The evaluation of the outcome of the interventions and the subsequent modification of the intervention strategy close the control loop. The importance of a closed loop is that it allows management decisions to be checked against the actual outcome of the decisions. The evaluation may be conducted by the manager who made the intervention decisions (internal evaluations), or it may be performed by a person who is not usually part of the quality control loop. All systems should include some external monitoring as an audit function, although it is not necessary for all evaluations to be external to the routine quality control activities. The important concern is that the evaluation be carried out objectively, using explicit criteria. The use of explicit criteria is necessary to allow the intervention strategy to be modified in a systematic fashion. If the evaluation is done intuitively, it will be very difficult to decide how changes in the intervention strategy are related to changes in the outcome of the intervention.
Documentation is a very important part of the evaluation task. The documentation should include enough information to allow the re-creation of the chain of events that led to the intervention, a description of the intervention, and a detailed report of the outcome of the intervention. Such documentation is necessary to allow the hospital board or other oversight body to monitor the management of the quality control activities. The documentation will also be important if the effectiveness of the quality control program become an issue in litigation. This is becoming more common as the courts begin to impose a duty to monitor medical care delivery.
The legal duty to monitor medical care delivery parallels the development of the JCAH requirement for quality assurance programs. Since the hospital themselves have determined (as expressed through their trade association) that part of their responsibility is to ensure the quality of medical care delivered within their confines, the courts have ruled that hospitals may be legally negligent if they breach the duty to monitor the quality of care.
The duty to intervene also requires that the hospital document why action was not taken in seemingly questionable situations. The law does not require the hospital to be infallible in its decisions. If it chooses not to intervene in a situation, and it can provide a plausible argument why intervention was not desirable, the hospital will not be liable for the subsequent injuries. The problem is that without proper documentation, produce at the time the decision not to intervene was made, the court will assume that the failure to intervene was due to negligence rather than a properly reasoned decision.
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