Clinical Risk Management
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- 2.1 Root Cause Analysis
1.5. GuidelinesThe third central feature of Risk Management is the updating of existing protocols, guidelines and algorithms. When used as a clinical risk modification tool to promote the “gold standard”, guidelines incorporate an assessment of risk that is held to be the same for all patients. This could come into conflict with an individual’s conception of desirable benefits and their own personal risk assessment. However, the physician who complies with a guideline that sets forth the standard of care could have a strong defence in a case of malpractice, that is he could use the guideline as exculpatory evidence but alternatively, failure to comply with a guideline might be evidence of negligence and thus would constitute inculpatory evidence. The validity of the guidelines is tightly centred on the rigorousness of the analysis and the revision of the scientific literature. Research is finalized to identify and synthesize the most remarkable evidence regarding specific clinical questions so as to understand any possible gap. The last phase is constituted from the synthesis of the evidence (Table 6).
The most important benefits of the guidelines are: - the homogeneity of the behaviours - the trade-off among efficiency and effectiveness of the diagnostic and therapeutic procedures - a better possibility to verify the outcome by opportune statistic tools. Among the disadvantages we summarize: - the reduction of the decisional autonomy of the doctors - the restriction of the logical-deductive thought - the induction of the “Defensive Medicine”, that is decisions made because of medical-legal motives rather than in accordance to the interest of the patient. The use of the guidelines as reference for the forensic evaluation of the adequacy of the clinical procedures has a “mathematical” limit that can be extrapolated from Bayes’ theorem: p(A | B) = p(B | A) p(A)_
Bayes' theorem gives the conditional probability distribution of a random variable A given B in terms of the conditional probability distribution of variable B given A and the marginal probability distribution of A alone. This theorem, for example, can calculate the probability of the existence of an illness when the clinical signs and the frequencies of the symptoms in the sick people and in the healthy people are known. This point of view could open the way to the constitution of algorithms. Therefore, a better way of selecting patients for a specific procedure is to use the Bayesian analysis. This method of decision making appears quite complex at first but in reality is simple if only a few basic concepts are understood. For example, before one can select patients for imaging, a few important considerations should be kept in mind. First among these considerations is the fact that the test in question should be indicated based on findings from a thorough history and physical examination of the patient. Doctors should ask themselves the following questions:
is this examination going to affect my diagnostic certainty about the differential diagnosis I am considering and, if so, how much? will the information expected to be provided by the examination change my diagnostic thinking enough so that it will significantly affect my choice of treatment? Other important considerations for the selection of patients for a clinical procedure include: the inherent risk of the examination to the patient the likelihood that the examination will be of benefit in establishing or refuting a diagnosis the potential benefit to the patient the risk of liability if the examination is requested or not requested. Keeping these points in mind, one cannot dismiss the importance of clinical intuition in the selection process. The doctor’s judgment coupled with these more statistically oriented considerations is the basis of the Bayesian analysis. However, it is important to remember that: there is no clear distinction between scientific and non-scientific evidence Bayes’ theorem is merely a formalization of logic and common sense Bayes’ theorem therefore isn’t an appropriate way for providing evidence but is good for general education and judicial notice it is not necessarily appropriate to instruct juries in formal logic instructions given to juries must comply with the requirements of logic. Hyams reminds us that healthcare reformers, physicians and guideline developers should know that guidelines are a double-edged sword. As exculpatory evidence, they could reduce the number of claims or lead to claims being dropped at an early stage in the litigation. But, insofar as physicians inappropriately fail to comply with them, guidelines can provide sturdy inculpatory evidence of the standard of care, as more and more malpractice attorneys are learning. If guidelines are developed and applied appropriately, this is not necessarily bad. Widespread use of guidelines in malpractice should lead to greater compliance with guidelines in the long term. Proponents of guidelines should be aware that the inculpatory use of guidelines in litigation may chill physicians' interest in developing more specific and prescriptive guidelines. However, education about the two-way use of practice guidelines in litigation should be a priority. Nevertheless, clinical judgment still demands complex reasoning skills. In the absence of sound clinical judgment, thoughtless adherence to the evidence or any other single source of medical knowledge will result in the practice of “cookbook medicine” (AMA). 2. Risk Analysis Risk analysis is the science of evaluating health, environmental and engineering risks resulting from past, current, or anticipated future activities (Anderson). The use of these evaluations include providing information for determining regulatory actions to limit risk, presenting scientific evidence in legal settings, evaluating products and potential liabilities. Risk analysis is an interdisciplinary science that relies on epidemiologic studies, collection of exposure and other field data, computer modelling and related social, economic and communication considerations; social dimensions of risk are also addressed by social scientists. There are some methods to analyze risks; the most interesting are: a) the Root Cause Analysis b) the map of the critical areas. 2.1 Root Cause AnalysisRoot Cause Analysis (RCA) is a generic term commonly used to refer to structured problem solving within organizations. Because control of operations within organizations is obtained through application of policies and procedures, effective root cause analysis must directly associate the root causes that permit and generate problems with the policies and procedures through which control can be accomplished. Business processes are the designed ways within an organization through which everything gets done: formally or informally, effectively or ineffectively, safely or unsafely, efficiently or inefficiently. Business processes are the only means by which an organization can manage and focus its activities in the direction of quality and efficiency. When any unwanted event occurs, root cause analysis will discover that there were business processes missing, ill-suited or unsupported that either generated or allowed the event to occur (Decision system). RCA analyses the “adverse events”, the "no harm events” and the “near misses”; RCA doesn’t focalize on the performance of the dependents but the processes. The analysis sinks the search (“drilling down”) on the basis of the following questions: a) what has happened? b) how has it happened? c) why has it happened? Finally, RCA suggests the necessary actions finalized to modify the gap in the system thus avoiding the repetition of the same event or of more serious events. Nevertheless, RCA should have some characteristics: it should involve the leadership and the managers of the organization, the experts of Risk Management and Quality Control, but also other professionals who can contribute to an exhaustive analysis of the causes of what happened (RCA Team) it should avoid contradictions or leave some questions on the causes of the adverse events unsolved it should make well-founded decisions based on the scientific evidence. 2.2 Map of the critical areas The map of the critical areas of the organization doesn’t analyse the single adverse event; it concerns instead the whole processes of the organization. A map of the risks can be built with various formalities, with reference to the demands of the search. Carroll, for example, suggests building the map on the basis of the frequency and gravity of the adverse events (in Table 7 the circles represent the Departments of the Healthcare Organization). Table 7. Map of critical areas (by Carroll) 
As well, rather than the frequency and the gravity of the events, it is possible to arrange the map on the basis of frequency and liability (Table 8). Table 7. Map of the critical areas (frequency and liability)
The third possibility is the construction of the map on the basis of frequency, gravity and liability, using reserved software to manage the collected data, after indexing the score of the three parameters. Download 179.21 Kb. Share with your friends:
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