Update of the EBF recommendation for the use of DBS in regulated bioanalysis integrating the conclusions from the EBF DBS-microsampling consortium.
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Voluntary coordination as a strategy of plan implementation for health systems agencies.
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Health planning agencies are faced with the difficult mission of guiding change within a large complex social system whose power is dispersed. Initial short- and long-range plans have been established as frameworks, and now the major focus is implementation. Regulation (non-voluntary coordination) and voluntary coordination are the major means of implementation. Voluntary coordination is a significant strategy for consideration by Health Systems Agencies (HSAs). It may interact with regulation as a competitor, substitute, or complement. Because of limited regulatory powers, HSAs are dependent upon voluntary coordination as a major means of influencing behavior. Conflict, a major feature of voluntary coordination, has the potential of being used as a constructive means for dialogue; negotiation and bargaining may become positive approaches to arriving at decisions. Legitimized community authority is the primary source of authority in a strategy dominated by voluntary coordination as contrasted to state or federal mandates in a regulatory strategy. Knowledge of the environment within which the HSA operates will assist HSA staff and board to arrive at rational and realistic decisions. (+info)
Evaluating the impact of certificate-of-need regulation using measures of ultimate outcome: some cautions from experience in Massachusetts.
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Prior evaluations of certificate of need (CON) have concluded that such regulation did little to reduce the level of hospital capital investment. These studies, however, failed to examine the underlying patterns of hospital investment behavior onto which CON was imposed and further neglected to determine the lag period that separates the introduction of regulation and the appearance of outcomes actually attributable to the presence of CON. This article addresses these two issues by using rate-setting data to examine the details of hospital capital investment across the whole voluntary hospital industry in one state--Massachusetts--both before and after the introduction of certificate of need. Massachusetts voluntary hospitals were found to devote most of their capital expenditures to the construction of major new inpatient facilities built in cycles of 14 years average duration throughout the post-World War II period. The date of completion of such a facility proved to be the major determinant of a hospital's capital expenditure pattern over time, and hospitals of similar teaching status and geographic location showed considerable synchrony in the construction of such facilities. At least in Massachusetts, the introduction of certificate-of-need regulation coincided with but was not responsible for the conclusion of a major construction peak among nonteaching hospitals and the beginning of such a peak among teaching hospitals, greatly complicating the evaluation of actual CON effects. Further, capital expenditures actually approved by CON did not appear until the third year of program operation, and even five years post-CON, the majority of hospital capital expenditures reflected projects approved in the first year of regulation, a period during which the program had neither the expert staff nor extensive review capacity that characterized CON function in later years. These findings hold implications for the evaluation of CON effectiveness and, indeed, for the future existence of certificate of need. (+info)
What price government regulations?
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Cost containment in health care will be a major target for governmental regulation in the coming decade. A number of potential economies in health care exist, among them a reduction of the heavy burden of government regulation. It is important to review pending congressional action as related to health cost, as well as congressional proposals for reform of the regulatory agencies. Organized medicine is involved in cost containment and the private sector has made some progress. However, there is much that individual practitioners can do. (+info)
Identifying complications and low provider adherence to normative practices using administrative data.
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OBJECTIVE: This study investigated whether unexpected length of stay (LOS) could be used as an indicator to identify hospital patients who experienced complications or whose care exhibited low adherence to normative practices. DATA SOURCES AND STUDY SETTING: We analyzed 1,477 cases admitted for one of three medical conditions. All cases were discharged from one of nine participating Department of Veterans Affairs (VA) hospitals from October 1987 through September 1989. Analyses used administrative data and information abstracted through chart reviews that included severity of illness indicators, complications, and explicit process of care criteria reflecting adherence to normative practices. STUDY DESIGN: We developed separate multiple linear regression models for each disease using LOS as the dependent measure and variables that could be assumed present at the time of admission as explanatory variables. Unexpectedly long LOS (i.e., discharges with high residuals) was used to target complications and unexpectedly short LOS was used to target cases whose care might have exhibited low adherence to normative practices. Information gleaned from chart reviews served as the gold standard for determining actual complications and low adherence. PRINCIPAL FINDINGS: Analyses of administrative data showed that unexpectedly long LOS identified complications with sensitivities ranging from 40 through 62 percent across the three conditions. Positive predictive values all were at greater than chance levels (p < .05). This represented substantial improvement over identification of complications using ICD-9-CM codes contained in the administrative database where sensitivities were from 26 through 39 percent. Unexpectedly short LOS identified low provider adherence with sensitivities ranging from 33 through 45 percent with positive predictive values all above chance levels (p < .05). The addition to the LOS models of chart-based severity of illness information helped explain LOS, but failed to facilitate identification of complications or low adherence beyond what was accomplished using administrative data. CONCLUSIONS: Administrative data can be used to target cases when seeking to identify complications or low provider adherence to normative practices. Targeting can be accomplished through the creation of indirect measures based on unexpected LOS. Future efforts should be devoted to validating unexpected LOS as a hospital-level quality indicator. RELEVANCE/IMPACT: Scrutiny of unexpected LOS holds promise for enhancing the usefulness of administrative data as a resource for quality initiatives. (+info)
Patients' rights to care under Clinton's Health Security Act: the structure of reform.
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Like most reform proposals, President Clinton's proposed Health Security Act offers universal access to care but does not significantly alter the nature of patients' legal rights to services. The act would create a system of delegated federal regulation in which the states would act like federal administrative agencies to carry out reform. To achieve uniform, universal coverage, the act would establish a form of mandatory health insurance, with federal law controlling the minimum services to which everyone would be entitled. Because there is no constitutionally protected right to health care and no independent constitutional standard for judging what insurance benefits are appropriate, the federal government would retain considerable freedom to decide what services would and would not be covered. If specific benefits are necessary for patients, they will have to be stated in the legislation that produces reform. (+info)
Protection of patient data in multi-institutional medical computer networks: regulatory effectiveness analysis.
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Privacy protection is one of the major issues in the development of multi-institutional clinical information networks. Judicial decisions have confirmed patient's rights to protection of a "reasonable expectation of privacy". Incorporating this protection into a system requires analysis of appropriate models. The National Practitioner Data Bank (NPDB) contains confidential data concerning physician competence. The medical profession had substantial input into the privacy protection features of the NPDB, which are much more comprehensive than those used in many clinical information systems. The NPDB represents the privacy protection which physicians expect for their own data. Regulatory Effectiveness Analysis can be used to analyze the suitability of the NPDB as a model for patient privacy protection. Judicial opinions set public policy and legal structures for privacy, and the NPDB provides an inventory of useable technical tools. After eliminating minor discontinuities, the NPDB can be used as a model to create a useable standard for privacy for multi institutional data transfers. (+info)