Prospective Hazard Analysis (PHA) Proactive risk assessment Looking for Trouble

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1 Prospective Hazard Analysis (PHA) Proactive risk assessment Looking for Trouble James Ward

2 Views on risk assessment? 2

3 Outline 1. Good practice in risk assessment 2. The PHA Toolkit 3. Case studies using the PHA Toolkit 4. Feedback on the PHA Toolkit 5. PHA future 6. Conclusions A taster of what PHA looks like 3

4 Retrospective vs. Prospective risk management A shift in the balance? Retrospective 1 9 Prospective Limitations 4

5 Risk assessment 5

6 Risk assessment An evidence-based decision making process Universal: All decision making, whatever the level of importance and significance, involves the explicit consideration of risks and the application of risk management to some appropriate degree. (BS ISO 31000: 2009) Versatile: Can be applied to work processes, and strategies and decisions, operations, processes, functions, projects, products, services and assets and to any type of risk (BS ISO 31000: 2009) Part of a design process: It is essential that risks are identified systematically from the early stages of planning a project. A system of risk management should be introduced that works effectively alongside the creative work. (BS :2008) 6

7 Risk management and Design for Patient Safety BUILD KNOWLEDGE BASE PROVIDE SAFE MEDICAL CARE DEFINE THE REQUIREMENTS EVALUATE THE MEDICAL SYSTEM DESIGN THE PRODUCT(S) DESIGN THE MEDICAL SYSTEM DELIVER THE MEDICAL SYSTEM MANAGE RISK 7

8 PHA Toolkit outline 8

9 Some aims / features of the PHA Toolkit Aim: distil good risk practice down into a Toolkit for NHS use: 1. Proactive 2. Holistic 3. Systematic 4. Flexible 5. Self-documenting 6. 9

10 The PHA Toolkit 10

11 PHA Toolkit Some questions it asks 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? 11

12 PHA Toolkit A template 12

13 PHA Toolkit A table for decision making A customisable table for risk-based decision making: Components Deviations Risks Etc. id. Component Deviation Concern Hazard Defence(s) Like Imp Z A B C D E F Infusion pump Elevated flow Yes Overdosing Check setting 3 5 Referral / patient told Referral made Discharge letter Discharge summary Letter taken to tray Patient not told Referral not drafted or drafted incorrectly Letter ambiguous or incomplete Letter does not get to GP Not done or incomplete Letter not put in tray Yes Yes Yes Yes Yes Yes Patient not told Referral not drafted Letter ambiguous Letter lost Summary incomplete Letter not in tray Induction, supervision, routine practice Routine practice, alert consultant / GP Routine practice, admin provide advice Routine practice, GP returns patient Ward clerk checks, cannot obtain drugs Routine practice, patient safety alert Risk Risk Action(s) Like Imp Risk 15 Overdose Check bloods Patient unaware, does not expect referral No appointment GP does not know about cancer GP does not know about cancer GP does not know about cancer No referral made Patient told verbally and in writing Checklist for clinicians - - Checklist, senior review Immediate handover, CDU tray, checklist

14 PHA Toolkit three key points 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? A Describing systems C Risk Ass t Techniques B Linking 14

15 A) Describing systems 15

16 Describing systems engineered systems How do you describe a system? Fly For Fun Boeing

17 Describing systems healthcare work systems? People Objects Places Tasks Timing Environment Culture and norms Information 17

18 Describing systems healthcare work systems? John John Varied smoker Fire setter Sectioned New admission Drug-induced psychosis, florid V, caring parents Against smoking 18

19 B) Linking systems descriptions to risk assessment techniques 19

20 Preliminary Risk Review / Linking diagrams and the risks Sources of harm provide an information feed to help systematically assess the risks 20 id. Component Deviation Concern Hazard Defence(s) Like Imp Z A B C D E F Infusion pump Elevated flow Yes Overdosing Check setting 3 5 Referral / patient told Referral made Discharge letter Discharge summary Letter taken to tray Patient not told Referral not drafted or drafted incorrectly Letter ambiguous or incomplete Letter does not get to GP Not done or incomplete Letter not put in tray Yes Yes Yes Yes Yes Yes Patient not told Referral not drafted Letter ambiguous Letter lost Summary incomplete Letter not in tray Induction, supervision, routine practice Routine practice, alert consultant / GP Routine practice, admin provide advice Routine practice, GP returns patient Ward clerk checks, cannot obtain drugs Routine practice, patient safety alert Risk Risk Action(s) Like Imp Risk 15 Overdose Check bloods Patient unaware, does not expect referral No appointment GP does not know about cancer GP does not know about cancer GP does not know about cancer No referral made Patient told verbally and in writing Checklist for clinicians - - Checklist, senior review Immediate handover, CDU tray, checklist

21 C) Risk assessment techniques 21

22 Many risk assessment techniques! Just a few of them: FMEA HFMEA THERP SLIM-MAUD FMECA HRMS HEART PHA APJ HACCP CREAM FTA HAZOP ST-PRA SWIFT SHERPA ETA TRACEr PRA JHEDI ATHEANA 22

23 Types of technique Checklists and standards Inductive What happens if? Deductive How could x happen? (Sherlock Holmes) Guidewords Human error (Human Reliability Assessment) PHA Toolkit selected a nominal 10 techniques with potential in the NHS 23

24 Human Reliability Assessment techniques it is important that due recognition is given to human and organizational factors when identifying risk. (BS EN ISO 31010: 2010) THERP SLIM-MAUD HRMS HEART SHERPA APJ 24 CREAM ATHEANA JHEDI THEA TRACEr

25 Systematic Human Error Reduction and Prediction Approach 1) Describe the tasks (Hierarchical Task Analysis) 2) Classify the tasks (Action / Retrieval / Checking / Selection / Information communication) 3) Consider the error modes (Guidewords: e.g. too long / wrong operation on right object) 4) Consider and rate the probability of occurrencee 5) Consider and rate the consequences 6) Consider the opportunities for error recovery 7) Consider remedial measures Linking Wrong information communicated Hospitals prescribe things they are not supposed to Budget consequences you get into trouble with PCT for prescribing certain drugs stressful for GP No M H More meetings between GP and hospital doctors Lyons, M.N., Ward, J.R., Barclay, S., Anderson, J., Buckle, P. And Clarkson, P.J. (2007) 'The feasibility of applying a systematic human error reduction and prediction approach (SHERPA) in healthcare: a case study of repeat prescribing in primary care' in Patient Safety Research Shaping the European Agenda, Porto, Portugal 25

26 PHAs done / ongoing 26

27 PHAs done and ongoing A = Acute, M = Mental Health, C = Community Medication (A) Violence (M) Ward closure (A) Perioperative Information (A) New screening process (A/C) Clinical documentation (A) Smoking (M) Door security (M) Physical journeys through a building (M) Urgent referral process (A) Admission of patients (M) Active Shooter response (A) Trauma Network (A/C) 27

28 PHA Feedback 28

29 Results Selected comments You talk about attitudes and I think that s the main thing that I ve suddenly had a change in! Actually this is quite important, and not because somebody s asked me to do it. [Junior Doc] These sessions are hugely beneficial; I ve learned so much. [But] speaking to people throughout the week that I ve been trying to explain it to them, they have gone rather glassy-eyed and [there s] jaw-dropping, and I ve said well it s not as bad as it sounds. [Nurse] The feedback has been unanimously positive in supporting the use of the tool as it has enabled the team to have confidence around each issue we have explored in depth and arrive at the correct decision. [Senior manager] [This has] saved money & significant clinical time, risk. [Senior manager] The idea of PHA within the NHS is clearly laudable. Anything that moves our view of medicines risks from reactive "why things went wrong" to proactive "how we can ensure a safe proactive environment" is to be applauded - but requires a major cultural change! [Senior Manager] 29

30 Some limitations 30

31 Limitations of PHA Clearly the profile and level of the risk in healthcare is generally different to that in e.g. nuclear power, where single incidents can cause major losses Resources and the opportunity cost System change and system diversity Quality of the data The counterfactuals Training staff and facilitators Culture of openness and analysis? Need for continuous process 31

32 What next with PHA? 32

33 PHA future 1. Developing the Toolkit 2. PHA evidence is it worth it 3. PHA training course 4. PHA marketing? 33

34 Conclusions 1. PHA readdress the reactive / proactive balance in risk management. 2. Extremely broad applicability supports decision making. 3. Appropriate? Tricky balancing act: e.g. limited resources vs. comprehensiveness and assurance 4. Positive feedback and effects (e.g. culture), but still much to do! 34

35 Thank you greenstreet berman James Ward Engineering Design Centre Department of Engineering University of Cambridge 35

36 Report and early version of the Toolkit: Google: PHA PSRP Or: 36

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