ML20010H339
| ML20010H339 | |
| Person / Time | |
|---|---|
| Issue date: | 08/10/1981 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML20010H324 | List: |
| References | |
| NUDOCS 8109240359 | |
| Download: ML20010H339 (2) | |
Text
APPENDIX A NOTICE OF VIOLATION Dr. Sadi R. Antonmattei, M.D.
License No. 52-19550-01 As a result of the inspection conducted on July 30, 1981, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified.
A.
License Condition 14 requires that technetium-99m separated from molyb-denum-99 by elution of a molybdenum-99 technetium-99m generator shall be tested to detect and quantify molybdenum-99 activity prior to administration to patients. These tests are referred to as molybdenum breakthrough tests.
Contrary to tl ' above, the requirement to perform molybdenum breakthrough tests was not met in that approximately twelve patients were administered technetium-99m without it being tested for molybdenum breakthrough.
This is a Severity Level V Violation (Supplement VII).
B.
License Condition 15 requires that licensed material be used in accordance with statements and procedures contained in your application received October 3, 1980 and letter dated March 16, 1981. One statement in your application requires you to have a Picker Model 655-186 survey meter in your laboratory.
Contrary to the above, the requirement to have a Picker survey meter in your laboratory was not met in that from July 17, 1981 to July 30, 1981, no survey meter was available for use in your laboratory.
This is a Severity Level V Violation (Supplement VII).
C.
License Condition 15 require that licensed material be used in accordance with statements and procedu.es contained in your application received October 3,1980 and letter dated March 16, 1981. One statement in your application requires you to measure the exposure rate of packages containing radioactive material upon receipt.
Contrary to the above, the requirement to measure exposure rates of pack-ages containing radioactive material was not met in that no exposure rate measurements were made of several packages of radioactive material received by you during June and July 1981.
This is a Severity Level V Violation (Supplement VII).
8109240359 31091(
NMS LIC30 52-19550-01 PDR;
Dr. Sadi R. Antonmattei, M.D.
2 License No. 52-19550-01 4
i D.
License Condition 15 requires that licensed material be used in accordance l
with statements and procedures. contained in your application received October 3, 1980 and letter dated March 16,'1981. One procedure in your application requires the performance of weekly contamination surveys.
I Contrary to the above, the requirement to perform weekly contamination surveys was not met in that the required surveys are being performed every two weeks.
This is a Severity Level V Violation (Supplement VII).
i Pursuant to the provisions of 10 CFR 2.201, you are.hereby required to submit to this office within thirty days of the date of this Notice, a written statement or explanation in reply, including: (1) admission or denial of the alleged viola-l tions; (2) the reasons for the violations if admitted; (3) the corrective steps l
which have been taken and the results achieved; (4) corrective steps which will l
be taken to avoid further violations; and (5) the date when full compliance will j
be achieved. Consideration may be given to extending your response ' time for good cause shown.
Under the authority of Section 182 of the Atomic Energy Act of j
1954, as amended, this response shall be submitted under oath or affirmation.
Date: AUG 101981 f
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