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The chief difference between a legally sound quality control program and a legally risky program is the extent to which the program emphasizes form over function. There is a tendency for medical quality control programs to be very complex. This complexity makes it more difficult to ensure that the management control loops are closed. More specifically, it increases the chance that a detected risk will not be managed. The more people involved in the quality control process, and the more involved the criteria used to evaluate the care rendered, the fewer the resources that will be available for intervention and feedback. This problem arises because most hospital oversight functions have evolved in response to various statutory and voluntary standards. These standards usually specify the administrative structure necessary for compliance, but seldom if ever do they establish guidelines for evaluating the effectiveness of the mandated programs.

The failure to judge the effectiveness of programs occurs because of the difficulty that an outside body has in determining the results of an oversight function. All an outside body can judge is whether the proper committees have been formed, whether meetings have been held, and whether the mandated forms are followed in documentation. This is in contrast to provider initiated programs that are developed to manage specific problems. For example, the JCAH mandates that hospitals ensure the competence of members of the medical staff. This mandate is obeyed by the formation of various committees that review certain aspects of hospital practice. As long as the committees meet and carry out some type of review, the mandate will be met.

Contrast this situation with a committee that is formed because the hospital is concerned about an excess of infections in surgical wounds. In this case, the objective criterion for success would be whether the number of infections is diminished. This can be described as goal-oriented versus process-oriented quality control. While process-oriented quality control in usually sufficient (and sometimes necessary) to meet voluntary standards and statutory duties, the reduction of legal risks demands a goal-oriented approach. The occurrence of specific risks must be identified, tabulated, and reduced. This type of strategy will require the explicit delineation of risks to be managed, to ensure that the medical quality control priorities reflect the legal seriousness of the problems. From this perspective, it becomes obvious that an increase in the death rate is much more serious than an excess of unnecessary appendectomies. an unnecessary appendectomy may be a statistical artifact, or it may reflect a murderer at large. In either case, the chance of litigation is much higher. If it is an artifact, it needs to be explained; and if it is a real increase, it must be investigated.

The investigation of an identified risk is basic to a legally effective quality control program. The goal of an investigation is to determine the seriousness of the risk, the cause of the risk, the persons involved and what (if any) steps need to be taken to mitigate the consequences of the risk. An added constraint is that the investigation should not compromise the hospital's legal position if the risk results in litigation. The administrator must ensure that the facility uses the available legal protections to its best advantage.

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