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Dr. Sami A. R. J. El Jundi, MD, MSc
                                       Forensic Advisor & Risk Analyst
                   Medico-legal Expert in Medical Malpractice Lawsuits
Coordinator 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 Office
Physicians facing the risk of incarceration due
to patient loss
Criteria 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 situation
Deal with health effects or, more recently,
with the ecological health or economic well-
being (in case of business risk analysis).
1.   Hazard (agent) identification
2.   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 outcome
Adverse event
Error
Preventable adverse event
Negligence
1.   Noncancer chemicals risk analysis (Hazard)
2.   Carcinogen risk analysis (Hazard)
3.   Epidemiological risk analysis (which could
     include both cancer and noncancer
     chemicals 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 experience
2.   Subjective
3.   Informal
4.   Caotic / not standardized
5.   Usually not measured
6.   Frequently not fully understood
7.   Hospital as a care (“safer”) place
7.  Awareness after catastrophic events,
    with short “half life”
8. Expensive to manage
9. Creates vulnerability for hospital and
    doctors
10. Support “witch-hunts” and lawsuits
11. 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 industry
2.   Healthcare has the lowest awareness
     among high-risk industries (eg. F1)
3.   Society has become more and more
     aware of its own safety
4.   To err (once) is human, twice may be
     criminal
samieljundi@risk-0.com

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Law and Order: helping hospital and doctors recognize and manage risk

  • 1. Dr. Sami A. R. J. El Jundi, MD, MSc Forensic Advisor & Risk Analyst Medico-legal Expert in Medical Malpractice Lawsuits Coordinator of the Medical Law Postgraduate Course at VJ/Porto Alegre
  • 2. 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)
  • 3. 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 Office Physicians facing the risk of incarceration due to patient loss Criteria for charging: “procedure futility” and “unproportional damage” (res ipsa loquitur)
  • 4. 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.
  • 5. Risk analysis applied in a particular situation Deal with health effects or, more recently, with the ecological health or economic well- being (in case of business risk analysis).
  • 6. 1. Hazard (agent) identification 2. 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)
  • 7. 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.
  • 8. “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
  • 9. 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)
  • 10. 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).
  • 12. 1. Noncancer chemicals risk analysis (Hazard) 2. Carcinogen risk analysis (Hazard) 3. Epidemiological risk analysis (which could include both cancer and noncancer chemicals 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
  • 13. 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
  • 14. 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.
  • 15. 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
  • 16. 1. Oriented by previous experience 2. Subjective 3. Informal 4. Caotic / not standardized 5. Usually not measured 6. Frequently not fully understood 7. Hospital as a care (“safer”) place
  • 17. 7. Awareness after catastrophic events, with short “half life” 8. Expensive to manage 9. Creates vulnerability for hospital and doctors 10. Support “witch-hunts” and lawsuits 11. Medical attention is individually shaped and not suitable for staging/planning
  • 18. “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.
  • 19. “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!
  • 20. 1. Healthcare is a high-risk industry 2. Healthcare has the lowest awareness among high-risk industries (eg. F1) 3. Society has become more and more aware of its own safety 4. To err (once) is human, twice may be criminal