Incorporating outcome standards into perinatal regulations.

State and local governments license and monitor hospitals to ensure that a minimum acceptable level of care is present as one means of improving the outcomes and health status of patients served. Standards developed to achieve these purposes, however, have focused almost exclusively on the inputs and processes believed to be necessary for quality care and optimal services. Even when the overwhelming consensus of professionals and providers is that such standards impact positively on outcomes, direct evidence of such causal relationships is often lacking. In 1983, the Chicago Department of Health began incorporating direct measurement of outcomes into its mandated regulatory functions for one operating unit of hospitals--the maternity and newborn services. Crude perinatal and neonatal mortality rates for Chicago hospitals are adjusted using an indirect standardization process that controls for both race and birth weight. This process allows for the calculation of adjusted mortality rates and standardized mortality ratios (SMRs) that are used as an initial screening instrument. Additional evaluation and investigation activities are then directed to hospitals identified through the initial screening process as meriting further study. Hospitals are also evaluated for compliance with the traditional standards and requirements. Information derived from both outcome and compliance evaluations is used to determine monitoring and regulatory activities such as penalties, waivers, and periodicity of future inspections. Use of this Outcome-Oriented Perinatal Surveillance System appears to be an objective, understandable, and acceptable basis for establishing monitoring, evaluation, and regulatory strategies for hospitals with maternity and newborn units.