ML20011A225
| ML20011A225 | |
| Person / Time | |
|---|---|
| Issue date: | 10/02/1981 |
| From: | Sreniawski D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20011A224 | List: |
| References | |
| NUDOCS 8110080325 | |
| Download: ML20011A225 (2) | |
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-Appendix A NOTICE'0F VIOLATION St. Francis Hospital License No. 13-02128-03
~
iAs a result of the~ inspection conducted on September 17, 1981, and in
.accordance with the' Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the'following violations were identified:
1.
'10 CFR 35.14(b)(6) requires that for Groups I, II and III any licensee using byproduct material for clinical procedures other than those specified in the product labeling (package. insert) shall comply with the labeling regarding:
(i).
Chemical and physical form; (ii)
Route of administration; and, (iii)
Dosage range.
Contrary to this requirement, it was determined through statements by licensee Lrepresentatives that intracatheterization of the urinary bladder (Cystogram) was performed on February 26, 1980, and June 13,
.1980.
This procedure is not described in the manufacturer's package insert as an authorized route of administration.
This is.a Severity Level V violation (Supplement VII).
2.
License Condition No. 18 requires that licensed material be possessed and used in accordance with statements, representation, and procedures
-contained in application dated September 18, 1978 and letter dated October 13, 1978.
The above referenced application states, the procedures described in Appendix D of the draft " Guide for Preparation of Applications for Medical Programs" will be followed. Appendix D requires the dose calibrator to be checked quarterly for linearity.
Contrary to the above requirement, it was determined through state-ments by licensee representatives and the NRC inspectors review of records that this condition is not being met.
Specifically, your dose calibrator was last checked for linearity on November 17, 1980.
This is a Severity Level V violation (Supplement VII).
N 110080325'811002
'; NMS LIC30
^-13-02128-02 PDR
d Appendix 1A ~
Pursuant to,the provisions of 10 CFR 2.201, you are required to submit to this office within' thirty days of the date of this Notice a written statement or explanation _in reply, including for each item of noncompliance:
(1) cor-
.rective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full compliance will be achieved. Under the authority of Section 182 of the Atomic Encrgy Act of 1954, as amended, this response shall be submitted under oath or affirmation. Consideration may be given to extending your response. time
'for good cause shown.
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D. J. Sreniawski, Chief Materials Radiation Protection Section 2
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