Prospective Hazard Analysis James Ward

Prospective Hazard Analysis (PHA)
Looking for Trouble
James Ward
Background
Dr James Ward, EDC, Univ. of Cambridge
Objectives
1. Retrospective / Prospective risk management

2. Prospective Hazard Analysis (PHA)
a) What, why, how, etc.
b) Urgent Cancer Referral Process in the ED
Work in progress
Some limitations of RCA

RCA is a good idea but
Costs (NHS / Staff / Patients, etc.)
Rawness can influence investigation:
these incidents drive an ever-increasing

ratchet of greater security and more intensive
containment, with ultimately unknown effects.
(Bowers et al., 2006)
Bowers, L. et al., 2006. Serious untoward incidents and their aftermath in acute inpatient psychiatry: The
Tompkins Acute Ward Study. International Journal of Mental Health Nursing, 15(4), pp.226-234.
4
Some limitations of RCA Risk controls

Systematic literature review of RCAs (n=60). Mostly US articles:
1. RCA takes time 30-40 person-hours
2. < reported on the risk controls; ~ risk controls were
implemented
3. 2/3 risk controls were administrative.
4. ~ studies reported effects.
5. risk controls based on training and education were negatively
correlated with improved outcomes that is, they made things
worse.
Some limitations of RCA Scope

A good RCA may not be enough:
Strictly, it focuses only on reducing risk of
incident reoccurring in exactly the same way
RCA tells us what HAS HAPPENED,

not what COULD HAPPEN
Some limitations of RCA Scope
Visible / known
RCA: what HAS HAPPENED

PHA: what COULD HAPPEN
You can see the tip of the iceberg,

but what lies beneath?
Not so visible / unknown
How much more underneath than above? ~90%?
Even if we do a good RCA, do the same incidents keep coming back?
Getting to know the known unknowns and the unknown unknowns

Reports that say that something hasn't
happened are always interesting to me,
because as we know,
there are known knowns; there are things
we know we know.
We also know there are known unknowns;
that is to say we know there are some things
we do not know.
But there are also unknown unknowns
the ones we don't know we don't know.
Donald Rumsfeld, 2002, Former US Secretary of Defense, and

Plain English Campaign Foot in Mouth Award Winner, 2003
8
Retrospective vs. prospective risk management

How do we work out known/unknown unknowns?
We should go further than just reactive risk management
RCA a GOOD thing, but not the ONLY thing
Retrospective vs. Prospective risk management

A balance to be struck?
4
Retrospective
Prospective
8
?
Where are we now?
Where should we be?
10
PHA
11
The PHA project

1.
2.
3.
4.
5.
6.
12
Background
Project outline
PHA Toolkit content
Lessons learned
Future work
Questions
PHA Background
greenstreet berman
Sponsors: Patient Safety Research Portfolio, Univ. of Bham / DH

Dec. 2006 Dec. 2009
Report published Oct. 2010.
13
PHA Background
What COULD go wrong?
PHA aims to help work out
whats down there
Aim: Produce a Toolkit of proactive risk assessment methods

NHS Friendly
Provide risk assessment
framework
Ask the right questions!
Describe the system
14
PHA Methods
How to choose the methods
How to use the methods
The PHA project

1.
2.
3.
4.
5.
6.
15
Background
Project outline
PHA Toolkit content
Lessons learned
Future work
Questions
PHA Project outline
Understand current practice and

identify users requirements
Create PHA
Guidance
Identify and
characterise PHA
methods
16
PHA Project outline
Evaluate PHA Toolkit through case studies in

different NHS settings
17
Update Toolkit and

launch to NHS
The PHA project

1.
2.
3.
4.
5.
6.
18
Background
Project outline
PHA Toolkit content
Lessons learned
Future work
Questions
PHA Toolkit content (general characteristics)

1. Proactive
2. Holistic / systemic
3. Systematic / structured
a. In analysis of parts of the system
b. In the method used to analyse it
= Complete
4. Flexible
5. Iterative
6. Self-documenting
19
PHA Toolkit content
20
PHA Toolkit content
Preliminary
risk review
Requirements
Trigger
Active
risk
management
Comprehensive
risk asst
Actions
21
PHA Toolkit content general process

1) Trigger: why undertake a review?
2) Articulate purpose: what is the purpose
of the review?
3) Define requirements: who, what, when?
4) Describe system: what is to be
assessed?
5) Identify hazards: what could go wrong?
6) Assess risks: will it go wrong?
7) Propose actions: what actions are
required?
8) Review process: what next?
Some similarities with RCA both are risk management

Scope of assessment and detail of methods different
22
PHA Toolkit content Urgent Referral from the ED
Case study
23
PHA Toolkit Preliminary Risk Review

Trigger for the review (tick all that apply):
1) Background:
Why undertake a review?
(a) an incident
(b) local concerns
(c) routine health check

(d) service improvement
Identify the nature of the trigger for the

review and provide brief details of its
source.
(e) new service

(f) technology introduction
(g) new staff
(h) external directive
(i) other
specify ...................................................
...................................................
Details of trigger
Serious Incident (SI)

10/09 Male presented chest pain and cough investigated for
PE lung cancer? Form completed for referral, but filed in
notes without action.
03/10 Presented to GP fast-tracked to clinic. When notes
pulled referral discovered.
Administrator had raised prior concerns regarding referral
process.
24
PHA Toolkit content
id.
Z
A
B
C
D
E
F
Component
Deviation
Infusion pump Elevated flow

Referral / patient
told
Patient not told
Referral not drafted

or drafted incorrectly
Letter ambiguous or
Discharge letter
incomplete
Letter does not get
to GP
Not
done or
Discharge summary
incomplete
Letter taken to tray Letter not put in
tray
Referral made
Concern
Hazard
Defence(s)
Yes
Overdosing
Check setting
Yes
Yes
Yes
Yes
Yes
Yes
Fax referral letter
No confirmation
Yes
Acceptance of
referral
Referral refused
Yes
Appointment made
Yes
Accepted, but no
action
Patient not made
aware of appointment
Yes
Induction, supervision,
routine practice
Routine
practice,
Referral not drafted
alert consultant / GP
Routine practice,
Letter ambiguous
admin provide advice
Routine practice,
Letter lost
GP returns patient
Summary incomplete Ward clerk checks,
cannot obtain drugs
Routine practice,
Letter not in tray
patient safety alert
Receipt not confirmed Confirmation request,
routine practice
Escalation
to senior
Referral refused
staff
Routine practice,
No appointment
culture, patient
Appointment
letter,
Patient not aware
chased by phone
Patient not told
Like Imp Risk
Risk
Action(s)
Like Imp Risk
Overdose
Check bloods
Patient unaware, does Patient told verbally

not expect referral
and in writing
15
16
10
No appointment
Checklist for clinicians
10
GP does not know

about cancer
GP does not know
about cancer
GP does not know
about cancer
Checklist,
senior review
Immediate handover,
CDU tray, checklist
Investigate merits of
tray clearing process
10
10
10
12
15
No referral made
10
No referral made
No referral made
10
No appointment made Consult with admin

staff re: tracking
Non-attendance
K
L
M
N
O
P
Q
R
S
T
25
PHA Toolkit content
Good news! Some overlap with some RCA techniques:

*Options Appraisal (proactive) or *Impact Analysis (retrospective) - Template (*delete as appropriate)
Flexible add in or remove columns
26
PHA Toolkit Preliminary Risk Review

Reason for further assessment (tick as many as apply):
8) Review process:
What next?
In most cases further assessment is
required to fully explore the risks within a
system. This being the case, identify the
reason for further assessment.
Provide clear recommendations for further

assessment, noting any specific actions
required prior to undertaking the
assessment.
(a) risk reduction actions have been identified
(b) lack of confidence in the results
(c) preliminary review is incomplete
Recommendations for further assessment
Complete further analysis with wider team (GP, IT, ED admin,

cancer admin, cancer clinic)
Confirm process assumptions (flow diagram may be useful)
Confirm likelihood assumptions (fault tree may be useful)
Actions required
Implement immediate changes to cancer tray

Implement immediate changes to ensure patient is told of
cancer and provide standard notification highlighting expected
timing of appointment and action if no notification
Consult IT with regard to possible IT reminders
Investigate the use of checklists
27
PHA Toolkit content
28
PHA Toolkit content System mapping
System mapping
Important for systemic and systematic

assessment
Difficult known unknowns and unknown
unknowns
29

Setting the boundaries (breadth)
Where to shine the light
Level of detail
How intense the light should be
Diagramming method(s) (system views)
Lighting angle(s) different views
How many lights to shine multiple views
30

Idef0
Process
Data-flow
Communication
Sequence
Flow
State
Stakeholder
Information
Swimlane
chart
diagram
transition
diagram
diagram
diagram
diagram
diagram
diagram
diagram
diagram
31
People
Objects
Places
Tasks
Environment
Timing
Culture and norms
Information
32
PHA Toolkit content Risk Assessment methods
33

Flexible
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
34
SWIFT
HAZOP
Influence diagram
FMEA
HEART
Barrier analysis
APJ
Event tree
Fault tree
Risk matrix

1.
2.
3.
4.
Bottom-up methods
Top-down methods
Human error-centred
Guide words:
5. What happens if?
Too soon
Too late
Omitted
Wrong direction
Wrong order
Wrong person
Too much
Too little
Difficultly
System complexity
Need for software, etc.
35
Example 1 Bottom-up FMEA

3.3 Splitting packs
3.4 Labelling medication
3.5
Consider all the steps

and how they could fail
Various versions of FMEA tables

FMEA has been used extensively in healthcare, relative to other PHA methods
36
Example 2 Top-down Fault Tree Analysis

Top Event
Logic gates
Intermediate and
Basic events
Probabilities
5 whys similarity
37
Example 2 FTA Urgent Cancer Referral in the ED

1. Top event no f/u of suspected cancer
2. Starting conditions Pt. self-presents to ED. No prior knowledge
of med. condition.
3. Boundary focus on CUH, with consideration of other processes
Illustration Work in progress!

Difficult to present on PowerPoint
38

1.
2.
3.
4.
Referral form not processed as expected

GP did not use the email box used by hospital
Results reporting alert system failed
The MDT alert email was not reviewed
GP and
2
Pt. checks
3
39

1 NoAccessTray
2 TrayNotKnown
3 LostAfterTray
4 DraftedIncorr
5 NoOneToAsk
6 TrayLost
2.0E-001
2.0E-001
1.0E-001
5.0E-002
5.0E-002
5.0E-002
39.0%
39.0%
19.5%
9.8%
9.8%
9.8%
GP and
Pt. checks
4
3
40
Trust wide internal cancer pathway to be agreed
ED to issue patient safety alert detailing process for referring these patients
IT to undertake review to ensure all consultants are included on radiology ALERT system
IT to implement new joiner system
Trust to work towards all GPs receiving electronic discharge summaries by agreed date
GP liaison to confirm all email addresses with GPs
GP liaison to implement a system of regular review of these addresses
Author of results reporting policy to review the policy and ensure all parties aware of
responsibilities
Clinical coding department to reinforce their practice for unfilled notes
Patient leaflet why have I been referred to be designed and issued to appropriate patients
on discharge
41
BUT4 near misses in last few months
42

GP and
Pt. checks
Incident 2
Incident 3
Incident 4
Incident 5
Incident 5
Incident 3
Incident 5
Incident 2
Incident 5
43
Can show a hierarchy of most effective areas for risk control based on probability
of contribution to the top event
Can show where is largest effect for minimum cost
Can consider more radical strategies e.g. adding in AND gates
Consider common-mode failures e.g. ignorance of procedures
Disagrees with recommendations made (note work in progress).
Working on cost effectiveness calculation.
44
Example 3 HEART
1 Describe the task
2 Assess the Nominal Error Rate
3 Consider Error Producing Conditions

- Unfamiliarity
- Shortage of time
- Distractions
4 Calculate Nominal
Likelihood of Human
Failure
45
Example 3 HEART
Populate the Fault Tree!
46
The PHA project

1.
2.
3.
4.
5.
6.
47
Background
Project outline
PHA Toolkit content
Lessons learned
Future work
Questions
Conclusions
1.
A challenging project!
2.
Little reported use of PHA methods in the NHS
3.
Little evidence of proactive, systematic or systemic risk assessment in NHS
4.
Toolkit was new to staff
5.
Staffs attitude towards PHA Toolkit was cautiously positive
6.
Some barriers for use in the NHS:

a) Time / resources
b) Culture / language / experience
c) System complexity
d) System change
e) Availability of accurate data
f)
7.
The QIPP Gap
Training of facilitators + mapping
Some enablers:
15 to 20 bn
a) Cost saving radical rethink

b) New developments
48
Key messages
1. RCA not enough on its own shows what HAS gone wrong
2. PHA helps to show what COULD go wrong
3. We should be more proactive, but this wont be easy
4. Mapping provides structure, which is the foundation for a comprehensive
assessment
5. PHA methods provide structure, also to assist with comprehensive PHA
6. PHA not all new overlap with RCA dealing with the same stuff, but
from a forwards perspective
7. RCA may complement PHA
8. Surely we should be AT LEAST doing PHA on new services
49
The PHA project

1.
2.
3.
4.
5.
6.
50
Background
Project outline
PHA Toolkit content
Lessons learned
Future work
Questions
PHA plans
1. Developing the Toolkit
2. PHA background evidence
a) PHAs how much did they cost?
b) Recommendations quality / effect?
3. PHA training course
51
The PHA project

1.
2.
3.
4.
5.
6.
52
Background
Project outline
PHA Toolkit content
Lessons learned
Future work
Questions
For further information

James Ward
Engineering Design Centre
Department of Engineering
University of Cambridge
jrw38@cam.ac.uk
53

Prospective Hazard Analysis James Ward

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Prospective Hazard Analysis (PHA)

Looking for Trouble

Dr James Ward, EDC, Univ. of Cambridge

1. Retrospective / Prospective risk management

Dr James Ward, EDC, Univ. of Cambridge

Some limitations of RCA

these incidents drive an ever-increasing

Dr James Ward, EDC, Univ. of Cambridge

Some limitations of RCA Risk controls

Dr James Ward, EDC, Univ. of Cambridge

Some limitations of RCA Scope

RCA tells us what HAS HAPPENED,

Dr James Ward, EDC, Univ. of Cambridge

Some limitations of RCA Scope

RCA: what HAS HAPPENED

You can see the tip of the iceberg,

Dr James Ward, EDC, Univ. of Cambridge

Getting to know the known unknowns and the unknown unknowns

Donald Rumsfeld, 2002, Former US Secretary of Defense, and

Dr James Ward, EDC, Univ. of Cambridge

Retrospective vs. prospective risk management

Dr James Ward, EDC, Univ. of Cambridge

Retrospective vs. Prospective risk management

Dr James Ward, EDC, Univ. of Cambridge

Dr James Ward, EDC, Univ. of Cambridge

The PHA project

Dr James Ward, EDC, Univ. of Cambridge

Sponsors: Patient Safety Research Portfolio, Univ. of Bham / DH

Dr James Ward, EDC, Univ. of Cambridge

Aim: Produce a Toolkit of proactive risk assessment methods

The PHA project

Dr James Ward, EDC, Univ. of Cambridge

PHA Project outline

Understand current practice and

Dr James Ward, EDC, Univ. of Cambridge

PHA Project outline

Evaluate PHA Toolkit through case studies in

Update Toolkit and

Dr James Ward, EDC, Univ. of Cambridge

The PHA project

Dr James Ward, EDC, Univ. of Cambridge

PHA Toolkit content (general characteristics)

Dr James Ward, EDC, Univ. of Cambridge

PHA Toolkit content

Dr James Ward, EDC, Univ. of Cambridge

PHA Toolkit content

Dr James Ward, EDC, Univ. of Cambridge

PHA Toolkit content general process

Some similarities with RCA both are risk management

Dr James Ward, EDC, Univ. of Cambridge

PHA Toolkit content Urgent Referral from the ED

Dr James Ward, EDC, Univ. of Cambridge

PHA Toolkit Preliminary Risk Review

(b) local concerns

(c) routine health check

Identify the nature of the trigger for the

(e) new service

Serious Incident (SI)

Dr James Ward, EDC, Univ. of Cambridge

PHA Toolkit content

Infusion pump Elevated flow

Patient not told

Referral not drafted

Fax referral letter