ML19259A893
| ML19259A893 | |
| Person / Time | |
|---|---|
| Site: | 07001437 |
| Issue date: | 11/09/1978 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML19259A881 | List: |
| References | |
| NUDOCS 7901110125 | |
| Download: ML19259A893 (2) | |
Text
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NOV 0 91978 AlPENDIX A NOTICE OF VIOLATION Auxilio Mutuo Hospital License Nos. 52-08827-02 SNM-1407 Based on the results of the NRC inspection conducted on September 25, 1978, it appears that certain of your activities were not conducted in full com-pliance with hTC regulations and License Conditions as indicated below.
These items have been categorized as described in our correspondence to you dated December 31, 1974.
License No. 52-08827-02 A.
10 CFR 35.14(b) requires, in part, that licensed radioactive isotope generators be eluted in accordance with instructions which are approved by the h7C and are furnished by the manufacturer in the leaflet that accompanies the generator. The manufacturer's leaflet provided to you stated that molybdenum-99 breakthrough test should be performed on the eluate from each elution of the generator.
Contrary to the above, as of September 1978, the licensee had never performed molybdenum-99 breakthrough tests on the eluate from tt e technetium-99m generators that had been used on a weekly basis sin :e November 1975.
This is an inf raction.
B.
10 CFR 19.11 requires in part, that each licensee shall post:
(1) current copies of parts 19, 20 and 21 of the regulations; (2) the license as amended; and (3) the operating procedures applicable to the licensed activities, wherever individuals work in or frequent any portion of a restricted area, or post a notice which describes the above documents and states where they may be examined.
Contrary to the above, copies of: (1) current parts of 19, 20 and 21 of the regulations; (2) the license as amended; (3) the operating procedures, were not posted in the radioisotope laboratory which is a restricted area, and a notice describing the items i;as not posted.
This is a deficiency.
License No. SNM-1407 C.
Condition 15 of license number SNM-1407 requires that, the licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient; and procedures for recovery and authorized disposal of the nuclear pacemaker by return to Medtronic, Inc., shall be followed upon the death of the patient.
79011101 M~
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, Auxilio Mutuo Hospital Appendix A License Nos. 52-08827-02 and Notice of Violation SNM-1407 Contrary to the above, on September 25, 1978, the licensee's representative could not provide information regarding patient implants, their location, or which implants were still living. This represents noncompliance with the patient follow-up provision of the above condition.
This is a deficiency.
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