ML20033C527
| ML20033C527 | |
| Person / Time | |
|---|---|
| Issue date: | 11/09/1981 |
| From: | Pang J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20033C524 | List: |
| References | |
| NUDOCS 8112030360 | |
| Download: ML20033C527 (3) | |
Text
e
.n APPEttDIX A f40TICE OF VIOLATION Pacific Radiophamacy, Ltd.
License No. 53-16991-OlMD 347 florth 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 Condition 22 requires that the licent.ee shall possess and use licensed material in accordance with statements, representations, and procedures contained in specified docunents submitted by the licensee to the Conmission.
(1) In the letter received by the Comission September 13, 1976, it is stated by the licensee that thyroid and urine counts will be perfomed monthly on the radiopharnacist and all technical personnel.
Contrary to the above requirement, thyroid counts were not perfomed on the radiopharmacist and assistant radiopharnacist for February, May and July of 1931. Also a thyroid count was not perfomed on the radiophamacist for June,1981.
This is a Severity Level IV Violation.
(Supplement VII).
B.
License Condition 17 recuires 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 rad'oactive waste.
l Contrary to the above requirenent, at the time of the inspection, a contaminated disposable surgical glove was found in the waste l
basketcontainingnonradioacgivetrash.
Contanination level of approxinately 1500 cpm /15 cm were measured with an Eberline E520, Serial flo.1943, using a HP-260 pancake probe.
l 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 natorial (other than Uranium or thorium) in an amount exceeding 10 times the l
quantity of such material sc;cified in Appendix C of this part shall be conspicuously posted with a sign on signs bearing the radiation caution symbol and the words: CAUTI0tl RADI0 ACTIVE fMTERIALS.
bsif$oo 811109 53-16991-01 pop
?.
Contrary 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 stored in two generator shields on the laboratory bench adjacent to the incubator. A licensee representative posted the required signs during this inspection.
This is a Severity Level IV Violation.
(SupplementVII) t D.
License Condition 14.A requires that each scaled source containing licensed material, other than Hydrogen 3, with a half-life greater than thirty days and in any fom other than gas shall be leak tested at intervals not to exceed six months.
Contrary to the above requirement, at the tine of the inspection, a 193 nicrocurie Cesiun-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.
(Supplenent VII)
E.
10 CFR 71.5(a) states that no licensees shall transport any licensed material outside the confinea 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 nane prescribed for naterial in 49 CFR 172.101 must be used.
49 CFP,172.203(d)(iv) and (v) also states that shipments of radioactive materials must include the category of label applied to each shipnent a,id the transport index assigned to each package in the shipment.
Contrary to the above requirenents, at the time of the inspection, the above information was not included on the copy of the shipping documents naintained by the licensee for routine shipments of radioactive materials during the past year.
(2) 49 CFR 173.394 requires that each rhipper of a specification 7A packaging must maintain on file for at least one year after the latest shipment, and be prepared to provide the Department, a complete certification and supporting safety analysis denonstrating that the construction methods, packaging design, and naterials of construction are in compliance with the specifications.
Contrary to the above requirenents, at the tine 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 (Supplement V)
c g
4 9
F.
10 CFR 20.401(a) requires that records of radiation exposure be maintained for all individuals for whon personnel nonitoring is required pursuant to 10 CFR 20.202.
10 CFR 20.401(c)(2)(ii) states that to detemine external radiation dose in the absence of personnel monitoring data, records of the results of surveys nust be maintained to detemine conpliance with this requirenent.
Contrary to the above reouirenent, an evaluation had not been made by the licensee to determine the radiation exposure for a radiopharnacy employee whose finger badge, covering the period of flovenber 25, 1980 to December 24, 1980, had been lost.
This is a Severity Level IV Violation.
(SupplementIV)
Pursuant to the provisions of 10 CFR 2.201, Pacific Radiopharnacy, Ltd. is hereby required to submit to this office within thirty days of the date of this flotice, a written statement or explanation in reply, including:
(1) the corrective steps which have been taken and the results achieved; (2) corrective steps which will be taken to avoid further itens of noncompliance; and (3) the date when full connliance will be achieved.
Consideration may be given to extending your response tine for good cause shown.
The responses directed by this notice are not subject to the clearance procedures of the Office of Manageneat and Budget as required by the Paperwork Reduction Action of 1980, PL 96-511.
dated R. D. Thce he s ~ J. Frank Pang, Radiation Specialist Radiological Safety Branch
-