ML20004E643
| ML20004E643 | |
| Person / Time | |
|---|---|
| Issue date: | 05/12/1981 |
| From: | Wiedeman D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20004E642 | List: |
| References | |
| NUDOCS 8106120425 | |
| Download: ML20004E643 (2) | |
Text
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O Appendix A NOTICE OF VIOLATION Resurrection Hospital License No. 12-05435-01 License No. 12-05435-03 As a result of the inspection conducted on April 30, 1981, and in accord-ance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980),
the following violations were identified:
1.
License No. 12-05435-01 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 rsnge.
Contrary to this requirement, it was determined through statements by licensee representatives that during the last nine months,three intra catheterization of the urinary bladder (Cystogram) were performed.
This procedure is not described in the ruanafacturer's package insert as an authorized route of administration.
This is a Severity Level V violation (Supplement VII).
2.
License No. 12-05435-03 10 CFR 34.22(c) states if a qualified expert does not perform the teletherapy monthly spot-check measurements, the results of the spot-check measurenents shall be reviewed by a qualified expert within 15 days.
Contrary to this requirement, it was determined throught statements by a licensee representr'ive that spot-check measurements performed by otner than a qualif3ed expert were not reviewed by a qualified expert within 15 days. Spacifically, as of April 30, 1981, monthly spot-checks for January, February, March and April, 1981, have not been reviewed by a qualified expert.
This is a Severity Level V violation (Supplement VII).
4 Appendix A Pursuant to the provisions of 10 CFR 2.201, you are required to submit to this office within twenty-five days of the date of this Notice a written statement or explanation in reply, including for each item of noncompliance:
(1) corrective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full com-pliance 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.
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M Dated D. G. Wiedeman, Acting Chief Materials Radiation Protection Section 1 l
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