ML20137B152
| ML20137B152 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 02/07/1997 |
| From: | Klingensmith J BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| Shared Package | |
| ML20137B137 | List: |
| References | |
| NUDOCS 9703210189 | |
| Download: ML20137B152 (3) | |
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i BIOCONTROL TECHNOLOGY,INC.
February 7,1997 Goo indian springs noad. Indiana, PA 15701 (412) 349-1811 Far (412) 349-8010 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, D.C. 20555 Re: Reply to a Notice of Violation Ref:
Docket No. 070-01342 License No. SNM-1319 To Whom It May Concern:
This letter is in response to the Notice of Violation dated January 7,1997, resulting from Inspection No. 070-01342/96-001 conducted by John McFadden on December 12,1996. Each violation has been listed below, followed by Biocontrol's response.
A. Condition 13 of License No. SNM-1319 requires that a physicalinventory 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 ofinventories 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.
j This is a Severity Level IV violation (Supplement VI).
- 1) the reasonfor the violation, or, ifcontested, the basisfor disputing the violation: This violation occurred because Biocontrol did not conduct a physical inventory oflicensed material at six month intervals.
- 2) the corrective steps that have been taken and the results achieved: A physical inventory accounting for all licensed material was completed on January 27,1997.
- 3) the corrective steps that will be taken to avoidfurther violations: The licensed material physical inventory has been placed on the calibration schedule with a six month interval to avoid further violations.
!) the date whenfull cornpliance will be achieved: January 27,1997.
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 satisfactory performance or the time of service before malfunction; and (c) the nature of malfunctions (if appropriate) of allimplanted Coratomic Model C-100, C-101, C-101-P, 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).
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- 1) the reasonfor the violation, or, ifcontested, the basisfor disputing the violation: Biocontrol relies on the timely response of physicians and medical institutions when compiling the annual report to the NRC. However, Biocontrol has no authority to enforce timely response from physicians or medical institutions. By striving to make the annual report complete and accurate, Biocontrol has been unable to comply with the license condition to submit the report to the NRC within ninety (90) days of the twelve-month period ending August 31.
- 2) the corrective steps that have been taken and the residts achieved: The 1995l1996 annual report was sent to the NRC on December 26,1996 and received by the NRC on December 30, 1996.
- 3) the corrective steps that will be taken to avoidfurther violations: A response cut-off date has been set at October 15, forty-five (45) days after August 31. All responses received from physicians and medical institutions before the cut-off date will be included in the current annual i
report. Any response received after the cut-off date will be included in the next annual report. By employing a response cut-off date, reports will be compiled and submitted within the required ninety (90) day time period. Biocontrol will continue to stress to physicians and medical institutions the importance of timely response.
- 4) the date whenfull compliance will be achieved: December 30,1996.
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 certificates indicating that leak tests had been made within six months prior to the transfers, have undergone receipt inspection involving cleaning and l
electrical testing prior to being put in storage without being leak tested.
l This is a Severity Level IV violation (Supplement VI).
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- 1) the reasonfor the violation, or, ifcontested, the basisfor disputing the violation: Biocontrol
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is only licensed to receive sealed sources contained in pacemakers removed (explanted) from patients. Biocontrol performs a package survey on the shipping package of each explanted pacemaker received, including a wipe test on the outside surface of the package to detect any removable contamination. If the pacemaker had a gross leak oflicensed material, the wipe test of 1
the package should detect the leak.
The package is then opened and the explanted pacemaker, handled with gloves, is i
immediately cleaned in cold sterilant. In the past, once clean, the pacemaker was electrically
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tested and placed into storage.
Biocontrol firmly believes that the greatest risk to our employees handling explanted pacemakers is from biological contamination and blood borne pathogens, including hepatitis and HIV (Aids), which may be on the surface of the pacemaker. The risk oflicensed material leakage from the pacemaker, considering the redundant hermetic encapsulations of the sealed source provided sy the pacemaker, is minimal. Leak testing the explanted pacemaker prior to cold sterilant cleaning would require tear-down and biological decontamination of the alpha counter after every leak test, which would be costly and could compromise reliability and calibration of i
the counter.
J February 7,1997 Reply to a Notice of Violation Page 2 1
- 2) the corrective steps that have been taken and the results achieved: All in-house sealed sources were checked for leakage before being placed into Biocontrol's new storage area on May 5,1995.
Twenty-three (23) sealed sources received since May 5,1995 were tested for leakage on January 22,1997. Therefore, all sealed sources received since March 1994 have been tested for leakage.
All sealed sources passed leak test.
- 3) the corrective steps that will be taken to avoidfurther violations: Blocontrol has instituted a wipe test for leakage immediately after cold sterilant cleaning of explanted pacemakers. All packaging material and the cold sterilant are retained until leak test results are known. If a i
pacemaker is received with sovere damage to the area containing the sealed source, only then is the pacemaker tested for leakage before cold steritant cleaning.
- 4) the date whenfull compliance will be achieved: January 27,1997.
D. 10 CFR 20.1501(b) requires that the licensee shall ensure that instmments 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 III, 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 VI).
- 1) the reasonfor the violation, or, ifcontested, the basisfor disputing the violation: Blocontrol's past paper-based calibration tracking system was not always sufficient for tracking all instmments requiring calibration.
- 2) the corrective steps that have been taken and the results achieved: A new electronic-based calibration tracking system has been instituted to track all measurement instruments requiring calibration. The two radiation survey instmments in question have been entered into this new system and are scheduled to be sent out immediately for calibration.
- 3) the corrective steps that will be taken to avoidfurther violations: Properly maintain electronic based calibration system.
- 4) the date whenfull compliance will be achieved: March 15,1997.
Sincerely,(W E
Joseph N. Klingensmith Radiation Safety Officer cc:
David L. Purdy, President i
William O. Chishko, Manager of Quality Assurance and Regulatory Compliance Regional Administrator, Region I February 7,1997 Reply to a Notice of Violation Page 3
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