ML20039G888

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IE Enforcement Conference Rept 81-01 Re License 53-16991-01MD on 811210.Major Areas discussed:810929 Insp & Licensee Corrective Actions.Licensee Response Acceptable
ML20039G888
Person / Time
Issue date: 01/13/1982
From: Book H, Engelken R, Thomas R
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
Shared Package
ML20039G885 List:
References
NUDOCS 8201190263
Download: ML20039G888 (3)


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U.:. TiUCLEAR REGULATORY COMMISS10tl CFFICE CF ItiSPECTI0tl AND E:?ORCEMEtlT REGIGN V Report ::o.81-02 License nc53-16991-01MDPriority 1

Category B

Licensee: Pacific Radiopharmacy, Ltd.

347 North Kuakini Street Honolulu, Hawaii 96817 Facility :.ame: (Same as above)

Inscection at: Licensee's Facility Inscection Concucteo: December 10, 1981 Inspectcrs:

44b

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M. H. Engelken, Regional Administrator Date Signeo X $ $ $ ) / fti YU D-R. U. Tnomas, Chiet Oa'te/ Signed Approved by: ~

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V H.' E. B~oof, Ch i e f 0~ ate Signed Radiological Safety Branch Enforcement Conference on December 10,1981 (Recort flo. 81-02)

The followino matters were discussed:

1.

NRC enforcement policies and procedures.

2.

Compliance history and items of noncompliance associated with the September 29, 1981 inspection.

3.

NRC actions to be take". in the present situation.

4 Possible future rtions by the NRC.

5.

Other matters of concern to NfsC.

This enforcement conference involved a total of one hour on site by two NRC representatives.

RV From 219 (1) 8201190263 820113 NMSSLIC30 53-16991-01MD PDR

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DETAILS 1.

Enforcement Conference Participants Phan The Tran, Director N. Rinaldi, Gamma Corporation-Consultant R. Engelken, Regional Administrator, NRC R. Thomas, Chief, Materials Radiation Protection Section, NRC T. Anamizu, State of Hawaii, Department of Health 2.

Enforcement Conference On December 10, 1981 an enforcement conference was held at the Pacific i

Radiopharmacy Ltd., Honolulu, Hawaii with the individuals listed above participating. The enforcement conference was related to the recent routine safety inspection of the activities authorized by NRC license number 53-16991-01 MD. The inspection was conducted on September 29, 1981. The enforcement conference was announced in a letter to the licensee dated November 3, 1981. A copy of that letter is attached.

The Notice of Violation dated November 9, 1981 had been received by the licensee, and a timely response dated November 25, 1981 was received by the NRC Regional Office. A copy of Appendix A to the Notice of Violation is attached.

During the conference, Mr. R. Thomas discussed tht 'ndividual items of noncompliance and the corresponding licensee's corrective actions.

The licensee was informed that the corrective actions taken were acceptable 3

with the exception of Item B of the Notice of Violation.

Mr. R. Thomas expressed NRC's concern related as to how a contaminated surgical glove could get into the nonradioactive trash. The licensee stated that the nonradioactive trash container was located in close proximity to the radioactive trash container and the individual working in the laboratory had thrown the surgical gloves, upon removal from his hands, into the wrong container.

The licensee stated that the following cor-ective actions would be taken to prevent the situation from happening again, (a) the nonradioactive waste container will be removed fr3m the immediate work area, (b) an,

i in-house monitoring procedure will be implemented to survey all nonradioactive trash prior to removal from the laboratory. The licensee was told these corrective actions would be acceptable.

At the time of the conference, the enforcement policies and procedures of the NRC, as published in 45 FR 66754, were explained by Mr. R. Engelken, Regional Administrator. Particular emphasis was placed on escalated 4

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enforcement actions such as civil penalties, orders to modify, suspend or revoke licenses, and orders to cease and desist. The relative significance of the different severity levels was explained, and it was pointed

'out that eny violations at this licensee would fall into Supplements IV and VII of the Federal DegistEr Notice. A copy of the Federal Register Notice was given to the licensee. The licensee was told that the enforcement action to be taken at this time consisted of the Notice of Violation in conjunction with the enforcement conference which was being held.

Mr. R. Thomas explained that if a violation was not corrected satisfactorily, if it was repeated, or if a similar violation occurred, esc 31ated enforcement action would probably be taken by the NRC.

It was also explained that this provision would remain in effect for two years or until the next 1

ir:oection, which ever one.was longer. The licensee was also informed that an early reinspection would be conducted by the NRC.

3.

ronclusions The licensee's reJoonse to the conference was acceptable. T'e licensee has established written ALARA precedures which should streng. hen the management control program and the auditing of the radiation safety program.

The enforcement conference was adjourned at 2:30 P.M.

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