ML20149F964

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Notice of Violation from Insp on 970303-07 & 0624.Violation noted:Sr-90 Eye Applicator Was Used by La Vazquex Ambulatory Surgery Clinic for Medical Use Without Specific License Issued by Commission or Agreement State
ML20149F964
Person / Time
Issue date: 06/30/1997
From:
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II)
To:
Shared Package
ML20149F963 List:
References
REF-QA-99990002-970630 99990002-97-01, 99990002-97-1, NUDOCS 9707220388
Download: ML20149F964 (1)


Text

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4 NOTICE OF VIOLATION

- The Luis A. V6zquez Ambulatory Surgery Clinic Docket No. 999-90002 Mayag0ez. Puerto Rico During an NRC inspection conducted on March 3-7. 1997, and subsequent telephone conversations and reviews of records conducted through June 24.

1997, a violation of NRC requirements was identified. In accordance with the

" General Statement of Policy and Procedure for NRC Enforcement Actions."

NUREG-1600, the violation is listed below:

10 CFR 35.11 recuires, in part, that no person possess or use byproduct material for mecical use except in accordance with a specific license issued by the Commission or an Agreement State.

Contrary to the above, on one occasion between Dr. Vdzquez' death in September 1993 and when Dr. Jos6 Fern 6ndez took over the 3ractice in i -January 1994 a strontium-90 eye applicator was used by t1e Luis A.

V4zquez Ambulatory Surgery Clinic for medical use without a. specific license issued by the Commission or an Agreement State.

l This is a Severity Level IV violation (Supplement VI).

The NRC has concluded that the information regarding the reasons for the violation. the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance will be achieved is already adequately addressed on the docket in Inspection Report Number 999-90002/97-01. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not

accurately reflect your corrective actions or your position. In that case, or i if you choose to respond clearly mark your res)onse as a " Reply to a Notice of Violation." and send it to the U.S. Nuclear Regulatory Commission.

ATTN: Document Control Desk. Washington. D.C. 20555 with a copy to the Regional Administrator. Region II. within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

If you choose to provide a response, it will be i Document Room (PDR). and to the extent possible,placed it should not'ininclude the NRCanyPublic l

personal privacy proarietary, or safeguards information so that it can be placed in the PDR wit 1out redaction.

Dated at Atlanta. Georgia

, this 30th day of June 1997 Enclosure 1 9707220308 970630 REQ 2 GA999 ESOPR 99990002 PDR J