ML20155A902
| ML20155A902 | |
| Person / Time | |
|---|---|
| Site: | 07002801 |
| Issue date: | 04/04/1986 |
| From: | Axelson W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML19298D841 | List: |
| References | |
| 70-2801-86-01, 70-2801-86-1, NUDOCS 8604100118 | |
| Download: ML20155A902 (1) | |
Text
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1 NOTICE OF VIOLATION St. Mary's Hospital License No. SNM-1804 As a result of the inspection conducted on March 3-5, 1986, and in accordance with the " General Policy and Procedures for NRC Enforcement Actions," 10 CFR Part 2, Appendix C (1985), the following violation was identified:
License Condition No.16 requires that licensed material be possessed and used in accordance with the statements, representations, and procedures contained in certain referenced applications and letters.
The referenced application dated January 24, 1978 and letter dated March 22, 1983 state, in part, that " Human Clinical Protocol for the Coratomic 101 Radioisotope Powered Cardiac Pacemaker," dated November 1, 1975, will be followed. This protocol states, in part, that implanted patients will receive follow-up contact at six month intervals until the pacemaker is removed.
Contrary to this requirement, yotAhave not been contacting implanted patients at six montn intervals. Specifically, prior to May, 1985, you conducted implanted patient follow-up contact at,12 month intervals.
This is a Severity Level IV violation (Supplement VI).
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 violation: (1) corrective action taken and the results achieved; (2) corrective action to be taken to avoid further violations; and (3) the date when full compliance will be achieved.
Consideration may be given to extending'your response time for good cause shown.
~ Dated YYb
' ~ 6 W. L. Axelson, Chief Nuclear Materials Safety and Safeguards Branch i 1 l
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