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Radiation in Medicine: A Need for Regulatory Reform
should be justified on the basis of cost and benefit, with both risks of harm to patients and expenditures entailed taken into account.
Today some data are collected on poor performance and adverse events. For example, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has a performance standard that requires intensive assessment when hospital performance varies from recognized standards. The JCAHO specifies confirmed transfusion reactions and significant adverse drug reactions as cause for further assessment, but it does not specifically require hospitals to report medication errors except in accord with the hospital's written procedures (JCAHO, 1995). As another case in point, the medical centers of the Department of Veterans Affairs are required to report and track medication errors. Generally, however, this type of reporting to a central authority does not appear to be practiced in the private sector.
In comparison, where radiation medicine is regulated by the NRC, either directly or through administration of NRC standards by the Agreement States, all administrations of radioactive materials must be documented and those that are classified as misadministrations must be reported. In 1992, the volume of services amounted to approximately 11 million NRC-regulated unsealed source radionuclide administrations in nuclear medicine and 130,600 NRC-regulated (brachytherapy and teletherapy) radiation therapy patients. Some members of the nuclear medicine and radiation therapy communities question whether the putative benefits of this level of regulatory oversight and reporting are commensurate with the costs (see Chapter 3), believing that relaxation of this recording and reporting system would not increase the risk of patient injury.
The committee was able to make rough approximations of the rate of misadministrations for medical procedures involving byproduct material. Because of the lack of data, it could not estimate rates for all ionizing radiation used in medicine.
Misadministrations and Adverse Events in Other Medical Modalities
The NRC had asked the Institute of Medicine to compare the errors in use of byproduct materials and the consequences of those errors with errors occurring in other medical interventions. Adverse events in administration of medications, including chemotherapy, blood transfusions, and surgical interventions, were specifically requested for this comparison. In statistical, clinical, and epidemiological terms, comparisons of the risks inherent in very different health care interventions can be problematic. However, the committee judged that such information