Dr. Sami A. R. J. El Jundi, MD, MScForensic Advisor & Risk Analyst

Medico-legal Expert in Medical Malpractice LawsuitsCoordinator of the Medical Law Postgraduate Course at VJ/Porto Alegre

In politics, “law and order” refers to demands for a strict criminal justice system, especially in relation to violent and property crime, through harsher criminal penalties.Supporters of "law and order" argue that effective deterrence combined with incarceration is the most effective means of crime prevention.Opponents of law and order argue that a system of harsh criminal punishment is ultimately ineffective because it does not address underlying or systemic causes of crime.

http://en.wikipedia.org/wiki/Law_and_order_(politics)

Plastic surgeons charged for second-degree murder (a killing caused by dangerous conduct and the offender's obvious lack of concern for human life)Criminal prosecution by the DA’s OfficePhysicians facing the risk of incarceration due to patient lossCriteria for charging: “procedure futility” and “unproportional damage” (res ipsa loquitur)

A body of knowledge (methodology) that evaluates and derives a probability of an adverse effect of an agent (chemical, physical, or other), industrial process, technology, or natural process.Definition of an "adverse effect" is a value judgement.

Risk analysis applied in a particular situationDeal with health effects or, more recently, with the ecological health or economic well-being (in case of business risk analysis).

1. Hazard (agent) identification2. Dose-response relationship (how is quantity,

intensity, or concentration of a hazard related to adverse effect)

3. Exposure analysis (who is exposed? to what and how much? how long? Other exposures?)

4. Risk characterization (reviews all of the previous items and makes calculations based on data, with all the assumptions clearly stated; often the conclusion is that more data and/or improvement in methodology is needed and that no numerical risk number can be derived to express accurately the magnitude of risk)

Deciding WHAT is an adverse effect (and to some extent hazard identification) is a value judgment that can be made by well-informed

citizens.◦ It could be defined as death or disease (in most cases of

human health risk analysis); it could be a failure of a nuclear power plant, or a chemical plant accident, or a loss of invested money. In some recent cases of risk analysis, even vaguely defined terms such as “quality of life” or “sense of community” have been evaluated using risk analysis.

“Yet the confidence in the unlimited power of science is only too often based on a false

belief that the scientific method consists in the application of a ready-made technique, or

in imitating the form rather than the substance of scientific procedure, as if one needed only to follow some cooking recipes

to solve all social problems.”

Hayek FA. 1991. Economic Freedom. Cambridge, MA (Oxford, UK). Basil Blackwell Ltd. p. 287

The very word risk implies uncertainty.The uncertainty in a risk assessment changes with time as information develops.Different uncertainties in risk estimation:◦ Stochastic uncertainty (largely random)◦ Type A and Type B uncertainties (variability vs.

uncertainty)◦ Systematic uncertainty◦ Subjective uncertainty (disagreement among those

assessing the risks)

The word “error” that is used in formal statistical theory has another connotation when used in discussions of public health and medicine and can mean “mistake”.Therefore, the words “uncertainty analysis” replace “theory of error”.In reactor safety analyses, for example, the postulated initiating event is often someone’s mistake or error.An analysis of the frequency and distribution of these mistakes is an important input to any full probabilistic risk analysis (PRA).

Adverse outcomeAdverse eventErrorPreventable adverse eventNegligence

1. Noncancer chemicals risk analysis (Hazard)2. Carcinogen risk analysis (Hazard)3. Epidemiological risk analysis (which could

include both cancer and noncancerchemicals or other nonchemical hazards, such as accidents, electromagnetic radiation, nutrition, etc.)

4. Probabilistic risk analysis associated with nuclear power plant safety and chemical plant safety

5. A posteriori risk analysis, which is applied in actuary science to predict future losses, either from natural phenomena, investments, or technology

6. Nonquantitative risk analysis, or “common sense” risk analysis, which can give only vague patterns of possible risks.

7. Systematic risk profiling 8. Comparative risk analysis

The thought process that goes into evaluating a particular hazard is more important than

the application of some sophisticated mathematical technique or formula, which

often may be based on erroneous assumptions or models of the world.

Potentially involved players after an adverse event:◦ Clinical staff◦ Legal staff◦ Hospital and/or practice administration◦ Risk managers or advisors◦ Quality/safety improvement personnel◦ Patients relatives◦ Media public

1. Oriented by previous experience2. Subjective3. Informal4. Caotic / not standardized5. Usually not measured6. Frequently not fully understood7. Hospital as a care (“safer”) place

7. Awareness after catastrophic events, with short “half life”

8. Expensive to manage9. Creates vulnerability for hospital and

doctors10. Support “witch-hunts” and lawsuits11. Medical attention is individually

shaped and not suitable for staging/planning

“More research is needed not only in thinking through the process of care but also in

showing that the heightened awareness of risk improves patient outcomes.

Implementing such an approach to define risk requires more than a distant external risk

expert to map the process of care and document the risks.

Health professionals need to be actively engaged.”

Donaldson, LJ; Noble, DJ. The need for risk profiling in patient safety. J Patient Saf, 6(3):125-7. Sep/2010.

“Voluntary” reduction in risks from pollution and technological risks in general are best

achieved by designing and enforcing intelligent environmental and occupational

laws.Carrots and sticks may be more effective in dealing with environmental and occupational

risks (accidents or pollution) than either sticks or carrots alone!

1. Healthcare is a high-risk industry2. Healthcare has the lowest awareness

among high-risk industries (eg. F1)3. Society has become more and more

aware of its own safety4. To err (once) is human, twice may be

criminal

samieljundi@risk-0.com