ML20038B061
| ML20038B061 | |
| Person / Time | |
|---|---|
| Issue date: | 11/04/1981 |
| From: | Pang J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20038B058 | List: |
| References | |
| NUDOCS 8111240664 | |
| Download: ML20038B061 (3) | |
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APPENDIX A E
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fl0TICE OF VIOLATI0ft
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y Guan Memorial Hospital License flo. 56-181M-01 P. O. Box AX Y
Agana, Guam 96910
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As a result of the inspection conducted Septenber 24, 1981i and in_
accordance with the Interin Enforcement Policy, 45 FR 66754 (October N i
1980), the following violations were identified:
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License Condition 15 requires that the licensee shall possess m
d and use licensed material in accordance with statements, representations,.;
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and procedures contained in application received Itay 1,1973;'Miplication dated October 11, 1979 and letter dated December 27, 1972
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s (1) Section 0410 of the Radiation Safety Manual containdd in the application received by the Comission on May.1,1978, contains procedures for conducting daily,and weekly.curveys and swipes.
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Contrary to the above requirement, daily surveys of <he aFeas l
used for elution, preparation and administration, and weekly-
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surveys of all laboratory areas in use had not been conducted during the period of February 17, 1980 to September 2 1980.
l (2) The Radiation Safety' Manual, attached to.the application received l
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j May 1,1978 requires that the Medical-Isotopes Comittee.will meet at least on a quarterly basis.
i Contrary to the above requirement, the Medical Isotopes Ccamittee' s
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i did not conduct meetings during the 4th quarter, of 197:9 and during the 2nd and 3rd quarters of 1980.
4 (3) Part II, Section 0202 of the Radiation Safety lianual a.ttached to the application received May 1,1978 requires that the 11edical Isctopes Comittee will conduct annual reviews of the' radiation safety program.
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Contrary to the above requirement, the Medical Isotopes Cen$1ttee-did r.ot conduct the annual reviews during the period of' March 29,1979 to July 16,'1981.
The above items constitute a Severity Level IV VioTatifon.
(Supplmpnt VII)H.
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8111240664 811104~~
NMS LIC30
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56-18134-01 P D_R,
sgy 7, B.
10 CFR 35.14(d) authorf zes licensees who ere licensed for one or more of the redicai use groups in 10 CrR 35.100, to receive, possess and ese any oyproduct material in annunts not to exceed 3 nillicuries per "ource as calibration sources, provided certain condit4ons are ne...
10 CFR 35.14(e) requires that such sources if qreater than 100 microcuries, beca-ganna, are required to be leak tested at-siX r. oath intervals', And that records of such tcsts must
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be maintr.ined.
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Contrary'io the aboie reauirement, at the time of the inspection, leak tests h&d nat paen conducted for the 201 nicrocuries Cesiun-137 souren, Sorial No. 319-lf>7-47. and the 5.5 nillicurje (as of 10-24-77)
Cobalt-d' ' source, Serial-90. 319-100-10 since Octoler, 1977 when they
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were leak tested by the oarafecturcr.
This is'h Severity Level IV Vic14 tion.
(SupriendntVII)
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USNiiC Prder dated March 12, 1979 amended certain medicel
!tcens'4s to require e!>e ;mrforcance of molyboenum-99 bec.akthrouet!
tests prior to administration of technetiun-99n to patients and required that records.of the bre 4throuqh test te maintained for three years following the performaace of the test. This order was effectiv9 within 10 days of the order issuance date.
Centrary to the abode requirenent, at the time of the inhedction, t
recordshaJ not been maintained of nolybdenun-99 breakthr_ough tests conducted dusing the perird of Decerber 3, 1978 to October 1, 1979.
This is a Severity Level IV Violation.
(SuppleegntVII),
. Pursuant to the provisions of.10 CFR ?.201, Guan'Maaorial Hospital is hereby required to submit to this of ffcc within thirty days of the date of this Notice, a :ritten statement or explanation in reply, including:
'l) the corrective steps which have been taken and the results achieved; f?) corrective steps which wril b0 taken to avoid further items of
'r.cocompliance; and (3) the date when full compliance will be achieved.
Conrideration ray be given to extending your response time for good cause shown.
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The responses directed by this notice are not subject to the clearance l
procedures of the Office of Manacement and Budget as required by the Paperwork Reduction Action of 1930, PL 96-511.
l dated l
J. Frank Pang, Radiation Specialist l
Radiological Safety Branch l
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