The large envelope of Figure 59-1 represents the health care provider, i.e., hospital, ambulatory care center, nursing home, or other patient care location. In the center of the large envelope is a gray, shaded area containing the terms “operator,” “facility,” “device,” “environment,” and “patient.” This represents a generic, device-related minisystem that delivers a clinical benefit. Each of the five components leads to smaller envelopes. These smaller envelopes contain the subcomponents of the five major components. There are a total of 14 subcomponents in the SRM. The five major components are at the end of the delivery system where patients receive care. The subcomponents are part of the end of the system that supports the minisystems at the patient care end (Cook and Woods, 1994). The flaws found within the subcomponents could lead to a component failure, that is, lead the minisystem outside its expected performance boundaries, or theycould cause a physical injury to the patient. More complex SRMs can be constructed by adding more devices or more operators. Flaws located within the subcomponents frequently can be traced to their origins, before they entered the clinical environment. For instance, a flaw in a device component may originate with its design and construction; a flaw in a facility component may originate during the planning and preconstruction phases; and a flaw in the operator component may originate during basic education and training. These factors are shown in Figure 59-1 as being outside the large envelope. The health care provider has an opportunity to minimize these flaws through careful examination of a component before it enters the care delivery environment. Once the component becomes active in the clinical environment, the provider has lost this opportunity and must manage the risks associated with any flaws that passed through the initial scrutiny. Health care providers organize their facilities to deliver care to a specific patient population; heart transplants generally are not performed at substance abuse centers. The facility component is designed, the device component is selected, and the operator component is trained to accommodate the selected population. Patients who fall outside this population are placed at a different risk level, which must be considered when analyzing minisystem failures
The large envelope of Figure 59-1 represents the health care provider, i.e., hospital, ambulatory care center, nursing home, or other patient care location. In the center of the large envelope is a gray, shaded area containing the terms “operator,” “facility,” “device,” “environment,” and “patient.” This represents a generic, device-related minisystem that delivers a clinical benefit. Each of the five components leads to smaller envelopes. These smaller envelopes contain the subcomponents of the five major components. There are a total of 14 subcomponents in the SRM. The five major components are at the end of the delivery system where patients receive care. The subcomponents are part of the end of the system that supports the minisystems at the patient care end (Cook and Woods, 1994). The flaws found within the subcomponents could lead to a component failure, that is, lead the minisystem outside its expected performance boundaries, or theycould cause a physical injury to the patient. More complex SRMs can be constructed by adding more devices or more operators. Flaws located within the subcomponents frequently can be traced to their origins, before they entered the clinical environment. For instance, a flaw in a device component may originate with its design and construction; a flaw in a facility component may originate during the planning and preconstruction phases; and a flaw in the operator component may originate during basic education and training. These factors are shown in Figure 59-1 as being outside the large envelope. The health care provider has an opportunity to minimize these flaws through careful examination of a component before it enters the care delivery environment. Once the component becomes active in the clinical environment, the provider has lost this opportunity and must manage the risks associated with any flaws that passed through the initial scrutiny. Health care providers organize their facilities to deliver care to a specific patient population; heart transplants generally are not performed at substance abuse centers. The facility component is designed, the device component is selected, and the operator component is trained to accommodate the selected population. Patients who fall outside this population are placed at a different risk level, which must be considered when analyzing minisystem failures
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