ML20009B303
| ML20009B303 | |
| Person / Time | |
|---|---|
| Issue date: | 07/08/1981 |
| From: | Wiedeman D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20009B304 | List: |
| References | |
| NUDOCS 8107150246 | |
| Download: ML20009B303 (1) | |
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=3 s-Appendix A NOTICE OF VIOLATION St. Joseph Hospital License No. 12-00610-02 As a result of the inspection conducted on June 16, 1981, and in accordance with the interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violation was identified:
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 the above requirement, it was determined through statements by licensee representatives and the NRC inspectors review of records that this condition is not being met.
Specifically, on March 10, 1981, an intra-urethra catheterization of the urinary bladder (Cystogram) was performed using one millicurie of technetium-99m. 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).
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, inclu: 'g for each item of ncncompliance:
(1) cor-rective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; an' (3) the date when full compliance will be achieved. Under the authority of Section 182 of the Atomic Energy Act of 1954, as amended, this response shall be submitted under oath or affirmation.
Consideration may be given to ektending your response time for good cause shown.
7lY9t bW - L.DL Date /
/
p D. G. WiedemanQAct'ing Chief f
Materials Radiation Protection Section 1 8107150246 810708 NMS LIC30 12-00610-02 PDR
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