ML20133E643
| ML20133E643 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 01/07/1997 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20133E637 | List: |
| References | |
| 70-1342-96-01, 70-1342-96-1, NUDOCS 9701130091 | |
| Download: ML20133E643 (2) | |
Text
NOTICE OF VIOLATION Biocontrol Technology, Inc.
Docket No. 070-01342 Indiana, Pennsylvania License No. SNM-1319 During an NRC inspection conducted on December 12,1996, violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG 1600, the violations are listed below:
A.
Condition 13 of License No. SNM-1319 requires that a physical inventory be conducted every six months to account for all sealed sources and devices containing licensed material received and possessed under the license and that records of inventories shall be maintained for five years from the date of each inventory.
Contrary to the above, as of December 12,1996, a physical inventory of all sealed sources and devices had not been conducted since June 1995.
This is a Severity Level IV violation (Supplement VI).
B.
Condition 15 of License No. SNM-1319 requires that, at twelve-month intervals, the licensee shall collect and tally data from all medical institutions with respect to: (a) accountability, removal, and recovery; (b) duration of l
satisfactory performance or the time of service before malfunction; and (c) the nature of malfunctions (if appropriate) of all implanted Coratomic Model C-100, C-101, C-101P, and Pulsar-N1 nuclear-powered pacemakers. Within ninety (90) days of the twelve-month period ending August 31, a copy of the report.
must be sent to the U.S. Nuclear Regulatory Commission, Region I, Nuclear Materials Safety Branch,475 Allendale Road, King of Prussia, Pennsylvania 19406.
Contrary to the above, as of December 12,1996, a copy of the report for 1995/1996 had not been sent to the U.S. Nuclear Regulatory Commission.
This is a Severity Level IV violation (Supplement VI).
C.
Condition 12.C of License No. SNM-1319 requires that, in the absence of a certificate from a transferor indicating that a leak test has been made within six months prior to the transfer, a sealed source received from another person shall not be put into use until tested.
Contrary to the above, as of December 12,1996, thirty-six sealed sources, received from other persons since March 1994 without leak test certificate:s i
indicating that leak tests had been made within six months prior to the [
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Notice of Violation transfers, have undergone receipt inspection involving cleaning and electrical testing prior to being put in storage without being leak tested.
This is a Severity Level IV violation (Supplement VI).
D.
10 CFR 20.1501(b) requires that the licensee shall ensure that instruments and equipment used for quantitative radiation measurements (i.e., dose rate and effluent monitoring) are calibrated periodically for the radiation measured.
Contrary to the above, as of December 12,1996, two radiation survey instruments (a Thyac lil, Serial No. 2341 and a Victoreen 488A, Serial No.
467), used for quantitative radiation measurements on January 6,1995 and June 18,1996, had not been calibrated since September 2,1993 and September 9,1993, respectively.
This is a Severity Level IV violation (Supplement IV).
Pursuant to the provisions of 10 CFR 2.201, Biocontrol Technology, Inc. is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a
" Reply to a Notice of Violation" and should include for each violation: (1) the reason
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for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified it' this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.
Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.
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