ML20148J621
| ML20148J621 | |
| Person / Time | |
|---|---|
| Issue date: | 10/13/1978 |
| From: | Davis A NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20148J602 | List: |
| References | |
| NUDOCS 7811160047 | |
| Download: ML20148J621 (1) | |
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Enclosure NOTICE OF VIOLATION P-L Biochemicals, Inc.
License No. 48-14075-02E Based on the results of the NRC inspection conducted on August 28, 1978, one activity conducted under NRC License No. 48-14075-02E appears to be in noncompliance with NRC regulations as indicated below. This item is a deficiency.
10 CFR 32.20 requires that you submit an annual summary report to the Commission within thirty days following the year ending June 30, stating the total quantity of each isotope transf erred under your license issued pursuant to 10 CFR.32.18.
Contrary to the above, your report for the year ending June 30, 1977, was not filed until August 1,1978, a period of more than one year af ter the year ending June 30, 1977.
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OCT 131978 License No. 21-15446-01 KMS Fusion, Inc.
ATTN:
Dr. Henry J. Gomberg License No. SNM-1341 President 3941 S. Research Park Drive Ann Arbor, MI 48106 Gentlemen:
This refers to the investigation conducted by Messrs. G. A. Phillip and D. J. Sreniawski of this office on August 30, 1978, of activ-ities authorized by NRC Byproduct Material Licenses No. 21-15446-01 and No. SNM-1341 and to the discussion of our findings with Dr. James F. Stiver, Radiological Safety Officer at the conclusion of the investigation. This is also to acknowledge receipt of the report submitted with Dr. Stiver's letter dated September 25, 1978.
This investigation was conducted to determine whether a 45-rem expo-sure to an employee's film badge represented an exposure to the individual. The investigat1on consisted of an examination of pertinent records and procedures, personal observations, and inter-views with personnel. A copy of the investigation report is enclosed.
We have concluded that no personal overexposure occurred.
No items of noncompliance with NRC requirements were identified during the course of this inves*.igation.
In accordance with Section 2.790 of the NRC's " Rules of Practice,"
Part 2, Title 10, Code of Federal Regulations, a copy of this letter and the enclosed investigation report will be placed in the NRC's Public Document Room, except as follows. If this report contains information that you or your contractors believe to be proprietary, you must apply in writing to this office, within twenty days of your receipt of this letter, to withhold such information from public' disclosure. The application must include a full statement of the reasons for which the information is con-sidered proprietary, and should be prepared so that proprietary information identified in the application is contained in an enclosure to the application.
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i KMS Fusion, Inc. OCT 131978~
.We will gladly discuss any questions you have concerning this investigation.
Sincerely, pDah James G. Keppler Director
Enclosure:
IE Investigation Reports No., 30-9126/78-01 and No. 70-1367/78-01 cc w/ encl:
Central Files Reproduction Unit NRC 20b PDR NSIC-1 l
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h U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION III IE Investigation Report No. 30-9126/78-01; 70-1367/78-01
Subject:
KMS Fusion, Inc Ann Arbor, MI 48106-Licenses No. 21-15446-01 and No. SNM-1341 A reported 45 rem exposure to an employee's film badge was determined not to represent a personal exposure.
Period of Investigation: August 30, 1978
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Investigators: ~ G. A. Phillip
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Sreniawski
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Reviewed By:
v C. E. Norelius, Asiristant to the Director M
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A. B. Davis, Chief
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Fuci Facility and Materials Saf ety Branch 1
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4 REASON FOR INVESTIGATION 25, 1978, the licensee reported to Region III by telephone that On August the film badge assigned to an employee during July 1978 showed a 45 rem exposure.
SCOPE OF INVESTIGATION This investigation was conducted to determine whether a 45 rem exposure to an employee's film badge was representative of an exposure received by the employee and consisted of an examination of pertinent records and procedures, personal observations and interviews with personnel.
SUKHARY OF FACTS 24, 1978, Radiation Detection Company, Sunnyvale, California, On August the licensee's film badge processor, notified the licensee by telephone that the film badge assigned to an employee during the month of July 1978 showed a 45 rem exposure to photons with energies of one MEV or more. It was ascertained that the film was exposed in its holder, in a stationary position and from one direction.
The licensee has no source of radiation which could deliver an exposure corresponding to that shown on the film. The employee stated that to her knowledge her July film badge had never left the licensee's premises and expressed the conviction that she had not received the exposure shown on the badge.
The employee had undergone medical examinations, the results of which provided no clinical evidence of an exposure of that magnitude.
It was concluded that the employee did not receive the exposure and in all likelihood, the badge was exposed to radiation at a location that other than the licensee's facility by person (s) unknown.
A remote possibility also exists that the reported exposure was the result of some mix-up which occurred at the film badge processor's facility.
This occurrence has received no publicity.
The State of Michigan Department of Public Health was informed of Region III's plan to conduct this investigation, and Mr. Thomas M. Dykstra, of that agency was present during this inves-tigation.
No items of noncompliance were identified during this investigation.
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- Introduction 1
On August 125, 1978, the licensee' report'ed to Region III by telephone.
1.
.th'at Radiation Detection Company (RDC), Sunnyvale, California, their film badgefsupplier,'hadLnotifie'd them'by telephone on August 24,
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'1978,:thatlthe film. badge. assigned to'an employee, hereafter referred j
J to Las ' Individual: A, during. July 1978 showed an exposure of 45 rem.
The licensee advised that they had initiated an' investigation and It that the individual would~ undergo medical tests and' examinations.
was: indicated that the cause of the' exposure had not~been determined and-that.there was ' doubt' that: the, exposure was related to NRC licen-sed material. EThe licensee' was requested to obtain more information
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-from RDC regarding.the exposed film badge.'
2.
On. August-28,' 1978, the licensee telephonically advised Region III
.l that according to RDC the exposure was-from high energy photons 4
of one'MEV or, greater. RDC 'also said that. the film' was not light struck and 'that it was a one-position exposure.
3.
.The licensee' stated'that they did not possess any se:irces of one i
MEV or greater energy' of sufficient intensity to have produced the 1
' exposure.
The highest. intensity source at KMS Fusion with' appropriate energy J
was source No.17 on the enclosed inventory _ sheet, (Exhibit A)~
listed as'92.25 uCi'of cobalt-60. The! time necessary for a 45 rem exposure.can be expressed as dose divided by dose race.
Using:
(17 a source to film distance (d) of 2cm, (2) the gammg constant (T) for a cobalt-60 point source' of 13.2 R/hr at 1 cm per millicurie..
. 1 2 Dose Rate'= T x 7
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=92.25uCi-Co-60xf*b uCi
- hr mci (2cm)
= 0.305 R/hr at the 2cm distance Dose Rate fo'r X_&-y
-# 0.305 rem /hr at 2cm from film badge 147.fpoursqeededtoproducetherequired
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Time =
305 rem hr exposure.
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An exposure at this distance (2cm) should have shown a density change across the film, with fading at the edges. The film badge processor stated this was not the case. The film showed the same density from edge to edge. If the film was moved any further from the source in an ef fort. to produce even density, then the need to expose the film
'for more time quickly surpasses the total time available.
The licen-see also indicated that the employee said the film badge had not been removed from the licensee's premises.
On August 29, 1978,-the licensee and the State of Michigan Department 4.
of Health were advised that Region III would initiate an investi-gation on' August 30, 1978.
Mr. Thomas M. Dykstra of the State of Michigan was present during this investigation.
Interview with James F. Stiver, Radiological Safety Officer 5.
Upon arrival at the licensee's f acility on August 30, 1978, James F Stiver provided the following information during an interview.
Through several telephone conversations, RDC informed Stiver the 6.
individual' in charge of RDC's analysis section had examined Indi-vidual A's film badge. The film received the exposure while in the holder and the exposure was caused by a high energy.x-ray or gamma source, i.e., one MEV or greater. Although it could not be definitely determined, RDC indicated the appearance of the film No neutron exposure suggested cobalt-60 as the source of exposure.
could be detected on the film. The exposure was from one direction and the film was stationary while being exposed, which is not typical of the film exposed while being woL-by an individual.
There was nb fading toward the edges of the film which would occur if it had been exposed for a long period of time to a small source.
7.
RDC informed Stiver that an identification number assigned to each individual is stamped on the film itself when it is removed from its packet in their darkroom. The likelihood of a mix-up in film is therefore remote.
RDC also advised that all other licensee employee badges used 8.
during July showed no detectable exposure with one exception.
Stiver said one employee had undergone a brain scan in which he was administered Technetium 99m and then came to werk. As a result.of wearing his film badge after arriving at work, his film badge showed 35 mrem exposure.
Individual A's August film badge which was sent to RDC on August 25, 1978, showed no exposure when it was processed..
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- A review of film badge records showed that Individual A had received 9.
no exposure during her employment with the licensee prior to the July 1978 film badge reading.
Stiver said that employee film badges were changed on July 5 and 10.
sent to RDC on July 7.
The July film badges were collected on August 1 and 2, and sent to RDC on August 4,1978.
All film for Individual A's July was received from RDC in a single package.
July film badge was packaged with those of the other employees Also, the film when it was returned to RDC for processing.
to the pro-badges are removed from their holders for shipment cessor and RDC had indicated the film was exposed in its holder.
This appears to eliminate the possibility that the film badge was somehow exposed while in transit.
in Stiver stated that there were two small x-ray machines present 11.
One machine has been out of order since some time the facility.
The other, a Faxitron, having a maximum output of in June 1978, 110 KEV, was used by Individual A.
A log of this unit's use is maintained and it showed that Individual A operated the Faxitron for a total of 12 3/4 minutes on three different settings on Stiver stated that although the unit's energy July 27, 1978.
range was not consistent with the source of the film badge expo-sure, he had examined the unit's operation and the interlock system had functioned properly. The unit is a small table top He unit which can accommodate only small objects to be x-rayed.
further advised that a film badge was placed on a wall adjacent to this unit as an area badge. The badge located there during July showed no exposure when d.t was processed.
Stiver also provided a listing of all byproduct material in the 12.
licensee's possession.
A copy of this listing is attached to this report as Exhibit A.
Stiver said there was one additional source not listed, a.05 microcurie gadolinium 148 source.
Stiver stated that effective July 5, 1978, the licensee had 13.
adopted the policy that employees are not to remove their film Employees have been instructed to badges from the premises.
place their film badges when not in use in a rack located in the lobby of the building next to a guard's desk. He indicated, however, that all employees do not place their badges there He indicated that during an when they are not being worn.
interview with Individual A, she informed him that she kept her badge fastened to her lab coat which she hung in her office when He said that while access to the building is not wearing it.
guard controlled, individual rooms and offices are not locked.
Individual A's film badge, when not being worn, would therefore be accessible to anyone in the building.
3 A
Interview with Individual A 30,-1978, Individual A was interviewed.
She stated that 14 On August she'had been employed by the licensee as a scientist since February 1976.
During recent months, specifically July, she had been working with microshells to develop a means of increasing-the uniformity of their compositions In this connection she had per-formed some. radiography with the x-ray unit but had spent most of her time on computer programming.
She indicated she had performed no other work with radioactive 15.
material or other. radiation sources. She had not undergone any medical diagnosis or treatment involving the use of radioisotopes She could recall no occurrence which would account for or x-rays.
any exposure to her film badge.
16.
She stated that to the best of her recollection she did not remove the film badge from the premises during July. She confirmed that she usually leaves her film badge clipped to the pocket of her lab coat which she leaves hanging in her of fice when she is not wearing She also said that occasionally she leaves her film badge in it.
her desk drawer. Neither the office nor her desk drawer can be locked. She said that although she may not wear her film badge for several successive days, she does wear it whenever she uses the x-ray machine. She could recall no occasion when her badge was lost or not available when she wanted to wear it.
17.
She confirmed that she used the x-ray machine on only one occasion during July and indicated she had performed x-ray work on several occasions during June 1978, and her film badge for that month showed no exposure'.
18.
She indicated that she knew of no one who might intentionally expose She denied having exposed the badge her badge for any reason.
herself. She said that she had undergone a medical examination fol-the results lowing the report of the film badge reading and that to date had been normal. Unless the final results of other medical tests, blood karyotyping, indicate otherwise, she indicated she was convinced that she did not receive the exposure shown on her badge.
Interview with Dr. O_t_t_o_K. Engelke 30, 1978, Dr. Otto K. Engelke was interviewed.
Engelke On August 19.
stated that he is retained by the licensee as a medical consul-In that capacity he had arranged for a medical examination tant.. _,
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of Individual A following notification of the film badge' exposure.
He advised that-aLeomplete. blood workup had been performed and the results were all within the normal range. He.also indicated that
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on July 29: blood samples had been~sent to. Wayne State-University He indi-
.and to Brookhaven National Laboratory-for karyotyping.
cated the results of that ef fort would not be available for at L
least-ten days.'
[l Tour of Facility 30, 1978, a tour was made of the facility which included 20.
On' August the x-ray units, Individual.A's. office,.and the. locations where j
radioactive materials are used and stored... Radiation surveys of these areas showed.rua unusual or high radiation levels.
- Management Discussion 21.
At the conclusion of the investigation, a closecut discussion was held with Stiver. He,was advised that no information was obtained:
which ' indicated the employee had received the exposure shown on her film badge an,d it appeared probable that the film badgs was exposed by some unknown individual (s)'at a' location other than the
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3 licensee's premises.
22.
Stiver stated that the results of the karyotyping would be made.
available,to Region.III when they are received by the licensee.
He also stated that the licensee would furnish the NRC a written the incident report of this occurrence although it appeared that was not reportable under 10 CFR Part 20.
Attachment:
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