ML20126M212

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Response to Appeal of Denial of Portions of Record Requested Per Foia.Grants Appeal
ML20126M212
Person / Time
Issue date: 07/06/1992
From: Thompson H
NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To: Desiree Davis
PLAIN DEALER, CLEVELAND, OH
References
FOIA-92-176 NUDOCS 9301080234
Download: ML20126M212 (1)


Text

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    • "* JUL 0 1992 Mr. Dave Davis IN RESPONSE REFER The Plain Dealer TO F01A-92-A-5 1801 Superior Avenue (F01A-92-176)

Cleveland, OH 44114

Dear Mr. Davis:

I am responding to your letter dated May 13, 1992, in which you appealed Mr. Donnie Grimsley's response dated May 5, 1992. Mr. Grimsley's response denied portions of a record and its attachment, identified on the enclosed appendix, which were subject to your Freedom of Information Act request for records related to the death of a patient, and overexposures of patients, at Riverside Methodist liospital in Columbus, Ohio, in the 1970s.

Acting on your appeal, I have carefully reviewed the record in this case and have determined that the previously withheld information can now be made publicly available. Your appeal is, therefore, granted.

The record and its attachment are enclosed.

Sine rely,

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M L. Thompso@, 7 J]

D'ty ty Executi >

re tor for Nuclear Materi s afety, Safeguards and Operations pport

Enclosures:

1. Appendix
2. Record and attachment 9301080234 920706

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FsESPONSE TO FREEDOM OF xx1 sir at I _ le*atiat INFORMATION ACT (FOlA) REQUEST o^it (e..s e MAY - 5 1992 UOCn ti kuust R(su ve weaa. net stout $1tR Dave Davis PART l.-AGE NCY RECORDS RE LL ASE D OR NOT LOCAT ED Gee checA ccf bosest i No arncy records swt. sect to the request have been located. l No additional agency records subject to the request have been located. --i '

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Requested rnores are available through another pubhc distribution progrom. see Comments section.

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Agency records subject to the request that ere ksentified in Appendialest are alreefy available for pubhc livspation and copying at the NRC Pubhc Document Rcram. 2120 L street N.W., Wadangton. DC.

p Agency records subs e ct to the request that are bentified in Apperdis(est A are be,ng m,$e ava,iabie for pubhe ins,.ction .nd copy,n, et the NRC Pubhc Document Room,21?O L street. N W., Washington, DC. in a folder under this FOIA number.

The nonproprietary verton of the propot.at(s) that vou agreed to accept m a telephone conversation with a member of rny staff is now being made available for pubbt snspection and copying at the NRC Pubhc Document Room 2120 L street, N.W., Wnhington, DC, in a folder urder this FOl A number.

Agency retords subject to the request that are identified in Appendia(es) may be inspected ar[ copied at tS NRC Local Pubhc Document Room identihed in the Comments section, inclosed es information on how you may obtain a'. cess to ead the charrs for copyirig records located et the NRC Publ6c Document Room,2 20 L Street, N W , Washington, DC, g Agency records subject to the request are enclosed

  • Records sutyect to the request have been referred to another Federsi agencylies) for review and direct response to you, fees You wit! be billed by the NHC for fees tetahng $

You weil receive a refund from the NRC in 'he amnunt of s in view of NRC's resrnme to th s request, no further action is being taken on appesi letter dated , No PART tl. A-INFORMATION WITHHELD F ROM PUBLIC OISCLOSURL Certain informanon in the reovested records is being aiibbeid from pubiic di.cioivre oursuant to the e..mptions described in and vor ise riosons steied _

in P8rt il, B C, and D, Any retened portions of the documents for which only part of the record is being withheld are being made avaitable for public enspection and copying 6n the NRC Pubhc Document Room. 7170 L Street N W , Weshington. DC 6n a folder under this Fol A number, COMME NT s

  • Agency records subject to your F01 A request that are identified on the enclosed Appendix A and the releasable portions of the record identified on the enclosed Appenaix B are enclosed.

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. . itLSPONSE 101 HELDOM OF INFORMATION ACT (FOI A) flEQUEST FOlA 92-176 m 51992 ICONTINUAT60NI PAQT I B APeticoOtt t xt urteoNs B

Qecords subject to the request that are descr6t,*d in the ersclosed AMendiatest are Laeing withheld in their entirety or In part under the I E momption No.ts) and for the reasontal gwen t.eiove pursuent to b U S C. f,57(b) and 10 CF R 917(e) of NRC regulations.

1 ite wahhow mf ameien is swovetty tiespfe$ surtwrit le (nowtive Orser. ((sempeon 1)

2. The .nhield in8o,meten eeleies soielv to the cieeial gerearrel tulee s'id twot edises of HRC (t sempton 2)

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l Satwn 147 e i .t Aiom.c tner, Act, wwwi puhnats it. dwooose of U,iseer* ed Se'epted, inso<meeen 14i UAc. 31$71.

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LintR PART I C-otNYING OFF6CIALS Pwivent to to CF R 9 mbi ami e 9 M,tii C ine U $ %c = e' Peeweiory Comm*vn resysooro it het t>een privm.ned that the *rdoematen .ithtwie se esempt t om pro duc .on ce disciowe est that ai roducbon o< d sciciv e 4 com<se y to the pubi c .nterest T he personi respons,tne to< the demei ve those of te e s seemit;ed beto. en oenvine vt.c.ri sno the o. recto,, o.. on os r reeoom v tedwn et on ead evutuoom se..en of f.re of Aamia.menon. to' en, oemri thet mae ta sores.ed to the t uevo,e o .ecio.

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Ot NVING Of fiCIAL tif tt '08 hC E #tCORDS OtNilD A ppt LL A f t OF F 6CI AL T5iiBEaTAdministrator im % tm o Mr. Bert Davis Appendix B XX

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PART I 0- APPEAL RIGHTS n,e sen,ei e, e-h ...,,, ou .de...ed ,n P..i n C m., t.e epowea in ihe Awne on.c .i eeued u.e.e. A,,, ,,h ,~ be made in .,nm. ..n 30 de,, e ,.

of this inponn. Apows evet be addren.s. ei oppoonete. to the I ucuuve Drector our oseeet.ons. to ihe seevetarv ett he Commision ce to it. Imc ciar Generei. U $. Nacioar Rco,ietory Comm>ia.on. *e .h.ngton. DC 70%5. e<=J thovid tieerty etste on the eavvoce end m ihe isttee that n is an Apress from en initial F oi A Dec iion."

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Appendix B F01A-92-176 To be withheld in part Date  : ascription _

. 07/29/77 Letter enclosing a copy of a report by NRC medical con 5Jltant (6p8925) - - - - - -

Exemption 6

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RE: FOIA-92-A-5 (F01A-92-176)-

1. 7/29/77 Letter from James report prepared by Dr. Keppler to Dr. William Eugene Saenger. Adrion,) attaching-(6 pages 4

! 21C6946366 P.D /SUBLRD M ICPT. F-004 T-930 P-002 APR 06 '92 17 G l

- se b c THE PLAIN DEALER omo's LAmstnt hewsPAPen 216 344 4500

  • I E Otto TOtirntf cLrVtLAND. OHIO dello 00 4 362-o727 FREE 00W 0F INFORMATION Y

April 6 1992 fwA-ec-ir c.

Hr. Donnie Grimstey SC h 7-7-g '

Director F0IA and Publication Services U.S. Nuclear Regulatory Commission _

Washington, D.C. 0055$

FAX: 301-492-4994 Dear Mr. Grimslaye Under the provisions of the federal Freedom of Information Acto I request that your office crevide copies of the following documents:

11. A July 11 1977, report by an NRC medical consultant which characterlied the '

death of a patient at Riverside Methodist Hospital, Columbusi Ohio, as radiation pneumonitis.

2). The NRC investigation report, n.ade public about August 18, 1976, into the over-exposures of hundreds of patients at Riverside Methodist Hospital, Columbus, Ohio in the 1970s.

As a reporter for The Plain Dealer, I ask that you waive any search or copying fees.

I creatly appreciate your help in obtaining this information. I can be reached at 216- i 344-4808 with questions.

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, Dave Davis

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-i July 29, 1977 l

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Franklin County Coroner'a' Office - - - - -.!

ATTN: Dr. Willian Adrios j Coroner- j 520 Elas Avemos Colisabes, 05 41310 l

Dear Dr. Adrios:

Enclosed is a copy of a roport prepared by Dr. Bogene L. Saenger t

concerning Columbus,'Chio, who died at.

Riverside Nethodist Boopital, Columbus,~ Ohio, em December 30,-1975.

As you are aware, Dr. Saenger is the NRC's Medical Consultaat.

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l . James 0. Kapplar Director

'i Encioeuros j- Hedical Report l

cc w/ enclosures

. Mr. - James Flynn, Associate -

' Administrator Riverside'Hathodist Hospital Central _. Files -

Information in this record was deleted i

-in accordance with the Freedom of informatiQn, Act, exemptions ' 4 F0IA ~ PA-M4 n111/I'fA7 rarig/ .

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- REPORT Of Eugene L. $senger, M.D.

University of Cincinnati Hedical Consultant Nuclear Regulatory Commission r

1. Clinical course 25 year old presnant femals'who entered-Riverside Methodist Hospital for final admission on December 1,1975land died on December 30,-1975.

The patient noted a lump in her neck in February 1975. The diagnosis of Hodgkin's disease was made in September 1975 and was consider,ed to be limited to the neck. On September 9,1975 abdominal exploration, liver biopsy and splenectomy revealed no evidence of Hodgkin's disease in- the 1

abdomen. g q gg $was,]approxima telyA4j.1/2. mon ths .- pregnant.* R5dia tion therapy was begun on-September 30, 1975' and concluded on October.31, 1975. Treatment was planned to the mediastinum, bilateral supracla-vicular, and axillary areas and the neck - a mantle technique using Cobalt 60 teletherapy. There were 19 treatments administered in 33 days and the doses initially calculated and subsequently recalculated are

.-shown i'n the following' table:

~

Total Doses to Treatment Areas (rads)

Hedias'tinum . Supraclavicular- Axillary Initial Calculated dose (10-31-75) 3420 3708 3519L 4

' Recalculated dose (6-8-76)- 4708 5546 -4314

, Ratio of Recalculated to initial dose 1.38 1.5 1.22-4 9 N

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  • At the beginning' of t reatment , September 30, 1975, the position of trinner. blocks to protect the lungs was checked by port films and appeared "essintially correct". Midway. through treatment, October 15, the patient complained of severe sore throat and increased nausea. On examination "her throat still appears markedly reddened and there are areas of patchy pseudomucinous formation". On a follow-up visit of November 2),1975, she developed a severe skin reaction over the upper portion of the mantle field af ter October 31 but the skin peeled and at that visit looked " virtually normal". "Overall she is doins well with good' appetite and slow weight gain".

Seven days prior to her final admission on December 1 she noted Bradual onset of progressive dyspnea and non-productive cough with substernal pleuritic chest pain. 09 the r day af ter admission *she spontaneou s y.m..s [ X.1 abbr [ed 'a 7 1/2 month fetus, s

11er. subsequent course was steadily downhill with increasing res-piratory difficulty, characteristic of a severe form of the adult respiratory distrew syndrome (llopewell and Murry, Ann. Rev. Hed.1976).

There was increasing abnormalities of blood gases and increasing pul-monary infiltrates by x-ray culminating in bilateral pneumothoraces. On the third hospital day there was clinical evidence of thrombophlebitis of the 'lef t lower extremity and laboratory evidence of pulmonary emboli.

In spite of vigorous therapy directed to the many manif estations of respiratory difficulty the patient failed to respond. Death occurred-December 30,1975 which was 92 days from the beginnies of radiation therapy andf60 da~ysifrod'its completion. ,

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A copy of ths necropsy record-of -the patient- f roa the Departnent ofi

> Pathology,- Riversids Hethodist- Hospital-is cpperidad (cttcchmant '1) .

2. Evaluation of the clinical course and autopsy findings ne rapidly progressing course involving primarily the lungs leading to death'within 60 days af ter completion of treatment is char- -- m. .

acteristic of a savare reaction to ionizing radiation. As_noted by Rubin and Casarett the typical acute response begins af ter a latent period of weeks to months before the onset of symptoms and signs. ney further state that typically the onset occurs one to three months af ter the completion of a four to six week course of x-irrad.iation (Rubin-and Casarret, p. 423). An earlier report of Whitfield, Bond and Arnott-(Quart. J. Hed. New Series 25: 67-86,1956) lists 3 cases of Bodgkin's disease with very similar courses and f atal outcomes in which deep x-ray .

therapy was used. Radiographic changes were similar to those experienced i ase. Schwarz, Whitcomb and Goldman (Chest 64: 88-93, 1973) describe similar roentgenographic changes including the - f act that radiographic changes can extend beyond the confines of the, treatment portals.

In his review of this case, Clarence C. - Lushbaugh, H.D. of-Oak Ridge Associated Universities, our consulting pathologist,' described as-r the cause of death "the severe pneumonitis which at the time of her death was actively extending, undergoing scarring and progressively thickening alveolar walls and filling alveolar spaces with cellular

-_d-tritis , multinucleated giant epithelial cells, masses = of . loose ep-ithelium, macrophages, pr einaceous edema fluid and mucin".

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Lushbaut.h' continues As follows: "h'n i l e it 25 true that sections fros-the periphery of the lungs are not as extensively involved as the more hilar ones, the'y have increased fibrosis and even in atelectatic areas

-have not collapsed normally. 1here is also pleural fibrosis...". 4 The rapid termination of life with severe pulmonary involvement i-following so quickly the radiation therapy given at an excessively high ,

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dose indicate that her death was due to acute radiation pneumonitis.

Eugene L. Saenger, M.D.

Medical Consultant -

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.c i Franklin County Coroner's Office i ATTE: Dr. William Adrion

Coroner

$20 King Avemos-Columbus 05- 41310 Dear Dr. Adrion Enclosed is a copy of a-report prepared by Dr. Eugene L. Saenger.

concerning Mrs. Edna Gail Valentine f ' Columbus, Ohio, who'.' died : st Riverside Hethodist Hospital, Columbus, Chio, on December 30, 1975..

As you are aware, Dr. Seengar is the NRC's Medisal Consultant.

Sincerely, i

James G.-Kappler Director Esclosure Medical Report ec v/enclosureb

-Mr. James:Flynn, Associate Administrator

-Riverside Methodist Hospital -

Central Files .;

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REPORT- ON' MRS. EDRA GAIL VALENTINE--

Eugene L. Saenger, M.D.

University of Cincinnati Medical Consultan*,

Nuclear Regulatory Commission

1. Clinical Course a 25 year old pregnant female who entered

[ krs. Edna Gail Valentine Riverside Methodist Hospital for final admission on December 1, 1975 and died on December 30, 1975.

The patient noted -a lump.in her neck in February 1975. The' diagnosis of Hodgkin's disease was' made in September 1975 and was considered to be limited to the neck. On September 9,1975 abdominal exploration, liver biopsy and splenectomy revealed no evidence of Hodgkin's disease in the abdomen. The patient.was approximately 41/2 months pregnant. Radiation therapy was begun on September 30 1975 and concluded on October 31, 1?75. Treatment was planned to the mediastinum, bilateral supracla-

-vicular, and axillary areas and the: neck--'a mantic technique using.

Cobalt 60 teletherapy. There were 19 treatments administered in 33 days and . the doses initially calculated and subsequently recalculated are -

shown in the following table:

+

Total Doses to Treatment Areas (rads)

~

Mediastinum Supraclavicular ~ Axi11ary

. Initial Calculated dose-(10-31-75) '3420 3708 35191

' Recalculated dose (6-8-76) -4708 5546 4314-Ratio of Recalculated to initial dose 1.38- 1.5 .'1.22 ;

S

'At the beginning'of treatment, ^$eptember 30, 1975, the position of

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_ trimmer blocks to protect the lungs was checked by port films and appeared " essentially correct". Midway through treatment, October 15, ,

the patient complained of severe sore throat and increased nausea. On examination "her throat still appears markedly reddened and there are arcar of patchy pseudomucinous formation". On a follow-up visit of November 24, 1975, she developed a severe skin reaction over the upper portion of the mantle field after October 31 but the skin peeled and at- a that visit looked " virtually normal", "Overall she is doing well with good appetite and slow weight gain".

Seven days prior to her final admission on December 1 she noted gradual onset of progressive dyspnea and non-productive cough with  :

substernal pleuritic chest pain. -On the day after admission he spontaneou ly aborted a 71/2 month fetus.

Her, subsequent course was steadily downhill with increaring res-piratory difficulty, characteristic of a severe form of the adult respiratory distress syndrome (Hopewell and Murry, Ann. Rev. Hed. '1976).

There vas-increasing abnormalities of blood gases and increasing pul-

- monary infiltrates by x-ray culminating in bilateral pneumothoraces. On the- third hospital day there was clinicc.1 evident.e of thrombophlebitis .

of the 'lef t lower extremity and laboratory evidence of pulmonary emboli.

In spite of vigorous therapy directed to the many manifestations of respiratory difficulty the patient failed to respond. Death occurred December 30, 1975 which was 92 days from the beginning of radiation therapy and 60 days from its completion.

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o A copy of the.necropsy record of the patient from the Department of Pathology, Riverside Methodist Hospital is appended (attachment 1).

2. Evaluation of the clinical course and autopsy findings The rapidly progressing course involving primarily the lungs

-leading to death within 60 days af ter completion of treatment is char-acteristic of a severe reaction to ionizing radiation. As noted by-Rubin and Casarett the typical acute response begins after a latent ,

period of weeks to months before the onset of symptoms and signs. They further state that typically the onset occurs one to three months after the completion of a four to six week course of x-irradiation (Rubin'and Casarret, p . 4 2 3) . An earlier report of Whitfield, Bond and Arnott (Quart. J. Med. New Series 25: 67-86,1956) lists 3 cases of Hodgkin's disease with very similar courses and f atal outcomcs in 'which deep x-ray therapy was used. Radiographic changes were similar to those experienced in Mrs. Valentine's case. Schwarz, Whitcomb and Goldman (Chest 64: 88-93, 1973) describe similar roentgenographic changes including the- f act that radiographic changes can extend beyond the confines of the treatment portals.

In his review of this case, Clarence C. Lushbaugh, M.D. of Oak Ridge A' s cociated Universities, our consulting pathologist, described as

'the cause of death "the severe pneumonitis which at the time of her death was actively extending, undergoing scarring and progressively thickening alveolar walls and filling alveolar spaces with cellular detritis , multinucleated giant . epithelial cells, masses of loose ep-ithelium, macrophages, proteincceous edema fluid and mucin".

Lushba' ugh continues as follows: "While it is true that 3.ctions from the' periphery of the lungs are not as extensively _ involved as the more

' hilar ones, the'y have increased fibrosis and even in atelectatic areas

'have_not collapsed normally.- There is also pleural fibrosis...".

The rapid termination of life with severe pu)monary involvement following so quickly the radiation therapy given at an excessively high - .

dose indicate that her death was due to acute radiation pneumonitis. .  :

Eugene L. Saenger, M.D.

Medical Cca.ultant

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-REFERENCES Hopewell PC, Murray JF: The Adult Respiratory Distress _ Syndrome, in Annual Review of Medicine: Selected Topics in the Clinical Sciences,

- W.P. Creger, ed. , Annual Reviews, Inc. , Palo Alto California, Vol. 27, 1976.

Rubin P, Casarett GW; Clinical Radiation Pathology, W.B. Saunders Company, Vol. 1, 1968.

-Whitfield AGW, Bond Wil, Arnott WM; Aadiation Reactions in the Lung, Quarterly Journal _of Medicine, New Series XXV, No. 97, January 1956.

Schwarz HI, Whitcomb HE, Goldman AL; The Spectrum of Dif fuse Pulmonary Infiltration in Halignant Disease, Chest, Vol. 64, No.1, July 1973.

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