ML20149H675
| ML20149H675 | |
| Person / Time | |
|---|---|
| Issue date: | 07/17/1997 |
| From: | Dan Collins NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | De Melecio C PUERTO RICO, COMMONWEALTH OF |
| References | |
| NUDOCS 9707250121 | |
| Download: ML20149H675 (5) | |
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July 17, 1997 Carmen Feliciano de Helecio, M.D., Secretary Puerto Rico Department of Health P. O. Box 70184 San Juan, PR 00936
SUBJECT:
PATIENT NOTIFICATION INFORMATION i
Dear Dra. Feliciano:
Based on a telephone conversation between Mr. H. Bermodez of my staff and Ms. D. Olivo of your staff cn July 14,~1997, it is our understanding that you
-did not receive the enclosures to our June 4, 1997 letter.
We are submitting the referenced enclosures to the letter and, as discussed in the letter, please be advised that Enclosures 4 and 5 contain sensitive medical file information that, under 10 CFR 2.790(a)(6), we do not disclose to the public. We would appreciate that you withhold this information from aublic disclosure and provide it to your staff and contractor on a need to-(now basis.
If additional information is needed, please do not hesitate to call me at (404) 562 4700, Sincerely, (original signed by D. M. Collins)
Douglas M. Collins, Acting Director Division of Nuclear Materials Safety
Enclosures:
- 1. Example notification given to Dr. Fern 6ndez's patients
- 2. Example notification given to Dr. V6zquez's patients
- 3. Updated Table of Patient Misadministrations
- 4. Patient Index Report
- 5. Address Labels Distribution w/o encls 4 and 5:
PUBLIC RII Docket File, DNMS 3
(*) See Next Page for Previous Concurrencences
'l 0FFIM Rft:DNMS Ril:DNMS RII:0RA SIGNATURE NAME HBermodez JPotter
- CEvans
- DATE 07 /
/ 97 07 /
/ 97 07 /
/ 97 07 /
/ 97 07 /
/ 97 07 /
/ 97 COPY?
.YES NO YES NO YES NO YES NO YES NO YES NO OttICIAL RECORD COPY DOCUMENT NAME:g:\\dnms\\mlib2\\fernande\\ letters \\fernaprl.hd4 9707250121 8i70917 i
PDR STPRO ESGPR
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1 C rmen Feliciano de Melecio. M.D.. Secretary Pu to Rico Department of Health P.
Box 70184 San J PR 00936
SUBJECT:
PATIENT NOTIFICATION INFORMATION Dear Dra. Fe iano:
Based on a telep ne conversation between Mr. H. Berm dez of my staff and Ms.
D. Olivo of your s ff on July 14, 1997 it is our understanding that you did not receive the encl ures to our June 4, 1997 letter.
The enclosures provide you the information yo need to evaluate each case and, as you deem appropriate, notify the fected 3atients involved in overexposure misadministrations associa d wit 1 a strontium-90 eye applicator.
We are submitting the referenc enclosures to the letter and, as discussed in the letter, please be advised th Enclosures 4 and 5 contain sensitive medical file information that, un.
10 CFR 2.790(a)(6), we do not disclose to the public.
We would appreciate tha you withhold this information from Jublic disclosure and provide it to yo staff and contractor on a need-to-(now basis.
If additional information is needed, please o not hesitate to call me at (404) 562-4700.
Sincerely, Douglas M. Collins, ting Director Division of Nuclear Ma rials Safety
Enclosures:
c
- 1. Example notification given to Dr. Fern 6ndez's patients
- 2. Example notification given to Dr. V6zquez's patients
- 3. Updated Table of Patient Misadministrations
- 4. Patient Index Report 1
- 5. Address Labels Distribution w/o encls 4 and 5:
PUBLIC RII Docket File. DNMS nfFICf off DNMS D1! 0WI[ sit t nDa SIGNATURE N
l NANE HBermodez
. w ter CEvans 07/.'k/97 07//f/97 OATE 07 /
/ 97 07 /
/ 97 07 /
/ 97 j
07 /
/ 97 COPY?
YES NO YES/ NO YES / NO YES NO YES NO VES NO Or F ICI AL RtC0ku COe f DUCUMtNi NAMt:g:\\dnms\\ml102sfernance\\ietters\\fernapri.nd4
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.DETITtrr0 CFTFU11CO DE PR PHONE tO. : 809 833 76ED Rug. 15 1993 04:3ep;1 p2
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ESUMADO SR(A):
EST.1575 REVISANDO NUESTROS RECORD DE PACIENTES OPERADOS DE PTERIGION galki cr.Luts A, HHuu HEMOS ENCONTRADOS QUE A USTED SE LE SUMINISTRO EL TRATAMIENTO DE RAYOS BETA PARA DISMINUIR LA POSIBILIDAD DE QUE VOLVIERA A SALIR LA CONDICION. AL RECALIBRAR LA FUEFTTE APLICADOR ESTRONCIO -90 BETA". ENCONTRAMOS QUE ESTA TENIA UNA CAllBRACION ANTIGUA QUE DIFIERE DE LA NUEVA POR MAS DE UN 20 % POR LO TANTO A USTED SE LE APLICO UNA CAV. rIDAD POR ENCIMA DE 20% DE LO RECETADO. LE INFORMAMOS ESTE HECHO AUN CUANDO (dillt!5 L3 f31813 CREEMO5 QUE EN SU CASO ESTO NO TUVO EFECTOS LESIVOS.
011cicsi A PtralIGrte~
SI DESE A. LE INVITO A PAS AR POR h6 OFICINA PARA UN BREVE EXAhEN.
Mlpgit2.t8 036M LIBRE DE COSTO.
l Aprtit350 Hipadtl.f8 00fal SI OUISIERA UN A COPIA DEL INFORME SOMETIDO A LA UNTTED STATES M
80H334g5 NUCLEAR REGULATORY COMISSION ( NRC ) RELACIONADO CON ESTO EI33YIE PUEDE SOLICITARLA A MIOFICINA.
allH334GIU Ut r&I3M131 M4-765 21Tl CORDtALMENE.
DR. JOSE L. FERNANDE2 DIRECIDR I
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CLINICA DE CIRUGIA AMBULATORIA DE P.R. INC.
APARTADO 3748 MAYAGUEZ. PUERTO RIC0 00681 3748 (sos p 4co 13 de marzo de 1997
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H acuse Hricord Estimad I
1 Ela7a de de 19 ustedfue operado dq Pterigium del ojo _
con aplicaci6n de Rayos
\\
w Beta, para dirminuir la posibilidad de que volviera a ocurrir la condicion.
Al recalibrar,afuente aplicador estroncio-90 " Beta", encontramos que ista tenia una calibraci6n antigua, que difere de la nueva por apraximadamente un 68%. Esto significa que a usted se le administr6 un 68% por encima de lo recetado. Le informamos este hecho, aan cuando entendemos que en su caso no tuvo efectos negativos.
o Estamos solicitando que pase por la opcina del Dr. Luis Alcard:, Oftalm6 Logo, ubicada en la Calle Munoz Rivera 18-A, en AguadRa, para un breve examen para determinar su condici6n. el cual serd libre de costo alpresentar esta carta. Para verificar diasy horas laborables, favor comunicarse a la oficina antes indicada al 882-4322.
Si desea una copia del informe sometido a la United States Nuclear Regulatory Commission (NRC)relacionado con esto, puede solicitarla a nuestra opcina.
i Cordialmente, i
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Sr. oberto aiz se.i, MHSA l
Ad sinistra I
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WHAT IS THE PROBLEM - EXTENT OF MISADMINISTRATIONS l
Incorrect radiation dose delivered 810 times between 1990 and 1995 518 administrations were less dose than prescribed (underdoses) 292 administrations were more dose than prescribed (overdoses)
Greatest risk of inadequate patient followup is with overdoses.
NRC proposed patient population for foc wvp:
-41 patients overdosed (By Dr. Luu %szquez) 1 patient overdosed (By Dr. Fern 6ndez at V6zquez Clinic) 192 patients overdosed (By Dr. Joss L. Fem 6ndez) 1 patient overdosed (By Dr. RaulP4rez at Dr. Fern 6ndez Office) 234' TOTAL
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1 l-2 1
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' The right totalis not 235 because one patient was common to both places.
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