ML20198G462
| ML20198G462 | |
| Person / Time | |
|---|---|
| Issue date: | 12/22/1998 |
| From: | Camper L NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Cartwright S KETTERING MEDICAL CENTER, ADVENTIST HEALTH SYSTEMS-EA |
| References | |
| NUDOCS 9812290082 | |
| Download: ML20198G462 (2) | |
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UNITED STATES j
j NUCLEAR REGULATORY COMMISSION
't WASHINGTON, D.C. 20555-0001 December 22, 1998 Steven Cartwright, Ph.D., DABR Radiation Safety Officer Kettering Medical Center 3535 Southem Blvd.
Kettering, Ohio 45429
Dear Dr. Cartwright:
I am writing in reference to your letter dated Septernber 15,1998, in which you discuss receiving an increasing number of requests to inject byproduct material away from your address of use.
You indicated that you have tried a number of times to write policies that would allow the nuclear medicine department to take doses of byproduct material to sites away from the hospital to perform injections. You stated that so far these policies have been disallowed by the Region ill office.
In your letter dated December 18,1995. you requested off-site use for byproduct materials used in cardiac stress tests and palliative agents as described b/10 CFR 35.300. In addition, you requested use of palliative agents at a current area of use. You stated that any off-site use will be treated as a mobile service under 10 CFR 35.29 and 35.80. You also indicated that cardiac stress tests are performed at sites contiguous to your licensed locations (private physician f
offices).
O I have reviewed your license file and it appears that you have been approved for your requests, with the exception of approval for all materials authorized in 10 CFR 35.300, as certain safety
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procedures for inpatients who receive radiopharmaceutical therapy were needed. Those
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materials that were approved were listed as line items on your license. In your letter dated March 21,1996, you withdrew your request for blanket approval of off-site administration of palliative agents, stating that you will request approval on a case-by-case basis, as needed.
Your approval for use of palliative agents at Svramore Hospital, a current area of use, was approved, limited to 2 radiopharmaceuticals '
utpatient treatment only. You still requested approval for off-site use of byproduct maten used in cardiac stress tests. You were approved for administering byproduct meterial at physician's offices that are physically connected to the licensed facility.
If there are specific procedures for which you wish to be authorized, you should detail these procedures in an amendment request to the Region lli office, specifically requesting any necessary exemptions along with a justification as to why the exemption (s) is(are) needed. All exemption requests are submitted, through the Region Ill office, to the Office of Nuclear Materials Safety and Safeguards, Division of Industrial and Medical Nuclear Safety (NMSS/IMNS), for review and approval.
You stated, in your letter dated September 15,1998, that the quantities of materials involved are small and their use infrequent. However, from your letter, it appears that this use may become more routine. NMSS/IMNS can always review and approve an emergency amendment to 3300G8 a R-J cb 9812290002 981222
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Steven Cartwright, Ph.D., DABR 2
handle emergencies which are dearly in the patient's best interest, such as administering Sr-89 to a patient in a nursing home for palliative treatment of bone pain. However, blanket approval cannot be given for a licensee to administer byproduct material to any location that is not authorized by the license, unless that use is authorized by license condition under the provisions of a mobile medical service (10 CFR 35.29 and 10 CFR 35.80). Specific radiation safety procedures must be established, including the safe transportation of the material, addressing radiation surveys and waste, and ensuring that no contamination remains at the off-site location.
Additionally, management of facilities into which you plan on bringing byproduct material for injecting a patient must be aware that byproduct material is entering their premises, hence the requirement to operate under a mobile service in accordance with 10 CFR 35.29 and 35.80.
Otherwise, specific addresses of use must be listed on the license You had also indicated that you avoided establishing a mobile nuclear medicine service since imaging is not required. Please note that imaging is not a requirement for establishing a mobile nuclear medicine service.
You asked the U.S. Nuclear Regulatory Commission to consider writing regulations that address this gray area of use. All petitions for rulemakings must be submitted in accordance with 10 CFR Part 2, Subpart H. I have enclosed a copy of 10 CFR Part 2 for your information and use.
I hope this addresses your concerns.
Sincerely, Larry W. Camper, Chief Materials Safety Branch Division of industrial and Medical Nuclear Safety
Enclosure:
10 CFR Part 2 cc: Cynthia D. Pederson, Director Division of Nuclear Materials Safety, Rlll Distribution: g:/ taylor / tickets /imns7158 MO #
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