ML20011D477
| ML20011D477 | |
| Person / Time | |
|---|---|
| Issue date: | 12/05/1989 |
| From: | Gresick J, Shanbaky M, Lester Tripp NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20011D472 | List: |
| References | |
| REF-QA-99990001-891207 99990001-89-15, NUDOCS 8912270302 | |
| Download: ML20011D477 (5) | |
Text
i U.S. NUCLEAR REGULATORY COMMISSION e
REGION I Report No. 9999001/89-015 Docket No. 99990001 Non NRC Licensee: Del-Med, Incorporated 3001 Hadley Road South Plainfield, New Jersey 07080 Facility Name: Del-Med Incorporated p
Inspection At: South Plainfield, New Jersey Inspection Conducted: October 18, 1989
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Inspectors:
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Jea A. Gresick, Senior Health Physicist,
' date
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Lester Tripp,-HeaKK Physicist
/ dape Approved by: W. C A
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f Mohame'd M. Shan6'aky,ghief
' date
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Nuclear Materials Safety Section A Inspection Summary: Special, announced inspection conducted on October 18,_
1989 (Inspection Report No. 9999001/89-015)
Areas Inspected:
Review of Reported Incidents Involving Radioactive Material; Handling of Incoming' Radioactive Material; Security of Radioactive Material; and Radiological Measurements.
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Results: No violations of NRC requirements were identified, s912270302 891205 g QA999 EMV*****
99990001 PDC t
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DETAILS t
1.
Personnel Contacted
- John ~ Hardy, President, Del-Med, Inc.
- Wendel-Lancaster, Director of Operations, Del-Med, Inc.
- Janice Ogletree, Consultant, Del-Med, Inc.
James Donlan, Radiation Safety Officer, Del-Med, Inc.
Lida Cook, Secretary, Del-Med, Inc.
- indicates personnel present at the exit interview.
2.
Circumstances Leading-to the NRC Visit to Del-Med, Inc.
Del-Med, Incorporated is a common carrier, which transports radioactive material from NRC-licensed suppliers and manufacturers to NRC-licensed users of radioactive material.
On October 16, 1989, at approximately 10:30 a.m.,.a' Region I inspector-received a phone call from the Radiation Safety Officer at Del-Med, Inc.
The RSO described an incident involving a spent Molybdenum-99 generator, which appeared on the back steps of the Del-Med warehouse in South Plainfield between the hours of 11:00 a.m. and 3:30 p.m. on October 6, 1989. The secretary at Del-Med received 'a call from an employee at Medi-Physics, -Inc... South Plainfield, New Jersey, at.about 3:30 p.m.,
who told her, over the phone, that he had received a phone call from an individual who drove by;the back of the; warehouse'and saw a box sitting e
there.
(Medi-Physics-is a distributor:of Molybdenum generators and other radioactive material products.) The box contained a spent Molybdenum-99 generator.
The Del-Med secretary retrieved the box and placed-it in the
-area of the warehouse designated for the storage of returned generators.
She then placed a call to the Director of Operations, who called'the Medi-Physics employee to obtain additional information. The Medi-Physics employee stated that he knew the identity of the individual who called him about the location of the box.
However, the individual wished to remain anonymous. The RSO told the inspector that he was concerned that another-incident involving the loss or unexpected appearance of radioactive esterial would occur.'
On October 17, at approximately 5:15 p.m., the Del-Med RSO called the inspector again, to report the loss of a package of one millicurie of Iodine-131 contained in a radiopharmaceutical preparation, which was destined for a hospital in Salsbury, Maryland. Del-Med personnel were informed of the loss of the material in the morning of the 17th of October, by the supplier of the product.
The RSO stated that Del-Med personnel confirmed, by reviewing their files, that the material was received at the Del-Med warehouse the evening of October 16, 1989.
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3 The NRC Region I office issued a Preliminary Notification (PNO-I-89-86) on October 18, 1989. At that time, inspectors were dispatched to the-facility to review the circumstances of these incidents and assess any.
potential radiological consequences resulting from these events.
3.
Purpose The purpose of this special, announced inspection was to determine whether-the potential existed for a breach of security during the transport of radioactive materials from NRC-licensed suppliers to NRC-licensed users.
NRC Region I management was also concerned over the potential for contamination of the Del-Med, Inc. facility, as a result of the' unexpected appearance of the spent Molybdenum-99 generator and the disappearance of the package of lodine-131 Iodohippurate and potential for improper /
unauthorized use of radioactive materials.
4.
Handling of Incoming Radioactive Material l
The inspector reviewed the Del-Med procedures for the receipt of radioactive i
material into the Del-Med warehouse and the subsequent organization of the shipments for delivery to the final destination.
The Del-Med procedure i
for handling the return shipments of spent Molybdenum-99 generators was I
also reviewed.
i 4.1 Packages Delivered to Users
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Packages of radioactive material were picked up by Del _-Med personnel:
from the Newark Airport and brought to the Del-Med-facility in South Plainfield.
Each shipment was checked in and'all shipping documents 4
were inspected to verify that each box received at the Del-Med l
warehouse had an associated package o.f shipping papers.
The last 1
copy of the package of shipping papers (the billing copy) was'. retained
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at the Del-Med warehouse.
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Once the last copy of the shipping papers was filed, the dispatcher 1
l then organized the paperwork according to delivery area and driver.
l The paperwork was given to the drivers, who loaded the. shipments into j
their vehicles, i
i The shipment destined for Salsbury, Maryland was loaded into a Del-Med vehicle which was loaded with deliveries for other drivers.
The specific shipment going south was to be picked up in the. area of Bensalem, Pennsylvania by another Del-Med driver. When the management of Del-Med questioned the driver 'who made the deliveries to' Maryland, 1
the driver stated that he never received the package of Iodine-131 l
iodohippurate, bound for the hospital in Salsbury, Maryland.
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4 4.2 Return of Spent Molybdenum-99 Generators From Users Del-Med drivers rou nely pick up spent Molybdenum generators from hospitals when they Jeliver a new Molybdenum generator. The hospital packages the generatcr into the original shipping box provided by the manufacturer.
In accordance with Department of Transportation-regulations, the hospital is required to ensure that radiation levels and contamination' levels do not exceed the limits specified in the regulations.. The hospitals are also required to provide the.
appropriate shipping: labels and shipping manifests.with information regarding the contents of the package, prior to the Del-Med pick.up.
The spent Molybdenum-99 generators are. returned to a large fenced and locked area within the Del-Med warehouse. Del-Med personnel verify the receipt of each generator only by ensuring that each box has a shipping manifest with it.
Del-Med personnel do not verify the contents of each box by the serial number of the generator,.
H Generators are loaded onto large wooden skids. When the skids are loaded to capacity, the entire skid is bound with bands, and wrapped with a shrink plastic.
Prepared skids of spent generators in their shipping boxes are picked up by.the generator manufacturer one or two days a week from the-Del-Med warehouse.
The generator which appeared at the back of the Del-Med wareho0se on 3 <l.cd October 6,1989 was originally consigned to Long Beach-Memorial-Hospital, Long Beach, New York.
The inspector confirmed'that'at
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Cel-Med driver did pick up a spent generator, from'Long~Beich' Hospital, on the morning.of October 6, 1989, when a delivery of a new generator was made. A review of the Del-Med " Daily Route Recap" sheets, which are filled out by the Del-Med drivers, indicated that a delivery and pick-up was made at approximately 3:10 a.m., on October 6,1989.
The Radiation Safety Officer at Del-Med contacted. the driver. about the spent Molybdenum-99 generator.
The driver stated to the RSO that he did not remember delivering material to Long Beach Memorial Hospital that morning.
The RSO told the inspector that this stop is a routine stop on this driver's route.
The Del-Med initial review of this event was inconclusive and did not l
identify the root causes.of this problem or the responsible individual.
l 5.
Security of Radioactive Material l
The inspector reviewed the' security of radioactive material in the Del-Med building, and security of radioactive material during the I
handling of material coming into and out of the facility.
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5 During the time the inspector was present, packages of radioactive material were never left without Del-Med personnel being present.
The large rear warehouse door was attended by Del-Med personnel whenever the door was open. The president of Del-Med stated that the rear door was never left open without the presence of an employee.
The facility lighting, at the rear of the warehouse, appeared bright enough to deter unauthorized individuals from loitering around the rear of the facility.
Further, it appeared that sufficient Del-Med personnel were presen during the loading and unloading operations to notice the presence of any unauthorized personnel.
A-large fenced and locked area within the warehouse was maintained, and stored spent generators and loading equipment. The fence was approximately ten (10) feet high with barbed wire placed at the top to deter access into the area by climbing over the fence, k'ithin the scope of this review, it appeared that Del-Med provided adequate security for the storage and handling of radioactive material.
6.
Radiological Measurements The inspector made measurements with NRC radiation survey instrumentation and Del-Med instrumentation.
The inspector also took wipe samples for analysis in the Region I laboratory.
Direct radiation survey measurements were made with a portable sodium iodide (Nal(T1)) detector attached to a single channel analyzer (an NRC instrument), and two of the Del-Med G-M survey meters.
Measurements were made of the warehouse area (general area survey), warehouse floor, rear outside steps (the place the spent generator was found), and the parking lot and rear of the parking lot behind the Del-Med facility, in a wooded area. All three instruments measured radiation levels less that 0.05 millirem pe" hour (mrem /hr) in all areas surveyed, except in the general area in 3.e the warehouse.
Because of the presence of many boxes of radioactive material being readied for distribution, the radiation level in this area was approximately 0.8 to 1.0 mrem /hr at approximately one meter from the pile of boxes.
Wipe samples were taken from six areas in the warehouse and on the steps at the back of the warehouse.
These samples were analyzed in the Regior I laboratory for the presence of Iodine-131, Molybdenum-99, and Technetium-99m.
No measurable contamination was found on the samples.
The inspector concluded that there was no radiological contamination of the Del-Med facility as a rwsuit of these two incidents.
7.
Exit Interview The inspector met with Del-Med representatives indicated in section 1.
l At that time, the findings of the review were discussed.
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