Introduction to Risk Management and a Just Culture Mary Coffey - PowerPoint PPT Presentation

Introduction to Risk Management and a “Just Culture” Mary Coffey

Safety in a Radiotherapy Department — Delivery of the correct treatment to all patients in a safety aware environment ◦ Patient ◦ Staff ◦ Public

Safety in a Radiotherapy Department — Delivery of the correct treatment to all patients in a safety aware environment ◦ Radiation safety ◦ Health and safety ◦ Infection control

Risk Management – definitions of risk — Risk: The combination of the probability of an event and its consequences (ISO/IEC Guide 73) • can be opportunities for benefit or threats to success — Risks are about events that, when triggered, cause problems (ERM Initiative Faculty) — Risk is a fact of life in radiotherapy, cannot be eliminated but it can be reduced and the impact minimised

Risk Management • “There is no such thing as an accident. What we call by that name is the effect of some cause which we did not not see” Voltaire (courtesy of Rob Lee) •

Risk Management • Traditionally risk management related to the business and financial world (including aviation and the nuclear industry) • Adopted by Medical specialities • Evolved more recently to include human factors, identification of emerging risk, risk to reputation and the role of risk culture

Risk Management • In business risk can be viewed as positive or negative • In the business world the choice can be to eliminate potential risks by not engaging in certain activities – in radiotherapy this is generally not an option

Risk Management • In the safety field, it is generally recognised that the consequences are only negative and therefore the management of safety risk is focused on prevention and mitigation of harm — (A Risk Management Standard – Institute of Risk Management) — How are these factors integrated in radiotherapy risk management?

Risk Management in radiotherapy • Minimise, monitor and control the probability and or impact of unfortunate events • NOT to maximise the realisation of opportunities

Risk Management in radiotherapy • Patients have a right to expect high quality treatment delivered in a safe environment • Moral and ethical responsibility to actively address the risk associated with radiotherapy • Create an environment of openness and transparency surrounding risk and how it is managed • Gained significant momentum in recent years ◦ Media interest ◦ Generates fear and uncertainty

Risk Management in radiotherapy • “For every complex problem there is invariably a simple solution ….. …. Which is almost always wrong” H.L. Mencken (courtesy of Rob Lee)

Risk Management in radiotherapy • Over reliance on rules and regulations • Too often treated as a compliance issue that can be solved by drawing up lots of rules and making sure that all employees follow them • BP example • Emphasized personal safety and rewarded supervisors for low occupational accident rates in their teams – very good personal safety record, Glaring warning signals regarding declining process safety were not reacted to or even taken note of — (Gudela Grote, Safety Science)

Risk Management in radiotherapy • Over reliance on rules and regulations • BP example • Major disaster • Individuals not enabled to identify, evaluate, communicate and address risks they faced • Proactive risk management

Risk Management in radiotherapy • Over reliance on rules and regulations • Many rules and regulations are sensible and do result in risk reduction and damage limitation • Rules-based risk management however, will not diminish either the likelihood or impact of a disaster — Kaplan and Mikes)

Risk Management in radiotherapy • Over reliance on rules and regulations • on what to do, what not to do and how to do it can encourage a ‘checklist’ mentality restricting challenge and discussion • The lack of opportunity or environment to question can lead to • Adherence to rules that result in error • Deviations from the rules that are not formally recorded – long term potential for error

Risk Management in radiotherapy • Over reliance on rules and regulations • The nature of errors changes with expertise • Routine based errors increase • Knowledge based errors decrease

Risk Management in radiotherapy • The same underlying systemic factors may be common to many different incident scenarios, each with different combinations of triggering events and circumstances • Failures of the system rather than simply human failure

Risk Management in radiotherapy • Consider every incident as a failure of the system • review even the most minor in this context • Human error or violation will be involved but not necessarily the cause • What circumstances/conditions/etc. led to the human error violation

Risk Management in radiotherapy • Learning from near incidents and incidents • Effective risk management will ensure that reported incidents are • Investigated • Analysed • Discussed • And that • Feedback is given to staff • Appropriate changes are put in place • Reporting systems have been integrated into safety management systems in many centres (ad hoc in many instances)

Risk Management in radiotherapy • Learning from near incidents and incidents • Most incidents or errors are minor • Reflect a real opportunity for learning • The basis of voluntary reporting systems • Reporting systems (safety information systems) • Demonstrates transparency • A department putting safety as a priority • A department engaged in active learning

Risk Management in radiotherapy • Learning from near incidents and incidents • Sharing of information on incidents and near incidents with the wider radiotherapy community can enhance learning and preempt potential errors • ROSIS (Radiation Oncology Safety Information System) • SAFRON (IAEA Safety in Radiation Oncology) • PRISMA (National – The Netherlands, Belgium) • Learning is informed by international experience

Risk Management in radiotherapy • Learning from near incidents and incidents • Effective risk management enables all staff to feel comfortable identifying and discussing things that could go wrong • “Activities such as peer review, multidisciplinary team meetings and ‘safety rounds’ help to establish a sense of openness, mutual respect, group participation and responsibility” ( Marks et al. PRO 2011)

Risk Management in radiotherapy • Analysing the risk and identifying effective change • Incident and near incident reporting is one element of risk management • A tool to facilitate analysis • Identify where change will be most effective

Risk Management in radiotherapy — Analysing the risk and identifying effective change • Radiotherapy is a complex procedure • “Safety management is not rocket science • The challenge of rocket science pales in comparison to the complexities of safety management” (James Reason 2005)

Risk Management in radiotherapy — Analysing the risk and identifying effective change • Range of methodologies for analysis and change can be used • Events and Causal Factors Analysis (ECFA) • Root Cause Analysis (RCA) • Failure Mode and Effects Analysis (FMEA) • LEAN (removing unnecessary steps in the process) • Six Sigma (eliminating the root causes of defect and errors in a process)

Retrospective: Cause and Effect (Fishbone ) 8 56 37 Patient ID RT Setup Accessories Isocentre Bolus Shielding Field size SSD/FSD Wedge Unobstructed Collimator field Angle Compensator 141 Gantry Angle Couch angle TBI Screen Couch height Undefined Treatment Delivery Orientation Energy Fld re-treated Positioning Field omitted, Aids field re-treated Extra # Dose # Missed Undefined 0-4 Field omitted 5-9 10-19 Dose Pt Position 20-29 30+ 5 35

Retrospective: Events and Causal Factors Analysis Management or supervisor Systemic factors failure Too many Systemic condtions Heavy workload staff Unclear Staff not Senile Lack of Observation Lack of Contributing factors setup familiar w Patient communication equipment failure instructions patient Patient Patient Beam Beam Treatment Unit Treated wrong Primary events changed positioned on Beam selected positioned positioned Service target/isocenter treatment unit couch incorrectly incorrectly Field/target Field names Contributing factors connection confusing missing R/V design Systemic condtions flaw

Prospective: Failure Modes and Effects Analysis (FMEA) Steps in Failure Failure Failure Likelihood Likelihood Severity Risk Actions to process Mode Causes Effects of of (1-10) Priority reduce Occurrenc Detection Number Occurrenc e (1-10 (1-10) e of Failure 1 2 3 4 Total RPN RPN: Likelihood of Occurrence x Likelihood of Detection x Severity

FMEA: The steps in the process http://www.qualitytrainingportal.com/resources/fmea/fmea_process.htm