ML20198L916
| ML20198L916 | |
| Person / Time | |
|---|---|
| Issue date: | 12/15/1998 |
| From: | Courtemanche S, Shanbaky M NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20198L906 | List: |
| References | |
| REF-QA-99990001-981215 99990001-98-15, NUDOCS 9901050165 | |
| Download: ML20198L916 (6) | |
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l U.S. NUCLEAR REGULATORY COMMISSION ,
l REGION I INSPECTION REPORT 1
t Report No. 99990001/98-015 l
Docket No. 99990001 License No. General Licensee: Women's Institute for Fertilit/ :
i Location: 5217 Militia Hill Road, Plymouth Meeting, Pennsylvania 19462 Inspection Dates: December 1,1998 i 1
Original Signed by: ,
inspector: Steven Courtemanche 12/15/98 i Steven Courtemanche date i
Health Physicist l
Originalsignedby ,
MohamedM. Shanbaky December 15,1998 l Approved By: i Mohamed M. Shanbaky, Chief date Nuclear Materials Safety Branch 1 Division of Nuclear Materials Safety l
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! 9901050165 981215 l' REG 1 GA999 EMV*****
99990001 PDR ,
1 i Document Name. G:ONMSDOcWORK\lNSPRPTEGENERAL.B l
EXECUTIVE
SUMMARY
Women's Institute for Fertility NRC Inspection Report No. 99990001/98-XXX An announced inspection was performed on December 1,1998 at the Women's Institute for Fertility (WIF). WIF was using lodine-125 radioimmunoassay (RIA) kits under the general !
license in 10 CFR 31.11 as a clinical laboratory (Registration Certificate No. 8480). A drum containing radioactive waste was found by the local police department near a dumpster on WIF's premises on November 28,1998 at 7:00 p.m. The drum was secured by a local fire department and the Pennsylvania Department of Environmental Protection (PADEP) was notified. PADEP notified the NRC of the event about 9:00 a.m. on December 1,1998.
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ii inspection Report No. 99990001/98-015 G:\DNMSDOCWORK\lNSPRPTTRGENERAL.B
. 1 REPORT DETAILS
1. Background
On December 1,1998, the Pennsylvania Department of Environmental Protection (PADEP) contacted the staff of NRC Region I to report that radioactive waste had been j found in a 55-gallon drum outside the Women's institute for Fertility (WIF) at Plymouth l Meeting, Pennsylvania. The local police department identified the drum on November '
28,1998 about 7:00 p.m. during their normal rounds and reported the finding to the local fire department. The local fire department made radiological surveys, identified the originator of the radioactive waste as WIF, and secured the drum by tightening the O- '
ring, moving the drum away from the dumpster and placing security tape about the drum. PADEP were notified of the event by telephone and responded with the NRC on December 1,1998.
II. Scope of the Program
- a. Inspection Scope I The inspector interviewed personnel and examined the radioactive waste to determine the scope of the program.
- b. Observations and Findinas
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The inspector determined that the licensee ceased using RfA kits in late 1995 when non-radioactive material using methodologies became available. The waste drum contained about 50 - 60 empty reagent bottles and 4 calibration reference standards. l The reference standards each contained approximately 0.05 microcuries of iodine-129 and were sealed in hard plastic.
- c. Conclusions No safety concerns were identified.
lil. Material Receipt, Use, Transfer, and Control
- a. Inspection Scope 1
The inspector interviewed personnel and examined records to verify the receipt, use, transfer, and control of licensed material.
- b. Observations and Findinas l I
l The licensee informed the inspector that the RfA kits were received from Diagnostic Products Corporation under a general license from the NRC. The licensee provided l documentation showing that it was registered with the NRC under 10 CFR 31.11 (Registration No. 8480) as Clinton Endocrine Laboratories. The RIA kits were used in in vitro studies and the use of the kits was discontinued in 1995 when non-radioactive 1 Inspection Report No. 99990001/98-015 l G:ONMsOOCWORK\lNsPRPTEGENERAL.B l
materials using methodologies became available. The licensee transferred licensed material to a :adioactive materials broker in 1993 and showed the inspector a Site Use permit for Barnwell, South Carolina which expired in 1993. The inspector confirmed that the RlA reagent bottles had expiration dates of 1993 through 1995.
The Ecensee informed the inspector of the circumstances surrounding the November 28, 1998 event involving the radioactive materials waste drum. The Plymouth Meeting office was being renovated on November 28,1998 to accommodate personnel and equipment being moved into the facility from the licensee's Philadelphia facility. The licensee noted the radioactive materials waste drum and informed contractor personnel involved with the renovation that the drum needed to be moved to make room for equipment. The licensee, however, did not inform the contractor personnel where to move the drum and did not note that the drum was moved next to the dumpster outside the facility,
- c. Conclusions No safety concerns were identified.
IV. Radioactive Waste Management
- a. Insoection Scope The inspector interviewed personnel to determine how radioactive wtste was handled by the licensee.
- b. Observations and Findinas The licensee informed that, up until 1993, the licensee transferred licensed material to a radioactive materials waste broker for disposal at the radioactive materials landfill in Barnwell, South Carolina. The licensee changed methodologies in 1995 and any radioactive waste generated after 1993 was kept in the facility in a radioactive materials waste drum. The last use of licensed material was in 1995 and consisted of iodine-125 RIA kits The half-life of iodine-125 is 60 days, therefore, a period of greater than 10 half-lives since the RIA kits were placed in storage have passed and the iodine-125 would have decayed to non-detectable concentrations. The drum also contained four iodine-129 calibration reference standards of 0.05 microcuries each. The standards, when measured with a Ludlum 16 Sodium-iodide detector by the inspector, exhibited a radiation exposure level slightly over natural background radiation levels (i.e.,400 counts per minute versus a background of 200 counts per minute). Measurements made with a Micro-R meter by the inspector did not reveal radiation exposure levels exccading that of natural background radiation levels. The licensee committed to sccuring the radioactive waste drum and contacting a radioactive materials waste broker to pick up the drum and dispose ofit.
- c. Conclusions No safety concerns were identified.
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1 V. Labeling i
l: a. Inspection Scope
- i. The inspector examined the radioactive materials waste drum for appropriate marking - .
! and labeling.
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l b. Observations and Findinga l L
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- The inspector observed that the radioactive materials waste drum was a standard issue
[- from a radioactive materials waste broker and had all of the required marking and
! labeling. !
- c. Conclusions I- No safety concems were identified.
i VI. EFit Meeting l
At the conclusion of the inspection, the inspection findings were discussed with the licensee.
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l PARTIAL LIST OF PERSONS CONTACTED Licensee i.
l Helaine Wallace, Researcher l Frances R. Batzer, Ph.D., Researcher l
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