ML20137R937
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Y i \ December 11, 1981 ,
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MEMORANDUM FOR: Vandy L. Miller, Chief 3
Material Licensing Branch William J. Walker, Th.D., Section Leader Medical and Academic Section Material Licensing Branch John E. Clenn, Ph.D., Section Leader Region I Licensing Section j Technical Staff Medical Licensing Sections j
j Material Licensing Branch j FROM: Bruce S. Mallett, Ph.D., Section Leader Region III Licensing Section j
SUBJECT:
REVISION OF THE STA!!DARD REVIEW PLAN FOR INSTITUTIONS OPERATING AS A MOBILE VAN The current standard review plan for mobile van operations does not list any limitations on the types of services that the NRC will approve.
i Consequently, a workshop was held on November 20, 1981 by representatives -
i of the Medical Licensing Sections of the Material Licepsing Branch to propose such limitations. The following is a list of'the limitations
- proposed
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, 1. Mobite van operations should be limited to diagnostic procedures i
j with the exception of iodine-131 for the treatment of hyperthyroidism t on an outpatient basis (i.e. no Group V or VI procedures shall be M allowed).
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Mobile van operations shall not be allowed to eetsbri ot tabs"
- in institulons such as hospitals with or without NRC licenses '
(i.e. Any receipt and storage of radioactive material in an j institution should be under an NRC license for that institution.
4 pa).7da Bruce S. Hallett, Section Leader Region III Licensing Section i
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I f, INFORMATION TO BE SUBMITTED FOR A MOBILE NUCLEAR MEDICINE LICENSE l
] Revised May 10, 1979 j j This is in reference to your request for information on how to acquire a mobile !
! nuclear medicine license. Our current requirements for this license are as ,
! follows:
A complete application in accordance with the enclosed Medical Licensing l 1
K' 1. Guide (Regulatory Guide 10.8). i 1
l \ 2. Confirmation that a physician shall be on-site at the time that radio-i pharmaceuticals are administered. The identity of this on-site physician ;
j must be included on your license application and this physician must have l 1 at least thirty (30) hours of training in basic radiological handling 1 techniques. (See Supplement A of Form NRC-313M.) ,
t l ?N 3. A statement from each hospital administrator granting approval for use of radioactive material at his facilities. 1 3 74. A complete description of the services to be furnished at each hospital. ;
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! 5. Verification that all diagnostic instrumentation transported by van shall j be calibrated at each location of use prior to conducting nuclear medicine procedures. j
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- 6. Verification that a contamination survey will be performed at each location l of use and that all sources of licensed material and all detectable con- '
tamination will be removed.
} )/ 7. A description of the procedures for ensuring that radioactive materials, i located in the van will be secured at all times.
l X 8. If your nuclear medicine laboratory is located at a hospital, the hospital i must have a separate license as required by Section 35.12(b) of Title 10, ;
j Code of Federal Regulations, Part 35. i Because of the radiation safety problems associated with the use of radio- l f9. active gases, xenon-133 has not been authorized for mobile nuclear medicine i services. If you wish to request the use of Xenon-133, then you are l required to submit all the information requested in Appendix M of the l
Medical Licensing Guide for each location of use.
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Enclosures:
- 1. Draft Medical Licensing Guide ;
l 2. Form NRC-313M
- 3. 10 CFR Parts 19, 20, 30, 35, and 170 i
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