ML20199F552
| ML20199F552 | |
| Person / Time | |
|---|---|
| Issue date: | 12/30/1998 |
| From: | Dan Collins NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | Jain K AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20199F556 | List: |
| References | |
| REF-QA-99990002-981230 EA-98-506, NUDOCS 9901210352 | |
| Download: ML20199F552 (6) | |
Text
e -e December 30,1998 i i
EA 98-506 l l
Tri State Medical Center l ATTN: Kirti K Jain, M.D. j Administrator 2628 Sth Avenue -
Huntington, WV 25704 )
SUBJECT:
NOTICE OF VIOLATION (OFFICE OF INVESTIGATIONS (01) REPORT NO. 2-1997-026 - NOW CARE INC.)
Dear Dr. Jain:
This refers to the Ol investigation conducted on November 18,1997, at your former facility at 611 Seventh Avenue, Huntington, West Virginia. The purpose of the investigation was to 1 determine the circumstances associated with the apparent transfer of control of NRC License No. 47-25152-01 from Now Care, Inc. to Tri-State Medical Center (TSMC) on or about January 15,1996. A copy of the synopsis to the Ol report is enclosed.
Based on the results of the investigation, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice). The violation, which is being cited against TSMC, involves possession and use of byproduct material for medical use without a specific license issued by the NRC. Specifically, TSMC assumed the nuclear medicine activities of Now Care, Inc., including the transfer, receipt, and use of byproduct material without an NRC license, during and after Now Care, Inc.'s bankruptcy proceedings. This is a matter of concern because the possession and use of byproduct material for medical use by unlicensed entities could result in the improper administration of this material to patients and result in undue and potentially serious personnel exposures and subsequent harm to the exposed individuals.
Generally, a violation of this nature would be considered for escalated enforcement action as described in the " General Statement of Policy and Procedures for NRC Enforcement Actions,"
(Enforcement Policy) NUREG-1600. However, after review of the circumstances, we determined that escalated enforcement was not warranted due to the overall significance of the violation. Notwithstanding the 01 conclusion in this case, we determined that the actual and potential safety consequences of this unlicensed use of byproduct material were low because the medical use of byproduct material was performed by qualified individuals, the materials were otherwise appropriately controlled, and operations were conducted at the original location of Now Care, Inc., thus NRC's ability to inspect was not impeded. However, in the future, if a similar violation is identified, we may take escalated enforcement action.
NRC granted TSMC a license on June 18,1998, to conduct nuclear medicine activities pursuant to 10 CFR Part 35. As an NRC license holder, you are reminded of the requirements of 10 CFR 30.34 (b) and (h)(1), and 10 CFR 30.41 (a) and (b)(5) regarding NRC not!'ication of' l
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9901210352 981230 RE92 GA999 EMD***** l 99990002 PDR g6) '
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i Tri-State Medical Center 2 bankruptcy, the transfer of control of licensed activities and/or ownership, and the trasfer of byproduct material, respectively.
l You are required to respond to this letter and should follow the instructions specified in the renclosed Notice when preparing your response. In your response, you should also address the actions you will take to ensure that you have an adequate understanding of the regulatory requirements associated with the medical use of licensed material and that you will take the appropriate actions to ensure compliance with these requirements. For your consideration and convenience, NRC Information Notice 96-28, " SUGGESTED GUIDANCE RELATING TO DEVELOPMENT AND IMPLEMENTATION OF CORRECTIVE ACTION,"is enclosed. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosures, and your response will be placed in the NRC Public Document Room.
Sincerely, original signed by C. Hosey for Douglas M. Collins, Director Division of Nuclear Materials Safety Docket No. 999-90002
Enclosures:
- 1. Notice of Violation
- 2. NRC Information Notice 96-28
- 3. Ol Report Synopsis cc w/encls 1 and 3:
State of West Virginia Distribution w/oncls 1 and 3:
PUBLIC Rll Docket File, DNMS J. Lieberman, OE B. Summers, OE (2)
- See next page for prior concurrence j OFFICE Ril.DNMS RilDNMS Rd: ORA EICS Hli 01 All ORA
- l. SIGNATURE NAME 'JHenson *MLesser ' A Boland *W.McNulty *C Evans DATE 12/ /98 12/ /98 12i i98 12/ 19 8 12/ /98 12/ /98 12/ /98 GOPY7 YES NO YES NO YES NO YES NO YES NO YES NO YLS NO OFFICIAL RECORD COPY DOCUMENT NAME: G:\DNMS\MLIB1\03032365.JLH I
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! Tri-State Medical Center 2 You are required to respond to this letter and should follow the instructiongspecified in the enclosed Notice when preparing your response. In your response, you s uld also address the actions you will take to ensure that you are adequately informed of the r ulatory requirements 1 associated with the medical use of licensed material and that you will t e the appropriate '
actions to ensure compliance with these requirements. For your cons' eration and convenience, an excerpt from NRC Information Notice 96-28, "SUG ESTED GUIDANCE RELATING TO DEVELOPMENT AND IMPLEMENTATION OF CO RECTIVE ACTION,"is enclosed. The NRC will use your response, in part, to determine hether further enforcement action is necessary to ensure compliance with regulatory require ents.
In accordance with 10 CFR 2.790 of the NRC's " Rules of Prac ce," a copy of this letter, its enclosures, and your response will be placed in the NRC Pub c Document Room.
Sincerely, Douglas M Collins, Director Division of uclear Materials Safety Docket No. 999-90002
Enclosures:
- 1. Notice of Violation
, 2. Excerpt from NRC Information No ice 96-28 l 3. Ol Report Synopsis 1
cc w/encls 1 and 3:
l State of West Virginia L
Distribution w/encls 1 and 3:
PUBLIC l Ril Docket File, DNMS l J. Lieberman, OE j B. Summers, OE (2)
! *See next page for prior concurrence . ,
OFFICE RH.DNMS All DNMS @S Ril On RilpRA ,
SIGNATURE j' / g g
! NAME 'JHenson *MLesser y BotJ bd *W.McNulty W C. Evans DAT E 1 21 /98 12i / 51 8 '98 12e /98 1 3 /98 12/ /98 12/ /98 f
COPY 7 YE5 NO YES NO [YES/ NO YES NO (iES J NO YES NO YES NO OFFICIAL RECORD COPY DOClknNT NAME: G:\DNMS\MDB1\03032365.JLH 1
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l l -Tri-State Medical Center 2 .
I enclosed. The NRC will use your response, in part, to determine whet er further enforcement action is necessary to ensure compliance with regulatory requirement In accordance with 10 CFR 2.700 of the NRC's " Rules of Practice," copy of this letter, it's enclosure, and your response will be placed in the NRC Public Do ment Room (PDR),
S;ncerely, l l l l Douglas M. Coll' s, Director l Division of Nu ar Materials Safety
- l. Docket No. 999 90002 l
Enclosures:
- 1. Notice of Violation l 2. Excerpt from NRC Information Notice 6-28
- 3. Ol Report Synopsis cc w/encls 1 and 3:
State of West Virginia Distribution w/encls 1and 3:
PUBLIC l Ril Docket File, DNMS '
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i OFFICE RilDNMS Ril.DpMS Rit oHA.E.lCS OT, $lC(ff SGNATURE gg / / jgg NAME JHb7: son b Less,er 4Boland V (gh @g gg l
DATE 12// / /9g yq /g j 12/ /98 12/ g Y /98 12/ /98 12/ /98 12/ /98 j GOPY7 YES (NO (YE5p ( g YES NO YE S NO YES NO YES NO YES NO OFFICIAL RECORD Cd'PY~ DOCUMENT NAME: G:\DNMS\MLIB1\03032365.JLH l /
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