ML20149F975

Insp Rept 99990002/97-01 on 970303-07 & 0624.Violation Noted.Major Areas Inspected:Jl Fernandez Mayaguez,Puerto Rico Facility

ML20149F975
Person / Time
Issue date:	06/30/1997
From:	NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II)
To:
Shared Package
ML20149F963	List: ML20149F960 ML20149F964 ML20149F975
References
REF-QA-99990002-970630 99990002-97-01, 99990002-97-1, NUDOCS 9707220391
Download: ML20149F975 (6)

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.U.S. NUCLEAR REGULATORY COMMISSION REGION II  ;

- Docket No.: 999-90002 License No.: N/A Report No.: 999-90002/97-01 Facility: The Luis A. V6zquez Ambulatory Surgery Clinic Location: Peral and de Diego Streets Mayag0ez, Puerto Rico- 00681 Dates: March 3-7, 1997 (onsite), with records reviews and subsequent telephone conversations conducted through June 24, 1997 4

Inspector: H. Berm 0dez Senior Radiation Specialist '

Accompanying J. Ibarra Senior Engineer Personnel: Office of. Analysis and Evaluation of Operational Data V. Ibarra Administrative Assistant Office of Administration Approved by: J. Potter Branch Chief t Materials Licensing / Inspection Branch-2 9

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Enclosure 2

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9707220391'970630 I

REG 2 GA999 ESGPR 99990002 PDR

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4 EXECUTIVE

SUMMARY

The Dr. Luis A. V6zquez Ambulatory Surgery Clinic NRC Inspection Report No. 999-90002/97 ,

.This special, announced inspection was conducted as a result of NRC ins)ection -

' findings at Dr.' Joss L. Fern 6ndez' Mayag0ez.. Puerto Rico facility (see iRC Ins Dr.pection Report Nos. 52-25114-01/95-01 and 52-25114-01/96-01).

Fern 4ndez took over Dr. V6zquez*. practice after Dr. V6zquez' death in September 1993. Dr. V4zquez conducted licensed activities under NRC License  :

No. 52-16660-03. which became void upon Dr. V6zquez' passing, and which was  !

terminated upon transfer of the licensed material to Dr. Ferndndez in January '

1994. .This inspection report documents that Dr. Vazquez performed 560

-strontium-90 radiation' dose misadministrations between 1990 and 1993. Of the - ,

560 misadministrations it a) pears that 44 resulted in overexposures by approximately 71 percent. T1e remaining 516 misadministrations resulted in underexposures ranging between approximately 25 and 33 percent. The inspection also revealed that or, one occasion the Clinic allowed the use of - i the material without a valid NRC license. That instance also resulted in a misadministration, with an overexposure by approximately 71 percent.

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Reoort Details I. Backaround In 1990. Dr. V6zquez' strontium-90 eye applicator was reported by a local physicist to indicate an incorrect output of 24 rads per second. Dr. V6zquez used the applicator numerous times until his death in September 1993. The eye applicator was used in connection with pterygium surgeries. Pterygium is a benign growth that occurs in the surface of the eye as a result of excessive exposure to sunlight. In many cases the application of strontium-90 beta radiation helps prevent recurrence of the growth. In January 1994.

Dr. Fern 6ndez assumed responsibility for licensed activities using Dr.

V6zquez' source by amending his existing NRC license to add the source and location of use. In October 1994. Dr. Fern 6ndez bought Dr. V6zquez' practice, but not the clinic in which Dr. V6zquez performed the pterygium surgeries. As a result of a routine inspection of Dr. Fern 6ndez' licensed activities, it was determined that the correct output of the eye applicator in question was 53 rads per second in January 1996. This revealed that all administrations performed by Dr. Fern 6ndez were a factor of approximately 2.21 in excess of the intended dose. As a result. there existed a need to evaluate whether any misadministrations occurred while the applicator was used by Dr. V6zquez. 1 Through discussions with Dr. Fern 6ndez and members of his staff on February 7. I 1997, the inspector determined that there were two ty)es of relevant records involved: patient records acquired by Dr. Fern 6ndez w1en he bought the practice, and surgery records kept by the Clinic. By reviewing Dr. Fern 6ndez' records, the inspector determined that approximately 572 Sterygium surgeries took place at the Clinic between 1990 and January 1994 (wlen Dr. Fern 6ndez took over). However, it could not be determined from Dr. Fern 6ndez' records what percentage of the surgeries involved the administration of radiation l

doses.. the actual radiation doses administered, or the identity of the l physician who performed the administration. The inspector determined that such information would be available in the records kept at the Clinic, but those records were not under Dr. Fern 6ndez' control. As a result, the NRC requested that the Clinic allow the review of the records in question to determine whether any misadministrations occurred between September 1990 and January 1994.

i II. Insoection Results 10 CFR 35.2 defines the term " misadministration." in art as a brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than 20 percent. Pursuant to 10 CFR 35.400(e), the use of strontium-90 as a sealed source in an applicator for treatment of superficial eye conditions is considered brachytherapy. Through review of the records requested to be made available and discussions with Clinic personnel '

, the inspector determined that Dr. V6zquez did not use the 24 rads per second output information provided by the physicist in 1990. Instead, apparently, except in 44 occasions. Dr. V6zquez used the original dose rate output information provided by the manufacturer when he acquired the applicator in 1976. By doing so. Dr. V6zquez neglected to correct the applicator's output for radioactive decay, thereby delivering doses that were smaller than what he l

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intended to deliver. Since the output of the applicator was known as a result

' of Dr. Fern 6ndez' inspection'and since Dr. V6zquez documented the exposure time and the dose he thought he was ' delivering., the inspector was able to estimate the actual dose delivered in each case. As a result. through review of surgery records, the inspector determined that between 1990 and January.

1994 Dr. V6zquez performed 516 underdose misadministrations ranging between

approximately 25 and 33 percent'below the intended dose. The inspector also determined that for reasons that could not be determined during the

[ inspection, on 44 instances during the last months of his life. Dr. V4zquez  ;

i deviated from his standard procedure of administering the radiation dose in 24

' seconds and elected to administer the dose in 60 seconds. This resulted in

. overdose misadministrations by approximately 71 percent. One potential reason .

for the use of two different times to deliver the same intended dose was that Dr. V6zquez might have used two different sources. However, when questioned  ;

! about the possibility that a second eye applicator may have been used. Clinic  !

i officialc and Dr. V6zquez' surgery room assistants stated that Dr. V6zquez had 1

only used one source for treatments and that there had been only one source-available for treatments for as long as they could remember, i.e. , many years.

10 CFR 35.11 prohibits the possession and use of byproduct material for

~ medical use except in accordance with a specific-license issued by the Commission or an Agreement State. Records at the facility showed a3 parent use of the source by five physicians after Dr. V6zcuez died and before Jr.

Fern 6ndez took over the practice. Subsequent ciscussions with these physicians and review of letters from these physicians showed that four doctors had not used the source for treatment. Therefore, the Clinic on one occasion between Dr. V6zquez' death in September 1993 and when Dr. Fern 6ndez took over the practice in January 1994, allowed the use of the strontium-90 eye applicator. The NRC license issued to Dr. V6zquez authorized use of the source only by Dr. V6zquez. The )ossession and use of material subject to licensing without having a valid 1RC license was identified as a violation of 10 CFR 35.11.

l III. Clinic's Resoonse to the Misadministrations 10 CFR 35.33(a)(1) requires that, for a misadministration the licensee notify by telephone the NRC Operations Center no later than the next calendar day 1

after discovery of the misadministration. Since the Clinic was not a licensee and since Clinic staff indicated they were not knowledgeable of reporting requirements associated with misadministrations, the inspector made the required notification after notifying Clinic management of the misadministrations. The inspector also requested that the Region II Office fax the Clinic's administrator a copy of applicable requirements associated with misedministrations.

10 CFR 35.33(a)(2) requires that a written report on the incident be submitted within 15 days of the discovery of a misadministration. This section further specifies the information required to be contained in the report. On March 21,1997. the Clinic submitted the required report containing the I required information. The report indicated that the Clinic had retained the services of three ophthalmologists to evaluate each patient who received a misadministration and, according to the physicians' recommendations for any

3 further followu). the Clinic will ensure that needed followup is performed on a case-by-case 3 asis. The report.further specifies that priority will be

.given-to the overexposure cases.

10 CFR 35.33(a)(3) requires. in part, that patients who receive misadministrations be notified of such by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or, if they cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> the patients must be notified as soon as possible. The Clinic's March 21, 1997 re] ort indicates that all patients who were overexposed had been notified and tlat they were proceeding to notify the rest'of the patients who were underexposed.

10 CFR 35.33(a)(4) requires, in part, that each patient who receives a misadministration also be notified in writing of-the misadministration. . This '

section further specifies the information that is required to be contained in the' noti fication. The Clinic's March 21, 1997. report presented a copy of the notification to be sent via certified. mail to those underexposed and those overexposed. The notifications contained the information required by 10 CFR 35.33(a)(4) and further requests that the patients visit their ophthalmologists for an evaluation free of charge.

IV. Exit Meetirq An exit meeting was held with licensee representatives on March 7. 1997. The preliminary findings from the inspection, including one violation of NRC requirements, were-discussed. No dissenting comments were received from the licensee. Proprietary information ()atient records) was reviewed during the >

inspection but is not contained in t11s report. The licensee requested and was given a copy of applicable regulatory requirements to ensure compliance in their response to the misadministrations. The licensee further indicated that the necessary corrective steps will be taken to ensure the well-being of the affected patients. Subsequent to the exit meeting, further review of this ,

case resulted in the need for more information to determine the extent of the  !

number of overexposure misadministrations. This was discussed with the Clinic's Administrator during a telephone conversation on June 24, 1997.

PARTIAL LIST OF PERSONS CONTACTED'

,Z. Arroyo. Administrator's Assistant A. Crespo. Admissions / Accounting Director

. L. Cruz.' M.D. , Director of Ophthalmology J. Fernendez M.D., Ophthalmologist

'R. Ruiz. Administrator N. Sorrentini. Records Manager INSPECTION PROCEDURES USED IP 92700: Licensee Event Followup y

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ITEMS OPENED AND CLOSED OPENED 97-001 VIO CONDUCT OF ACTIVITIES SUBJECT TO LICENSING WITHOUT A VALID NRC LICENSE

. LOSED 97-001 VIO CONDUCT OF ACTIVITIES SUBJECT TO LICENSING WITHOUT A VALID NRC LICENSE i

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