ML20039G890
| ML20039G890 | |
| Person / Time | |
|---|---|
| Issue date: | 11/03/1981 |
| From: | Engelken R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | Tran P PACIFIC RADIOPHARMACY HONOLULU, HI |
| Shared Package | |
| ML20039G885 | List: |
| References | |
| NUDOCS 8201190265 | |
| Download: ML20039G890 (1) | |
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November 3,1981 License No. 53-16991-01 MD Pacific Radiopharmacy Ltd.
347 Nortn Kuakini Street Honolulu, Hawaii % 817 Attention: Pnan The Tran, Director Gentlemen:
S!!BJECT: NRC ENFORCEMENT CONFERE! ICE This will confirm the telephone-conversation between you and Mr. R. Thomas of my staff on November 2,1981, concerning the re:cheduling of an enforcement conference to be held between NRC management and the management of Pacific Radiopnarmacy, Ltd. We will arrive at your office at 1:30 P.M. cn Thursday, December 10, 1981. The following matters will be discussed:
1.
Results of last inspection 2.
NRC enforcement options 3.
NRC concerns 4.
License.e management responsibilities We anticipate that the entire meeting will take between one and 1-1/2 hours.
Sincerely, bec: State of llawa i i V. Millec, NMSS A. Grella, IE:HQ R. H. Engelken Director 65 920113 l
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1 APPENDIX A fl0TICE Or VIOLATION Pacific Radiopharmacy, Ltd.
License flo. 53-16991-Olf t0 347 North Kuakini Street Honolulu, Hawaii 96817 As a result of the inspection conducted September 29, 1981, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980),
the following violations were identified:
A.
License Conditica 22 requires that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in specified documents submitted by the licensee to the Commission.
(1) In the letter ree.eived by the Commission September 13, 1976, it is stated by the licensee that thyroid and urine counts will be performed monthly on the radiopharmacist and all technical personnel.
Contrary to the above requirement, thyroid counts were not performed on the radiopharmacist and assistant radiopharmacist for February, May and July of 1981. Also a thyroid count was not performed on the radiopharmacist for June,1981.
This is a Severity Level IV Violation.
(SupplementVII).
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B.
License Condition 17 requires that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in part in the letter dated October 10, 1977.
Item 15 of the letter describes the procedure for the disposal of radioactive waste.
j Y\\P Contrary to the above requirement, at the time of the inspection, Y
a contaminated disposable surgical glove was found in the waste basketcontainingnonradioacgivetrash. Contamination level of i
approximately 1500 cpm /15 cm were measured with an Eberline E520, Serial flo.1943, using a hP-260 pancake probe.
This is a Severity Level IV Violation. (Supplement VII)
C.
10 CFR 20.203(f) requires that each area or room in which licensed material is used or stored and which contains any radioactive material (other than Ilranium or thorium) in an amount exceeding 10 times the quantity nf such material specified in Appendix C nf this part shall be cunspicuously ptr;ted with a sign or *.irjns bearing the radiation caution symbol and the words: CAUTI0fl RADIOACTIVE MATERI ALS.
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O Jontrary to the above requirement, at the time of the inspection, the area or room on the second floor where the quality control area is located, was not posted. Radioactive materials in excess of 10 times the quantity of such material specified in Appendix C was
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stored in two generator shielis on the laboratory bench adjacent
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to the incubator. A licensee representative posted the required signs during this inspection.
This is a Severity Level IV Violation.
(Supplement VII)
D.
License Condition 14.A requires that each sealed source containing licensed material, other than Hydrogen 3, with a half-life greater than thirty days and in any f6m other than gas saall be leak tested at intervals not to exceed six months.
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Contrary to the above requirement, at the time of the inspection.
Y a 193 microcurie Cesium-137 calibration source Serial No.
NES-356, had not been leak tested during the period of July 2,.
1980 to September 29, 1981.
This is a Severity Level IV Violation.
(Supplement VII)
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E.
10 CFR 71.5(a) states that no licensees shall transoort any licensed material outside the confines of his plant or other place of use unless the licensee complies with the applicable requirements of the Department of Transportation 49 CFR Parts 170-189.
(1) 49 CFR 172.202(a) states that the proper shipping name I
prescribed for material in 49 CFR 172.101 must be used.
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49 CFR 172.203(d)(iv) and (v) also states that shipments of radinactive materials must include the category of label applied to each shipment and the transport index assigned to each package in the shipment.
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Contrary to the above requirements, at.the time of the c
inspection, the above infomation was not included on the
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copy of the shipping documents maintained by the licensee
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y for routine shiprents of radioactive materials during the past year.
(2) 49 CFR 173.394 requires that each shipper of a specification 7A oackaging must maintain on file for at least one year after the latest shipment, and be prepared to provide the Departnent, a complete certification and supporting safety analysis demonstrating that the construction methods, packaning design, and materials of construction are in compliance with the specifications.
Contrary to the above requirements, at the time of the inspection, documentation of the above infomation for the packaging used by the licensee to ship Technetium-99m generators was not available.
The above items constitute a Severity level IV Violation (SupplementV) s.. k 3.y,....:..e';
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(( 10 CFR 20.401(a) requires that records of radiation exposure be maintained for all individuals for whom personnel monitoring is required pursuant to 10 CFR 20.202. 10 CFR 20.401(c)(2)(ii) states that to determine external radiation dose in the absence of personnel monitoring dat, records of the results of surveys must be maintained to determine conpliance with this requirement.
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Contrary to the above reouirenent, an evaluation had not been nade l'
by the licensee to determine the radiation exposure for a radiopharnacy employee whose fincer badge, covering the period of November 25, 1980 to Decenber 24, 1980, had been lost.,'
This is a Severity Level IV Violation. (Supplement IV)
Pursuant to the provisions of 10 CTR 2.201, Pacific Radiopharracy, Ltd. is hereby required to submit to this office within thirty days of the date of this Notice, a written statement or explanation in reply, including:
(1) the corrective steps which have been taken and the results achieved; (2) corrective stens which will be taken to avoid further items of nonconnliance; and (3) the date when full compliance will be achieved.
Consideration may be given to extending your response time for good cause shown.
The responses directed by this notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Action of 1980, PL 96-511.
It0V g 1981 dated 8 D. Thomas
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fo r: J. Frank Pang, Radiation Specialist Radiological safety eranch O
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