ML20245H105
| ML20245H105 | |
| Person / Time | |
|---|---|
| Site: | 07002134 |
| Issue date: | 02/13/1986 |
| From: | Austin B GRANDVIEW HOSP. & MEDICAL CENTER, DAYTON, OH |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20244B344 | List: |
| References | |
| 380261, 80754, NUDOCS 8902150465 | |
| Download: ML20245H105 (2) | |
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GIBNDVIEW Hospital and Medical Center February 13, 1986-N rnc:
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Please consider this application fdf renewal of USNRC License No SNM-1603, issued to this hospital for follow up of patients implanted with Cordis Nuclear Pacemakers.
~The hospital wishes to maintain authorization 'for posession of fourteen (14)
' Cordis, Omni-Stancor, Model 184 units that are implanted in patients that are presently being followed. No additional nuclear pacemakers are to be authorized and none are to be implante.d in the future under the terms of this License.
The activities to be conducted under this License are limited to following patients with. implanted pacemakers and the explant and return of nuclear pacemakers to the manufacturer upon pacemaker malfunction or patient death. These activities will be conducted as previously specified in license applications, except that follow-up is to be by telephonic means, as requested in amentment application dated November 24, 1985 (Control number 80261).
The listing of physicians. involved with the nuclear pacemaker program remains unchanged with follow up examinations continuing to be performed by James G. Laws, D.O.
as in the past.
No fee is included with this application, since the hospital holds USNRC License No 34-06404-01 for other human use activities.
Please do not hesitate to contact me at (513) 226-7824 should any questions arise concerning this renewal.
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8902150465 0B0323 Bruce T. Austin, Ph. D REG 3 LIC70 111 Medical Physicist SNM-1603 PNU Radiation Safety Of ficer CONTROLNO. 8 0 7 5 4 FEB 181986 405 Grand Avenue Phone Member Dayton, Ohio 45405 (513) 226-3200 American Osteopathic Hospital Association c _ _ __.
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798 ROOSEVELT MOAD OLEN ELLYN, ILLINOIS 60137 BETWEEN: William O. Miller, Chief-License Fee Management Branch Office of Administration Regional License Section Material Licensing Branch FCMS, Office of Nuclear Material Safety & Safeguards LICENSE FEE TRANS ITTAL A.
REGIO 1.
APPLICATION ATTACHED Applicant / Licensee:
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Amendment Renewal License
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22 Enclosed please find payment in the amount of $120.00 fonamendintnt of USNRC License Nos. 34-06904-01 and SNM 1603, which are issued.to Grandviewfg1f spital for activities at Grandview Hospital and Southview Hos,pital and Family Health Center.
Please amend item Nos. 6E, 7E, 8E and 9E of ficense No 34-06904-01, to delete authorization for posession and use of Phosphorous-32 in any chemical form and quantity. This material will no longer be used under the conditions of this i
license.
Please amend item No 8H to revise the quantity specified to a nominal activity of 200 mci. This calibration source is to be reloaded and modified by the manufacturer for use in the calibration range described in Attachment 1 of this application. Procedures for calibration including documentation and scope of service to be provided remain unchanged from those previously described in the application dated January 6, 1983. Calculated dose rates with the source opened and unattenuated will not exceed 2.0 mR in an hour in any adjacent, unrestricted or restricted area outside the calibration range. Adequacy of adjacent area protection will be verified prior to routine use of the calibration source.
Please amend items No. 6, 7, 8, and 9 to authorize possession and use of up to 1,800 mci of Gadolinium-153 as GdO in the f rm f a sealed source not exceeding 4
2 1,500 mci per source for Bone Mineral analysis. The source (s) (including posession l
of a source decayed to levels that are no longer useful for analytical procedures),
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will be a Gulf Nuclear Model GD-1, Amersham Model GDC. Cyl, New England Nuclear Model NER-430, Lunar Model GD or equivalent NRC registered sealed source (s).
The source will be installed in a Lunar DP-3 Scanner, NRC device registration NR-430-D-101-S with the source installed in a lead lined source holder, Lunar model DP3-A-SRC-0100-0 or, if necessary pursuant to installation and/or replacement, in a i
lead shielded container within a secured area of the Nuclear Medicine Department.
The source will be installed, leak tested and replaced by the Radiation Safety Of ficer or a trained designee c.f ter training by the manufacturer's representative and in accordance with the manuf acturer's instructions.
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Personnel who are to use the device for bone mineral analysis will be trained in device operation and routine safety precautions by the manufacturer's representative at the time of installation.
Routine operating procedures will be l
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, 3P @N REGION III 405 Grand Avenue Phone Member Dayton Ohio 45405 (513) 226-3200 CONTROLNO. R 0 2 6 Amencan Osteopathic HospitaMssociabon mo At e emvFartm a
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Please amend item 12 to authorize the use of Gadolinium-153 by John C. Knox,
- D.O..for bone mineral. analysis.
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Please amend item 12 to delete William Everd Rogers, M.D. from activities authorized under the conditions of this License.
Please also amend this item to include Mariano Fernandez-Ulloa, M.D. for the use of Diagnostic Groups I, II, and III; Xenon-133; Iodine-131 for the treatment of hyperthyroidism, cardiac dysfunction, and thyroid carcinoma; In Vitro studies; and Gadolinium-153 for bone mineral analysis.
Dr. Fernandez is currently listed on Byproduct Material License No. 34-00855-07 for these materials and uses.
Pursuant to item 17 of the license, which authorizes decay-in-storage of radioactive wastes, please approve addition of the room illustrated in Attachment I to this application ~ as a storage area for waste matprials. Material quantity and -
geometry will be maintained to prevent radiation in excess of 2.0 mR in an hour in all adjacent areas.
Present material storage areas, as have use areas recently vacated by the Department of Nuclear Medicine, will be surveyed by the Radiation Safety Of ficer using low-level survey instrumentation to determine residual radiation levels and the presence of removable activity prior to release for unrestricted use.
Record of the area release survey, including instrument sensitivity and calibration data, will be maintained in the licensee's files for inspection by USNRC personnel.
Please amend item No. 22 to authorize suspension of testing of the Xenon-133 trapping device ' for saturation if unused for a period of 30 days since the last saturation test.
Please amend Application item No. 9, Appendix C, last amended July 30, 1984, to include replacement of a Picker MICRO-Z LF0V Camera with a Technicare SPECT Camera.
Please amend license No. SNM 1603 to authorize routine use of telephonic monitoring information provided by Cardiac Datacorp, Inc., Philadelphia, Pa.,
to obtain semi-annual follow-up data on Cordis, Omni-Stanicor Cardiac pacemaker patients.
Experience to date indicates that all useful patient monitoring data may be reliably acquired using this methodology supplemented by clinical observation during patient visits.
Thank you for your prompt attention to this amendment request.
Should any j
question arise concerning these matters, please do not hesitate to contact me at (513) 226-7824.
Sincerely-I Bruce T. Austin, Ph. D.
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