ML20149G109

Insp Rept 99990002/97-04 on 970609.No Violations or Deviations/Noncompliance Noted.Major Areas Inspected:Patient Notification Process

ML20149G109
Person / Time
Issue date:	07/10/1997
From:	NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II)
To:
Shared Package
ML20149G099	List: ML20149G094 ML20149G109
References
REF-QA-99990002-970710 99990002-97-04, 99990002-97-4, NUDOCS 9707230011
Download: ML20149G109 (3)

Text

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U. S. NUCLEAR REGULATORY COMMISSION REGION 11

' Docket No.:

999-90002 Report No.:

3999-00002/97-04 Licensee:

Clinica de Cirugia Ambulatoria Dr. Luis A. V4zquez Location:

Mayaguez, Puerto Rico Date:

June 9,1997

. Inspector:

Joss M. Diaz V6lez, Radiation Specialist Materials Licensing / Inspection Branch 2 Division of Nuclear Materials Safety I

Approved by:

John P. Potter, Chief Materials Licensing / Inspection Branch 2 Division of Nuclear Materials Safety l

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Enclosure 9707230011 970710 i

i REG 2 GA999 EMDPUERT 99990002 PDR a

EXECUTIVE

SUMMARY

1 Clinica de Cirugia Ambulatoria 1

Dr. Luis A. Vdzquez NRC Inspection Report No. 999-00002/97-04 This special, announced inspection was conducted to review the Clinic's patient notification process as a result of the reported medical misadministrations that occurred during the period 1990-1993. Areas covered in this report included review of required patient notifications to j

ensure compliance with 10 CFR 35.33 Results The inspector found that reasonable efforts to notify all of the patients have been made by the Clinic.

The inspector found that despite the Clinic's efforts to notify all of the patients, current address and telephone numbers were not available for four patients who received overdose misadministrations. This resulted in the Clinic's inability to notify those patients. The inspector also sampled records of patients who received underexposure misadministrations and determined that the Clinic also made reasonable efforts to notify those patients.

LIST OF PERSONS CONTACTED Licensee Roberto Ruiz Asencio, Administrator' Zoraida Arroyo, Administrator's Assistant'

'Present at exit meeting on June 9,1997 l

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REPORT DETAILS Patient Notificatina a.

Scope The inspector reviewed the Clinic's patient records and interviewed Clinic -

l representatives in order to verify that a misadministration notification attempt had been j

made in all overdose misadministration cases and in a sample of the underdose misadministration cases.

b.

Observations and Findinaq I

Through discussions with cognizant Clinic representatives and review of patient records, the inspector determined that the Clinic attempted to notify all patients who were exposed' to Sr-90 beta radiation from 1990 to January 1994. The inspector determined that the Clinic mailed notification letters to patients using U. S. Postal Service Retum Receipts.

Also, the inspector noted that four of the patients who received overexposure L

misadministrations did not receive notifications because their address and telephone number on record were not current and there were no other reasonable means available to the Clinic to get in touch with them. The patients who have not been notified are listed in the attached table (Attachment).

c.

Conclusions The inspector found that the Clinic made reasonable efforts to notify all patients based on the means available to the Clinic. The inspector determined that the Clinic was unable to notify four patients who were identified as overexposed as of June 9,1997.

No violations of NRC requirements were identified during this inspection.

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'For more details about this incident, see NRC Inspection Report 999-90002/97-01.

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