ML20035D416
| ML20035D416 | |
| Person / Time | |
|---|---|
| Issue date: | 01/27/1993 |
| From: | Fuller M, Hosey C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML20035D404 | List: |
| References | |
| REF-QA-99990001-930329 99990001-93-01, 99990001-93-1, NUDOCS 9304130190 | |
| Download: ML20035D416 (3) | |
Text
J#"D UNIT E D STATES g
g NUCLEAR REGULATORY COMMISSION
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REGION 11 n
5 101 MARIETTA STREET, N.W.
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ATLANT A, GEORGI A 30323
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WR 2 9 1993 facility Name:
Hiram Qui ones, M.D.
Ponce, Puerto Rico 00731 Inspection Conducted: January 8, 11-13 and 20, 1993 Inspector:
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M. Fuller, Radiation Specialist Date Signed Approved by:
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C. Hosey Date Signed Nuclear Materials Inspelction Section.
Nuclear Materials Safety and Safeguard Branch Division of Radiation Safety and Safeguards
SUMMARY
Scope:
This special, unannounced inspection was conducted to determine the circumstance surrounding the transfer of licensed materials to a person who r
was not authorized to receive them.
Results:
An apparent violation was identified with respect to the transfer of a 6
strontium 90 beta eye applicator during the sale of an ophthalmology practice.
Within the areas inspected, the following apparent violation was identified:
l Failure of an individual to obtain an NRC byproduct material license i
prior to possessing and using byproduct material (paragraph 2).
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9304130190 930329 REG 2 GA999 EMD*****.
99990001 PDR
t REPORT DETAILS l
1.
Persons Contacted
- Hiram Quihones, M.D.
Ophthalmologist i
Luis A. Morales, M.D.
Ophthalmologist (Previous owner of medical practice
- Participated in a exit interview on January 8, 1993 l
2.
Licensed Material Program (87100) i 10 CFR 30.3 requires, in part, that except for persons exempted, no person shall possess or use byproduct material except as authorized by a specific or general license issued pursuant to Title 10, Chapter 1,. Code of Federal Regulations.
On January 8,.1993, an NRC inspector attempted to conduct a routine unannounced inspection of Dr. Luis Morales, an individual who held an i
NRC license to possess and use a strontium-90 eye applicator in his ophthalmologic practice.
During a visit to the facility, the inspector determined that Dr. Morales had retired from the practice of ophthalmology and had sold the practice to another ophthalmologist, Dr.
Qui 5cnes, and along with it, the strontium-90 eye applicator.
Dr.
Qui 8ones stated during the inspection that he had purchased the practice in August of 1989, shared use of the beta eye applicator with Dr. Morales until January 1990, and since that time, had been the sole user of it. Dr. Quihones stated that he had been performing 2 to 3 procedures per week to treat a tropical eye disease. Through discussion with Dr. Qui 6ones, the inspector determined that the strontium-90 eye applicator is, and has been, continuously stored and used at the location indicated in Dr Morales' license. Dr. Qui 5ones was not listed as an authorized user on Dr. Morales' license and stated that he had never been named on any other license and had not been informed that he needed to apply for his own license. Dr. Qui 6ones stated that he is a certified ophthalmologist and completed his residency at the University of Puerto Rico, Department of Ophthalmology. When the inspector showed f
Dr. Qui ones the training requirements to use the beta eye applicator i
located in 10 CFR 35.941, Dr.-Qui 80nes stated that he met the requirements and could assemble the-necessary documentation.
On January 11, 1993, NRC inspector telephoned Dr. Morales to inform him that an inspection of his license had been conducted and to discuss the findings. Dr. Morales stated at that time that on July 31, 1989, he informed Dr. Qui 5ones that he would have to apply for his own license to possess the beta eye applicator. According to Dr. Morales, Dr. Quiuones gave his word that he would apply for a license in the immediate future.
Dr. Morales also stated that he felt Dr. Qui 6ones was fully qualified to use the source.
In a telephone conversation with the inspector on January 12, 1993 Dr. Qui 60nes stated that he was unaware that he was required to apply for his own license. He further stated that since he had been paying the NRC annual fees for the past two years and signed a L
2 certificate requesting small business entity classification, he assumed that the NRC knew that he had taken over the practice of Dr. Morales.
The inspector verified prior to leaving the licensee's facility that the strontium-90 eye applicator had been placed in storage by Dr. Qui 6ones.
In addition, the inspector verified that Dr. Qui 6cnes understood the conditions of the Confirmation of Action Letter (CAL) that was issued to him by the NRC on January 8, 1993. The CAL required that Dr. Qui 6cnes discontinue use of the source, the source be placed in locked storage, Dr. Qui 6ones apply for an NRC license within 14 days and that the source be leak tested prior to any further use.
Failure of Dr. Qui 6cnes to obtain a specific NRC license pursuant to Title 10, Chapter 1, Code of Federal Regulations, prior to possessing and using the Strontium-90 eye applicator, was identified as an apparent violation of 10 CFR 30.3.
3.
Exit Interview The inspection scope and findings were summarized in an exit interview with the individual listed in Paragraph 1.
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