ML20052A211
| ML20052A211 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/1982 |
| From: | Stephen Burns NRC OFFICE OF THE EXECUTIVE LEGAL DIRECTOR (OELD) |
| To: | Johnston A JOHNSTON, A.S. |
| References | |
| EA-81-032, EA-81-32, NUDOCS 8204280010 | |
| Download: ML20052A211 (9) | |
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A. Sidney Johnston, Esq.
as 135 South LaSalle Street 9
Suite 1252 Chicago, Illinois y
Re:
IS0 TOPE MEASUREMENTS LABORATORIES, INC.
(License No. 12-13568-01; EA 81-32)
Dear Mr. Johnston:
In our conversation several weeks ago, I raised the possibility of the NRC staff and Isotope Measurements Laboratories reaching a stipulation of facts in this civil penalty proceeding. Since our disagreement in this proceeding centers on the legal significance of the events in question, and not on whether those events in fact occurred, a stipulation seems appropriate.
I enclose for your consideration proposed stipulations of fact and stipulations as to the admissibility of certain documents. Copies of the referenced documents are included.
I would be happy to discuss this proposal at your convenience.
I will be not be in my office until April 12th, but please call me af ter that date or send me in the meantime any written suggestions that you may have.
Sincerely, Stephen G. Burns unse r NE Staff se Stipulations of Fact)
Distribution:
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J. Liebennan, IE J. Keppler, RIII Cortified BY-t I
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- 32" "
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION I
BEFORE THE ADMINISTRATIVE LAW JUDGE In the Matter of
).
IS0 TOPE MEASUREMENTS Docket No. 30-4291 LABORATORIES, INC.
Byproduct Materials License No.
12-13568-01 3304 Commercial Avenue
)
Northbrook, Illinois 60062
)
(EA81-32)
JOINT MOTION TO ACCEPT STIPULATIONS AGREED TO BY THE NRC STAFF AND THE LICENSEE In a notice of hearing issued by the Commission, the Administrative Law Judge has been assigned to preside over this civil penalty proceeding. See 47 Fed. Reg. 1191 (Jan. 11, 1982). As a result of discussions between counsel for the parties, the NRC staff and the licensee, Isotope Measurements Laboratories, Inc. (IML), have agreed to stipulate certain facts and the admissibility of certain documents which bear on the issues in this proceeding. These stipulations are appended to this motion as an Appendix with attached exhibits.
Accordingly, pursuant to 10 CFR 2.730 and 2.753, the NRC staff and the licensee jointly move that the Administrative Law Judge accept the Stipulations of Fact and Stipulations as to the Admissibility of Certain Documents appended to this motion into the record of this proceeding.
Respectfully submitted, Stephen G. Burns Counsel for NRC Staff A. Sidney Johnston Counsel for Licensee Dated:
APPENDIX STIPULATIONS OF FACT AND STIPULATIONS AS TO THE ADMISSIBILITY OF CERTAIN DOCUMENTS 1.
Isotope Measurements Laboratories, Inc.-(IML), is in the business of providing nuclear medicine services to hospitals in Indiana, Illinois, and other states.
IML contracts with client hospitals to provide equipment, consulting services, and technical staff for a client hospital's nuclear medicine department.
2.
License No. 12-13568-01 was first issued to IML on February 13, 1970.
From August through November 1980, IML was authorized to possess and use by-product material under Amendment No. 4 to Materials License No.
12-13568-01 which was issued by the Nuclear Regulatory Commission on March 4, 1980. Joint Exhibits 1(a) through 1(d) are, respectively, true copies of Amendment No. 4 to Materials License No. 12-13568-01 dated March 4, 1980, and documents dated January 24, 1975, May 5, 1975, and January 17, 1980, that are incorporated in the license by reference in License Condition No.16. Joint Exhibit 2 is a true copy of a letter dated April 4, 1975 from Nathan Bassin, Materials Branch, Division of Materials and Fuel Cycle Licensing, to IML.
3.
On March 8,1979, Mr. Rivkin submitted on behalf of IML an application to amend Materials License No. 12-13568-01. Joint Exhibit 3 is a true copy of the application dated March 8, 1979.
4.
On April 27, 1979, Michael A. Lamastra of the License Management Branch, Division of Fuel Cycle and Material Safety,.0ffice of Nuclear Material Safety and Safeguards, sent a letter to Mr. Rivkin concerning IML's application dated March 8, 1979. Joint Exhibit 4 is a true copy of Mr. Lamastra's letter.
5.
On or about April 27,1979, Michael A. Lamastra spoke with Mr.
Rivkin by telephone and informed him that the practice of eluting generators at one licensed hospital and distributing the eluates to other licensed hospitals was not authorized under IML's existing license.
6.
Between June 1978 and May 1980, IML, through its employees, had eluted technetium-99m from generators possessed by Putnam County Hospital, Greencastle, Indiana, and then transferred 'the technetium-99m to other hospitals in Indiana.
7.
During an inspection in May 1980, NRC inspectors discovered that distributions of technetium-99m had been made from Putnam County Hospital to other hospitals. On May 22, 1980, James G. Keppler, Director of NRC Region III, sent a letter, which was labeled an "Immediate Action Letter," to John D. Fajt, Executive Director of Putnam County Hospital.
Joint-Exhibit 5 is a true copy of the letter dated May 22, 1980.
8.
On June 11, 1980, a conference was held in Greencastle, Indiana, i
among representatives of NRC Region III, IML, Putnam County Hospital, Vermillion County Hospital, Clinton, Indiana, Mary Sherman Hospital, i
Sullivan, Indiana, Greene County Hospital, Clinton, Indiana, and Clay County Hospital, Brazil, Indiana. Ashwin Patel, Manager of Technical Services, was among the representatives of IML who attended the meeting.
9.
At the June 11, 1980, conference, NRC officials stated that, in NRC's view, distribution of technetium-99m or other licensed material i
from Putnam County Hospital through IML to other hospitals was not authorized.
4
- 10. On or about August 5,1980, NRC inspectors conducted an inspection of IML's records and interviewed IML personnel, including William Rivkin, at IML's offices in Northbrook, Illinois. Mr. Rivkin was IML's Secretary-Treasurer and was the IML officer primarily responsible for liaison with the NRC. The results of the inspection of records and interviews indicated that IML had distributed technetium-99m l
j eluted from generators possessed by Illini Hospital, Silvis, Illinois, Utlaut Memorial Hospital, Greenville, Illinois, Mason District Hospital, Havana, Illinois, or Pana Community Hospital, Pana, Illinois, 4
l to other NRC licensees on various occasions since June 1978.
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- 11. As a result of the inspections described in paragraph 10, James G.
Keppler, Director of NRC Region III, sent a letter dated August 8,1980, t
which was labeled an "Immediate Action Letter," to William Rivkin, l
Secretary-Treasurer of IML. Joint Exhibit 6 is a true copy of the letter dated August 8, 1980.
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- 12. Mr. Rivkin received the letter dated August 8,1980, from Mr.
Keppler. Mr. Rivkin dio not inform Mr. Keppler or any other NRC official that IML would not take the action delineated in the letter.
- 13. After receiving the letter from Mr. Keppler, Mr. Rivkin did not direct the IML technician to cease distribution of material from Mason District-Hospital to Hopedale Medical Complex until after the NRC initiated another inspection of IML's activities on or about November 20, 1980.
- 14. On August 26, 1980, September 2,16, and 23,1980, October 4, 7, 21 and 28, 1980, and November 4, 1980, an IML nuclear medicine technician, employed to provide services for IML client hospitals, eluted technetium-99m from a generator possessed by Mason District Hospital, Havana, Illinois, and then transferred the _ technetium-99m in the form of radiopharmaceutical doses to Hopedale Medical Complex, Hopedale, Illinois.
In eluting the 1
generator' and transferring the material the IML technician was acting for IML within the scope of his employment as a nuclear medicine technician.
15 On the dates specified in paragraph 14, Mason District Hospital's sole license from NRC was to possess and use byproduct material, including molybdenum-99/ technetium-99m generators, under the authori of Materials License No. 12-16996-01 (Amendment Nos. 2 & 3), which was issued and amended by the Nuclear Regulatory Commission on March 15, 1977, and August 14, 1978. Joint Exhibits 7(a) through 7(f) are true copies, respectively, of Amendment No. 2 (March 15,1977) and Amendment No. 3'(August 14,1978) to Materials License No. 12-16996-01 and documents dated April 22,1976, June 4,1976, January 18, 1977, and February 14, 1977, which are incorporated by reference in License Condition No. 14. Joint Exhibit 8 is a true copy of a letter dated May 17, 1976, from Patricia C. Vacca, Radioisotopes Licensing Branch, Division of Fuel Cycle and Mr'.erial Safety, to Jon M. Dosher, Administrator, Mason District Hospital. Joint Exhibit 9 is a true copy of the " Application for Byproduct Material License" referred to in Amendment No. 3 to Materials License No. 12-16996-01.
- 16. Although If!L initially suspended distribution of material from Pana Community Hospital to Hillsboro Hospital af ter receiving the August 8, 1980'lttter from Mr. Keppler, Mr. Rivkin authorized the IML technician later in August 1980 to continue distribution of material from Pana Community Hospital to Hillsboro Hospital. Mr. Rivkin did not direct the i
IML technician to cease distribution until after the NRC initiated another inspection of IML's activities on or about November 20, 1980.
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- 17. On August 11, 14, 18 and 21, 1980, September 2, 8, 9, 12, 13, 20, 22 and 23, 1980, an IML nuclear medicine technician, employed to provide i
t
services for IML client hospitals, eluted technetium-99m from a generator possessed by Pana Community Hospital, Pana, Illinois, and then transferred the technetium-99m in the form of radiopharmaceutical doses to Hillsboro Hospital, Hillsboro, Illinois.
In eluting the generators and transferring the eluted material, the technician was acting for IML within the scope of his employment as a nuclear medicine technician.
- 18. On the dates specified in paragraph 17, Pana Community Hospital's sole license from NRC was to possess and use byproduce material, including molybdenum-99/ technetium-99m generators under the authority of Materials License No. 12-18890-01, which license was-issued by the Nuclear Regulatory Comission on April 11, 1980. Joint Exhibits 10(a) through 10(c) are true copies, respectively, of Materials License No.
12-18890-01 dated April 11, 1980, and documents dated February 25, 1980, j
and March 25, 1980, which are incorporated in the license by reference in License Condition No. 15. Joint Exhibit 11 is a true copy of a letter dated March 4,1980 from John W. Cooper, Chief, Regional Licensing i
Section, Material Licensing Branch, Division of Fuel Cycle and Material Safety, to Pana Community Hospital.
- 19. Neither Mr. Rivkin nor any other IML official asked Mr. Keppler or any other NRC official for authorization to make the distributions that are described in paragraphs 14 and 17.
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- 20. The NRC Staff and the licensee stipulate that the exhibits identified herein and attached to this appendix are admitted as evidence in this proceeding.
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