ML20010G348

Notice of Violation from Insp on 810903.Noncompliance Noted: Procedure of intra-urethra Catheterizations of Urinary Bladder Not Described in Manufacturer Package Insert as Authorized Route of Administration

ML20010G348
Person / Time
Issue date:	09/10/1981
From:	Wiedeman D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML20010G342	List: ML20010G341 ML20010G348
References
NUDOCS 8109150608
Download: ML20010G348 (2)

Text

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Appendix A I

NOTICE OF VIOLATION i

j Illinois Valley Community Hospital License No. 12-15465-01 1

As a result of the inspection conducted on September 3, 1981, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:

i 1.

10 CFR 35.*'-(b)(6) requires that for Groups I, II and III any licensee using Fyproduct 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 state-ments by licensee representatives and the NRC inspector's review of records that this condition is not being met.

Specifically, during the last six months, two intra-urethra catheterizations of the urinary bladder (Cystograms) were performed. This proceduto is not

- described in the manufacturer's package insert as an authorized route of administration.

i This is a Severity Level V violation (Supplement VII).

2.

License Condition No. 17 states that Appendix I of the NRC Medical Licensing Guide will be followed. Appendix I requires that specific laboratory areas be surveyed weekly and monthly. The survey shall consist of a measurement with a survey meter and a series of wipe tests. The method for performing wipe tests will be sufficiently 3

sensitive to detect 100 dpm per 100 cm for the contaminant involved.

1 Contrary to the above requirement, wipe tests were not performed during 1980 and 1981.

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, including for each item of noncompliance:

(1) cor-rective action taken and the results achieved; (2) corrective action to be b

8109150608 810910 NMS LIC:30 12-15465-01 PDR __

Appendix A 2-taken to avoid further noncompliance; and (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 affirm tion.

Consideration may be given to extending your response time for good cause shown.

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Dated

- M D. G. Wiedeman,geting Chief g

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Materials Radiation Protectirn Section 1 f

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