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Radiation in Medicine: A Need for Regulatory Reform
of workers and the general public. NRC inspectors utilize direct observations of work activities, interviews with workers, and detailed reviews of licensee records to determine compliance with regulatory requirements.
Enforcement actions may be taken against licensees when violations of NRC regulations are discovered. Such violations range from failure to follow procedures detailed in a QM program to threats to public health and safety. Sanctions include more frequent inspections, release of negative publicity to the media, civil fines and penalties, and license revocation.
The discussion throughout the report focuses on "quality management" as the concept has been defined by the NRC and put into operational form through its QM rule. The committee recognized, however, that issues relating to the measurement and improvement of quality of health care go far beyond this narrow interpretation. Given the complexities of its charge, the committee opted not to examine issues relating to quality assurance in any detail, but it recognized that the NRC's approach was not consistent with contemporary efforts by health care institutions and plans to implement continuous quality improvement programs within their own facilities and by their own practitioners and members.
The Quality Management Rule
The NRC's QM rule calls upon NRC licensees to establish a QM program in compliance with 10 CFR 35.32 and 35.33 in three circumstances: (1) if they administer radiation from sealed sources containing byproduct material for therapy (brachytherapy); (2) if they administer cobalt teletherapy; or (3) if they administer therapeutic unsealed radionuclides (therapeutic nuclear medicine). The rule also applies to any diagnostic administration of greater than 30 microcuries of sodium iodide containing I-125 or I-131. 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.
The QM rule is a performance-based approach to quality management. This approach has five specific objectives:
Prior to an administration, a written directive must be prepared.
Prior to each administration, the patient's identity must be verified using more than one method as the individual named on the written directive.
Final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery must be in accordance with the respective written directives.
Each administration must be in accordance with the written directive.
Any unintended deviation from the written directive must be identified and evaluated, and appropriate action must be taken.