ML20039G900

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Confirms 811102 Telcon Re Rescheduling Enforcement Conference to 811210 to Discuss Results of Last Insp
ML20039G900
Person / Time
Issue date: 11/03/1981
From: Engelken R
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To: Matsura M
ST. FRANCIS MEDICAL CENTER, HONOLULU, HI (FORMERLY
Shared Package
ML20039G893 List:
References
NUDOCS 8201190273
Download: ML20039G900 (1)


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November 3,1981 License No. 53-11966-01 St. Francis Hospital Nuclear Medicine Department 2230 L111ha Street Honolulu, Hawaii 96817 Attention: ft. Matsura Hospital Administrator Gentlemen:

SUBJECT:

NRC ENFORCEM:NT CONFERENCE This will confirm the telepnone conversation between fir. H. Tong of your staff and Mr. R. Thomas of my staff on November 2,1981, concerning the rescheduling of an enforcement conference to be held between NRC management and the management of St. Francis Hospital. We will arrive at your office at 9:30 A.M. on Thursday, December 10, 1981. The following matters will be discussed.

1.

Results of last inspection 2.

NRC enf r ement options 3.

NRC concerns 4.

Licensee management responsibilities We anticipate that the entire meeting will take between one and 1-1/2 hoi:1 s.

Sincerely, bcc: State of Hawaii R. H. Engelken V. Miller, NMSS Director A. Grella, IE:HQ 8201190273 820113 NMSSLIC30 53-12966-01 PDR

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OFFICIAL RECORD COPY uw" i~--a s

APPENDIX A I

t'0TICE OF V10LATIO1 St. Francis Hospital License Mo. 53-11966-01 fiuclear Medicine Department 2230 Liliha Street Honolulu, Hawaii 96317

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As a result of the inspection conducted September 30, 1931, and in accordance 1

with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:

A.

10 CFR 20.207 requires that licensed materials stored in an unrestricted area shall be secured from unauthorized removal from the place of l

storage or shall be tended under the constant surveillance and inmediate g

control of the licensee.

i Contrary to the above requirement, at the time of the inspection.

j the inspector observed that the door to the nuclear medicine i

p laaoratory was open and unattended. Also, the door to

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the RIA laboratory where licensed material is used and stored was open i

and unattended. When these conditions exist, the areas are considered unrestricted.

This is a Severity level III Violation (Supplement IV).

B.

License Condition 19 requires that licensed material shall be used

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in accordance with statements, representations, and procedures contained in applications dated October 2,1978 and April 4,1979 and letters i

f ated April 4,197') and December 6,1979.

I (1) In the application dated Octcher 2, 1978, item 10, page 1, states procedures for conducting daily constancy checks, quarterly linearity I

checks and annual calibrations of the dose calibrator.

Contrary to the abovr. requirement, constancy checks were not being conducted on a daily basis. The inspector observed that during i

the period of July 10, 1980 through September 29, 1981, 80 daily I

constancy checks had not been conducted.

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This is a Severity Level IV Violation (Supplement Vil).

(?) in the application dated October 2,1978, iten 7, page ?, states that it is the responsthility nf the Medical Isntopes Cormittee to review the radiation safety progran on an annual basis.

Contrary to the above requirement, an annual review of the radiation safety program was not conducted by the Medical Isotopes Comittec in 1979 and 1980.

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This is a Severity Level IV Violation (Supplement VII).

(3) In the letter dated December 6,1979, page 9 of item 23 states the requirements for the maintenance of records of surveys conducted.

.i Contrary to the above requ'irement, at the time of the inspection, y

records of daily surveys conducted by the Nuclear fledicine department i

were not being maintained, i

(4) In the application dated October 2,1978, item 14, page 1, the procedures for safely opening packages containing radioactive materials requires that packages be surveyed upon receipt.

l Contrary to the above requirement, packages 7 radioactive materials have never been surveyed upon receipt including those containing more than 100 millicuries of technetium-99m, as also required by 10 CFR 20.205(b)(1)(V).

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(5) In the application dated October 2, 1978, item 17, page 1, survey' procedures require that all elution, preparation, and injection

, ~.q areas.,will be surveyed daily and decontaminated if necessary.

Contrary to the above requirement, daily surveys had not been conducted during the intervals of September 17-20, August 30 -

September 8. June 23-25 and Januacy 6-11 of 1981.

(6) In the application dated October 2, 1978, item 17, page 1, states

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that laboratory areas where small quantities of radioactive material are used will be surveyed monthly.

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Contrary to the above requirement, at the time of the inspection, monthly surveys of the surgical laboratory for April and June, i

1981 had not been conducted.

1 it, These items (3-6) constitute a Severity Level IV Violation (Supplement IV C.

10 CFR 20.401(b) requires that records of disposals made pursuant to 10 CFR 20.303 be maintained.

I Contrary to the above requirement, at the time of the inspection, records of liquid waste disposal into the sanitary sewerage system by the RIA laboratory were not maintained for the period of January 20, 1979 to April 22, 1980.

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This is a Severity Level VI Violation (Supplement IV).

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Pursuant to the provisions of 10 CFR 2.201, St. Francis Hospital 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 steps which will be taken to avoid further items of noncompliance; and (3) the date when full compliance will be achieved. Consideration may be given to extending your response time for good cause shown.

g 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 Act of 1980, PL 96-511.

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i-dated i

h-J. Frank Pang, Radiation Specialist

~' Radiological Safety Branch M

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