12 VAC 5-481-3400 A 1, 12 VAC 5-481-3400 A 3 and 12 VAC 5-481-3400 C 1: The language “a radiation therapy physicist or a private inspector” is confusing. It is not at all clear what distinction the word “or” is calling out. The DEFINITIONS say that "Radiation therapy physicist" means an individual qualified in accordance with 12 VAC 5-481-340 (note that the definition does not say “registered”). The DEFINITIONS also say "Private inspector" means an individual who meets the requirements set forth in 12 VAC 5-481-340 and who has demonstrated to the satisfaction of the agency that such individual possesses the knowledge, training and experience to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs. So the qualifications for a “private inspector” are more stringent than those for a “radiation therapy physicist.” 12 VAC 5-481-340 describes three categories of inspector, namely “diagnostic X-ray (except mammography)” in section A, “therapeutic X-ray and teletherapy machines” in section B, and “mammography” in section C. I note that section B does not include any language regarding radiation protection surveys, only language regarding calibration and spot-checks of machines. Given all that, the paragraph seems to me very unclear as to who is qualified to perform the work specified in 12 VAC 5-481-3400 A 1, 12 VAC 5-481-3400 A 3 or 12 VAC 5-481-3400 C 1. 12 VAC 5-481-3400 C: The placement of this section in amongst several other sections concerned with radiation protection surveys is confusing, especially since the term “dosimetry equipment” is never defined but does not seem to be related to protection surveys. One presumes the section refers to the equipment necessary to perform an absolute measurement of the output of the therapeutic radiation machine, but that is not made clear. 12 VAC 5-481-3400 C 1: The last sentence of the first paragraph, “An independent survey shall be conducted by a private inspector or radiation therapy physicist other than the person performing the original survey prior to the equipment being used except as described in 12 VAC 5-481-3400 A 4,” makes no sense as applied to dosimetry equipment. It appears to have been misplaced from another section. It is a mystery how one goes about surveying dosimetry equipment. The reference to 12 VAC 5-481-3400 A 4, which is related to remediation of problems detected during a radiation protection survey, just deepens the mystery. Surely this sentence is a mistake. 12 VAC 5-481-3410: There is no Appendix P or Appendix Q. There is nothing else in the proposed regulations regarding the form and content of the required quality management program. 12 VAC 5-481-3430 C: I believe that most modern therapeutic X-ray machines, equipped as they routinely are with multi-leaf collimators (MLC), cannot satisfy the requirements of this section as written. The requirements, particularly 12 VAC 5-481-3430 C 1 as qualified by 12 VAC 5-481-3430 C 3 a, are apparently more stringent than the current IEC requirements (standard 60601-2-1). 12 VAC 5-481-3430 Q 4: The requirement for “continuous” two-way aural communication is unworkable as worded. It is clearly important that there be two-way aural communication between the operator and the patient, and the monitoring of the patient should be continuous. However, it is neither desirable nor workable for aural communication in the other direction, from the operator to the patient, to be continuous. A great deal of conversation takes place at the console before, during and after patient treatment that should not be overheard by the patient for a variety of reasons, including but by no means limited to consideration of HIPAA requirements regarding the privacy of other patients. The preferred, and typical, mode is that the operator can push a button on the intercom to communicate on demand with the patient when necessary. 12 VAC 5-481-3430 Q 10: This requirement seems to be too stringent. As written and strictly interpreted, this paragraph would require a survey each time a wedge filter is used and removed. It is well known that wedges and other treatment aids are activated on each use, and the wedges are quite clearly components of the machine. One presumes the intent of the paragraph is to reduce exposure to service personnel who may handle components of the accelerator head which are normally inaccessible and can become highly activated, but the wording of the paragraph does not make that distinction and would pose an undue hardship if interpreted strictly as written.