In January 1986, Washington Hospital Center in Washington, D.C., reported that a patient was administered 150 rads of radiation with no request or desire for treatment from the referring physician. This event caused the NRC commissioners to direct staff to develop rulemaking that would initiate quality assurance (QA) programs to reduce the chance for therapy misadministrations. A year later the NRC published a proposed rule of "Basic Quality Assurance in Radiation Therapy" and an advance notice of proposed rulemaking, which called for a comprehensive QA program for any medical use of radioactive byproduct material. The NRC claimed that voluntary QA programs may not adequately assure public health and safety, but it limited the scope of the proposed prescriptive rule to radiation therapy and diagnostic procedures involving radioactive iodine.

These actions precipitated a major response from the medical community, including the recommendation that the proposed rulemaking should be performance-based rather than prescriptive. After several public hearings and discussions with medical organizations, the NRC published a proposal in 1990 for a new performance-based QM program and for revised recordkeeping and reporting requirements related to misadministrations. the NRC also announced that it would conduct a pilot program to evaluate the effectiveness of the proposed rule.

The NRC made a concerted effort to respond to critics of the 1990 proposed rule. In response to those who claimed that the rule would have little impact on reducing the already small number of misadministrations, the NRC emphasized that the number of reported therapeutic misadministrations in 1990 had increased to 24 from the average number of 10 for previous years. The proposed QM rule, it argued, was a legitimate regulatory response to a continuing problem in the use of radioactive byproduct material. Responding to critics who asserted that the NRC was duplicating standards of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the agency claimed that adherence to JCAHO standards is voluntary and that there is no guarantee that all licensees would implement a QM program.

Quality management rule. In January 1992, the NRC implemented the final version of its QM rule (NRC, 1992). The NRC's QM rule calls upon NRC licensees to establish a QM program in compliance with 10 CFR 35.32 and 35.33 if they administer radiation from sealed sources containing byproduct material for therapy (brachytherapy), if they administer cobalt teletherapy, or if they administer therapeutic unsealed radionuclides (therapeutic nuclear medicine) (see Chapter 2). The rule also applies to any diagnostic administration of greater than 30 microcuries of sodium iodide I-125 or I-131 (see Chapter 2 and Appendix D). Moreover, it requires NRC licensees to submit written certification that they have implemented a QM program. Whereas NRC licensees have been living with this rule since January 1992, Agreement States were not required to follow suit until January 1995.

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