Only 10 percent of ionizing radiation used in medicine is subject to the NRC and Agreement State regulatory system. The remaining 90 percent is not federally regulated; in some instances, it is not state regulated either. Because no federal requirement exists for data collection pertaining to non-byproduct radiation sources (other than the Food and Drug Administration (FDA) reporting requirements concerning death, serious injury, or equipment malfunction), realistic, accurate data on the incidence and type of problems associated with non-byproduct radiation medicine remain elusive.
The lack of data is a continuation of a problem noted by the NRC's Office of Policy and Planning in 1993 in its Task Force Report on Medical Radiation Protection. The report stated that sufficient data are not available to assess the level of protection for all sources of medical radiation. Although the report noted that acquisition of selected performance data could provide insights needed to consider appropriate regulatory changes, it concluded that "reliable data to assess risk and program effectiveness will be difficult to acquire, especially for non-byproduct sources of radiation" (NRC, 1993, p. 4).
The General Accounting Office (GAO) has also considered the issue of inadequate data (GAO, 1993) and offered two recommendations. First, it advised the NRC to establish common performance indicators to obtain comparable data from all users of byproducts in radiation medicine practice, including both facilities regulated by the NRC and those regulated by Agreement States. The GAO believed that such information would facilitate an evaluation of the effectiveness of the NRC's program and those of the Agreement States. Second, the GAO recommended that the NRC establish specific criteria and procedures for suspending or revoking an Agreement State's program.
The GAO report asserted that the NRC lacked both good criteria and data by which to evaluate the effectiveness of its radioactive materials programs, especially with respect to adequate protection of the public from radiation in either Agreement States or NRC-regulated states (GAO, 1993). It emphasized the need for a common set of performance indicators to evaluate Agreement State and NRC licensees and the need for all users to be required to collect and report information using the same definitions, procedures, and criteria.
As a general proposition, the committee subscribes to the view that performance indicators can serve the health care industry. Many areas of health care other than radiation medicine deserve equal attention, as suggested by the data cited below on adverse effects of medications in general. With regard to NRC data collection, the committee cautions that efforts directed at radiation medicine