TabularTimeline

•Brainstorming•ChangeAnalysis

•Barrier Analysis

•PDSA Cycle•Report

Template

•Classification Framework &

Fishbone •Five Why’s

•Brainstorming

For further information on investigating and managing concerns, including training

material go to www.patientsafetywales.org.uk



J.Rix.V9. of 43

1 Final Report for the Investigation of Concerns

Final Report for the Investigation of Concerns

Name of organisation

Summary CONFIDENTIAL

Please follow the arrangements in place in relation to the confidential nature of the report and

arrangements for circulation.

Concern Reference Number

(Datix number)

D23

Date of concern 15.3.11

Investigation lead T.Smith – Risk Manager

Investigating Group

Name, Designation, Department

R.Rovers – Ward Manager

L.Peters – Pharmacy Manager

Report Prepared by


T.Smith – Risk Manager

Report Date 6.11.11

Name of Executive Lead

(For Serious Concerns only)

W.Jones – Director of Medicine

Concern closed by:

Name, Designation, Department/Division

Or

Divisional Quality and Patient Safety

Committee

Concern sign off/or closed means that the actions

to address the concerns have been implemented.

Where this has not been possible e.g. quarterly

audit, this should be noted and monitored for

closure at a later date.


J.Rix.V9. of 43

TERMS OF REFERENCE

To establish the facts across all relevant disciplines and specialties

i.e.:- what happened, to whom, when, where, how and why

To establish whether problems occurred in care and/or service delivery

To look for improvements rather than to apportion blame

To establish how recurrence may be reduced or eliminated (solutions work)

To produce an action plan in conjunction with local leads.

Recommendations that feed in to the action plan should be developed by

Divisional staff to ensure local ownership.

To provide a report as a record of the investigation process

To provide a means of sharing learning from the concern

1. EXECUTIVE SUMMARY- Concise summary of the Concern

Putting Things Right

Initial Grading

4


Final Grading

4

Risk Rating (5 x 5 – severity

by Likelihood)

25

Date of Concern April 2010

Division / Service Area

Emergency Department

Source and implication of

concern

Examples: Adverse Incident, Formal/VerbalComplaint, Audit

(external and internal), adverse publicity etc, etc.


J.Rix.V9. of 43

2. MAIN BODY OF INVESTIGATION REPORT

Background to the concern

No more than a couple of paragraphs, a brief summary of what lead to the incident.

Scope of investigation

e.g. The investigation covers the period from when the Department admitted the patient to the ward

etc

Level of investigation – (Ref to Table 1 above)

For further guidance in relation to RCA see : www.patientsafetywales.org.uk

Involvement and support of patient and relatives

e.g. The patient has been informed about the incident and given the name of one contact. It has been

explained that further details will become available throughout the investigation process and that a

meeting to update them on initial findings has been arranged for the 3rd March 20012. Due to the

complexity of the incident it has been explained that they will need to be contacted with ongoing

updates as information becomes available.

Support and ongoing briefing for staff involved in the concern

This could include an initial de-briefing, but must not be seen as a one off process. Counselling support

also needs to be offered. Staff have been informed that an investigation is underway.

Description of key events (Tabular Timeline)

This should be concise and include the essential points only, as details will be included in the Tabular

Timeline (Annex 1 of the report).

Notable practice

Points in the incident or investigation process where care and/or practice had an important positive

impact and may provide valuable learning opportunities.

e.g. Actions taken to inform the patient and relatives of the error in an open and honest way, and

patient and carer having the opportunity to express their views on the incident.

Care delivery or local problems (Tabular Timeline/Brainstorming and/or Change

Analysis)

Care delivery or local problems are problems that relate to direct provision of care. They arise in the

process of care and are usually actions or omissions by members of staff. They have two essential

features a) care deviated beyond safe limits of practice b) the deviation had at least a potential direct or

indirect impact on the eventual adverse outcome for the patient, member of staff or "general public"

e.g. failure to monitor.

Service delivery or organisational problems (Tabular Timeline/Brainstorming and/or

Change Analysis)

Service delivery or organisational problems are failures identified during the analysis of the concern,

which are associated with the way a service is delivered and the decisions, procedures and systems that

are part of the whole process of service delivery.

e.g. No maintenance contract for equipment.



J.Rix.V9. of 43

Contributory factors (Classification Framework& Fishbone or 5 Why’s)

A summary of the significant problems need to be listed and each one analysed to identify the factors

which contributed to the problem.

Where many contributory factors are identified, the classification framework (and fishbone) should be

included in the Appendices to show the full list of factors identified.

e.g.

Staffing levels were low at the time due to unfilled vacancies.

There were no emergency ambulances available to respond to the initial emergency call as the Region has 5 ambulance outside **** emergency department waiting to handover their patients to emergency department staff.

Root causes (Classification Framework& Fishbone or 5 Why’s)

These are the most fundamental underlying factors which contributed to the incident that can be

addressed. Root causes should be meaningful, (not sound bites such as communication failure) and

there should be a clear link, by analysis, between root CAUSE and EFFECT on the patient.

Root causes will be a summary of the most important contributory factors identified in the process

above.

Lessons learned

Key safety and practice issues identified which directly contributed to the incident from which we can

learn to prevent the concern from recurring.

Incidental Learning: Other problems identified during the investigation which did

not impact upon the concern

Key safety and practice issues identified which may not have contributed to this incident but from which

others can learn.

e.g. During the investigation it became evident that the clinical information documented on the patient

clinical record was below an acceptable standard and hindered the investigation process i.e. results not

filed and observations not recorded.

Recommendations: including summary of solutions (Barrier Analysis & Action Plan,

PDSA Cycle)

Recommendations (numbered and referenced) should be directly linked to root causes and lessons

learned, they should be clear but not detailed (detail belongs in the action plan). It is generally agreed

that key recommendations should be kept to a minimum where ever possible.

Arrangements for sharing and learning

Describe how learning has been or will be shared with staff and other organisations (e.g. through

bulletins, professional networks, etc.). Must ensure that there is organisational wide learning. Where

appropriate the report will be shared with Welsh Government and other networks to support wider pan

NHS Wales learning.

Was this a joint investigation with another organisation?

Investigation undertaken in conjunction with WAST and etc.

External Organisations Informed

e.g. Welsh Government, Health and Safety Executive.


J.Rix.V9. of 43

Please ensure that all completed Appendices are included with this report


J.Rix.V9. of 43

2 Example of a completed Tabular Timeline Event Date and

Time

20/1/04 1/2/04 11.30 12:00 12:30

Event Pt (JH) contacts medical team

to rearrange treatment plan due

to work commitments

Mr R S, Pharmacist

contacts SpR Dr L

to query the

prescription for

methotrexate for

administration on

same day as

Vincristine

Dr L introduces Sr Lynch to Dr D Campbell, a

locum SpR who will be assisting the team

Pt rings ward and tells

Staff nurse Abe that she

is caught in traffic and

will be about 2 hours

late

A staff nurse delivers the

Vincristine for pt JH to the ward

Supplementary

Information

The Pts IV Vincristine was

already booked for the morning

of 1/2/04. The Consultant Dr M

agrees to allow pt to have

intravenous and intrathecal

chemotherapy on the same day.

Iv in the morning and Intrathecal

in the afternoon. The SpR

covering the day of planned

treatment is informed of the

change

Dr L informs Mr S

that it has been

authorised by the

Pts consultant, Dr M

and that she will

take full

responsibility

On enquiry Sr Lynch is informed that Dr Campbell

is able to carry out all clinical duties that she would

usually do.

Sr L raises concerns with Dr L about the

Intrathecal chemotherapy procedures and the fact

that Dr C is not on the register Dr L assures Sr L

that Dr C is competent, that he comes

recommended by Dr M, the Consultant, and that

he has authorised his inclusion on the register. Sr

L confirms that Pt (JH) treatment will still be under

Dr L’ s care

SN A Kamole informs

Sr L. Sr L tells SN K that

she has to leave early

for a dental appointment

and asks AK to ensure

that Sr Roberts knows

what is happening. She

tells Abe she will also

write it in the notes

SN arrived on ward and asked

SR Lynch for the keys. These

were handed over and the nurse

put the drug in the fridge. It was

not discovered until after the

incident that she had placed the

Vincristine in the Methotrexate

dedicated fridge.

Sr L then leaves before Sr

Roberts arrives

Good Practice

Pharmacist was

aware of departure

from protocol and

questioned this

change

Care/ Service

Delivery

Problems

Failure to heed concerns raised by

members of clinical team. Dr L

overruled or ignored queries from the

Pharmacist and ward sister


J.Rix.V9. of 43

3 Example of a completed Change Analysis

Normal Procedure Procedure as occurred

during Incident

Is a change

in process

evident?

Did the

change

cause the

problem or

influence it?

Surgeon knew patient’s

condition - both feet

gangrenous

Theatre list correct &

reviewed by surgeon

after typing

Marking of site follows

procedure. Carried out

by surgeon prior to list

using skin pencil, after

checking with pt and

notes

Site prepared after

checking notes and

consent form

Surgeon knew patient’s

condition - both feet

gangrenous

Theatre list changed

hand written by SHO

and RIGHT leg not

clearly identified

Left calf marked by

Registrar using Biro

night before operation

when consent form

signed. Patient crossed

his legs and mark

transferred to left leg

Site prepared after

checking theatre list

and seeing mark on left

leg

No

Yes

Yes

Yes

No

Yes

Yes

Yes


J.Rix.V9. of 43

4 Completed Fishbone. NB: Fishbone template MUST be used with the Classification Framework

Failure to identify

incorrect drug

and route

Patient Factors Task Factors

Education

and Training

Factors

Working

Conditions

Individual

Staff Factors

Team & Social

Factors

Equipment

and Resource

Factors

Communication

Factors

Organisational

and Strategic

Factors

Pt listening to walkman

and not included in

procedure

Interruptions from bleep

Pt had requested change

to treatment plan

Drug checking procedure

not followed (Further

analysis - 5 Whys)

SHO not trained or

registered to carry

out the task

Locum SpR

unfamiliar with ward

& policies

SHO unqestioning

and helpful working

outside

competence

Lack of team

safety vigilence

Lack of clarity of

roles & skills

No formal induction

for locum SpR

Able to connect an IV

syringe to an

Intrathecal route

Ward emergency

during procedure

took SN away

Hierarchical structure not

conducive to discussion or

questionning

Lack of safety

culture/awareness

Lack of Systems for

managing Locum staff

Pt was late & stressed

Workload and staff absence left

two staff unfamiliar with pt and

protocols to carry out procedure

Time pressures,

other pts waiting

Lack of senior medical

supervision of junior/

inexperienced staff

Lack of leadership - nobody revisited

allocation of staff as a result of changes to

treatment plan and staff absence

No check of

competence/experience

built into task

No safety features

on chemotherapy

drug fridge

SHO stated

“Vincristine” SpR

did not pick up

incorrect drug

SpR consistently

referred to

Methotrexate as

“Chemo”

Neither clinician

checked drug

route

No visual clues in

allocated bay about

risks associated with

procedure

Lack of appropriately

trained staff

Breakdown of

multidisciplinary

team communication

Lack of consultant

support for locum

when SpR left


J.Rix.V9. of 43

5 Example of a completed Five Why’s Diagram


J.Rix.V9. of 43

6 Example of a completed Barrier Analysis

Activity/Incident: Giving a controlled drug to a specified person.

Hazard(s) What Barriers

are in place?

Importance

to safe

practice?

How

effective?

S/M/W

What additional

barriers are

required?

How

effective?

S/M/W

Cost

implications

Whose

responsibility

Wrong

drug

Two person

checks

Yes Weak Bar-coding Strong Medium Clinical Gov.

Committee

Wrong

patient

Patient ID

checks

Yes Weak Electronic

prescribing

Strong High Trust Board

Wrong

dose etc

Ward based

pharmacy

checks

Yes Medium ‘Time Gap’

between drawing

up drug, check and

administration

Medium Low Risk Man.

Committee


J.Rix.V9. of 43

Annex 1b – Templates for Concerns Report, plans and

investigation tools

1 Final Report for the Investigation of Concerns

Final Report for the Investigation of concerns

Name of organisation

Summary CONFIDENTIAL

Concern Reference Number

(Datix number)

Date of concern

Investigation lead

Investigating Group


Report Prepared by


Report Date

Name of Executive Lead

(For Serious Concerns only)

Concern closed by:

Name, Designation, Department/Division

Or

Divisional Quality and Patient Safety

Committee


J.Rix.V9. of 43

TERMS OF REFERENCE

To establish the facts across all relevant disciplines and specialties

i.e.:- what happened, to whom, when, where, how and why

To establish whether problems occurred in care and/or service delivery

To look for improvements rather than to apportion blame

To establish how recurrence may be reduced or eliminated (solutions work)

To produce an action plan in conjunction with local leads.

Recommendations that feed in to the action plan should be developed by

Divisional staff to ensure local ownership.

To provide a report as a record of the investigation process

To provide a means of sharing learning from the concern

1. EXECUTIVE SUMMARY- Concise summary of the Concern


Initial Grading


Final Grading

Risk Rating (5 x 5 – severity

by Likelihood)

Date of Concern

Division / Service Area

Source and implication of

concern


J.Rix.V9. of 43

2 MAIN BODY OF INVESTIGATION REPORT

Background to the concern

Scope of investigation

Involvement and support of patient and relatives

Support and ongoing briefing for staff involved in the concern

Description of key events (Tabular Timeline )

Notable practice

Care delivery or local problems (Tabular Timeline/Brainstorming and/or Change

Analysis)

Service delivery or organisational problems (Tabular Timeline/Brainstorming and/or

Change Analysis)


J.Rix.V9. of 43

Contributory factors (Classification Framework & Fish bone)

Root causes (Classification Framework & Fish bone)

Lessons learned

Incidental Learning: Other problems identified during the investigation which did

not impact upon the concern

Recommendations: including summary of solutions (Barrier Analysis & Action

Plan; PDSA Cycle)

Arrangements for sharing and learning

External Organisations Informed

Please ensure that all completed Appendices are included with this report


J.Rix.V9. of 43

Tabular Timeline

Event date and

time

Event

Supplementary

information

Include cross –

referencing of

source

Notable Practice

Care / Service

delivery

problems


J.Rix.V9. of 43

Change Analysis Normal Procedure Procedure as

occurred during

Incident

Is a change in

process evident?

Did the change

cause the problem

or influence it?


J.Rix.V9. of 43

Classification Framework & Fishbone

This Framework must be used in conjunction with the Fishbone diagram. Select

the relevant components which relate to the problem identified and add to the

appropriate factor.

Individual

Factors Components

Physical issues General Health (e.g. nutrition, diet, exercise, fitness)

Physical disability (e.g. eyesight problems, dyslexia) Fatigue

Psychological

Issues

Stress (e.g. distraction / preoccupation) Specific mental health illness (e.g. Depression) Mental impairment (e.g. illness, drugs, alcohol, pain) Motivation (e.g. boredom, complacency, low job satisfaction) Cognitive factors (e.g. attention deficit, distraction, preoccupation,

overload and boredom)

Social Domestic Domestic / lifestyle problems

Personality

Issues

Low self confidence / over confidence Gregarious / interactive, reclusive Risk averse / risk taker

Team Factors Components

Role

Congruence

Is there parity of understanding Are role definitions correctly understood Are roles clearly defined

Leadership Is there effective leadership – clinically Is there effective leadership – managerially Can the leader lead Are leadership responsibilities clear and understood Is the leader respected

Support and

cultural factors

Are there support networks for staff Team reaction to adverse events Team reaction to conflict Team reaction to newcomers Team openness


J.Rix.V9. of 43

Communication

Factors

Components

Verbal

communication

Verbal commands / directions unambiguous Tone of voice and style of delivery appropriate to situation Correct use of language Made to appropriate person(s) Recognised communication channels used (e.g.head of service)

Written

communication

Are records easy to read Are all relevant records stored together and accessible when

required Are the records complete and contemporaneous (e.g. availability

of patient management plans, patient risk assessments, etc) Are memo’s circulated to all members of team Are communications directed to the right people

Non verbal

communication

Body Language issues (closed, open, aggressive, relaxed, stern faced)

Task Factors Components

Guidelines

Procedures and

Policies

Up-to-date Available at appropriate location (e.g. accessible when needed) Understandable / useable Relevant; Clear; Unambiguous; Correct Content; Simple Outdated; Unavailable/missing; Unrealistic Adhered to / followed Appropriately targeted ( e.g. aimed at right audience)

Decision making

aids

Availability of such aids e.g. CTG machine, risk assessment tool, fax machine to enable remote assessment of results

Access to senior / specialist advice Easy access flow charts and diagrams Complete information - test results, informant history

Procedural or

Task Design

Do the guidelines enable one to carry out the task in a timely manner

Do staff agree with the ‘task/procedure design’ Are the stages of the task such that each step can realistically be

carried out


J.Rix.V9. of 43

Education and

Training

Components

Competence Adequacy of knowledge Adequacy of skills Length of experience Quality of experience Task familiarity Testing and Assessment

Supervision Adequacy of supervision Availability of mentorship Adequacy of mentorship

Availability /

accessibility

On the job training Emergency Training Team training Core skills Training Refresher courses

Appropriateness Content Target audience Style of delivery Time of day provided

Equipment Components

Displays Correct information Consistent and clear information Legible information Appropriate feedback No interference

Integrity Good working order Appropriate size Trustworthy Effective safety features Good maintenance programme

Positioning Correctly placed for use Correctly stored

Usability Clear controls User manual Familiar equipment New equipment Standardisation


J.Rix.V9. of 43

Work Environment

Factor

Component

Administrative

factors

The general efficiency of administrative systems e.g. reliability Systems for requesting medical records Systems for ordering drugs Reliability of administrative support

Design of physical

environment

Office design: computer chairs, height of tables, anti-glare screens, security screens, panic buttons, placing of filing cabinets, storage facilities, etc.

Area design: length, shape, visibility, cramped, spacious

Environment Housekeeping issues – cleanliness Temperature Lighting Noise levels

Staffing Skill mix Staff to patient ratio Workload / dependency assessment Leadership Use Temporary staff Retention of staff / staff turnover

Work load and hours

of work

Shift related fatigue Breaks during work hours Staff to patient ratio Extraneous tasks Social relaxation, rest and recuperation

Time Delays caused by system failure or design Time pressure

Organisational Factor

Components

Organisational

structure

Hierarchical structure, not conducive to discussion, problem sharing, etc.

Tight boundaries for accountability and responsibility Clinical versus the managerial model

Priorities Safety driven External assessment driven e.g. Star Ratings Financial balance focused

Externally imported

risks

Locum / Agency policy and usage Contractors Equipment loan PFI

Safety culture Safety / efficiency balance Rule compliance Terms and Conditions of Contracts Leadership example (e.g. visible evidence of commitment to

safety) Open culture


J.Rix.V9. of 43

Patient Factors Components

Clinical condition Pre-existing co-morbidity Complexity of condition Seriousness of condition Treatability

Social factors Culture / religious beliefs Life style (smoking / drinking / drugs / diet) Language Living accommodation (e.g. dilapidated) Support networks

Physical factors Physical state – malnourished, poor sleep pattern, etc.

Mental/

psychological factors

Motivation (agenda, incentive) Stress (family pressures, financial pressures) Existing mental health disorder Trauma

Interpersonal

relationships

Staff to patient and patient to staff Patient to patient Inter family – siblings, parents, children


J.Rix.V9. of 43

Fishbone (NB: only to be used with classification framework)

Patient factors:

Clinical condition

Social factors

Physical factors

Psychological / mental factors

Interpersonal

relationships

Individual (staff) factors:

Physical issues

Psychological

Personality

Social / domestic

Task factors:

Guidelines /

procedures /

protocols

Decision aids

Task design

Communication factors:

Verbal

Non-verbal

Written

Electronic

Team + social factors:

Role congruence

Leadership

Support + cultural factors

Education + Training Factors:

Competence

Appropriateness

Availability

Accessibility

Supervision

Equipment + resources:

Equipment supplies

Visual display

Integrity

Positioning

Usability

Working condition factors:

Environment

Design of physical environment

Administrative

Staffing

Time / workload

Organisational + strategic factors:

Organisational structure

Policy, standards, goals

Externally imported risks

Safety culture

Priorities

Problem

or issue

(CPD/SDP)


J.Rix.V9. of 43

BARRIER ANALYSIS

*Strong, Medium, Weak

Activity:

Hazard(s)/Issue What Barriers are in

place?

Importance to

safe practice?

How

effective?

S / M / W*

What additional barriers are

required?

How

effective?

S / M / W*

Cost

Implications

Who’s

responsibility?


J.Rix.V9. of 43

Action Plan (Title)

* Strong, Medium, Weak

Recommended

Action

Action Control*

S

M

W

By Whom By When Actual

Completed

Date*

Progress/Remarks Monitoring

For

Compliance

1

2

3

4


J.Rix.V9. of 43

Appendix 1: PTR Grading and Risk Ratings

Example Risk Rating Matrix - SIMPLE RISK QUANTIFICATION

AS/NZS 4360:1999 Risk Management defines risk as “The chance of something happening

that will have an impact on objectives. It is measures in terms of consequences and

likelihood”. Risk = Severity / Impact Likelihood

ESTIMATING RISK- QUALITATIVE MEASURES OF CONSEQUENCE (Impact / severity)

ESTIMATING RISK QUALITATIVE MEASURES OF LIKELIHOOD Whilst taking account of the controls in place and their adequacy, how likely is it that such an incident could occur?

5 Almost Certain Likely to occur on many occasions

4 Likely Will probably occur but is not a persistent issue

3 Possible / Moderate Do no expect it to happen but it is possible

2 Unlikely May occur occasionally

1 Rare Can’t believe that this will ever happen

Level Descriptor Actual or Potential

impact on individual

Actual or

Potential impact

on organisation

Number of

Persons

affected

The potential for

complaint /

litigation

5 Catastrophic DEATH

Sentinel event, Toxic offsite

Release

National Adverse

publicity, WG

investigation

Many, e.g. cervical screening disaster, evacuation etc.

Litigation expected /

Certain

4 Major Long Term Sickness. Permanent Injury Loss of body part(s), Mis-diagnosis, poor prognosis, RIDDOR Reportable Injury

Service closure RIDDOR reportable

Moderate number e.g. loss of

specimens etc

Litigation expected / Certain

3 Moderate SEMI-PERMANENT INJURY / DAMAGE e.g. taking up to 1 year to resolve

Needs careful PR, RIDDOR & MHRA Reportable Short Term Sickness

Small numbers e.g. 3 - 10

Litigation possible but not certain. High potential for complaint

2 Minor SHORT TERM – INJURY / DAMAGE e.g. injury that has been resolved in 1 month

Minimal Risk to organisation

One Complaint possible Litigation unlikely

1 Insignificant / Negligible

NO INJURY OR ADVERSE OUTCOME

No Risk to the Organisation

0-1 Unlikely to cause complaint Remote risk of litigation


J.Rix.V9. of 43

RISK RATING CHART

Likelihood Severity/Impact

1 Insignificant

2 Minor

3 Moderate

4 Major

5 Catastrophic

1 - Rare 1 2 3 4 5

2 - Unlikely 2 4 6 8 10

3 - Moderate 3 6 9 12 15

4 - Likely 4 8 12 16 20

5 - Almost Certain

5 10 15 20 25

No Action this

12 months

Action within 12 months

Urgent Action

2 PTR GRADING FRAMEWORKS FOR DEALING WITH ALL CONCERNS

The All Wales grading framework is based on a risk matrix developed by the National Patient Safety Agency 1 and has been used to assess and manage risks and incidents. This approach has been built on to develop a framework for determining the level of investigation required in dealing with all types of concerns in order to promote a consistent approach across NHS Wales. The impact or harm experienced by the patient is always the overriding factor for grading concerns. The harm grading is dynamic in nature and must be considered throughout the investigation. Due consideration should also be given to the potential for litigation, regardless of the harm grading. However there may be situations where the grading of harm is low i.e. a grade 2, but there is indication there they will be pursuing a claim. The examples listed are meant only to be a guide and not an exhaustive list. Grade

Harm Examples of concerns Consider potential for qualifying liability / Redress

J.Rix.V9. of 43

1 None a) Concerns which normally involve issues that can be easily / speedily addressed; b) Potential to cause harm but impact resulted in no harm having arisen; c) Outpatient appointment delayed, but no consequences in terms of health;, d) Difficulty in car parking; e) Patient fall – no harm or time of work; f) Concerns which have impacted on a positive patient experience.

Highly unlikely

2 Low a) Concerns regarding care and treatment which span a number of different aspects/specialities; b) Increase in length of stay by 1 - 3 days; c) Patient fall - requiring treatment; d) Requiring time off work - 3 days; e) Concern involves a single failure to meet internal standards but with minor implications for patient safety;

Unlikely

J.Rix.V9. of 43

Moderate Serious

Concern occurs

Concern graded

(Putting Things Right & Risk Grading) (Appendix 2)

Appropriate Manager & Patient Safety Department Informed.

Immediate action taken to make situation safe by local team

Reported to Quality & Safety Mgnt. Board

Exec. Lead Identified Investigation Group Identified Ward/Local Manager to investigate with a number of staff

Consider if concern should be escalated &

included on risk register

Reported to local group

Consider if concern should be included on local risk register

1st test of Incident Decision Tree initiated by

appropriate manager

o Was there Intended Harm?

Being Open Conversation Initiated

o Contact with patients/carers

Appropriate Support Provided

De-brief staff involved in the incident &

keep them informed

Solutions Work/ Recommendations. Solutions to be developed with ownership by local managers.

Implementation of solutions – the responsibility of local manager

WHAT happened?

HOW it happened WHY it happened

Solution Development

Chronology

Unsafe Act Care & Service Delivery Problems (CDP/SDP) Contributory Factors Fix what is broken

Tabular Timeline

Tabular Timeline/Brainstorming/Change Analysis

Classification Framework Five Ways/Brainstorming

Barrier Analysis Plan,

Do, Study, Act (PDSA)

Consider if concern can

be managed & closed

immediately at source

Appendix 2 Key Stages in the Investigation and Management of Concerns

J.Rix.V9. of 43

Sign off: exec Board & Welsh Government Serious Incident Report

how to learn lessons from concerns - patient safety wales · 2016-02-02 · appendix 1 – ptr...

Documents