ML20039G897
| ML20039G897 | |
| 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 | |
| ML20039G893 | List: |
| References | |
| NUDOCS 8201190271 | |
| Download: ML20039G897 (3) | |
Text
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U.S. fiUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION V Report No. 91_n?
License No.st1toAA nl Priority a
Category n Licensee: St. Francis Hosoital 2230 Liliha Street Honolulu. Hawaii 96817 I
Facility Name: (Same as above)
Inspection at: Lice'nsee's location Inspection Ccnducted: December 10, 1981 Inspectors:
M i//wh1_
~
R. H. Engelken,' Regional Administrator Date Signed bk?
%'d W
/ 5 R. D.
homas, Chief Aate' Signed Approved by:
/ /kM H. E. ' Book, Chief
'Date Signed Radiological Safety Branch l
Summary:
Enforcement Conference on December 10, 1981 (Report No. 81-02)
The following matters were discussed:
1.
NRC enforcement policies and procedures.
2.
Compliance history and items of noncompliance associated with the September 30, 1981 inspection.
3.
'RC actions to be taken in the present situation.
4.
Possible future actions by the NRC.
5.
Other matters of concern to NRC.
This enforcement conference involved a total of its hours on site by two NRC representatives.
RV From 219 (1) 8201190271 82011J NMSSLIC30 53-11966-01 PDR
a l
DETAILS 1.
Enforcement Conference Participants M. Keleher, Chief Executive Officer M. Matsura, Hospital Administrator M. Tong, Assistant Administrator
{
W. Lee, Directer, Nuclear Medicine A. Leong, Supervisor, Nuclear Medicine H. Rinaldi, Gamma Corporation-Consultant R. Engelken, Regional Administrator, NRC R. Thomas, Chief, Materials Radiation Protection Section, NRC j
T. Anamizu, State of Hawaii, Department of Health 2.
Enforcement Conference 1
On December 10, 1981 an enforcement conference was held at the Saint a
1 Francis Hospital, 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 4
number 53-11966-01, for the nuclear medicine service. The inspection was conducted on September 30, 1981. The enforcement conference was announced in a letter tc the licensee dated October 23, 1981. A copy l
of that letter is attached.
l Ine Notice of Violation dated November 5, 1981 had been received by the licensee, and a, timely response dated November 30, 1981 was received j
by the NRC Regional Office. A copy of Appendix A to the Notice of 4
Violation is attached.
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During the conference, Mr. R. Thomas discussed the individual items 3
of noncompliance and the corresponding licensee's correc'ive actions.
The licensee was intarmed that the corrective actions taken were acceptable 1
with the exception cf Item B(4) of the Notice of Violation. Mr. Thomas i
explained that due to the rather unique method by which radiopharmaceuticals are delivered by Pacific Radiopharmacy to the hospital, certain conditions i
of the Department of Transportation (00T) regulations and applicable j
parts of 10 CFR 20 must be understood by the licensee. Pursuant to 00T regulations the Pacific Radiopharmacy is considered the supplier /
1 shipper of the radioactive materiais. As a private carrier the Pacific Radiopharmacy transports the individual packages of radiopharmaceuticals in a metal attache' cne which has been approved as a 7A container by DOT standards. Upon arrival at the hospital, a representative of Pacific Radiopharmacy physically transfers a package from the 7A container j
to the storage location of the licensee. At this time a receipt of transfer shall be initiated and a radiological survey shall be conducted by the licensee in accordance with 10 CFR 20.205(b)(1), if applicable i
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_2 to the type and quantity of material received. Based upon the above interpretation of DOT regulations, the citation quoted in Item B(4) i is valid.
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 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 any violations at this licensee would fall into Supplements IV and VII of the Federal Register 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, esca15ted 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 inspection, which ever one was longer. The licensee was also informed that an early reinspection would be conducted by the NRC.
3.
NRC Conrern Since the licensee uses a consultant (Ganma Corporation) for a radiological safety program, Mr. Thomas expressed NRC's concern regarding the in-house, day-by-cry radiological safety officer coverage in the hospital.
The need for periodic radiological surveys, receipt and transfer records, and personnel monitoring was stressed. The licensee stated that the role of an Assi; tant Radiological Safety Officer would be assigned to the Supervisor of Nuclear Medicine. All activities of the Assistant RSO would be subject to the instructions and audits by the consultant.
4.
Conclusions i
The licensee's response to the cnnference was acceptable, and a very positive assurance and commitment for a stronger management control program was made.
The enforcement conference was adjourned at 11:00 A.M.
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