12 VAC 5-481-10: The definition of “misadministration” for teletherapy (teletherapy seems to be defined to include therapeutic x-ray machines) based on a percentage of prescribed dose is very difficult to interpret in the context of modulated beam delivery, now common practice. The prescription for IMRT necessarily consists of a set of upper and lower dose-volume constraints for a number of target and sensitive anatomic structures, not a single dose value to a single point. 12 VAC 5-481-10 and 12 VAC 5-481-3430 R 1: The proposed regulations provide a definition of “misadministration” for teletherapy (teletherapy seems to be defined to include therapeutic x-ray machines), and 12 VAC 5-481-3430 R 1 f requires that the facility employ the services of a radiation therapy physicist who shall be responsible for “performance of calculations/assessments regarding misadministrations,” but there is nothing in the proposed regulations regarding reporting requirements for misadministrations. What are the radiation therapy physicist’s role, authority and responsibility in the event of a suspected teletherapy misadministration? 12 VAC 5-481-340 B 2 b: The requirement that the therapy private inspector survey a minimum of one facility and one machine each year is difficult to interpret since the terms “survey [a] facility” and “survey [a] machine” are not defined elsewhere in the proposed regulations. If the intent is that each inspector perform both at least one machine calibration and at least one radiation protection survey per year, then the wording should be modified accordingly. If that is in fact the intent, then I would raise the further objection that many private inspectors in radiation therapy who perform regular machine calibrations do not perform radiation protection surveys at all and so will chronically fail to remain qualified. 12 VAC 5-481-340 B 2 a: The requirement of this paragraph cannot be met since only physicians are awarded Continuing Medical Education (CME) credits. Medical Physicists can earn Medical Physics Continuing Education Credit (MPCEC) credits from educational programs that are accredited by CAMPEP. There may also be other sources of continuing education credit for physicists but they are not called CMEs. 12 VAC 5-481-340 B 2 b: The requirement to perform at least one annual machine calibration (if that is what the language of this paragraph means) per 12 months to remain qualified is too stringent. The timing of the annual calibration of an accelerator is fixed in a particular month at the time of its installation. A physicist who works only at one facility and calibrates only one accelerator at that facility will be unduly punished if he/she changes jobs in mid-cycle and moves to a clinic whose machine has an annual calibration date later in the annual cycle than the one from which he/she came. 18 to 24 months is a more reasonable frequency requirement. 12 VAC 5-481-3390 D 1: The term "compliance survey" is not defined. 12 VAC 5-481-3390 D 2: There is no Appendix M. 12 VAC 5-481-3390 F: What is the scope of the "written safety procedures and rules?" This paragraph seems unworkably vague. 12 VAC 5-481-3390 J 4: This paragraph seems to require that even routine maintenance or simple repair of a minor component requires a signature from someone in authority acting on behalf of the licensee before returning the machine to use. That is far too stringent a requirement given the frequency of minor repairs and preventive maintenance. Perhaps addition of the qualifier “[service] that could affect beam quality, steering or output” would be a useful clarification.