Page 307 of 12 VAC5-481 states that x-ray machine operators must be licensed by the state or ARRT certified. This would make it unlawful for students to perform radiographs. Students must perform radiographs to become radiologic technologists. The guidelines under which they are allowed to do this are clearly delineated by the Joint Review Committee on Education in Radiologic Technology (JRCERT). Ideally the statment should read "those who are licensed by the state, ARRT certified or are enrolled in a school of radiologic technology that is accredited by an agency acceptable by the ARRT."  As the Director of an x-ray school I must emphasize how important this matter is. Facilities will not allow our students to perform radiographs if this clause is not added for fear of breaking the law. Where will the next generation of technologists come from?

on page 307 of this document it notes that only state licensed technologists and ARRT certified technologists may operate x-ray equipment. This needs to be ammended by adding "or students enrolled in a school of radiologic technology that is accredited by an orginization acceptable to the ARRT such as the JRCERT". In addition there should be a gratis time from the date of graduation until the technologist becomes ARRT certified. Such technologists are registry elligible but may not have recieved their test date and thus may not be ARRT certified for a period of time to be agreed upon.

The present proposed regulation would limit both mammographic and diagnostic physicist working at one facility from surveying their own facility’s equipment. This is not the case in therapy. Therapy private inspectors are required to complete only one facility and one unit per year. This makes no sense. The mammographic requirements are three times that of the present Federal MQSA standard which only require 2 facilities in a 24 month period. Why the State would choose to supercede the federal requirements, is not clear. The requirements for diagnostic inspections seem unusually high, 10 facilities and 20 tubes. Why they need to exceed the requirements for mammography is unclear.

I would propose that the mammography requirements be aligned with those of the MQSA and that the diagnostic be similar to therapy in that they require 1 facility and 3 tubes in a 12 month period.

If passed in their present format, the regulations would severely impact on the ability of facilities to get required surveys done by placing unnecessary restriction on the physicist performing diagnostic surveys and undoubtably increase the cost to those facilities.

Nothing in these regulations defines either the educational, continuing education or continuing experience requirements for State Inspectors. I think it is in the public healths interest to ensure that State Inspectors meet the same minimum requirements for the inspection of facilities and equipment that are required for Private Inspectors. It has been implied in the past that they do so by job definition but that is not clearly delineated in these regulations and thus allows the State to employee State Inspectors who are not qualified to meet the same level set forth in these regulations. This is not only misleading to the registrant who might choose to use them but an unfair competitive edge since the State is in essence competing with the private sector in this market. At a minimum, State Inspectors should have to meet all of the educational, continuing educational and experience requirements set forth for Private Inspectors if they are going to provide inspection services for a fee.

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.

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.

12 VAC 5-481-3430 R 1 a: This paragraph seems to require that the same radiation therapy physicist perform both calibration and protection surveys. These are two different subspecialties of medical physics and not all radiation therapy physicists do both. The wording should be modified to explicitly accommodate the fact that protection surveys may be performed by a different qualified expert than the calibration and other tasks of 12 VAC 5-481-3430 R 1. 12 VAC 5-481-3430 T 2, 12 VAC 5-481-3430 T 3, 12 VAC 5-481-3430 U 1, 12 VAC 5-481-3430 U2 and 12 VAC 5-481-3430 U 6: The AAPM task group reports cited were meant to be advisory documents to be used by qualified medical physicists in the development of acceptance and quality management programs that are appropriate to the local circumstances. Furthermore, much of their content has been rendered somewhat obsolete by recent rapid developments in technology, and the AAPM is in the process of dramatically revising their recommendations. It is inappropriate for these specific task group reports or their specific recommendations to be included in their entirety as regulatory requirements. 12 VAC 5-481-3430 U 7 f: Weekly checking of all emergency power cutoff switches is excessive and burdensome. Many therapeutic x-ray machines have They are typically tested monthly at most (as is recommended by the AAPM’s TG-40 report). The language of this paragraph is unclear as to whether one switch per week must be tested or whether all switches must be tested weekly or whether the facility retains discretion to determine the appropriate testing schedule. 12 VAC 5-481-3450 B: There is no Appendix O. Missing: The proposed regulations do not specify the protocol by which a teletherapy unit is to be calibrated. It would be preferable to require that a teletherapy machine be calibrated using a protocol currently recommended by the AAPM.

The “Proposed Virginia Radiation Protection Regulations” contains many new requirements however very few stakeholders were made aware of the comment period. Also the Appendixes are referenced as part of the regulation but are not available for review. I suggest a more through notification process for the stakeholders, and that the comment period should be extended three months after the appendixes are published. Comments on 12 VAC 5-481-10. Definitions. p. 42 "mAa" means milliampere. >>Should this read "mA" means milliampere? p. 43 "Misadministration" means the administration of: …. >>Consider using NRC’s term Medical Event instead of Misadministration. p. 48 Noise" means the standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression: >>Consider broadening definition to include other imaging modalities p. 58 "Radiation detector">> Consider combining the two different “radiation detector” definitions that are on the same page but with different definitions. >>It seems that there are two similar but different definitions for therapy simulators. p 59 "Radiation therapy simulation system" p. 68 "Simulator (radiation therapy simulation system)" P. 85 "Written directive >> Will it be acceptable to order procedures through electronic charting instead of in writing? p. 77 "Teletherapy physicist" means an individual identified as the qualified teletherapy physicist on an agency license. >>Some faculties have more than one qualified teletherapy physicist; therefore, consider replacing the word “the” with “a”. p. 84 "Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee. >> Will Effective Dose Equivalent (EDE) correction factors be allowed for calculating occupational workers whole body doses that wear protective aprons? For example ((EDE = 1.5 x H1 + 0.04 x H2) where H1 is the deep dose component from the under-apron badge and H2 is the component from the collar badge. P. 97 12 VAC 5-481-150. Communications. All communications and reports …at the following address: Virginia Department of Health , Radiological Health Program, 1500 E. Main Street, Room 240, Richmond, Va. 23119-2448. >>Is the address correct? P 106 12 VAC 5-481-280. Shielding plan review. F 1 a. >>Will there be a grandfather clause for existing control booths that are less than 7.5 square feet and/or with a dimension that is less than 2 feet? If allowed will the grandfathered dimension be allowed with installation of a new console? P 115 12 VAC 5-481-340. Private Inspector Qualifications. 12 VAC 5-481-340 A 2 a >>The total required credit is 15 CME per 3 years and since MQSA requires 15 CME per 3 years and since many CME programs are designed to provide the needed credits in one trip to a 15 hour course, consider changing the State requirement to match MQSA’s time cycle of the same total but over three years instead of the current 5 per year. 12 VAC 5-481-340 C 2 a. Continuing education…..This continuing education shall include training appropriate to each mammographic modality evaluated by the private inspector …>> MQSA no longer requires that the training be specific to the modalities evaluated. P 122 12 VAC 5-481-370. Certification of X-ray systems. A 4. Certification may be denied if any non-compliances are not corrected within 45 days from the date of inspection. >>Will both serious and non-serious non-compliances have the same time limit for correction? P. 207 12 VAC 5-481-740 B 6. Sealed sources, except teletherapy and brachytherapy sources, which are stored, not being used and identified as in storage. >>Stored not in use Brachytherapy sources should also be exempt from leak testing to help keep workers hand doses ALARA. PART VI USE OF DIAGNOSTIC X-RAYS IN THE HEALING ARTS 12 VAC 5-481-1580 Throughout the Diagnostic sections consider using the word image in place of film, as many facilities are now “filmless” This will avoid a potential loophole for imaging that doesn’t use film p. 295 12 VAC 5-481-1590. General and administrative requirements. A. 1. An X-ray system which does not meet the provisions of these regulations shall not be operated for diagnostic purposes. >> Does this mean that the any system will have to be immediately removed from service for any minor separation form the requirements? 12 VAC 5-481-1590 B 2 b The darkroom shall be light tight ……fogging of the film. >>How often will darkroom fog have to be determined for non-mammography darkrooms?