ML20038B754
| ML20038B754 | |
| Person / Time | |
|---|---|
| Issue date: | 12/02/1981 |
| From: | Sreniawski D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20038B744 | List: |
| References | |
| NUDOCS 8112090077 | |
| Download: ML20038B754 (2) | |
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Appendix A NOTICE OF VIOLATION Southwestern Michigan Health License No. 21-04177-01 Care Association License No. 21-04177-02 As a result of the inspection conducted on November 4, 1981, and in accord-ance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:
License No. 21-04177-01 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 representatives that on September 24, 1981, an intra-urethra catheterization of the urinary bladder (Cystogram) was performed. This procedure is not described in the manufacturer's package insert as an authorized route of administration.
l l
This is a Severity Level V violation (Supplement VII).
l 2.
License Condition No. 17 requires that licensed material be possessed and used in accordance with statements, representation, and procedures contained in application dated September 2, 1977, and letter dated December 10, 1981.
The above referenced letter states, the procedures described in Appendix D of the draft " Guide for Preparation of Applications for Medical Programs" will be followed. Appendix D requires that your dose calibrator be checked annually for instrument accuracy.
Contrary to tbe 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, the last accuracy check on your dose calibrator was performed on October 10, 1978.
This is a Severity Level V violation (Supplement VII).
8112090077 811202 NMS LIC30 21-04177-01 PDR
Appendix A License No. 21-04177-02 3.
10 CFR 35.25(a) requires the licensee to maintain, for inspection by the Commission, calibration records of instruments used to make full calibrations of teletherapy units.
Contrary to the above requirement, it was determined through statements by licensee representatives that this condition is not being met.
Specifically, on the day of this inspection, the above record was not maintained for inspection.
This is a Severity Level VI 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 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 a ffirmation. Consideration may be given to extending your response time for good cause shown.
Dated D. J. Sreniawski, Chief Materials Radiation Protection Section 2
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