Risk management and risk response strategies in the medical laboratory

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1 Risk management and risk response strategies in the medical laboratory Jean Maritz Division of Medical Virology National Health Laboratory Service Tygerberg and Stellenbosch University

2 What is risk? And why a management nightmare?? Risk is: The effect of uncertainty on objectives or, the prospect of pain or the potential for gain Uncertainty consists of two pillars: 1. Measurable risk ( known knowns ) 2. Immeasurable risk ( known unknowns and unknown unknowns ) Because we can only measure the measureable risk calculations are always incomplete, and always in a way that we can never know how incomplete

3 The root cause of risk It is impossible to know every factor that can or will influence an outcome: 1. All events are cause/effect occurrences but often the cause is too obscure to be detected 2. Cause and outcome may be non-linear or non-proportional (small causes may have big effects) 3. The greater the interval between cause and effect, the less likely that the relationship will be recognised

4 What game and chaos theory teach about addressing risk You can never completely predict a cause or an outcome Risk is not a fixed measurement; it is mutable by events and susceptible to change Look to the best, but plan for the worst To the extent possible, reduce surprise by increasing information

5 Why is risk management important We analyze thousand of samples from which we derive patient and management information Poor information can lead to poor outcomes Our samples have some variables that we can control, and others that are difficult to control, and others that we can not either foresee or control for medical laboratories? Regardless of contributing events, the laboratory is usually viewed as the source of the problem

6 The medical laboratory s risk footprint

7 Risk management and impact on resources Error Resources

8 When is risk reduction enough? Error Resources????

9 When is risk reduction enough? Error Resources QC Audit EQA Consultant

10 Medical laboratory standards on quality and risk ISO 15189:2012 Medical Laboratories: requirements for quality and competence ISO 22367: 2008 Medical laboratories: Reduction of error through risk management and continual improvement Quality Management Framework Risk Management Framework

11 Risk reduction through quality systems Predominantly based on ISO 15189:2012 External quality assurance programmes (EQA) and other external audit Internal audits Preventive actions Identifying opportunities for improvement Corrective actions management

12 Risk reduction tools Outcome focused tools: Severity-occurrence grid SWOT analysis Precision focused tools: Failure mode studies, e.g. failure mode effects analysis (FMEA)

13 FMEA Examine every step of the procedure or process Consider every way in which it could fail Develop an alternative strategies for each potential failure (new monitoring, new procedure) Reassemble the process with new safeguards in place Thorough Systematic Lengthy Detailed Useful in a setting where there is a lot of information and control

14 Severity-occurrence grid Consider only two major issues about potential negative outcomes How terrible could the outcome be? How frequent could it occur? Less complete than FMEA Broad brushstroke approach Helpful to assist decision making Useful in a setting where risk is a concern but circumstance and control is less rigid

15 Severity-occurrence analysis

16 Severity-occurrence analysis Example: Severity in a microbiology laboratory

17 Severity-occurrence analysis

18 Severity-occurrence analysis

19 Risk level and decision making High risk does not necessarily mean absolutely avoid Low risk does not necessarily mean forget about it BUT risk level sets the level of responsibility for RISK DECISION MAKING

20 Decision making for risk Factors that may impact risk decision making: Safety Cost Liability Confidence Reputation Alternatives/choices Can you mitigate the risk? Can you share the risk?

21 Using S-O analysis for risk mitigation

22 Using S-O analysis for risk mitigation

23 Using S-O analysis for risk mitigation

24 Partnering to reduce risk

25 In summary 1. Accept that the nature of risk is uncertainty 2. A quality management system can considerably reduce the opportunity for significant errors 3. Laboratories should develop strategies to incorporate risk management techniques within the quality management system to prevent error 4. Such strategies will never prevent all adverse events, but can prevent or identify many potential causes of error 5. Risk management tools require a team effort as well as thoughtful time

Risk Management in the Medical Laboratory: Reducing Risk through Application of Standards

Risk Management in the Medical Laboratory: Reducing Risk through Application of Standards Michael A Noble MD FRCPC Chair, Program Office for Laboratory Quality Management University of British Columbia